Financial Data and Key Metrics Changes - The cash position as of September 30 was $102.6 million, with no debt reported [15] - Cash utilized in operating activities during the quarter was $8.6 million, with a current cash balance of over $120 million, indicating a cash runway of more than three years at the current utilization rate [16] - Research and development expenses for the quarter were $7.3 million, down from $11.6 million in the same quarter last year, while general and administrative expenses increased to $3.5 million from $2.7 million [16][17] - The net loss for the quarter was $9.8 million, equating to $0.11 per share [17] Business Line Data and Key Metrics Changes - The company is focused on advancing its precision medicine compounds, particularly Blarcamesine and ANAVEX®3-71, with ongoing clinical trials and regulatory actions [3][11] - Blarcamesine has shown significant clinical efficacy in slowing cognitive decline in early Alzheimer's disease patients, with a reported decline of less than 2.68 points on the ADAS-Cog13 scale compared to control groups [9][10] Market Data and Key Metrics Changes - The company is exploring regulatory opportunities beyond the European Union and the United States for Blarcamesine [25] - Initial contacts have been made with U.S. authorities regarding the Alzheimer's disease program, with further updates expected [6] Company Strategy and Development Direction - The company aims to expand collaborative initiatives and strategic partnerships while progressing clinical trials and regulatory actions [3] - There is a focus on addressing unmet medical needs in Alzheimer's disease and exploring the potential of ANAVEX®3-71 in treating schizophrenia and depression associated with Alzheimer's [11][14] Management's Comments on Operating Environment and Future Outlook - Management highlighted the complexity of Alzheimer's disease and the unmet medical need following recent setbacks in the industry, emphasizing the unique mechanism of action of Blarcamesine [23] - The company remains committed to working with regulatory bodies to advance its investigational therapies and is optimistic about the re-examination of Blarcamesine by the CHMP [4][66] Other Important Information - The company has published several scientific studies supporting the efficacy of Blarcamesine, including findings on its mechanism of action and long-term benefits in clinical trials [7][10] - The company plans to present additional data at upcoming conferences, reinforcing its commitment to advancing its therapeutic pipeline [10][73] Q&A Session Summary Question: What is the likely commercial impact of the failure of semaglutide on the outlook for Blarcamesine in Alzheimer's disease? - Management noted that the recent setbacks in the industry highlight the unmet medical need and complexity of Alzheimer's disease, positioning Blarcamesine favorably due to its unique mechanism of action [23][24] Question: When is the next formal discussion of Blarcamesine scheduled to take place with the FDA? - Management indicated that updates will follow initial discussions with U.S. regulators and expressed excitement about these discussions [24] Question: What initiatives does Anavex plan near-term to pursue Blarcamesine approval in regions beyond the European Union and the United States? - The company is exploring other regulatory geographies and moving forward to address open questions [25] Question: Can you elaborate on the additional information needed by the CHMP? - Management stated that the focus is on demonstrating that the benefits of Blarcamesine outweigh the risks, including providing objective biomarker data [27][28] Question: Can the AbClear data be included for consideration on re-examination? - Management confirmed that the AbClear data showing significant cognitive benefits will be emphasized in discussions with regulators [31][32] Question: If approval ultimately came from the EMA, how long would a conditional trial take? - Management noted that it is difficult to speculate on timelines but emphasized the significant unmet need for effective treatments [34] Question: How is the company exploring options for marketing Blarcamesine if approved? - Management highlighted the focus on expanding corporate development partnership activities and participation in key industry conferences [38] Question: Does Anavex have support from the community for its re-evaluation? - Management stated that the community is aware of the drug, and the company is committed to the process of gaining regulatory confidence [68]

Anavex Life Sciences (NasdaqGS:AVXL) Q4 2025 Earnings Call November 25, 2025 08:30 AM ET Company ParticipantsSandra Boenisch - Principal Financial OfficerChristopher Missling - President and CEONone - Company RepresentativeConference Call ParticipantsJesse Silvera - AnalystTom Bishop - AnalystOperatorI'll be your host for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and during this session, if you would like to ask a question, ...

Financial Data and Key Metrics Changes - The company reported a cash position of $102.6 million as of September 30, 2025, with no debt [14] - Cash and cash equivalents utilized in operating activities during the quarter were $8.6 million, with a current cash balance exceeding $120 million, indicating a cash runway of more than three years at the current utilization rate [15] - Research and development expenses for the quarter were $7.3 million, down from $11.6 million in the same quarter last year, while general and administrative expenses increased to $3.5 million from $2.7 million [15][16] - The net loss for the quarter was reported at $9.8 million, equating to $0.11 per share [16] Business Line Data and Key Metrics Changes - The company is focused on advancing its clinical trials and regulatory actions for oral Blarcamesine and ANAVEX®3-71, with significant progress reported in both areas [3][11] - Positive top-line results were announced for ANAVEX®3-71 in a phase two clinical study for schizophrenia, achieving its primary endpoint with a favorable safety profile [11] Market Data and Key Metrics Changes - The company is exploring regulatory approvals for Blarcamesine in regions beyond the European Union and the United States, indicating a strategic expansion of its market reach [20] Company Strategy and Development Direction - The company aims to maximize the potential of its pipeline, focusing on collaborative initiatives and strategic partnerships [3] - There is a commitment to continue working with global regulatory bodies to advance science and treatment options for patients, particularly in Alzheimer's disease [4][5] - The company plans to present additional data and findings at upcoming conferences, emphasizing the relationship between cognitive function and brain atrophy [10] Management's Comments on Operating Environment and Future Outlook - Management highlighted the unmet medical need in Alzheimer's treatment, especially following recent setbacks in the industry, which underscores the complexity of the disease [18] - The company remains optimistic about the re-examination of Blarcamesine by the CHMP, with plans to provide relevant biomarker data to support its case [22][43] Other Important Information - The company has successfully completed a full Good Clinical Practice inspection of trial data by the EMA, and the manufacturing package has passed EMA review [4] - New scientific publications have been released, showcasing the efficacy of Blarcamesine in preventing cognitive decline in Alzheimer's patients [6][8] Q&A Session Summary Question: What is the likely commercial impact of the failure of semaglutide on the outlook for Blarcamesine in Alzheimer's disease? - Management noted that the unmet medical need is highlighted by recent setbacks in the industry, emphasizing the complexity of Alzheimer's disease biology and the lack of available compounds to address this need [18][19] Question: When is the next formal discussion of Blarcamesine scheduled to take place with the FDA? - Management indicated that updates will follow initial discussions with U.S. regulators as they become available [19] Question: What initiative does Anavex plan near-term to pursue Blarcamesine approval in regions beyond the European Union and the United States? - The company is exploring other regulatory geographies and moving forward to address open questions [20] Question: Can you elaborate on the additional information needed by the CHMP? - Management stated that the focus is on demonstrating that the benefits of the drug outweigh the risks, including providing objective biomarker data [21][22] Question: Will you be immediately refiling for the EMA re-evaluation? - Management confirmed that they will request re-examination as soon as possible, with a timeline similar to previous re-evaluations [43]

