What changed in this filing

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Item 2. Management’s Discussion and Analysis

2022-05-10 compared with 2022-02-09 · 165 added, 181 removed, 633 unchanged (35% of the section changed)

Discussion and Analysis of Financial Condition and Results of Operations.

MANAGEMENT’S DISCUSSION AND ANALYSIS

OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

Forward-Looking Statements

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Such forward-looking statements include, without limitation, statements regarding:

in our stock and in the markets in general;

ability to successfully conduct clinical and preclinical trials for our product candidates;

ability to raise additional capital on favorable terms and the impact of such activities on our stockholders and stock price;

impact of the COVID-19 outbreak and its effect on us;

ability to generate any revenue or to continue as a going concern;

ability to execute our research and development plan on time and on budget;

products ability to demonstrate efficacy or an acceptable safety profile of our product candidates;

ability to obtain the support of qualified scientific collaborators;

ability, whether alone or with commercial partners, to successfully commercialize any of our product candidates that may be approved

ability to identify and obtain additional product candidates;

reliance on third parties in non-clinical and clinical studies;

ability to defend against product liability claims;

ability to safeguard against security breaches;

ability to obtain and maintain sufficient intellectual property protection for our product candidates;

ability to comply with our intellectual property licensing agreements;

ability to defend against claims of intellectual property infringement;

ability to comply with the maintenance requirements of the government patent agencies;

ability to protect our intellectual property rights throughout the world;

anticipated start dates, durations and completion dates of our ongoing and future clinical studies;

anticipated designs of our future clinical studies;

impact of fast track designation on receipt of actual FDA approval;

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;

anticipated future cash position.

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;

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;

our anticipated future cash position.

We have based these forward-looking statements largely

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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

The following table summarizes key information about our programs:

* = Orphan Drug Designation by the FDA;

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in a range of patient age demographics and geographic regions, utilizing a convenient oral liquid once-daily formulation of ANAVEX ® 2-73.

The first Phase 2 study, (ANAVEX®2-73-RS-001), which took place in the

United States, was completed in December 2020.

This trial was a randomized double-blind, placebo-controlled safety, tolerability, pharmacokinetic

and efficacy study of oral liquid ANAVEX ® 2-73 formulation in 25 adult female patients with Rett syndrome over a 7-week

treatment period including ANAVEX ® 2-73-specific genomic precision medicine biomarkers.

The primary endpoint of the trial

The dosing of 5 mg ANAVEX ® 2-73 was well-tolerated and demonstrated dose-proportional PK (pharmacokinetics).

All secondary efficacy endpoints of the trial showed statistically significant and clinically meaningful response in the Rett Syndrome

Behaviour Questionnaire (RSBQ AUC) Total scores, when compared to placebo, in the ITT cohort (all participants, p = 0.011).

66.7% of ANAVEX ® 2-73

treated subjects showed a statistically significant improvement in RSBQ response as compared to 10% of the subjects on placebo in the

ITT cohort (all participants, p = 0.011).

ANAVEX ® 2-73 treatment resulted in a sustained improvement in Clinical Global

Impression Improvement (CGI-I) scores throughout the 7-week study, when compared to placebo in the ITT cohort (all participants, p = 0.014).

Consistent with previous ANAVEX ® 2-73 clinical trials, patients carrying the common form of the SIGMAR1 gene treated with

ANAVEX ® 2-73 experienced stronger improvements in the prespecified efficacy endpoints.

The first Phase 2 study, (ANAVEX®2-73-RS-001),

which took place in the United States, was completed in December 2020.

This trial was a randomized double-blind, placebo-controlled safety,

tolerability, pharmacokinetic and efficacy study of oral liquid ANAVEX ® 2-73 formulation in 25 adult female patients with

Rett syndrome over a 7-week treatment period including ANAVEX ® 2-73-specific genomic precision medicine biomarkers.

primary endpoint of the trial was safety.

The dosing of 5 mg ANAVEX ® 2-73 was well-tolerated and demonstrated dose-proportional

PK (pharmacokinetics).

All secondary efficacy endpoints of the trial showed statistically significant and clinically meaningful response

in the Rett Syndrome Behaviour Questionnaire (RSBQ AUC) Total scores, when compared to placebo, in the ITT cohort (all participants, p

66.7% of ANAVEX ® 2-73 treated subjects showed a statistically significant improvement in RSBQ response as compared

to 10% of the subjects on placebo in the ITT cohort (all participants, p = 0.011).

