What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2023-08-08 compared with 2023-05-09 · 213 added, 172 removed, 800 unchanged (32% of the section changed)

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

volatility in our stock price and in the markets in general;

our ability to successfully conduct preclinical studies and clinical 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 candidates’ ability to demonstrate efficacy or an acceptable safety profile;

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 studies and clinical trials;

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 trials;

the anticipated designs of our future clinical trials;

our ability to attract and retain qualified employees;

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 and ability to obtain funding for our operations.

volatility in our stock price and in the

markets in general;

our ability to successfully conduct preclinical

studies and clinical 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 candidates’ ability

to demonstrate efficacy or an acceptable safety profile;

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

studies and clinical trials;

our ability to defend against product liability

our ability to safeguard against security

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 trials;

the anticipated designs of our future clinical

our ability to attract and retain qualified

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 and

ability to obtain funding for our operations.

We have based these forward-looking statements

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New risk factors emerge from time to time and it is not possible for our management to predict all risk factors,

nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause

nor can we assess the impact of all factors on our business or the extent to which any factor,

or combination of factors, may cause

actual results to differ materially from those contained in any forward-looking statements.

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occupancy with SIGMAR1 in the brain.

Reyes S et al., Sci Rep.

Reyes S et al.,

Cellular Homeostasis

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This trial completed enrollment in February 2023, exceeding

the original enrollment target and topline results are expected in the second half of 2023.

All patients who participate in the

trial will be eligible to receive ANAVEX ® 2-73 under a voluntary open label extension protocol, which is currently

the original enrollment target.

In June 2023, this trial completed dosing of all participants, and topline results are expected

in the second half of 2023.

All patients who participate in the trial will be eligible to receive ANAVEX ® 2-73 under

a voluntary open label extension protocol, which is currently ongoing.

Parkinson’s Disease

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Central Nervous System Diseases

Alzheimer’s disease – In 2023, an estimated 6.7 million Americans age 65 and older are suffering from Alzheimer’s disease.

Alzheimer’s disease – In 2023, an estimated 6.7 million Americans aged 65 and older are suffering from Alzheimer’s disease.

The Alzheimer’s Association ® estimates that the annual number of new cases of Alzheimer’s and other dementias is projected to double by 2050.

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Patents, Trademarks and Intellectual

We hold ownership or exclusive rights to eighteen

We hold ownership or exclusive rights to twenty

patents, twenty-one U.S.

patent applications, and various PCT or ex-U.S.

patent applications relating to our drug candidates, methods

associated therewith, and to our research programs.

patent applications relating to our drug candidates,

methods associated therewith, and to our research programs.

We own one issued U.S.

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directed to a novel and synergistic neuroprotective compound combined with donepezil and other cholinesterase inhibitors.

is expected to expire in June 2034, absent any patent term extension for regulatory delays.

patent is expected to expire in June 2034, absent any patent term extension for regulatory delays.

We own one issued U.S.

patent entitled “A2-73

crystalline polymorph compositions of matter and methods of use thereof”.

It claims crystals of A2-73 freebase or its fumarate salt,

dosage forms and pharmaceutical formulations.

This patent is expected to expire in July 2039, absent any patent term extension for regulatory

We own three issued U.S.

patents each with claims directed to crystalline forms of ANAVEX ® 2-73.

The first of these

three patents claims crystalline forms of ANAVEX ® 2-73, dosage forms and compositions containing crystalline ANAVEX ® 2-73,

and methods of treatment for Alzheimer’s disease using them.

This patent is expected to expire in July 2036, absent any patent term

extension for regulatory delays.

The second of these three patents claims pharmaceutical compositions containing a crystalline form of

ANAVEX ® 2-73, and methods of treatment for Alzheimer’s disease using the compositions.

This patent is expected to

expire in June 2037, absent any patent term extension for regulatory delays.

The third of these three patents claims pharmaceutical compositions

containing a crystalline form of ANAVEX ® 2-73, and methods of treatment for Alzheimer’s disease using the compositions.

This patent is expected to expire in June 2037, absent any patent term extension for regulatory delays.

entitled “A2-73 crystalline polymorph compositions of matter and methods of use thereof”.

