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Transcript - please let me know of any corrections before I update the compiled DD.

Anavex Life Sciences Corp. (AVXL) CEO Christopher Missling on Q4 2018 Results - Earnings Call Transcript Dec. 12, 2018 11:55 PM ET

Executives
Scott Gordon - IR
Christopher Missling - President & CEO
Sandra Boenisch - Principal Financial Officer
Analysts

Operator


Good afternoon my name is Darryl, and I will be your conference call operator today. Welcome to the Anavex Life Sciences 2018 Fiscal Year End Financial Results Conference Call. As a reminder this conference call is being recorded.
I will now like to introduce your host for today's conference, Scott Gordon. Please go ahead.

Scott Gordon

Thank you, Darryl, and good afternoon everyone. We appreciate you joining us today for the Anavex Life Sciences conference call and webcast. Our agenda is to review the Company's financial results for 2018 fiscal year end, provide a clinical study update and highlight recent corporate developments. A taped replay of this call will be available approximately two hours after the call's conclusion and will remain available for one month. The call will also be available for replay on Anavex's website at www.anavex.com.

With us today is Dr. Christopher Missling, President and Chief Executive Officer; and Sandra Boenisch, Principal Financial Officer. Dr. Missling and Ms. Boenisch will make prepared remarks, and then we will take questions from equity analysts.

Before we begin, please note that during this conference call, the Company will make some projections and forward-looking statements regarding future events. 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. These factors may include without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of the clinical trials or regulatory approvals, need and ability to obtain future capital and maintenance of intellectual property rights.

And with that, I would now like to turn the call over to Dr. Missling.

Christopher Missling

Thank you. I'd like to thank everyone for joining us on today's conference call to review our full year 2018 financial results and share with you our clinical updates for ANAVEX2-73.

First, we were pleased to report that we have successfully activated 100% of all planned clinical study sites representing 20 clinical trial sites for the Phase 2 ANAVEX2-73 Parkinson disease dementia study. Enrollment and dosing of patients is currently proceeding as planned. The company has also successfully activated 75% of all planned clinical study sites representing 9 clinical trial sites for the Phase 2b/3 ANAVEX2-73 Alzheimer disease study. Enrollment and dosing of patients is currently proceeding as planned. Regarding the Rett Syndrome first study in humans, we successfully initiated the first clinical trial site for the study and expect to add further planned study sites and to enroll the first patient within a short period of time.

Last month Anavex announced the appointment of Dag Aarsland, MD, PhD to it's Scientific Advisory Board. Dr. Aarsland is a distinguished researcher for clinical treatment of Parkinson's disease dementia. Anavex had recently announced that it has enrolled the first patient in it's Phase 2 double-blind randomized placebo-controlled 14-week safety and efficacy trial of ANAVEX2-73 for the treatment of Parkinson's disease dementia. The Phase 2 study will enroll approximately 120 patients randomized 1-21-21 [ph] to two different ANAVEX2-73 doses or placebo. Previously, Anavex announced that it had enrolled it's first patient in it's Phase 2b/3 double-blind randomized placebo-controlled 48-week safety and efficacy trial of ANAVEX2-73 for the treatment of early Alzheimer disease. The Phase 2b/3 trial will enroll approximately 450 patients randomized 1-21-21 [ph] to different ANAVEX2-73 doses or placebo.

In October Anavex presented new clinical data for ANAVEX2-73 in our presentation at the 2018 clinical trials on Alzheimer disease CTAP meeting. At 148 weeks into the 5-year extended Phase 2a clinical study of ANAVEX2-73, data confirmed a significant association between ANAVEX2-73 concentration in both exploratory functional and cognitive endpoint as measured by the ADCLS-ADL [indiscernible] living evaluation, and the mini-mental state examination, MMSE, respectively. The genetic biomarker signal identified previously at week-57 of the study was also confirmed at week-148. The data identified genetic variance within the Sigma R1, and COMT genes with a significant impact on response of patients exposed to ANAVEX2-73, specifically the genomic biomarkers signal 1 and the direct -- which is the direct target of ANAVEX2-73, as well as COMT, a gene involved in memory function on the drug response level was identified leading to ANAVEX2-73 specific biomarker.

