Item 1. Financial Statements
ITEM 1. FINANCIAL STATEMENTS
4
Anavex Life Sciences Corp.
Condensed Consolidated Interim Financial Statements
June 30, 2024
(Unaudited)
5
Anavex
Life Sciences Corp.
Condensed
Consolidated Interim Balance Sheets
(in
thousands, except share and per share amounts)
June 30,
September 30,
2024
2023
(Unaudited)
Assets
Current
Cash and cash equivalents
$ 138,756
$ 151,024
Incentive and tax receivables
1,720
2,709
Prepaid expenses and other current assets
1,059
653
Total Assets
$ 141,535
$ 154,386
Liabilities and Stockholders' Equity
Current Liabilities
Accounts payable
$ 3,503
$ 4,322
Accrued liabilities - Note 4
7,334
7,295
Deferred grant income - Note 3
917
917
Total Liabilities
$ 11,754
$ 12,534
Commitments and Contingencies - Note 6
—
—
Capital stock
Authorized:
10,000,000 preferred stock, par value $ 0.001 per share
—
—
200,000,000 common stock, par value $ 0.001 per share
Issued and outstanding:
84,795,517 common shares (September 30, 2023 - 82,066,511 )
85
82
Additional paid-in capital
454,236
434,839
Share proceeds receivable
( 89 )
—
Accumulated deficit
( 324,451 )
( 293,069 )
Total Stockholders' Equity
$ 129,781
$ 141,852
Total Liabilities and Stockholders' Equity
$ 141,535
$ 154,386
See
Accompanying Notes to Condensed Consolidated Interim Financial Statements
6
Anavex Life Sciences Corp.
Condensed Consolidated Interim Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(Unaudited)
Three months ended June 30,
Nine months ended June 30,
2024
2023
2024
2023
Operating expenses
General and administrative
$ 2,859
$ 3,248
$ 8,258
$ 9,447
Research and development
11,870
10,283
30,283
33,657
Total operating expenses
14,729
13,531
38,541
43,104
Operating loss
( 14,729 )
( 13,531 )
( 38,541 )
( 43,104 )
Other income (expense)
Grant income
—
—
—
25
Research and development incentive income
526
565
1,591
2,048
Interest income, net
1,796
1,828
5,561
4,561
Other financing expense
—
—
—
( 964 )
Foreign exchange gain (loss)
67
( 101 )
72
146
Gain on settlement of accounts payable
59
—
59
—
Total other income, net
2,448
2,292
7,283
5,816
Net loss before provision for income taxes
( 12,281 )
( 11,239 )
( 31,258 )
( 37,288 )
Income tax recovery (expense), current
67
( 41 )
( 124 )
( 71 )
Net loss and comprehensive loss
$ ( 12,214 )
$ ( 11,280 )
$ ( 31,382 )
$ ( 37,359 )
Net Loss per share
Basic and diluted
$ ( 0.14 )
$ ( 0.14 )
$ ( 0.38 )
$ ( 0.47 )
Weighted average number of shares outstanding
Basic and diluted
84,535,328
80,875,235
83,022,330
79,051,038
See
Accompanying Notes to Condensed Consolidated Interim Financial Statements
7
Anavex
Life Sciences Corp.
