Thank you for joining the H.C. Wainwright Fifth Annual Neuro Perspectives Virtual Conference. My name is Kyle Murie, and I'm an analyst on the corporate access team. H.C. Wainwright is a full-service investment bank dedicated to providing corporate finance, strategic advisory, and related services to public and private companies across multiple sectors and regions. We have a total of 24 publishing senior analysts and over 650 companies covered across all sectors. If you would like more information, go check out our website, hcwco.com. From a logistics standpoint, please make sure to reference your virtual conference online portal that provides you your individual links to all your meetings and presentations. With that said, have a productive and enjoyable day. I'd like to introduce Christopher Missling, CEO of Anavex. Thank you.
Thank you for the kind introduction. I'd like to present to you Anavex Life Sciences. It's a public company, so I'd like you to read the forward-looking statement. Anavex is dedicated to pushing the boundaries of scientific discovery with novel oral small molecules tailored to potentially offer hope and relief. We're doing this in a majority of many diseases, but the most relevant one is right now Alzheimer's disease, which is experiencing an almost exponential increase in cases projected to be up to 150 million by 2050, with large amounts of cost, $20 trillion in cumulative cost from 2015 to 2050, and one in three Medicare dollars will be spent on Alzheimer's and other dementias in 2050. It's also expected that 11 million Americans are providing unpaid care for people with Alzheimer's. So we are addressing this very large market with our transformative precision medicine.
As a summary of Anavex, we are in the submission stage, a CNS company with a novel therapeutic system mechanism, which we will address in a minute. We are meeting also with regulatory bodies, authorities, to discuss our latest phase II/III study in Alzheimer's disease, in early Alzheimer's disease in the U.S. and abroad. Regarding the financial situation, we have estimated operations and clinical programs funding expected for the next four years, given our cash balance as of today, with no debt. We believe that our oral drug, blarcamesine, has demonstrated superior clinical safety and efficacy compared to the current antibodies Leqembi, lecanemab, and donanemab. Also, we slowed the neurodegeneration in Alzheimer's disease, which is unique for blarcamesine. We also have a very good IP protection plan for our drugs, and blarcamesine is given once daily oral, very convenient and scalable.
We not only have Alzheimer's disease as an indication. We also have other indications: Parkinson's and Parkinson's dementia. In the rare disease franchise, we have oral liquid formulation separating from the oral solid formulation. The most advanced indications so far are Rett syndrome. Fragile X is going to happen, is going to start this year. Also other indications like infantile spasms and Angelman syndrome are planned if we are moving forward based on the preclinical data which we have. But we also have another compound in our pipeline, which is called Anavex 3-71, where we started after successful phase I and safety data, a study in schizophrenia. It's a phase II study in schizophrenia, which is ongoing nicely.
In summary, our pipeline of orally administered candidates offers significant potential for clinical benefit relative to the costly and logistically challenging biologics, including antibodies, which also often present additional safety challenges which could be avoided with our drug. In a nutshell, the mechanism is an upstream mechanism, restoring neural homeostasis. Via a protein which is called sigma-1 receptor. And I'd like to share with you how this works in Alzheimer's specifically because it's the most relevant indication for the time being. The brain of the human brain has several constituents which are working against the survival of brain cells. One is aging, and the other one is neurotoxicity based on Alzheimer's pathology, for example, Aβ amyloid, tau, and tau.
The way the antibodies are treating so far is by removing the Aβ plaque by using an infusion of a monoclonal antibody, which then will try to capture the Aβ parts and remove them out of the brain. Conversely, with our oral once daily drug, blarcamesine, which is a simple once daily capsule, we are able to remove the Aβ and tau damage of the brain through autophagy activation, which happens through sigma- 1 activation. This is described as an upstream neuroprotection pathway. It's probably more elegant because it not only removes the Aβ and plaque and other features of pathology, but also repairs the system in the body and also regenerates the system.
