Core Insights - Anavex Life Sciences Corp. has reported a peer-reviewed publication confirming the autophagy restoration mechanism of its drug candidate blarcamesine through sigma-1 receptor (S1R) activation, which is significant for treating neurodegenerative diseases like Alzheimer's [1][2] Company Overview - Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company focused on developing innovative treatments for various CNS disorders, including Alzheimer's disease, Parkinson's disease, and Rett syndrome [1][4] - The lead drug candidate, ANAVEX®2-73 (blarcamesine), has completed Phase 2a and Phase 2b/3 clinical trials for Alzheimer's disease and has shown potential in treating other CNS disorders [4][5] Research Findings - The publication in iScience details how blarcamesine activates S1R, restoring impaired autophagy and acting upstream of amyloid and tau pathologies, which are critical in neurodegeneration [1][2] - Enhanced autophagic flux and increased proteostasis capacity were observed in studies involving human cells and C. elegans, indicating the drug's potential to ameliorate conditions caused by protein aggregation [1][2] Mechanism of Action - S1R activation promotes autophagy, leading to the degradation of amyloid-beta precursor protein (APP) and normalizing Aβ production, which is crucial for neuroprotection [2][4] - The interaction of blarcamesine with autophagy proteins facilitates autophagosome biogenesis and lysosome fusion, highlighting its role as a direct autophagy receptor [2][5] Clinical Implications - The findings suggest that blarcamesine's mechanism of restoring autophagy may precede the onset of amyloid-beta and tau pathologies, positioning it as a potential early intervention in chronic CNS diseases [2][5] - Anavex's compounds, including ANAVEX®3-71, are also being studied for their effects on mitochondrial performance and neuroinflammation, further supporting their therapeutic potential [2][5]

Core Insights - Anavex Life Sciences Corp. reported a peer-reviewed publication demonstrating that pre-treatment with blarcamesine can prevent cognitive decline and brain injury associated with Alzheimer's disease, indicating its potential as a pharmacological preventive treatment [2][3][6]. Company Overview - Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company focused on developing innovative treatments for various CNS disorders, including Alzheimer's disease, Parkinson's disease, and schizophrenia [2][10]. - The lead drug candidate, ANAVEX®2-73 (blarcamesine), has completed multiple clinical trials for Alzheimer's disease and other CNS disorders, showing potential to halt or reverse disease progression [10]. Research Findings - The study published in Neuroscience Letters indicates that blarcamesine prevents amyloid beta-induced memory impairment and oxidative injury in a preclinical model, suggesting its role in Alzheimer's disease prevention [2][3]. - Blarcamesine's mechanism involves the activation of SIGMAR1, which enhances autophagy and helps normalize amyloid-beta production, thereby restoring cellular homeostasis [4][5]. Market Context - Alzheimer's disease is a significant public health issue, with an estimated 7.2 million Americans currently affected and costs associated with the disease projected to rise from $781 billion in 2020 to $1.1 trillion by 2050 [8][9]. - The global prevalence of dementia is expected to increase from over 50 million currently to nearly 152 million by 2050, highlighting the urgent need for effective treatments [9].

PART I – FINANCIAL INFORMATION [ITEM 1. FINANCIAL STATEMENTS](index=4&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) This section presents Anavex Life Sciences Corp.'s unaudited condensed consolidated interim financial statements for the period ended June 30, 2025, including balance sheets, statements of operations and comprehensive loss, cash flows, and changes in stockholders' equity, along with detailed notes explaining business operations, accounting policies, accrued liabilities, other income, equity offerings, commitments, contingencies, and subsequent events [Condensed Consolidated Interim Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Interim%20Balance%20Sheets) **Condensed Consolidated Interim Balance Sheet Highlights (in thousands):** | Metric | June 30, 2025 | September 30, 2024 | | :-------------------------------- | :------------ | :----------------- | | Cash and cash equivalents | $101,164 | $132,187 | | Total Assets | $102,432 | $135,567 | | Total Liabilities | $11,474 | $15,304 | | Total Stockholders' Equity | $90,958 | $120,263 | [Condensed Consolidated Interim Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) **Condensed Consolidated Interim Statements of Operations and Comprehensive Loss (in thousands, except per share amounts):** | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Nine months ended June 30, 2025 | Nine months ended June 30, 2024 | | :---------------------------------- | :------------------------------- | :------------------------------- | :------------------------------ | :------------------------------ | | Total operating expenses | $14,459 | $14,603 | $40,564 | $38,606 | | Operating loss | $(14,459) | $(14,603) | $(40,564) | $(38,606) | | Total other income, net | $1,216 | $2,389 | $4,014 | $7,224 | | Net loss and comprehensive loss | $(13,243) | $(12,214) | $(36,550) | $(31,382) | | Net Loss per share (Basic and diluted) | $(0.16) | $(0.14) | $(0.43) | $(0.38) | | Weighted average shares outstanding | 85,380,587 | 84,535,328 | 85,085,795 | 83,022,330 | [Condensed Consolidated Interim Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Cash%20Flows) **Condensed Consolidated Interim Statements of Cash Flows (in thousands):** | Metric | Nine months ended June 30, 2025 | Nine months ended June 30, 2024 | | :-------------------------------------- | :------------------------------ | :------------------------------ | | Net cash used in operating activities | $(30,440) | $(24,154) | | Net cash (used in) provided by financing activities | $(583) | $11,886 | | Decrease in cash and cash equivalents | $(31,023) | $(12,268) | | Cash and cash equivalents, end