Trial of the century

Perspective Therapeutics Provides Recent Business Highlights and Reports Fiscal Year 2023 Financial Results

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Thursday, March 28, 2024
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SEATTLE, March 28, 2024 (GLOBE NEWSWIRE) -- Perspective, Therapeutics, Inc. (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body, today provided a business update and announced fiscal year 2023 financial results for the period ended December 31, 2023.

Key Points: 
  • SEATTLE, March 28, 2024 (GLOBE NEWSWIRE) -- Perspective, Therapeutics, Inc. (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body, today provided a business update and announced fiscal year 2023 financial results for the period ended December 31, 2023.
  • “We made tremendous progress during 2023 in building a fully integrated radiopharmaceuticals company dedicated to advancing potentially best- or first-in-class alpha-particle therapies,” said Thijs Spoor, Perspective Therapeutics' CEO.
  • Preliminary results from Cohorts 1 and 2 of the Phase 1/2a trial are expected in the third quarter 2024.
  • In January 2024, Perspective Therapeutics entered into strategic agreements with Lantheus Holdings, Inc. and its affiliates (“Lantheus”) (NASDAQ: LNTH).

JenaValve Announces Publication of ALIGN-AR Pivotal Trial Results in The Lancet

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Thursday, March 28, 2024
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IRVINE, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced the publication of results from the ALIGN-AR Pivotal Trial in The Lancet .

Key Points: 
  • IRVINE, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced the publication of results from the ALIGN-AR Pivotal Trial in The Lancet .
  • As presented at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) Annual Scientific Symposium, the ALIGN-AR trial met prespecified non-inferiority criteria for its primary safety endpoint and primary efficacy endpoint.
  • The positive outcomes reported from the ALIGN-AR trial in The Lancet usher in a new era for these patients.” Said Duane Pinto, MD, MPH, Chief Medical Officer at JenaValve.
  • Results from the study are intended to support a Premarket Approval submission to the U.S. Food and Drug Administration (FDA).

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

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Thursday, March 28, 2024
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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.

Daré Bioscience Reports Full Year 2023 Financial Results and Provides Company Update

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Thursday, March 28, 2024
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SAN DIEGO, March 28, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today reported financial results for the year ended December 31, 2023 and provided a company update.

Key Points: 
  • In addition, we are excited about the increased attention that women’s health has received more broadly,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
  • In December 2023, Daré announced positive topline results from the Phase 1 study evaluating the pharmacokinetics (PK), safety, and exploratory efficacy of DARE-PDM1.
  • Financial Highlights for the Year Ended December 31, 2023 and 2024 Projections
    Cash and cash equivalents: $10.5 million at December 31, 2023.
  • Daré will host a conference call and live webcast today, March 28, 2024, at 4:30 p.m. Eastern Time to review financial results for the year ended December 31, 2023 and to provide a company update.

Nexalin Technology Announces Positive Results of Clinical Study Validating its Gen-2 tACS Device for Reducing Pain Among Veterans with Mild Traumatic Brain Injury at University of California, San Diego

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Thursday, March 28, 2024
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HOUSTON, TEXAS, March 28, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (the “Company” or “Nexalin”) (Nasdaq: NXL; NXLIW) today announced the positive results of a clinical study evaluating Nexalin’s Gen-2 tACS device for reducing pain in veteran patients with Mild Traumatic Brain Injury (mTBI). The study was conducted at The University of California, San Diego, and is further detailed in an abstract co-authored by the United States Department of Veterans Affairs (VA) San Diego Healthcare System, and the Radiology, Psychiatry and Neurosciences Departments of UC San Deigo.

Key Points: 
  • mTBI is a leading cause of sustained physical, cognitive, emotional, and behavioral deficits in veterans and the general public.
  • However, the underlying pathophysiology is not completely understood, and there are few effective treatments for post-concussive symptoms (PCS).
  • The study was conducted as a randomized, double-blind, placebo-controlled clinical trial over an eight-week period, with two groups being examined: an active tACS group and a sham tACS group.
  • Mark White, CEO of Nexalin Technology, stated, "We are encouraged by the results of the clinical study, reinforcing the significant reduction in pain and other persistent symptoms of mild traumatic brain injury among veteran patients.