Condensed
Consolidated Interim Statements of Changes in Stockholders' Equity
For
the three months ended June 30, 2024 and 2023
(in
thousands, except share and per share amounts)
(Unaudited)
Common Stock
Additional Paid-in
Share proceeds
Accumulated
Shares
Par Value
Capital
Receivable
Deficit
Total
Balance, April 1, 2024
83,616,218
$ 84
$ 447,345
$ ( 234 )
$ ( 312,237 )
$ 134,958
Shares issued under 2023 purchase agreement
Purchase shares
950,000
1
3,870
234
—
4,105
Commitment shares
1,939
—
—
—
—
—
Shares issued pursuant to exercise of stock options
227,360
—
533
( 89 )
—
444
Share based compensation
—
—
2,488
—
—
2,488
Net loss
—
—
—
—
( 12,214 )
( 12,214 )
Balance, June 30, 2024
84,795,517
$ 85
$ 454,236
$ ( 89 )
$ ( 324,451 )
$ 129,781
Balance, April 1, 2023
80,235,398
$ 80
$ 416,728
$ —
$ ( 271,643 )
$ 145,165
Shares issued under 2023 Purchase Agreement
Purchase shares
1,050,000
1
8,534
—
—
8,535
Commitment shares
4,268
—
—
—
—
—
Shares issued pursuant to exercise of stock options
101,250
—
468
—
—
468
Share based compensation
—
—
3,867
—
—
3,867
Net loss
—
—
—
—
( 11,280 )
( 11,280 )
Balance, June 30, 2023
81,390,916
$ 81
$ 429,597
$ —
$ ( 282,923 )
$ 146,755
See
Accompanying Notes to Condensed Consolidated Interim Financial Statements
8
Anavex Life Sciences Corp.
Condensed Consolidated Interim Statements of Changes in Stockholders' Equity
For the nine months ended June 30, 2024 and 2023
(in thousands, except share and per share amounts)
(Unaudited)
Common Stock
Additional Paid-in
Share proceeds
Accumulated
Shares
Par Value
Capital
Receivable
Deficit
Total
Balance, October 1, 2023
82,066,511
$ 82
$ 434,839
$ —
$ ( 293,069 )
$ 141,852
Shares issued under 2023 purchase agreement
Purchase shares
2,450,000
3
11,281
—
—
11,284
Commitment shares
5,646
—
—
—
—
—
Shares issued pursuant to exercise of stock options
273,360
—
691
( 89 )
—
602
Share based compensation
—
—
7,425
—
—
7,425
Net loss
—
—
—
—
( 31,382 )
( 31,382 )
Balance, June 30, 2024
84,795,517
$ 85
$ 454,236
$ ( 89 )
$ ( 324,451 )
$ 129,781
Balance, October 1, 2022
77,942,815
$ 78
$ 387,977
$ —
$ ( 245,564 )
142,491
Shares issued under 2023 Purchase Agreement
Initial commitment shares
75,000
—
845
—
845
Purchase shares
3,125,000
3
26,684
—
26,687
Commitment shares
13,348
—
—
—
—
Shares issued pursuant to exercise of stock options
234,753
—
908
—
—
908
Share based compensation
—
—
13,183
—
—
13,183
Net loss
—
—
—
—
( 37,359 )
( 37,359 )
Balance, June 30, 2023
81,390,916
$ 81
$ 429,597
$ —
$ ( 282,923 )
146,755
See
Accompanying Notes to Condensed Consolidated Interim Financial Statements
9
Anavex Life Sciences Corp.
Condensed Consolidated Interim Statements of Cash Flows
(in thousands, except share and per share amounts)
(Unaudited)
Nine months ended June 30,
2024
2023
Cash Flows used in Operating Activities
Net loss
$
( 31,382
)
$
( 37,359
)
Adjustments to reconcile net loss to net cash used in operations:
Non-cash financing related charges
—
845
Gain on settlement of accounts payable
( 59
)
—
Share-based compensation
7,425
13,183
Changes in working capital balances related to operations:
Incentive and tax receivables
989
1,027
Prepaid expenses and deposits
( 406
)
( 473
)
Accounts payable
( 760
)
327
Accrued liabilities
39
41
Deferred grant income
—
473
Net cash used in operating activities
( 24,154
)
( 21,936
)
Cash Flows provided by Financing Activities
Issuance of common shares
11,284
26,687
Proceeds from exercise of stock options
602
908
Net cash provided by financing activities
11,886
27,595
Increase (decrease) in cash and cash equivalents during the period
( 12,268
)
5,659
Cash and cash equivalents, beginning of period
151,024
149,158
Cash and cash equivalents, end of period
$
138,756
$
154,817
Supplemental Cash Flow Information
Cash paid for state and local minimum income taxes
$
220
$
209
See
Accompanying Notes to Condensed Consolidated Interim Financial Statements
10
Anavex
Life Sciences Corp.