of period | $101,164 | $138,756 | [Condensed Consolidated Interim Statements of Changes in Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) **Changes in Stockholders' Equity (in thousands, except share amounts):** | Metric | June 30, 2025 | October 1, 2024 | | :------------------------------------ | :------------ | :-------------- | | Common Stock Shares | 85,411,692 | 84,795,517 | | Additional Paid-in Capital | $463,494 | $456,249 | | Accumulated Deficit | $(372,621) | $(336,071) | | Total Stockholders' Equity | $90,958 | $120,263 | - During the nine months ended June 30, 2025, the company issued **360,021 shares** from stock option exercises and **550,000 shares** from cashless exercises, while withholding **293,846 shares** for taxes and cashless exercises. Share-based compensation recognized was **$7,828 thousand**[20](index=20&type=chunk) [Notes to the Condensed Consolidated Interim Financial Statements](index=10&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Interim%20Financial%20Statements) [Note 1 Business Description](index=10&type=section&id=Note%201%20Business%20Description) - Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company focused on developing precision medicine therapeutics for central nervous system (CNS) diseases with high unmet needs, including Alzheimer's, Parkinson's, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases like Rett syndrome[21](index=21&type=chunk)[22](index=22&type=chunk) [Note 2 Basis of Presentation](index=10&type=section&id=Note%202%20Basis%20of%20Presentation) - The unaudited condensed consolidated interim financial statements are prepared in accordance with SEC rules and U.S. GAAP for interim reporting, with certain disclosures condensed or omitted. Management believes current working capital is sufficient for over 12 months, but future financing may be needed for costly drug development[23](index=23&type=chunk)[28](index=28&type=chunk)[29](index=29&type=chunk) - The Company has not generated any revenue from operations to date and expects negative cash flows for the foreseeable future[27](index=27&type=chunk) - As of June 30, 2025, **15,463,566** potentially dilutive common shares related to outstanding options and warrants were excluded from diluted loss per share calculation due to their anti-dilutive effect[35](index=35&type=chunk) [Note 3 Accrued Liabilities](index=12&type=section&id=Note%203%20Accrued%20Liabilities) **Principal Components of Accrued Liabilities (in thousands):** | Component | June 30, 2025 | September 30, 2024 | | :----------------------------- | :------------ | :----------------- | | Accrued investigator payments | $149 | $860 | | Accrued compensation and benefits | $1,188 | $1,527 | | Milestone-based contract accruals | $547 | $557 | | All other accrued liabilities | $2,045 | $1,891 | | **Total accrued liabilities** | **$3,929** | **$4,835** | [Note 4 Other Income](index=12&type=section&id=Note%204%20Other%20Income) - The Company recognized **$25 thousand** and **$37 thousand** in grant income for the three and nine months ended June 30, 2025, respectively, from a **$1.0 million** Michael J. Fox Foundation research grant for ANAVEX2-73 in Parkinson's disease. **$0.8 million** remains as deferred grant income[39](index=39&type=chunk)[40](index=40&type=chunk) **Research and Development Incentive Income (in millions):** | Period | 2025 (USD) | 2025 (AUD) | 2024 (USD) | 2024 (AUD) | | :----------------------------- | :--------- | :--------- | :--------- | :--------- | | Three months ended June 30, | $0.1 | $0.2 | $0.5 | $0.8 | | Nine months ended June 30, | $0.6 | $1.0 | $1.6 | $2.4 | - Research and development incentive income, primarily from the Australia R&D credit, decreased for both the three and nine months ended June 30, 2025, compared to 2024. The Company's tax incentive claims from 2020 to 2024 are open to potential review by the ATO[42](index=42&type=chunk)[46](index=46&type=chunk) [Note 5 Equity Offerings](index=13&type=section&id=Note%205%20Equity%20Offerings) - The Company has a **$150.0 million** purchase agreement with Lincoln Park Capital Fund, LLC (2023 Purchase Agreement) valid until February 3, 2026. As of June 30, 2025, **$110.8 million** remains unused, and a prospectus supplement is required to access these funds[49](index=49&type=chunk)[51](index=51&type=chunk) - No shares were issued under the 2023 Purchase Agreement during the nine months ended June 30, 2025, compared to **2,455,646 shares** for **$11.3 million** in the comparable 2024 period[51](index=51&type=chunk) - The 2020 Sales Agreement with Cantor Fitzgerald & Co. and SVB Leerink LLC was terminated on July 24, 2024, with no shares sold during the nine months ended June 30, 2024[52](index=52&type=chunk)[53](index=53&type=chunk)[54](index=54&type=chunk) - During the nine months ended June 30, 2025, the Company issued **217,503 common shares** to its CEO and **38,651 shares** to a director upon net exercise of stock options, involving withholding shares for exercise price and tax obligations[55](index=55&type=chunk)[56](index=56&type=chunk) [Note 6 Commitments and Contingencies](index=15&type=section&id=Note%206%20Commitments%20and%20Contingencies) **Operating Lease Costs (in thousands):** | Period | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Nine months ended June 30, 2025 | Nine months ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :------------------------------ | :------------------------------ | | Operating lease costs | $33 | $31 | $99 | $92 | **401(k) Plan Contributions (in thousands):** | Period | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Nine months ended June 30, 2025 | Nine months ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :------------------------------ | :------------------------------ | | Contributions to 401(k) plan | $56 | $98 | $213 | $223 | - A shareholder class action lawsuit filed on March 13, 2024, alleging violations related to ANAVEX2-73 Rett syndrome clinical trials, was dismissed on June 18, 2025, but the plaintiff filed an appeal. Two similar derivative lawsuits have been stayed pending the outcome of the class