Item 1.
FINANCIAL STATEMENTS
ANAVEX LIFE SCIENCES CORP.
INTERIM CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2019
(Unaudited)
ANAVEX LIFE SCIENCES CORP.
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
June 30, 2019 and September 30, 2018
|
|
June 30,
|
|
|
September 30,
|
|
|
|
2019
|
|
|
2018
|
|
|
|
(Unaudited)
|
|
|
|
|
Assets
|
|
|
|
|
|
|
Current
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
21,249,206
|
|
|
$
|
22,930,638
|
|
Sales tax recoverable
|
|
|
93,314
|
|
|
|
40,171
|
|
Prepaid expenses
|
|
|
459,618
|
|
|
|
1,251,798
|
|
Deposits - short term
|
|
|
15,000
|
|
|
|
-
|
|
|
|
|
21,817,138
|
|
|
|
24,222,607
|
|
Deferred costs
|
|
|
151,133
|
|
|
|
101,133
|
|
Deposits
|
|
|
-
|
|
|
|
52,396
|
|
Total Assets
|
|
$
|
21,968,271
|
|
|
$
|
24,376,136
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity
|
|
|
|
|
|
|
|
|
Current
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
$
|
4,336,607
|
|
|
$
|
3,884,626
|
|
Total Liabilities
|
|
|
4,336,607
|
|
|
|
3,884,626
|
|
|
|
|
|
|
|
|
|
|
Commitments - Note 5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital stock
|
|
|
|
|
|
|
|
|
Authorized:
|
|
|
|
|
|
|
|
|
10,000,000 preferred stock, par value $0.001 per share
100,000,000 common shares, par value $0.001 per share
|
|
|
|
|
|
|
|
|
Issued and outstanding:
|
|
|
|
|
|
|
|
|
51,509,871 common shares (September 30, 2018 - 45,933,472)
|
|
|
51,511
|
|
|
|
45,935
|
|
Additional paid-in capital
|
|
|
148,927,688
|
|
|
|
129,377,542
|
|
Accumulated deficit
|
|
|
(131,347,535
|
)
|
|
|
(108,931,967
|
)
|
Total Stockholders’ Equity
|
|
|
17,631,664
|
|
|
|
20,491,510
|
|
Total Liabilities and Stockholders’ Equity
|
|
$
|
21,968,271
|
|
|
$
|
24,376,136
|
|
See Accompanying Notes to Condensed Consolidated
Interim Financial Statements
ANAVEX LIFE SCIENCES CORP.
INTERIM CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
For the three and
nine months ended June 30, 2019 and 2018
(Unaudited)
|
|
Three months ended June 30,
|
|
|
Nine months ended June 30,
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
$
|
1,388,729
|
|
|
$
|
1,620,379
|
|
|
$
|
5,211,287
|
|
|
$
|
4,507,632
|
|
Research and development
|
|
|
5,758,446
|
|
|
|
2,997,634
|
|
|
|
17,549,442
|
|
|
|
8,936,969
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
(7,147,175
|
)
|
|
|
(4,618,013
|
)
|
|
|
(22,760,729
|
)
|
|
|
(13,444,601
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expenses)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant income
|
|
|
74,944
|
|
|
|
74,528
|
|
|
|
223,999
|
|
|
|
74,528
|
|
Research and development incentive income
|
|
|
-
|
|
|
|
1,629,513
|
|
|
|
-
|
|
|
|
1,629,513
|
|
Interest income, net
|
|
|
34,838
|
|
|
|
112,226
|
|
|
|
165,103
|
|
|
|
171,249
|
|
Gain on settlement of accounts payable
|
|
|
36,978
|
|
|
|
|
|
|
|
36,978
|
|
|
|
-
|
|
Financing related charges
|
|
|
-
|
|
|
|
(30,943
|
)
|
|
|
-
|
|
|
|
(30,943
|
)
|
Foreign exchange gain (loss), net
|
|
|
(54,546
|
)
|
|
|
(16,475
|
)
|
|
|
(4,854
|
)
|
|
|
(22,833
|
)
|
Total other income, net
|
|
|
92,214
|
|
|
|
1,768,849
|
|
|
|
421,226
|
|
|
|
1,821,514
|
|
Net loss before provision for income taxes
|
|
|
(7,054,961
|
)
|
|
|
(2,849,164
|
)
|
|
|
(22,339,503
|
)
|
|
|
(11,623,087
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense
|
|
|
(19,300
|
)
|
|
|
-
|
|
|
|
(76,065
|
)
|
|
|
(37,266
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss and comprehensive loss
|
|
$
|
(7,074,261
|
)
|
|
$
|
(2,849,164
|
)
|
|
$
|
(22,415,568
|
)
|
|
$
|
(11,660,353
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
$
|
(0.14
|
)
|
|
$
|
(0.06
|
)
|
|
$
|
(0.47
|
)
|
|
$
|
(0.26
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
|
49,622,465
|
|
|
|
45,212,074
|
|
|
|
47,691,921
|
|
|
|
44,365,683
|
|
See Accompanying Notes to Condensed Consolidated
Interim Financial Statements
ANAVEX LIFE SCIENCES CORP.
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For the nine months ended June 30, 2019 and 2018
(Unaudited)
|
|
2019
|
|
|
2018
|
|
Cash Flows used in Operating Activities
|
|
|
|
|
|
|
Net loss
|
|
$
|
(22,415,568
|
)
|
|
$
|
(11,660,353
|
)
|
Adjustments to reconcile net loss to net cash used in operations:
|
|
|
|
|
|
|
|
|
Stock-based compensation
|
|
|
5,194,343
|
|
|
|
4,025,412
|
|
Changes in non-cash working capital balances related to operations:
|
|
|
|
|
|
|
|
|
Sales tax recoverable
|
|
|
(53,143
|
)
|
|
|
3,603
|
|
Prepaid expenses and deposits
|
|
|
792,180
|
|
|
|
(522,632
|
)
|
Deposits
|
|
|
37,396
|
|
|
|
-
|
|
Accounts payable and accrued liabilities
|
|
|
451,981
|
|
|
|
(375,264
|
)
|
Net cash used in operating activities
|
|
|
(15,992,811
|
)
|
|
|
(8,529,234
|
)
|
|
|
|
|
|
|
|
|
|
Cash Flows provided by Financing Activities
|
|
|
|
|
|
|
|
|
Issuance of common shares
|
|
|
14,361,379
|
|
|
|
6,966,569
|
|
Deferred financing charges
|
|
|
(50,000
|
)
|
|
|
(50,000
|
)
|
Net cash provided by financing activities
|
|
|
14,311,379
|
|
|
|
6,916,569
|
|
|
|
|
|
|
|
|
|
|
Decrease in cash and cash equivalents during the period
|
|
|
(1,681,432
|
)
|
|
|
(1,612,665
|
)
|
Cash and cash equivalents, beginning of period
|
|
|
22,930,638
|
|
|
|
27,440,257
|
|
Cash and cash equivalents, end of period
|
|
$
|
21,249,206
|
|
|
$
|
25,827,592
|
|
See Accompanying Notes to Condensed Consolidated Interim Financial
Statements
ANAVEX LIFE SCIENCES CORP.
INTERIM CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY
For the three months ended June 30, 2019 and 2018
(Unaudited)
|
|
Common Stock
|
|
|
|
|
|
|
|
|
|
Shares
|
|
|
Par Value
|
|
|
Additional
Paid-in
Capital
|
|
|
Common
Shares to be
Issued
|
|
|
Accumulated
Deficit
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, April 1, 2019
|
|
|
48,173,241
|
|
|
$
|
48,175
|
|
|
$
|
138,696,975
|
|
|
$
|
(292,700
|
)
|
|
$
|
(124,273,274
|
)
|
|
$
|
14,179,176
|
|
Shares issued under 2015 Purchase Agreement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase shares
|
|
|
2,619,403
|
|
|
|
2,619
|
|
|
|
7,833,451
|
|
|
|
292,700
|
|
|
|
-
|
|
|
|
8,128,770
|
|
Commitment shares
|
|
|
14,070
|
|
|
|
14
|
|
|
|
(14
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Shares issued under 2019 Purchase Agreement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase shares
|
|
|
375,000
|
|
|
|
375
|
|
|
|
1,163,400
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,163,775
|
|
Commitment shares
|
|
|
328,157
|
|
|
|
328
|
|
|
|
(328
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Shares issued pursuant to cashless exercise of warrants
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Share based compensation
|
|
|
-
|
|
|
|
-
|
|
|
|
1,234,204
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,234,204
|
|
Net loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(7,074,261
|
)
|
|
|
(7,074,261
|
)
|
Balance, June 30, 2019
|
|
|
51,509,871
|
|
|
$
|
51,511
|
|
|
$
|
148,927,688
|
|
|
$
|
-
|
|
|
$
|
(131,347,535
|
)
|
|
$
|
17,631,664
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, April 1, 2018
|
|
|
44,573,788
|
|
|
$
|
44,575
|
|
|
$
|
122,724,029
|
|
|
$
|
-
|
|
|
$
|
(100,289,747
|
)
|
|
$
|
22,478,857
|
|
Shares issued under 2015 Purchase Agreement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase shares
|
|
|
650,000
|
|
|
|
649
|
|
|
|
2,277,550
|
|
|
|
-
|
|
|
|
-
|
|
|
|
2,278,199
|
|
Commitment shares
|
|
|
4,093
|
|
|
|
5
|
|
|
|
(5
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Shares issued pursuant to cashless exercise of options
|
|
|
86,274
|
|
|
|
86
|
|
|
|
(86
|
)
|
|
|
|
|
|
|
-
|
|
|
|
-
|
|
Share based compensation
|
|
|
-
|
|
|
|
-
|
|
|
|
1,677,731
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,677,731
|
|
Net loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(2,849,164
|
)
|
|
|
(2,849,164
|
)
|
Balance, June 30, 2018
|
|
|
45,314,155
|
|
|
$
|
45,315
|
|
|
$
|
126,679,219
|
|
|
$
|
-
|
|
|
$
|
(103,138,911
|
)
|
|
$
|
23,585,623
|
|
See Accompanying Notes to Condensed Consolidated
Interim Financial Statements
ANAVEX LIFE SCIENCES CORP.
