Overview
- TickerAVXL on Nasdaq1
- IndustryBiological Products, (No Diagnostic Substances)1
- HeadquartersNew York, New York1
- Business address630 5Th Avenue, 20Th Floor, New York, Ny 101113
- Filer categoryLarge accelerated filer, Smaller reporting company3
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Activities of Daily Living (“ADCS-ADL”) and Clinical Dementia Rating – Sum of Boxes for cognition and function (“CDR-SB”).5 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Key numbers, fiscal 2025
Financial statements
Every line of the income statement as filed: the last 3 fiscal years, latest first.2
| Period ending | 2025-09-30 | 2024-09-30 | 2023-09-30 |
|---|---|---|---|
| General and administrative | $13.8M | $11.0M | $12.0M |
| Research and development | $37.6M | $41.8M | $43.7M |
| Total operating expenses | $51.4M | $52.9M | $55.8M |
| Operating loss | -$51.4M | -$52.9M | -$55.8M |
| Grant income | $37.0K | $75.0K | $25.0K |
| Research and development incentive income | $648.0K | $2.3M | $2.7M |
| Interest income, net | $4.7M | $7.3M | $6.5M |
| Other financing expense | -$964.0K | ||
| Foreign exchange gain (loss) | -$332.0K | $189.0K | -$40.0K |
| Total other income, net | $5.0M | $9.9M | $8.3M |
| Net loss and comprehensive loss | -$46.4M | -$43.0M | -$47.5M |
| Net Loss per share, Basic | -$0.54 | -$0.52 | -$0.60 |
| Net Loss per share, Diluted | -$0.54 | -$0.52 | -$0.60 |
| Weighted average number of shares outstanding, Basic | 85.3M shares | 83.5M shares | 79.8M shares |
| Weighted average number of shares outstanding, Diluted | 85.3M shares | 83.5M shares | 79.8M shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 4 fiscal years (annual) or 4 quarters (quarterly), latest first.2
| Period ending | 2025-09-30 | 2024-09-30 | 2023-09-30 | 2022-09-30 |
|---|---|---|---|---|
| Cash and cash equivalents | $102.6M | $132.2M | ||
| Incentive and tax receivables | $809.0K | $2.4M | ||
| Prepaid expenses and other current assets | $429.0K | $931.0K | ||
| Total Assets | $103.8M | $135.6M | ||
| Accounts payable | $4.2M | $9.6M | ||
| Accrued liabilities - Note 3 | $3.9M | $4.8M | ||
| Deferred grant income - Note 4 | $805.0K | $842.0K | ||
| Total Liabilities | $8.9M | $15.3M | ||
| Capital stock Authorized: 200,000,000 common stock, par value $0.001 per share Issued and outstanding: 86,668,521 common shares (2024 - 84,795,517) | $87.0K | $85.0K | ||
| Additional paid-in capital | $477.2M | $456.2M | ||
| Accumulated deficit | -$382.4M | -$336.1M | ||
| Total Stockholders Equity | $94.9M | $120.3M | $141.9M | $142.5M |
| Total Liabilities and Stockholders Equity | $103.8M | $135.6M | ||
| Preferred stock, authorized | 10.0M shares | 10.0M shares | ||
| Preferred stock, par value | $0.00 | $0.00 | ||
| Common shares, authorized | 200.0M shares | 200.0M shares | ||
| Common shares, par value | $0.00 | $0.00 | ||
| Common shares, issued | 86.7M shares | 84.8M shares | ||
| Common shares, outstanding | 86.7M shares | 84.8M shares |
| Period ending | 2025-09-30 | 2024-09-30 | 2023-09-30 | 2022-09-30 |
|---|---|---|---|---|
| Cash and cash equivalents | $102.6M | $132.2M | ||
| Incentive and tax receivables | $809.0K | $2.4M | ||
| Prepaid expenses and other current assets | $429.0K | $931.0K | ||
| Total Assets | $103.8M | $135.6M | ||
| Accounts payable | $4.2M | $9.6M | ||
| Accrued liabilities - Note 3 | $3.9M | $4.8M | ||
| Deferred grant income - Note 4 | $805.0K | $842.0K | ||
