Clayton Robertson - The Trout Group Christopher Missling - President and Chief Executive Officer Sandra Boenisch - Principal Financial Officer.

Jason Helfstein - Oppenheimer Caroline Palomeque - NOBLE Life Science.

Good afternoon. My name Michelle and I will be your conference operator today. Welcome to the Anavex Life Sciences Fiscal Year 2017 Result Conference Call. As a reminder, this conference is being recorded. I would now like to introduce your host for today’s conference Clayton Robertson of The Trout Group. Please go ahead, sir..

Thank you, and good afternoon everyone. We appreciate you joining us today for Anavex Life Sciences conference call and webcast. Our agenda is to review the company’s financial results for fiscal year 2017 and to highlight some key corporate developments.

A taped replay of this call will be available approximately two hours after the call’s conclusion and will remain available for two weeks. 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. Before we begin, please note that during the course of 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 Form’s 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 to 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. With that, I’d like to turn the call over to Dr. Missling..

Thank you, Clayton. I’d like to thank everyone for joining us today’s conference call to review our financial results and clinical progress. I am pleased to have the opportunity to share our exciting accomplishments from 2017, and give you a sense of some key milestones to look forward to in 2018.

Anavex Life Sciences is a clinical stage biotechnology company, focused on developing effective targeted therapies for the treatment of neurodevelopmental and neurodegenerative diseases under the precision medicine paradigm. This entails applying to a targeted treatment approach, genomics data and algorithm analysis.

Our lead compound is ANAVEX 2-73, an orally available small molecule activator of the sigma-1 receptor. Through the sigma-1 receptor activation, ANAVEX 2-73 helps to restore cellular homeostasis in both neurodegenerative diseases and neurodevelopmental diseases.

This includes reducing protein misfolding, mitochondrial dysfunction, oxidative stress, and inflammation, as well as modulating calcium and providing neuroprotection.

Last month at CTAD, Anavex presented pharmacokinetic and pharmacodynamic data from our Phase 2a clinical trial and Phase 2a extension trial with ANAVEX 2-73 in Alzheimer’s Disease, as well as ongoing favorable safety data. We are advancing ANAVEX 2-73 into a Phase 2/3 study in Alzheimer’s disease.

Extensive analysis of Phase 2a data, including the integration of genome sequencing information from the patients treated with ANAVEX 2-73 has been performed in order to understand the trial parameters, which should help to increase the odds of late stage trial success.

We are currently in the process of making the necessary regulatory submissions for the Phase 2/3 trial, which we expect will be completed within the upcoming quarter. A brief word about Alzheimer’s disease. A very recent study supported by the National Institute of Health, NIH, indicates that the number of people in the U.S.

population with Alzheimer’s, an estimated 6 million adults is anticipated to more than double by 2060 that is an increase to 15 million by 2060.

In addition to the advancement of ANAVEX 2-73 for Alzheimer’s disease, we have continued to make significant progress in ANAVEX 2-73 for other targeted and genetically caused indications, especially in Rett syndrome and Parkinson Disease.

Rett syndrome is a severe neurological disorder caused by mutations in the X-linked gene MECP2, methyl-CpG-binding protein 2.

We recently filed an IND for ANAVEX 2-73 in Rett syndrome, and we are currently expecting feedback from the FDA to finalize the clinical trial protocol for this study, which will be a 12-week randomized double-blind placebo controlled study.

As start-up activities with clinical trial sites have been underway, we anticipate dosing of the first patient in due course following FDA approval of the IND. ANAVEX 2-73 has been granted orphan drug designation by the FDA.

In May of this year, we reported additional pre-clinical data for ANAVEX 2-73 from an experiment sponsored by the Rett syndrome.org foundation. The additional pre-clinical study support progressing into clinical study for Rett syndrome.

As previously reported, Rettsyn.org has committed a financial ground of a minimum of $600,000 towards the cost of the planned U.S. multi-center study. A brief word about Rett syndrome.

Rett syndrome is a rare X-linked genetic neurological and developmental disorder that affects the way the brain develops, including protein description, which is altered and as a result leads to severe disruption in neural homeostasis. It is a rare progressive neurodevelopmental disorder and is caused by a single mutation in the MECP2 gene.