INTERIM CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY
For the nine months ended June 30, 2019 and 2018
(Unaudited)
|
|
Common Stock
|
|
|
|
|
|
|
|
|
|
Shares
|
|
|
Par Value
|
|
|
Additional
Paid-in
Capital
|
|
|
Common
Shares to be
Issued
|
|
|
Accumulated
Deficit
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, October 1, 2018
|
|
|
45,933,472
|
|
|
$
|
45,935
|
|
|
$
|
129,377,542
|
|
|
$
|
-
|
|
|
$
|
(108,931,967
|
)
|
|
$
|
20,491,510
|
|
Shares issued under 2015 Purchase Agreement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase shares
|
|
|
4,848,995
|
|
|
|
4,849
|
|
|
|
13,192,755
|
|
|
|
-
|
|
|
|
-
|
|
|
|
13,197,604
|
|
Commitment shares
|
|
|
23,701
|
|
|
|
27
|
|
|
|
(27
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Shares issued under 2019 Purchase Agreement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase shares
|
|
|
375,000
|
|
|
|
375
|
|
|
|
1,163,400
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,163,775
|
|
Commitment shares
|
|
|
328,157
|
|
|
|
324
|
|
|
|
(324
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Shares issued pursuant to cashless exercise of warrants
|
|
|
546
|
|
|
|
1
|
|
|
|
(1
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Share based compensation
|
|
|
-
|
|
|
|
-
|
|
|
|
5,194,343
|
|
|
|
-
|
|
|
|
-
|
|
|
|
5,194,343
|
|
Net loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(22,415,568
|
)
|
|
|
(22,415,568
|
)
|
Balance, June 30, 2019
|
|
|
51,509,871
|
|
|
$
|
51,511
|
|
|
$
|
148,927,688
|
|
|
$
|
-
|
|
|
$
|
(131,347,535
|
)
|
|
$
|
17,631,664
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, October 1, 2017
|
|
|
43,330,817
|
|
|
$
|
43,332
|
|
|
$
|
115,689,221
|
|
|
$
|
-
|
|
|
$
|
(91,478,558
|
)
|
|
$
|
24,253,995
|
|
Shares issued under 2015 Purchase Agreement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase shares
|
|
|
1,883,580
|
|
|
|
1,883
|
|
|
|
6,964,686
|
|
|
|
-
|
|
|
|
-
|
|
|
|
6,966,569
|
|
Commitment shares
|
|
|
12,514
|
|
|
|
13
|
|
|
|
(13
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Shares issued pursuant to cashless exercise of options
|
|
|
87,244
|
|
|
|
87
|
|
|
|
(87
|
)
|
|
|
|
|
|
|
-
|
|
|
|
-
|
|
Share based compensation
|
|
|
-
|
|
|
|
-
|
|
|
|
4,025,412
|
|
|
|
-
|
|
|
|
-
|
|
|
|
4,025,412
|
|
Net loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(11,660,353
|
)
|
|
|
(11,660,353
|
)
|
Balance, June 30, 2018
|
|
|
45,314,155
|
|
|
$
|
45,315
|
|
|
$
|
126,679,219
|
|
|
$
|
-
|
|
|
$
|
(103,138,911
|
)
|
|
$
|
23,585,623
|
|
See Accompanying Notes to Condensed Consolidated
Interim Financial Statements
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
June 30, 2019
(Unaudited)
|
Note 1
|
Business Description and Basis of Presentation
|
Business
Anavex Life Sciences Corp. (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 studies to identify biomarkers, which select patients that will receive the therapeutic benefit 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”).
Basis
of Presentation
These unaudited interim condensed
consolidated 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
interim condensed consolidated 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, 2018 was derived from the audited annual financial statements but does not include all disclosures required
by U.S. GAAP. The accompanying unaudited interim condensed consolidated 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, 2018 filed with the SEC on December 12, 2018. The Company follows the same accounting policies in
the preparation of interim reports.
Operating results for the nine
months ended June 30, 2019 are not necessarily indicative of the results that may be expected for the year ending September 30,
2019.
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 for the foreseeable future and cannot predict when, if ever, our business
might become profitable.
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
June 30, 2019
(Unaudited)
|
Note 1
|
Business Description and Basis of Presentation
–
(continued)
|
The Company believes that its
existing cash and cash equivalents, along with existing financial commitments from third parties, will be sufficient to meet its
cash commitments for in excess of two years after the date these condensed consolidated interim financial statements are issued.
The process of drug development can be costly, and the timing and outcomes of clinical trials is 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.
Other than our rights related
to the Sales Agreement (Note 4) and the 2019 Purchase Agreement (Note 4), there can be no assurance that additional financing will
be available to the Company 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, the Company 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 deferred income tax asset valuations, asset impairment,
stock-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.
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
June 30, 2019
(Unaudited)
|
Note 1
|
Business Description and Basis of Presentation
–
(continued)
|
Principles
of Consolidation
These consolidated financial
statements include the accounts of Anavex Life Sciences Corp. and its wholly-owned subsidiaries, Anavex Australia Pty Limited,
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.
|
The book value of cash and
cash equivalents and accounts payable and accrued liabilities approximate their fair values due to the short-term maturity of those
instruments.
At June 30, 2019 and September
30, 2018, the Company did not have any Level 3 assets or liabilities.
Basic
and Diluted Loss per Share
Basic loss per common share
is computed by dividing net loss available to common stockholders by the weighted average number of common shares outstanding during
the period. Diluted loss per common share is computed similar to basic loss per common share except that the denominator is increased
to include the weighted average number of all potentially dilutive securities convertible into shares of common stock that were
outstanding during the period.
As of June 30, 2019, loss per
share excludes 8,818,766 (September 30, 2018 – 7,185,296) potentially dilutive common shares related to outstanding options
and warrants, as their effect was anti-dilutive.
Reclassifications
Certain amounts from the prior year have been reclassified to conform to the current year’s presentation.
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
June 30, 2019
(Unaudited)
|
Note 2
|
Recent Accounting Pronouncements
|
Recently
Adopted Accounting Pronouncements
In May 2014, the FASB and the
International Accounting Standards Board (IASB) issued a converged standard on revenue recognition from contracts with customers,
ASU 2014-09 (Topic 606 and IFRS 15). This standard superseded nearly all existing revenue recognition guidance. ASU 2014-09 was
effective for the Company on a prospective basis beginning on October 1, 2018. The adoption of this standard did not have a material
impact for any period presented.
In May
2017, the FASB issued ASU No. 2017-09, “Compensation–Stock Compensation (Topic 718): Scope of Modification Accounting,”
clarifying when a change to the terms or conditions of a share-based payment award must be accounted for as a modification. The
new guidance requires modification accounting if the fair value, vesting condition or the classification of the award is not the
same immediately before and after a change to the terms and conditions of the award. The new guidance was effective for the Company
on a prospective basis beginning on October 1, 2018. The adoption of this standard did not have a material impact for any period
presented.
Recent Accounting Pronouncements
Not Yet Adopted
In February
2016, the FASB issued Accounting Standards Update No. 2016-02,
Leases
. The guidance would require lessees to recognize most
leases on their balance sheets as lease liabilities with corresponding right –of use assets. The guidance is effective for
annual and interim reporting periods beginning on or after December 15, 2018. The new guidance is effective for the Company on
a prospective basis beginning on October 1, 2019. The Company is currently evaluating the impact this guidance will have on its
financial condition, results of operations and cash flows.
In June
2018, the FASB issued ASU 2018-07, Compensation-Stock Compensation (Topic 718), Improvements to Nonemployee Share-based Payments
(“ASU 2018-07”). This ASU expands the scope of Topic 718 to include share-based payment transactions for acquiring
goods and services from nonemployees. The effective date for the standard is for interim periods in fiscal years beginning after
December 15, 2018, with early adoption permitted, but no earlier than the Company’s adoption date of Topic 606. The new guidance
is effective for the Company beginning on October 1, 2019. The new guidance is required to be applied retrospectively with the
cumulative effect recognized at the date of initial application. The Company is currently evaluating the impact this guidance will
have on its financial condition, results of operations and cash flows.
Other
than noted above, the Company does not expect the adoption of recently issued accounting pronouncements to have a significant impact
on its results of operations, financial position or cash flow.
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
June 30, 2019
(Unaudited)
Grant
Income
Clinical
Study Grant
During
the year ended September 30, 2017, the Company was awarded grant funding in the amount of $597,886. The grant is being received
in equal quarterly installments over a period of two years beginning during the year ended September 30, 2018 in exchange for a
commitment to complete clinical testing for a therapeutic drug candidate for the treatment of Rett syndrome.
The grant
income is deferred when received and amortized to other income as the related research and development expenditures are incurred.
During the three and nine months ended June 30, 2019, the Company recognized $74,944 and $223,999, respectively (2018: $74,528
and $74,528, respectively) of this grant on its statement of operations within grant income.
|
Note 4
|
Equity Offering Agreements
|
Controlled Equity Offering
Sales Agreement
On July 6, 2018, the Company
entered into a Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald &
Co., as agent (“Cantor Fitzgerald”), pursuant to which the Company may offer and sell shares of common stock, for aggregate
gross sale proceeds of up to $50,000,000 from time to time through Cantor Fitzgerald (the “Offering”).