It claims crystals of A2-73

freebase or its fumarate salt, dosage forms and pharmaceutical formulations.

This patent is expected to expire in July 2039, absent

any patent term extension for regulatory delays.

We own four issued U.S.

patents each with claims directed to crystalline forms

of ANAVEX ® 2-73.

The first of these four patents claims crystalline forms of ANAVEX ® 2-73, dosage forms

and compositions containing crystalline ANAVEX ® 2-73, and methods of treatment for Alzheimer’s disease using

This patent is expected to expire in July 2036, absent any patent term extension for regulatory delays.

The second of these

four patents claims pharmaceutical compositions containing a crystalline form of ANAVEX ® 2-73, and methods of treatment

for Alzheimer’s disease using the compositions.

This patent is expected to expire in June 2036, absent any patent term extension

for regulatory delays.

The third of these four patents claims pharmaceutical compositions containing a crystalline form of ANAVEX ® 2-73,

and methods of treatment for Alzheimer’s disease using the compositions.

This patent is expected to expire in June 2036,

absent any patent term extension for regulatory delays.

The fourth of these four patents claims method of making certain crystalline

forms ANAVEX ® 2-73.

This patent is expected to expire in October 2036, absent any patent term extension for regulatory

We also own two issued U.S.

for seizure treatment.

The first of these two patents claims methods and dosage forms for treating seizures, the dosage forms containing

a low-dose anti-epilepsy drug combined with either:

(i) ANAVEX ® 2-73 and its active metabolite ANAVEX ® 19-144;

patents for seizure treatment.

The first of these two patents claims methods and dosage forms

for treating seizures, the dosage forms containing a low-dose anti-epilepsy drug combined with either:

(i) ANAVEX ® 2-73

and its active metabolite ANAVEX ® 19-144;

or (ii) ANAVEX ® 19-144.

The second of these two patents further claims a combination seizure treatment involving

administration of an anti-epilepsy drug combined with (i) ANAVEX ® 19-144, or (ii) ANAVEX 19-144 ® and

ANAVEX 2-73 ® .

Both patents are expected to expire in October 2035, absent any patent term extension for regulatory

The second of these two patents further

claims a combination seizure treatment involving administration of an anti-epilepsy drug combined with (i) ANAVEX ® 19-144,

or (ii) ANAVEX 19-144 ® and ANAVEX 2-73 ® .

Both patents are expected to expire in October 2035, absent

any patent term extension for regulatory delays.

We also own three issued U.S.

patents with claims directed to treating neurodevelopmental disorders.

These patents claim

methods for treating a neurodevelopmental disorder, multiple sclerosis, or their related biochemical and functional abnormalities

by administering ANAVEX ® 2-73, ANAVEX ® 19-144, and/or ANAVEX ® 1-41 (another sigma receptor

ligand similar to ANAVEX ® 2-73), or compositions thereof.

All three patents are expected to expire in January 2037,

absent any patent term extension for regulatory delays.

patents with claims directed to treating neurodevelopmental

These patents claim methods for treating a neurodevelopmental disorder, multiple sclerosis, or their related biochemical

and functional abnormalities by administering ANAVEX ® 2-73, ANAVEX ® 19-144, and/or ANAVEX ® 1-41

(another sigma receptor ligand similar to ANAVEX ® 2-73), or compositions thereof.

All three patents are expected

to expire in January 2037, absent any patent term extension for regulatory delays.

In addition, we own one issued U.S.

Patent with claims directed to methods

of treating melanoma with a compound related to ANAVEX ® 2-73.

This patent is expected to expire in February 2030,

absent any patent term extension for regulatory delays.

claims directed to methods of treating melanoma with a compound related to ANAVEX ® 2-73.

This patent is expected

to expire in February 2030, absent any patent term extension for regulatory delays.

We also own an issued U.S.

patent that claims crystalline forms of ANAVEX ® 19-144,

dosage forms and compositions containing the crystalline forms of ANAVEX ® 19-144, and methods of treatment for Alzheimer’s

This patent is expected to expire in July 2036, absent any patent term extension for regulatory delays.

Further, we own

one issued U.S.

