CSF

Key Carbon & Cartesian Enter into $18 Million Carbon Financing

Retrieved on: 
Thursday, March 21, 2024
Carbon, Climate change, Entrepreneurship, CSF, Partnership, Climate, Sale, Acquisition, VCM, Biomass, Renewable energy

(All dollar amounts are in United States dollars)

Key Points: 
  • The deal comprises new funding through Key Carbon as well as the partial sale of an earlier Key Carbon investment.
  • Key Carbon creates strategic partnerships with high-quality project developers and provides them with direct financing and operational support.
  • Luke Leslie, Co-Founder and CEO of Key Carbon, said: "Key Carbon continues to attract institutional investors and corporations into the VCM through creating appealing investable products.
  • This latest transaction with Cartesian further endorses Key Carbon as a preferred route for investors to finance impactful decarbonization projects and access high quality carbon credits."

Nurix Therapeutics Reports First Clinical Evidence of CNS Activity of NX-5948, a Brain-Penetrant, Orally Available, BTK Degrader in Development for B Cell Malignancies

Retrieved on: 
Tuesday, April 9, 2024
Histology, Brain, Rituximab, Chronic lymphocytic leukemia, CLL, Lymphoma, Disease, CSF, Central nervous system, SAN, CNS, Patient, PCNSL, BCL2, Cancer, Leukemia, Inflammation, Cerebrospinal fluid, NHL, Lymph, AACR, Proteolysis targeting chimera, Neoplasm, Therapy, MYC, BTK, Myenteric plexus, Lymphoid leukemia, Spleen, Medical imaging

SAN FRANCISCO, April 09, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced the presentation of the first findings of clinical responses in the brain for NX-5948, an orally available, selective degrader of Bruton’s tyrosine kinase (BTK). The presentation included case studies for two patients, one with CLL with CNS involvement and the other with PCNSL, each demonstrating clinically meaningful responses. The presentation also provided evidence of measurable drug levels in the CNS of multiple patients in the ongoing Phase 1 trial who had CNS tumor involvement. These data were presented by Gwenn M. Hansen, Ph.D., chief scientific officer of Nurix, as part of the Major Symposium session Molecular Glues, PROTACs, and Next-Gen Degraders: Discovery and Early Preclinical Advances at the AACR 2024 Annual Meeting, which is being held from April 5-10, 2024, in San Diego, CA.

Key Points: 
  • The presentation included case studies for two patients, one with CLL with CNS involvement and the other with PCNSL, each demonstrating clinically meaningful responses.
  • The presentation also provided evidence of measurable drug levels in the CNS of multiple patients in the ongoing Phase 1 trial who had CNS tumor involvement.
  • “These data are the first demonstration of clinical activity in the brain of a targeted protein degrader, opening the door for new therapeutic strategies to treat leukemias and lymphomas with CNS involvement,” said Dr. Hansen.
  • “The CLL patient with CNS involvement showed an impressive durable response with NX-5948 as single agent therapy in this setting.

Annovis Bio Provides Corporate Updates and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, April 2, 2024
Research, Failure, Plasma, KPMG, TDP43, Disease, PD, CSF, Yale University, Patient, Inflammation, Biomarker, CMC, Equity, TAR, Human, European, Drug development, ATM, Safety, Phase, Therapy, Vaccine, Treasury, Syneos Health, Axonal transport, Pharmaceutical industry

MALVERN, Pa., April 02, 2024 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, today provided a summary of corporate updates and reported fourth quarter and full year 2023 financial results.

Key Points: 
  • MALVERN, Pa., April 02, 2024 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, today provided a summary of corporate updates and reported fourth quarter and full year 2023 financial results.
  • For the quarter ended December 31, 2023, Annovis reported a net loss of $22.2 million, compared to a net loss of $7.7 million for the same period in 2022.
  • For the full year ended 2023, Annovis reported a net loss of $56.2 million, compared to a net loss of $25.3 million in 2022.
  • Other income (expense) for the quarter ended December 31, 2023 was ($11.2) million, compared to $0.2 million for the same period in 2022.