Upon delivery of a placement
notice based on the Company’s instructions and subject to the terms and conditions of the Sales Agreement, Cantor Fitzgerald
may sell the Shares by methods deemed to be an “at the market offering” 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 is not obligated to make
any sales of Shares under the Sales Agreement. The Company or Cantor Fitzgerald may suspend or terminate the offering of Shares
upon notice to the other party, subject to certain conditions. Cantor Fitzgerald will act as sales agent on a commercially
reasonable efforts basis consistent with its normal trading and sales practices and applicable state and federal law, rules and
regulations and the rules of Nasdaq.
The Company has agreed to pay
Cantor Fitzgerald commissions for its services of acting as agent of up to 3.0% of the gross proceeds from the sale of the Shares
pursuant to the Sales Agreement. The Company has also agreed to provide Cantor Fitzgerald with customary indemnification
and contribution rights. At June 30, 2019, the Company had incurred $151,133 in legal and accounting fees associated with the Sales
Agreement. This amount is included in deferred financing charges at June 30, 2019 and is expected to be reclassified to share capital
upon issuance of shares under the Sales Agreement. At June 30, 2019, no shares have been sold pursuant to the Offering.
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
June 30, 2019
(Unaudited)
|
Note 4
|
Equity Offering Agreements
– Continued
|
2015 Purchase Agreement
On October 21, 2015, the Company
entered into a $50,000,000 purchase agreement (the “2015 Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln
Park”), pursuant to which the Company could sell and issue to Lincoln Park, and Lincoln Park was obligated to purchase, up
to $50,000,000 in value of its shares of common stock from time to time over a 36-month period.
During the nine months ended
June 30, 2019, the Company issued to Lincoln Park an aggregate of 4,872,696 (2018: 1,896,094) shares of common stock under the
Purchase Agreement, including 4,848,995 (2018: 1,883,580) shares of common stock for an aggregate purchase price of $13,197,604
(2018: $6,966,569) and 23,701 (2018: 12,514) commitment shares. At June 30, 2019, all remaining purchase amounts available under
the 2015 Purchase Agreement have been utilized. As such, no further shares will be sold under the 2015 Purchase Agreement.
2019 Purchase Agreement
On June 7, 2019, the Company
entered into a $50,000,000 purchase agreement (the “2019 Purchase Agreement”) with Lincoln Park, which succeeded the
Company’s 2015 Purchase Agreement, pursuant to which the Company may sell and issue to Lincoln Park, and Lincoln Park is
obligated to purchase, up to $50,000,000 in value of its shares of common stock from time to time over a 36-month period starting
from the effective date of the respective registration statement, to June 12, 2022.
The Company may direct Lincoln
Park, at its sole discretion, and subject to certain conditions, to purchase up to 200,000 shares of common stock on any business
day, provided that at least one business day has passed since the most recent purchase. The amount of a purchase may be increased
under certain circumstances provided, however that Lincoln Park’s committed obligation under any single purchase shall not
exceed $2,000,000. The purchase price of shares of common stock related to the future funding will be based on the then prevailing
market prices of such shares at the time of sales as described in the 2019 Purchase Agreement.
The 2019 Purchase Agreement
limits the Company’s sale shares of Common Stock to Lincoln Park to 10,076,680 shares of Common Stock, representing 19.99%
of the shares of the Common Stock outstanding on the date of the 2019 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 Lincoln Park under the 2019
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.
In consideration for entering
into the 2019 Purchase Agreement, the Company issued to Lincoln Park 324,383 shares of common stock as a commitment fee and agreed
to issue up to 162,191 shares pro rata, when and if, Lincoln Park purchases at the Company’s discretion the $50,000,000 aggregate
commitment.
During the nine months ended
June 30, 2019, the Company issued to Lincoln Park an aggregate of 703,157 (2018: Nil) shares of common stock under the Purchase
Agreement, including 375,000 (2018: Nil) shares of common stock for an aggregate purchase price of $1,163,775 (2018: $Nil) and
328,157 (2018: Nil) commitment shares. At June 30, 2019, an amount of $48,836,225 remained available under the 2019 Purchase Agreement.
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
June 30, 2019
(Unaudited)
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.
|
b)
|
Share Purchase Warrants
|
A summary of the status of the
Company’s outstanding share purchase warrants is presented below:
|
|
Number of Shares
|
|
|
Weighted Average
Exercise Price
|
|
Balance, October 1, 2017
|
|
|
1,609,309
|
|
|
$
|
2.66
|
|
Issued
|
|
|
350,000
|
|
|
$
|
4.19
|
|
Exercised
|
|
|
(756,143
|
)
|
|
$
|
2.96
|
|
Expired
|
|
|
(524,787
|
)
|
|
$
|
3.00
|
|
Balance, September 30, 2018
|
|
|
678,379
|
|
|
$
|
2.87
|
|
Exercised
|
|
|
(1,250
|
)
|
|
$
|
1.68
|
|
Expired
|
|
|
(319,629
|
)
|
|
$
|
1.46
|
|
Balance, June 30, 2019
|
|
|
357,500
|
|
|
$
|
4.12
|
|
During
the nine months ended June 30, 2019, the Company issued 546 shares in connection with the exercise of 1,250 share purchase warrants
on a cashless basis.
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
June 30, 2019
(Unaudited)
|
Note 5
|
Commitments
– (Continued)
|
|
c)
|
Stock–based
Compensation Plan
|
2015 Stock Option Plan
On September 18, 2015, the Company’s
board of directors (the “Board”) approved a 2015 Omnibus Incentive Plan (the “2015 Plan”), which provides
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 is 6,050,553 shares, subject to adjustment in the event of a change of the Company’s
capitalization.
The 2015 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 of directors 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 2015 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 2015 Plan.
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. Under the terms of the 2019 Plan, 6,000,000
additional shares of Common Stock are available for issuance under the 2019 Plan, in addition to the shares available under the
2015 Plan. Any awards outstanding under the 2015 Plan or the Company’s 2007 Stock Option Plan (the “2007 Plan”)
will remain subject to and be paid under the 2015 Plan or the 2007 Plan, respectively, and any shares subject to outstanding awards
under the 2015 Plan or the 2007 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 2019 Plan.
The 2019 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 of directors 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 2019 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 2019 Plan.
Anavex Life Sciences Corp.
Notes to the Condensed Consolidated Interim Financial Statements
June 30, 2019
(Unaudited)
|
Note 5
|
Commitments
– (Continued)
|
|
c)
|
Stock–based Compensation Plan – (Continued)
|
A summary of the status of Company’s
outstanding stock purchase options is presented below:
|
|
Number of
Shares
|
|
|
Weighted
Average
Exercise Price
|
|
|
Weighted Average
Grant Date Fair Value
|
|
|
Aggregate
intrinsic value
|
|
Outstanding at October 1, 2017
|
|
|
5,092,030
|
|
|
$
|
4.13
|
|
|
|
|
|
|
$
|
5,280,544
|
|
Granted
|
|
|
1,730,000
|
|
|
$
|
2.71
|
|
|
$
|
2.09
|
|
|
|
|
|
Forfeited
|
|
|
(164,280
|
)
|
|
$
|
3.66
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
(150,833
|
)
|
|
$
|
1.18
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2018
|
|
|
6,506,917
|
|
|
$
|
3.83
|
|
|
|
|
|
|
$
|
2,353,088
|
|
Granted
|
|
|
2,240,399
|
|
|
$
|
2.79
|
|
|
$
|
2.27
|
|
|
|
|
|
Forfeited
|
|
|
(286,050
|
)
|
|
$
|
3.30
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2019
|
|
|
8,461,266
|
|
|
$
|
3.58
|
|
|
|
|
|
|
$
|
5,196,106
|
|
Exercisable at June 30, 2019
|
|
|
5,460,583
|
|
|
$
|
3.79
|
|
|
|
|
|
|
$
|
3,798,337
|
|
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, 2019.
During the three and nine months
ended June 30, 2019, the Company recognized stock-based compensation expense in connection with the issuance and vesting of
stock options in exchange for services. These amounts have been included in general and administrative expenses and research
and development expenses on the Company’s statement of operations as follows:
|
|
Three months ended June 30,
|
|
|
Nine months ended June 30,
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
General and administrative
|
|
$
|
579,636
|
|
|
$
|
802,592
|
|
|
$
|
2,586,223
|
|
|
$
|
1,999,633
|
|
Research and development
|
|
|
654,568
|
|
|
|
875,139
|
|
|
|
2,608,120
|
|
|
|
2,025,779
|
|
Total share based compensation
|
|
$
|
1,234,204
|
|
|
$
|
1,677,731
|
|
|
$
|
5,194,343
|
|
|
$
|
4,025,412
|
|
An amount of approximately $6,446,000
in stock-based compensation is expected to be recorded over the remaining term of such options through June 2022.
The fair value
of each option award is estimated on the date of grant using the Black Scholes option pricing model based on the following weighted
average assumptions:
|
|
2019
|
|
|
2018
|
|
Risk-free interest rate
|
|
|
2.51
|
%
|
|
|
2.73
|
%
|
Expected life of options (years)
|
|
|
6.04
|
|
|
|
6.84
|
|
Annualized volatility
|
|
|
104.51
|
%
|
|
|
108.67
|
%
|
Dividend rate
|
|
|
0.00
|
%
|
|
|
0.00
|
%
|
Subsequent to June 30, 2019,
the Company received research and development incentive income of $1,658,277 (AUD 2,360,201). This amount will be recognized as
other income during the Company’s fourth quarter, in accordance with the Company’s accounting policy which requires
the Company to recognize such income in the period in which it is received.
