What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-08-12 compared with 2025-05-13 · 187 added, 190 removed, 837 unchanged (31% of the section changed)

MANAGEMENT’S 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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without limitation, statements regarding:

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;

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 product 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 U.S.

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;

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 product 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 U.S.

Food and Drug Administration (“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;

the timing and likelihood

of the accomplishment of various scientific, clinical, regulatory filings and approvals and other product development objectives,

including the timing of a decision by the European Medicines Agency, or EMA, regarding whether to approve the Marketing Authorization

Application, or MAA, for blarcamesine for the treatment of Alzheimer’s disease;

anticipated future cash position and ability to obtain funding for our operations.

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;

the timing and likelihood of the accomplishment of various scientific, clinical, regulatory filings and approvals and other product development objectives, including the timing of a decision by the European Medicines Agency, or EMA, regarding whether to approve the Marketing Authorization Application, or MAA, for blarcamesine for the treatment of Alzheimer’s disease;

our anticipated future cash position and ability to obtain funding for our operations.

We have based these forward-looking statements largely

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including without limitation the risks described in “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K filed

with the Securities and Exchange

Commission on December 23, 2024.

with the Securities and Exchange Commission on December 23, 2024 and the risks described in Part II, Item 1A of this Quarterly Report

on Form 10-Q.

These risks are not exhaustive.

Other sections of this Quarterly Report

on Form 10-Q include additional factors which could adversely impact our business and financial performance.

Moreover, we operate in a

very competitive and rapidly changing environment.

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

You should not rely

upon forward-looking statements as predictions of future events.

We cannot assure you that the events and circumstances reflected in the

forward-looking statements will be achieved or occur and actual results could differ materially from those projected in the forward-looking

Except as required by applicable laws including the securities laws of the United States, we assume no obligation to update

or supplement forward-looking statements.

Other sections of this Quarterly Report on Form 10-Q include additional factors which could

adversely impact our business and financial performance.

we operate in a very competitive and rapidly changing environment.

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 actual results to differ

materially from those contained in any forward-looking statements.

You should not rely upon forward-looking statements as predictions

of future events.

We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved

or occur and actual results could differ materially from those projected in the forward-looking statements.

Except as required by applicable

laws including the securities laws of the United States, we assume no obligation to update or supplement forward-looking statements.

As used in this Quarterly Report on Form 10-Q, the

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or receptor occupancy with SIGMAR1 in the brain.

Reyes Setal.,

Reyes S et al.,

Cellular Homeostasis

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Alternatively, these comments or requests could lead us to decide,

after consultation with our advisors or the regulatory authorities, to withdraw our MAA for blarcamesine.

The Company plans to announce

the results when the EMA review and decision-making is finished and does not plan to provide interim updates.

after consultation with our advisors or the regulatory authorities, to withdraw or amend our MAA for blarcamesine.

The Company plans to

announce the results when the EMA review and decision-making is finished and does not plan to provide interim updates.

A long-term open label extension study of ANAVEX ® 2-73,

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In October 2020, we completed a double-blind, randomized,

placebo-controlled proof-of-concept Phase 2 trial with ANAVEX ® 2-73 in Parkinson’s disease dementia in Spain and

Australia, to study the effect of the compound on both the cognitive and motor impairment of Parkinson’s disease.

The trial enrolled

approximately 132 patients for 14 weeks, randomized 1:1:1 to two different ANAVEX ® 2-73 doses, 30 mg and 50 mg, or placebo.

The ANAVEX ® 2-73 Phase 2 Parkinson’s disease dementia trial design incorporated genomic precision medicine biomarkers

identified in the ANAVEX ® 2-73 Phase 2a Alzheimer’s disease trial.

placebo-controlled proof-of-concept Phase 2 trial with ANAVEX ® 2-73 in Parkinson’s disease dementia in Spain and Australia,

to study the effect of the compound on both the cognitive and motor impairment of Parkinson’s disease.

The trial enrolled approximately

132 patients for 14 weeks, randomized 1:1:1 to two different ANAVEX ® 2-73 doses, 30 mg and 50 mg, or placebo.