Notes
to the Condensed Consolidated Interim Financial Statements
June
30, 2024
(Unaudited)
Note 1 Business Description
Business
Anavex Life Sciences Corp. (“Anavex” or
the “Company”) is a clinical stage biopharmaceutical company engaged in the development of differentiated therapeutics by
applying precision medicine to central nervous system (“CNS”) diseases with high unmet need. Anavex analyzes genomic data
from clinical trials to identify biomarkers, which are used in the analysis of its clinical trials for the treatment of neurodegenerative
and neurodevelopmental diseases.
The Company’s lead compound ANAVEX ® 2-73
is being developed to treat Alzheimer’s disease, Parkinson’s disease and potentially other central nervous system diseases,
including rare diseases, such as Rett syndrome, a rare severe neurological monogenic disorder caused by mutations in the X-linked gene,
methyl-CpG-binding protein 2 (“MECP2”).
Note 2 Basis of Presentation
Basis of Presentation
These accompanying unaudited condensed consolidated
interim financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”)
and accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim reporting. Accordingly,
certain information and note disclosures normally included in the annual financial statements in accordance with U.S. GAAP have been condensed
or omitted pursuant to such rules and regulations. In the opinion of management, the disclosures are adequate to make the information
presented not misleading.
These accompanying unaudited condensed consolidated
interim financial statements reflect all adjustments, consisting of normal recurring adjustments, which in the opinion of management are
necessary for fair presentation of the information contained herein. The consolidated balance sheet as of September 30, 2023 was derived
from the audited annual financial statements but does not include all disclosures required by U.S. GAAP. The accompanying unaudited condensed
consolidated interim financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto
included in the Company’s annual report on Form 10-K for the year ended September 30, 2023 filed with the SEC on November 27, 2023.
The Company follows the same accounting policies in the preparation of interim reports.
Operating results for the nine months ended June 30,
2024 are not necessarily indicative of the results that may be expected for the year ending September 30, 2024.
Liquidity
All of the Company’s potential drug compounds
are in the clinical development stage and the Company cannot be certain that its research and development efforts will be successful or,
if successful, that its potential drug compounds will ever be approved for sales to pharmaceutical companies or generate commercial revenues.
To date, we have not generated any revenues from our operations. The Company expects the business to continue to experience negative cash
flows from operations for the foreseeable future and cannot predict when, if ever, our business might become profitable.
Management believes that the current working capital
position will be sufficient to meet the Company’s working capital requirements beyond the next 12 months after the date that these
condensed consolidated interim financial statements are issued. The process of drug development can be costly, and the timing and outcomes
of clinical trials are uncertain. The assumptions upon which the Company has based its estimates are routinely evaluated and may
be subject to change. The actual amount of the Company’s expenditures will vary depending upon a number of factors including
but not limited to the design, timing and duration of future clinical trials, the progress of the Company’s research and development
programs and the level of financial resources available. The Company has the ability to adjust its operating plan spending levels based
on the timing of future clinical trials.
11
Anavex
Life Sciences Corp.
Notes
to the Condensed Consolidated Interim Financial Statements
June
30, 2024
(Unaudited)
Other than our rights related to the 2023 Purchase
Agreement (as defined below in Note 5), there can be no assurance that additional financing will be available to us when needed or, if
available, that it can be obtained on commercially reasonable terms. If the Company is not able to obtain the additional financing on
a timely basis, if and when it is needed, it will be forced to delay or scale down some or all of its research and development activities.
Use of Estimates
The preparation of financial statements in accordance
with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the
date of the financial statements and the reported amounts of revenue and expenses in the reporting period. The Company regularly evaluates
estimates and assumptions related to accounting for research and development costs, incentive income receivable, valuation and recoverability
of deferred tax assets, share based compensation, and loss contingencies. The Company bases its estimates and assumptions on current facts,
historical experience, and various other factors that it believes to be reasonable under the circumstances, the results of which form
the basis for making judgments about the carrying values of assets and liabilities and the accrual of costs and expenses that are not
readily apparent from other sources. The actual results experienced by the Company may differ materially and adversely from the Company’s
estimates. To the extent there are material differences between the estimates and the actual results, future results of operations will
be affected.