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Forward-Looking Statements
This Quarterly Report on Form 10-Q includes
forward-looking statements. All statements other than statements of historical facts contained in this Quarterly Report on Form
10-Q, including statements regarding our anticipated future clinical and regulatory milestone events, future financial position,
business strategy and plans and objectives of management for future operations, are forward-looking statements. The words “believe,”
“may,” “estimate,” “continue,” “anticipate,” “intend,” “expect”
“should,” “forecast,” “could,” “suggest,” “plan” and similar expressions,
as they relate to us, are intended to identify forward-looking statements. Such forward-looking statements include, without limitation,
statements regarding:
|
●
|
our ability to generate any revenue or to continue as a going concern;
|
|
●
|
our ability to successfully conduct clinical and preclinical trials for our product candidates;
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|
●
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our ability to raise additional capital on favorable terms;
|
|
●
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our ability to execute our research and development plan on time and on budget;
|
|
●
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our products ability to demonstrate efficacy or an acceptable safety profile;
|
|
●
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our ability to obtain the support of qualified scientific collaborators;
|
|
●
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our ability, whether alone or with commercial partners, to successfully commercialize any of our
product candidates that may be approved for sale;
|
|
●
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our ability to identify and obtain additional product candidates;
|
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●
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our reliance on third parties in non-clinical and clinical studies;
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●
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our ability to defend against product liability claims;
|
|
●
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our ability to safeguard against security breaches;
|
|
●
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our ability to obtain and maintain sufficient intellectual property protection for our product
candidates;
|
|
●
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our ability to comply with our intellectual property licensing agreements;
|
|
●
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our ability to defend against claims of intellectual property infringement;
|
|
●
|
our ability to comply with the maintenance requirements of the government patent agencies;
|
|
●
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our ability to protect our intellectual property rights throughout the world;
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|
●
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the anticipated start dates, durations and completion dates of our ongoing and future clinical
studies;
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|
●
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the anticipated designs of our future clinical studies;
|
|
●
|
our anticipated future regulatory submissions and our ability to receive regulatory approvals to
develop and market our product candidates; and
|
|
●
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our anticipated future cash position.
|
We have based these forward-looking statements
largely on our current expectations and projections about future events, including the responses we expect from the U.S. Food and
Drug Administration, (“FDA”), and other regulatory authorities and financial trends that we believe may affect our
financial condition, results of operations, business strategy, preclinical and clinical trials, and financial needs. These forward-looking
statements are subject to a number of risks, uncertainties and assumptions including without limitation the risks described in
“Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K. 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 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 terms “we,” “us,” “our,” and “Anavex” mean Anavex Life Sciences Corp.,
unless the context clearly requires otherwise.
Our Current Business
Anavex Life Sciences Corp. 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 studies to identify
biomarkers, which select patients that will receive the therapeutic benefit for the treatment of neurodegenerative and neurodevelopmental
diseases.
Our lead compound, ANAVEX
®
2-73,
is being developed to treat Alzheimer’s disease, Parkinson’s disease and potentially other central nervous system diseases,
including rare diseases, such as Rett syndrome, a rare severe neurological monogenic disorder caused by mutations in the X-linked
gene, methyl-CpG-binding protein 2 (“MECP2”).
Our total portfolio currently consists
of five programs. To prioritize the allocation of our resources, we designate certain programs as core programs and others as seed
programs, and we currently have two core programs and three seed programs. Our core programs are at various stages of clinical
and preclinical development, in neurodegenerative and neurodevelopmental diseases.
The following table summarizes key information about our programs:
Anavex has a portfolio of compounds varying
in sigma-1 receptor (S1R) binding activities. The SIGMAR1 gene encodes the S1R protein, which is an intracellular chaperone protein
with important roles in cellular communication. S1R is also involved in transcriptional regulation at the nuclear envelope and
restores homeostasis and stimulates recovery of cell function when activated. In order to validate the ability of our compounds
to activate quantitatively the S1R, we performed in collaboration with Stanford University a quantitative Positron Emission Tomography
(PET) imaging scan in mice, which demonstrated a dose-dependent ANAVEX
®
2-73 target engagement or receptor occupancy
(RO) with S1R in the brain.
Cellular Homeostasis
Many diseases are possibly directly caused
by chronic homeostatic imbalances or cellular stress of brain cells. In pediatric diseases like Rett syndrome or infantile spasms,
the chronic cellular stress is possibly caused by the presence of a constant genetic mutation. In neurodegenerative diseases, such
as Alzheimer’s and Parkinson’s diseases, chronic cellular stress is possibly caused by age-correlated buildup of cellular
insult and hence chronic cellular stress. Specifically, defects in homeostasis of protein or ribonucleic acid (“RNA”)
lead to the death of neurons and dysfunction of the nervous system. The spreading of protein aggregates resulting in a proteinopathy,
a characteristic finding in Alzheimer’s and Parkinson’s diseases that results from disorders of protein synthesis,
trafficking, folding, processing or degradation in cells. The clearance of macromolecules in the brain is particularly susceptible
to imbalances that result in aggregation and degeneration in nerve cells. For example, Alzheimer’s disease pathology is characterized
by the presence of amyloid plaques, neurofibrillary tangles, which are aggregates of hyperphosphorylated Tau protein that are a
marker of other diseases known as tauopathies as well as inflammation of microglia. With the SIGMAR1 activation through SIGMAR1
agonists like ANAVEX
®
2-73, our approach is to restore cellular balance, i.e. homeostasis. Therapies that correct
defects in cellular homeostasis might have the potential to halt or delay neurodevelopmental and neurodegenerative disease progression.
ANAVEX
®
2-73-specific Biomarkers
A full genomic analysis of Alzheimer’s
disease (AD) patients treated with ANAVEX
®
2-73 resulted in the identification of actionable genetic variants. A
significant impact of the genomic biomarkers SIGMAR1, the direct target of ANAVEX
®
2-73 and COMT, a gene involved
in memory function, on the drug response level was identified, leading to an early ANAVEX
®
2-73-specific biomarker
hypothesis. It is expected that
excluding
patients with these two identified biomarker variants (approximately 10%-20% of
the population) in prospective studies would identify approximately 80%-90% patients that would display clinically significant
improved functional and cognitive scores. The consistency between the identified DNA and RNA data related to ANAVEX
®
2-73,
which are considered independent of AD pathology, as well as multiple endpoints and time-points, provides support for precision
medicine clinical development of ANAVEX
®
2-73 by using genetic biomarkers identified within the study population
itself to target patients who are most likely to respond to ANAVEX
®
2-73 treatment in AD as well as indications like
Parkinson’s disease dementia (PDD) or Rett syndrome (RTT) in which ANAVEX
®
2-73 is currently studied or planned
to be studied.
Clinical Studies Overview
Alzheimer’s Disease
In November 2016, we completed a Phase
2a clinical trial, consisting of PART A and PART B, which lasted a total of 57 weeks, for ANAVEX
®
2-73 in mild-to-moderate
Alzheimer’s patients. This open-label randomized trial met both primary and secondary endpoints and was designed to assess
the safety and exploratory efficacy of ANAVEX
®
2-73 in 32 patients. ANAVEX
®
2-73 targets sigma-1 and
muscarinic receptors, which have been shown in preclinical studies to reduce stress levels in the brain believed to restore cellular
homeostasis and to reverse the pathological hallmarks observed in Alzheimer’s disease. In October 2017, we presented positive
pharmacokinetic (PK) and pharmacodynamic (PD) data from the Phase 2a study, which established a concentration-effect relationship
between ANAVEX
®
2-73 and study measurements. These measures obtained from all patients who participated in the entire
57 weeks include exploratory cognitive and functional scores as well as biomarker signals of brain activity. Additionally, the
study appears to show that ANAVEX
®
2-73 activity is enhanced by its active metabolite (ANAVEX19-144), which also
targets the sigma-1 receptor and has a half-life approximately twice as long as the parent molecule.
In March 2016, we received approval from
the Ethics Committee in Australia to extend the Phase 2a clinical trial by an additional 108 weeks, which had been requested by
patients and their caregivers. Subsequently, in May 2018, we received approval from the Ethics Committee in Australia to further
extend the Phase 2a extension trial for an additional two years. The two consecutive trial extensions have allowed participants
who completed the 52-week PART B of the study to continue taking ANAVEX
®
2-73, providing an opportunity to gather
extended safety data for a cumulative time period of five years.
In October 2018, we presented new long-term
clinical data for ANAVEX
®
2-73 in a presentation at the 2018 Clinical Trials on Alzheimer’s Disease (CTAD)
Meeting. At 148 weeks into the five-year extended Phase 2a clinical study, data confirmed a significant association between ANAVEX
®
2-73
concentration and both exploratory functional and cognitive endpoints as measured by the Alzheimer’s Disease Cooperative
Study-Activities of Daily Living (ADCS-ADL) evaluation and the Mini Mental State Examination (MMSE), respectively. The
cohort of patients treated with higher ANAVEX
®
2-73 concentration maintained ADCS-ADL performance compared to the
lower concentration cohort (p<0.0001). As well, the patient cohort with the higher ANAVEX
®
2-73 concentration
performed better at MMSE compared to the lower concentration cohort (p<0.0008). A significant impact on the drug response levels
of both the SIGMAR1 (p<0.0080) and COMT (p<0.0014) genomic biomarkers, identified and specified at week 57, was also confirmed
over the 148-week period. Further, ANAVEX
®
2-73 demonstrated continued favorable safety and tolerability through
148 weeks.
