NEW YORK, July 30, 2026 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (Anavex or the Company) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for central nervous system $(CNS)$ diseases with high unmet medical needs, today reported preliminary financial results for its fiscal second quarter ended March 31, 2026. The Company's primary focus is on advancing its lead compound ANAVEX$(R)$ 2-73 (blarcamesine) in the Company's clinical program for the treatment of mild cognitive impairment ("MCI") due to Alzheimer's disease ("AD") and mild AD (collectively known as "early AD"), and for Rett syndrome and Fragile X syndrome, both of which are neurodevelopmental rare diseases.
"Anavex remains firmly committed to our lead candidate oral blarcamesine (ANAVEX(R) 2-73) for patients with Alzheimer's disease, and we are prioritizing engagement with the U.S. FDA to align on a clear, data-driven regulatory and clinical development strategy," stated Terrie Kellmeyer, PhD, Interim Chief Executive Officer. "A qualified data-driven approach will guide every decision we make. I have spent nearly three decades building and leading clinical and regulatory functions in drug development, and I'm bringing that experience to bear every day as we implement a disciplined regulatory strategy and build the right foundation for our programs. We are committed to advancing blarcamesine towards a clear regulatory path. I also want to recognize our employees, who have continued to show up for the patients who are counting on us, and the patients and families living with Alzheimer's disease, Rett syndrome and Fragile X, who are depending on us to continue this important work on these urgent unmet medical needs. We are continuing to execute on the mission of developing targeted, orally delivered therapies for a specific range of CNS related diseases."
Business Update & Anticipated Upcoming Milestones
-- Anavex is prioritizing programs that the Company believes have the
greatest potential for success. The strategy concentrates resources on
blarcamesine across three CNS indications: early Alzheimer's disease and
Rett syndrome, where the Company's clinical and regulatory foundation is
most advanced, and Fragile X, where FDA Orphan Drug Designation,
supportive preclinical and biomarker data, and the absence of any
approved therapy may lead to a promising regulatory path with the FDA.
Alzheimer's Disease Program
-- At the end of March 2026, the Company opened an Investigational New Drug
$(IND)$ application for early Alzheimer's disease with the FDA. This is an
important milestone: the IND enables clinical studies to be conducted in
the U.S. and provides the basis for substantive discussions with the FDA
to align on the Company's future clinical development for early
Alzheimer's disease.
-- Two foundational clinical pharmacology studies are proceeding
under this IND in the U.S.: an absorption, distribution,
metabolism, and excretion $(ADME)$ study and a drug-drug interaction
$(DDI)$ study with a goal to strengthen and support the Company's
regulatory pathway for all blarcamesine indications.
-- The Company anticipates initiation of the ADME study to take place
in the third quarter of the 2026 calendar year, and dosing in the
DDI study is already underway.
-- These studies are not sequential requirements. Rather, they
support the overall FDA regulatory requirements for blarcamesine
while the Company continues to advance its early Alzheimer's
disease program in parallel.
-- The Company intends to engage with the FDA on a U.S. clinical development
strategy for early Alzheimer's disease. The Company continues to review
the European Medicines Agency $(EMA)$ Committee for Medicinal Products for
Human Use $(CHMP)$ assessment report and intends to use it to inform and
support its clinical development strategy with the FDA.
-- In July 2026, Anavex attended the Alzheimer's Association International
Conference $(AAIC)$ in London, England, which provided the Company with an
opportunity to engage with clinicians, researchers and the broader
Alzheimer's community and to reinforce the Company's continued commitment
to bringing a treatment option to market for patients with early
Alzheimer's disease.
Rett Syndrome Program
-- The FDA has already granted Orphan Drug Designation, Rare Pediatric
Disease $(RPD)$ Designation and Fast Track Designation for blarcamesine in
Rett syndrome.
-- The Company has aligned with the FDA on a Phase 3 clinical trial
protocol for Rett syndrome for adults only. The Company intends to
discuss with the FDA adding pediatric patients to the protocol,
with a more detailed program update expected at a future date.
Fragile X Syndrome Program
-- The FDA has already granted Orphan Drug Designation for Fragile X
syndrome.
-- The Company plans to initiate discussions with the FDA on the
clinical development strategy for the Fragile X syndrome clinical
program building on this designation, with further details to be
shared as the program advances.