Patent with claims directed to methods of treating cardiac dysfunction with ANAVEX ® 2-73.

is expected to expire in July 2038, absent any patent term extension for regulatory delays.

patent that claims

crystalline forms of ANAVEX ® 19-144, dosage forms and compositions containing the crystalline forms of ANAVEX ® 19-144,

and methods of treatment for Alzheimer’s disease.

This patent is expected to expire in July 2036, absent any patent term

extension for regulatory delays.

Further, we own one issued U.S.

Patent with claims directed to methods of treating cardiac dysfunction

with ANAVEX ® 2-73.

This patent is expected to expire in July 2038, absent any patent term extension for regulatory

Additionally, we own one issued U.S.

Patent with claims directed to methods of treating insomnia or anxiety with ANAVEX ® 2-73, ANAVEX ® 19-144,

and/or ANAVEX ® 1-41.

This patent is expected to expire in September 2038, absent any patent term extension for regulatory

Patent with claims directed to methods of treating insomnia or anxiety with ANAVEX ® 2-73,

ANAVEX ® 19-144, and/or ANAVEX ® 1-41.

This patent is expected to expire in September 2038, absent any

patent term extension for regulatory delays.

Further, we own one issued U.S.

Patent with claims directed to a method of treating

systolic hypertension using ANAVEX ® 2-73.

This patent is expected to expire in July 2039, absent any patent term

extension for regulatory delays.

Additionally, we own one issued U.S.

Patent with claims directed to pharmaceutical dosage forms

of (-) enantiomer of ANAVEX ® 2-73.

This patent is expected to expire in July 2036, absent any patent term extension

for regulatory delays.

We also own two issued U.S.

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and other administrative expenses and professional services.

Comparison of the three and six months ended

March 31, 2023 and 2022

Comparison of the three and nine months

ended June 30, 2023 and 2022

Operating Expenses

Total operating expenses for the quarter ended

March 31, 2023 were $14.2 million, compared to $11.5 million for the comparable quarter ended March 31, 2022.

June 30, 2023 were $13.5 million, compared to $12.5 million for the comparable quarter ended June 30, 2022.

Total operating expenses

for the six months ended March 31, 2023 were $29.6 million, compared to $23.2 million for the comparable six month period ended

March 31, 2022.

for the nine months ended June 30, 2023 were $43.1 million, compared to $35.7 million for the comparable nine-month period ended

June 30, 2022.

Our research and development expenses for the

three months ended March 31, 2023 were $11.3 million, as compared to $8.6 million for the three months ended March 31, 2022.

three months ended June 30, 2023 were $10.3 million, as compared to $9.3 million for the three months ended June 30, 2022.

increase in research and development expenses is primarily related to (i) an increase in personnel costs of $0.6 million as a result

of the expansion of our team engaged in research and development activities, (ii) an increase of approximately $1.0 million over

the comparable period, relating to the manufacture of additional clinical trial supply for ANAVEX ® 2-73 and ANAVEX ® 2-73

manufacturing development activities, (iii) an increase of approximately $0.40 million over the comparable period relating to the

manufacture and associated Phase 1 activities for ANAVEX ® 3-71 tablets and (iv) an increase in clinical site costs

associated with expanded enrollment in our EXCELLENCE trial.

of the expansion of our team engaged in research and development activities and (ii) an increase of approximately $0.4 million

over the comparable period relating to the manufacture and associated Phase 1 activities for ANAVEX ® 3-71 tablets.

Our research and development expenses for the

six months ended March 31, 2023 were $23.4 million, as compared to $17.3 million for the six months ended March 31, 2022.

nine months ended June 30, 2023 were $33.7 million, as compared to $26.5 million for the nine months ended June 30, 2022.

in research and development expenses is primarily related to (i) an increase in personnel costs of $1.8 million and an increase

in stock-based compensation expense of $1.1 million as a result of the expansion of our team engaged in research and development

activities, (ii) an increase of approximately $2.1 million over the comparable period, relating to manufacturing activities for

both our ANAVEX ® 2-73 and ANAVEX ® 3-71 programs and (iii) an increase in costs associated with expanded

enrollment in our EXCELLENCE trial.