In terms of the next steps of the company, I'd like to share with you that we are planning to release data, full data from the phase II/III Alzheimer's disease study in early Alzheimer's disease. We also are planning to submit a full submission for the drug for Alzheimer's disease for EMA, the European Medicines Agency. We also have data from the phase II/III study in Alzheimer's disease consisting of mRNA sequence, and this is expected by mid of this year. We also expect data from the open label extension study, which is a 96-week study of patients after the placebo control have completed, that they were able to join an open label study lasting 96 weeks. It's called the ATTENTION-AD study. We will report that this year as well.
Then we also are planning to start, initiate a Parkinson's disease study as well as a Fragile X study. Regarding Fragile X, you should expect additional biomarker data coming up of a confirmed biomarker which takes place or is observed in pathology both in humans and in animals in July next month. We're also expecting to start another rare disease which we have not disclosed. We're expecting further publications coming from Anavex. What's also intriguing, our pipeline products, blarcamesine and Anavex 3-71, have demonstrated not only a therapeutic effect but also a preventative effect in animal models. For the future, that is very intriguing to know. Let me now share with you the total pipeline in the overview slide, and it shows that it's a promising pipeline with progress towards commercialization.
And that's the direction the company is taking to also prepare for that eventually with a balanced portfolio of several compounds in the pipeline with different stages and with Anavex 3-71 emerging nicely with its first trial in schizophrenia, which is moving nicely and Anavex and complementing nicely blarcamesine's pipeline advanced level. Regarding the individual indications, I want to go quickly over them. We mentioned about Alzheimer's disease, a progressive neurological disorder, which is the most common cause of dementia. And it impacts families and almost at every aspect of a person's life as it progresses: short-term memory loss, confusion, difficult learning and new things, delusions, disorientation, the ability to recognize common things and people. And the current annual cost of dementia is estimated to be $1 trillion, a figure expected to double by 2030. And there are 35 million people today worldwide living with Alzheimer's disease.
In the U.S. alone, it's 6.9 million. We have done several studies already, a phase II study and a phase II/III study, and we are now in an open-label study, as we mentioned. Also nicely, Anavex 3-71 has demonstrated preclinically nicely clinical data, preclinical data confirming the effect also on Anavex 3-71. Regarding Parkinson's disease and Parkinson's dementia, Parkinson's disease is a disorder which has tremors and inability of moving. We have data in phase II in Parkinson's dementia, and we're planning now on Parkinson's disease dementia separately. Rare disease, Rett syndrome, we have completed three studies. Two were very successful. One was just missed one of the endpoints. We will move forward with a planned study to repeat that what we have missed using what we have learned, lessons learned going forward.
It's going to be a 12-week study as previously and making sure that we are avoiding what was the prior effect of a little bit too high placebo effect. We also have extremely encouraging long-term feedback from Rett syndrome, where patients have responded favorably about having been requesting to stay on study drug even after the placebo control study and even after the open label extension study, which we offered in all trials. We have now three jurisdictions, Canada, and the U.K. and Australia, where this compassionate use has been implemented for patients who continue to stay on blarcamesine. Some patients are now on blarcamesine over four years without interruption, demonstrating a resilience and an interest to stay on study drug and not to give it up. These are very sick patients.
So it is very intriguing that they are so interested in staying on blarcamesine because of the benefits which are described here briefly: improved mobility in some patients and reduction of seizures as well, which is part of the pathology. Now I'd like to move to the Alzheimer's study, which is the phase II/III study. The design was a 48-week study of three arms: a high-dose arm, target dose 50, a medium-dose arm, target dose 30, and a placebo arm. We had patients with Alzheimer's pathology confirmed in multiple ways, including Aβ status of the tau pathology. After the trial was completed, there was an open-label extension study of 96 weeks. We had in the design a co-primary endpoint of ADAS-Cog 13 and ADCS-ADL.
