Qualigen Therapeutics Enters into Commercialization Agreement for its FastPack® Diagnostic Products in China

Yi Xin Zhen Duan Jishu will develop new generations of FastPack-based diagnostic systems while manufacturing and selling current products

CARLSBAD, Calif., Oct. 8, 2020 /PRNewswire/ -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN) announces it has entered into an agreement with Yi Xin Zhen Duan Jishu (Suzhou) Ltd, of Suzhou, China to develop, manufacture and sell new generations of diagnostic test systems based on Qualigen's core FastPack® "laboratory in a pouch" technology.  In addition, Yi Xin Zhen Duan Jishu (Yi Xin) will have the rights to manufacture and sell Qualigen's current generations of rapid point-of-care FastPack diagnostic products in China. 

Under the terms of this agreement, Qualigen is to receive net cash payments this quarter and next quarter totaling in the mid- to high-hundreds of thousands of dollars, plus low- to mid-single-digit royalties on net sales.  Qualigen will provide technology transfer and patent/know-how license rights to facilitate Yi Xin's development and commercialization.

Qualigen granted Yi Xin exclusive rights for China – a new market for Qualigen – both for Yi Xin's new generations of FastPack-based products and for Yi Xin-manufactured versions of Qualigen's existing FastPack 1.0, IP and PRO product lines.  After May 1, 2022, Yi Xin will have the right to sell its new generations of FastPack-based diagnostic test systems throughout the world, excluding Qualigen's then-current FastPack customers; on a worldwide basis, except in the U.S., Yi Xin will also have the right to sell Yi Xin-manufactured versions of Qualigen's existing FastPack 1.0, IP and PRO product lines, and in the U.S. Yi Xin will have the right to buy Qualigen FastPack 1.0, IP and PRO products from Qualigen at distributor prices for resale, again excluding Qualigen's then-current FastPack customers.

"We are excited to work with our new partner, Yi Xin, to further capitalize on our patented FastPack diagnostics technology, and to provide access to the Chinese market," stated Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen. "Through this agreement, we will receive cash from a geography we would not otherwise have entered and from products we would not have brought through development. Importantly, this non-dilutive funding will contribute to our strategic shift toward the development of therapeutics products."

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 almost 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 aptamer of ALAN, AS1411, is also being studied for use in treating or even preventing viral-based infectious diseases, including COVID-19.   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/.  

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 expected payments to the Company under the Yi Xin agreement and Yi Xin's future development, manufacturing and sales activities. Actual events or results may differ from the Company's expectations. For example, there can be no assurance that Yi Xin's future development, manufacturing and sales activities will proceed as anticipated or that Yi Xin (which is a newly-formed company) will be able to honor its contractual obligations to the Company; that clinical trials will be applied for by or approved to begin by any projected timeline 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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SOURCE Qualigen, Inc.