(ii) an increase of approximately $2.9 million over the comparable period, relating to the manufacturing activities

for both our ANAVEX ® 2-73 and ANAVEX ® 3-71 programs;

(iii) an increase of approximately $0.4 million

in costs associated with new trial start up activities and (iv) an increase of approximately $1.6 million for our Rett syndrome

program, primarily associated with expanded enrollment in our EXCELLENCE trial.

These increases were offset by a decrease in license

fees of $0.5 million over the comparable period, paid in connection with the completion of the Phase 1 clinical trial for ANAVEX ® 3-71.

The following table summarizes our research

and development expenses for the three and six months ended March 31, 2023 and 2022 (in thousands):

and development expenses for the three and nine months ended June 30, 2023 and 2022 (in thousands):

Three months ended

Six months ended

Nine months ended

Cost of external service providers

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Total research and development costs

During the three and six months ended March

During the three and nine months ended June

30, 2023 and 2022, external service providers cost by product candidate was as follows (in thousands):

Three months ended

Six months ended

Nine months ended

ANAVEX ® 2-73

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General and administrative expenses were $3.2

million for the three months ended March 31, 2023, as compared to $2.9 million for the same quarter of fiscal 2022.

million for the three months ended June 30, 2023, as compared to $3.2 million for the same quarter of fiscal 2022.

administrative expenses were consistent between both periods.

General and administrative expenses were $6.2 million

for the six months ended March 31, 2023, as compared to $6.0 million for the same six-month period of fiscal 2022, an increase of $0.2

million mostly relating to an increase in professional and IP related costs.

During the first half of fiscal 2023, we utilized cash and

cash equivalents of $14.3 million to fund our operations, compared to $13.1 million during the same period of fiscal 2022.

Our cash position

was $153.5 million at March 31, 2023 compared to $149.2 million at our fiscal year ended September 30, 2022.

General and administrative expenses were $9.4

million for the nine months ended June 30, 2023, as compared to $9.2 million for the same nine-month period of fiscal 2022, an

increase of $0.2 million mostly relating to an increase in professional and IP related costs.

During the first nine months of fiscal 2023,

we utilized cash and cash equivalents of $21.9 million to fund our operations, compared to $20.2 million during the same period

of fiscal 2022.

Our cash position was $154.8 million at June 30, 2023 compared to $149.2 million at our fiscal year ended September

We expect to continue an increase in our research

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The net amount of other income for the three

months ended March 31, 2023 was $1.1 million as compared to $1.1 million for the comparable three months ended March 31, 2022.

An increase in interest income on excess cash invested was offset by a one time financing expense of $964,344 associated with entering

into the 2023 Purchase Agreement (as described below).

The net amount of other income for the six

months ended March 31, 2023 was $3.5 million as compared to $2.0 million for the comparable six-months ended March 31, 2022.

months ended June 30, 2023 was $2.3 million as compared to $0.2 million for the comparable three months ended June 30, 2022.

increase in other income for the quarter is primarily related to an increase in return on excess cash invested in cash equivalents

Net loss for the three months ended March 31,

and a reduction in foreign exchange fluctuation losses due to the stabilization of the Australian dollar against the US dollar.

The net amount of other income for the nine

months ended June 30, 2023 was $5.8 million as compared to $2.2 million for the comparable nine months ended June 30, 2022.

increase in other income for the nine-month period is primarily related to an increase in return on excess cash invested in cash

equivalents, partially offset by a financing charge of $1.0 million in connection with the 2023 Purchase Agreement.

Net loss for the three months ended June 30,

2023, was $11.3 million, or $0.14 per share, as compared to $12.4 million, or $0.16 per share in the comparative quarter of fiscal

The increase in net loss for the quarter is primarily related to increased research and development fees as discussed above.

Net loss for the six months ended March 31,

The decrease in net loss for the quarter is primarily related to an increase in other income as discussed above.

Net loss for the nine months ended June 30,

2023, was $37.4 million, or $0.47 per share, as compared to $33.7 million, or $0.44 per share in the comparative period of fiscal

The increase in net loss for the six-month period is primarily related to increased research and development fees as discussed

The increase in net loss for the nine-month period is primarily related to increased research and development fees as discussed

Liquidity and Capital Resources

Working Capital

March 31, 2023

June 30, 2023

September 30, 2022

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$ 142,491,042

At March 31, 2023, we had current assets of

At June 30, 2023, we had current assets of

$157.8 million, an increase of $5.1 million from September 30, 2022.

