Synucleinopathies

Latest Series A3 financing includes Labcorp, along with new and longtime investors SCOTTSDALE, Ariz., May 1, 2025 /PRNewswire/ -- CND Life Sciences, Inc. (CND) announced today that it has raised $13.5 million in its Series A equity financing round, with $8.6 million in its most recent Series A3 offering. The company's strong growth has been fueled by its innovative Syn-One Test® that uses skin biopsy tissue to detect and quantify the abnormal form of the alpha-synuclein protein, a known pathological hallmark of Parkinson's disease (PD), dementia with Lewy bodies (DLB), multiple system atrophy and other related disorders. Continue Reading CND Life Sciences closes $13.5M Series A equity financing round to continue neurodiagnostics growth and innovation. Post this (PRNewsfoto/CND Life Sciences) "This is a defining time for the neurodegeneration field," said Richard J. Morello, CND's chief executive officer. "CND uses proven technology to help clinicians diagnose diseases like Parkinson's earlier and more precisely than ever before, while collaborating with biopharmaceutical companies to improve the chances for successful clinical trials for novel therapies. We are grateful for the significant support of our mission by many dedicated investors." CND launched its Syn-One Test in late 2019, which has been used by nearly 3,000 neurologists and other clinicians to aid in the diagnosis of synuclein-associated disorders like PD for more than 35,000 patients. In 2024, CND published a key study in the Journal of the American Medical Association demonstrating Syn-One's 95.5% sensitivity overall in detecting abnormal synuclein in patients with different synuclein-associated diseases. Additionally, Syn-One Biomarker Technology™, which leverages CND's AI-assisted platform NerValence™ to quantify the amount of synuclein detected in cutaneous nerves, is being applied in multiple pharmaceutical clinical trials with the hope of measuring an investigational drug's effect on the pathological protein. "Without accurate diagnosis and objective measures of disease progression and therapy response, treatment of the synuclein-related disorders will be hampered," said Christopher Gibbons, MD, chief scientific officer of CND. "Using our proprietary technology, we are able to support a more precise diagnosis and provide convenient, reproducible measures of disease progression and severity in PD, DLB and other synucleinopathies. These advancements offer real opportunities to deliver more effective patient care and accelerate development of disease-modifying therapies." CND's latest Series A3 round included funding from existing investor groups Cambrian Capital Partners, Tanis Ventures, Lupo Labs, Top Corner Capital, HonorHealth, Triana, Gold Bench Capital and BlueStone Ventures and from new investors Labcorp, a global leader of innovative and comprehensive laboratory services, MBX Capital and Vilas Ventures. "We are excited to support CND's mission to scale access to their Syn-One Test as part of our deep commitment to help deliver innovative neurology tests and treatments," said Megann Vaughn Watters, Labcorp's vice president of New Ventures & Strategic Alliances. "We are encouraged by the strong adoption of CND's innovative testing that is providing actionable information to ordering clinicians and closing gaps in care for patients facing neurodegenerative diseases." About CND Life Sciences CND Life Sciences supports the care of patients facing the potential diagnosis of neurodegenerative disease and other neurological conditions. Operating a CLIA-certified and CAP-accredited laboratory in Scottsdale, Arizona, CND developed the Syn-One Test to help clinicians diagnose synucleinopathies that include Parkinson's disease, dementia with Lewy bodies, multiple system atrophy, pure autonomic failure and REM sleep behavior disorder. Syn-One uses proprietary immunofluorescence techniques to detect, visualize and quantify phosphorylated alpha-synuclein in cutaneous nerves. Results of a prospective, multicenter NIH-sponsored study of the Syn-One Test were published in the Journal of the American Medical Association (JAMA) in 2024 demonstrating >95% sensitivity overall in patients with a clinically determined synucleinopathy.1 The test analyzes three small skin biopsy samples collected in a clinician's office through an in-office patient procedure and includes an assessment of intraepidermal nerve fiber density and other important pathologic markers. Nearly 3,000 neurologists and other clinicians in 50 states have used the Syn-One Test to support their diagnostic evaluation of patients. The company also collaborates with biopharmaceutical companies on clinical trials for investigational therapies targeting neurodegenerative diseases and is conducting studies assessing the test's ability to provide early disease detection and prognostic insights. For more information, visit cndlifesciences.com or connect with us on LinkedIn. 1Gibbons CH, Levine T, Adler C, et al. Skin biopsy detection of phosphorylated α-synuclein in patients with synucleinopathies. JAMA. 2024;331(15):1298–1306. doi:10.1001/jama.2024.0792. Media Contact: Jaryd Leady (856) 803-7855 [email protected] Company Contact: Kathryn Van Wie SVP, Commercial Strategy & Market Development [email protected] SOURCE CND Life Sciences WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Study ANAVEX3-71-SZ-001 successfully completes enrollment with a total of 71 participants Both Part A (16 participants) and Part B (55 participants) of the placebo-controlled Phase 2 study fully enrolled Top line data expected in the second half of 2025 NEW YORK, May 01, 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 the successful completion of enrollment in its Phase 2 clinical study of ANAVEX®3-71 for the treatment of schizophrenia (ANAVEX3-71-SZ-001, NCT06245213). The study has enrolled a total of 71 participants, with 16 participants in Part A and 55 participants in Part B. Part A of the study, which investigated multiple ascending doses, has been completed with encouraging preliminary safety and electroencephalography (EEG) biomarker results previously reported. Part B, which includes more participants and a longer treatment duration, will provide more comprehensive clinical and biomarker data on the efficacy and safety of ANAVEX®3-71 in individuals with schizophrenia. “We are pleased to announce the full enrollment of our ANAVEX3-71-SZ-001 study and would like to thank all the patients and investigators for their participation in this first clinical efficacy trial of ANAVEX®3-71,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “There is a substantial unmet medical need for a drug that can effectively address all symptoms of schizophrenia, and we are hopeful that these results are encouraging for further development of ANAVEX®3-71 for people with schizophrenia.” Oral ANAVEX®3-71 is a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator with agonistic effects. This novel mechanism of action offers the potential to treat all symptom domains of schizophrenia without the side effects of standard of care antipsychotics. The Company expects to report top-line data from the study in the second half of 2025. This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval. About Schizophrenia Schizophrenia is a persistent and often disabling mental illness impacting how a person thinks, feels, and behaves, and affects nearly 24 million people worldwide, including 2.8 million people in the U.S. It is characterized by three symptom domains: positive symptoms (hallucinations and delusions), negative symptoms (difficulty enjoying life and withdrawal from others), and cognitive impairment (deficits in memory, concentration, and decision-making). In part due to limitations with current treatments, people living with schizophrenia often struggle to maintain employment, live independently, and manage relationships. While current treatments can be effective in managing select symptoms, approximately 34% of people do not respond to therapy, 1 with an additional 50-60% experiencing only a partial improvement in symptoms or unacceptable side effects.2 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. For Further Information:Anavex Life Sciences Corp.Research & Business DevelopmentToll-free: 1-844-689-3939Email: info@anavex.com Investors:Andrew J. BarwickiInvestor RelationsTel: 516-662-9461Email: andrew@barwicki.com 1 Potkin SG, Kane JM, Correll CU, et al. The neurobiology of treatment-resistant schizophrenia: paths to antipsychotic resistance and a roadmap for future research. NPJ Schizophr. 2020;6(1):1. Published 2020 Jan 7. doi:10.1038/s41537-019-0090-z2 Nucifora FC Jr, Woznica E, Lee BJ, Cascella N, Sawa A. Treatment resistant schizophrenia: Clinical, biological, and therapeutic perspectives. Neurobiol Dis. 2019;131:104257. doi:10.1016/j.nbd.2018.08.016

Study ANAVEX3-71-SZ-001 successfully completes enrollment with a total of 71 participants Both Part A (16 participants) and Part B (55 participants) of the placebo-controlled Phase 2 study fully enrolled Top line data expected in the second half of 2025 NEW YORK – May 01, 2025 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 the successful completion of enrollment in its Phase 2 clinical study of ANAVEX®3-71 for the treatment of schizophrenia (ANAVEX3-71-SZ-001, NCT06245213). The study has enrolled a total of 71 participants, with 16 participants in Part A and 55 participants in Part B. Part A of the study, which investigated multiple ascending doses, has been completed with encouraging preliminary safety and electroencephalography (EEG) biomarker results previously reported. Part B, which includes more participants and a longer treatment duration, will provide more comprehensive clinical and biomarker data on the efficacy and safety of ANAVEX®3-71 in individuals with schizophrenia. “We are pleased to announce the full enrollment of our ANAVEX3-71-SZ-001 study and would like to thank all the patients and investigators for their participation in this first clinical efficacy trial of ANAVEX3-71,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "There is a substantial unmet medical need for a drug that can effectively address all symptoms of schizophrenia, and we are hopeful that these results are encouraging for further development of ANAVEX®3-71 for people with schizophrenia.” Oral ANAVEX®3-71 is a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator with agonistic effects. This novel mechanism of action offers the potential to treat all symptom domains of schizophrenia without the side effects of standard of care antipsychotics. The Company expects to report top-line data from the study in the second half of 2025. This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval. About Schizophrenia Schizophrenia is a persistent and often disabling mental illness impacting how a person thinks, feels, and behaves, and affects nearly 24 million people worldwide, including 2.8 million people in the U.S. It is characterized by three symptom domains: positive symptoms (hallucinations and delusions), negative symptoms (difficulty enjoying life and withdrawal from others), and cognitive impairment (deficits in memory, concentration, and decision-making). In part due to limitations with current treatments, people living with schizophrenia often struggle to maintain employment, live independently, and manage relationships. While current treatments can be effective in managing select symptoms, approximately 34% of people do not respond to therapy, [1] with an additional 50-60% experiencing only a partial improvement in symptoms or unacceptable side effects.[2] 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. 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 [1] Potkin SG, Kane JM, Correll CU, et al. The neurobiology of treatment-resistant schizophrenia: paths to antipsychotic resistance and a roadmap for future research. NPJ Schizophr. 2020;6(1):1. Published 2020 Jan 7. doi:10.1038/s41537-019-0090-z 2 [2]Nucifora FC Jr, Woznica E, Lee BJ, Cascella N, Sawa A. Treatment resistant schizophrenia: Clinical, biological, and therapeutic perspectives. Neurobiol Dis. 2019;131:104257. doi:10.1016/j.nbd.2018.08.016