| Total Liabilities | $8.9M | $15.3M | ||
| Capital stock Authorized: 200,000,000 common stock, par value $0.001 per share Issued and outstanding: 86,668,521 common shares (2024 - 84,795,517) | $87.0K | $85.0K | ||
| Additional paid-in capital | $477.2M | $456.2M | ||
| Accumulated deficit | -$382.4M | -$336.1M | ||
| Total Stockholders Equity | $94.9M | $120.3M | $141.9M | $142.5M |
| Total Liabilities and Stockholders Equity | $103.8M | $135.6M | ||
| Preferred stock, authorized | 10.0M shares | 10.0M shares | ||
| Preferred stock, par value | $0.00 | $0.00 | ||
| Common shares, authorized | 200.0M shares | 200.0M shares | ||
| Common shares, par value | $0.00 | $0.00 | ||
| Common shares, issued | 86.7M shares | 84.8M shares | ||
| Common shares, outstanding | 86.7M shares | 84.8M shares |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 3 fiscal years, latest first.2
| Period ending | 2025-09-30 | 2024-09-30 | 2023-09-30 |
|---|---|---|---|
| Net loss | -$46.4M | -$43.0M | -$47.5M |
| Non cash financing related charges | $845.0K | ||
| Share based compensation | $11.5M | $9.4M | $16.4M |
| Incentive and tax receivables | $1.6M | $260.0K | $484.0K |
| Prepaid expenses and deposits | $502.0K | -$278.0K | -$299.0K |
| Accounts payable | -$5.4M | $5.3M | $497.0K |
| Accrued liabilities | -$943.0K | -$2.5M | $1.4M |
| Deferred grant income | -$37.0K | -$75.0K | $473.0K |
| Net cash used in operating activities | -$39.0M | -$30.8M | -$27.8M |
| Issuance of common shares, net of share issue costs | $9.2M | $11.3M | $27.9M |
| Payment for taxes related to cashless exercise of options | -$2.7M | ||
| Proceeds from exercise of stock options | $2.9M | $691.0K | $1.8M |
| Net cash provided by financing activities | $9.4M | $12.0M | $29.7M |
| (Decrease) Increase in cash and cash equivalents during the year | -$29.6M | -$18.8M | $1.9M |
| Cash paid for state and local franchise taxes | $125.0K | $300.0K | $136.0K |
| Common stock issued upon cashless exercise of stock options | $1.5M |
No quarter-by-quarter statement was filed.
Corporate structure
ANAVEX LIFE SCIENCES CORP. sits at the top of its group. 4 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of ANAVEX LIFE SCIENCES CORP.
- VANGUARD CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G on ANAVEX LIFE SCIENCES CORP., latest Jul 31, 2026
- VANGUARD GROUP INC Filed SCHEDULE 13G/A on ANAVEX LIFE SCIENCES CORP., latest Mar 26, 2026 (4 filings since Feb 9, 2022)
- BlackRock Filed SC 13G/A on ANAVEX LIFE SCIENCES CORP., latest Jan 25, 2024 (3 filings since Feb 3, 2022)
- State Street Corporation Filed SC 13G/A on ANAVEX LIFE SCIENCES CORP., latest Jan 22, 2024 (3 filings since Feb 9, 2022)
- ANAVEX LIFE SCIENCES CORP. New York, New York
- Anavex Australia Pty Limited Subsidiary · Australia
- Anavex Canada Ltd. Subsidiary · Ontario, Canada
- Anavex Germany GmbH Subsidiary · Germany
Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What ANAVEX LIFE SCIENCES CORP. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $102.6M2 Sep 30, 2025 | $132.2M2 Sep 30, 2024 | −22.4% |
Properties, in its own words
We do not own any real property. We maintain a corporate head office at 630 5th Avenue, 20th Floor, New York, NY, USA. During the fiscal year 2025, our costs for our physical office were approximately $11,000 per month. We believe our offices are suitable and adequate to operate our business currently, as they provide us with sufficient space to conduct our operations.