Just a few months ago, a guidance from the FDA came out in March explaining that for early Alzheimer's disease, the population of this trial, a functional measure, which is ADCS-ADL, is not warranted because of the low level of impairment in that domain. The only measure required for a primary endpoint will be a cognitive endpoint. That represents squarely ADAS-COG-13. We're very intrigued about these new guidelines because it would address our study's outcome very nicely. We also have additional biomarkers, including MRI and other biomarkers of Aβ 42/40, tau, and so forth, including genetic variant analysis, which can confirm the mechanism of action of the drug as well.
What I'd like to point out briefly is that the feature of this pathology in Alzheimer's disease is also very well described since the first time Alzheimer's disease was described by Alois Alzheimer, that the patient's brain is shrinking. The shrinking of the brain, which is called atrophy or brain volume loss, is clearly manifested in MRI images, as you can see in the slide. What's very intriguing is that in our study, we described or we noticed, and we were part of the disclosure when we come out, that in the regions of the brain which are related to cognition and function, that the shrinking of the brain was attenuated or delayed or even stopped. That's extremely encouraging because that's actually a sign of stopping the neurology of this disease.
In summary, I'd like to point out that Anavex blarcamesine advantage can be described as an oral administration drug, a good safety profile, novel target that impacts neurodegeneration described by the MRI stopping of the shrinking of the brain with promising clinical results, which will be released, as I mentioned, forthcoming. Also regarding the next positioning, the plans for positioning our data, we are now moving forward with discussing with payers and providers and advocacy groups this data. We also believe we have a very strong IP protection with our study drugs given our very strong IP protection philosophy to give us protection for the future. I also want to mention in all indications we have in our horizon at this point in time, these are all markets which are very large. Talk about not only Alzheimer's disease, but also Parkinson's disease.
Schizophrenia is 1.6 million patients in the U.S. We also have the rare disease franchise of frontotemporal dementia, Rett syndrome, and Fragile X syndrome. I want to point out that Fragile X is 6x the size of Rett syndrome. In regards to financial situation, we are comfortably having sufficient cash runway due to our disciplined operations and non-dilutive cash strategy by getting money from advocacy groups like Michael J. Fox Foundation and International Rett Syndrome Foundation, and also the Australian Government. That allows us to utilize efficiently our cash for the upcoming studies and progress. The last cash balance as of last March 31st was $139.4 million in cash without any debt. Last year, the entire year, fiscal year, we spent $27.8 million. It's going to be a little bit higher this year.
However, we are calculating the guiding cash amount utilization planned for this year that we still have enough runway at least for about four years. With this sustainable cash runway, we continue to move forward. I'd also like to mention that we are moving also forward with expanding the team, with providing the company with the right resources to move to the next stage of the company's evolution in terms of moving towards commercialization stage and using the expertise of people which we just hired. We hired three senior vice presidents, Juan Carlos Lopez-Talavera and Terrie Kellmeyer. We also hired a VP Clinical Pharmacology, Jeffrey Edwards, who are all very experienced in their job in expanding the horizon of the company to move forward.
I'd also like to point out Kun Jin's background as 27 years with the FDA, which gives us input into the regulatory side of things. Last but not least, I want to also mention that we have a strong scientific advisory board, which also is expanding. We just added Marwan Sabbagh as a lead as a chairman of the scientific advisory board. In total, I want to summarize our philosophy. The Anavex advantage is really the platform scalability, which allows for an equitable and accessible approach for diverse populations and maintains sustainability within the global healthcare system, which is a major concern today given the limited resources for the healthcare system. With that, I'll finish. I'd like to let you know, if you'd like to access further information, please go to our website at anavex.com and feel free to reach out to us.
Thank you for your attention.
Thank you, Christopher, for leading a very productive and informative presentation. We appreciate all the time and effort that went into putting this together. We're very grateful for your flexibility and presence at our conference this year. I just want to thank you again from the entire H.C. Wainwright team. Thank you as well.