A larger Phase 2b/3 double-blind, placebo-controlled
study of ANAVEX
®
2-73 in Alzheimer’s disease commenced in October 2018, which is independent of the ongoing
Phase 2a extension study. The Phase 2b/3 study will enroll approximately 450 patients for 48 weeks, randomized 1:1:1 to two different
ANAVEX
®
2-73 doses or placebo. The trial is currently taking place in Australia; however, North American sites may
also be added. The ANAVEX
®
2-73 Phase 2b/3 study design incorporates genomic precision medicine biomarkers identified
in the ANAVEX
®
2-73 Phase 2a study. Primary and secondary endpoints will assess safety and both cognitive and functional
efficacy, measured through Alzheimer’s Disease Assessment Scale – Cognition (ADAS-Cog), ADCS-ADL and Clinical Dementia
Rating – Sum of Boxes for cognition and function (CDR-SB).
Rett Syndrome
In February 2016, we presented positive
preclinical data for ANAVEX
®
2-73 in Rett syndrome, a rare neurodevelopmental disease. The study was funded by the
International Rett Syndrome Foundation (“Rettsyndrome.org”). In January 2017, we were awarded a financial grant from
Rettsyndrome.org of a minimum of $0.6 million to cover some of the costs of a multicenter Phase 2 clinical trial of ANAVEX
®
2-73
for the treatment of Rett syndrome. This award is being received in quarterly instalments which commenced during fiscal 2018.
In March 2019, the Company commenced a
Phase 2 clinical trial of ANAVEX
®
2-73 for the treatment of Rett syndrome. The study is the first in a planned Anavex
Rett syndrome program in a range of patient age demographics and geographic regions. The Phase 2 study is taking place in the United
States and is a randomized double-blind, placebo-controlled safety, tolerability, pharmacokinetic and efficacy study of oral liquid
ANAVEX
®
2-73 formulation to treat Rett syndrome. Pharmacokinetic and dose findings will be investigated in a total
of 15 patients over a 7-week treatment period including ANAVEX
®
2-73-specific genomic precision medicine biomarkers.
All patients who participate in the study will be eligible to receive ANAVEX
®
2-73 under a voluntary open label extension
protocol. This study is being followed by a placebo-controlled safety and efficacy evaluation of ANAVEX
®
2-73 over
a 3-month treatment period. Primary and secondary endpoints include safety as well as Rett syndrome conditions such as cognitive
impairment, motor impairment, behavioral symptoms and seizure activity. The ANAVEX
®
2-73 Phase 2 Rett syndrome study
designs incorporate genomic precision medicine biomarkers identified in the ANAVEX
®
2-73 Phase 2a Alzheimer’s
disease study.
In June 2019, the Company commenced a Phase
2 double-blind, randomized, placebo-controlled study of ANAVEX
®
2-73 for the treatment of Rett syndrome, called AVATAR.
The Phase 2 study is taking place in Australia and is using a convenient once-daily oral liquid ANAVEX
®
2-73 formulation.
Similar to the United States based Phase 2 study for Rett syndrome, the study will evaluate the safety and efficacy of ANAVEX
®
2-73
in approximately 30 patients over a 7-week treatment period including ANAVEX
®
2-73 specific precision medicine biomarkers.
All patients who participate in the study will be eligible to receive ANAVEX
®
2-73 under a voluntary open label extension
protocol.
Parkinson’s Disease
In September 2016, we presented positive
preclinical data for ANAVEX
®
2-73 in Parkinson’s disease, which demonstrated significant improvements on all
measures: behavioral, histopathological, and neuroinflammatory endpoints. The study was funded by the Michael J. Fox Foundation.
Additional data was announced in October 2017 from the model for experimental parkinsonism. The data presented indicates that ANAVEX
®
2-73
induces robust neurorestoration in experimental parkinsonism. The encouraging results we have gathered in this model, coupled with
the favorable profile of this compound in the Alzheimer’s disease trial, support the notion that ANAVEX
®
2-73
is a promising clinical candidate drug for Parkinson’s disease.
In October 2018, the Company initiated
in Spain, a double-blind, randomized, placebo-controlled Phase 2 trial with ANAVEX
®
2-73 in Parkinson’s Disease
Dementia (PDD), which will study the effect of the compound on both the cognitive and motor impairment of Parkinson’s disease.
The Phase 2 study will enroll approximately 120 patients for 14 weeks, randomized 1:1:1 to two different ANAVEX
®
2-73
doses or placebo. The ANAVEX
®
2-73 Phase 2 PDD study design incorporates genomic precision medicine biomarkers identified
in the ANAVEX
®
2-73 Phase 2a study.
Our Pipeline
Our research and development pipeline includes
ANAVEX
®
2-73 currently in three different clinical studies, and several compounds in different stages of pre-clinical
study.
Our proprietary SIGMACEPTOR™ Discovery
Platform produced small molecule drug candidates with unique modes of action, based on our understanding of sigma receptors. Sigma
receptors may be targets for therapeutics to combat many human diseases, both of neurodegenerative nature, including Alzheimer’s
disease, as well as of neurodevelopmental nature, like Rett syndrome. When bound by the appropriate ligands, sigma receptors influence
the functioning of multiple biochemical signals that are involved in the pathogenesis (origin or development) of disease.
Compounds that have been subjects of our
research include the following:
ANAVEX
®
2-73
ANAVEX
®
2-73 may offer a
disease-modifying approach in neurodegenerative and neurodevelopmental diseases by activation of sigma-1 receptors.
In Rett syndrome, administration of ANAVEX
®
2-73
resulted in both significant and dose related improvements in an array of behavioral paradigms in the MECP2 HET Rett syndrome disease
model. In addition, in a further experiment sponsored by Rettsyndrome.org, ANAVEX
®
2-73 was evaluated in automatic
visual response and respiration tests in 7-month old mice, an age at which advanced pathology is evident. Vehicle-treated MECP2
mice demonstrated fewer automatic visual responses than wild-type mice. Treatment with ANAVEX
®
2-73 for four weeks
significantly increased the automatic visual response in the MECP2 Rett syndrome disease mouse. Additionally, chronic oral dosing
daily for 6.5 weeks of ANAVEX
®
2-73 starting at ~5.5 weeks of age was conducted in the MECP2 HET Rett syndrome disease
mouse model assessed the different aspects of muscular coordination, balance, motor learning and muscular strengths, some of the
core deficits observed in Rett syndrome. Administration of ANAVEX
®
2-73 resulted in both significant and dose related
improvements in an array of these behavioral paradigms in the MECP2 HET Rett syndrome disease model.
In March 2019, the Company initiated a
Phase 2 clinical trial of ANAVEX
®
2-73 for the treatment of Rett syndrome. The Phase 2 study is taking place in the
United States and is a randomized double-blind, placebo-controlled safety, tolerability, pharmacokinetic and efficacy study of
oral liquid ANAVEX
®
2-73 formulation to treat Rett syndrome. Pharmacokinetic and dose finding will be investigated
in a total of 15 patients over a 7-week treatment period using ANAVEX®2-73-specific genomic precision medicine biomarkers.
All patients who participate in the study will be eligible to receive ANAVEX®2-73 under a voluntary open label extension protocol. This
study is part of a planned Rett syndrome program.
In June 2019, the Company commenced a Phase
2 double-blind, randomized, placebo-controlled study of ANAVEX
®
2-73 for the treatment of Rett syndrome, called AVATAR.
The Phase 2 study is taking place in Australia and is using a convenient once-daily oral liquid ANAVEX
®
2-73 formulation.
Similar to the United States based Phase 2 study for Rett syndrome, the study will evaluate the safety and efficacy of ANAVEX
®
2-73
in approximately 30 patients over a 7-week treatment period including ANAVEX
®
2-73 specific precision medicine biomarkers.
All patients who participate in the study will be eligible to receive ANAVEX
®
2-73 under a voluntary open label extension
protocol
In May 2016 and June 2016, the FDA granted
Orphan Drug Designation to ANAVEX
®
2-73 for the treatment of Rett syndrome and infantile spasms, respectively.
For Parkinson’s disease, data demonstrates
significant improvements and restoration of function in a disease modifying animal model of Parkinson’s disease. Significant
improvements were seen on all measures tested: behavioral, histopathological, and neuroinflammatory endpoints. In July 2018 the
Company received approval from the Spanish Agency for Medicinal Products and Medical Devices (AEMPS), to initiate its Phase 2,
double-blind, placebo-controlled 14-week trial of the safety and efficacy of ANAVEX
®
2-73 for the treatment of Parkinson’s
disease dementia. The Phase 2 study commenced in October 2018 and will involve approximately 120 patients, randomized 1:1:1 to
two different ANAVEX
®
2-73 doses or placebo, in up to 24 clinical study sites.
In Alzheimer’s disease (AD) animal
models, ANAVEX
®
2-73 has shown pharmacological, histological and behavioral evidence as a potential neuroprotective,
anti-amnesic, anti-convulsive and anti-depressive therapeutic agent, due to its potent affinity to sigma-1 receptors and moderate
affinities to M1-4 type muscarinic receptors. In addition, ANAVEX
®
2-73 has shown a potential dual mechanism which
may impact both amyloid and tau pathology. In a transgenic AD animal model Tg2576, ANAVEX
®
2-73 induced a statistically
significant neuroprotective effect against the development of oxidative stress in the mouse brain, as well as significantly increased
the expression of functional and synaptic plasticity markers that is apparently amyloid-beta independent. It also statistically
alleviated the learning and memory deficits developed over time in the animals, regardless of sex, both in terms of spatial working
memory and long-term spatial reference memory.
Based on the results of pre-clinical testing,
we initiated and completed a Phase 1 single ascending dose (SAD) clinical trial of ANAVEX
®
2-73. In this Phase 1
SAD trial, the maximum tolerated single dose was defined per protocol as 55-60 mg. This dose is above the equivalent dose shown
to have positive effects in mouse models of AD. There were no significant changes in laboratory or electrocardiogram (ECG) parameters.
