Qualigen Therapeutics CEO Issues Letter to Stockholders

CARLSBAD, Calif., July 13, 2020 /PRNewswire/ — Qualigen Therapeutics, Inc. (NASDAQ: QLGN) (“Qualigen” or the “Company”), announced that today Chief Executive Officer Michael Poirier has issued a letter to Qualigen’s stockholders. The full text of that letter is as follows:

To My Fellow Stockholders,

Many of you likely saw last week’s exciting announcement that Qualigen Therapeutics raised $8 million in new capital. 

In connection with this important development, I would like to provide some context as to how we expect to use those funds, and why we believe our plans will help build significant shareholder value.

We expect to advance the following key projects with existing cash resources and these new funds:

  • We plan to advance clinical trials with our pipeline of drug candidates for the treatment of certain cancers and infectious diseases.  One of these drug candidates, AS1411, has been shown to be effective in halting the replication of viruses in proof-of-concept in vitro studies performed at the University of Louisville’s prestigious Center for Infectious Disease,  and could be used to treat patients who have COVID-19, the disease caused by the novel coronavirus SARS-CoV-2, as well as other similar viral-based diseases.  We are aiming to commence a Phase 1 clinical trial of another of our drug candidates, ALAN, against acute myeloid leukemia in 2021.
  • We plan to continue to expand our pipeline of therapeutics, specifically in oncology through additional licenses and strategic relationships. We believe that having a robust and synergistic portfolio of potentially life-saving drugs is critical to building long-term shareholder value.
  • Finally, we plan to enhance the production automation our flagship FastPack® rapid diagnostic disposables and begin production of our new FastPack PRO analyzer, which is an upgraded version of our current FastPack IP analyzer. The test menu for FastPack PRO will include cFN, a new stroke assessment test being developed as a companion diagnostic for Prediction Sciences LLC, and our new SARS-CoV-2 IgG immunoassay test for COVID-19 antibodies.  We have already submitted notification to the U.S. Food and Drug Administration that we intend to commence commercial distribution of the SARS-CoV-2 IgG immunoassay test later this month. 

Overall, we believe these new funds will provide Qualigen with significant operational runway through calendar year 2021, allow us to build our team and product lines, and create new opportunities for the future benefit of Qualigen and our stockholders.

I extend thanks to you, our stockholders, and to everyone involved in this successful funding.


Michael Poirier

President, Chief Executive Officer and Chairman 

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 FastPack menu includes tests for cancer, men’s health, hormone function, vitamin D status and antibodies against SARS-CoV-2. 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 viral-based infectious diseases, including COVID-19. RAS-F is a small molecule RAS oncogene protein-protein inhibitor for blocking RAS mutations that lead to tumor formation, especially in pancreatic, colorectal and lung cancers. STARS™ is a DNA/RNA-based treatment device for removal from circulating blood of precisely targeted tumor-produced and viral compounds. 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 potential future development, testing, launch of product candidates and the expected closing of the offering. Actual events or results may differ from the Company’s expectations. For example, there can be no assurance 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 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; that adoption and placement of FastPack PRO System instruments (which are the only FastPack instruments on which the Company’s SARS-CoV-2 IgG and cFN test kits can be run) will be widespread; that the Company will be able to manufacture the FastPack PRO System instruments and the SARS-CoV-2 IgG and cFN test kits successfully; or that any commercialization of the FastPack PRO System instruments and SARS-CoV-2 IgG and cFN test kits will be profitable.  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.