action[61](index=61&type=chunk)[63](index=63&type=chunk)[64](index=64&type=chunk) **Stock Option Activity (Nine months ended June 30, 2025):** | Metric | Number of Options | Weighted Average Exercise Price ($) | Weighted Average Grant Date Fair Value ($) | | :-------------------------- | :---------------- | :-------------------------------- | :--------------------------------------- | | Outstanding, Sept 30, 2024 | 15,037,754 | 6.80 | 5.12 | | Granted | 1,488,500 | 8.58 | 6.22 | | Expired | (100,000) | 16.24 | — | | Exercised | (910,021) | 2.45 | 1.40 | | Forfeited | (62,667) | 4.79 | 3.59 | | Outstanding, June 30, 2025 | 15,453,566 | 7.17 | 5.41 | | Exercisable, June 30, 2025 | 10,541,530 | 6.07 | 4.73 | **Share-based Compensation Expense (in thousands):** | Expense Category | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Nine months ended June 30, 2025 | Nine months ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :------------------------------ | :------------------------------ | | General and administrative | $1,717 | $997 | $3,124 | $2,901 | | Research and development | $2,607 | $1,491 | $4,704 | $4,524 | | **Total share-based compensation** | **$4,324** | **$2,488** | **$7,828** | **$7,425** | [Note 7 Subsequent Events](index=19&type=section&id=Note%207%20Subsequent%20Events) - On July 25, 2025, the Company entered into a Sales Agreement with TD Securities (USA) LLC to offer and sell up to **$150 million** in common stock through an 'at the market offering' or negotiated transactions, with commissions up to **3.0%** of gross proceeds[80](index=80&type=chunk)[81](index=81&type=chunk)[82](index=82&type=chunk) - On July 4, 2025, the 'One Big Beautiful Bill Act' was signed into law, which is expected to allow for more taxpayer-favorable treatment of R&D expenditures for US income tax purposes, and the Company is evaluating its financial impact[83](index=83&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.](index=20&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS.) This section provides management's perspective on the Company's financial condition and operational results, highlighting its clinical-stage biopharmaceutical focus, pipeline development, and financial performance. It details R&D efforts, clinical trial progress for key drug candidates (ANAVEX2-73, ANAVEX3-71), intellectual property, and financial results including operating expenses, net loss, and liquidity, along with forward-looking statements and risk factors [Forward-Looking Statements](index=20&type=section&id=Forward-Looking%20Statements) - The report contains forward-looking statements regarding future clinical and regulatory milestones, financial position, business strategy, and operations, identified by words like 'believe,' 'may,' 'expect,' and 'will.'[84](index=84&type=chunk) - These statements are based on current expectations and projections but are subject to risks and uncertainties, including stock price volatility, ability to conduct trials, raise capital, generate revenue, and obtain regulatory approvals[85](index=85&type=chunk)[86](index=86&type=chunk) [Overview and Strategy](index=21&type=section&id=Overview%20and%20Strategy) - Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company developing differentiated therapeutics for CNS diseases using precision medicine and genomic data to identify biomarkers[89](index=89&type=chunk) - The Company focuses on innovative treatments for Alzheimer's, Parkinson's, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases like Rett syndrome, with a pipeline including ANAVEX2-73 and ANAVEX3-71[90](index=90&type=chunk) - Anavex's compounds target sigma-1 receptor (SIGMAR1), an intracellular chaperone protein crucial for cellular communication and restoring homeostasis, which is believed to be involved in the pathogenesis of many neurodegenerative and neurodevelopmental diseases[91](index=91&type=chunk)[93](index=93&type=chunk)[94](index=94&type=chunk) [Clinical Program Overview](index=23&type=section&id=Clinical%20Program%20Overview) - ANAVEX2-73 (blarcamesine) is being developed as a disease-modifying approach for neurodegenerative and neurodevelopmental diseases through SIGMAR1 activation, available in oral capsule and liquid formulations[96](index=96&type=chunk) [ANAVEX®2-73 (blarcamesine)](index=23&type=section&id=ANAVEX%C2%AE2-73%20(blarcamesine)) [Alzheimer's Disease](index=23&type=section&id=Alzheimer's%20Disease) - ANAVEX2-73's Phase 2b/3 trial in early Alzheimer's disease met co-primary endpoints, showing significant improvements in ADAS-Cog13 (P < **0.025**) and CDR-SB (P < **0.025**) at **48 weeks**, slowing clinical progression by **36.3%** overall[101](index=101&type=chunk)[102](index=102&type=chunk) - The drug also significantly slowed brain atrophy in key regions (whole brain by **37.6%**, total grey matter by **63.5%**, lateral ventricles by **25.1%**) and showed a good safety profile, with dizziness as a common, transient adverse event[102](index=102&type=chunk)[103](index=103&type=chunk) - A Marketing Authorisation Application (MAA) for ANAVEX2-73 for Alzheimer's disease was submitted to and accepted by the European Medicines Agency (EMA) in November/December 2024 for scientific review[104](index=104&type=chunk) [Parkinson's Disease](index=24&type=section&id=Parkinson's%20Disease) - ANAVEX2-73 demonstrated clinically meaningful, dose-dependent, and statistically significant improvements in cognitive (CDR computerized assessment) and motor impairment (MDS-UPDRS total score) in a Phase 2 trial for Parkinson's disease dementia[108](index=108&type=chunk) - Preliminary data from the **48-week** Open Label Extension (OLE) trial showed longitudinal beneficial effects on primary and secondary objectives, with consistent improvement in MDS-UPDRS Part II + III and CGI-I after resuming treatment[110](index=110&type=chunk) - The Company plans further clinical trials for ANAVEX2-73 in Parkinson's disease dementia and received a **$1.0 million** research grant from The Michael J. Fox Foundation to explore PET imaging biomarkers[111](index=111&type=chunk)[112](index=112&type=chunk) [Rett Syndrome](index=25&type=section&id=Rett%20Syndrome) - ANAVEX2-73 has received Orphan Drug, Rare