Qualigen Therapeutics Issues CEO Letter to Stockholders with 2021 Outlook

Rhea-AI Summary

Qualigen Therapeutics (Nasdaq: QLGN) reported significant developments in its 2021 outlook. The company has raised $12 million in a direct offering, bringing its total cash reserves to $24 million, extending its operational runway into 2022. Key initiatives for 2021 include initiating a Phase 2a clinical trial for AS1411 against COVID-19 and a Phase 1 trial for ALAN in acute myeloid leukemia. The diagnostics platform is also set for expansion, particularly with its FastPack® COVID-19 antibody test. Qualigen's management team has been strengthened with new appointments.

Positive

• Raised $12 million in direct offering, totaling $24 million in cash.
• Plans to initiate Phase 2a clinical trial for AS1411 targeting COVID-19.
• Initiate Phase 1 clinical trial for ALAN in acute myeloid leukemia.
• Strengthened management team with experienced executives.

Negative

• None.

CARLSBAD, Calif., Dec. 22, 2020 /PRNewswire/ -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, announces that Michael Poirier, Chairman, Chief Executive Officer and President, has issued a letter to Qualigen's stockholders. The full text is as follows:

To My Fellow Stockholders,

This year has been very exciting and eventful for Qualigen Therapeutics as we became a publicly traded company in May, and subsequently delivered against our business plan with various licensing agreements signed, patents filed and issued, and substantial capital raised, among other key accomplishments.

Last week we announced the closing of a $12 million registered direct offering, which brings us to a total of approximately $24 million in cash going into calendar 2021.  We expect this capital will extend our operational runway well into calendar 2022.  Even more importantly, it will allow us to expedite the development of multiple pipeline efforts in parallel, providing Qualigen with several opportunities to reach major value inflection points in the coming year, including the following:

• AS1411: Conduct Phase 2a clinical trial with AS1411 for the treatment of COVID-19. Preclinical research has demonstrated that AS1411 has potent antiviral activity against SARS-CoV-2, the coronavirus responsible for COVID-19. Having received a positive response to our Pre-Investigational New Drug application (Pre-IND) meeting request from the U.S. Food and Drug Administration (FDA), we plan to file an IND and subsequently initiate a Phase 2a clinical trial in the first half of calendar 2021. If there are positive Phase 2a results, we could potentially enter pivotal trials by the end of 2021. Furthermore, with our current capital we could commence broader development of AS1411 against other viral diseases and explore expanded methods of delivery such as through eye drops, nasal spray or inhalers, as described in our patent application filed in September.
• ALAN: Initiate Phase 1 clinical trial with ALAN for the treatment of acute myeloid leukemia (AML). Our research partner, the University of Louisville (UofL), continues to advance preclinical AML studies with ALAN (the AS1411 aptamer attached to a gold nanoparticle) under the amended sponsored research agreement we announced in October. Qualigen plans to file an IND for ALAN and subsequently initiate a Phase 1 clinical trial for the treatment of AML in the second half of calendar 2021. Moreover, with our current cash position we can also now advance studies in other indications for ALAN such as glioblastoma and non-small cell lung cancer. In addition, earlier this month a U.S. patent was issued that protects the ALAN technology for use with radiation therapy, MRI and other types of tumor imaging, further expanding the potential uses and opportunities.
• RAS: Identify lead RAS interaction inhibitor drug candidate. Pursuant to an exclusive worldwide license agreement signed in July, we continue to collaborate with UofL to evaluate the RAS-F family of RAS oncogene protein-protein interaction inhibitor small molecule drug candidates. In 2021, we plan to identify a lead drug candidate as a therapeutic for pancreatic, colorectal and/or lung cancers. RAS oncogenes are the most frequently mutated class of genes in human cancers, and KRAS, HRAS or NRAS mutations are present in approximately one-third of all cancer patients. The additional capital will enable us to accelerate development of our lead compound through the preclinical stage, with the goal of filing an IND for an initial cancer indication in the first half of calendar 2022.
• Diagnostics: Leverage our diagnostics platform. In October 2020, we signed an important agreement with Yi Xin Zhen Duan Jishu (Suzhou) Ltd. for it to develop, manufacture and market next-generation FastPack® products in China, including a high-throughput analyzer that utilizes our patented pouch system. We have also recently been in communication with the FDA on our Emergency Use Authorization (EUA) submission for our FastPack® SARS-CoV-2 IgG test for COVID-19 antibodies. We remain confident that the data meet or exceed the FDA guidelines for an EUA. As vaccines are deployed, we believe the FastPack COVID-19 antibody test has the ability to provide an accurate rapid solution in the marketplace.
• Pursue other strategic opportunities. In addition, we will act strategically to identify and evaluate other opportunities that can broaden our therapeutics pipeline.

To strengthen our senior management team, earlier this month we announced that Amy Broidrick joined Qualigen as Executive Vice President, Chief Strategy Officer, having served as a Director on our Board since August.  With more than 25 years of experience across numerous business and commercial functions in the biopharmaceutical industry, Ms. Broidrick brings a wealth of experience to leverage as we advance Qualigen's therapeutic programs. Moreover, she will be instrumental in our continued evaluation of opportunities that may hold substantial potential to enhance our pipeline.

In addition, the Board of Directors appointed Sidney Emery, Jr. as an independent Director. Mr. Emery is a successful entrepreneur and executive with more than 50 years of leadership experience.  Mr. Emery served 10 years as Chairman and CEO of MTS Systems (Nasdaq: MTSC), the world's leading manufacturer of mechanical testing solutions and high-performance industrial sensors.  We are confident that Mr. Emery will provide valuable insight to Qualigen given his significant background leading both public and private companies.

We are pleased with the progress at Qualigen Therapeutics this past year and are looking forward to an eventful and dynamic 2021. We also look forward to keeping you informed of our progress. On behalf of my colleagues at Qualigen and our Board of Directors, I would like to thank our employees for their tremendous efforts, and thank our investors for their continued support.

Sincerely,

Michael Poirier
Chairman, Chief Executive Officer and President

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/.

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 the Company's operational cash runway, the likelihood and timing of future approvals for and initiation of clinical trials, the Company's development plans, activity under the Company's China agreement, identification of and desirability of other outside opportunities, and contributions expected from Ms. Broidrick and Mr. Emery. Actual events or results may differ from the Company's expectations. For example, there can be no assurance that 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 FastPack 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.

FAQ

What are Qualigen Therapeutics' plans for AS1411 in 2021?

Qualigen plans to initiate a Phase 2a clinical trial for AS1411 to treat COVID-19.

How much capital has Qualigen Therapeutics raised recently?

Qualigen Therapeutics raised $12 million in a direct offering, bringing total cash to $24 million.

What is the timeline for Qualigen's Phase 1 clinical trial for ALAN?

Qualigen plans to initiate a Phase 1 clinical trial for ALAN in the second half of 2021.

What is the goal of Qualigen's FastPack® COVID-19 antibody test?

The FastPack COVID-19 antibody test aims to provide an accurate rapid solution for COVID-19 antibody detection.

Who are the new executives appointed at Qualigen Therapeutics?

Amy Broidrick joined as Executive Vice President, Chief Strategy Officer, and Sidney Emery, Jr. was appointed as an independent Director.