ANAVEX ® 2-73 treatment resulted in a

sustained improvement in Clinical Global Impression Improvement (CGI-I) scores throughout the 7-week study, when compared to placebo in

the ITT cohort (all participants, p = 0.014).

Consistent with previous ANAVEX ® 2-73 clinical trials, patients carrying the

common form of the SIGMAR1 gene treated with ANAVEX ® 2-73 experienced stronger improvements in the prespecified efficacy

second, international study of ANAVEX ® 2-73 for the treatment of Rett syndrome, called the AVATAR study, commenced in June

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Subsequently the AVATAR study was updated from a Phase 2 to a Phase 3 study.

The data of the AVATAR study was released in

February 2022.

The study met all primary and secondary efficacy and safety endpoints, with consistent improvements in primary

efficacy endpoint, RSBQ AUC (p = 0.037) response, and secondary efficacy endpoints, ADAMS (p = 0.010) and CGI-I (p = 0.037)

Efficacy endpoints demonstrated statistically significant and clinically meaningful reductions in Rett syndrome symptoms.

Convenient once daily oral liquid doses of up to 30mg of ANAVEX ® 2-73 were also well tolerated with good medication

All patients who participated in the study are eligible to receive ANAVEX ® 2-73 under a voluntary open

label extension protocol, which is currently ongoing.

The data of the AVATAR study was released in February

The study met all primary and secondary efficacy and safety endpoints, with consistent improvements in primary efficacy endpoint,

RSBQ AUC (p = 0.037) response, and secondary efficacy endpoints, ADAMS (p = 0.010) and CGI-I (p = 0.037) response.

Efficacy endpoints

demonstrated statistically significant and clinically meaningful reductions in Rett syndrome symptoms.

Convenient once daily oral liquid

doses of up to 30mg of ANAVEX ® 2-73 were also well tolerated with good medication compliance.

All patients who participated

in the study are eligible to receive ANAVEX ® 2-73 under a voluntary open label extension protocol, which is currently ongoing.

In July 2020, we commenced the third study of ANAVEX ® 2-73

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as of neurodevelopmental nature, like Rett syndrome.

When bound by the appropriate ligands, sigma receptors influence the functioning

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.

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Treatment with ANAVEX ® 2-73 for four weeks significantly increased

the automatic visual response in the MECP2 Rett syndrome disease mouse.

the automatic visual response in the MECP2 Rett syndrome disease mice.

Additionally, chronic oral dosing daily for 6.5 weeks of ANAVEX ® 2-73

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to obtain regulatory guidance.

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.

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.

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

Based on the results of pre-clinical testing, we initiated

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precision medicine biomarkers identified in the ANAVEX ® 2-73 Phase 2a study.

The Phase 2b/3 study, which commenced in October 2018, randomized 1:1:1 to either two different ANAVEX ® 2-73

doses or placebo, completed enrollment in June 2021.

The Phase 2b/3 study, which commenced in October

2018, randomized 1:1:1 to either two different ANAVEX ® 2-73 doses or placebo, completed enrollment in June 2021.

Preclinical data also validates ANAVEX ® 2-73

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Central Nervous System Diseases

● Alzheimer’s disease – In 2021, an estimated 5.7 million Americans were suffering from Alzheimer’s

Alzheimer’s disease – In 2021, an estimated 5.7 million Americans were suffering from Alzheimer’s disease.

The Alzheimer’s Association ® estimates that by 2050, this number will rise to nearly 14 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 lead to severe disruptions

in neuronal homeostasis.

It is considered a rare, progressive neurodevelopmental disorder and is caused by a single mutation in the MECP2

Because males have a different chromosome combination from females, boys who have the genetic MECP2 mutation are affected in devastating

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.

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.

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

● Epilepsy – Epilepsy is a common chronic neurological disorder characterized by recurrent unprovoked

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.

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.

● Malignant Melanoma – Predominantly a skin cancer, malignant melanoma can also occur in melanocytes

found in the bowel and the eye.

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.

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.

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

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.

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

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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 Securities and Exchange Commission

on November 24, 2021.

“Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K filed with the Securities and Exchange Commission on November

Financial Highlights

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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.

ended December 31, 2021 compared to three months ended December 31, 2020

During the three months ended December 31, 2021, we

completed our second randomized placebo-controlled clinical trial of ANAVEX ® 2-73

for the treatment of Rett syndrome , the AVATAR Phase 3 study, and reported positive top-line results from this study in February

2022, as described above under Clinical Studies Overview – Rett Syndrome .

We continued to advance enrollment of our EXCELLENCE

international Phase 2/3 pediatric Rett syndrome clinical trial through the activation of additional clinical sites in new regions across

We also completed the first in human Phase 1 clinical trial of ANAVEX ® 3-71 with focus on the treatment of Frontotemporal

Dementia (FTD) and positive topline results were announced in January 2022, as described above under Clinical Studies Overview –

Frontotemporal Dementia.

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.

of the three and six months ended March 31, 2022 and 2021

During the three and six months ended March

31, 2022, we continued to advance enrollment of our EXCELLENCE international Phase 2/3 pediatric Rett syndrome clinical trial.

activated clinical sites in the United Kingdom and Canada to access additional patient populations and we are actively recruiting in

these new regions.

We also continued to advance our double blind,

placebo-controlled Phase 2b/3 study for the treatment of Alzheimer’s disease as planned, which study completed enrollment in June

Additionally, we continued to run open label extensions of our recently completed AVATAR study and the Phase 2 clinical trial in

Parkinsons Disease Dementia.

Operating Expenses

Total operating expenses for the first quarter of

fiscal 2022 were $11.7 million, compared to $9.4 million for the comparable first quarter of fiscal 2021.

Total operating expenses for the second quarter of

fiscal 2022 were $11.5 million, compared to $9.0 million for the comparable second quarter of fiscal 2021.

Total operating expenses for

the first half of fiscal 2022 were $23.2 million compared to $18.4 million for the same period in fiscal 2021.

General and administrative expenses were $2.9 million

for the three months ended December 31, 2021, as compared to $1.5 million for the first quarter of fiscal 2021.

The increase is primarily

related to an increase in non-cash stock option compensation charges of $1.3 million period over period in connection with the vesting

of milestone-based options.

Our research and development expenses for the first

quarter of fiscal 2022 were $8.7 million, as compared to $7.9 million for the first quarter of fiscal 2021.

The increase is primarily

related to an increase in non-cash stock option compensation charges of $1.7 million period over period in connection with the vesting

of milestone-based options.

continue to see an increase in our research and development expenditures as we advance our ANAVEX ® 2-73 clinical studies,

including extension studies to allow us to continue to gather longer term data, continuing to advance our other pipeline compounds such

as ANAVEX ® 3-71, and as we continue to add additional staff to manage and support these clinical studies.

for the three months ended March 31, 2022, as compared to $2.2 million for the second quarter of fiscal 2021.

Similarly, general and administrative

expenses were $6.0 million for the six months ended March 31, 2022, as compared to $3.7 million for the six months ended March 31, 2021.

The increase in general and administrative expense is primarily related to (i) an increase in non-cash stock option compensation charges

of $0.8 million and $2.0 million, in the three and six month periods respectively, in connection with the vesting of stock options to

an expanding team and (ii) an increase in corporate insurance costs.

Our research and development expenses for the three

months ended March 31, 2022 were $8.6 million, as compared to $6.7 million for the three months ended March 31, 2022.

Our research and

development expenses were $17.3 million for the six-month period ended March 31, 2022, as compared to $14.6 million for the comparable

six-month period in 2021.

The increase in research and development expenses is primarily driven by an increase in non-cash stock option

compensation charges of $1.8 million and $3.5 million in the three and six month periods respectively, associated with an expanding team directly engaged in support of ongoing

research and development activities.

For the six-month period ended March 31, 2022, this increase was partially offset by a decrease in

clinical trial expenditures over the comparable period, associated with the completion of Phase 2 trial with ANAVEX ® 2-73

in Parkinson’s Disease Dementia (PDD) and completed enrollment and recruitment activities associated with our Phase 2b/3 trial in

Alzheimer’s disease.

Other income (net)

The net amount of other income for the first quarter

of fiscal 2022 was $0.9 million as compared to $1.6 million for the comparable first quarter of fiscal 2021.

decrease in other income is attributable to a decrease in Australian research and development incentive income in connection with the

decrease in eligible clinical activities in Australia over the comparable period such as the completion of the ANAVEX ® 3-71

The net amount of other income for the three months

ended March 31, 2022 was $1.1 million as compared to $0.8 million for the comparable three months ended March 31, 2021 and $2.0 million

for the six-month period as compared to $2.4 million for the comparable six-month period in fiscal 2021.

