Anavex Life Sciences Reports Fiscal 2024 Third Quarter Financial Results and Provides Business Update
Anavex Life Sciences reported fiscal 2024 Q3 results and provided a business update. Key highlights include:
1. Advancement of blarcamesine (ANAVEX®2-73) for Alzheimer's disease, with full regulatory submission expected in Q4 2024.
2. Progress in ANAVEX®3-71 Phase 2 trial for schizophrenia.
3. Planned initiation of ANAVEX®2-73 Phase 2b/3 trial for Parkinson's disease in H2 2024.
4. Cash position of $138.8 million as of June 30, 2024, providing an estimated 4-year runway.
5. Net loss of $12.2 million ($0.14 per share) for the quarter.
Anavex Life Sciences ha riportato i risultati del terzo trimestre fiscale 2024 e fornito un aggiornamento aziendale. Punti salienti includono:
1. Avanzamento di blarcamesina (ANAVEX®2-73) per la malattia di Alzheimer, con una completa presentazione regolatoria prevista per il quarto trimestre del 2024.
2. Progressi nella sperimentazione di fase 2 di ANAVEX®3-71 per la schizofrenia.
3. Inizio pianificato della sperimentazione di fase 2b/3 di ANAVEX®2-73 per il morbo di Parkinson nel secondo semestre del 2024.
4. Posizione di cassa di 138,8 milioni di dollari al 30 giugno 2024, che fornisce una previsione di 4 anni.
5. Perdita netta di 12,2 milioni di dollari (0,14 dollari per azione) per il trimestre.
Anavex Life Sciences informó los resultados del tercer trimestre fiscal 2024 y proporcionó una actualización empresarial. Los aspectos más destacados incluyen:
1. Avance de blarcamesina (ANAVEX®2-73) para la enfermedad de Alzheimer, con una presentación regulatoria completa esperada para el cuarto trimestre de 2024.
2. Progreso en el ensayo de fase 2 de ANAVEX®3-71 para la esquizofrenia.
3. Inicio planeado del ensayo de fase 2b/3 de ANAVEX®2-73 para la enfermedad de Parkinson en la segunda mitad de 2024.
4. Posición de efectivo de 138,8 millones de dólares al 30 de junio de 2024, proporcionando una proyección de 4 años.
5. Pérdida neta de 12,2 millones de dólares (0,14 dólares por acción) para el trimestre.
Anavex Life Sciences는 2024 회계연도 3분기 실적을 발표하고 비즈니스 업데이트를 제공했습니다. 주요 내용은 다음과 같습니다:
1. 알츠하이머 병을 위한 blarcamesine (ANAVEX®2-73)의 진전, 2024년 4분기에는 전체 규제 제출이 예상됩니다.
2. 정신분열증에 대한 ANAVEX®3-71 Phase 2 시험에서의 진행.
3. 2024년 하반기에 파킨슨 병을 위한 ANAVEX®2-73 Phase 2b/3 시험 시작 계획.
4. 2024년 6월 30일 기준으로 1억 3,880만 달러의 현금 보유, 4년간의 운영 자금 제공 예정.
5. 분기 동안 1천 2백 20만 달러의 순손실(주당 0.14달러).
Anavex Life Sciences a rapporté les résultats du troisième trimestre fiscal 2024 et a fourni une mise à jour sur ses activités. Les points clés incluent :
1. Avancement de blarcamesine (ANAVEX®2-73) pour la maladie d'Alzheimer, avec une soumission réglementaire complète prévue pour le quatrième trimestre 2024.
2. Progrès dans l'essai de phase 2 d'ANAVEX®3-71 pour la schizophrénie.
3. Démarrage prévu de l'essai de phase 2b/3 d'ANAVEX®2-73 pour la maladie de Parkinson au second semestre 2024.
4. Position de trésorerie de 138,8 millions de dollars au 30 juin 2024, offrant une marge de 4 ans.
5. Perte nette de 12,2 millions de dollars (0,14 dollar par action) pour le trimestre.
Anavex Life Sciences hat die Ergebnisse des dritten fiskalischen Quartals 2024 berichtet und Updates zum Geschäft bereitgestellt. Wichtige Höhepunkte sind:
1. Fortschritte mit blarcamesine (ANAVEX®2-73) für Alzheimer-Krankheit, mit vollständiger regulatorischer Einreichung, die für das vierte Quartal 2024 erwartet wird.
