ANAVEX LIFE SCIENCES CORP. Forward-Looking Statements
This Quarterly Report on Form 10-Q includes forward-looking statements. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our anticipated future clinical and regulatory milestone events, future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. The words "believe," "may," "estimate," "continue," "anticipate," "intend," "expect" "should," "forecast," "could," "suggest," "plan" and similar expressions, as they relate to us, are intended to identify forward-looking statements. Such forward-looking statements include, without limitation, statements regarding:
? volatility in our stock and in the markets in general;
? our ability to successfully conduct clinical and preclinical trials for
our product candidates;
? our ability to raise additional capital on favorable terms and the impact
of such activities on our stockholders and stock price;
? the impact of the COVID-19 outbreak and its effect on us;
? our ability to generate any revenue or to continue as a going concern;
? our ability to execute our research and development plan on time and on
budget;
? our products'' ability to demonstrate efficacy or an acceptable safety
profile of our product candidates;
? our ability to obtain the support of qualified scientific collaborators;
? our ability, whether alone or with commercial partners, to successfully
commercialize any of our product candidates that may be approved for sale;
? our ability to identify and obtain additional product candidates;
? our reliance on third parties in non-clinical and clinical studies;
? our ability to defend against product liability claims;
? our ability to safeguard against security breaches;
? our ability to obtain and maintain sufficient intellectual property
protection for our product candidates;
? our ability to comply with our intellectual property licensing agreements;
? our ability to defend against claims of intellectual property
infringement;
? our ability to comply with the maintenance requirements of the government
patent agencies;
? our ability to protect our intellectual property rights throughout the
world;
? competition;
? the anticipated start dates, durations and completion dates of our ongoing
and future clinical studies;
? the anticipated designs of our future clinical studies;
? the impact of fast track designation on receipt of actual FDA approval;
? our anticipated future regulatory submissions and our ability to receive
regulatory approvals to develop and market our product candidates,
including any orphan drug or fast track designations; and
? our anticipated future cash position.
We have based these forward-looking statements largely on our current
expectations and projections about future events, including the responses we
expect from the
19
As used in this Quarterly Report on Form 10-Q, the terms "we," "us," "our," and
"Anavex" mean
Our Current Business
Our lead compound, ANAVEX®2-73, is being developed to treat Alzheimer's disease, Parkinson's disease and potentially other central nervous system diseases, including rare diseases, such as Rett syndrome, a rare severe neurological monogenic disorder caused by mutations in the X-linked gene, methyl-CpG-binding protein 2 ("MECP2").
We currently have two core programs and two seed programs. Our core programs are at various stages of clinical and preclinical development, in neurodegenerative and neurodevelopmental diseases.
The following table summarizes key information about our programs:
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* = Orphan Drug Designation by the FDA; Dashed lines indicate planned clinical studies
Anavex has a portfolio of compounds varying in sigma-1 receptor (S1R) binding
activities. The SIGMAR1 gene encodes the S1R protein, which is an intracellular
chaperone protein with important roles in cellular communication. S1R is also
involved in transcriptional regulation at the nuclear envelope and restores
homeostasis and stimulates recovery of cell function when activated. In order to
validate the ability of our compounds to activate quantitatively the S1R, we
performed, in collaboration with
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Source: Reyes S et al., Sci Rep. 2021 Aug 25; 11(1):17150s
Cellular Homeostasis
Many diseases are possibly directly caused by chronic homeostatic imbalances or cellular stress of brain cells. In pediatric diseases like Rett syndrome or infantile spasms, the chronic cellular stress is possibly caused by the presence of a constant genetic mutation. In neurodegenerative diseases, such as Alzheimer's and Parkinson's diseases, chronic cellular stress is possibly caused by age-correlated buildup of cellular insult and hence chronic cellular stress. Specifically, defects in homeostasis of protein or ribonucleic acid ("RNA") lead to the death of neurons and dysfunction of the nervous system. The spreading of protein aggregates resulting in a proteinopathy, a characteristic finding in Alzheimer's and Parkinson's diseases that results from disorders of protein synthesis, trafficking, folding, processing or degradation in cells. The clearance of macromolecules in the brain is particularly susceptible to imbalances that result in aggregation and degeneration in nerve cells. For example, Alzheimer's disease pathology is characterized by the presence of amyloid plaques, neurofibrillary tangles, which are aggregates of hyperphosphorylated Tau protein that are a marker of other diseases known as tauopathies as well as inflammation of microglia. With the SIGMAR1 activation through SIGMAR1 agonists like ANAVEX®2-73, our approach is to restore cellular balance, i.e. homeostasis. Therapies that correct defects in cellular homeostasis might have the potential to halt or delay neurodevelopmental and neurodegenerative disease progression.