ProMIS Neurosciences Announces Full Year 2023 Financial Results and Recent Highlights

Retrieved on: 
Monday, April 1, 2024
Research, PMN, FTLD, Biotechnology, MSA, ALS, Multiple system atrophy, CSF, Patient, Neuroscience, Epitope, Immunoglobulin G, RACK1, Cerebrospinal fluid, Activated, Synucleinopathy, Clinical trial, PROMIS, Antibody, Vaccination, Safety, Pharmacokinetics, Interim, Therapy, Blood, SAD, Frontotemporal lobar degeneration, Pharmaceutical industry

This is a very exciting opportunity for both ProMIS and the AD patients we aim to serve.

Key Points: 
  • This is a very exciting opportunity for both ProMIS and the AD patients we aim to serve.
  • ProMIS dosed the first participants in a first-in-human Phase 1a clinical trial of PMN310 as a potential treatment for AD in November 2023 (Study NCT06105528 ).
  • Using a proprietary computational platform, ProMIS identified potential conformational epitopes (misfolded portions) unique to toxic alpha-synuclein involved in synucleinopathies.
  • Cash and cash equivalents were $12.6 million as of December 31, 2023, compared to $5.9 million as of December 31, 2022.

Annovis Announces Publication That Supports Understanding of Buntanetap’s Mechanism of Action in Humans

Retrieved on: 
Monday, April 1, 2024
CSF, Tmax, AUC, Patient, Cerebrospinal fluid, Cmax, Kinetics, APP, SILK

MALVERN, Pa., April 01, 2024 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, today announced the publication of new data from an earlier study supporting buntanetap as a translational inhibitor of amyloid precursor protein (APP) in patients with early Alzheimer’s Disease (AD).

Key Points: 
  • Buntanetap is an oral molecule that selectively binds to an iron-responsive element in the mRNA of APP and other neurotoxic proteins and inhibits their translation.
  • Through this mechanism, buntanetap was shown to decrease the production of amyloid beta (Aβ), a key hallmark in AD.
  • Here, SILK was used to measure the kinetics of APP in early AD patients and to quantify Aβ40 in CSF.
  • Notably, the analysis of adverse events demonstrated no dose-dependent effect of buntanetap compared to placebo, affirming the drug’s safety and tolerability.

Vaxxinity Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Corporate Updates

Retrieved on: 
Wednesday, March 27, 2024
Research, Neurodegenerative disease, Notifiable disease, LDL, Obesity, University, Comparison, PCSK9, Central Florida, Translational research, COVID-19, PD, CSF, Diabetes, Amprion, Patient, CNS, Mayo Clinic, Vaccine, Journal, Biomarker, Travel, Myostatin, Hope, SARS-CoV-2, D&O, Investment, Solid lipid nanoparticle, MDS, Marketing, Parkinson's disease, Hypercholesterolemia

CAPE CANAVERAL, Fla., March 27, 2024 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (Nasdaq: VAXX ), a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • CAPE CANAVERAL, Fla., March 27, 2024 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (Nasdaq: VAXX ), a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.
  • We also seek to advance UB-311, our anti-Aβ Alzheimer’s candidate, as we resume dialogue with regulatory authorities and partners.
  • General and administrative expenses were $3.4 million and $7.7 million for the three months ended December 31, 2023, and 2022, respectively.
  • General and administrative expenses were $22.4 million and $28.4 million for the years ended December 31, 2023, and 2022, respectively.

Inhibikase Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Activity

Retrieved on: 
Wednesday, March 27, 2024
Research, Malignancy, Absorption, PD, CSF, Imatinib, Central nervous system, International, Patient, Gastrointestinal tract, Journal, CML, NDA, Pharmacist, Traffic barrier, Cerebrospinal fluid, Insurance, D&O, Dark Ages, Therapy, Division, Blood, Bone marrow, FDA, SAD, Physician, Approximation error, Pharmaceutical industry

The Meeting Minutes confirmed that the 505(b)(2) pathway appears to be appropriate for approval of IkT-001Pro.