ANAVEX
®
2-73 was well tolerated below the 55-60 mg dose with only mild adverse events in some subjects. Observed
adverse events at doses above the maximum tolerated single dose included headache and dizziness, which were moderate in severity
and reversible. These side effects are often seen with drugs that target CNS conditions, including AD.
The ANAVEX
®
2-73 Phase 1
SAD trial was conducted as a randomized, placebo-controlled study. Healthy male volunteers between the ages of 18 and 55 received
single, ascending oral doses over the course of the trial. Study endpoints included safety and tolerability together with pharmacokinetic
parameters. Pharmacokinetics includes the absorption and distribution of a drug, the rate at which a drug enters the blood and
the duration of its effect, as well as chemical changes of the substance in the body. This study was conducted in Germany in collaboration
with ABX-CRO, a clinical research organization that has conducted several Alzheimer’s disease studies, and the Technical
University of Dresden.
In December 2014, a Phase 2a clinical trial
was initiated for ANAVEX
®
2-73, which is being evaluated for the treatment of Alzheimer’s disease. The open-label
randomized trial was designed to assess the safety and exploratory efficacy of ANAVEX
®
2-73 in 32 patients with mild-to-moderate
Alzheimer’s disease. ANAVEX
®
2-73 targets sigma-1 and muscarinic receptors, which have been shown in preclinical
studies to reduce stress levels in the brain believed to restore cellular homeostasis and to reverse the pathological hallmarks
observed in Alzheimer’s disease.
The Phase 2a study met both primary and
secondary objectives of the study. The 31-week preliminary exploratory safety and efficacy data from the Phase
2a study of ANAVEX
®
2-73 in Alzheimer’s patients, with most receiving also donepezil, the current standard
of care, demonstrated favorable safety, maximum tolerated dose, positive dose response, sustained efficacy response
through 31 weeks for both cognitive and functional measures, as well as positive unexpected therapeutic response events. ANAVEX
®
2-73
continued to demonstrate a favorable adverse event (AE) profile through 31 weeks in a patient population of elderly Alzheimer’s
patients with varying degrees of physical fragility. The most common side effects across all AE categories tended to be of
mild severity grade 1 and were resolved with dose reductions that were anticipated within the adaptive design of the study
protocol.
Through 57 weeks,
Alzheimer’s patients taking a daily oral dose between 10mg and 50mg of ANAVEX
®
2-73 was well tolerated. There
were no clinically significant treatment-related adverse events and no serious adverse events. Despite non-optimized dosing of
ANAVEX
®
2-73 throughout the 57-week study, continued significant improvements from baseline of cognitive, functional
and behavioral scores in a group of patients were observed, respectively. This data was analyzed using refined mathematical modeling
methods in conjunction with the detailed pharmacokinetic (PK) information.
In October 2017,
we presented positive PK and PD data from the Phase 2a study, which established a concentration-effect relationship between ANAVEX
®
2-73
and study measurements. These measures, obtained from all patients who participated in the entire 57 weeks, include exploratory
cognitive and functional scores as well as biomarker signals of brain activity. Additionally, the study appears to show that ANAVEX
®
2-73
activity is enhanced by its active metabolite (ANAVEX19-144), which also targets the sigma-1 receptor and has a half-life approximately
twice as long as the parent molecule.
Pre-specified
exploratory analyses included the cognitive (MMSE) and the functional (ADCS-ADL) changes from baseline. A continued stabilization
of both cognitive and functional measures in patients treated with ANAVEX
®
2-73 was observed. This correlation was
positive within all measured scores (MMSE, ADCS-ADL, Cogstate, HAM-D and EEG/ERP).
In July 2018,
we presented the results of a genomic DNA and RNA evaluation of the participants in the Phase 2a study. More than 33,000 genes
were analyzed using unbiased, data driven, machine learning, artificial intelligence (AI) system for analyzing DNA & RNA data
in patients exposed to ANAVEX
®
2-73. The analysis identified genetic variants that impacted response to ANAVEX
®
2-73,
among them variants related to the Sigma-1 receptor (SIGMAR1), the target for ANAVEX
®
2-73. Results showed that study
participants without the SIGMAR1 (rs1800866) variants, which is about 80 percent of the population worldwide, demonstrated improved
cognitive (MMSE) and the functional (ADCS-ADL) scores. The results from this evaluation may enable a precision medicine approach,
since these signatures can now be applied to neurological indications tested in clinical studies with ANAVEX
®
2-73
including Alzheimer’s disease, Parkinson’s disease dementia and Rett syndrome.
ANAVEX
®
2-73
data presented met prerequisite information in order to progress into a Phase 2b/3 placebo-controlled study. On July 2, 2018, the
Human Research Ethics Committee in Australia approved the initiation of our Phase 2b/3, double-blind, randomized, placebo-controlled
48-week safety and efficacy trial of ANAVEX
®
2-73 for the treatment of early Alzheimer’s disease. This Phase
2b/3 study design incorporates inclusion of genomic precision medicine biomarkers identified in the ANAVEX
®
2-73
Phase 2a study. The Phase 2b/3 study, which is expected to enroll approximately 450 patients, randomized 1:1:1 to either two different
ANAVEX
®
2-73 doses or placebo, commenced in October 2018.
Preclinical data also validates ANAVEX
®
2-73
as a prospective platform drug for other neurodegenerative diseases beyond Alzheimer’s disease, Parkinson’s disease
or Rett syndrome, more specifically, epilepsy, infantile spasms, Fragile X syndrome, Angelman syndrome, multiple sclerosis and,
more recently, tuberous sclerosis complex (TSC). ANAVEX
®
2-73 demonstrated significant improvements in all of these
indications in the respective preclinical animal models.
In a study sponsored by the Foundation
for Angelman Syndrome, ANAVEX
®
2-73 was assessed in a mouse model for the development of audiogenic seizures. The
results indicated that ANAVEX
®
2-73 administration significantly reduced audiogenic-induced seizures. In a study
sponsored by FRAXA Research Foundation regarding Fragile X syndrome, data demonstrated that ANAVEX
®
2-73 restored
hippocampal brain-derived neurotrophic factor (BDNF) expression to normal levels. BDNF under-expression has been observed in many
neurodevelopmental and neurodegenerative pathologies. BDNF signaling promotes maturation of both excitatory and inhibitory synapses.
ANAVEX
®
2-73 normalization of BDNF expression could be a contributing factor for the positive data observed in both
neurodevelopmental and neurodegenerative disorders like Angelman and Fragile X syndromes.
Preclinical data presented also indicates
that ANAVEX
®
2-73 demonstrates protective effects of mitochondrial enzyme complexes during pathological conditions,
which, if impaired, are believed to play a role in the pathogenesis of neurodegenerative and neurodevelopmental diseases.
Preclinical data on ANAVEX
®
2-73
related to multiple sclerosis indicates that ANAVEX
®
2-73 may promote remyelination in multiple sclerosis disease.
Further, data also demonstrates that ANAVEX
®
2-73 provides protection for oligodendrocytes (“OL’s”)
and oligodendrocyte precursor cells (“OPC’s”), as well as central nervous system neurons in addition to helping
repair by increasing OPC proliferation and maturation in tissue culture.
In March 2018, we presented preclinical
data of ANAVEX
®
2-73 in a genetic mouse model of tuberous sclerosis complex (“TSC”). TSC is a rare genetic
disorder characterized by the growth of numerous benign tumors in many parts of the body with a high incidence of seizures. The
new preclinical data demonstrates that treatment with ANAVEX
®
2-73 significantly increases survival and reduces seizures.
ANAVEX
®
3-71
ANAVEX
®
3-71 is a preclinical
drug candidate with a novel mechanism of action via sigma-1 receptor activation and M1 muscarinic allosteric modulation, which
has been shown to enhance neuroprotection and cognition in Alzheimer’s disease models. ANAVEX
®
3-71 is a CNS-penetrable
mono-therapy that bridges treatment of both cognitive impairments with disease modifications. It is highly effective in very small
doses against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau
pathologies, and also has beneficial effects on inflammation and mitochondrial dysfunctions. ANAVEX
®
3-71 indicates
extensive therapeutic advantages in Alzheimer’s and other protein-aggregation-related diseases given its ability to enhance
neuroprotection and cognition via sigma-1 receptor activation and M1 muscarinic allosteric modulation.
A preclinical study examined the response
of ANAVEX
®
3-71 in aged transgenic animal models and showed a significant reduction in the rate of cognitive deficit,
amyloid beta pathology and inflammation with the administration of ANAVEX 3-71. In April 2016, the FDA granted Orphan Drug Designation
to ANAVEX
®
3-71 for the treatment of Frontotemporal dementia (FTD).
During pathological conditions ANAVEX
®
3-71
demonstrated the formation of new synapses between neurons (synaptogenesis) without causing an abnormal increase in the number
of astrocytes. In neurodegenerative diseases such as Alzheimer’s and Parkinson’s disease, synaptogenesis is believed
to be impaired. Additional preclinical data presented also indicates that in addition to reducing oxidative stress, ANAVEX
®
3-71
demonstrates protective effects of mitochondrial enzyme complexes during pathological conditions, which, if impaired, are believed
to play a role in the pathogenesis of neurodegenerative and neurodevelopmental diseases.
ANAVEX
®
1-41
ANAVEX
®
1-41 is a sigma-1
agonist. Pre-clinical tests revealed significant neuroprotective benefits (i.e., protects nerve cells from degeneration or death)
through the modulation of endoplasmic reticulum, mitochondrial and oxidative stress, which damages and impairs cell viability.
