Clinical trial

Vivos Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Operational Update

Retrieved on: 
Thursday, March 28, 2024
CARE, Sleep apnea, CPAP, Continuous positive airway pressure, Exercise, Environment, VIP, Obstructive sleep apnea, PAP, Shareholder, Webcast, Patient, DME, Sleep, DNA, ODO, AHI, Messenger, Myotherapy, Security (finance), Danaher Corporation, Clinical trial, Therapy, Annual report, Optimism, Dentist, FDA, Food, Pharmaceutical industry

LITTLETON, Colo., March 28, 2024 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (“Vivos” or the “Company’’) (NASDAQ: VVOS), a leading medical device and technology company specializing in the development and commercialization of highly effective proprietary treatments for sleep related breathing disorders (including all severities of obstructive sleep apnea (OSA in adults)), today reported financial results and operating highlights for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Importantly, Vivos believes that governmental investigations of unrelated third parties with non-FDA approved products in the sleep apnea treatment space adversely impacted new Vivos case starts and VIP enrollments during 2023.
  • Vivos’ CARE appliances include the flagship DNA oral appliance, the mRNA oral appliance and the mmRNA oral appliance.
  • Since then, we’ve received high levels of inquiries related to our Vivos CARE products that treat OSA in adults.
  • A live webcast of the conference call can be accessed on Vivos’ website at https://vivos.com/investor-relations .

Unicycive Therapeutics Announces Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 28, 2024
ODD, Research, Hyperphosphatemia, DGF, CRRT, ERA, Administration, Congress, Conference, OLC, CKD, Patient, AKI, National Kidney Foundation, Mitochondrion, NDA, Kidney transplantation, Insurance, Kidney disease, Critical care, Acute kidney injury, Clinical trial, Therapy, Drug development, Safety, Chronic kidney disease, Dialysis, LOS, Research and development, SAD, FDA, KATP, Food, Pharmaceutical industry

LOS ALTOS, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the year ended December 31, 2023, and provided a business update.

Key Points: 
  • LOS ALTOS, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the year ended December 31, 2023, and provided a business update.
  • Completed a private placement with new and existing healthcare institutional investors that generated $50 million in gross proceeds to Unicycive.
  • Cash Position: As of December 31, 2023, cash and cash equivalents totaled $9.7 million.
  • Subsequent to year end, in March 2024, Unicycive completed a private placement of preferred stock which generated $50 million in gross proceeds.

SELLAS Life Sciences Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 28, 2024
Ovarian cancer, SLS, Survival, Lymphoma, Fast track (FDA), PTCL, National Cancer Institute, CMC, Clinical trial, Committee, Research, NCI, European School, Bone marrow, AML, GPS, Pembrolizumab, Doctor of Science, Nivolumab, Safety, MRD, CDK9, BLA, Food, CR2, Zanubrutinib, Mesothelioma, BIW, MD, Completeness, WT1, FDA, DLBCL, IDMC, Therapeutic index, Type, Fast Track, Biomarker, BTK, Pharmaceutical industry

The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed.

Key Points: 
  • The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed.
  • The first patient who achieved a complete response continues on the study and remains leukemia-free 9 months post-enrollment.
  • The net proceeds from the offering strengthen the Company’s financial position and will be used for research and development activities, working capital, and general corporate purposes.
  • Cash Position: As of December 31, 2023, cash and cash equivalents totaled approximately $2.5 million.

Mustang Bio Announces Vision for CAR T-Cell Therapy Platform Expansion into Autoimmune Diseases

Retrieved on: 
Thursday, March 28, 2024
Mustang, Rheumatoid arthritis, Rituximab, Chronic lymphocytic leukemia, Patient, DSM-IV codes, CD20, Cancer, Translation, NHL, B cell, Clinical trial, Society, Waldenström macroglobulinemia, Hematology, Health, Lymphoma, Waldenström, Autoimmune disease, Pharmaceutical industry

WORCESTER, Mass., March 28, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced its expansion into autoimmune diseases with MB-106, a personalized CD20-targeted, 3rd-generation autologous CAR T-cell therapy. MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center (“Fred Hutch”). Mustang and Fred Hutch are in preliminary discussions to explore a potential Phase 1 investigator-sponsored clinical trial to evaluate MB-106 for the treatment of autoimmune diseases.