Pediatric Disease, and Fast Track designations from the FDA for Rett syndrome treatment[114](index=114&type=chunk) - The AVATAR Phase 3 trial met all primary and secondary efficacy and safety endpoints, showing statistically significant improvements in RSBQ (p = **0.037**), ADAMS (p = **0.010**), and CGI-I (p = **0.037**) responses[117](index=117&type=chunk) - The EXCELLENCE Phase 2/3 trial in pediatric patients showed improvement on the RSBQ co-primary endpoint, with a statistically significant rapid onset of action at **4 weeks** (p=**0.041**), and no new safety signals[120](index=120&type=chunk)[121](index=121&type=chunk)[123](index=123&type=chunk) [Other indications](index=27&type=section&id=Other%20indications) - Preclinical data supports ANAVEX2-73's potential as a platform drug for other neurodegenerative diseases, including epilepsy, infantile spasms, Fragile X syndrome, Angelman syndrome, multiple sclerosis, and tuberous sclerosis complex (TSC)[125](index=125&type=chunk) - ANAVEX2-73 significantly reduced audiogenic-induced seizures in Angelman syndrome mouse models and restored hippocampal brain-derived neurotrophic factor (BDNF) expression in Fragile X syndrome models[126](index=126&type=chunk) - Preclinical data also suggests ANAVEX2-73 may promote remyelination in multiple sclerosis and provide protection for oligodendrocytes, OPCs, and CNS neurons[128](index=128&type=chunk) [ANAVEX2-73 (blarcamesine)-specific Biomarkers](index=28&type=section&id=ANAVEX2-73%20(blarcamesine)-specific%20Biomarkers) - Genomic analysis of Alzheimer's patients treated with ANAVEX2-73 identified actionable genetic variants, including SIGMAR1 and COMT, which significantly impact drug response[130](index=130&type=chunk) - Excluding patients with the identified SIGMAR1 biomarker variant (**10%-20%** of the population) in prospective studies could lead to **80%-90%** of patients showing clinically significant improved functional and cognitive scores[130](index=130&type=chunk) [ANAVEX3-71](index=28&type=section&id=ANAVEX3-71) - ANAVEX3-71 is an orally available clinical drug candidate with a novel mechanism of action via SIGMAR1 activation and M1 muscarinic allosteric modulation, showing neuroprotection and cognition enhancement in Alzheimer's models[131](index=131&type=chunk) - The Phase 1 clinical trial met primary and secondary endpoints for safety, tolerability, and PK, with no serious adverse events or dose-limiting toxicities, and demonstrated linear, dose-proportional, and time-invariant pharmacokinetics[135](index=135&type=chunk)[137](index=137&type=chunk) - Based on preclinical and Phase 1 results, the Company plans to advance ANAVEX3-71 into a biomarker-driven clinical development program for schizophrenia, Frontotemporal Dementia (FTD), and Alzheimer's disease[138](index=138&type=chunk) [Schizophrenia](index=29&type=section&id=Schizophrenia) - The U.S. FDA-cleared ANAVEX3-71-SZ-001 Phase 2 trial in schizophrenia commenced in March 2024, exploring multiple ascending doses and a **28-day** treatment period, utilizing standard clinical outcome measures and novel fluid/electrophysiological biomarkers[139](index=139&type=chunk) - Preliminary results from Part A showed a dose-dependent effect of ANAVEX3-71 on two key EEG biomarkers, reversing known abnormalities associated with schizophrenia and correlating with positive, negative, and cognitive symptoms[140](index=140&type=chunk) - Enrollment for Part B of the Phase 2 study was completed in May 2025, with top-line data expected in the second half of 2025[141](index=141&type=chunk) [ANAVEX1-41](index=30&type=section&id=ANAVEX1-41) - ANAVEX1-41 is a sigma-1 agonist that demonstrated significant neuroprotective benefits in preclinical tests by modulating endoplasmic reticulum, mitochondrial, and oxidative stress, and preventing caspase-3 expression[142](index=142&type=chunk)[143](index=143&type=chunk) [ANAVEX1066](index=30&type=section&id=ANAVEX1066) - ANAVEX1066, a mixed sigma-1/sigma-2 ligand, is designed for neuropathic and visceral pain treatment, showing rapid, dose-dependent efficacy in preclinical models without affecting normal gastrointestinal transit[144](index=144&type=chunk) [ANAVEX1037](index=30&type=section&id=ANAVEX1037) - ANAVEX1037 is a synthetic compound with high affinity for sigma-1 receptors, designed for prostate and pancreatic cancer treatment, demonstrating antitumor potential by selectively killing cancer cells and suppressing tumor growth in preclinical studies[145](index=145&type=chunk)[146](index=146&type=chunk) [Our Target Indications](index=30&type=section&id=Our%20Target%20Indications) - The Company is developing compounds for Central Nervous System Diseases, including Alzheimer's disease (**7.2 million** Americans aged 65+ in 2025), Parkinson's disease (**10+ million** worldwide), Rett syndrome (**1 in 10,000-15,000 females**), Schizophrenia (**24 million** worldwide), Fragile X (**1.4 million** worldwide), and Depression[148](index=148&type=chunk)[149](index=149&type=chunk) - Target indications also include Epilepsy (**3.4 million** Americans in 2015), Neuropathic Pain, and Cancer, specifically Malignant Melanoma (market expected to reach **$7.5 billion** by 2029), Prostate Cancer (market expected to reach **$10.1 billion** by 2030), and Pancreatic Cancer (market expected to reach **$3.7 billion** by 2027)[150](index=150&type=chunk)[155](index=155&type=chunk) [Patents, Trademarks and Intellectual Property](index=32&type=section&id=Patents,%20Trademarks%20and%20Intellectual%20Property) - Anavex holds ownership or exclusive rights to **30 issued U.S. patents** and **20 pending U.S. patent applications**, along with numerous PCT and ex-U.S. applications, related to its drug candidates and research programs[151](index=151&type=chunk) - Key patents include those for ANAVEX2-73 (composition of matter, crystalline polymorphs, seizure treatment, neurodevelopmental disorders, cardiac dysfunction, insomnia/anxiety/agitation, systolic hypertension), ANAVEX19-144, ANAVEX1-41, ANAVEX1066, and