In addition, in animal models, ANAVEX
®
1-41 prevented the expression of caspase-3, an enzyme that plays a key role
in apoptosis (programmed cell death) and loss of cells in the hippocampus, the part of the brain that regulates learning, emotion
and memory. These activities involve both muscarinic and sigma-1 receptor systems through a novel mechanism of action.
Preclinical data presented also indicates
that ANAVEX
®
1-41 demonstrates protective effects of mitochondrial enzyme complexes during pathological conditions,
which, if impaired, are believed to play a role in the pathogenesis of neurodegenerative and neurodevelopmental diseases.
ANAVEX
®
1066
ANAVEX
®
1066, a mixed sigma-1/sigma-2
ligand is designed for the potential treatment of neuropathic and visceral pain. ANAVEX
®
1066 was tested in two preclinical
models of neuropathic and visceral pain that have been extensively validated in rats. In the chronic constriction injury model
of neuropathic pain, a single oral administration of ANAVEX
®
1066 dose-dependently restored the nociceptive threshold
in the affected paw to normal levels while leaving the contralateral healthy paw unchanged. Efficacy was rapid and remained significant
for two hours. In a model of visceral pain, chronic colonic hypersensitivity was induced by injection of an inflammatory agent
directly into the colon and a single oral administration of ANAVEX
®
1066 returned the nociceptive threshold to control
levels in a dose-dependent manner. Companion studies in rats demonstrated the lack of any effects on normal gastrointestinal transit
with ANAVEX
®
1066 and a favorable safety profile in a battery of behavioral measures.
Our compounds are in the pre-clinical and
clinical testing stages of development, and there is no guarantee that the activity demonstrated in pre-clinical models will be
shown in human testing.
ANAVEX
®
1037
ANAVEX
®
1037 is designed
for the treatment of prostate and pancreatic cancer. It is a low molecular weight, synthetic compound exhibiting high affinity
for sigma-1 receptors at nanomolar levels and moderate affinity for sigma-2 receptors and sodium channels at micromolar levels.
In advanced pre-clinical studies, this compound revealed antitumor potential. It has also been shown to selectively kill human
cancer cells without affecting normal/healthy cells and also to significantly suppress tumor growth in immune-deficient mice models.
Scientific publications highlight the possibility that these ligands may stop tumor growth and induce selective cell death in various
tumor cell lines. Sigma receptors are highly expressed in different tumor cell types. Binding by appropriate sigma-1 and/or sigma-2
ligands can induce selective apoptosis. In addition, through tumor cell membrane reorganization and interactions with ion channels,
our drug candidates may play an important role in inhibiting the processes of metastasis (spreading of cancer cells from the original
site to other parts of the body), angiogenesis (the formation of new blood vessels) and tumor cell proliferation.
We continue to identify and initiate discussions
with potential strategic and commercial partners to most effectively advance our programs and realize maximum shareholder value.
Further, we may acquire or develop new intellectual property and assign, license, or otherwise transfer our intellectual property
to further our goals.
Our Target Indications
We have developed compounds with potential
application to two broad categories and several specific indications. including:
Central Nervous System Diseases
|
●
|
Alzheimer’s disease – In 2018, an estimated
5.5 million Americans were suffering from Alzheimer’s disease. The Alzheimer’s Association
®
reports
that by 2025, 7.1 million Americans will be afflicted by the disease, about a 29 percent increase from currently affected patients.
Medications on the market today treat only the symptoms of Alzheimer’s disease and do not have the ability to stop its onset
or its progression. There is an urgent and unmet need for both a disease modifying cure for Alzheimer’s disease as well
as for better symptomatic treatments.
|
|
●
|
Parkinson’s disease – Parkinson’s
disease is a progressive disease of the nervous system marked by tremors, muscular rigidity, and slow, imprecise movement. It
is associated with degeneration of the basal ganglia of the brain and a deficiency of the neurotransmitter dopamine. Parkinson’s
disease afflicts more than 10 million people worldwide, typically middle-aged and elderly people. The Parkinson’s disease
market is set to expand from $2.1 billion in 2014 to $3.2 billion by 2021, according to business intelligence provider GBI Research.
|
|
●
|
Rett syndrome - Rett syndrome is a rare X-linked genetic
neurological and developmental disorder that affects the way the brain develops, including protein transcription, which is altered
and as a result leads to severe disruptions in neuronal homeostasis. It is considered a rare, progressive neurodevelopmental disorder
and is caused by a single mutation in the MECP2 gene. Because males have a different chromosome combination from females, boys
who have the genetic MECP2 mutation are affected in devastating ways. Most of them die before birth or in early infancy. For females
who survive infancy, Rett syndrome leads to severe impairments, affecting nearly every aspect of the child’s life; severe
mental retardation, their ability to speak, walk and eat, sleeping problems, seizures and even the ability to breathe easily.
Rett syndrome affects approximately 1 in every 10,000-15,000 females.
|
|
●
|
Depression - Depression is a major cause of morbidity
worldwide according to the World Health Organization. Pharmaceutical treatment for depression is dominated by blockbuster brands,
with the leading nine brands accounting for approximately 75% of total sales. However, the dominance of the leading brands is
waning, largely due to the effects of patent expiration and generic competition.
|
|
●
|
Epilepsy - Epilepsy is a common chronic neurological
disorder characterized by recurrent unprovoked seizures. These seizures are transient signs and/or symptoms of abnormal, excessive
or synchronous neuronal activity in the brain. According to the Centers for Disease Control and Prevention, epilepsy affects 3.4
million Americans. Today, epilepsy is often controlled, but not cured, with medication that is categorized as older traditional
anti-epileptic drugs and second generation anti-epileptic drugs. Because epilepsy afflicts sufferers in different ways, there
is a need for drugs used in combination with both traditional anti-epileptic drugs and second generation anti-epileptic drugs.
GBI Research estimated that the epilepsy market will be $4.5 billion by 2019.
|
|
●
|
Neuropathic Pain – We define neuralgia, or neuropathic
pain, as pain that is not related to activation of pain receptor cells in any part of the body. Neuralgia is more difficult to
treat than some other types of pain because it does not respond well to normal pain medications. Special medications have become
more specific to neuralgia and typically fall under the category of membrane stabilizing drugs or antidepressants.
|
Cancer
|
●
|
Malignant Melanoma - Predominantly a skin cancer,
malignant melanoma can also occur in melanocytes found in the bowel and the eye. Malignant melanoma accounts for 75% of all deaths
associated with skin cancer. The treatment includes surgical removal of the tumor, adjuvant treatment, chemo and immunotherapy,
or radiation therapy. According to IMS Health the worldwide malignant melanoma market is expected to grow to $4.4 billion by 2022.
|
|
●
|
Prostate Cancer – Specific to men, prostate
cancer is a form of cancer that develops in the prostate, a gland in the male reproductive system. The cancer cells may metastasize
from the prostate to other parts of the body, particularly the bones and lymph nodes. Drug therapeutics for prostate cancer are
expected to increase to nearly $13.5 billion in 2024 according to Datamonitor Healthcare.
|
|
●
|
Pancreatic Cancer - Pancreatic cancer is a malignant
neoplasm of the pancreas. In the United States, approximately 55,000 new cases of pancreatic cancer will be diagnosed this year
and approximately 44,000 patients will die as a result of their cancer, according to the American Cancer Society. Sales predictions
by GBI Research forecast that the market for the pharmaceutical treatment of pancreatic cancer in the United States and five largest
European countries will increase to $2.9 billion by 2021.
|
Patents, Trademarks and Intellectual
Property
Anavex holds ownership or exclusive rights
to four U.S. patents, nine 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.
We own one issued U.S. patent entitled
“ANAVEX
®
2-73 and certain anticholinesterase inhibitors composition and method for neuroprotection” claims
a composition of matter of ANAVEX®2-73 directed to a novel and synergistic neuroprotective compound combined with donepezil
and other cholinesterase inhibitors. This patent is expected to expire in June 2034, absent any patent term extension for
regulatory delays. A related continuation application is also pending in the U.S. 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.
With regard to ANAVEX
®
3-71,
we own exclusive rights to two issued U.S. patents with claims respectively directed to the ANAVEX
®
3-71 compound
and methods of treating various diseases including Alzheimer’s with the same. These patents are expected to expire in April
2030, and January 2030, respectively, absent any patent term extension for regulatory delays. We also own exclusive rights to related
patents or applications that are granted or pending in Australia, Canada, China, Europe, Japan, Korea, New Zealand, Russia, and
South Africa, and are expected to expire in January 2030.
We also own other patent applications directed
to enantiomers, formulations and uses that may provide additional protection for one or more of our product candidates.
We regard patents and other intellectual
property rights as corporate assets. Accordingly, we attempt to optimize the value of intellectual property in developing our business
strategy including the selective development, protection, and exploitation of our intellectual property rights. In addition to
filings made with intellectual property authorities, we protect our intellectual property and confidential information by means
of carefully considered processes of communication and the sharing of information, and by the use of confidentiality and non-disclosure
agreements and provisions for the same in contractor’s agreements. While no agreement offers absolute protection, such agreements
provide some form of recourse in the event of disclosure, or anticipated disclosure.
Our intellectual property position, like
that of many biomedical companies, is uncertain and involves complex legal and technical questions for which important legal principles
are unresolved. For more information regarding challenges to our existing or future patents, see Item 1A “Risk Factors.”