2 unchanged sentences

under the 2023 Purchase Agreement, described below, offset by cash used in operations of $21.9 million.

At March 31, 2023, we had current liabilities of

$14.0 million, an increase of $3.8 million from September 30, 2022.

A portion of this increase relates to an increase in deferred grant

income of $0.5 million relating to amounts received during the quarter for a research grant awarded by the Michael J.

Fox Foundation

for Parkinson’s Research.

Other increases in current liabilities relate to amounts owed at period end for manufacturing activities

and programs and laboratory and analysis work relating to the ANAVEX ® 2-73 Phase

2b/3 clinical trial in Alzheimer’s disease.

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.

At June 30, 2023, we had current liabilities

of $11.1 million, an increase of $0.8 million from September 30, 2022.

A portion of this increase relates to an increase in deferred

grant income of $0.5 million relating to amounts received during the quarter for a research grant awarded by The Michael J.

Foundation for Parkinson’s Research.

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.

The following

table summarizes cash flows during the six months ended March 31, 2023 and 2022:

table summarizes cash flows during the nine months ended June 30, 2023 and 2022:

Net cash flows used in operating activities

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Cash flow used in operating activities

Net cash used in operating activities for the six

months ended March 31, 2023 was $14.3 million, compared to $13.1 million during the comparable period ended March 31, 2022.

The principal

reason for this increase in net cash used in operating activities in the current period is due to the increase in net loss over the comparable

Net cash used in operating activities for the

nine months ended June 30, 2023 was $21.9 million, compared to $20.2 million during the comparable period ended June 30, 2022.

The principal reason for this increase in net cash used in operating activities in the current period is due to the increase in

net loss over the comparable quarter.

Cash flow provided by financing activities

Cash provided by financing activities for the

six months ended March 31, 2023 was $18.6 million, mainly attributable to the issuance of common shares under the 2023 Purchase

Agreement, described below, while cash provided by financing activities for the six months

ended March 31, 2022 was $14.4 million, primarily attributable to the sale of common shares at various market prices under

nine months ended June 30, 2023 was $27.6 million, mainly attributable to the issuance of common shares under the 2023 Purchase

Agreement, described below, while cash provided by financing activities for the nine months

ended June 30, 2022 was $21.3 million, primarily attributable to the sale of common shares at various market prices under

the Sales Agreement, described below.

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On any business day and subject to certain

customary conditions, the Company may direct LPC to purchase up to 200,000 shares of Common Stock (such purchases, “ Regular

customary conditions, the Company may direct Lincoln Park to purchase up to 200,000 shares of Common Stock (such purchases, “ Regular

Purchases ”).

1 unchanged sentence

Common Stock;

provided, however, that LPC’s committed obligation under any Regular Purchase shall not exceed $4,000,000.

provided, however, that Lincoln Park ‘s committed obligation under any Regular Purchase shall not exceed $4,000,000.

The purchase price of shares of Common Stock will be based on the then prevailing market prices of such shares at the time of sales

as described in the Purchase Agreement.

There are no limits on the price per share that LPC may pay to purchase Common Stock under

the Purchase Agreement.

In addition, if the Company has directed LPC to purchase the full amount of Common Stock available as a

Regular Purchase on a given day, it may direct LPC to purchase additional amounts as “accelerated purchases” and “additional

accelerated purchases” as set forth in the Purchase Agreement.

There are no limits on the price per share that Lincoln Park may pay to purchase Common

Stock under the Purchase Agreement.

In addition, if the Company has directed Lincoln Park to purchase the full amount of Common

Stock available as a Regular Purchase on a given day, it may direct Lincoln Park to purchase additional amounts as “accelerated

purchases” and “additional accelerated purchases” as set forth in the Purchase Agreement.