Key Points: 
  • The Meeting Minutes confirmed that the 505(b)(2) pathway appears to be appropriate for approval of IkT-001Pro.
  • Inhibikase will host a conference call and webcast to discuss its full-year 2023 financial results and business highlights tomorrow, March 28, 2024, at 8:00am ET.
  • The conference call can be accessed by dialing 1-877-407-0789 (United States) or 1-201-689-8562 (International) and referencing Inhibikase Therapeutics.
  • After the live webcast, the event will be archived on Inhibikase’s website for approximately 90 days after the call.

Vigil Neuroscience Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, March 26, 2024
Research, Administration, CSF1R, TREM2, MRI, Data analysis, PD, CSF, Magnetic resonance imaging, Patient, Biomarker, Microglia, Osteopontin, Fluid mechanics, IGNITE, Investment, Clinical trial, Pharmacokinetics, Interim, Research and development, Data, FDA, AFL, Pharmaceutical industry

WATERTOWN, Mass., March 26, 2024 (GLOBE NEWSWIRE) --  Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided an update on recent progress.

Key Points: 
  • “Among our many recent milestones, the most significant for Vigil was the positive data readout from our ongoing Phase 2 IGNITE trial and ILLUMINATE Natural History Study.
  • We are also pleased to have enrolled 20 patients in our IGNITE trial, exceeding our target of 15 patients.
  • Cash Position: Cash, cash equivalents, and marketable securities were $117.9 million as of December 31, 2023, compared to $133.6 million as of September 30, 2023.
  • The increase year-over-year was primarily attributable to increases in headcount-related costs and professional service fees to support the Company’s growth.

BrainStorm Cell Therapeutics Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Phase 3b Trial in ALS

Retrieved on: 
Tuesday, April 9, 2024
Neurology, Neuroprotection, Element, Conference call, Institutional review board, Cerebrospinal fluid, Survival, Disease, ALS, SPA, Bone marrow, CSF, Data monitoring committee, Webcast, Patient, Protocol, Biomarker, Mortality, Microsoft Exchange Server, Stem cell, DMC, Screening, Agency, Safety, CAFS, Brainstorm, Therapy, Marketing, FDA, BLA, Neuroinflammation, Food, Pharmaceutical industry

NEW YORK, April 9, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS). 

Key Points: 
  • (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS).
  • The SPA agreement with the FDA validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn, demonstrating their adequacy for addressing objectives that support a future BLA (Biologics License Application) in ALS.
  • We appreciate the Agency's engagement and guidance during the SPA process and look forward to moving forward with the study."
  • The Phase 3b trial (Study BCT-006-US) will be a two-part, multicenter, study designed to assess the efficacy and safety of NurOwn in patients with ALS.

Plus Therapeutics Announces Validation & Clinical Implementation of CSF-01 Leptomeningeal Cancer Cell Diagnostic

Retrieved on: 
Monday, March 25, 2024
Diagnosis, Certification, LM, Plus Therapeutics, NSCLC, CSF, Partnership, Central nervous system, Patient, CNS, Breast, PSTV, Lung cancer, Clinical trial, Therapy, Cancer, Rhenium, CLIA, Research institute, Cancer prevention, Feinberg School of Medicine, Associate professor

AUSTIN, Texas, March 25, 2024 (GLOBE NEWSWIRE) --  Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced it has successfully completed key validation testing and implementation of its tumor cell enumeration assay, known as CSF-01, to be used initially as an exploratory endpoint in its ReSPECT-LM clinical trials.

Key Points: 
  • “In mid-2023, the Company licensed CSF-01, as well as a broader CSF diagnostic testing portfolio due to high conviction that routine implementation will substantially improve diagnosis and clinical management of LM,” said Marc H. Hedrick, M.D., President & CEO of Plus Therapeutics.
  • While validated for use in Plus’ clinical development programs, full Clinical Laboratory Improvement Amendments (CLIA) certification is not anticipated until 2025.
  • The ReSPECT-LM trial, including support for CSF-01 testing, is currently receiving grant funding from the Cancer Prevention and Research Institute of Texas (CPRIT).
  • If the FORSEE data is positive, we intend to work toward increasing commercial reimbursement for the CLIA-certified test and explore partnerships to maximize diagnostic utilization for the broader CNS cancer space.