Key Points: 
  • MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center (“Fred Hutch”).
  • Mustang and Fred Hutch are in preliminary discussions to explore a potential Phase 1 investigator-sponsored clinical trial to evaluate MB-106 for the treatment of autoimmune diseases.
  • “MB-106’s observed safety profile, encouraging efficacy data, and our robust manufacturing capabilities have the potential to translate to improved outcomes for patients with autoimmune diseases.
  • Several antibody therapies targeting CD20 on B-cells have successfully transitioned from cancer to autoimmune diseases, such as rituximab for both lymphoma and rheumatoid arthritis.

Candel Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Thursday, March 28, 2024
OS, Lung cancer, Research, Administration, Conference, Development, Prostate cancer, Survival, Immunotherapy, Fast track (FDA), HGG, Patient, Brain, Standard of care, MD, Society, Insurance, Pancreatic cancer, Clinical trial, Therapy, Breast cancer, SITC, FDA, CADL, Pharmaceutical industry

Research and Development Expenses: Research and development expenses were $7.3 million for the fourth quarter of 2023 compared to $5.0 million for the fourth quarter of 2022, and $24.5 million for the full year 2023 compared to $20.8 million for the full year 2022.

Key Points: 
  • Research and Development Expenses: Research and development expenses were $7.3 million for the fourth quarter of 2023 compared to $5.0 million for the fourth quarter of 2022, and $24.5 million for the full year 2023 compared to $20.8 million for the full year 2022.
  • General and Administrative Expenses: General and administrative expenses were $3.1 million for the fourth quarter of 2023 compared to $3.2 million for the fourth quarter of 2022, and $13.9 million for the full year 2023 compared to $14.1 million for the full year 2022.
  • The change from net other income in the fourth quarter of 2022 to net other expense in the fourth quarter of 2023 was primarily related to the change in the fair value of the Company’s warrant liability.
  • Cash Position: Cash and cash equivalents as of December 31, 2023 were $35.4 million, as compared to $70.1 million as of December 31, 2022.

4DMT Announces Update on Regulatory Interactions and Development Path for 4D-710 for Treatment of Cystic Fibrosis

Retrieved on: 
Thursday, March 28, 2024
CDMO, Conference, TDN, Patient, Lung, Cohort, RNA, EMA, Technology transfer, Cystic fibrosis, European Medicines Agency, GMP, Clinical trial, ECFS, Safety, CFTR, AMD, Food, FDA, VG, Pharmaceutical industry

Phase 3 clinical endpoints include changes after 4D-710 treatment in ppFEV1, quality-of-life (Cystic Fibrosis Questionnaire Revised Respiratory Domain, CFQ-R-RD) and frequency of pulmonary exacerbations.

Key Points: 
  • Phase 3 clinical endpoints include changes after 4D-710 treatment in ppFEV1, quality-of-life (Cystic Fibrosis Questionnaire Revised Respiratory Domain, CFQ-R-RD) and frequency of pulmonary exacerbations.
  • The Company anticipates initiation of technology transfer to a commercial contract development and manufacturing organization (CDMO) in H1 2025.
  • Our goal is to initiate Phase 3 development in H2 2025 with 4D-710 suspension GMP process clinical trial material.
  • We look forward to sharing interim clinical data from the AEROW Phase 1/2 clinical trial at the ECFS conference in June 2024.”

Invivyd Reports Full Year 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Thursday, March 28, 2024
Hook effect, Administration, U.S. FDA, Pre-exposure prophylaxis, Risk, COVID-19, Ageing, SARS-CoV-2, Research and development, Clinical trial, Vaccination, Immunodeficiency, Food, FDA, Vaccine

“We made remarkable progress throughout 2023 and in recent months.