ANAVEX®2-73-specific Biomarkers
A full genomic analysis of Alzheimer's disease (AD) patients treated with ANAVEX®2-73 resulted in the identification of actionable genetic variants. A significant impact of the genomic biomarkers SIGMAR1, the direct target of ANAVEX®2-73 and COMT, a gene involved in memory function, on the drug response level was identified, leading to an early ANAVEX®2-73-specific biomarker hypothesis. It is expected that excluding patients with SIGMAR1 identified biomarker variant (approximately 10%-20% of the population) in prospective studies would identify approximately 80%-90% patients that would display clinically significant improved functional and cognitive scores.
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The consistency between the identified DNA and RNA data related to ANAVEX®2-73,
which are considered independent of AD pathology, as well as multiple endpoints
and time-points, provides support for precision medicine clinical development of
ANAVEX®2-73 by using genetic biomarkers identified within the study population
itself to target patients
Clinical Studies Overview Alzheimer's Disease
In
Two consecutive trial extensions for the Phase 2a trial have allowed
participants
A larger Phase 2b/3 double-blind, placebo-controlled study of ANAVEX®2-73 in
Alzheimer's disease commenced in
In
Rett Syndrome
In
In
22
The first Phase 2 study, (ANAVEX®2-73-RS-001), which took place in
The second, international study of ANAVEX®2-73 for the treatment of Rett
syndrome, called the AVATAR study, commenced in
The data of the AVATAR study was released in
In
Parkinson's Disease
In
In
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Within this study ANAVEX®2-73 was safe and well tolerated in oral doses up to
50mg once daily. The results show clinically meaningful, dose-dependent, and
statistically significant improvements in the
In
Frontotemporal Dementia
In
The Phase 1 clinical trial was a prospective double-blind, randomized, placebo-controlled study. A total of 36 healthy male and female subjects were included. Single escalating doses of ANAVEX®3-71 were administered in order to evaluate the safety, tolerability, and pharmacokinetics (PK) of ANAVEX®3-71 and the effects of food and gender on its PK in healthy volunteers.
The study met its primary and secondary endpoints of safety, with no serious adverse events (SAEs) or dose-limiting toxicities observed. ANAVEX®3-71 was well tolerated in all cohorts receiving ANAVEX®3-71 in single doses ranging from 5 mg to 200 mg daily with no SAEs and no significant lab abnormalities in any subject. In the study, ANAVEX®3-71 exhibited linear pharmacokinetics. Its pharmacokinetics was also dose proportional for doses up to 160 mg. Gender had no effect on the PK of the drug and food had no effect on the bioavailability of ANAVEX®3-71. The study also met the secondary objective of characterizing the effect of ANAVEX®3-71 on electrocardiogram (ECG) parameters. There were no clinically significant ECG parameters throughout the study. Participant QTcF measures were normal across all dose groups with no difference between ANAVEX®3-71 and placebo.
Based on these results, and ANAVEX®3-71 pre-clinical profile, the Company
intends to advance ANAVEX®3-71 into a biomarker-driven clinical development
dementia program for the treatment of FTD, schizophrenias and Alzheimer's
disease, evaluating longitudinal effect of treatment with ANAVEX®3-71. We
believe the results of these studies could serve as the basis for advancing into
respective registration studies in the
Our Pipeline
Our research and development pipeline includes ANAVEX®2-73 currently in three different clinical study indications, and several other compounds in different stages of clinical and pre-clinical study.
Our proprietary SIGMACEPTOR™ Discovery Platform produced small molecule drug candidates with unique modes of action, based on our understanding of sigma receptors. Sigma receptors may be targets for therapeutics to combat many human diseases, both of neurodegenerative nature, including Alzheimer's disease, as well as of neurodevelopmental nature, like Rett syndrome. When bound by the appropriate ligands, sigma receptors influence the functioning of multiple biochemical signals that are involved in the pathogenesis (origin or development) of disease. Multiple viruses including SARS-CoV-2 (COVID-19) induce cellular stress by intrinsic mitochondrial apoptosis and other related cellular processes, in order to ensure survival and replication. Hence, it is possible that S1R could play a role in modulating the cellular response to viral infection and ameliorate pathogenesis.