The ANAVEX ® 2-73

Phase 2 Parkinson’s disease dementia trial design incorporated genomic precision medicine biomarkers identified in the ANAVEX ® 2-73

Phase 2a Alzheimer’s disease trial.

The trial demonstrated that ANAVEX ® 2-73

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with the administration of ANAVEX ® 3-71.

The FDA has granted Orphan Drug Designation to ANAVEX ® 3-71

for the treatment of FTD.

The FDA has granted Orphan Drug Designation to ANAVEX ® 3-71 for the

treatment of FTD.

During pathological conditions ANAVEX ® 3-71

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Central Nervous System Diseases

disease – In 2024, an estimated 6.9 million Americans were suffering from Alzheimer’s disease according to the Alzheimer’s

Association ® .

The Alzheimer’s Association ® estimates that the annual number of new cases

of Alzheimer’s and other dementias is projected to double by 2050.

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.

We believe that there is an urgent

and unmet need for both a disease modifying cure for Alzheimer’s disease as well as for better symptomatic treatments.

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 deficiency of the neurotransmitter

Parkinson’s disease currently is estimated to afflict more than 10 million people worldwide, typically middle-aged

and elderly people.

The Parkinson’s disease market is expected to reach $11.5 billion by 2029, according to GlobalData.

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.

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

Alzheimer’s disease – An estimated 7.2

million Americans aged 65 and older are living with Alzheimer’s dementia in 2025, according to the Alzheimer’s Association ® .

The Alzheimer’s Association ® estimates that the annual number of new cases of Alzheimer’s and other dementias

is projected to double by 2050.

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.

We believe that 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 deficiency of the neurotransmitter dopamine.

Parkinson’s disease currently

is estimated to afflict more than 10 million people worldwide, typically middle-aged and elderly people.

The Parkinson’s disease

market is expected to reach $11.5 billion by 2029, according to GlobalData.

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.

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.

Schizophrenia - Schizophrenia is a persistent and

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Worldwide, more than 1,400,000 people could be affected by FXS.

Depression – Depression is a major cause of

morbidity worldwide according to the World Health Organization.

Depression – Depression is a major cause

of morbidity worldwide according to the World Health Organization.

The global antidepressant drug market is projected to reach $21 billion

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Patents, Trademarks and Intellectual Property

We hold ownership or exclusive rights to twenty-seven

(27) issued U.S.

patents, twenty-two (22) pending U.S.

We hold ownership or exclusive rights to thirty (30)

patents, twenty (20) pending U.S.

patent applications, and numerous PCT and 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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This patent is expected to expire in September 2038.

The second and

third of the three patents claim dosage forms comprising any of, or any combination of ANAVEX ® 2-73, ANAVEX ® 19-144,

The second and third

of the three patents claim dosage forms comprising any of, or any combination of ANAVEX ® 2-73, ANAVEX ® 19-144,

and/or ANAVEX ® 1-41.

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expenses and professional services.

Comparison of the three- and six- months ended

March 31, 2025 and 2024

Comparison of the three- and nine- months ended

June 30, 2025 and 2024

Operating Expenses

Total operating expenses for the three months ended

March 31, 2025 were $12.5 million, compared to $12.6 million for the comparable three months ended March 31, 2024.

June 30, 2025 were $14.5 million, compared to $14.6 million for the comparable three months ended June 30, 2024.

Total operating expenses

for the six months ended March 31, 2025 were $26.1 million, compared to $24.0 million for the comparable six months ended March 31, 2024.

for the nine months ended June 30, 2025 were $40.6 million, compared to $38.6 million for the comparable nine months ended June 30, 2024.

Our research and development expenses for the three

months ended March 31, 2025 were $9.9 million, as compared to $9.7 million for the three months ended March 31, 2024.

months ended June 30, 2025 were $10.0 million, as compared to $11.8 million for the three months ended June 30, 2024.

Our research and

development expenses for the six months ended March 31, 2025 were $20.3 million, compared to $18.4 million in the comparable six months

ended March 31, 2024.