Item 2 of the 10-K filed Nov 25, 2025.5
Leadership
Who has led ANAVEX LIFE SCIENCES CORP., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chair
Chief financial officer
Chief operating officer
- Chief executive officerTerrie Kellmeyer May 14, 2026 to now15
- Chief executive officerChristopher U. Missling Jul 15, 2013 to May 14, 202616
- Chief executive officerHerve De Kergrohen Jun 19, 2009 to Jun 19, 200917
- Chief executive officerPanos Kontzalis Feb 6, 2007 to Feb 21, 200718
- Chief executive officerYang Wu Apr 26, 2006 to Apr 26, 200619
- Chief executive officerHarvey Lalach Jun 14, 2006 to Jul 2, 201020
- ChairCameron Durrant Feb 10, 2011 to Feb 10, 201121
- PresidentChristopher U. Missling Jul 15, 2013 to now16
- PresidentHarvey Lalach Apr 26, 2006 to May 29, 201222
- PresidentYang Wu Apr 26, 2006 to Apr 26, 200619
- Chief financial officerChristopher U. Missling Jul 15, 2013 to Nov 16, 201516
- Chief financial officerHarvey Lalach Jun 4, 2008 to Jul 2, 201023
- Chief operating officerHarvey Lalach Feb 23, 2011 to May 29, 201224
- Chief operating officerPei Ru Wu Apr 26, 2006 to Apr 26, 200625
Board members and other officers (24)
- Principal Financial OfficerSandra Boenisch Oct 9, 2015 to now26
- Executive DirectorGeorge F. Tidmarsh Oct 13, 2011 to Feb 10, 201227
- Chief Scientific OfficerAlexandre Vamvakides Feb 6, 2007 to Feb 6, 200728
- VP Business DevelopmentAngela Vernadaki Feb 8, 2007 to Feb 21, 200729
- VP Strategic PlanningGeorge Kalkanis Feb 8, 2007 to Feb 21, 200730
- Board memberAxel Paeger May 1, 2026 to now31
- Board memberJiong Ma Jun 9, 2021 to now32
- Board memberClaus Vander Velden Apr 24, 2018 to now33
- Board memberPeter D.o. Donhauser Feb 16, 2017 to now34
- Board memberSteffen Thomas Jun 25, 2015 to now35
- Board memberBernd Metzner May 19, 2014 to Sep 26, 201636
- Board memberElliot Favus May 19, 2014 to May 25, 202137
- Board memberChristopher U. Missling Jul 15, 2013 to now16
- Board memberAthanasios Skarpelos Nov 5, 2013 to now38
- Board memberWilliam Sean Lowry Mar 3, 2011 to Mar 3, 201139
- Board memberGeorge F. Tidmarsh Oct 13, 2011 to Feb 10, 201227
- Board memberAlison E. Ayers May 21, 2008 to Jul 2, 201040
- Board memberDavid L. Tousley Jun 4, 2008 to Sep 29, 201041
- Board memberAlexandre Vamvakides Feb 6, 2007 to Feb 6, 200728
- Board memberPanos Kontzalis Feb 6, 2007 to Feb 21, 200718
- Board memberCameron Durrant Dec 20, 2007 to Jul 2, 201042
- Board memberHarvey Lalach Apr 26, 2006 to May 29, 201222
- Board memberPei Ru Wu Apr 26, 2006 to Apr 26, 200625
- Board memberYang Wu Apr 26, 2006 to Apr 26, 200619
Subsidiaries and ownership
Subsidiaries (Exhibit 21)
- Anavex Australia Pty Limited Australia4
- Anavex Canada Ltd. Ontario, Canada4
- Anavex Germany GmbH Germany4
The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.
