QLGN Qualigen Therapeutics Inc

Qualigen Therapeutics, Inc. (NASDAQ: QLGN), a biotechnology company focused on developing novel therapeutics for the treatment of cancer and viral diseases, announced today it has entered into a Material Evaluation and Option Agreement with the University College London (UCL) to advance development of and potentially expand toward future commercial uses of Qualigen's leading anticancer drug candidate AS1411-GNP, also known as ALAN (Aptamer-Linked Anti-Nucleolin).

In collaboration with the University of Louisville, Qualigen will evaluate the use of ALAN with G-quadruplex binders (GQBs) developed by Professor Stephen Neidle and colleagues from UCL. Research at UCL, supported by the UCL Technology Fund, has shown encouraging results using GQBs and targeted cancer therapeutics, particularly for the treatment of pancreatic cancer. Qualigen believes the combination of these GQBs with ALAN may increase the cancer selectivity, and therefore also the efficacy, of ALAN. Qualigen has secured an option to pursue a worldwide commercial license for this promising technology from UCL Business Ltd, the commercialization company of UCL.

“This agreement with UCL will allow Qualigen to study a significant potential indication for ALAN with improved selectivity for pancreatic cancer cells. In addition to the pancreatic cancer treatment indication, we also continue to evaluate ALAN to treat leukemia and glioblastoma, and as an adjuvant therapy to stop the recurrence of cancer after initial treatment,” stated Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen.

“We look forward to collaborating with Qualigen and continuing to support our partners in the development of exciting new therapeutics around G-quadruplex binders and other targeted cancer therapeutics,” said Prof. Stephen Neidle of UCL “The use of our proprietary GQBs to potentially increase the efficacy of ALAN could provide a major leap forward in the treatment of often terminal diseases such as pancreatic cancer.”

According to the American Cancer Society, for all stages of pancreatic cancer combined, the one-year relative survival rate is 20%, and the five-year rate is 9%.

ALAN is a combination of Qualigen’s AS1411 DNA aptamer plus a DNA-coated gold nanoparticle to dramatically increase its potency. This cancer drug candidate has the potential to target and destroy tumor cells in a various types of cancer with minimal side effects. The Company is aiming to commence Phase 1 human trials in 2021 for acute myeloid leukemia, its lead indication. Qualigen has an exclusive worldwide license agreement from the University of Louisville for ALAN.

About Qualigen Therapeutics, Inc.

Qualigen Therapeutics, Inc. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack® System, which has been used successfully in diagnostics for 20 years. The Company's cancer therapeutics pipeline includes ALAN (AS1411-GNP), RAS-F and STARS™. ALAN (AS1411-GNP) is a DNA coated gold nanoparticle cancer drug candidate that has the potential to target various types of cancer with minimal side effects. The foundational nucleolin-targeting DNA aptamer of ALAN, AS1411, is also a drug candidate for use in treating COVID-19 and other viral-based infectious diseases. RAS-F is a family of RAS oncogene protein-protein interaction inhibitor small molecules for preventing mutated RAS genes’ proteins from binding to their effector proteins; preventing this binding could stop tumor growth, especially in pancreatic, colorectal and lung cancers. STARS is a DNA/RNA-based treatment device candidate for removal from circulating blood of precisely targeted tumor-produced and viral compounds. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test kits, used in physician offices, clinics and small hospitals around the world. The FastPack System menu includes rapid point-of-care diagnostic tests for cancer, men's health, hormone function, vitamin D status and antibodies against SARS-CoV-2. Qualigen's facility in Carlsbad, California is FDA and ISO Certified and its FastPack product line is sold worldwide by its commercial partner Sekisui Diagnostics, LLC. For more information on Qualigen Therapeutics, Inc., please visit https://www.qualigeninc.com/.

About UCL Business (UCLB)

UCL Business Ltd (UCLB), part of UCL Innovation & Enterprise, is the commercialisation company for UCL. Working with UCL’s globally renowned faculties and associated hospitals; University College London Hospitals, Moorfields Eye Hospital, Great Ormond Street Hospital for Children and the Royal Free London Hospital, it brings together exceptional ideas, innovations and industry to benefit society and the economy.

UCLB’s track record of success includes over £1.5 billion raised in investment for UCL spinouts, and its Portico Ventures Programme is enabling the next wave of technology-based businesses to thrive in a fast-moving ecosystem. Its fund offerings - Apollo Therapeutics (in partnership with leading UK universities and pharmaceutical companies), UCL Technology Fund, and Social Ventures fund - help to bring pioneering technologies from the laboratory to market, enabling academic entrepreneurs to tackle global challenges, from energy and engineering to healthcare and the environment.

www.uclb.com

Forward-Looking Statements

This news release contains forward-looking statements by the Company that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. These statements include those related to evaluation of and potential future negotiation toward a license for GQBs, the possible effectiveness of ALAN (or ALAN with GQBs) against cancers and the approval and timing of clinical trials. Actual events or results may differ from the Company’s expectations. For example, there can be no assurance that joint use of ALAN and GQBs will be safe and/or efficacious against any type of cancer; that the Company will choose to seek a worldwide license for GQBs from UCL; that, if the Company does seek one that the Company will be able to agree with UCL on terms for such a license on favorable terms or at all; that any clinical trials will be approved to begin by or will proceed as contemplated by any projected timeline; that the Company will successfully develop any drugs or therapeutic devices; that preclinical or clinical development of the Company's drugs or therapeutic devices will be successful; that future clinical trial data will be favorable or that such trials will confirm any improvements over other products or lack negative impacts; that any drugs or therapeutic devices will receive required regulatory approvals or that they will be commercially successful; that patents will issue on the Company’s owned and in-licensed patent applications; that such patents, if any, and the Company’s current owned and in-licensed patents would prevent competition; that the Company will be able to procure or earn sufficient working capital to complete the development, testing and launch of the Company’s prospective therapeutic products; that the Company will be able to maintain or expand market demand and/or market share for the Company’s diagnostic products generally, particularly in view of COVID-19-related deferral of patients’ physician-office visits and FastPack reimbursement pricing challenges; that adoption and placement of FastPack PRO System instruments (which are the only FastPack instruments on which the Company's SARS-CoV-2 IgG test kits can be run) will be widespread; that the Company will be able to manufacture the FastPack PRO System instruments and SARS-CoV-2 IgG test kits successfully; that any commercialization of the FastPack PRO System instruments and SARS-CoV-2 IgG test kits will be profitable; or that the FDA will ultimately approve an Emergency Use Authorization for the Company’s SARS-CoV-2 IgG test. The Company’s stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fails to occur or is delayed or if any actual future event otherwise differs from expectations. Additional information concerning these and other risk factors affecting the Company's business (including events beyond the Company's control, such as epidemics and resulting changes) can be found in the Company's prior filings with the Securities and Exchange Commission, available at www.sec.gov. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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