ANAVEX3-71[152](index=152&type=chunk)[153](index=153&type=chunk)[154](index=154&type=chunk)[156](index=156&type=chunk)[157](index=157&type=chunk)[158](index=158&type=chunk)[159](index=159&type=chunk)[160](index=160&type=chunk)[161](index=161&type=chunk)[162](index=162&type=chunk)[163](index=163&type=chunk)[165](index=165&type=chunk) - Most of these patents are expected to expire between **2030** and **2039**, absent any patent term extensions for regulatory delays[152](index=152&type=chunk)[153](index=153&type=chunk)[154](index=154&type=chunk)[156](index=156&type=chunk)[157](index=157&type=chunk)[158](index=158&type=chunk)[159](index=159&type=chunk)[160](index=160&type=chunk)[161](index=161&type=chunk)[162](index=162&type=chunk)[163](index=163&type=chunk)[164](index=164&type=chunk)[165](index=165&type=chunk) [Financial Overview](index=34&type=section&id=Financial%20Overview) - The Company is in the development stage and has not earned any revenue since its inception in 2004, anticipating revenue only upon establishing alliances for product development, licensing, or marketing[170](index=170&type=chunk) [Operating Expenses](index=34&type=section&id=Operating%20Expenses) **Operating Expenses (in thousands):** | Expense Category | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Nine months ended June 30, 2025 | Nine months ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :------------------------------ | :------------------------------ | | Total operating expenses | $14,459 | $14,603 | $40,564 | $38,606 | | Research and development | $9,959 | $11,811 | $30,298 | $30,224 | | General and administrative | $4,500 | $2,792 | $10,266 | $8,382 | - The decrease in R&D expenses for the three-month period was primarily due to a **$1.9 million** decrease in manufacturing for ANAVEX2-73 and a **$1.0 million** decrease in the Alzheimer's program, partially offset by a **$1.1 million** increase in stock-based compensation[175](index=175&type=chunk)[178](index=178&type=chunk) - G&A expenses increased for both periods, mainly due to higher corporate and intellectual property legal fees, and an increase in non-cash stock-based compensation from new milestone-based options[177](index=177&type=chunk) [Other income (net)](index=36&type=section&id=Other%20income%20(net)) **Net Other Income (in thousands):** | Period | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Nine months ended June 30, 2025 | Nine months ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :------------------------------ | :------------------------------ | | Net other income | $1,216 | $2,389 | $4,014 | $7,224 | - The decrease in net other income for both periods was primarily due to a reduction in research and development incentive income (following the completion of Australian clinical trials) and lower interest income (due to reduced cash balances and market interest rates)[179](index=179&type=chunk) [Net loss](index=36&type=section&id=Net%20loss) **Net Loss and EPS:** | Period | Net Loss (in millions) | EPS | | :------------------------------- | :--------------------- | :---- | | Three months ended June 30, 2025 | $(13.2) | $(0.16) | | Three months ended June 30, 2024 | $(12.2) | $(0.14) | | Nine months ended June 30, 2025 | $(36.6) | $(0.43) | | Nine months ended June 30, 2024 | $(31.4) | $(0.38) | - The increase in net loss for both periods is primarily attributed to the net increases in operating expenses and net decreases in other income[181](index=181&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) [Working Capital](index=36&type=section&id=Working%20Capital) **Working Capital (in thousands):** | Metric | June 30, 2025 | September 30, 2024 | | :---------------- | :------------ | :----------------- | | Current Assets | $102,432 | $135,567 | | Current Liabilities | $11,474 | $15,304 | | **Working Capital** | **$90,958** | **$120,263** | - Net current assets decreased by approximately **$29.3 million** from September 30, 2024, to June 30, 2025, primarily due to cash utilized in operations[182](index=182&type=chunk) [Cash Flows](index=36&type=section&id=Cash%20Flows) **Summary of Cash Flows (in thousands):** | Activity | Nine months ended June 30, 2025 | Nine months ended June 30, 2024 | | :-------------------------------------- | :------------------------------ | :------------------------------ | | Net cash used in operating activities | $(30,440) | $(24,154) | | Net cash (used in) provided by financing activities | $(583) | $11,886 | | Decrease in cash and cash equivalents | $(31,023) | $(12,268) | - Net cash used in operating activities increased by **$6.3 million**, from **$24.2 million** in 2024 to **$30.4 million** in 2025, primarily due to an increased net loss and decreased working capital balances[185](index=185&type=chunk) - Cash flows from financing activities shifted from a **$11.9 million** inflow in 2024 (primarily from common share issuance under the 2023 Purchase Agreement) to a **$0.6 million** outflow in 2025 (due to tax withholding for stock option exercises)[186](index=186&type=chunk)[187](index=187&type=chunk)[188](index=188&type=chunk) [Other Financings](index=37&type=section&id=Other%20Financings) - On July 25, 2025, the Company entered into a Sales Agreement with TD Securities (USA) LLC to sell up to **$150 million** in common stock through an 'at the market offering' or negotiated transactions, with commissions up to **3.0%**[189](index=189&type=chunk)[190](index=190&type=chunk)[191](index=191&type=chunk) - The 2023 Purchase Agreement with Lincoln Park Capital Fund, LLC allows the Company to sell up to **$150.0 million** in common stock until February 3, 2026. As of June 30, 2025, **$110.8 million** remains unused, and no shares were issued under this agreement during the nine months ended June 30, 2025[192](index=192&type=chunk)[197](index=197&type=chunk)[198](index=198&type=chunk) [Off-Balance Sheet Arrangements](index=38&type=section&id=Off-Balance%20Sheet%20Arrangements) - The Company has no off-balance sheet arrangements that have or are reasonably likely to have a material current or future effect on its financial condition, revenues, expenses, results of operations, liquidity, or capital resources[199](index=199&type=chunk) [CRITICAL ACCOUNTING POLICIES](index=38&type=section&id=CRITICAL%20ACCOUNTING%20POLICIES) - There