Nasdaq Compliance
-- On July 20, 2026, the Company submitted a plan to regain compliance with
Nasdaq Listing Rule 5250(c)(1).
Preliminary Fiscal Second Quarter 2026 Highlights
The financial results in this press release are preliminary and subject to completion of the Company's financial closing procedures. Actual results may vary materially from these preliminary financial results due to the completion of the Company's financial closing procedures and other developments or information that may arise between now and the time of the finalization of the Company's financial results for three and six months ended March 31, 2026.
Preliminary cash and cash equivalents were $127.4 million as of March 31, 2026, compared to $102.6 million as of September 30, 2025. The Company expects the cash balance at the end of the second fiscal quarter of 2026 to fund operations into mid-to-late fiscal 2028.
Preliminary general and administrative expenses were $2.3 million for the second fiscal quarter of 2026 compared to $2.6 million for the second fiscal quarter of 2025. The decrease was primarily related to a decrease in legal and professional fees over the comparable period.
Preliminary research and development expenses were $4.2 million for the second fiscal quarter of 2026 compared to $9.9 million for the second fiscal quarter of 2025. The decrease was primarily attributable to the completion of the ANAVEX(R) 3-71 clinical trial for schizophrenia and a decrease in clinical manufacturing activities over the comparable period.
Preliminary Net loss for the second fiscal quarter of 2026 was $5.3 million, or $0.06 per share, compared to a net loss of $11.2 million, or $0.13 per share, for the second fiscal quarter of 2025.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded clinical stage biopharmaceutical company engaged in the development of novel therapeutics for the treatment of central nervous system ("CNS") diseases with high unmet medical need. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements relating to the Company's preliminary financial results for the second quarter of 2026; the Company's plans to prioritize engagement with the U.S. FDA to align on a clear, data-driven regulatory and clinical development strategy; the Company's plans to continue to execute on its mission of developing targeted, orally delivered therapies for a specific range of CNS-related diseases; the timing, progress and results of advancement of ANAVEX(R) 2-73 in clinical programs for the treatment of early Alzheimer's, Rett syndrome and Fragile X syndrome; the Company's plans to align with the FDA on a U.S. clinical development strategy for early Alzheimer's disease, align on a Phase 3 protocol for Rett syndrome in both adult and pediatric patients, and align on a clinical development strategy for the Fragile X clinical program; and the Company's expectations regarding its cash runway. These statements are based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such forward-looking statements due to various factors, including, but not limited to, risks related to the Company's failure to timely file its Form 10-Q for the quarterly period ended March 31, 2026 and the Company's ability to regain compliance with Nasdaq Listing Rule 5250(c)(1); that actual financial results may vary materially from the preliminary financial results presented in this press release; volatility in the Company's stock price and the market in general; the Company's ability to raise additional capital; Fast Track designation that the Company has received or may seek out may not actually lead to a faster FDA review and approval process; the Company may be unable to maintain any benefits associated with orphan drug designation, including market exclusivity; undesirable side effects caused by the Company's product candidates; the Company's ability to attract and retain highly qualified personnel; the Company's ability to obtain the support of qualified scientific collaborators; the Company's reliance on third parties; the Company's ability to obtain and maintain sufficient intellectual property protection for its product candidates; the Company's ability to defend against claims of intellectual property infringement;
the Company's ability to compete in the highly competitive biotechnology and pharmaceutical industries; and other risks and uncertainties set forth in the Company's Annual Report on Form 10-K for the fiscal year ended September 30, 2025, and subsequent filings and furnishings with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof except as required by law.
Investor Relations & Media Contact:
SCR Partners, LLC
Alex Arzeno
Tel: 203-550-3972
Email: alex@scr-ir.com
Tripp Sullivan
Tel: 615-942-7077
Email: tsullivan@scr-ir.com
Company Contact:
Sandra Boenisch
Principal Financial Officer
Anavex Life Sciences Corp.
Tel: 1-844-689-3939
Email: ir@anavexcorp.com
Anavex Life Sciences Corp.