Affimed Reports 2023 Financial Results and Operational Progress

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Thursday, March 28, 2024
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MANNHEIM, Germany, March 28, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today reported financial results and provided an update on clinical and corporate progress for the year ended December 31, 2023.

Key Points: 
  • MANNHEIM, Germany, March 28, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today reported financial results and provided an update on clinical and corporate progress for the year ended December 31, 2023.
  • Based on the promising results, Affimed expanded enrollment in this cohort to 40 patients.
  • Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the IASB.
  • Affimed will host a conference call and webcast on March 28, 2024, at 8:30 a.m. EDT / 13:30 CET to discuss full year 2023 financial results and corporate developments.

Dyadic Announces Change in Board and Management Leadership Roles

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Thursday, March 28, 2024
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The Board has decided not to fill the vacancy due to Dr. Buckland’s retirement which will result in a reduction of the size of the Board from seven to six members.

Key Points: 
  • The Board has decided not to fill the vacancy due to Dr. Buckland’s retirement which will result in a reduction of the size of the Board from seven to six members.
  • Finally, Joseph Hazelton has been appointed Chief Operating Officer, effective immediately, and will oversee the day-to-day operations of the Company.
  • Mr. Lucy joined the Board in January 2021 and serves on the company’s Science and Technology Committee.
  • "I am excited to assume the role as Chairman of the Dyadic board of directors.

IMUNON Reports 2023 Financial Results and Provides Business Update

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Thursday, March 28, 2024
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LAWRENCEVILLE, N.J., March 28, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing DNA-mediated immuno-oncology therapies and next-generation vaccines, today reported financial results for the year ended December 31, 2023. The Company also provided an update on its clinical development programs with IMNN-001, a DNA-based interleukin-12 (IL-12) immunotherapy in Phase 2 clinical development for the treatment of first-line, locally advanced-stage ovarian cancer, and on its PlaCCine modality, a proprietary mono- or multi-cistronic DNA plasmid and a synthetic DNA delivery technology for the expression of pathogen antigens in preclinical studies for the development of next-generation vaccines.

Key Points: 
  • “We remain on track to report topline results mid-year from the OVATION 2 Study with IMNN-001 in advanced ovarian cancer.
  • In September 2023, the Company announced interim PFS and OS data with IMNN-001 in its OVATION 2 Study.
  • The Company is hosting a conference call to provide a business update, discuss 2023 financial results and answer questions at 10:00 a.m. Eastern time today.
  • To participate in the call, please dial 866-777-2509 (Toll-Free/North America) or 412-317-5413 (International/Toll) and ask for the IMUNON 2023 Earnings Call.

Spectral AI Announces 2023 Fourth Quarter and Full Year Financial Results

Retrieved on: 
Wednesday, March 27, 2024
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DALLAS, March 27, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced financial results for the fourth quarter (“Q4 2023”) and full year (“FY 2023”) ended December 31, 2023 and provided an update on its ongoing business activities.

Key Points: 
  • DALLAS, March 27, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced financial results for the fourth quarter (“Q4 2023”) and full year (“FY 2023”) ended December 31, 2023 and provided an update on its ongoing business activities.
  • “Spectral AI achieved much in 2023, and our progress along multiple fronts has continued into 2024,” said Peter M. Carlson, Chief Executive Officer.
  • “
    In September 2023, we were awarded the largest contract in our history from the US Government valued at up to $150.0 million.
  • All comparisons to Q4 2023 and FY 2023 are to the comparable periods ended December 31, 2022, unless otherwise stated.

Revive Therapeutics Submits Type C Meeting Request Package to FDA for Clinical Study of Bucillamine to Treat Long COVID

Retrieved on: 
Wednesday, March 27, 2024
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Following the submission of the Type C meeting request package, the Company expects to hear from the FDA on a firm date for the meeting.

Key Points: 
  • Following the submission of the Type C meeting request package, the Company expects to hear from the FDA on a firm date for the meeting.
  • The CDC estimates that 7.5 percent of U.S. adults have long COVID symptoms1.
  • Currently, the Company is exploring the use of Bucillamine as a potential treatment for long COVID.
  • The Company is advancing the clinical development of Bucillamine by leveraging the published research and data from its previous Phase 3 clinical trial (the “Study”) and is finalizing the regulatory and clinical package that includes a proposed clinical study for long COVID to present to the FDA.