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Compounds that have been subjects of our research include the following:
ANAVEX®2-73 (blarcamesine)
ANAVEX®2-73 may offer a disease-modifying approach in neurodegenerative and neurodevelopmental diseases by activation of sigma-1 receptors.
In Rett syndrome, administration of ANAVEX®2-73 resulted in both significant and dose related improvements in an array of behavioral paradigms in the MECP2 HET Rett syndrome disease model. In addition, in a further experiment sponsored by Rettsyndrome.org, ANAVEX®2-73 was evaluated in automatic visual response and respiration tests in 7-month old mice, an age at which advanced pathology is evident. Vehicle-treated MECP2 mice demonstrated fewer automatic visual responses than wild-type mice. Treatment with ANAVEX®2-73 for four weeks significantly increased the automatic visual response in the MECP2 Rett syndrome disease mice. Additionally, chronic oral dosing daily for 6.5 weeks of ANAVEX®2-73 starting at ~5.5 weeks of age was conducted in the MECP2 HET Rett syndrome disease mouse model assessed the different aspects of muscular coordination, balance, motor learning and muscular strengths, some of the core deficits observed in Rett syndrome. Administration of ANAVEX®2-73 resulted in both significant and dose related improvements in an array of these behavioral paradigms in the MECP2 HET Rett syndrome disease model.
In
Further, in
For Parkinson's disease, data demonstrates significant improvements and
restoration of function in a disease modifying animal model of Parkinson's
disease. Significant improvements were seen on all measures tested: behavioral,
histopathological, and neuroinflammatory endpoints. In
The study found that ANAVEX®2-73 was safe and well tolerated in oral doses up to
50mg once daily. The results show clinically meaningful, dose-dependent, and
statistically significant improvements in the
In Alzheimer's disease (AD) animal models, ANAVEX®2-73 has shown pharmacological, histological and behavioral evidence as a potential neuroprotective, anti-amnesic, anti-convulsive and anti-depressive therapeutic agent, due to its potent affinity to sigma-1 receptors and moderate affinities to M1-4 type muscarinic receptors. In addition, ANAVEX®2-73 has shown a potential dual mechanism which may impact amyloid, tau pathology and inflammation. In a transgenic AD animal model Tg2576, ANAVEX®2-73 induced a statistically significant neuroprotective effect against the development of oxidative stress in the mouse brain, as well as significantly increased the expression of functional and synaptic plasticity markers that is apparently amyloid-beta independent. It also statistically alleviated the learning and memory deficits developed over time in the animals, regardless of sex, both in terms of spatial working memory and long-term spatial reference memory.
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Based on the results of pre-clinical testing, we initiated and completed a Phase 1 single ascending dose (SAD) clinical trial of ANAVEX®2-73. In this Phase 1 SAD trial, the maximum tolerated single dose was defined per protocol as 55-60 mg. This dose is above the equivalent dose shown to have positive effects in mouse models of AD. There were no significant changes in laboratory or electrocardiogram (ECG) parameters. ANAVEX®2-73 was well tolerated below the 55-60 mg dose with only mild adverse events in some subjects. Observed adverse events at doses above the maximum tolerated single dose included headache and dizziness, which were moderate in severity and reversible. These side effects are often seen with drugs that target CNS conditions, including AD.
In
In
ANAVEX®2-73 data presented met prerequisite information in order to progress
into a Phase 2b/3 placebo-controlled study. On
Preclinical data also validates ANAVEX®2-73 as a prospective platform drug for other neurodegenerative diseases beyond Alzheimer's disease, Parkinson's disease or Rett syndrome, more specifically, epilepsy, infantile spasms, Fragile X syndrome, Angelman syndrome, multiple sclerosis and, more recently, tuberous sclerosis complex (TSC). ANAVEX®2-73 demonstrated significant improvements in all of these indications in the respective preclinical animal models.
In a study sponsored by the
Preclinical data presented also indicates that ANAVEX®2-73 demonstrates protective effects of mitochondrial enzyme complexes during pathological conditions, which, if impaired, are believed to play a role in the pathogenesis of neurodegenerative and neurodevelopmental diseases.