The increase in research and development expenses

during the three- and six-month periods is primarily related to the following:

(i) an increase of approximately $2.1 million in the three-month period and $3.7 million in the six-month

period over the comparable periods relating to expenditures on the ANAVEX ® 3-71-SZ-001 clinical trial, which trial commenced

in the second quarter of fiscal 2024.

(ii) an increase in personnel costs of $0.9 million for the six-month period related to the addition of new

consultants engaged to assist in the preparation of the submission of our Marketing Authorisation Application (MAA) to the European Medicines

Agency (EMA);

(iii) an increase of approximately $1.2 million in the six-month period over the comparable period relating

to manufacturing activities of ANAVEX ® 2-73 for potential commercial use, and to support the MAA.

These increases were partially offset by (i) a decrease

of approximately $0.6 million in the three-month period and $1.2 million in the six-month period in expenditures over the comparable periods

relating to our Alzheimer’s program, as a result of the completion of the Phase 2b/3 clinical trial open label extension and (ii)

a decrease in stock based compensation charges of $0.8 million in the three-month period and $0.9 million in the six-month period due

to a change in estimates associated with milestone-based options.

development expenses for the nine months ended June 30, 2025 were $30.3 million, compared to $30.2 million in the comparable nine months

ended June 30, 2024.

The decrease in research and development expenses

during the three-month period is primarily related to the following:

(i) a decrease of approximately $1.9 million over the comparable periods relating to the completion of a large

manufacturing campaign for ANAVEX ® 2-73 for potential commercial use, and to support the MAA;

(ii) a decrease of approximately $1.0 million related to our Alzheimer’s program, as a result of the

completion of the Phase 2b/3 open label extension in June 2024.

These decreases were partially offset by an increase

of approximately $1.1 million in stock-based compensation charges due to a new grant of milestone-based options to existing staff in March

2025, which expense is being recorded over the expected vesting period.

Research and development expenses were consistent

during the nine-month period as related to the comparable nine-month period.

An increase of approximately $3.6 million over the comparable

period relating to expenditures on the ANAVEX ® 3-71-SZ-001 clinical trial, which commenced in March 2024 was offset by (i)

a decrease of approximately $3.0 million in expenditures over the comparable period relating to our Alzheimer’s program, as a result

of the completion of the Phase 2b/3 clinical trial open label extension in June 2024 and (ii) a decrease of approximately $0.7 million

relating to the manufacturing activities for Anavex ® 3-71 completed in the comparable period, for use in future clinical

The following table summarizes our research and development

expenses for the three- and six-months ended March 31, 2025 and 2024 (in thousands):

Three months ended March 31,

Six months ended March 31,

expenses for the three- and nine-months ended June 30, 2025 and 2024 (in thousands):

Three months ended June 30,

Nine months ended June 30,

Cost of external service providers

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Total research and development costs

During the three- and six-months ended March 31, 2025

During the three- and nine-months ended June 30, 2025

and 2024, external service provider costs by product candidate was as follows (in thousands):

Three months ended March 31,

Six months ended March 31,

Three months ended June 30,

Nine months ended June 30,

ANAVEX ® 2-73

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Total external service provider costs

General and administrative expenses were $2.6

million for the three months ended March 31, 2025, as compared to $2.9 million for the same quarter of fiscal 2024.

administrative expenses were $5.8 million for the six months ended March 31, 2025, as compared to $5.6 million for the six months

ended March 31, 2024.

In both periods, increases in legal fees were offset by a decrease in stock

based compensation charges.

General and administrative expenses were $4.5 million for the three months ended

June 30, 2025, as compared to $2.8 million for the same quarter of fiscal 2024.

General and administrative expenses were $10.3 million

for the nine months ended June 30, 2025, as compared to $8.4 million for the nine months ended June 30, 2024.

In both periods the increases

were primarily related to corporate legal fees and intellectual property legal fees associated with legal matters and patent filings and

In the three month period, the increase was also related to an increase in non-cash stock based compensation charges associated

with a new grant of milestone-based options to existing staff in March 2025.

