Qualigen Therapeutics, Inc. - QLGN STOCK NEWS

Qualigen Therapeutics (Nasdaq: QLGN) has contracted with STA Pharmaceutical for GMP production of AS1411, its leading COVID-19 drug candidate, to facilitate upcoming clinical trials. Preclinical studies at the University of Louisville demonstrated AS1411's capability to protect cells from coronavirus damage. Qualigen aims to file an IND application in early 2021 and start Phase 2a clinical trials in COVID-19 patients by mid-2021. AS1411 has previously shown a strong safety profile in over 100 cancer patients.

Qualigen Therapeutics (Nasdaq: QLGN) received positive feedback from the FDA regarding its Type B Pre-IND meeting for AS1411, a nucleolin-targeting drug candidate aimed at treating COVID-19. The FDA supports moving forward with a Phase 2a proof-of-concept study, assessing safety and dosing in hospitalized patients. This progress allows Qualigen to prioritize AS1411's clinical trials starting in H1 2021, followed by studies on ALAN against acute myeloid leukemia. Past preclinical trials have shown AS1411's effectiveness against SARS-CoV-2, suggesting its potential as a novel antiviral therapeutic.

Qualigen Therapeutics (Nasdaq: QLGN) announced a partnership with Yi Xin Zhen Duan Jishu (Suzhou) Ltd to develop and sell advanced diagnostic test systems in China. This agreement includes cash payments in the hundreds of thousands, plus royalties on sales. Yi Xin gains exclusive rights for the Chinese market, allowing them to manufacture and sell both new and existing FastPack products. The CEO highlighted that this non-dilutive funding will support the company’s strategic shift towards therapeutic product development.

Qualigen Therapeutics, Inc. (NASDAQ: QLGN) has expanded its research agreement with the University of Louisville to advance the development of its anticancer drug candidate AS1411-GNP, also known as ALAN. The amended agreement aims to conduct preclinical studies on acute myeloid leukemia (AML), glioblastoma, and non-small cell lung cancer. These studies are critical as they address significant unmet clinical needs in cancer treatment. Qualigen is targeting to initiate Phase 1 human trials for AML in 2021, which may expand its product pipeline significantly.

Qualigen Therapeutics, Inc. (Nasdaq: QLGN) has filed a provisional patent application in partnership with the University of Louisville for a method to inhibit coronavirus infections using the antiviral candidate AS1411. This application aims to protect against SARS-CoV-2 via delivery mechanisms such as inhalers, nose sprays, or eye drops. The company plans to initiate IND-enabling studies and file for IND with the FDA in late 2020, with a goal to begin Phase 1/2 clinical trials in COVID-19 patients in early 2021.

Qualigen Therapeutics (Nasdaq: QLGN) has contracted with IRISYS LLC to manufacture its lead drug candidate AS1411, aimed at treating viral diseases, including COVID-19. Preclinical studies from the University of Louisville indicate AS1411’s potential to protect cells from the novel coronavirus. Qualigen plans to file an IND application with the FDA in Q4 2020 and initiate Phase 1/2 clinical studies early next year. The drug has shown safety in prior trials involving over 100 cancer patients. This step is crucial for advancing AS1411’s development as an antiviral therapeutic.

Qualigen Therapeutics (Nasdaq: QLGN) has appointed Amy Broidrick to its Board of Directors, bringing over 25 years of pharmaceutical experience, including roles in the launches of VYTORIN™ and Celebrex™. Broidrick's background in corporate development and marketing is expected to support Qualigen’s therapeutic development initiatives, particularly drugs targeting cancer and COVID-19. The company focuses on innovative therapeutics and diagnostic systems, with its FastPack System currently in operation.

Qualigen Therapeutics, Inc. (NASDAQ: QLGN) has announced the issuance of patent No. 10,744,257 for its Selective Target Antigen Removal System (STARS™) technology, aimed at removing viral and tumor-produced compounds from blood. With this patent, Qualigen's intellectual property portfolio expands to 26 issued patents. The STARS technology, still in early development stages, shows promising in vitro results and is intended for applications in cancer and infectious diseases. Qualigen aims to leverage its existing diagnostic systems to further advance STARS.

Qualigen Therapeutics reported its fiscal Q1 2021 results, showing total revenues of $0.9 million, down from $1.5 million in Q1 2020, largely attributed to the COVID-19 pandemic's impact on diagnostic test volumes. The company raised $18 million through equity financing, with cash reserves now at $16 million, adequate to fund operations into 2022. Significant developments include exclusive licensing agreements with the University of Louisville for cancer drug candidates and COVID-19 treatment. However, net loss surged to $18.6 million, inclusive of a $16.2 million non-cash charge for warrant liabilities.