Former names
- Thrifty Printing Inc.Jan 13, 2005 to Jan 25, 20073
Timeline
- Oct 15, 20268-K Other events43
- Sep 28, 20268-K Change in control; Shareholder vote44
- Sep 9, 20268-K Other events45
- Sep 2, 20268-K Other events46
- Aug 25, 20268-K Results of operations47
- Aug 17, 20268-K Regulation FD disclosure48
- Aug 11, 20268-K Regulation FD disclosure49
- Aug 3, 20268-K Regulation FD disclosure50
- Jul 30, 20268-K Results of operations51
- Jul 20, 20268-K Other events52
- Jun 26, 20268-K Other events53
- May 22, 20268-K Listing notice or transfer; Other events54
- May 14, 2026New chief executive Terrie Kellmeyer becomes CEO15
- Jul 15, 2013New chief executive Christopher U. Missling becomes CEO16
- Jun 19, 2009New chief executive Herve De Kergrohen becomes CEO17
- Feb 6, 2007New chief executive Panos Kontzalis becomes CEO18
- Jun 14, 2006New chief executive Harvey Lalach becomes CEO20
- Apr 26, 2006New chief executive Yang Wu becomes CEO19
Calendar
Coming up
- Nov 24, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.11) a share, on Nov 25, 2025.55
When it reported results
- Aug 25, 2026Reported quarterly or annual results47
- Jul 30, 2026Reported quarterly or annual results51
- Feb 9, 2026Reported quarterly or annual results56
- Nov 25, 2025Reported quarterly or annual results57
- May 9, 2024Reported quarterly or annual results58
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
169 filings to the SEC since October 2021: 7 annual reports, 16 quarterly reports, 35 major events, 49 insider forms, 11 large holders, 51 other. The latest 20:
- Oct 15, 20268-K EDGAR
- Oct 5, 20263 EDGAR
- Oct 5, 20263 EDGAR
- Sep 28, 20264 EDGAR
- Sep 28, 20268-K EDGAR
- Sep 21, 2026DFAN14A EDGAR
- Sep 18, 2026DFAN14A EDGAR
- Sep 17, 2026DFAN14A EDGAR
- Sep 15, 2026DEFA14A EDGAR
- Sep 15, 2026DFAN14A EDGAR
- Sep 14, 2026DEFA14A EDGAR
- Sep 10, 2026DFAN14A EDGAR
- Sep 10, 2026DFAN14A EDGAR
- Sep 9, 20268-K EDGAR
- Sep 9, 2026DFAN14A EDGAR
- Sep 8, 2026DEFA14A EDGAR
- Sep 4, 2026DEFA14A EDGAR
- Sep 4, 2026DFAN14A EDGAR
- Sep 3, 2026DFAN14A EDGAR
- Sep 2, 20268-K EDGAR
The 169 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Insider trades
5 open-market trades by officers, directors and large owners since October 2021: 2 buys and 3 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Jun 14, 2024 | Donhauser Peter D.O.Director | Buy | 2,835 | $3.64 | $10.3K | Form 4 |
| May 15, 2024 | Thomas SteffenDirector | Buy | 5,000 | $4.52 | $22.6K | Form 4 |
| Mar 28, 2024 | MISSLING CHRISTOPHER UPresident and CEO | Sale | 73,380 | $5.11 | $375.0K | Form 4 |
| Jun 28, 2023 | MISSLING CHRISTOPHER UPresident and CEO | Sale | 268,000 | $7.98 | $2.1M | Form 4 |
| May 25, 2022 | Skarpelos AthanasiosDirector | Sale | 50,000 | $9.06 | $453.0K | Form 4 |
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- VANGUARD CAPITAL MANAGEMENT LLCSCHEDULE 13G, 1 filing Jul 31, 202659