Preclinical data on ANAVEX®2-73 related to multiple sclerosis indicates that ANAVEX®2-73 may promote remyelination in multiple sclerosis disease. Further, data also demonstrates that ANAVEX®2-73 provides protection for oligodendrocytes ("OL's") and oligodendrocyte precursor cells ("OPC's"), as well as central nervous system neurons in addition to helping repair by increasing OPC proliferation and maturation in tissue culture.
26
In
ANAVEX®3-71
ANAVEX®3-71 is a clinical drug candidate with a novel mechanism of action via sigma-1 receptor activation and M1 muscarinic allosteric modulation, which has been shown to enhance neuroprotection and cognition in Alzheimer's disease models. ANAVEX®3-71 is a CNS-penetrable potential disease modifying treatment for cognitive impairments. It is highly effective in very small doses against the major Alzheimer's hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also has beneficial effects on inflammation and mitochondrial dysfunctions. ANAVEX®3-71 indicates extensive therapeutic advantages in Alzheimer's and other protein-aggregation-related diseases given its ability to enhance neuroprotection and cognition via sigma-1 receptor activation and M1 muscarinic allosteric modulation.
A preclinical study examined the response of ANAVEX®3-71 in aged transgenic
animal models and showed a significant reduction in the rate of cognitive
deficit, amyloid beta pathology and inflammation with the administration of
ANAVEX 3-71. In
During pathological conditions ANAVEX®3-71 demonstrated the formation of new synapses between neurons (synaptogenesis) without causing an abnormal increase in the number of astrocytes. In neurodegenerative diseases such as Alzheimer's and Parkinson's disease, synaptogenesis is believed to be impaired. Additional preclinical data presented also indicates that in addition to reducing oxidative stress, ANAVEX®3-71 demonstrates protective effects of mitochondrial enzyme complexes during pathological conditions, which, if impaired, are believed to play a role in the pathogenesis of neurodegenerative and neurodevelopmental diseases.
In
Based on these results, and ANAVEX®3-71 pre-clinical profile, the Company
intends to advance ANAVEX®3-71 into a biomarker-driven clinical development
dementia program for the treatment of FTD, schizophrenias and Alzheimer's
disease, evaluating longitudinal effect of treatment with ANAVEX®3-71. Anavex
believes the results of these studies, could serve as the basis for advancing
into respective registration studies in the
ANAVEX®1-41
ANAVEX®1-41 is a sigma-1 agonist. Pre-clinical tests revealed significant neuroprotective benefits (i.e., protects nerve cells from degeneration or death) through the modulation of endoplasmic reticulum, mitochondrial and oxidative stress, which damages and impairs cell viability. In addition, in animal models, ANAVEX®1-41 prevented the expression of caspase-3, an enzyme that plays a key role in apoptosis (programmed cell death) and loss of cells in the hippocampus, the part of the brain that regulates learning, emotion and memory. These activities involve both muscarinic and sigma-1 receptor systems through a novel mechanism of action.
Preclinical data presented also indicates that ANAVEX®1-41 demonstrates protective effects of mitochondrial enzyme complexes during pathological conditions, which, if impaired, are believed to play a role in the pathogenesis of neurodegenerative and neurodevelopmental diseases.
27 ANAVEX®1066
ANAVEX®1066, a mixed sigma-1/sigma-2 ligand, is designed for the potential treatment of neuropathic and visceral pain. ANAVEX®1066 was tested in two preclinical models of neuropathic and visceral pain that have been extensively validated in rats. In the chronic constriction injury model of neuropathic pain, a single oral administration of ANAVEX®1066 dose-dependently restored the nociceptive threshold in the affected paw to normal levels while leaving the contralateral healthy paw unchanged. Efficacy was rapid and remained significant for two hours. In a model of visceral pain, chronic colonic hypersensitivity was induced by injection of an inflammatory agent directly into the colon and a single oral administration of ANAVEX®1066 returned the nociceptive threshold to control levels in a dose-dependent manner. Companion studies in rats demonstrated the lack of any effects on normal gastrointestinal transit with ANAVEX®1066 and a favorable safety profile in a battery of behavioral measures.