Principles of Consolidation
These consolidated financial statements include the
accounts of Anavex Life Sciences Corp. and its wholly-owned subsidiaries, Anavex Australia Pty Limited (“Anavex Australia”),
a company incorporated under the laws of Australia, Anavex Germany GmbH, a company incorporated under the laws of Germany, and Anavex
Canada Ltd., a company incorporated under the laws of the Province of Ontario, Canada. All inter-company transactions and balances have
been eliminated.
Fair
Value Measurements
The fair value hierarchy under GAAP is based on three
levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value which
are the following:
Level 1 - quoted prices (unadjusted) in active
markets for identical assets or liabilities;
Level 2 - observable inputs other than Level 1, quoted
prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets
that are not active, and model-derived prices whose inputs are observable or whose significant value drivers are observable; and
Level 3 - assets and liabilities whose significant
value drivers are unobservable by little or no market activity and that are significant to the fair value of the assets or liabilities.
At June 30, 2024 and September 30, 2023, the Company
did not have any Level 3 assets or liabilities.
Basic
and Diluted Loss per Share
Basic income/(loss) per common share is computed by
dividing net income/(loss) available to common stockholders by the weighted average number of common shares outstanding during the period.
Diluted income/(loss) per common share is computed by dividing net income/(loss) available to common stockholders by the sum of (1) the
weighted-average number of common shares outstanding during the period, (2) the dilutive effect of the assumed exercise of options and
warrants using the treasury stock method and (3) the dilutive effect of other potentially dilutive securities. For purposes of the diluted
net loss per share calculation, options and warrants are potentially dilutive securities and are excluded from the calculation of diluted
net loss per share because their effect would be anti-dilutive.
As of June 30, 2024 loss per share excludes 15,190,254
(June 30, 2023: 14,858,863 ) potentially dilutive common shares related to outstanding options and warrants, as their effect was anti-dilutive.
12
Anavex
Life Sciences Corp.
Notes
to the Condensed Consolidated Interim Financial Statements
June
30, 2024
(Unaudited)
Recently Adopted Accounting
Pronouncements
In November 2023, the Financial
Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2023-07, “Segment Reporting: Improvements to Reportable
Segment Disclosures.” This guidance requires disclosure of incremental segment information on an annual and interim basis. This
amendment is effective for our fiscal year ending September 30, 2025 and our interim periods within the fiscal year ending September 30,
2026. The Company is currently assessing the impact of this guidance on its disclosures.
In December 2023, the FASB
issued ASU No. 2023-09, “Income Taxes: Improvements to Income Tax Disclosures.” This guidance requires consistent categories
and greater disaggregation of information in the rate reconciliation and disclosures of income taxes paid by jurisdiction. This amendment
is effective for our fiscal year ending September 30, 2026. The Company is currently assessing the impact of this guidance on its disclosures.
Note 3 Other Income
Grant Income
As of June 30, 2024, the
Company had received a $ 1 .0 million research grant awarded by the Michael J. Fox Foundation for Parkinson’s Research. The grant
will be used to fund a clinical trial of the Company’s lead compound, ANAVEX ® 2-73 related to Parkinson’s disease.
Of the total, $ 0.5 million was received during the year ended September 30, 2023 and $ 0.5 million was received during the year ended September
30, 2021.
The grant income has been
deferred when received and is being amortized to other income as the related research and development expenditures are incurred. During
the three and nine months ended June 30, 2024, the Company recognized $ 0 and $ 0 , respectively (2023: $ 0 and $ 25,000 , respectively) of
this grant on its statements of operations as grant income. At June 30, 2024, an amount of $ 0.9 million (September 30, 2023: $ 0.9 million)
of this grant is recorded as deferred grant income, representing the amount of this grant which has not yet been recognized to other income.
The Company will recognize this income on its statement of operations as the relating expenditures are incurred to offset the income.