have been no significant changes to the Company's critical accounting policies and estimates since its Annual Report on Form 10-K for the year ended September 30, 2024[201](index=201&type=chunk) [RECENT ACCOUNTING PRONOUNCEMENTS](index=38&type=section&id=RECENT%20ACCOUNTING%20PRONOUNCEMENTS) - The Company refers to Note 2, 'Recent Accounting Pronouncements,' in its Condensed Consolidated Interim Financial Statements for details on new FASB ASUs, including ASU No. 2023-07 (Segment Reporting) and ASU No. 2023-09 (Income Taxes), and is currently assessing their impact[36](index=36&type=chunk)[37](index=37&type=chunk)[202](index=202&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS.](index=38&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISKS.) As a smaller reporting company, Anavex Life Sciences Corp. is not required to provide quantitative and qualitative disclosures about market risks in this quarterly report - The Company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risks[203](index=203&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=38&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) This section confirms the effectiveness of Anavex Life Sciences Corp.'s disclosure controls and procedures as of June 30, 2025, based on management's evaluation, and states that no material changes to internal control over financial reporting occurred during the quarter [Disclosure Controls and Procedures](index=38&type=section&id=Disclosure%20Controls%20and%20Procedures) - As of June 30, 2025, the Company's disclosure controls and procedures were evaluated by management, including the principal executive and financial officers, and concluded to be effective[204](index=204&type=chunk)[205](index=205&type=chunk) [Changes in Internal Control over Financial Reporting](index=39&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) - No changes to the Company's internal control over financial reporting were identified during the quarter ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, internal controls[206](index=206&type=chunk) PART II – OTHER INFORMATION [ITEM 1. LEGAL PROCEEDINGS](index=39&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) Anavex Life Sciences Corp. is involved in several legal proceedings, including a shareholder class action lawsuit related to ANAVEX2-73 Rett syndrome clinical trials, which was dismissed but is under appeal. Two similar derivative lawsuits have been stayed pending the outcome of the class action. The Company believes no loss is probable and has not recorded any contingencies - A shareholder class action complaint filed on March 13, 2024, alleging violations related to ANAVEX2-73 Rett syndrome clinical trials, was dismissed on June 18, 2025, but the plaintiff filed a notice of appeal on July 17, 2025[208](index=208&type=chunk) - Two derivative lawsuits with similar allegations have been filed against the Company and its officers/directors, both of which have been stayed pending the resolution of the initial class action lawsuit[210](index=210&type=chunk)[211](index=211&type=chunk) - The Company believes it is not probable that any loss will occur from these lawsuits and has not recorded any loss contingencies in the financial statements[208](index=208&type=chunk)[210](index=210&type=chunk)[211](index=211&type=chunk) [ITEM 1A. RISK FACTORS](index=40&type=section&id=ITEM%201A.%20RISK%20FACTORS) This section updates the risk factors, emphasizing the lengthy, complex, and unpredictable nature of pharmaceutical marketing approval processes, particularly with the EMA and FDA. It highlights that approval in one jurisdiction does not guarantee approval in others and that the Company's business could be adversely affected by litigation, government investigations, and changes in U.S. and international trade policies - There have been no material changes to the risk factors discussed in the Annual Report on Form 10-K, except for specific risks related to the marketing approval process and business operations[213](index=213&type=chunk) - The marketing approval process for pharmaceutical products by the EMA, FDA, and other authorities is lengthy, complex, and unpredictable, with no guarantee of approval, and a failure or delay in one jurisdiction can negatively impact others[213](index=213&type=chunk)[215](index=215&type=chunk)[216](index=216&type=chunk) - The Company's business is subject to risks from litigation, government investigations, and enforcement actions, which can be expensive and time-consuming, potentially resulting in fines, penalties, and reputational damage[217](index=217&type=chunk)[218](index=218&type=chunk) - Changes in U.S. and international trade policies, such as tariffs, could adversely impact the Company's business, affecting import/export costs, product demand, and commercial activities[219](index=219&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=41&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) Anavex Life Sciences Corp. did not report any unregistered sales of equity securities during the period covered by this Quarterly Report on Form 10-Q that were not previously disclosed - The Company has not sold any equity securities that were not registered under the Securities Act of 1933 and not previously reported in a Current Report on Form 8-K during the period[220](index=220&type=chunk) [ITEM 3. DEFAULTS UPON SENIOR SECURITIES](index=41&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) Anavex Life Sciences Corp. reported no defaults upon senior securities during the period - There were no defaults upon senior securities during the reporting period[221](index=221&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURES](index=41&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This item is not applicable to Anavex Life Sciences Corp - This item is not applicable to the Company[222](index=222&type=chunk) [ITEM 5. OTHER INFORMATION](index=41&type=section&id=ITEM%205.