Welcome to our dedicated page for Qualigen Therapeutics news (Ticker: QLGN), a resource for investors and traders seeking the latest updates and insights on Qualigen Therapeutics stock.
Qualigen Therapeutics, Inc. (symbol: QLGN) is an early-clinical-stage therapeutics company dedicated to the development of innovative treatments for both adult and pediatric cancer. Headquartered in Carlsbad, California, the company's core focus lies in its pioneering research to tackle malignant diseases through its advanced therapeutic programs.
Core Business:
Qualigen's primary business activity revolves around its two key therapeutic programs. The flagship program, QN-302, is an investigational small molecule that acts as a G-quadruplexes (G4)-selective transcription inhibitor. This molecule exhibits a strong binding affinity to G4 structures prevalent in cancer cells, making it a potent candidate in cancer therapy. Additionally, Qualigen has another promising preclinical therapeutic program in its pipeline.
Recent Achievements:
- Recently, Qualigen transitioned from a preclinical to a clinical-stage company following the Investigational New Drug (IND) clearance for QN-302. This milestone marks a significant progression in clinical development and potential cancer treatment breakthroughs.
- The company also divested its FastPack® diagnostics business for approximately $5 million in an all-cash transaction. This strategic move enables Qualigen to concentrate resources on advancing its therapeutics pipeline.
Current Projects:
The ongoing development of QN-302 is a testament to Qualigen's commitment to pioneering cancer treatment solutions. The company is actively engaged in early-phase clinical trials to validate the efficacy and safety of QN-302 and other pipeline candidates.
Financial Condition:
The financial stability of Qualigen is bolstered by the sale proceeds from the divested diagnostics business, providing the necessary capital to fund ongoing and future therapeutic projects. Continuous investments in research and development underscore the company's dedication to discovering and developing novel cancer therapies.
Partnerships:
Qualigen collaborates with various research institutions and industry leaders to advance its drug development initiatives. These partnerships are crucial for fostering innovation and expediting the therapeutic development process.
For more information about Qualigen Therapeutics, Inc., please visit www.qlgntx.com.
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.
Qualigen Therapeutics (NASDAQ: QLGN) will host a business update conference call on August 18, 2020, at 4:30 p.m. Eastern time. The call will cover the company's business strategy, drug development program, and fiscal first quarter 2021 financials. Participants can pre-register for immediate access. A replay will be available after the call and until August 25, 2020. Qualigen develops therapeutics for cancer and infectious diseases using FDA-approved diagnostics.
Qualigen Therapeutics announced the closing of a registered direct offering on Aug. 4, 2020, raising $10 million through the sale of 1,717,106 shares of common stock and 1,287,829 warrants. The offering was priced at $5.82375 per share and includes warrants with an exercise price of $6.00, valid for two years. A.G.P./Alliance Global Partners acted as placement agent. Qualigen focuses on developing therapeutics for cancer and infectious diseases, with its only commercial product currently being the FastPack diagnostic system.
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