Other income (net)

Net other income for the three-months ended March

31, 2025 was $1.3 million, as compared to $2.1 million for the comparable three-months ended March 31, 2024.

The decrease in other income

is primarily related to a decrease in interest income associated with a change in market wide rates and principal balances held, as well

as decrease in research and development incentive income, as a result of the completion of the open label extensions of our Australian

clinical trials.

Net other income for the six months ended March 31,

2025 was $2.8 million as compared to $4.8 million for the comparable six months ended March 31, 2024.

The decrease in other income for

the six-month period is also primarily related to a decrease in interest income associated with a change in market wide rates and principal

balances held, as well as decrease in research and development incentive income, as a result of the completion of the open label extensions

of our Australian clinical trials

Net loss for the three-months ended March 31, 2025,

Net other income for the three-months ended June 30,

2025 was $1.2 million, as compared to $2.4 million for the comparable three-months ended June 30, 2024.

Net other income for the nine

months ended June 30, 2025 was $4.0 million as compared to $7.2 million for the comparable nine months ended June 30, 2024.

In both periods,

the decrease in other income is related to a decrease of research and development incentive income, as a result of the completion of Australian

clinical trials, as well as a decrease in interest income as a result of lower cash balances and market interest rates.

Net loss for the three-months ended June 30, 2025,

was $13.2 million, or $0.16 per share, as compared to $12.2 million, or $0.14 per share in the comparative quarter of fiscal 2024.

Net loss for the six-months ended March 31, 2025,

was $23.3 million, or $0.27 per share, as compared to $19.2 million, or $0.23 per share for the six-months ended March 31, 2024.

in net loss for the quarter and year-to-date periods is primarily related to an increase in research and development expenditures and

a decrease in other income, as discussed above.

Net loss for the nine-months ended June 30, 2025,

was $36.6 million, or $0.43 per share, as compared to $31.4 million, or $0.38 per share for the nine-months ended June 30, 2024.

in net loss is primarily related to the net increases in operating expenses and net decreases in other income, as more fully described

Liquidity and Capital Resources

Working Capital (in thousands)

June 30, 2025

September 30, 2024

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Working Capital

On March 31, 2025, we had net current assets of $99.8

On June 30, 2025, we had net current assets of $91.0

million, a decrease of approximately $29.3 million from our year ended September 30, 2024.

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The following

table summarizes cash flows during the six months ended March 31, 2025 and 2024 (in thousands):

table summarizes cash flows during the nine months ended June 30, 2025 and 2024 (in thousands):

Net cash flows used in operating activities

Net cash flows provided by financing activities

Net cash flows (used in) provided by financing activities

Decrease in cash and cash equivalents

Cash flow used in operating activities

Net cash used in operating activities for the six-months

ended March 31, 2025 was $18.0 million, compared to $19.0 million during the comparable period ended March 31, 2024.

Net cash used in operating activities for the nine-months

ended June 30, 2025 was $30.4 million, compared to $24.2 million during the comparable period ended June 30, 2024.

The principal reason

for this is due to changes in working capital as a result of (i) the receipt of the annual research and development incentive tax refund

during the current quarter, whereas such amount was received in third quarter of fiscal 2024 and (ii) an increase in accrued liabilities

related to activities associated with a large manufacturing run for ANAVEX ® 2-73, which work was not yet invoiced at March

for this is due to a net increase in net loss over the comparable period, as described above, as well as a decrease in working capital

balances during the period, as compared to the prior period.

Cash flow provided by financing activities

Cash flows from financing activities for the six-month

period ended March 31, 2025 was $1.6 million, compared to cash provided from financing activities of $7.3 million during the comparable

six-month period ended March 31, 2024.

During the six months ended March 31, 2025, we received

Cash flows used in financing activities for the nine-month

period ended June 30, 2025 was $0.6 million, compared to cash provided from financing activities of $11.9 million during the comparable

nine-month period ended June 30, 2024.

During the nine months ended June 30, 2025, we received

$1.7 million in cash from the exercise of stock options by our employees.