The mutation is X-linked. Since males have only one X-chromosome where females have two, males who have the genetic MECP2 mutation are affected in devastating ways, most die before birth or in early infancy. For females, who survive infancy, Rett syndrome leads to severe impairments affecting nearly every aspect of the child’s life.

That is severe cognitive impairment, inability to speak, walk or eat without the use of feeding tube, as well as sleeping problems and seizures. Rett syndrome affects approximately one in every 10,000 to 15,000 females.

For Parkinson’s disease, in October, we announced additional data for ANAVEX 2-73 in a model for experimental parkinsonism at The Michael Fox Foundation’s Parkinson’s Disease Therapeutics Conference. The encouraging results gathered further supported the notion that ANAVEX 2-73 is a promising clinical candidate for Parkinson’s disease.

The company is planning to file an upcoming clinical trial application, CTA with European regulatory authorities to conduct a Phase 2 trial for ANAVEX 2-73 in Parkinson’s disease in the randomized double-blind placebo controlled study.

Our team is prepared and excited to execute these studies in Rett syndrome, Alzheimer’s disease and Parkinson disease, all indications with high unmet medical need upon regulatory approval. In addition to these trials, we have made significant progress in other indications in 2017.

In October of this year, we announced the release of additional pre-clinical data related to multiple sclerosis. The data was presented in an oral presentation by Wayne State University School of Medicine. The data presented indicates that ANAVEX 2-73 may promote rate myelination in multiple sclerosis disease.

We also announced developments in ANAVEX 2-73 application to Angelman Syndrome and Fragile X Syndrome, both indications caused by underlying genetic mutations. In the study sponsored by the foundation for Angelman Syndrome, ANAVEX 2-73 was assessed in a mouse model for the development of autogenic seizures.

The results indicated that ANAVEX 2-73 administration significantly reduces autogenic induced seizures. Fragile X Syndrome, a single gene mutation of the FMR 1 gene, which is Fragile X mental retardation 1 gene is the most common form of inherited intellectual disability and the most frequent cause of autism.

In a study sponsored by Fraxa Research Foundation, a non-profit organization focused on finding a cure for Fragile X, data demonstrated that ANAVEX 2-73 restored hippocampal Brain-derived neurotrophic factor, BDNF expression to normal levels. BDNF under expression has been observed in many new developmental and new degenerative [ph] diseases.

BDNF signaling promotes maturation of both excitatory and inhibitory synopsis. Previously, ANAVEX 2-73 had demonstrated to significantly improve all behaviors tested in a Fragile X Syndrome Mouse Model, hypolocomotion, associated learning, and model [indiscernible].

We also committed to further progressing other compounds in our pipeline and we are making encouraging progress. In April, we presented new mechanism of action data related to the three ANAVEX compound, ANAVEX 2-73, ANAVEX 3-71, and ANAVEX 1-41. Finally, during fiscal year 2017, we have continued to strengthen our team. In May, we appointed Dr.

Emmanuel Fadiran, a Senior Vice President of Regulatory Affairs. Dr. Fadiran has 24 years of regulatory experience within the U.S. in Food and Drug Administration, FDA. Having held leadership positions at the FDA Center of Drug Evaluation and Research, CDER.

At this time, I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Anavex for a financial update..

Thank you, Christopher, good afternoon. During 2017, we maintained a strong balance sheet. Our cash resources at September 30, 2017 were $27.4 million as compared to $9.2 million on September 30, 2016. In addition, Anavex had working capital of $24.2 million on September 30, 2017, compared to $6.3 million on September 30, 2016.

We believe this is adequate cash resources to fund all our objectives beyond fiscal 2018 and we have no debt. We are entering fiscal 2018 with the strongest balance sheet in the history of the company.

As always, we continue to be prudent in controlling costs, working with foundations, and focusing our resources on advancing the most promising programs, which we believe will add value for the company and its shareholders. During the 2017 fiscal year, the company used $9 million in cash to fund operations.

This was in-line with the company’s cash utilization guidance after adjusting for research and development incentive income of $2 million. Operating expenses for fiscal 2017 were $15.7 million, which included $4.1 million in non-cash charges, compared to $15.6 million for the comparable period in fiscal year 2016.

