SPA

Dundee Precious Metals Delivers Strong First Quarter Gold Production; Announces Timing of First Quarter Financial Results

Retrieved on: 
Monday, April 8, 2024
PIN, IXM, SPA, Gold, Copper, Chelopech, Metal, Sale, News, MD, Bank statement, DPM

Gold production was in line with expectations while copper production was slightly lower than planned due to lower copper grades.

Key Points: 
  • Gold production was in line with expectations while copper production was slightly lower than planned due to lower copper grades.
  • During the first quarter of 2024, the Tsumeb smelter processed approximately 54,800 tonnes of complex concentrate.
  • The Company plans to release its first quarter 2024 operating and financial results after market close on Tuesday, May 7, 2024.
  • On Wednesday, May 8, 2024, at 9 AM EDT, DPM will host a conference call and audio webcast to discuss the results, followed by a question-and-answer session.

Iterum Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 28, 2024
Research, Symantec Endpoint Protection, Prejudice, SPA, Patient, CRL, NDA, G&A, CMC, Disclosure, Insurance, Senior, Woman, Investment, Infection, Therapy, Urinary tract infection, ATM, FDA, ITRM, Food, Pharmaceutical industry

DUBLIN, Ireland and CHICAGO, March 28, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported financial results for the fourth quarter and year ended December 31, 2023.

Key Points: 
  • Iterum reported positive top-line data in January 2024 and plans to resubmit its NDA early in the second quarter of 2024.
  • In connection with this strategic process, Iterum has engaged a financial advisor to assist management and the board in evaluating strategic alternatives.
  • In addition, during the fourth quarter of 2022, a change in the discount rate impacted the fair value of the Royalty-Linked Notes.
  • Iterum will host a conference call today, Thursday, March 28, 2024 at 8:30 a.m. Eastern Time.

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.

Systems Planning & Analysis Sponsors Future Assistance Dogs from Guide Dog Foundation and America’s VetDogs

Retrieved on: 
Monday, March 18, 2024
Socialization, Culture, Veteran, SPA, Partnership, Learning, Volunteering, Dog, Disability, Workplace, Family, PTSD, Navy, Management

At the core of Guide Dog Foundation’s and America’s VetDogs mission is the recruitment of dedicated volunteers, recognizing the substantial 16–18-month commitment required to nurture exemplary behavior and social aptitude in these young canines.

Key Points: 
  • At the core of Guide Dog Foundation’s and America’s VetDogs mission is the recruitment of dedicated volunteers, recognizing the substantial 16–18-month commitment required to nurture exemplary behavior and social aptitude in these young canines.
  • To assist volunteers in blending work requirements with puppy nurturing, SPA encourages employee puppy raisers to bring their trainees to the workplace, a unique opportunity among Guide Dog Foundation and America’s VetDogs corporate partners.
  • Future assistance dogs cannot be raised in kennels; they need socialization and exposure to the world they will be navigating when they are paired with their future handler.
  • Volunteering to raise a future guide or service dog is a commitment that requires time, patience, and unwavering dedication.

Spero Therapeutics Announces Fourth Quarter and Full Year 2023 Operating Results and Provides a Business Update

Retrieved on: 
Wednesday, March 13, 2024
Gram-negative bacteria, Department of Defence, Urinary tract infection, GSK, Patient, Human services, Quality of life, IND, Tebipenem, Clinical trial, Therapy, Infection, Research, Policy, Treasurer, Carbapenem-resistant enterobacteriaceae, Safety, Pharmacokinetics, Federal, Food, AP, Drug discovery, Disease, Kidney, SPA, Acinetobacter baumannii, MDR, Pyelonephritis, Annual report, FDA, Army, HBR, Government, Unitary state, NTM, Assistant, Fungal infection, Pseudomonas aeruginosa, Hope, National Institutes of Health, ID, Mycobacterium avium complex, Bangladesh Technical Education Board, Administration, Pharmaceutical industry

“2023 was a productive year for Spero and we have been focused on execution across our programs,” said Sath Shukla, President, and Chief Executive Officer of Spero.

Key Points: 
  • “2023 was a productive year for Spero and we have been focused on execution across our programs,” said Sath Shukla, President, and Chief Executive Officer of Spero.
  • Top-line data from the Phase 2a proof-of-concept clinical trial in treatment-naive and treatment-experienced non-refractory NTM-PD patients is expected in 2H 2024.
  • Spero commenced enrollment in PIVOT-PO, a global, randomized, double-blind, Phase 3 clinical trial of tebipenem HBr in patients with cUTI, including AP in December 2023.
  • Total revenue for the fourth quarter of 2023 was $73.5 million, compared with total revenue of $47.4 million for the fourth quarter of 2022.

Clearside Biomedical Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, March 12, 2024
Patient, G&A, BioCryst Pharmaceuticals, Eye, Drug delivery, Clinical trial, AAO, Extension, Webcast, Pharming, CPT, Safety, Disease, SPA, American Academy of Ophthalmology, Compass, Insurance, Diabetic retinopathy, Conference call, Aura, AMD, TKI, CLS, FDA, Administration, Conference, SCS, DME, American Academy, OASIS, Injection, Research and development, Axitinib, Pharmaceutical industry

ALPHARETTA, Ga., March 12, 2024 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today reported financial results for the fourth quarter and year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • License Revenue: License and other revenue for the fourth quarter of 2023 was $6.3 million, compared to $0.3 million for the fourth quarter of 2022.
  • Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2023 were $6.3 million, compared to $5.0 million for the fourth quarter of 2022.
  • General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2023 were $2.9 million, compared to $3.2 million for the fourth quarter of 2022.
  • Other Expense: Non-cash interest expense for the fourth quarter of 2023 was $2.3 million, compared to $2.0 million for the fourth quarter of 2022.