During the six months ended March 31, 2024, cash provided

We utilized $2.3 million to satisfy tax withholding obligations

associated with the net exercise of an employee stock option to our CEO, in exchange for the withholding of shares.

During the nine months ended June 30, 2024, cash provided

by financing activities was primarily attributable to cash received from the issuance of common shares at various market prices under

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Other Financings

Sales Agreement

On July 25, 2025, we entered into a Sales Agreement

(the “Sales Agreement”) with TD Securities (USA) LLC (the “Sales Agent”).

Pursuant to the Sales Agreement, the

Company may offer and sell up to an aggregate offering price of $150 million (the “Offering”) in shares of common stock from

time to time through the Sales Agent.

Upon delivery of a placement notice based on our instructions

and subject to the terms and conditions of the Sales Agreement, the Sales Agent may sell shares of common stock by methods deemed to be

an “at the market offering”, in negotiated transactions at market prices prevailing at the time of sale or at prices related

to such prevailing market prices, or by any other method permitted by law, including negotiated transactions, subject to our prior written

We are not obligated to make any sales of shares under the Sales Agreement.

We or the Sales Agent may suspend or terminate the

Offering upon notice to the other party, subject to certain conditions.

The Sales Agent will act as sales agent on a commercially reasonable

efforts basis consistent with its normal trading and sales practices, applicable state and federal law, rules and regulations and the

rules of Nasdaq.

We have agreed to pay the Sales Agent commissions

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

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

2023 Purchase Agreement

On February 3, 2023, the Company entered into a $150,000,000

On February 3, 2023, we entered into a $150,000,000

purchase agreement (the “2023 Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant

to which the Company has the right to sell and issue to Lincoln Park, and Lincoln Park is obligated to purchase, up to $150.0 million

in value of its shares of Common Stock from time to time over a three-year period until February 3, 2026.

to which we have the right to sell and issue to Lincoln Park, and Lincoln Park is obligated to purchase, up to $150.0 million in value

of our shares of Common Stock from time to time over a three-year period until February 3, 2026.

On any business day and subject to having an effective

registration statement and subject to certain customary conditions, the Company may direct Lincoln Park to purchase up to 200,000 shares

of Common Stock (such purchases, “Regular Purchases”).

The amount of a Regular Purchase may increase under certain circumstances

based on the market price of the Common Stock;

registration statement and subject to certain customary conditions, we may direct Lincoln Park to purchase up to 200,000 shares of Common

Stock (such purchases, “Regular Purchases”).

The amount of a Regular Purchase may increase under certain circumstances based

on the market price of the Common Stock;

provided, however, that Lincoln Park’s committed obligation under any Regular Purchase

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may pay to purchase Common Stock under the 2023 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,” each as set forth in the 2023 Purchase Agreement.

In addition, if we have directed Lincoln Park to purchase the full

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

purchases” and “additional accelerated purchases,” each as set forth in the 2023 Purchase Agreement.

The 2023 Purchase Agreement limits the Company’s

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the “commitment shares”), when and if, Lincoln Park purchased, at the Company’s discretion, the $150.0 million aggregate

During the six-months ended March 31, 2025, the Company

During the nine-months ended June 30, 2025, the Company

did not issue any shares of common stock under the 2023 Purchase Agreement.

During the six-month period ended March 31, 2024, the Company

During the nine-month period ended June 30, 2024, the Company

issued to Lincoln Park an aggregate of 2,455,646 shares of Common Stock under the 2023 Purchase Agreement, including 2,450,000 shares

of Common Stock for an aggregate purchase price of $7,411,700 and 3,707 commitment shares.

On March 31, 2025, there was an unused amount of $110.8

of Common Stock for an aggregate purchase price of $11.3 million and 5,646 commitment shares.

On June 30, 2025, there was an unused amount of $110.8

million under the 2023 Purchase Agreement.

The Company will need to obtain effectiveness of a new registration statement in order to access

funds under the 2023 Purchase Agreement.

The Company will need to file a prospectus supplement in order to access funds under the 2023

Purchase Agreement.

Off-Balance Sheet Arrangements

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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