ANAVEX®1037
ANAVEX®1037 is designed for the treatment of prostate and pancreatic cancer. It is a low molecular weight, synthetic compound exhibiting high affinity for sigma-1 receptors at nanomolar levels and moderate affinity for sigma-2 receptors and sodium channels at micromolar levels. In advanced pre-clinical studies, this compound revealed antitumor potential. It has also been shown to selectively kill human cancer cells without affecting normal/healthy cells and also to significantly suppress tumor growth in immune-deficient mice models. Scientific publications highlight the possibility that these ligands may stop tumor growth and induce selective cell death in various tumor cell lines. Sigma receptors are highly expressed in different tumor cell types. Binding by appropriate sigma-1 and/or sigma-2 ligands can induce selective apoptosis. In addition, through tumor cell membrane reorganization and interactions with ion channels, our drug candidates may play an important role in inhibiting the processes of metastasis (spreading of cancer cells from the original site to other parts of the body), angiogenesis (the formation of new blood vessels) and tumor cell proliferation.
Our compounds are in the pre-clinical and clinical testing stages of development, and there is no guarantee that the activity demonstrated in pre-clinical models will be shown in human testing.
We continue to identify and initiate discussions with potential strategic and commercial partners to most effectively advance our programs and realize maximum shareholder value. Further, we may acquire or develop new intellectual property and assign, license, or otherwise transfer our intellectual property to further our goals.
Our Target Indications
We have developed compounds with potential application to two broad categories and several specific indications. including:
Central Nervous System Diseases
? Alzheimer's disease - In 2022, an estimated 6.5 million Americans were
suffering from Alzheimer's disease. The Alzheimer's Association® estimates
that by 2050, this number will rise to 12.7 million Americans. Medications
on the market today treat only the symptoms of Alzheimer's disease and do
not have the ability to stop its onset or its progression. There is an
urgent and unmet need for both a disease modifying cure for Alzheimer's
disease as well as for better symptomatic treatments.
? Parkinson's disease - Parkinson's disease is a progressive disease of the
nervous system marked by tremors, muscular rigidity, and slow, imprecise
movement. It is associated with degeneration of the basal ganglia of the
brain and a deficiency of the neurotransmitter dopamine. Parkinson's
disease afflicts more than 10 million people worldwide, typically
middle-aged and elderly people. The Parkinson's disease market is expected
to expand to $11.5 billion by 2029, according to business intelligence
provider GBI Research .
? Rett syndrome - Rett syndrome is a rare X-linked genetic neurological and
developmental disorder that affects the way the brain develops, including
protein transcription, which is altered and as a result leads to severe
disruptions in neuronal homeostasis. It is considered a rare, progressive
neurodevelopmental disorder and is caused by a single mutation in the
MECP2 gene. Because males have a different chromosome combination from
females, boys who have the genetic MECP2 mutation are affected in
devastating ways. Most of them 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; severe mental
retardation, their ability to speak, walk and eat, sleeping problems,
seizures and even the ability to breathe easily. Rett syndrome affects
approximately 1 in every 10,000-15,000 females.
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? Depression - Depression is a major cause of morbidity worldwide according
to the World Health Organization . Pharmaceutical treatment for depression
is dominated by blockbuster brands, with the leading nine brands
historically accounting for approximately 75% of total sales. However, the
dominance of the leading brands is waning, largely due to the effects of
patent expiration and generic competition.
? Epilepsy - Epilepsy is a common chronic neurological disorder
characterized by recurrent unprovoked seizures. These seizures are
transient signs and/or symptoms of abnormal, excessive or synchronous
neuronal activity in the brain. According to the Centers for Disease
Control and Prevention , in 2015 epilepsy affected 3.4 million Americans.
Today, epilepsy is often controlled, but not cured, with medication that
is categorized as older traditional anti-epileptic drugs and second
generation anti-epileptic drugs. Because epilepsy afflicts sufferers in
different ways, there is a need for drugs used in combination with both
traditional anti-epileptic drugs and second generation anti-epileptic
drugs.
? Neuropathic Pain - We define neuralgia, or neuropathic pain, as pain that
is not related to activation of pain receptor cells in any part of the
body. Neuralgia is more difficult to treat than some other types of pain
because it does not respond well to normal pain medications. Special
medications have become more specific to neuralgia and typically fall
under the category of membrane stabilizing drugs or antidepressants.
Cancer
? Malignant Melanoma - Predominantly a skin cancer, malignant melanoma can
also occur in melanocytes found in the bowel and the eye. Malignant
melanoma accounts for 75% of all deaths associated with skin cancer. The
treatment includes surgical removal of the tumor, adjuvant treatment,
chemo and immunotherapy, or radiation therapy. According to
iHealthcareAnalyst, Inc. the worldwide malignant melanoma market is
expected to grow to $6.4 billion by 2027.