Preliminary Condensed Consolidated Interim Statements
of Operations and Comprehensive Loss(1)
(in thousands, except share and per share amounts)
(Unaudited)
Three months ended March 31,
2026 2025
------------ -----------
Operating Expenses
General and administrative $ 2,292 $ 2,621
Research and development 4,192 9,892
Total operating expenses 6,484 12,513
------------ -----------
Operating loss (6,484) (12,513)
Other income
Research and development incentive
income 27 96
Interest income, net 1,061 1,210
Foreign exchange gain (loss) 58 11
Total other income, net 1,146 1,317
------------ -----------
Net loss before provision for income
taxes (5,338) (11,196)
Income tax expense, current - -
------------ -----------
Net loss and comprehensive loss $ (5,338) $ (11,196)
============ ===========
Net loss per share
Basic and diluted $ (0.06) $ (0.13)
Weighted average number of shares
outstanding
Basic and diluted 92,675,753 85,073,769
------------------------------------ ------------ -----------
(1 The financial results in this press release are
preliminary and subject to completion of the Company's
financial closing procedures. Actual results may vary
materially from these preliminary financial results
due to the completion of the Company's financial closing
procedures and other developments or information that
may arise between now and the time of the finalization
of the Company's financial results for three and six
months ended March 31, 2026.)
Anavex Life Sciences Corp.
Preliminary Condensed Consolidated Interim Statements
of Operations and Comprehensive Loss(2)
(in thousands, except share and per share amounts)
(Unaudited)
Six months ended March 31,
2026 2025
----------- ----------
Operating Expenses
General and administrative $ 4,417 $ 5,767
Research and development 8,849 20,338
Total operating expenses 13,266 26,105
----------- ----------
Operating loss (13,266) (26,105)
Other income
Grant income - 12
Research and development incentive
income 60 508
Interest income, net 2,140 2,604
Foreign exchange gain (loss) 65 (326)
Total other income, net 2,265 2,798
----------- ----------
Net loss before provision for income
taxes (11,001) (23,307)
Income tax expense, current (18) -
----------- ----------
Net loss and comprehensive loss $ (11,019) $ (23,307)
=========== ==========
Net loss per share
Basic and diluted $ (0.12) $ (0.27)
Weighted average number of shares outstanding
Basic and diluted 90,832,571 84,938,400
-------------------------------------- ----------- ----------
(2 The financial results in this press release are
preliminary and subject to completion of the Company's
financial closing procedures. Actual results may vary
materially from these preliminary financial results
due to the completion of the Company's financial closing
procedures and other developments or information that
may arise between now and the time of the finalization
of the Company's financial results for three and six
months ended March 31, 2026.)
Anavex Life Sciences Corp.
Preliminary Condensed Consolidated Interim Balance
Sheets(3)
(in thousands, except share and per share amounts)
(Unaudited)
March 31, 2026 September 30, 2025
------------------------------- ---------------- ----------------------
Assets (unaudited)
------------------------------- ---------------- ----------------------
Current
------------------------------- ---------------- ----------------------
Cash and cash equivalents $ 127,422 $ 102,577
-------------------------------- ----------- ---------------
Incentive and tax receivables 932 809
-------------------------------- ----------- ---------------
Prepaid expenses and other
current assets 412 429
-------------------------------- ----------- ---------------
Total Assets $ 128,766 $ 103,815
-------------------------------- =========== ===============
Liabilities and stockholders'
equity
------------------------------- ---------------- ----------------------
Current Liabilities
------------------------------- ---------------- ----------------------
Accounts payable $ 2,520 $ 4,249
-------------------------------- ----------- ---------------
Accrued liabilities 3,734 3,892
-------------------------------- ----------- ---------------
Deferred grant income 805 805
-------------------------------- ----------- ---------------
Total Liabilities 7,059 8,946
-------------------------------- ----------- ---------------
Capital Stock 93 87
-------------------------------- ----------- ---------------
Additional paid-in capital 515,081 477,230
-------------------------------- ----------- ---------------
Accumulated deficit (393,467) (382,448)
-------------------------------- ----------- ---------------
Total Stockholders' Equity 121,707 94,869
-------------------------------- ----------- ---------------
Total Liabilities and
Stockholders' Equity $ 128,766 $ 103,815
-------------------------------- =========== ===============
(3 The financial results in this press release are
preliminary and subject to completion of the Company's
financial closing procedures. Actual results may vary
materially from these preliminary financial results
due to the completion of the Company's financial closing
procedures and other developments or information that
may arise between now and the time of the finalization
of the Company's financial results for three and six
months ended March 31, 2026.)
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