- VANGUARD GROUP INCSCHEDULE 13G/A, 4 filings Feb 9, 2022 to Mar 26, 202660
- BlackRockSC 13G/A, 3 filings Feb 3, 2022 to Jan 25, 202461
- State Street CorporationSC 13G/A, 3 filings Feb 9, 2022 to Jan 22, 202462
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2024 | Christopher Missling | $700.0K | $2.8M63 | |
| 2024 | Sandra Boenisch | $201.5K | $402.2K63 | |
| 2023 | PresidentChief Executive | $700.0K | $3.9M63 | |
| 2023 | Principal Financial | $186.9K | $501.1K63 | |
| 2022 | Officer and Director | $586.4K | $6.8M63 | |
| 2022 | Officer and Treasurer | $174.9K | $452.5K63 |
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| BlackRock, Inc. | 8,055,628 | $20.9M | 0.0% | +446,010 |
| Vanguard Capital Management LLC | 4,054,589 | $10.5M | 0.0% | +190,639 |
| Two Sigma Investments, LP | 3,046,538 | $7.9M | 0.0% | −201,350 |
| Geode Capital Management, LLC | 2,407,473 | $6.2M | 0.0% | +219,198 |
| State Street Corp | 1,922,770 | $5.0M | 0.0% | −2,589,258 |
| Federated Hermes, Inc. | 1,071,809 | $2.8M | 0.0% | +539,557 |
| Aqr Capital Management LLC | 963,014 | $2.5M | 0.0% | +206,222 |
| Vanguard Portfolio Management LLC | 948,633 | $2.5M | 0.0% | +165,485 |
| Summit Financial, LLC | 909,430 | $2.4M | 0.0% | −31,025 |
| Goldman Sachs Group Inc | 890,634 | $2.3M | 0.0% | +86,199 |
| Marshall Wace, Llp | 889,523 | $2.3M | 0.0% | +470,026 |
| Northern Trust Corp | 784,494 | $2.0M | 0.0% | +59,307 |
| Barclays PLC | 754,226 | $2.0M | 0.0% | +215,949 |
| Charles Schwab Investment Management Inc | 734,795 | $1.9M | 0.0% | −21,763 |
| Bank Of America Corp /de/ | 654,295 | $1.7M | 0.0% | −208,855 |
| Vanguard Fiduciary Trust Co | 621,451 | $1.6M | 0.0% | −25,718 |
| UBS Group AG | 620,374 | $1.6M | 0.0% | +50,418 |
| Private Advisor Group, LLC | 504,000 | $1.3M | 0.0% | +4,300 |
| LPL Financial LLC | 406,109 | $1.1M | 0.0% | −12,531 |
| Stifel Financial Corp | 332,597 | $861.4K | 0.0% | +95,793 |
| Citadel Advisors LLC | 329,115 | $852.4K | 0.0% | −230,320 |
| Pvg Asset Management Corp | 327,344 | $847.8K | 0.5% | −200 |
| Susquehanna International Group, Llp | 319,529 | $827.6K | 0.0% | −676,134 |
| Bank of New York Mellon Corp | 288,199 | $746.4K | 0.0% | +40,350 |
| Apella Capital, LLC | 227,995 | $617.9K | 0.0% | +74,989 |
13F reports cover disclosed long positions in U.S. stocks only.
Members of Congress who traded it
2 trades disclosed by members of Congress. “Vs S&P since” is the stock’s change since the trade minus the S&P 500’s.
| Date | Member | Trade | Amount | Vs S&P since | Filing |
|---|---|---|---|---|---|
| Dec 12, 2022 | Christopher L. Jacobs, House | Sale | $1,001 - $15,000 | +178.3% | Report |
| Oct 12, 2022 | Christopher L. Jacobs, House | Buy | $1,001 - $15,000 | −204.1% | Report |
Members report amounts as ranges, not exact figures. Returns are price-only (no dividends).