We reported a 47% increase in research and development expenditures. The increase was primarily attributable to expenditures in connection with preparations for Phase 2 and Phase 2/3 clinical trials. The ongoing clinical trial extension and expanded preclinical work.

This increase in research and development expenditures was offset by a 40% decrease in general and administrative expenditures, which was associated with reduced professional fees, reduced one-time compensation related charges.

The net loss for the fiscal year was $13.5 million or $0.33 per share, compared to a net loss of $14.7 million, or $0.42 per share, for fiscal 2016. With that, I would like to turn the call back over to Christopher..

Thank you, Sandra. We are looking forward to 2018 to applying all diligent proprietary work, including the integration of genome sequencing information from patients treated with ANAVEX 2-73, which we expect will enable more robust regulatory submissions.

In summary, we are entering fiscal 2018 with our strongest balance sheet to date, which allows the company to carry out planned clinical studies for ANAVEX 2-73. This year has been an extraordinarily productive period for Anavex with advanced preparation underway for studies in Rett Syndrome, Alzheimer’s disease, and Parkinson’s disease.

All indications with high unmet medical need. The upcoming year will be focused on deploying key programs through clinical trials with the anticipation of a number of data readouts in 2018. We look forward to updating you as we advance our key programs. I would like now to open the call for questions. Operator, please go ahead..

Thank you, sir. [Operator Instructions] First question comes from Jason Helfstein from Oppenheimer. Your line is open sir..

Hi. Congrats on the progress and thanks for taking my questions. I'm curious about the open-label extension trial you have running in Alzheimer's, can you remind us when we might see data from that study and do you need that data before you meet with the FDA to discuss your next Alzheimer’s study..

The answer to both questions is that the data will be - the trial will be finished in end of 2018. It will be a full 104 weeks, plus a 57 week from the previous 002 study. So, total of three-year cumulated daily dosing of ANAVEX 2-73.

The answer to the second question is, we do not need that data or we do not have to wait for the end of that extension study to initiate a larger Alzheimer’s study. As a matter of fact, it will start before that trial will be finishing..

Okay, thank you.

And then, have you disclosed what types of patience you will be studying in your next Alzheimer’s trial, will there be mild-to-moderate and how many patients you are planning to enroll in your next trial?.

Yes. We did disclose at the CTAD conference that the inclusion will be patient with mild disease. We've found a correlation of stronger signal with the patients who had a milder disease stage than more severe stage. So, we will focus on mild patient.

The final calculation of the patient will depend, as you just heard, from the integration of the genomic data and that would lead them to the final number of patients in the Phase 2/3 study..

Okay great, thank you.

And then just on multiple sclerosis, it looks like you have some very interesting preclinical data, when should we expect to see you start a clinical trial in MF [ph]?.

We are moving forward with that program as well. We will update once we have better clarity on that in the close of the coming year..

Okay, great. Thanks again for taking my questions..

Thank you..

The next question in the queue comes from Caroline with NOBLE Life Science. Your line is open ma’am..

Hi. Thanks for taking the questions.

I just have a few questions about the Parkinson's disease, the Phase 2 trial in Parkinson’s, is that now going to be EU only or do you also plan on conducting trial in the United States?.

This will be now a European trial. We focus on one region that will be in Europe. It is not going to be a study large enough to require additional continents..

Okay, great.

And then just a quick follow-up, do you still expect the initiations to - of Rett syndrome and also Parkinson's to take place by the end of this year or is that also being pushed out until like maybe the first quarter of 2018 calendar?.

The IND was filed for Rett syndrome and we are expecting any day of the feedback from the agencies. So, theoretically this could become still a 2017 stop and the Parkinson will likely be a quarter in 2018 because the submission will be in early 2018 - in the first quarter 2018..

Okay, thank you..

Thank you..

And there are no other questions in the queue at this time..

Thank you all for participating in today's conference call. I hope you are as excited as we are about the great progress we have made, and the prospect for 2018. We will continue to work hard to advance our program and build shareholder value.

Should you need 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?.

Thank you, sir. Ladies and gentlemen this concludes your call today..