Research and development
incentive income
Research and development
incentive income represents the income earned by Anavex Australia of the Australia R&D credit. This cash incentive is received by
Anavex Australia, upon filing of a claim in connection with Anavex Australia’s annual income tax return.
During the three and nine
months ended June 30, 2024 the Company recorded research and development incentive income of $ 0.5 million (AUD 0.8 million) and $ 1.6 million
(AUD 2.4 million), respectively (2023: $ 0.6 million (AUD 0.9 million) and $ 2 .0 million (AUD 3.1 million), respectively) in respect of
the Australia R&D credit for eligible research and development expenses incurred during the period. This amount is included within
Other income on the consolidated statements of operations.
At June 30, 2024, Incentive
and tax receivables includes $ 1.5 million (AUD 2.3 million) (September 30, 2023: $ 2.5 million (AUD 3.9 million)) relating to Australia
R&D credits earned during the year that are expected to be reimbursed upon filing of the Company’s annual claim under this program.
The Australia R&D credit
program is a self-assess program whereby the Company must assess its eligibility each year to determine (i) if the entity is eligible
(ii) if the specific R&D activities are eligible and (iii) if the individual R&D expenditures have nexus to such R&D activities.
The Company evaluates its eligibility under the tax incentive program as of each balance sheet date based on the most current and relevant
data available. Anavex Australia is able to continue to claim the R&D tax incentive for as long as it remains eligible and continues
to incur eligible research and development expenditures.
13
Anavex
Life Sciences Corp.
Notes
to the Condensed Consolidated Interim Financial Statements
June
30, 2024
(Unaudited)
Although the Company believes
that it has complied with all the relevant conditions of eligibility under the program for all periods claimed, the Australian Tax Office
(ATO) has the right to review the Company’s qualifying programs and related expenditures for a period of four years. If such a review
were to occur, the ATO may have different interpretations of certain eligibility requirements. If the ATO disagreed with the Company’s
assessments and any related subsequent appeals, it could require adjustment to and repayment of current or previous years’ claims
already received. Additionally, if the Company was unable to demonstrate a reasonably arguable position taken on such claims, the ATO
could also assess penalties and interest on such adjustment.
Currently, the Company’s
tax incentive claims from 2020 to 2023 are open to potential review by the ATO. Additionally, the period open for review is indefinite
if the ATO suspects fraud. The Company has not provided any allowance for any such potential adjustments, should they occur in the future.
Note 4 Accrued Liabilities
The principal components of accrued liabilities consist of (in thousands):
Schedule of principal components of accrued liabilities
June 30,
September 30,
2024
2023
Accrued clinical site and patient visits costs
$ 795
$ 2,006
Accrued compensation and benefits
1,030
1,360
Fixed contract accruals
—
38
Milestone based contract accruals
3,231
1,267
All other accrued liabilities
2,278
2,624
Total accrued liabilities
$ 7,334
$ 7,295
Note 5 Equity Offerings
Common Stock
Common shares are voting and are entitled to dividends
as declared at the discretion of the Board of Directors (the “Board”).
Preferred Stock
The Company’s Board has the authority to
issue preferred stock in one or more series and to fix the rights, preferences, privileges, restrictions and the number of shares constituting
any series or the designation of the series.
2020 Sales Agreement
The Company entered into a Controlled Equity Offering
Sales Agreement on July 6, 2018, which was amended and restated on May 1, 2020 (the “2020 Sales Agreement”) with Cantor Fitzgerald &
Co. and SVB Leerink LLC (together the “Sales Agents”), pursuant to which the Company could offer and sell shares of common
stock (“Shares”) registered under an effective registration statement from time to time through the Sales Agents (the “Offering”).
Upon delivery of a placement notice based on the Company’s
instructions and subject to the terms and conditions of the 2020 Sales Agreement, the Sales Agents could sell the Shares 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 the prior
written consent of the Company. The Company was not obligated to make any sales of Shares under the 2020 Sales Agreement. The Company
or Sales Agents could suspend or terminate the offering of Shares upon notice to the other party, subject to certain conditions. The Sales
Agents would act as agents on a commercially reasonable efforts basis consistent with their normal trading and sales practices and applicable
state and federal law, rules and regulations and the rules of Nasdaq.