The impact on the drug response level of both Sigma R1 and COMT genomic biomarkers were significant with P-values smaller than 0.008 and P-value smaller than 0.0014 respectively. All forthcoming ANAVEX2-73 clinical study designs will incorporate the inclusion of these genomic precision medicine biomarkers identified in the ANAVEX2-73 Phase 2a study. We are very excited as we embark on this next phase clinical trials as this could be a unique differentiating factor for Anavex and that we are incorporating a precision medicine paradigm approach. Additionally, we continue to add staff members to our team so we can execute on our strategic objectives and meet our planned milestones.

And now I would like to direct you -- the call to Sandra Boenisch, Principal Financial Officer of Anavex for a brief financial update.

Sandra Boenisch


Thank you, Christopher and good afternoon. Our cash resources at September 30, 2018, were $22.9 million. We believe we are sufficiently capitalized to fund our objectives for the next two years given the support we received from the Australian Government and third-partners.

During 2018 we used $12.6 million in cash for operations. Operating expenses for the year were $19.3 million, which included $5.5 million in non-cash charges, compared to $15.7 million for 2017, inclusive of $4.1 million in non-cash charges. The increase in operating expenses is primarily attributable to an increase in research and development expenses of $2.7 million due to an increase in expenses incurred in connection with our recently commenced clinical trials including manufacturing costs and preparatory activities, as well as additions to our scientific team. The net loss for 2018 was $17.5 million or $0.39 per share, compared to a net loss of $13.5 million or $0.33 per share in 2017.

Thank you. And now I'll turn it back to Christopher.

Christopher Missling

Thank you, Sandra. In summary, we believe that 2019 will be a year of execution and we continue to maintain a strong balance sheet, which will allow us to execute the current clinical studies for ANAVEX2-73. We anticipated several key milestones and accomplishments in 2019 related to the three clinical studies utilizing a precision medicine approach. And we will provide enrollment information of the respective clinical studies in the near future. We look forward to updating you as advancements are made.
I would now like to open the call for questions. Operator, please go ahead.

Question-and-Answer Session


Operator


[Operator Instructions] And we do have a question from Ram Selvaraju [ph].

Unidentified Analyst

Regarding the Parkinson's disease positioning for 273, I was wondering if you could maybe frame for us a little bit more the specific opportunity as you see it? And how you view 273 fitting into the overall treatment continuum specifically with Parkinson's disease? And also, just a housekeeping item, could you update us on the current status of the ATM facility and whether or not you plan to utilize that at any point in the near-term? Thank you.

Christopher Missling


So the first question related to Parkinson's disease dementia; so Parkinson's disease is a disease of loss of dopaminergic cells in the brain and they cause the motor impairment of the patient, and that is getting worse with age. What has been now a very relatively successfully accomplished, a steady-state of dopa, L-dopa administration to patients which basically replaces the produced dopaminergic cells, and so outside L-dopa will cause the patient to not have too much of the movement impairment or delay that onset. It's not a disease qualifying approach but it's a temporary approach of addressing this disease. However, that also means that these patients will live longer and they have been identified that the Parkinson's disease patients will also eventually become cognitive impaired as they age; and that is now a significant unmet need in the Parkinson community because there is no treatment available for those patients. And we have currently 1 million patients in the U.S. alone with Parkinson's disease and that number is obviously much larger around the world. So this is addressing the first question.

I'd like also to add to that that ANAVEX2-73 has demonstrated in an animal model of Parkinsonian disease modification model which was a 6OHDA [ph] model, which is a very difficult model to have improvement in, where the animals are getting eradicated their dopaminergic region with a chemical and then hence are impaired with motor impairment, with significant motor impairment. ANAVEX2-73 treatment in these animals was able to a certain extent restore or meliorate [ph] the movement impairment. So we are now also looking in our study for the signal on motor impairment as a secondary endpoint. So we try to basically address the cognitive decline feature which is reaching almost 80% of all Parkinsonian patients, and also in parallel to that, however also the motor impairment. So that is important to appreciate in this study.