2. Fortschritte in der Phase-2-Studie zu ANAVEX®3-71 für Schizophrenie.
3. Geplante Einleitung der Phase-2b/3-Studie zu ANAVEX®2-73 für Parkinson-Krankheit in der zweiten Hälfte von 2024.
4. Bargeldbestand von 138,8 Millionen USD zum 30. Juni 2024, der einen geschätzten Abstand von 4 Jahren bietet.
5. Nettoverlust von 12,2 Millionen USD (0,14 USD pro Aktie) für das Quartal.
- Positive Phase 2b/3 clinical trial results for blarcamesine in Alzheimer's disease
- Regulatory submission for blarcamesine expected in Q4 2024
- Strong cash position of $138.8 million, providing 4-year runway
- Expansion of leadership team with experienced executives
- Increased net loss to $12.2 million compared to $11.3 million in the same quarter last year
- Higher research and development expenses of $11.9 million compared to $10.3 million in the previous year
Insights
Anavex's Q3 FY2024 results reveal a stable financial position with
The increased R&D spending reflects Anavex's commitment to advancing its pipeline, particularly its lead candidate blarcamesine for Alzheimer's disease. With MAA submission planned for Q4 2024, Anavex is positioning itself for potential market entry in Europe, targeting a sizable 7 million patient population. This regulatory milestone could be a significant catalyst for the stock.
Investors should monitor the upcoming peer-reviewed publication of blarcamesine's Phase 2b/3 results and interim data from ongoing trials in H2 2024, which could further validate the drug's potential and impact stock performance.
Anavex's pipeline progress is promising, particularly in Alzheimer's disease. The positive Phase 2b/3 results for blarcamesine, showing significant slowing of clinical decline with a good safety profile, are encouraging. The lack of neuroimaging adverse events is noteworthy, as it differentiates blarcamesine from some competitors in the field.
The company's multi-pronged approach to CNS disorders, including Parkinson's, schizophrenia and rare diseases like Rett syndrome, provides multiple shots on goal. The advancement of ANAVEX®3-71 in schizophrenia and plans for a Parkinson's trial demonstrate pipeline depth.
The focus on biomarkers and precision medicine is strategically sound, potentially leading to more targeted and effective treatments. The upcoming RNA-seq analysis could provide valuable insights into disease mechanisms and treatment effects, potentially strengthening Anavex's scientific position and attracting partner interest.
Anavex's focus on Alzheimer's disease positions it in a high-growth market, with European patient numbers expected to double by 2030. The company's expansion into other CNS disorders like Parkinson's and schizophrenia further broadens its market potential.
The addition of experienced leadership in R&D and clinical development strengthens Anavex's ability to navigate the complex regulatory landscape and potentially accelerate pipeline progress. This could enhance investor confidence in the company's execution capabilities.
Anavex's engagement with patient communities and presence at key conferences like AAIC and NFXF demonstrate a commitment to stakeholder relationships, which can be important for patient recruitment and eventual market adoption.
However, investors should note that while Anavex's pipeline is diverse, it faces significant competition in the Alzheimer's space from larger pharmaceutical companies. The company's success will depend on differentiation and clinical superiority of its candidates.
Company to host a webcast today at 8:30 a.m. Eastern Time
NEW YORK, Aug. 06, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) diseases, today reported financial results for its fiscal quarter ended June 30, 2024.
“We continue to meaningfully advance our differentiated precision medicine clinical program, highlighted by the recent presentation of comprehensive results from the Phase 2b/3 clinical trial of blarcamesine (ANAVEX®2-73), which were presented at the Alzheimer’s Association International Conference (AAIC), showing that oral, once daily blarcamesine significantly slowed clinical decline for early Alzheimer's disease patients with good comparative safety profile and no associated neuroimaging adverse events. We are also pleased to report that the clinical team continues to beat the planned timelines in the ongoing ANAVEX®3-71-SZ-001 Phase 2 trial of ANAVEX®3-71 in schizophrenia patients,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “Additionally, we remain dedicated to developing medicines for individuals suffering from brain disorders within neurodegenerative and neurodevelopmental disorders, which could further expand our differentiated precision medicine platform to deliver scalable treatment options coupled with convenient oral dosing.”
Key Pipeline Updates:
- Alzheimer’s disease:
- Full data from the blarcamesine in Alzheimer’s disease Phase 2b/3 placebo-controlled clinical trial will be published in an upcoming peer-reviewed journal. The initiated process for submitting a Marketing Authorisation application (MAA) to the European Medicines Agency (EMA) under the Centralised Procedure is underway, with full regulatory submission of blarcamesine expected in Q4 2024. The Marketing Authorisation would allow direct market access throughout the European Union for oral blarcamesine for the treatment of Alzheimer’s disease. There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 2030, according to the European Brain Council.1
- Analysis of RNA sequencing (RNA-seq), which would reveal which genes are actively transcribed (expressed) in Alzheimer’s patients in comparison between placebo and blarcamesine of the placebo-controlled Phase 2b/3 blarcamesine trial in early Alzheimer’s disease. This data might have relevant value since it may provide insight into Alzheimer’s disease pathology and how cells function in presence of placebo or in presence of blarcamesine, respectively. Interim data expected in the second half of 2024.