14
Anavex
Life Sciences Corp.
Notes
to the Condensed Consolidated Interim Financial Statements
June
30, 2024
(Unaudited)
The Company agreed to pay the Sales Agents commissions
for their services of up to 3.0 % of the gross proceeds from the sale of the Shares pursuant to the 2020 Sales Agreement. The Company also
agreed to provide the Sales Agents with customary indemnification and contribution rights. During the nine months ended June 30, 2024
and 2023, no shares were sold pursuant to the Offering. At June 30, 2024, an amount of $ 142.4 million (September 30, 2023: $ 142.4 million)
was registered pursuant to an effective registration statement. The Company terminated the 2020 Sales Agreement on July 24, 2024.
2023 Purchase Agreement
On February 3, 2023, the Company entered into a $150.0
million 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.
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”)
and agreed to issue up to an additional 75,000 shares pro rata, when and if, Lincoln Park purchased, at the Company’s discretion,
the $ 150 .0 million aggregate commitment. The Company determined the fair value of the initial commitment shares was $ 0.8 million with
reference to the closing price of the Company’s shares on the Purchase Agreement date. In addition, the Company incurred third party
expenses of $ 0.1 million in connection with entering into the Purchase Agreement. These amounts were expensed to other financing expense
on the statements of operations during the year ended September 30, 2023.
During the nine months 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 $ 11,283,200 and 5,646 commitment shares. During the nine months ended June 30, 2023,
the Company issued to Lincoln Park an aggregate of 3,138,348 shares of common stock under the 2023 Purchase Agreement, including 3,125,000
shares of common stock for an aggregate purchase price of $ 26,687,017 , 13,348 commitment shares and the 75,000 initial commitment shares.
At June 30, 2024, an amount of $ 110.8 million remained
available under the 2023 Purchase Agreement.
Note 6 Commitments and Contingencies
Leases
The Company leases office space under an operating
lease with an initial term of 12 months or less. Under the terms of the office lease, the Company is required to pay its proportionate
share of operating costs.
During the three
and nine months ended June 30, 2024 and 2023, operating lease costs were as follows (in thousands):
Schedule of operating lease costs
Three months ended June 30,
Nine months ended June 30,
2024
2023
2024
2023
Operating lease costs
$ 31
$ 25
$ 92
$ 85
Employee 401(k) Benefit Plan
The Company has
a defined-contribution savings plan under Section 401(k) of the Internal Revenue Code. The plan covers all United States based employees.
United States based employees eligible to participate in the plan may contribute up to the current statutory limits under the Internal
Revenue Service regulations. The 401(k) plan permits the Company to make additional matching contributions on behalf of contributing employees.
15
During the three and nine months ended June 30, 2024
and 2023, the Company made matching contributions under the 401(k) plan as follows (in thousands):
Schedule of contributions
plan
Three months ended June 30,
Nine months ended June 30,
2024
2023
2024
2023
Contributions to 401(k) plan
$ 56
$ 76
$ 223
$ 176
Litigation
The Company is subject
to claims and legal proceedings that arise in the ordinary course of business. Such matters are inherently uncertain, and there can be
no guarantee that the outcome of any such matter will be decided favorably to the Company or that the resolution of any such matter will
not have a material adverse effect upon the Company’s consolidated financial statements. The Company does not believe that any of
such pending claims and legal proceedings will have a material adverse effect on its consolidated financial statements.
On
March 13, 2024, a shareholder class action complaint was filed in the United States District Court for the Southern District of New York.
The complaint is captioned Blum v. Anavex Life Sciences, Corp. et al., case number 1:24-cv-01910, and names the Company and Christopher
Missling as Defendants. The complaint alleges violations of the Securities and Exchange Act of 1934 resulting from disclosures and statements
made about certain clinical trials for ANAVEX ® 2-73. On July 12, 2024, the lead plaintiff filed an amended complaint. The
Company believes the complaint is without merit. The Company is vigorously pursuing its defenses and a potential dismissal of all claims
asserted in the lawsuit.