The increase in other income

for the three-month period is related to differences in foreign exchange fluctuations of the Australian dollar against the US dollar as

they relate to incentive and tax receivables denominated in Australian Dollars.

The decrease in

other income for the six-month period is attributable to a decrease in Australian research and development incentive income in connection

with the decrease in eligible clinical activities in Australia over the comparable period such as the completion of the ANAVEX ® 3-71

Phase 1 clinical study.

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on incentive and tax receivables during the period.

Net loss for the first quarter of fiscal 2022

was $10.9 million, or $0.14 per share, as compared to $7.9 million, or $0.12 per share in the comparative first quarter of fiscal 2021.

Net loss for the second quarter of fiscal 2022

was $10.4 million, or $0.14 per share, as compared to $8.2 million, or $0.12 per share in the comparative second quarter of fiscal 2021

and $21.3 million, or $0.28 per share, for the six-month period ended March 31, 2022, as compared to $16.0 million, or $0.24 per share

in the comparative six-month period ended March 31, 2021.

Liquidity and Capital Resources

Working Capital

December 31, 2021

March 31, 2022

September 30, 2021

Current Assets

$ 156,896,368

$ 161,616,490

Current Liabilities

Working Capital

$ 146,367,706

$ 150,818,104

At December 31, 2021, we held $151.1 million in cash and cash equivalents, a decrease of $1.0 million from September 30, 2021.

Cash expenditures

for the quarter of approximately $7.0 million were offset by a net reduction of incentive and tax receivables of $3.8 million, resulting

in a net cash used in operating activities of $3.5 million for the quarter.

We received cash from financing activities of $2.5 million

primarily from the issuance of shares of common stock under the Sales Agreement (as defined below).

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.

Three months ended December 31,

At March 31, 2022, we held $153.3 million in cash and cash equivalents, an increase of $1.2 million from September 30, 2021.

used in operations was $13.1 million for the six-month period ended March 31, 2022, compared to $15.2 million in the comparable six-month

period ended March 31, 2021.

We received cash from financing activities of $14.4 million, primarily from the issuance of shares of common

stock under the Sales Agreement (as defined below).

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.

Six months ended March 31,

Net cash flows used in operating activities

$ (3,500,955 )

$ (7,871,378 )

Net cash flows from financing activities

(Decrease) increase in cash and cash equivalents

Increase in cash and cash equivalents

Cash flow used in operating activities

Net cash used in operating activities for the

first quarter of fiscal 2022 was $3.5 million, compared to $7.9 million during the comparable period of fiscal 2021.

The principal reason

for this decrease in net cash used in operating activities in the current period is due to the receipt of research and development incentive

tax refunds during the period, as compared to no such receipts during the comparable period.

six months ended March 31, 2022 was $13.1 million, compared to $15.2 million during the comparable six months ended March 31, 2021.

principal reason for this decrease in net cash used in operating activities in the current period is due to the receipt of research and

development incentive tax refunds during the period, as compared to no such receipts during the comparable period.

Cash flow provided by financing activities

Cash provided by financing activities for the

three months ended December 31, 2021 was $2.5 million, primarily attributable to cash received from the issuance of common shares at various

six months ended March 31, 2022 was $14.4 million, primarily attributable to cash received from the issuance of common shares at various

market prices under the Sales Agreement

Cash provided

by financing activities for the three months ended December 31, 2020 was $26.0 million, attributable to cash received from the issuance

provided by financing activities for the six months ended March 31, 2021 was $61.8 million, attributable to cash received from the issuance

of common shares at various market prices under the 2019 Purchase Agreement and the Sales Agreement.

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the Sales Agents with customary indemnification and contribution rights.

During the three months ended

December 31, 2021, 99,588 shares were sold pursuant to the At-the-Market Offering for gross proceeds of $2.3 million (net proceeds of

During the six months ended

March 31, 2022, 1,066,389 shares were sold pursuant to the At-the-Market Offering for gross proceeds of $14.8 million (net proceeds of

$14.3 million after deducting commissions and offering expenses).

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Accounting Pronouncements” in notes to our Interim Condensed Consolidated Financial Statements included in this Form 10-Q.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT

MARKET RISKS.

Not applicable

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis