Qualigen (NASDAQ: QLGN)

 

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Qualigen Therapeutics Inc. (NASDAQ: QLGN)
 
   
  Website: https://www.qualigeninc.com
 Qualigen Therapeutics, Inc.SEC Filings on EDGAR
Qualigen Therapeutics November 13, 2020 CEO Letter to Stockholders

Qualigen Therapeutics, Inc. (NASDAQ: QLGN) 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 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 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 ge
nes’ 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 product candidate for removal from circulating blood of precisely targeted tumor-produced and viral compounds. Qualigen’s only products that are currently commercially available are its FastPack System diagnostic instruments and test kits. 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, or Sekisui.

Qualigen’s first FastPack cancer diagnostic product, Total PSA, was introduced in 2002. Since then, Qualigen’s FastPack test menu has expanded to include additional tests for cancer, men’s health, hormones and metabolic biomarkers. To increase stockholder value, Qualigen has recently revised its strategy toward a primary focus on developing its therapeutic device and drug opportunities (particularly in the cancer area), while maintaining its diagnostics business. In 2018, Qualigen, Inc. accelerated its transition into cancer therapeutics with development and licensing partnerships with the University of Louisville, or UofL, and Advanced Cancer Therapeutics, LLC. Today, Qualigen has a pipeline of cancer and infectious-disease therapeutics product candidates to complement its commercialized diagnostic-device products.

Products and Solutions

Since its introduction in 2000, Qualigen’s FastPack System diagnostic instruments and kits have demonstrated the ability to detect cancer, other diseases and medical conditions, and biological factors. Qualigen’s anticancer drug candidates, ALAN and RAS-F, are designed to destroy tumors (or stop tumor growth) 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. STARS is a therapeutic device product candidate, currently in the preclinical development stage, which is designed to remove circulating tumor cells, viruses, inflammation factors and immune checkpoints. Qualigen’s only products that are currently commercially available are its FastPack System diagnostic instruments and test kits.

FastPack®

The FastPack System is a rapid, onsite immunoassay testing system consisting of the FastPack Analyzer and the FastPack test pouch, a single-use, disposable, foil packet which includes the FastPack reagent chemistry. Since the initial conception of the system, Qualigen has developed three successive versions of the analyzer and test pouch, known as “1.0”, “IP” and “PRO”, and has expanded its assay menu to 12, including tests for prostate cancer, thyroid function, metabolic disorders, research applications and antibodies against SARS-CoV-2. Qualigen has sold FastPack products in the United States and overseas for almost 20 years. Since inception, sales of FastPack products have exceeded $100 million. Qualigen manufactures the FastPack products at its FDA and ISO certified Carlsbad, California facility. Pursuant to a distribution agreement, Qualigen is required to rely on its diagnostics distribution partner Sekisui for most FastPack distribution worldwide until May 2022. Qualigen maintains direct distribution for certain house accounts, including Low T Center, Inc.

Qualigen seeks and maintains patent protection for its FastPack products in the United States and selected foreign jurisdictions. For example, in 2018 Qualigen was granted patents in China for the FastPack system.

ALAN (AS1411-GNP) and AS1411

ALAN (Aptamer-Linked Anti-Nucleolin or AS1411-GNP) is an aptamer-based anticancer drug candidate that is designed to treat different types of cancer. This novel technology potentially has several additional applications, including enhancement of radiation therapy, enhancement of tumor imaging, and delivery of other anti-cancer compounds directly to tumor cells. A key component of this drug candidate, DNA aptamer AS1411, has been shown, primarily on a preclinical basis, to have the potential to target and destroy cancer cells. This component has been administered in Phase 1 and Phase 2 clinical trials to over 100 cancer patients and appears to be well tolerated with no evidence of severe side effects, with at least seven patients appearing to have long-lasting clinical responses where their cancers disappeared or shrank substantially.

ALAN is an enhanced version of AS1411 where the DNA aptamer is attached to a gold nanoparticle.

In a Qualigen-sponsored UofL in-vitro preclinical study involving tumor-associated macrophages, ALAN was shown to have stronger anti-cancer activity versus AS1411. Tumor-associated macrophages are a class of immune cells present in high numbers around solid tumors and affect most aspects of tumor cell biology; they drive pathological phenomena including tumor cell proliferation, tumor angiogenesis, invasion and metastasis, immunosuppression, and drug resistance. In most cancers, the tumor-associated macrophages have an M2 phenotype, which may inhibit the anti-tumor effects of immune checkpoint inhibitor drugs, such as Merck’s Keytruda (pembrolizumab). Converting these M2 macrophages to the M1 phenotype could enhance the activity of these immune checkpoint inhibitors. In this study, ALAN increased the conversion of M2 macrophages to the M1 phenotype, while also reducing the overall proliferation of macrophages.

Moreover, a UofL in-vitro preclinical study with triple negative breast cancer cells (MDA-MB-231) indicated that ALAN, in combination with radiation therapy, resulted in reduced tumor cell colony size (i.e., resulted in increased tumor cell necrosis) compared to radiation alone. Qualigen believes that, in addition to its potential use as a stand-alone anticancer drug, ALAN could potentially be used as a component of the STARS device or used as a combination treatment with it.

In addition, Qualigen plans to advance toward clinical trials with AS1411 for the treatment of certain infectious diseases. AS1411 has been shown to be effective in halting the replication of viruses in proof-of-concept in vivo studies performed at the UofL, and Qualigen believes that clinical trials may show it could be used to treat patients who have COVID-19 or other similar viral-based diseases. In addition, Qualigen and the UofL have filed a United States provisional patent application for the use of AS1411 as a preventative against COVID-19 and other similar viral-based infections.

RAS-F

RAS is the most common oncogene in human cancer. Activating mutations in one of the three human RAS gene isoforms (KRAS, HRAS or NRAS) are present in about one-fourth of all cancers. For example, mutant KRAS is found in 98% of pancreatic ductal adenocarcinomas, 52% of colon cancers, and 32% of lung adenocarcinomas. For these three cancer types, cancers with mutant KRAS are diagnosed in more than 170,000 people each year in the US and cause more than 120,000 deaths. There is currently no FDA-approved direct RAS protein inhibitor available. Although drugs that target downstream signaling of RAS are available, they have shown limited clinical activity (most likely because RAS acts like a hub that activates multiple effectors). As such, blocking any single pathway, or even two, typically provides disappointing clinical effect. By contrast, the RAS-F small molecules’ intended mechanism of action is to inhibit or block the binding of mutated RAS genes’ proteins to their effector proteins, thereby leaving the proteins from mutated RAS unable to cause further harm. Qualigen believes that preventing this binding could stop tumor growth, especially in pancreatic, colorectal and lung cancers.

STARS™

Since its inception, Qualigen’s initial research and development focus has been on its FastPack diagnostic system and related core technologies. These same technologies are now the basis for Qualigen’s planned expansion into therapeutic applications for the treatment of cancer and infectious disease. Qualigen’s Selective Target Antigen Removal System, or STARS, is designed to utilize core expertise in advanced reagents and coatings to remove disease associated agents, including viruses and tumor-produced compounds, directly from a patient’s blood. The key components of STARS, membranes coated with target capture reagents, utilize several proprietary processes developed and used in the FastPack product lines. Proprietary STARS cartridges are expected to be designed for use with conventional dialysis or hemofiltration machines to remove immune checkpoints, metastatic cells and inflammation factors from cancer patients’ bloodstreams. Qualigen believes STARS can also be used to treat infectious diseases, by removing circulating viruses sufficiently to facilitate patient stabilization and recovery.



How STARS would remove viruses and tumor-produced compounds from blood.

Timeline and Milestones

Qualigen’s currently-expected key milestones for the next several years are listed in the timeline below, which will involve Qualigen’s cancer therapeutics product candidates. Phase 1 clinical human trials for ALAN are expected to take place in 2021. Assuming that these trials are successful, Qualigen believes that Phase 2 trials could begin as early as 2021. Qualigen expects RAS-F and STARS trials to follow in 2022 and 2023, respectively. These timelines would be subject to change if Qualigen decides that other product candidates are more promising and prioritizes clinical trials for the other product candidates instead.



Regulatory Matters


Qualigen has demonstrated success in regulatory affairs, having obtained 17 FDA approvals and 26 CE-Marks for its diagnostic products (FastPack analyzers, immunoassays, control kits, calibration kits and verifications kits) to date. However, Qualigen has not obtained FDA or other regulatory approval for any drug candidate.