On May 8, 2024,
another purported shareholder of the Company filed a similar lawsuit against the same defendants that raised similar allegations and in
addition, raised allegations related to disclosures and statements made about the AVATAR trial. The shareholder sought to consolidate
the cases and be appointed lead plaintiff of the consolidated action. The court denied the consolidation motion and lead plaintiff motion
on June 13, 2024. The Company plans to vigorously defend the lawsuit.
On May 13, 2024,
a purported shareholder filed a derivative lawsuit on behalf of the Company against the board of directors. The complaint asserts various
common law claims (including breach of fiduciary duty) and violation of Section 14(a) regarding the same allegations at issue in the two
purported class action lawsuits related to disclosures and statements made about certain clinical trials. The Company is named as a Nominal
Defendant. The defendants plan to vigorously defend the lawsuit.
Share Purchase Warrants
A summary of the status of the Company’s outstanding
share purchase warrants is presented below:
Schedule of warrants
outstanding
Number of Warrants
Weighted Average Exercise Price
($)
Balance, September 30, 2022
160,000
3.72
—
—
Balance, September 30, 2022 and 2023
160,000
3.72
Expired
( 150,000 )
3.17
Balance, June 30, 2024
10,000
12.00
At June 30, 2024, the Company had share purchase warrants
outstanding as follows:
Schedule of share purchase warrants
outstanding
Number
Exercise Price
Expiry Date
10,000
$ 12.00
April 21, 2026
Stock–based Compensation
Plan
2015 Stock Option Plan
On September 18, 2015, the Company’s Board approved
a 2015 Omnibus Incentive Plan (the “2015 Plan”), which provided for the grant of stock options and restricted stock awards
to directors, officers, employees and consultants of the Company.
The maximum number of our common shares reserved for
issue under the plan was 6,050,553 shares, subject to adjustment in the event of a change of the Company’s capitalization.
16
Anavex
Life Sciences Corp.
Notes
to the Condensed Consolidated Interim Financial Statements
June
30, 2024
(Unaudited)
2019 Stock Option Plan
On January 15, 2019, the Board approved the 2019 Omnibus
Incentive Plan (the “2019 Plan”), which provides for the grant of stock options and restricted stock awards to directors,
officers, employees, consultants and advisors of the Company.
The maximum number of our common shares reserved for
issue under the plan was 6,000,000 shares, subject to adjustment in the event of a change of the Company’s capitalization.
During the year ended September 30, 2022, 406,453
options previously available under the 2019 Plan and the 2015 Plan became available under the 2022 Plan (as defined below).
2022 Stock Option Plan
On March 25, 2022, the Board approved the 2022 Omnibus
Incentive Plan (the “2022 Plan”). The 2022 Plan was approved by stockholders on May 24, 2022. Under the terms of the 2022
Plan, 10,000,000 additional shares of Common Stock will be available for issuance under the plan, in addition to the shares available
under the 2019 Plan and the 2015 Plan. Any awards outstanding under a previous stock option plan will remain subject to and be paid under
such plan, and any shares subject to outstanding awards under a previous plan that subsequently cease to be subject to such awards (other
than by reason of settlement of the awards in shares) will automatically become available for issuance under the 2022 Plan.
The 2022 Plan provides that it may be administered
by the Board, or the Board may delegate such responsibility to a committee. The exercise price will be determined by the Board at the
time of grant shall be at least equal to the fair market value on such date. If the grantee is a 10% stockholder on the grant date, then
the exercise price shall not be less than 110% of fair market value of the Company’s shares of common stock on the grant date. Stock
options may be granted under the 2022 Plan for an exercise period of up to ten years from the date of grant of the option or such lesser
periods as may be determined by the Board, subject to earlier termination in accordance with the terms of the 2022 Plan. At June 30, 2024,
5,300,000 options had been issued under the 2022 Plan and 5,319,702 options were available for issue under the 2022 Plan.