Arsenal Biosciences Announces Presentation of Four Abstracts at AACR Annual Meeting Highlighting New CAR T-Focused Research

Retrieved on: 
Friday, April 5, 2024
Biotechnology, Pharmaceutical, Health, Oncology, Ovarian cancer, Short interspersed nuclear element, B cell, Fas, SPA, Glomus tumor, MSLN, Neoplasm, Research, RNA, Tumor microenvironment, Abstract, AACR, CA9, Clinical trial, Cancer, CRISPR, Primer, TCR, Engineering, PSMA, Cas9, ICT, Vaccine

Arsenal Biosciences, Inc. (ArsenalBio), a clinical-stage programmable cell therapy company focused on engineering advanced CAR T-cell therapies for solid tumors, today announced the presentation of four abstracts at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA., May 5-10, 2024.

Key Points: 
  • Arsenal Biosciences, Inc. (ArsenalBio), a clinical-stage programmable cell therapy company focused on engineering advanced CAR T-cell therapies for solid tumors, today announced the presentation of four abstracts at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA., May 5-10, 2024.
  • AB-2100 will be studied in a phase 1/2 clinical trial as a potential therapy for clear cell renal cell carcinoma (ccRCC) ( NCT06245915 ).
  • To better characterize CAR induction and receptor turnover, we conducted a series of assays, ultimately demonstrating preclinically that all PrimeR ICT cells have the potential to induce CAR.
  • Leveraging a reductionist in vitro model system, we were also able to analyze CAR induction and receptor turnover.

Quince Therapeutics Provides Business Update and Reports Fourth Quarter and Fiscal 2023 Financial Results

Retrieved on: 
Monday, April 1, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, A-T, DSP, Disease, SPA, Half-life, Hematology, Patient, NDA, EU4, Acquisition, Standard of care, Pivotal, Cancer, Quality of life, Biology, AIDE, Investment, Clinical trial, Therapy, NEAT, FDA, Pharmaceutical industry

Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company developing an innovative drug delivery technology designed to leverage a patient’s own biology to deliver rare disease therapeutics, today provided an update on the company’s development pipeline and reported financial results for the fourth quarter and fiscal year ended December 31, 2023.

Key Points: 
  • Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company developing an innovative drug delivery technology designed to leverage a patient’s own biology to deliver rare disease therapeutics, today provided an update on the company’s development pipeline and reported financial results for the fourth quarter and fiscal year ended December 31, 2023.
  • Pivotal Phase 3 NEAT clinical trial will be conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food & Drug Administration (FDA).
  • Expect to report Phase 3 NEAT topline results in the second half of 2025 with a potential NDA submission in 2026, assuming positive study results.
  • Quince estimates there are an aggregate of approximately 10,000 patients with A-T in the U.S., U.K., and EU4 countries.

Aura Biosciences Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights

Retrieved on: 
Wednesday, March 27, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, NMIBC, Research, Melanoma, Growth, Disease, SPA, Incidence, Paratriathlon, Inflammation, Patient, Necrosis, Travel, Light, Aes, American Academy, Cancer, Șaeș, Bladder cancer, Radiation, Eye, Doctor of Philosophy, MIBC, Visual acuity, Neoplasm, ILS, Aura, Safety, Recurrence, AAO, Annual general meeting, Food, Pharmaceutical industry

Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision immunotherapies to treat solid tumors to preserve the function of the afflicted organ with cancer, today reported financial results for the fourth quarter and year ended December 31, 2023, and provided recent business highlights.

Key Points: 
  • Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision immunotherapies to treat solid tumors to preserve the function of the afflicted organ with cancer, today reported financial results for the fourth quarter and year ended December 31, 2023, and provided recent business highlights.
  • The primary endpoint is time to tumor progression when the last patient completes 15 months of follow up.
  • As of December 31, 2023, Aura had cash and cash equivalents and marketable securities totaling $226.2 million.
  • General and administrative expenses include $1.2 million and $1.1 million of stock-based compensation for the three months ended December 31, 2023 and 2022, respectively.

Novo Integrated Sciences Provides Update on Certain Current Actions and Events

Retrieved on: 
Tuesday, March 26, 2024
Alternative Medicine, Health, Other Health, Other Science, Managed Care, General Health, Science, Transfer, Assignment, SPA, VAP, District court, United States district court, Acquisition, Successor, Black sheep, Procurement, Gold, Collection, Court

2:19-cv-04299 VAP (JPRx) to acquire a certain collection of 43 gemstones, 42 of which are certified by the Gemological Institute of America, (the “Ophir Collection”), for $60,000,000.

Key Points: 
  • 2:19-cv-04299 VAP (JPRx) to acquire a certain collection of 43 gemstones, 42 of which are certified by the Gemological Institute of America, (the “Ophir Collection”), for $60,000,000.
  • On December 1, 2023, the Court approved the Ophir Agreement.
  • Within two business days following the Company’s execution of the Ophir Agreement, the Company was required to, and did, deposit $25,000 with the Successor Receiver.
  • The UCC-3 filing provides for the partial assignment and transfer of the full face-value of the Bond to Novo for a maximum term of 15-years without the benefit of annual interest.