SEC filer profile
How ANAVEX LIFE SCIENCES CORP. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARANAVEX LIFE SCIENCES CORP.1
- CIK0001314052
- Employer ID (EIN)98-06084045
- Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company5
- Incorporated inNevada5
- Fiscal year endsSeptember 301
- Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address630 5Th Avenue, 20Th Floor, New York, NY 101111
- Phone844-689-39391
- Shares outstanding92,696,842 as of Aug 28, 202612
- Public float$708.0M as of Mar 31, 20255
- AuditorGRANT THORNTON LLP, Melville, New York PCAOB ID 248; it also attests to the company’s internal control over financial reporting5
- On EDGAR sinceJan 13, 20051
- Filings631 in all: 4 (168), 8-K (130), 10-Q (55), 3 (27), UPLOAD (22), 10-K (18), DEF 14A (16), DEFA14A (16)1
All 53 form types
CORRESP (12), SC 13G/A (12), 424B5 (11), DFAN14A (11), EFFECT (11), NT 10-Q (11), 10QSB (9), 424B3 (7), 8-K/A (7), SC 13G (7), S-3 (5), SB-2/A (5), 10-K/A (4), ARS (4), D (4), PRE 14A (4), S-1 (4), S-3/A (4), 10-Q/A (3), 10KSB (3), 10QSB/A (3), POS AM (3), S-1/A (3), S-8 (3), SC 13D/A (3), 144 (2), DEFC14A (2), NT 10-K (2), PREC14A (2), PRRN14A (2), SC 13D (2), 4/A (1), 5 (1), 8-A12B (1), 8-A12G (1), AW (1), AW WD (1), CERTNAS (1), CT ORDER (1), F-8/A (1), S-3ASR (1), SB-2 (1), SC 14F1 (1), SCHEDULE 13G (1), SCHEDULE 13G/A (1)
- Latest filingsAnnual report (10-K) Nov 25, 2025
Quarterly report (10-Q) Aug 28, 2026
Proxy statement (DEF 14A) Apr 25, 2025
Latest 8-K (8-K) Oct 15, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock Par Value $0.001 | AVXL | NASDAQ |
From the cover page of the 10-K filed Nov 25, 2025 (Section 12(b) of the Exchange Act).5
Risk factors and legal proceedings
The risks ANAVEX LIFE SCIENCES CORP. names in Item 1A of its 10-K filed Nov 25, 2025: 51 risks under these headings, as written.5
- Risks Related to our Company
- We have had a history of losses and no revenue, which raises a risk regarding our ability to continue as a going concern in the future.
- We are a clinical stage pharmaceutical research and development company and may never be able to successfully develop marketable products or generate any revenue. We have a very limited relevant operating history upon which an evaluation of our future performance and prospects can be made. There is no assurance that our future operations will result in profits. If we cannot generate sufficient revenues, we may suspend or cease operations.
- We may be unable to raise additional capital when needed, which would force us to delay, reduce or eliminate our research and development activities.
- A decline in the price of our common stock could affect our ability to raise further working capital and adversely impact our operations and would severely dilute existing or future investors if we were to raise funds at lower prices.
- Risks Related to the Discovery and Development of Our Current and Future Product Candidates
- The marketing approval process for pharmaceutical products is a lengthy, complex and highly regulated process and we cannot predict the outcome of any interactions with the regulatory authorities or when we will receive marketing approval, if at all.
- Obtaining and maintaining regulatory approval of blarcamesine or any future product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of those product candidates in other jurisdictions.
- Even if we are able to develop our potential drug compounds, we may not be able to receive regulatory approval, or if approved, we may not be able to generate significant revenues or successfully commercialize our products, which will adversely affect our financial results and financial condition and we will have to delay or terminate some or all of our research and development plans which may force us to cease operations.