Financial Performance - Cash and cash equivalents were $102.6 million as of September 30, 2025, down from $132.2 million a year earlier, indicating a decrease of approximately 22.3%[12] - The net loss for the fourth quarter was $9.8 million, or $0.11 per share, compared to a net loss of $11.6 million, or $0.14 per share for the same quarter in fiscal 2024, showing an improvement of 15.9%[12] - The company reported a total operating loss of $51.4 million for the year ended September 30, 2025, compared to $52.9 million for the previous year, indicating a slight improvement of 2.8%[18] Expenses - Research and development expenses for the fourth quarter were $7.3 million, a decrease of 37.8% compared to $11.6 million in the same quarter of fiscal 2024[12] - General and administrative expenses for the quarter increased to $3.5 million, up from $2.7 million in the comparable quarter of fiscal 2024, representing a rise of 29.6%[12] - Total operating expenses for the fourth quarter were $10.8 million, down from $14.3 million in the same quarter of fiscal 2024, reflecting a decrease of 24.8%[12] Clinical Development - The company plans to advance ANAVEX®3-71 towards pivotal clinical studies for the treatment of schizophrenia-related disorders[4] - Anavex's clinical pipeline includes updates on regulatory and clinical trials for blarcamesine in early Alzheimer's disease, Parkinson's disease, and Rett syndrome[4] - Anavex intends to request a re-examination of the CHMP opinion regarding the Marketing Authorisation Application for blarcamesine, following a negative trend vote[12] Cash Position - The company has a current cash runway of more than 3 years based on its current cash utilization rate, with a cash balance of over $120 million as of now[12]

Company to host a webcast today at 8:30 a.m. Eastern Time NEW YORK, Nov. 25, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today reported financial results for its fourth quarter of ...

NEW YORK, Nov. 19, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced that it will present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14th ...

Core Viewpoint - Anavex Life Sciences Corp. is under investigation for potential securities fraud and unlawful business practices following a negative trend vote on its Marketing Authorisation Application for blarcamesine, leading to a significant drop in stock price [1][2]. Group 1: Company Overview - Anavex Life Sciences Corp. (NASDAQ: AVXL) is facing scrutiny from Pomerantz LLP regarding possible securities fraud or other unlawful business practices [1]. - The company announced a negative trend vote from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) concerning its drug blarcamesine [2]. Group 2: Market Reaction - Following the announcement of the negative trend vote, Anavex's stock price decreased by $2.05 per share, representing a decline of 35.94%, closing at $3.65 per share on November 14, 2025 [2].

Webcast and Conference Call To be Held Tuesday, November 25, 2025, 8:30 am ETNEW YORK, Nov. 18, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced that it will issue fina ...

Core Insights - U.S. stock futures are lower, with Dow futures down approximately 100 points [1] - Red Cat Holdings Inc reported disappointing third-quarter results, leading to a significant drop in its stock price [2] Company Performance - Red Cat Holdings Inc's third-quarter revenue was $9.65 million, falling short of analyst expectations of $16.68 million [2] - The company reported a loss of 16 cents per share, which was worse than the anticipated loss of 10 cents per share [2] - Following the earnings report, Red Cat's shares fell by 15.1% to $6.57 in pre-market trading [2] Other Companies' Performance - TSS Inc experienced a 40.2% decline to $9.10 after reporting a year-over-year decrease in third-quarter results [4] - StubHub Holdings Inc's shares dropped 18.8% to $15.28 due to worse-than-expected third-quarter EPS results [4] - WhiteFiber Inc's stock fell 13.4% to $17.21 after reporting disappointing third-quarter financial results [4] - Anavex Life Sciences Corp. saw a decline of 12.3% to $4.99, following an 18% drop the previous day [4] - Verastem Inc's shares dipped 9.4% to $7.35 after announcing a $90 million public offering [4] - POET Technologies Inc fell 8.5% to $4.30 due to weak quarterly results [4] - Solaris Energy Infrastructure Inc declined 5.8% to $42.32 in pre-market trading [4]

Company plans to request re-examination after CHMP opinion feedback following its oral explanation FDA advises Company to meet and discuss Company’s Alzheimer's Disease clinical trial results NEW YORK, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, ...