Key Points: 
  • “We made remarkable progress throughout 2023 and in recent months.
  • Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.
  • Cash Position: Cash and cash equivalents were $200.6 million as of December 31, 2023.
  • Basic and diluted net loss per share was $1.81 for the year ended December 31, 2023, compared to $2.23 for the year ended December 31, 2022.

Cocrystal Pharma Reports 2023 Financial Results and Provides Updates on its Antiviral Drug-Development Programs

Retrieved on: 
Thursday, March 28, 2024
COCP, MERS, Research, SARS, Enzyme, Drug discovery, Influenza, CFO, COVID-19, Lung, Coronavirus, RNA, Gastroenteritis, G&A, Death, SARS-CoV-2, Trial of the century, IND, Disease, World Health Organization, Post-exposure prophylaxis, Clinical trial, CDC, Safety, Pharmacokinetics, Cocrystal, Therapy, FDA, Pharmaceutical industry

Our drug-discovery process focuses on the highly conserved regions of the viral enzymes and inhibitor-enzyme interactions at the atomic level.

Key Points: 
  • Our drug-discovery process focuses on the highly conserved regions of the viral enzymes and inhibitor-enzyme interactions at the atomic level.
  • Cocrystal reported unrestricted cash as of December 31, 2023 of $26.4 million, compared with $37.1 million as of December 31, 2022.
  • Net cash used in operating activities for 2023 was $14.7 million, compared with $21.4 million for 2022.
  • The Company had working capital of $25.0 million and 10.2 million common shares outstanding as of December 31, 2023.

Galera Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
Thursday, March 28, 2024
Research, HNC, Symantec Endpoint Protection, Head, Type, Manganese, Chronic kidney disease, Incidence, ASN, CKD, New Drug Application, LAPC, Patient, Layoff, CRL, NDA, Cancer, Galera, Workforce, Pancreatic cancer, Clinical trial, Cisplatin, Society, Therapy, GRECO, File, Food, SOM, FDA, PDUFA, Pharmaceutical industry

We are continuing to explore strategic options to maximize value to our shareholders, including a potential development path for avasopasem.

Key Points: 
  • We are continuing to explore strategic options to maximize value to our shareholders, including a potential development path for avasopasem.
  • The Prescription Drug User Fee Act (PDUFA) target date assigned by the FDA for the NDA was August 9, 2023.
  • Research and development expenses were $3.2 million in the fourth quarter of 2023, compared to $8.1 million for the same period in 2022.
  • General and administrative expenses were $2.0 million in the fourth quarter of 2023, compared to $5.0 million for the same period in 2022.

Tenax Therapeutics Provides Business and Clinical Development Updates with Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 28, 2024
Q&A, Exercise, Patient, Pulmonary hypertension, Cardiovascular Research, Clinical trial, IP, Therapy, LINK, Research, Science, LEVEL, Public expenditure, Heart failure, Development, Tenax, Disease, KOL, TNX-102, First, Research and development, MPH, Cardiology, Conference, Patent, Doctor of Philosophy, Faculty, MBA, Levosimendan, THT, Feinberg School of Medicine, Pharmaceutical industry

We also made important progress in further expanding levosimendan’s U.S. intellectual property protections, securing the future commercial value of TNX-103.

Key Points: 
  • We also made important progress in further expanding levosimendan’s U.S. intellectual property protections, securing the future commercial value of TNX-103.
  • In February 2024, Tenax Therapeutics announced that the first patient had enrolled in the Phase 3 LEVEL Study (LEVosimendan to Improve Exercise Limitation in PH-HFpEF Patients) ( NCT05983250 ).
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    Tenax Therapeutics reported cash and cash equivalents of $9.8 million as of December 31, 2023.
  • Tenax Therapeutics reported a net loss for 2023 of $7.7 million, compared to a net loss of $11.0 million in 2022.