- Our research and development plans will require substantial additional future funding which could impact our operations and financial condition.
- If we or any companion diagnostic collaborator of ours are unable to successfully develop and obtain regulatory approval for companion diagnostic tests for our drug candidates, or experience significant delays in doing so, we may not realize the commercial potential of our drug candidates.
- The regulatory approval processes of the FDA, EMA and comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable, which could lead to our inability to generate product revenue.
The other 40 risks
- All but one of our clinical trials to date have been conducted outside the United States, and the FDA, EMA and other foreign regulatory authorities may not accept data from such trials.
- We have received Fast Track designation for one of our compounds and may seek such designation or breakthrough therapy and priority review for other compounds in the future. Fast Track designation or breakthrough therapy designation may not actually lead to a faster FDA review and approval process.
- We have received orphan drug designation for several of our compounds, but we may be unable to maintain any benefits associated with orphan drug designation, including market exclusivity.
- If we fail to demonstrate efficacy in our non-clinical studies and clinical trials our future business prospects, financial condition and operating results will be materially adversely affected.
- If a particular product candidate causes undesirable side effects, then we may be unable to receive regulatory approval of or commercialize such product candidate.
- Even if we receive regulatory approval for one or more compounds, we will be subject to continuing regulatory obligations and ongoing regulatory review, which may result in significant additional expense. Additionally, our compounds, if approved, could be subject to labeling and other restrictions on marketing or withdrawal from the market, and we may be subject to penalties, if we fail to comply with regulatory requirements or if we experience unanticipated problems with our compounds, when and if any of them are approved.
- Material modifications in the methods of product candidate manufacturing may result in additional costs or delay.
- We have advanced our research and development efforts on the treatment of neurodegenerative and central nervous system, or CNS, disorders, a field that has seen very limited success in product development.
- The use of any of our products in clinical trials may expose us to liability claims, which may cost us significant amounts of money to defend against or pay out, causing our business to suffer.
- Risks Related to our Business
- We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
- If we do not obtain the support of qualified scientific collaborators, our revenue, growth and profitability will likely be limited, which would have a material adverse effect on our business.
- We may not be able to develop, market or generate sales of our products to the extent anticipated. Our business may fail and investors could lose all their investment in our Company.
- None of our potential drug compounds may reach the commercial market for a number of reasons and our business may fail.
- If our competitors succeed in developing products and technologies faster or that are more effective or with a better profile than our own, or if scientific developments change our understanding of the potential scope and utility of our potential products, then our technologies and future products may be rendered undesirable or obsolete.
- Our reliance on third parties, such as university laboratories, contract manufacturing organizations and contract or clinical research organizations, may result in delays in completing, or a failure to complete, non-clinical testing or clinical trials if they fail to perform under our agreements with them or non-compliance with regulations.
- If we fail to compete successfully with respect to partnering, licensing, mergers, acquisitions, joint venture and other collaboration opportunities, we may be limited in our ability to research and develop our potential drug compounds.
- If our information systems or data, or those of third parties upon whom we rely, are or were compromised, our business may be adversely affected.
- Changes in funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal functions on which the operation of our business may rely, which could negatively impact our business.
- Our business could be affected by litigation, government investigations and enforcement actions.
- Changes in U.S. and international trade policies may adversely impact our business and operating results.
- We receive Australian government research and development income tax incentive refunds. If our research and development expenditures are not deemed to be eligible for the refund, proposed modifications to the tax incentive program are enacted, or the tax incentive program is discontinued by the Australian government, it could have a negative effect on our future cash flows and the funding of future research and development projects.
- A variety of risks are associated with operating our business internationally which could materially adversely affect our business.
- Our ability to use our net operating loss (“NOL”) carryforwards and certain tax credit carryforwards may be subject to limitation.
- We are subject to healthcare laws and regulations which may require substantial compliance efforts and could expose us to criminal sanctions, civil and administrative penalties, contractual damages, reputational harm and diminished profits and future earnings, among other penalties.