- Completed last patient last visit in the ATTENTION-AD open-label extension 96-week trial. Interim data expected in the second half of 2024.
- AAIC 2024 meeting resulted in constructive feedback received coupled with enthusiasm around our Alzheimer’s disease program strengthened by the recent addition of an experienced clinical team, which support Anavex future plans. Educational reach out to continue towards MAA submission and beyond.
- Schizophrenia: The placebo-controlled ANAVEX®3-71-SZ-001 Phase 2 clinical trial of ANAVEX®3-71 for the treatment of schizophrenia has completed dosing of the first cohort and is nearing the completion of enrollment of the second cohort of schizophrenia patients in Part A of the trial.
- Parkinson’s disease: Initiation of ANAVEX®2-73 Phase 2b/3 >6-month trial, including biomarkers, which we believe may be key to understanding drug effects on Parkinson’s disease pathophysiology and account for the recently changing context in the field of Parkinson’s disease is expected in the second half of 2024.
- Rett syndrome: An educational presentation was provided at the 2024 IRSF Rett Syndrome Scientific Meeting, June 18 – June 19, 2024, which demonstrated the commitment of Anavex to the Rett syndrome community through direct engagement with patients and families. Positive and supportive feedback was received from families and investigators about the continued Anavex Rett syndrome program.
- Fragile X: New disease-specific, translatable, and objective biomarker data generated with ANAVEX®2-73, supporting the initiation of the ANAVEX®2-73 Phase 2/3 clinical trial was presented at the 19th NFXF International Fragile X Conference. Meeting with NFXF leadership team strengthened Anavex’s relationship with community coupled with increased awareness of Anavex’s Fragile X syndrome (FXS) program by engaging with patients and families in attendance.
- New Rare disease: Initiation of ANAVEX®2-73 Phase 2/3 clinical trial.
- Medical Affairs: Building Medical Affairs capabilities to expand education and physician support activities to ensure optimal medical impact including continued clinical publications involving ANAVEX®2-73 and ANAVEX®3-71.
Recent Business Highlights:
- On May 22, 2024, Anavex announced new additions to its leadership team with the appointment of Juan Carlos Lopez-Talavera, MD, PhD as Senior Vice President, Head of Research and Development, Terrie Kellmeyer, PhD as Senior Vice President of Clinical Development, and Jeffrey Edwards, PhD as Vice President of Clinical Pharmacology and Science, all with a track record of successfully bringing drugs to market.
- On July 28, 2024, comprehensive results from the Phase 2b/3 clinical trial of ANAVEX®2-73 (blarcamesine) were presented at the Alzheimer’s Association Conference (AAIC), showing that oral, once daily blarcamesine significantly slowed clinical decline for early Alzheimer's disease patients with good comparative safety profile and no associated neuroimaging adverse events. The clinical benefit of blarcamesine was consistently observed for both 30 mg and 50 mg treatment groups, and the results demonstrated benefits of blarcamesine on both cognitive and functional parameters (ADAS-Cog13, CDR-SB, CGI-I), as well as amyloid-beta and brain volume, two underlying pathological hallmarks of Alzheimer’s disease.
- On July 30, 2024, Anavex reported positive preclinical results in biomarkers that are directly translatable to humans for individuals with FXS for ANAVEX®2-73 (blarcamesine), in a disease model of Fragile X syndrome (FXS). The findings presented at the 19th NFXF International Fragile X Conference reports positive results for electroencephalogram (EEG) biomarkers that are directly translatable to humans and present in both individuals with FXS and animal models of FXS.
Financial Highlights:
- Cash and cash equivalents of
$138.8 million at June 30, 2024 compared to$151.0 million at fiscal yearend September 30, 2023. The Company anticipates at the current cash utilization rate a runway of approximately 4 years. - General and administrative expenses for the quarter of
$2.9 million compared to$3.2 million for the comparable quarter of fiscal 2023. - Research and development expenses for the quarter of
$11.9 million compared to$10.3 million for the comparable quarter of fiscal 2023. - Net loss for the quarter of
$12.2 million , or$0.14 per share, compared to a net loss of$11.3 million , or$0.14 per share for the comparable quarter of fiscal 2023.
The financial information for the fiscal quarter ended June 30, 2024, should be read in conjunction with the Company’s condensed consolidated interim financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com.
Webcast / Conference Call Information:
The live webcast of the conference call will be available on Anavex’s website at www.anavex.com.