%20OTHER%20INFORMATION) Anavex Life Sciences Corp. reported no adoption, modification, or termination of Rule 10b5-1 or non-Rule 10b5-1 trading arrangements by its directors or Section 16 officers during the three-month period ended June 30, 2025 - None of the Company's directors or Section 16 officers adopted, modified, or terminated a 'Rule 10b5-1 trading arrangement' or 'non-Rule 10b5-1 trading arrangement' during the three-month period ended June 30, 2025[223](index=223&type=chunk) [ITEM 6. EXHIBITS](index=42&type=section&id=ITEM%206.%20EXHIBITS) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including articles of incorporation, bylaws, an amendment to the 2022 Omnibus Incentive Plan, Rule 13a-14(a)/15(d)-14(a) certifications, Section 1350 certifications, and XBRL instance documents - The exhibits include Articles of Incorporation, Amended and Restated Bylaws, Amendment No. 1 to the 2022 Omnibus Incentive Plan, Rule 13a-14(a)/15(d)-14(a) Certifications, Section 1350 Certifications, and XBRL documents[224](index=224&type=chunk) SIGNATURES - The report was duly signed on August 12, 2025, by Christopher Missling, PhD, Chief Executive Officer (Principal Executive Officer), and Sandra Boenisch, CPA, CGA, Principal Financial Officer (Principal Financial and Accounting Officer)[227](index=227&type=chunk)[228](index=228&type=chunk)

Financial Data and Key Metrics Changes - The company's cash position as of June 30, 2025, was $101.2 million with no debt [7] - Cash utilized in operating activities during the quarter was $12.5 million, indicating a runway of more than three years at the current adjusted cash utilization rate [7] - Research and development expenses for the quarter were $10 million, down from $11.8 million in the same quarter last year [8] - General and administrative expenses increased to $4.5 million from $2.8 million in the comparable quarter of last year [8] - The company reported a net loss of $13.2 million for the quarter, equating to $0.16 per share [8] Business Line Data and Key Metrics Changes - The focus remains on advancing precision medicine compounds, particularly blacahamazine for Alzheimer's disease and schizophrenia [4][10] - Clinical feedback emphasizes the importance of orally administered therapies, which are seen as more accessible compared to injectable options [5] Market Data and Key Metrics Changes - A survey indicated a strong preference for oral therapies in Alzheimer's care across EU member states, highlighting the potential for broader market penetration [5] - The recent Alzheimer's Association International Conference showcased data supporting the therapeutic potential of blacahamazine, with patients showing continued benefits over four years [6] Company Strategy and Development Direction - The company aims to provide scalable treatment alternatives with the ease of oral administration, focusing on Alzheimer's disease and schizophrenia [10] - There is an emphasis on the importance of early intervention in Alzheimer's treatment to maximize drug benefits [15] - The company is exploring the potential for preventative trials for Alzheimer's, based on promising preclinical results [34] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing development of their compounds and the potential impact on patients' lives [10] - The company is preparing for potential commercialization in Europe and is in discussions with various partners regarding marketing strategies [60] Other Important Information - The company has retained lobbying services to engage with policymakers, emphasizing the need for awareness and funding for Alzheimer's disease [36] - The EMA review process is ongoing, with expectations for feedback in the first quarter of the following year [25][59] Q&A Session Summary Question: Clarification on four-year data and patient groups - Management explained the distinction between early start and late start patient groups in the trial, emphasizing the importance of early treatment for Alzheimer's [15][17] Question: Applicability of the drug to moderate stage patients - Management confirmed that blacahamazine has shown benefits for both mild and moderate Alzheimer's patients [22] Question: Guidance on EMA review timeline - Management indicated that feedback from the EMA is expected in the first quarter of next year, following the standard review process [25][59] Question: Commercialization strategy for blacahamazine - Management stated that all options are open regarding commercialization, including potential partnerships or solo marketing efforts [60][73] Question: Increase in noncash compensation expenses - Management clarified that the increase is influenced by stock price fluctuations and the vesting period of awards [62]

Core Viewpoint - Anavex Life Sciences Corp. is advancing its clinical-stage biopharmaceutical developments, particularly focusing on innovative treatments for Alzheimer's disease and other CNS disorders, with promising financial results and clinical data supporting its lead drug candidate, blarcamesine [1][2]. Recent Highlights - Anavex presented open-label extension data for blarcamesine at the AAIC 2025, showing continued clinically meaningful benefits in early-stage Alzheimer's patients [2][7]. - The company participated in the AAIC 2025, emphasizing the importance of sharing knowledge to advance dementia science [7]. Financial Highlights - Cash and cash equivalents stood at $101.2 million as of June 30, 2025, down from $132.2 million at the end of fiscal 2024, indicating a cash runway of over 3 years at current utilization rates [4][7]. - Research and development expenses for the quarter were $10.0 million, a decrease from $11.8 million in the same quarter of fiscal 2024 [4][7]. - General and administrative expenses increased to $4.5 million from $2.8 million in the comparable quarter of fiscal 2024 [4][7]. - The net loss for the quarter was $13.2 million, or $0.16 per share, compared to a net loss of $12.2 million, or $0.14 per share for the same quarter in fiscal 2024 [4][7]. Clinical Development - Blarcamesine has shown benefits over a period of up to 4 years in treated patients, as measured by clinical endpoints ADAS-Cog13 and ADCS-ADL [7]. - The drug candidate is designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors, with preclinical studies indicating its potential to halt or reverse Alzheimer's disease [9].