- We expect current and future legislation affecting the pharmaceutical industry, including drug pricing reform, to impact our business generally, which could adversely affect our business operations.
- The coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate product revenue.
- Risks Related to our Common Stock
- If we issue additional shares of common stock in the future, it will result in the dilution of our existing stockholders and may cause the share price of our common stock to fall.
- Our stock price has been volatile and may be volatile in the future.
- Our common stock may become the target of a “short squeeze.”
- Risks Related to our Intellectual Property
- If we are unable to obtain and maintain sufficient intellectual property protection for our product candidates, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize product candidates similar or identical to ours, and our ability to successfully commercialize our product candidates that we may pursue may be impaired.
- Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
- If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose intellectual property rights that are important to our business.
- Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.
- If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected and our business would be harmed.
- We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
- We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful and could harm our business.
- We may be subject to claims challenging the inventorship of our patents and other intellectual property.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- We may not be able to protect our intellectual property rights throughout the world.
- Changes in patent law could diminish the value of our patents and patent applications in general, thereby impairing our ability to protect our product candidates.
Legal proceedings
The Company is subject to claims and legal proceedings that arise during the course of business. The Company is currently subject to the following lawsuits:
On March 13, 2024, a shareholder class action complaint was filed in the United States District Court for the Southern District of New York, and it named the Company and an officer of the Company as Defendants. The complaint was amended on July 12, 2024 (the “Initial Action”). The complaint alleged violations of the Securities and Exchange Act of 1934 associated with disclosures and statements made with respect to certain clinical trials for ANAVEX®2-73 related to Rett syndrome. This lawsuit was dismissed by the United States District Court for the Southern District of New York on June 18, 2025. The plaintiff filed a notice of appeal on July 17, 2025. Briefing on the appeal concluded October 30, 2025. No decision has been entered. No amount has been recorded in our consolidated financial statements for any loss contingencies associated with this lawsuit as the Company believes that it is not probable that any loss will occur.
On May 8, 2024, a similar complaint was filed in the same court by Kenneth Downing, a purported shareholder of the Company, against the same defendants. The Company believed that this lawsuit was without merit and filed a motion to dismiss the complaint. Plaintiff Downing voluntarily dismissed this complaint subsequent to the filing of the motion to dismiss.
The opening of Item 3, Legal Proceedings.5
Sources
The numbers on this page point here. Each one links to the record it came from.
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- 19SEC EDGARYang Wu, Chief executive officer
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- 21SEC EDGARCameron Durrant, Chair
- 22SEC EDGARHarvey Lalach, President
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- 25SEC EDGARPei Ru Wu, Chief operating officer
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- 31SEC EDGARAxel Paeger, Board member
- 32SEC EDGARJiong Ma, Board member
- 33SEC EDGARClaus Vander Velden, Board member
- 34SEC EDGARPeter D.o. Donhauser, Board member
- 35SEC EDGARSteffen Thomas, Board member
- 36SEC EDGARBernd Metzner, Board member
- 37SEC EDGARElliot Favus, Board member
- 38SEC EDGARAthanasios Skarpelos, Board member
- 39SEC EDGARWilliam Sean Lowry, Board member
- 40SEC EDGARAlison E. Ayers, Board member
- 41SEC EDGARDavid L. Tousley, Board member
- 42SEC EDGARCameron Durrant, Board member
- 43SEC EDGAROther events
- 44SEC EDGARChange in control; Shareholder vote
- 45SEC EDGAROther events
- 46SEC EDGAROther events
- 47SEC EDGARResults of operations
- 48SEC EDGARRegulation FD disclosure
- 49SEC EDGARRegulation FD disclosure
- 50SEC EDGARRegulation FD disclosure
- 51SEC EDGARResults of operations
- 52SEC EDGAROther events
- 53SEC EDGAROther events
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