The conference call can be also accessed by dialing 1 929 205 6099 for participants in the U.S. using the Meeting ID# 821 9280 7728 and reference passcode 121725. A replay of the conference call will also be available on Anavex’s website for up to 30 days.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer's disease, Parkinson's disease, schizophrenia, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients and one Phase 2/3 study in pediatric patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson's disease. We believe that ANAVEX®3-71, which targets SIGMAR1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company on Twitter, Facebook, Instagram, and LinkedIn.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions 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 statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. 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.
____________________
1 https://www.braincouncil.eu/projects/rethinking-alzheimers-disease/
| Anavex Life Sciences Corp. | ||||||
| Condensed Consolidated Interim Statements of Operations and Comprehensive Loss | ||||||
| (in thousands, except share and per share amounts) | ||||||
| Three months ended June 30, | ||||||
| 2024 | 2023 | |||||
| Operating Expenses | ||||||
| General and administrative | $ | 2,859 | $ | 3,248 | ||
| Research and development | 11,870 | 10,283 | ||||
| Total operating expenses | 14,729 | 13,531 | ||||
| Operating loss | (14,729 | ) | (13,531 | ) | ||
| Other income | ||||||
| Research and development incentive income | 526 | 565 | ||||
| Interest income, net | 1,796 | 1,828 | ||||
| Foreign exchange gain (loss) | 67 | (101 | ) | |||
| Gain on settlement of accounts payable | 59 | - | ||||
| Total other income, net | 2,448 | 2,292 | ||||
| Net loss before provision for income taxes | (12,281 | ) | (11,239 | ) | ||
| Income tax recovery (expense), current | 67 | (41 | ) | |||
| Net loss and comprehensive loss | $ | (12,214 | ) | $ | (11,280 | ) |
| Net loss per share | ||||||
| Basic and diluted | $ | (0.14 | ) | $ | (0.14 | ) |
| Weighted average number of shares outstanding | ||||||
| Basic and diluted | 84,535,328 | 80,875,235 | ||||
| Anavex Life Sciences Corp. | ||||||
| Condensed Consolidated Interim Statements of Operations and Comprehensive Loss | ||||||
| (in thousands, except share and per share amounts) | ||||||
| Nine months ended June 30, | ||||||
| 2024 | 2023 | |||||
| Operating Expenses | ||||||
| General and administrative | $ | 8,258 | $ | 9,447 | ||
| Research and development | 30,283 | 33,657 | ||||
| Total operating expenses | 38,541 | 43,104 | ||||
| Operating loss | (38,541 | ) | (43,104 | ) | ||
| Other income | ||||||
| Grant income | - | 25 | ||||
| Research and development incentive income | 1,591 | 2,048 | ||||
| Interest income, net | 5,561 | 4,561 | ||||
| Other financing expense | - | (964 | ) | |||
| Foreign exchange gain (loss) | 72 | 146 | ||||
| Gain on settlement of accounts payable | 59 | - | ||||
| Total other income, net | 7,283 | 5,816 | ||||
| Net loss before provision for income taxes | (31,258 | ) | (37,288 | ) | ||
| Income tax expense, current | (124 | ) | (71 | ) | ||
| Net loss and comprehensive loss | $ | (31,382 | ) | $ | (37,359 | ) |
| Net loss per share | ||||||
| Basic and diluted | $ | (0.38 | ) | $ | (0.47 | ) |
| Weighted average number of shares outstanding | ||||||
| Basic and diluted | 83,022,330 | 79,051,038 | ||||
| Anavex Life Sciences Corp. | ||||||
| Condensed Consolidated Interim Balance Sheets | ||||||
| (in thousands, except share and per share amounts) | ||||||
| June 30, | September 30, | |||||
| 2024 | 2023 | |||||
| Assets | ||||||
| Current | ||||||
| Cash and cash equivalents | $ | 138,756 | $ | 151,024 | ||
| Incentive and tax receivables | 1,720 | 2,709 | ||||
| Prepaid expenses and other current assets | 1,059 | 653 | ||||
| Total Assets | $ | 141,535 | $ | 154,386 | ||
| Liabilities and stockholders' equity | ||||||
| Current Liabilities | ||||||
| Accounts payable | $ | 3,503 | $ | 4,322 | ||
| Accrued liabilities | 7,334 | 7,295 | ||||
| Deferred grant income | 917 | 917 | ||||
| Total Liabilities | 11,754 | 12,534 | ||||
| Capital Stock | 85 | 82 | ||||
| Additional paid-in capital | 454,236 | 434,839 | ||||
| Share proceeds receivable | (89 | ) | - | |||
| Accumulated deficit | (324,451 | ) | (293,069 | ) | ||
| Total Stockholders' Equity | 129,781 | 141,852 | ||||
| Total Liabilities and Stockholders' Equity | $ | 141,535 | $ | 154,386 | ||
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: andrew@barwicki.com
FAQ
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