Core Viewpoint - Anavex Life Sciences Corp. is set to release its financial results for the third fiscal quarter on August 12, 2025, and will host a conference call to discuss these results and the company's growth strategy [1][2]. Company Overview - Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company focused on developing innovative treatments for various central nervous system (CNS) disorders, including Alzheimer's disease, Parkinson's disease, schizophrenia, and Rett syndrome [1][4]. - The company's lead drug candidate, ANAVEX®2-73 (blarcamesine), has completed multiple clinical trials for Alzheimer's disease and has shown potential in treating Parkinson's disease dementia and Rett syndrome [4]. - ANAVEX®2-73 is designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors, with preclinical studies indicating its ability to halt or reverse Alzheimer's disease progression [4]. - Another promising drug candidate, ANAVEX®3-71, targets SIGMAR1 and M1 muscarinic receptors and has demonstrated disease-modifying activity against Alzheimer's disease in preclinical trials [4]. Conference Call Details - The conference call will take place on August 12, 2025, at 8:30 am ET, where management will review financial results and provide updates on the company's growth strategy [2][3]. - Participants can access the call via a live webcast on Anavex's website or by dialing a specific phone number with a Meeting ID and passcode [3].

Core Insights - Anavex Life Sciences Corp. announced significant findings regarding its drug blarcamesine for early Alzheimer's disease, demonstrating up to 84.6 weeks (19.5 months) of 'time saved' through early treatment initiation [3][4][5] Group 1: Clinical Trial Results - The ATTENTION-AD Phase IIb/III trial showed that patients treated with blarcamesine continued to accrue cognitive and functional benefits over a period of up to 192 weeks [3] - In the intent-to-treat population, significant differences were observed in cognitive function (ADAS-Cog13) and daily living activities (ADCS-ADL) between early-start and late-start treatment groups at Week 192 [3] - The GWAS-identified population ABCLEAR24 showed even greater improvements in cognition (ADAS-Cog13: LS mean difference −5.43, P = 0.0035) and function (ADCS-ADL: LS mean difference +9.50, P < 0.0001) [3] Group 2: Mechanism of Action - Blarcamesine is confirmed to restore impaired autophagy by activating SIGMAR1, acting upstream of amyloid and tau pathologies [5][6] - The drug's mechanism was established through both in vitro and in vivo studies, demonstrating enhanced autophagic flux and increased proteostasis capacity [6][7] Group 3: Safety Profile - Blarcamesine exhibited a favorable safety profile with no treatment-related deaths reported during the trials [4][5] - Common treatment-emergent adverse events included transient dizziness, mostly mild to moderate in severity [8] Group 4: Future Implications - The findings suggest that earlier initiation of treatment with blarcamesine may significantly impact disease progression and provide sustained benefits for patients with early Alzheimer's disease [5][9] - The company emphasizes the importance of a long-term therapeutic strategy for chronic diseases like Alzheimer's, with blarcamesine's convenient once-daily oral dosing potentially enhancing patient adherence [9]

Company Overview - Anavex Life Sciences (AVXL) currently holds a Momentum Style Score of A, indicating strong momentum characteristics [3] - The company has a Zacks Rank of 2 (Buy), suggesting a favorable outlook compared to the market [4] Performance Metrics - Over the past week, AVXL shares have increased by 13.82%, significantly outperforming the Zacks Medical - Biomedical and Genetics industry, which rose by 2.88% [6] - In a longer time frame, AVXL's shares have shown a monthly price change of 31.22%, while the industry only experienced a 0.29% increase [6] - For the past quarter, AVXL shares have risen by 21.72%, and over the last year, they have gained 132.9%, compared to the S&P 500's increases of 15.13% and 13.62%, respectively [7] Trading Volume - The average 20-day trading volume for AVXL is 910,751 shares, which serves as a useful indicator of market interest and price movement [8] Earnings Outlook - In the past two months, one earnings estimate for AVXL has been revised upward, while none have been revised downward, leading to an increase in the consensus estimate from -$0.69 to -$0.52 [10] - For the next fiscal year, one estimate has moved upwards with no downward revisions during the same period [10] Conclusion - Considering the strong performance metrics and positive earnings outlook, AVXL is positioned as a promising investment opportunity with a Momentum Score of A [12]

Company Performance - Adaptive Biotechnologies (ADPT) has gained approximately 96.8% year-to-date, significantly outperforming the average return of -3.1% for Medical companies [4] - The Zacks Consensus Estimate for ADPT's full-year earnings has increased by 5.5% over the past 90 days, indicating improved analyst sentiment and a stronger earnings outlook [4] - Adaptive Biotechnologies holds a Zacks Rank of 2 (Buy), suggesting it has favorable characteristics to outperform the market in the near term [3] Industry Context - Adaptive Biotechnologies is part of the Medical - Biomedical and Genetics industry, which consists of 495 companies and currently ranks 85 in the Zacks Industry Rank [6] - The average performance of the Medical - Biomedical and Genetics industry has seen a loss of 1.1% year-to-date, highlighting ADPT's superior performance within its industry [6] - Another company in the same sector, Anavex Life Sciences (AVXL), has also shown strong performance with a year-to-date increase of 0.5% and a Zacks Rank of 2 (Buy) [5][6]

Core Viewpoint - Kaskela Law LLC is investigating potential breach of fiduciary duty claims against Anavex Life Sciences Corp. on behalf of long-term shareholders due to alleged misleading statements regarding the company's research program and product efficacy [1][4][6]. Company Overview - Anavex Life Sciences Corp. is primarily focused on its product blarcamesine, which is being studied as a treatment for pediatric Rett syndrome patients through the "Excellence" Phase II/Phase III study [3]. Legal Proceedings - A securities fraud complaint has been filed against Anavex for misleading investors during the Class Period from February 1, 2022, to January 1, 2024, regarding the company's research and the likelihood of success of blarcamesine in clinical trials [2][4]. Study Results and Impact - On January 2, 2024, Anavex announced the results of the Excellence study, revealing that the study failed to achieve statistical significance on all but one measure, leading to a significant drop in stock price by $3.26, or over 35%, closing at $6.05 per share [5]. Investigation Focus - The investigation aims to determine if Anavex's board of directors violated securities laws or breached fiduciary duties related to the alleged misconduct during the Class Period [6].