The following summarizes information about stock option
activity during the year ended September 30, 2023 and nine months ended June 30, 2024:
Schedule of stock option
activity
Number of Options
Weighted Average Exercise Price
($)
Weighted Average Grant Date Fair Value
($)
Aggregate intrinsic value
($)
Outstanding, September 30, 2022
13,169,616
6.61
4.96
62,267,309
Granted
1,959,000
9.30
6.60
—
Exercised
( 759,753 )
2.34
0.95
4,629,026
Forfeited
( 257,083 )
12.00
6.74
—
Outstanding, September 30, 2023
14,111,780
7.12
5.27
22,290,069
Granted
1,815,500
5.48
3.96
—
Exercised
( 273,360 )
2.53
1.11
601,407
Forfeited
( 473,666 )
11.78
8.17
—
Outstanding, June 30, 2024
15,180,254
6.86
7,471,069
Exercisable, June 30, 2024
9,826,089
5.50
7,452,002
17
Anavex
Life Sciences Corp.
Notes
to the Condensed Consolidated Interim Financial Statements
June
30, 2024
(Unaudited)
The following summarizes information about stock options
at June 30, 2024 by a range of exercise prices:
Schedule of stock options exercise prices
Range of exercises prices
Number of
Weighted average remaining
Weighted
Number of
Weighted
From
To
outstanding options
contractual life (in years)
average exercise price
vested options
average exercise price
$ 0.92
$ 3.00
3,015,700
4.04
$ 2.39
3,015,700
$ 2.39
$ 3.01
$ 5.00
2,232,500
4.17
$ 3.41
2,035,416
$ 3.29
$ 5.01
$ 9.00
6,660,554
6.32
$ 6.57
3,469,639
$ 6.20
$ 9.01
$ 13.00
1,806,500
7.57
$ 10.46
729,917
$ 11.05
$ 13.01
$ 25.00
1,465,000
6.70
$ 18.18
575,417
$ 18.41
15,180,254
5.73
$ 6.86
9,826,089
$ 5.50
The weighted average grant date fair value of options
vested at June 30, 2024 was $ 4.34 (September 30, 2023: $ 3.94 ). At June 30, 2024, the weighted average contractual life of options outstanding
was 5.7 years (September 30, 2023: 6.0 years) and for options exercisable was 4.2 years (September 30, 2023: 4.75 years).
The aggregate intrinsic value is calculated as the
difference between the exercise price of the underlying awards and the quoted market price of the Company’s stock for the options
that were in-the-money at June 30, 2024.
During the three and nine months ended June 30, 2024,
the Company recognized stock-based compensation expense of $ 2.5 million and $ 7.4 million, respectively (2023: $ 3.9 million and $ 13.2 million,
respectively) in connection with the issuance and vesting of stock options and warrants in exchange for services. These amounts have
been included in general and administrative expenses and research and development expenses on the Company’s condensed consolidated
interim statement of operations as follows (in thousands):
Schedule of stock-based compensation
Three months ended June 30,
Nine months ended June 30,
2024
2023
2024
2023
General and administrative
$ 997
$ 1,451
$ 2,901
$ 4,451
Research and development
1,491
2,415
4,524
8,732
Total stock-based compensation
$ 2,488
$ 3,866
$ 7,425
$ 13,183
An amount of approximately $ 10.6 million in stock-based
compensation is expected to be recorded over the remaining term of such options through fiscal 2026.
The fair value of each option award
granted during the three and nine months ended June 30, 2024 and 2023 is estimated on the date of grant using the Black Scholes option
pricing model based on the following weighted average assumptions:
Schedule of weighted average assumptions
2024
2023
Risk-free interest rate
4.29 %
3.69 %
Expected life of options (years)
5.77
5.63
Annualized volatility
84.82 %
85.16 %
Dividend rate
0.00 %
0.00 %
The fair value of stock compensation charges recognized
during the three and nine months ended June 30, 2024 and 2023 was determined with reference to the quoted market price of the Company’s
shares on the grant date.
Note 7 Subsequent Events
On July 24, 2024, the Company terminated the 2020 Sales Agreement.
18
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.