Financial Highlights
Operating expenses for the third quarter
of fiscal 2019 were $7.1 million, compared to $4.6 million for the comparable quarter in fiscal 2018. The operating expenses include
an aggregate of $1.2 million, as compared to $1.7 million in third quarter fiscal 2018, in non-cash charges related to the issuance
and vesting of stock options. The increase in operating expenses is primarily attributable to a $2.8 million increase in research
and development expenses to $5.8 million in the third quarter of fiscal 2019, mainly due to the commencement of three clinical
studies for ANAVEX®2-73, a Phase 2b/3 Alzheimer’s disease clinical study, a Phase 2 Parkinson’s disease dementia
clinical study, and a Phase 2 Rett syndrome clinical study.
Net loss for the third quarter of fiscal
2019 was $7.1 million, or $0.14 per share, as compared to $2.8 million, or $0.06 per share in the comparative quarter of fiscal
2018.
Results of Operations
Revenue
We
are in the development stage and have not earned any revenues since our inception and we do not anticipate earning any revenues
until we can establish an alliance with other companies to develop, co-develop, license, acquire or market our products.
Three
and nine months ended June 30, 2019 compared to three and nine months ended June 30, 2018
Operating Expenses
Total operating expenses for the third
quarter of fiscal 2019 were $7.1 million, compared to $4.6 million for the third quarter of fiscal 2018. Total operating expenses
for the nine months ended June 30, 2019 were $22.8 million compared to $13.4 million for the same period in fiscal 2018. This represents
an increase of $2.5 million for the three-month period and $9.4 million for the nine-month period.
Research and development expenses have
increased by $2.8 million to $5.8 million for the three months ended June 30, 2019, and by $8.6 million to $17.5 million for the
nine-month period ended June 30, 2019, as compared to the applicable prior year periods.
Research
and development expenses includes approximately $3.7 million for the three-month period and $9.7 million for the nine-month period
ended June 30, 2019 spent in connection with the clinical stage development of ANAVEX
®
2-73.
The increases were associated with expenditures incurred in connection with the commencement of three clinical studies for ANAVEX
®
2-73.
During fiscal 2019, the Company has commenced a Phase 2b/3 clinical study for the treatment of Alzheimer’s disease, a Phase
2 clinical study for the treatment of Parkinsons Disease Dementia and a Phase 2 clinical study program for the treatment of Rett
syndrome. In addition, the Company’s Phase 2a extension study in Alzheimer’s disease continues. Research and development
expenses include approximately $0.4 million for the three-month period and $2.3 million for the nine-month period spent in preclinical
development activities for ANAVEX
®
2-73 and ANAVEX
®
3-71.
Other income
The net amount of other income was $0.1
million for the three-month period ended June 30, 2019, as compared to $1.8 million for the comparable three-month period in fiscal
2018 and $0.4 million for the nine-month period ended June 30, 2019 as compared to $1.8 million for the comparable nine-month period
in fiscal 2018. The decline in other income was due to the delay in receipt of the Australian research and development incentive
income. This income was received during the fourth quarter of fiscal 2019 as compared to the third fiscal quarter of fiscal 2018.
During fiscal 2019 we have received
$0.2 million in grant income from the Rett Syndrome Foundation, which is being utilized towards the
ANAVEX
®
2-73 Phase 2 clinical study for Rett syndrome, which commenced in March 2019.
Liquidity and Capital Resources
Working Capital
|
|
June 30,
2019
|
|
|
September 30,
2018
|
|
Current Assets
|
|
$
|
21,817,138
|
|
|
$
|
24,222,607
|
|
Current Liabilities
|
|
|
4,336,607
|
|
|
|
3,884,626
|
|
Working Capital
|
|
$
|
17,480,531
|
|
|
$
|
20,337,981
|
|
At June 30, 2019, we had $21.2 million in cash and cash equivalents, a decrease of $1.7 million from September 30, 2018. The principal
reason for this decrease is due to an increase in cash utilized in operations to $16.0 million, due to an increase in clinical
development activities, as described above, offset by cash received of $14.4 million from the issuance of shares of common stock
issued under the 2015 Purchase Agreement and 2019 Purchase Agreement (as defined below).
Cash Flows
|
|
Nine months ended June 30,
|
|
|
|
2019
|
|
|
2018
|
|
Net cash flows used in operating activities
|
|
$
|
(15,992,811
|
)
|
|
$
|
(8,529,234
|
)
|
Net cash flows from financing activities
|
|
|
14,311,379
|
|
|
|
6,916,569
|
|
Decrease in cash and cash equivalents during the period
|
|
$
|
(1,681,432
|
)
|
|
$
|
(1,612,665
|
)
|
Cash flow used in operating activities
Net cash used in operating activities for
the first nine months in fiscal 2019 was $16.0 million, compared to $8.5 million during the comparable period during fiscal 2018.
The principal reason for this increase in net cash used from operating activities in the current period is due to the increase
in operating expenses, particularly clinical development costs, as described above.
Cash flow provided by financing
activities
Cash provided by financing activities for
the first nine months in fiscal 2019 was $14.3 million, attributable to cash received from the issuance of common shares at various
market prices under the 2015 Purchase Agreement and 2019 Purchase Agreement.
Cash provided by financing activities for
the first nine months in fiscal 2018 was $6.9 million, attributable to cash received from the issuance of common shares at various
market prices under the 2015 Purchase Agreement.
Other Financing
Controlled
Equity Offering Sales Agreement
On July 6, 2018, we entered into a Controlled
Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co., as agent (“Cantor
Fitzgerald”), pursuant to which we may offer and sell shares of common stock, for aggregate gross sale proceeds of up to
$50,000,000 from time to time through Cantor Fitzgerald (the “At-the-Market Offering”).
Upon delivery of a placement notice based
on the Company’s instructions and subject to the terms and conditions of the Sales Agreement, Cantor Fitzgerald may sell
shares of common stock by methods deemed to be an “at the market offering” 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. We are not obligated to make any
sales of shares under the Sales Agreement. We or Cantor Fitzgerald may suspend or terminate the At-the-Market Offering upon notice
to the other party, subject to certain conditions. Cantor Fitzgerald will act as sales agent on a commercially reasonable
efforts basis consistent with its normal trading and sales practices and applicable state and federal law, rules and regulations
and the rules of Nasdaq.
The Company has agreed to pay Cantor Fitzgerald
commissions for its services of acting as agent of up to 3.0% of the gross proceeds from the sale of the Shares pursuant to the
Sales Agreement. We have also agreed to provide Cantor Fitzgerald with customary indemnification and contribution rights.
To date, no shares of common stock have been sold pursuant to the Sales Agreement.
Purchase Agreement
On June 7, 2019, we entered into a Purchase
Agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park committed to purchase
up to $50,000,000 of our common stock. Concurrently with the execution of the 2019 Purchase Agreement, we issued 324,383 shares
of our common stock to Lincoln Park as a fee for its commitment to purchase shares of our common stock under the 2019 Purchase
Agreement and shall issue up to 162,191 shares pro rata, when and if Lincoln Park purchases, at our discretion, the $50,000,000
aggregate commitment. The purchase shares that may be sold pursuant to the 2019 Purchase Agreement may be sold by us to Lincoln
Park at our discretion from time to time until July 1, 2022.
We may direct Lincoln Park, at our sole
discretion, and subject to certain conditions, to purchase up to 200,000 shares of common stock on any business day, provided that
at least one business day has passed since the most recent purchase. The amount of a purchase may be increased under certain circumstances
provided, however that Lincoln Park’s committed obligation under any single purchase shall not exceed $2,000,000. The purchase
price of shares of common stock related to the future funding will be based on the then prevailing market prices of such shares
at the time of sales as described in the 2019 Purchase Agreement.
The 2019 Purchase Agreement limits the
Company’s sale shares of Common Stock to Lincoln Park to 10,076,680 shares of Common Stock, representing 19.99% of the shares
of the Common Stock outstanding on the date of the 2019 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 Lincoln Park under the 2019 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.
Upon entering into the 2019 Purchase Agreement,
we maintained the ability to direct Lincoln Park to purchase shares of common stock under our existing Purchase Agreement with
Lincoln Park, dated October 21, 2015 (the “2015 Purchase Agreement”) until the earlier of (i) September 6, 2019 (ii)
such time as we terminate the 2015 Purchase Agreement or (iii) such time as all of the shares of common stock remaining registered
and available for purchase under the 2015 Purchase Agreement have been sold to Lincoln Park. At June 30, 2019, all remaining purchase
amounts available under the 2015 Purchase Agreement have been utilized.
Liquidity
Other than our rights related to the At-the-Market
Offering and the Lincoln Park financing, 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 we are not able to obtain the additional financing
on a timely basis, if and when it is needed, we will be forced to delay or scale down some or all of our research and development
activities or perhaps even cease the operation of our business.
We expect that we will be able to continue
to fund our operations through existing cash on hand and through equity and debt financing in the future. If we raise additional
financing by issuing equity securities, our existing stockholders’ ownership will be diluted. Obtaining commercial loans,
assuming those loans would be available, would increase our liabilities and future cash commitments.
Off-Balance
Sheet Arrangements
We
have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition,
changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources
that are material to our stockholders.
CRITICAL ACCOUNTING POLICIES
We prepare our interim condensed consolidated
financial statements in accordance with accounting principles generally accepted in the United States of America, and make estimates
and assumptions that affect our reported amounts of assets, liabilities, revenue and expenses, and the related disclosures of contingent
liabilities. We base our estimates on historical experience and other assumptions that we believe are reasonable in the circumstances.
Actual results may differ from these estimates.
There have been no significant changes
in the critical accounting policies and estimates described in our Annual Report on Form 10-K for the year ended September 30,
2018 as filed with the SEC on December 12, 2018.
RECENT ACCOUNTING PRONOUNCEMENTS
Please refer to Note 2 “Recent Accounting
Pronouncements” in notes to our Interim Condensed Consolidated Financial Statements included in this Form 10-Q.