Qualigen plans to seek to obtain Orphan Drug status for ALAN, which is expected to confer several advantages including faster review and increased market protection, for one or more indications, such as pancreatic cancer, acute myeloid leukemia (AML) and pediatric neuroblastoma.

Strategic Partners


Qualigen has licensed key components of and intellectual property covering ALAN, AS1411 and RAS-F and their uses from UofL and Qualigen’s scientists are working closely with UofL’s development team in order to optimize and prepare ALAN and AS1411 for human trials. A separate team at UofL, funded by Qualigen, is developing RAS-F. In addition, Qualigen has secured the rights to the core AS1411 aptamer from Advanced Cancer Therapeutics, LLC.

In 2016, Qualigen entered into an agreement with Sekisui whereby Sekisui distributes Qualigen’s FastPack diagnostic product line worldwide. Qualigen is also developing a novel stroke assay, FastPack cFN (cellular fibronectin), for Prediction Sciences LLC, or Prediction Sciences, to be used as a companion diagnostic for Prediction Science’s new stroke drug, and to be launched in Europe in 2020. Qualigen in-licenses several patents from DiaSource Immuno Assays, s.a., and Future Diagnostics, b.v., for reagents that are used in its FastPack Vitamin D Assay.

Sales Channels

Qualigen sells its FastPack diagnostic product line worldwide through its distribution partner Sekisui. In the US, Sekisui commercializes the FastPack product line through its own direct sales force and distribution agreements with McKesson Medical-Surgical, Henry Schein Medical, Medline Industries and National Distribution & Contracting, the largest distributors of physician office laboratory products in the US. Outside of the US, Sekisui commercializes the FastPack product line through a network of distributors in Europe, Asia, Middle East, and North Africa. In addition, among its other direct sales accounts, Qualigen sells FastPack products directly to Low T Center, Inc., the largest men’s health group in the US, with over 47 locations. Sales to Sekisui accounted for 61% of Qualigen’s total revenues during the fiscal year ended March 31, 2020 and sales to Low T Center, Inc. accounted for 32% of Qualigen’s total revenues during the fiscal year ended March 31, 2020.

Manufacturing

Qualigen conducts internal immunoassay development and production and instrument engineering and assembly at its approximately 25,000 square feet facility in Carlsbad, CA. Qualigen’s laboratory and manufacturing practices are governed by a series of internally published Standard Operating Procedures, in accordance with FDA and ISO guidelines. While Qualigen produces many of its own raw materials and sub-components, it also purchases certain materials from third-party suppliers such as Thermo Fisher Scientific, Equitech-Bio, Surmodics, OYC Americas, PerfecSeal, 3M, VWR, Gilson, Impact Project Management, Enstrom, Hi-Tech Products, and Hamamatsu.

Research and Development

Qualigen intends to focus its internal research and development on the STARS therapeutic device, while continuing to support the FastPack diagnostic line. In addition, Qualigen is leveraging the scientific and technical resources and laboratory facilities of UofL, through technology licensing and sponsored research agreements, which are focused on Aptamer technology and applications in the field of cancer treatment.

Leadership

Michael S. Poirier
President, CEO and Chairman


Michael S. Poirier founded Qualigen in 1996 and is its Chairman, President and Chief Executive Officer. Prior to founding Qualigen, Mr. Poirier was Vice President of Marketing for Ashirus Technologies, Inc., a Minneapolis-based manufacturer of innovative high-precision dispensing pumps and related equipment for the medical industry. From 1993 to 1995, Mr. Poirier was Director of US Area Operations for EnSys, Inc., located in Research Triangle, North Carolina. EnSys developed and manufactured field-portable immunoassay test kits for the environmental remediation industry. From 1991 to 1993, Mr. Poirier was employed by Sanofi Pasteur in Chaska, Minnesota, as a Marketing Manager responsible for launching the ACCESS® Immunoassay System. This novel diagnostic system was later acquired by Beckman-Coulter and is now one of the leading immunoassay test systems worldwide. From 1985 to 1991, Mr. Poirier was employed by Abbott Diagnostics, a division of Abbott Laboratories, Inc. in various marketing and sales positions, including Worldwide Immunoassay Product Manager for the IMx® and AxSym® immunoassay diagnostic systems. Both IMx and later, AxSym, became the leaders in their respective markets. Prior to working at Abbott, Mr. Poirier served as an officer in the United States Navy, assigned to the US Atlantic Fleet. Mr. Poirier holds a B.A. from Providence College and attended the University of Zürich, Switzerland, School of Law.