? Prostate Cancer - Specific to men, prostate cancer is a form of cancer
that develops in the prostate, a gland in the male reproductive system.
The cancer cells may metastasize from the prostate to other parts of the
body, particularly the bones and lymph nodes. Drug therapeutics for
prostate cancer are expected to increase to nearly $13.5 billion in 2024
according to Datamonitor Healthcare .
? Pancreatic Cancer - Pancreatic cancer is a malignant neoplasm of the
pancreas. In the United States , approximately 55,000 new cases of
pancreatic cancer will be diagnosed this year and approximately 44,000
patients will die as a result of their cancer, according to the American
Cancer Society . Sales predictions by FutureWise forecast that the market
for the global pharmaceutical treatment of pancreatic cancer will increase
to $4.7 billion by 2027.
Patents, Trademarks and Intellectual Property
We hold ownership or exclusive rights to fifteen
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We own one issued
We also own two issued
For ANAVEX®2-73, ANAVEX®19-144, ANAVEX®1-41, and ANAVEX®1066, we also have
granted or pending applications in
With regard to ANAVEX®3-71, we own exclusive rights to two issued
We also own other patent applications directed to enantiomers, crystals, formulations, uses, and patient selection methods that may provide additional protection for one or more of our product candidates.
We regard patents and other intellectual property rights as corporate assets. Accordingly, we attempt to optimize the value of intellectual property in developing our business strategy including the selective development, protection, and exploitation of our intellectual property rights. In addition to filings made with intellectual property authorities, we protect our intellectual property and confidential information by means of carefully considered processes of communication and the sharing of information, and by the use of confidentiality and non-disclosure agreements and provisions for the same in contractor's agreements. While no agreement offers absolute protection, such agreements provide some form of recourse in the event of disclosure, or anticipated disclosure.
Our intellectual property position, like that of many biomedical companies, is
uncertain and involves complex legal and technical questions for which important
legal principles are unresolved. For more information regarding challenges to
our existing or future patents, see "Risk Factors" in Part I, Item 1A of our
Annual Report on Form 10-K filed with the
30 Financial Overview
We are in the development stage and have not earned any revenues since our inception in 2004. We do not anticipate earning any revenues until we can establish an alliance with other companies to develop, co-develop, license, acquire or market our products.
Our operating costs consist primarily of research and development activities
including the cost of clinical studies and clinical supplies as well as clinical
drug manufacturing and formulation. Research and development expenses also
include personnel related costs such as salaries and wages, and third-party
contract research organization (CRO) expenses in support of these clinical
studies. Personnel costs include salaries and wages, benefits, and non-cash
stock-based compensation charges associated with options and other equity awards
granted to employees and consultants
General and administrative expenses consist of personnel costs, expenses for outside professional services and expenses associated with operating as a public company. Personnel costs consist of salaries and wages, benefits and stock-based compensation for general and administrative personnel. Outside professional services and public company expenses include expenses related to compliance and reporting, additional insurance expenses, audit and SOX compliance, expenses associated with patent research, applications and filings, investor and shareholder relations activities and other administrative expenses and professional services.
Comparison of the three and nine months ended
During the three and nine months ended
With respect to our double blind, placebo-controlled Phase 2b/3 study for the
treatment of Alzheimer's disease the last patient visit was completed end of
We also recently completed this quarter the last patient visit with respect to the 48-week open label extension of the Phase 2 clinical trial in Parkinsons Disease Dementia.
Additionally, we continued to run open label extensions of our recently completed AVATAR study and the Phase 2b/3 Alzheimer's disease study.
Operating Expenses
Total operating expenses for the third quarter of fiscal 2022 were
General and administrative expenses were
Our research and development expenses for the three months ended
31 Other income (net)
The net amount of other income for the three months ended
As well, the decrease in other income for the three and nine-month periods is
attributable to a decrease in Australian research and development incentive
income in connection with the decrease in eligible clinical activities in
Net loss
Net loss for the third quarter of fiscal 2022 was
Liquidity and Capital Resources
Working Capital
June 30,
2022 September 30, 2021
Current Assets
10,798,386
Working Capital $ 150,736,600 $ 150,818,104 At
We intend to continue to use our capital resources to advance our clinical trials for ANAVEX®2-73 and ANAVEX®3-71, and to perform work necessary to prepare for future development of our pipeline compounds.
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