The second question regarding to the ATM, so the ATM6 potentially hit the market facility. We have a '18 market facility set-up which we have not yet used to-date, and we will not yet -- we have no plans yet to use it and it's really a facility for emergency or if the opportunity arises that we might utilize it but right now we have no plans to utilizing it as we speak since we have sufficient cash available right now in our balance sheet.

Unidentified Analyst

And then just a very quick follow-up on the Rett syndrome program; there were two items that I wanted to query you about. Regarding the therapeutic signature of 273 and in particular, I was curious to know your opinion on whether you had anticipate there being an impact of 273 on echnia [ph] in Rett syndrome patients? And secondarily, if again, within the treatment continuum you would envisage potentially there being the possibility of 273 being employed either as a standalone or as part of poly-pharmacy for example being combined with either of the experimental drugs that are also in late-stage testing for Rett syndrome, namely [indiscernible]?

Christopher Missling

Regarding the question in the echnia [ph] or the tautological [ph] signature; the ANAVEX2-73 has demonstrated the following phenotype improvements which are relevant for Rett syndrome, and is really no -- I would see sequence of priority here but one of the key features of the movement impairment and cognitive impairment, as well as seizures and anxiety, to certain extent also echnia [ph] and the preclinical animal studies which were in two different animal models showed that we have seen an improvement in motor impairment and improvement also in echnia [ph]. And in other animal models we saw an improvement in seizures and cognitive impairment and anxiety; so in a way, our compound has shown an independent tautological models, the ability to restore function in what causes the entire -- I would say Rett syndrome tautology, dysfunction or phenotype.

The second question about standalone or poly-pharmacy; obviously this is something which we have not yet decided to test it, because also it doesn't -- is not dependent on us, ourselves only because those drugs you mentioned still have to be concluded successfully in clinical studies, so that's one requirement. However, we do know from poly-pharmacy that we have relatively good sense about ability of being able to join existing treatment regiments and has been demonstrated in the Alzheimer study where Alzheimer patients [indiscernible] a lot of treatment regiments for other tautologies or insufficiencies like cardiovascular disease inefficiencies and other age-related insufficiencies. And we have not seen any problems with the administration of ANAVEX with patients receiving additional other medications.

Operator


And we have no more questions at this time. Wait, we do have a question from Caroline [ph].

Unidentified Analyst

Any updates on the genomic data and will you be having any other readouts come out either while the trails are ongoing? And then other question is on, can you update us anything -- any more enrollment number on the ongoing trail? Thanks.

Christopher Missling

So the first question about the genomic data, so all studies which we are now undergoing Alzheimer disease study, the Parkinson's disease dementia study and the Rett syndrome studies; they all require all the patients to get the entire genomic readout analyzed and this will be done throughout all the studies with all patients. We have not yet decided when to announce data but before we do that we would have to analyze that data. I suspect that this analysis of this gene data will be done in parallel with the analysis of the endpoints of the top line data readout, so I would expect that there might be a relevant information coming along the same timeframe.

Regarding the enrollment rate, we are very happy with the pickup on the sites on the enrollment and we will be able to share more specific and quantitative enrollment levels in the foreseeable future.

Operator


And it doesn't look like we have any more questions at this time. I'm going to go ahead and turn it back to Dr. Missling.

Christopher Missling

So, thank you for all the participating in today's conference call. I hope you are as excited as we are about the recent progress and the prospects for the year ahead. Should you need any additional information or have any questions, please visit our website at www.anavex.com or call or email us. This concludes our remarks for today, operator please.

Operator

And thank you, ladies and gentlemen, this concludes today's conference. Thank you for participating. You may now disconnect.




In Peace, In War
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