Christopher L. Lotz
Chief Financial Officer


Christopher L. Lotz joined Qualigen as Director of Finance in 2002 and was appointed Vice President and Chief Financial Officer in 2003. Prior to joining Qualigen, Mr. Lotz was Director of Finance for the United States subsidiaries of Bexcom, a procurement management software company based in Singapore from 1999 to 2001. From 1998 to 1999 Mr. Lotz served as Controller of California Furniture Collections, Inc. a custom furniture manufacturer, and from 1987 to 1998 Mr. Lotz was Controller and then Vice President and Chief Financial Officer of Group Publishing, Inc. a book and magazine publisher. Mr. Lotz holds a B.S. in Business Administration from Colorado State University.

Shishir K. Sinha
Vice President, Operations, Corporate Secretary


Shishir K. Sinha joined Qualigen as Vice President, Operations & QA/QC in 2006 and was appointed Corporate Secretary in 2017. Prior to joining Qualigen, Mr. Sinha held leadership roles in the molecular diagnostics industry including Director of Manufacturing for Nanogen, and Senior Manager of Oligonucleotide Manufacturing for Celera Diagnostics from 2004-2006. From 2001-2004, Mr. Sinha served as Director of Manufacturing for Sequenom, a developer of industry leading methods and equipment to analyze DNA. Mr. Sinha was Packaging Manager for Sandoz Pharmaceutics (Novartis) from 2000-2001, and from 1989 to 2000 held various management positions in QC, manufacturing, planning and production control with Microgenics Corp, a manufacturer of immunoassay diagnostic kits. Mr. Sinha holds an MBEE in Biotechnology Enterprise from John Hopkins University and B.A. in Genetics from the University of California, Berkeley.

Wajdi Abdul-Ahad, PhD
Vice President, R&D, Chief Scientific Officer


Dr. Abdul-Ahad is Qualigen’s Vice President of Research and Development and Chief Scientific Officer. Since joining the Company in 2006, he has successfully developed and commercialized numerous complex immunoassays on both the FastPack and FastPack IP Systems. In addition, Dr. Abdul-Ahad is responsible for all surface coating, nanotechnology and reagent manufacturing, as well as integration of new drug manufacturing systems and processes. Prior to joining Qualigen, Dr. Abdul-Ahad led multifunctional design teams at Beckman Coulter that developed and commercialized over 15 assays on their industry leading Access and Synchron automated systems. From 1988 to 1990, Dr. Abdul-Ahad held various management positions with the National Diagnostics Center and Noctech, Inc., both located in Galway, Ireland. Dr. Abdul-Ahad holds a PhD in Biochemistry from National University of Ireland, Galway; an MS in Clinical Chemistry from the University of Surrey, England; an MBA from the University of La Verne, California and a BS in Pharmacy from the University of Baghdad, Iraq. He also holds certifications and licenses from the American Board of Clinical Chemistry, State of California (Registered Pharmacist), National Registry of Clinical Chemistry and the National Academy for Clinical Biochemistry. Dr. Abdul-Ahad’s professional affiliations include the Association of Clinical Biochemistry (ACB-UK), the American Association for Clinical Chemistry and the American Pharmaceutical Association. Dr. Abdul-Ahad is also the author or co-author of numerous scientific publications.

Qualigen Therapeutics, Inc.

Price $3.40

NASDAQSymbol:   QLGN

Market Cap: $79 million

Shares Outstanding: 23 millionn


2042 Corte Del Nogal
Carlsbad, CA 92011

Phone: (760) 918-9165

Website: www.qualigeninc.com 


     

QUALIGEN THERAPEUTICS Submits Notification to FDA to Commence Distribution of its FastPack® COVID-19 Antibody Test


 
 
Qualigen has sold FastPack products in the United States and overseas for almost 20 years. 

 
Since inception, sales of FastPack products have exceeded $100 million.

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