Qualigen Therapeutics, Inc. - QLGN STOCK NEWS

Qualigen Therapeutics reported that it received a notification from Nasdaq regarding its failure to file the Annual Report on Form 10-K for the year ending December 31, 2022, as mandated by Nasdaq Rules. The delay in the filing, due to additional information required for the company’s acquisition of a majority interest in NanoSynex, Ltd, resulted in the company filing a Notification of Late Filing on Form 12b-25. While this notification does not immediately affect the Nasdaq listing, failure to regain compliance may lead to delisting. Qualigen is working to file the Form 10-K by June 20, 2023, which would help avoid submitting a formal compliance plan.

Qualigen Therapeutics (Nasdaq: QLGN) announced significant findings from its QN-302 program presented at the AACR Annual Meeting 2023. The data highlighted QN-302's potential as a treatment for pancreatic cancer, showing 10-fold greater potency compared to existing therapies like gemcitabine in resistant cell lines. Doctor Tariq Arshad stated that these results support their goal to submit an IND application to the FDA to initiate Phase 1 trials for QN-302. The research demonstrated that QN-302 targets the S100P gene, a promising biomarker for therapy tracking, and confirmed anti-tumor activity in various in vivo models.

QN-302 has already been granted Orphan Drug Designation by the FDA, underlining its potential as a novel treatment strategy against cancers characterized by G4 structures.

Qualigen Therapeutics (Nasdaq: QLGN) has presented promising in vivo efficacy data regarding its QN-247 program at the American Association for Cancer Research (AACR) Annual Meeting 2023. This data suggests that QN-247 could serve as an effective nano-immunotherapy against triple negative breast cancer. The study showed significant reductions in tumor volumes without toxic side effects.

QN-247, a nucleolin-targeted oligonucleotide conjugate, demonstrates potential against various malignancies, including acute myeloid leukemia and glioblastoma. The company is actively seeking partners to advance the development of QN-247. Qualigen's broader portfolio includes diagnostics and other investigational compounds targeting different cancer types.

Qualigen Therapeutics announces the grant of U.S. Patent No. 11,560,380 for its lead oncology drug candidate, QN-302. This patent protects the composition of matter for QN-302, a small molecule selective transcription inhibitor targeting G4 complexes in solid tumors, including pancreatic cancer, with exclusivity until 2040. The company also received a Notice of Intent for a similar patent in the E.U. CEO Michael Poirier emphasized the importance of this patent for QN-302's development, and the company is preparing to submit an Investigational New Drug (IND) application soon. QN-302 has already received Orphan Drug Designation from the FDA for pancreatic cancer.

Qualigen Therapeutics (Nasdaq: QLGN) announces participation at the AACR Annual Meeting 2023 in Orlando, FL, held from April 14-19. The company will present five posters, highlighting their lead program QN-302 and a study on QN-247 in Triple Negative Breast Cancer. Key presentations include a comparison of QN-302 and CX-5461, findings on S100P gene down-regulation, and anti-tumor activity of QN-302. QN-302 targets G-Quadruplex structures in various tumors, while QN-247 focuses on nucleolin-expressing cancers. Orphan Drug Designation for QN-302 in pancreatic cancer was granted in January 2023.

Qualigen Therapeutics has presented promising data at the AACR Special Conference on RAS, highlighting its novel small molecules targeting RAS in pancreatic and breast cancer models. The studies demonstrated significant anti-RAS activity, showing compounds that bind specifically to certain KRAS mutations, thereby inhibiting cancer cell growth. Chief Medical Officer Tariq Arshad emphasized the potential of these RAS-targeted compounds to improve therapeutic outcomes, particularly for cancers with high relapse rates. The RAS oncogene is implicated in a substantial portion of various cancers, presenting a significant medical need.

Qualigen Therapeutics published significant findings in the journal Molecules, demonstrating that their lead compound QN-302 exhibits strong anti-tumor activity against pancreatic cancer cell lines. The study reveals QN-302 downregulates the S100P gene, associated with several cancers, suggesting its potential as a biomarker for treatment response in pancreatic cancer. The Chief Medical Officer emphasized that this publication reinforces the compound's therapeutic prospects. Pancreatic cancer remains a major health challenge, and Qualigen is advancing QN-302 towards IND application submission in the near future.

Qualigen Therapeutics (Nasdaq: QLGN) provided an update on its progress in 2022, highlighting significant achievements amidst macroeconomic challenges. The company is advancing its lead program, QN-302, a cancer treatment with Orphan Drug Designation for pancreatic cancer, aiming to file an IND application in the first half of 2023. Qualigen also emphasizes ongoing RAS discovery efforts, therapeutic partnerships, and funding strategies. Additionally, QN-247 shows promise in preclinical studies for Triple Negative Breast Cancer, while a focus on NanoSynex aims to enhance rapid antibiotic testing. Austerity measures have been implemented to extend cash runway through 2023.