The Purchase Agreement limits the Company’s

sale shares of Common Stock to LPC to 15,606,426 shares of Common Stock, representing 19.99% of the shares of the Common Stock

outstanding on the date of the Purchase Agreement unless (i) shareholder approval is obtained to issue more than such amount

or (ii) the average price of all applicable sales of Common Stock to LPC under the Purchase Agreement equals or exceeds the

lower of (A) the closing price of the Common Stock on the Nasdaq Capital Market immediately preceding the Execution Date or (B)

the average of the closing price of the Common Stock on the Nasdaq Capital Market for the five Business Days immediately preceding

the Execution Date.

sale of shares of Common Stock to Lincoln Park to 15,606,426 shares of Common Stock, representing 19.99% of the shares of the Common

Stock outstanding on the date of the Purchase Agreement unless (i) stockholder approval is obtained to issue more than such

amount or (ii) the average price of all applicable sales of Common Stock to Lincoln Park under the Purchase Agreement equals

or exceeds the lower of (A) the closing price of the Common Stock on the Nasdaq Capital Market immediately preceding the Execution

Date or (B) the average of the closing price of the Common Stock on the Nasdaq Capital Market for the five Business Days immediately

preceding the Execution Date.

The Purchase Agreement also prohibits the Company

from directing LPC to purchase any shares of Common Stock if those shares, when aggregated with all other shares of Common Stock

then beneficially owned by Lincoln Park and its affiliates, would result in LPC and its affiliates having beneficial ownership,

at any single point in time, of more than 4.99% of the then total outstanding shares of Common Stock, as calculated pursuant to

Section 13(d) of the Securities Exchange Act of 1934, as amended, and Rule 13d-3 thereunder.

from directing Lincoln Park to purchase any shares of Common Stock if those shares, when aggregated with all other shares of Common

Stock then beneficially owned by Lincoln Park and its affiliates, would result in Lincoln Park and its affiliates having beneficial

ownership, at any single point in time, of more than 4.99% of the then total outstanding shares of Common Stock, as calculated

pursuant to Section 13(d) of the Securities Exchange Act of 1934, as amended, and Rule 13d-3 thereunder.

In consideration for entering into the 2023

Purchase Agreement, the Company issued to Lincoln Park 75,000 shares of Common Stock as a commitment fee (the “initial commitment

shares”) during the six months ended March 31, 2023 and agreed to issue up to 75,000 shares pro rata, when and if, Lincoln

shares”) during the nine months ended June 30, 2023 and agreed to issue up to 75,000 shares pro rata, when and if, Lincoln

Park purchased, at the Company’s discretion, the $150,000,000 aggregate commitment.

During the six months ended March 31, 2023, the Company issued to Lincoln Park

an aggregate of 2,159,080 (2022:

Nil) shares of common stock under the 2023 Purchase Agreement, including 2,075,000 (2022:

of common stock for an aggregate purchase price of $18.2 million (2022:

$Nil) and 9,080 (2022:

Nil) commitment shares.

As of March 31, 2023, an amount of $131.8

During the nine months ended June 30, 2023,

the Company issued to Lincoln Park an aggregate of 3,138,348 (2022:

0) shares of Common Stock under the 2023 Purchase Agreement,

including 3,125,000 (2022:

0) shares of Common Stock for aggregate proceeds of $26.7 million (2022:

$0) and 13,348 (2022:

0) commitment

As of June 30, 2023, an amount of $123.3

million in shares of our common stock remain available for purchase by Lincoln Park under the Purchase Agreement.

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applicable state and federal law, and rules and regulations and the rules of Nasdaq.

We have agreed to pay the Sales Agents’ commissions

for their services of 3.0% of the gross proceeds from the sale of shares of common stock pursuant to the Sales Agreement.

agreed to provide the Sales Agents with customary indemnification and contribution rights.

No shares were sold during the six months ended

March 31, 2023 under the Sales Agreement.

During the six months ended March 31, 2022,

We have agreed to pay the Sales Agents’

commissions for their services of 3.0% of the gross proceeds from the sale of shares of Common Stock pursuant to the Sales Agreement.

We have also agreed to provide the Sales Agents with customary indemnification and contribution rights.

No shares were sold during the nine months

ended June 30, 2023 under the Sales Agreement.

During the nine months ended June 30, 2022,

1,623,566 shares were sold under the Sales Agreement for gross proceeds of $21.0 million (net proceeds of $20.3 million after deducting

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QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET

Not applicable

There have been no

material changes in our exposure to market risk from that disclosed in Item 7A of our Annual Report on Form 10-K for the year ended

September 30, 2022.

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