Qualigen Therapeutics provides letter to shareholders

Qualigen Therapeutics issued the following letter to its stockholders: "I am excited to update you on our significant accomplishments for 2022 and to review our priorities for the coming months. The year 2022 was one in which we faced significant macro-environmental headwinds, including supply chain shortages and higher interest rates affecting our industry…. In advancing our cancer therapeutics pipeline, our activities centered around our lead program, QN-302… At the end of December 2022, upon our request, we received Pre-IND feedback from the U.S. Food and Drug Administration. This feedback has been instructive in our activities to help us prepare our Investigational New Drug submission, which we remain on track to file with the FDA in the first half of 2023. Following clearance of the IND submission, we intend to initiate a Phase 1 clinical trial, for which we look forward to providing more detailed information at the appropriate time. In the meantime, we are very pleased that QN-302 was granted Orphan Drug Designation for the treatment of pancreatic cancer by the FDA just a couple of weeks ago… we are focused on executing on our strategy to secure non-dilutive funding for various QN-302 development efforts. Upon execution of a potential agreement at a future time, we would ensure all derivative intellectual property be exclusively owned by Qualigen Therapeutics. Expanded RAS discovery efforts to target KRAS G12D and G12C. In parallel with our QN-302 development, we continue to advance the efforts in our RAS therapeutic platform, with the goal of identifying a lead compound to enter IND-enabling studies. As part of these activities, we have been actively submitting data to scientific conferences for presentation and publication. Last May, two of our abstracts were featured in the American Society for Clinical Oncology’s (ASCO) Annual Meeting Abstract Book. Recently, in October 2022, our collaborator presented two posters on efficacy in two cancer types at the National Cancer Institute’s 4th Annual RAS Symposium, a gathering of worldwide RAS experts. Invitations to present data at these key scientific venues provided validation that our development approach has merit within the oncology research community. Development partners sought for QN-247 program… Qualigen believes the encouraging efficacy and safety results in TNBC animal model warrant further investigation. As a result, we are seeking partners to help advance this program into IND-enabling studies, as we focus our therapeutics resources on the development of QN-302 and our RAS platform. NanoSynex Progressing Antimicrobial Susceptibility Testing platform. Leveraging our diagnostics know-how, in May 2022, we announced our majority investment in private Israeli diagnostics developer NanoSynex, which is developing an Antimicrobial Susceptibility Testing platform that aims to provide clinical laboratories with a rapid, accurate and personalized test for bacterial infections, with the goal of quickly matching the correct antibiotics to treat a patient’s particular infection… NanoSynex’s AST platform is designed to enable better targeting of antibiotics for their most suitable uses to ultimately result in faster and more efficacious treatment, hence reducing hospital mortality and morbidity rates."