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Qualigen to participate in next funding round for NanoSynex
QLGN has closed green 8 of the last 10
Marizyme Enters Into Co-Development Agreement With Qualigen Therapeutics for the Commercialization of FDA-Cleared DuraGraft(TM)
Qualigen sold its FastPack® diagnostics business to Chembio Diagnostics, Inc in 2023 for roughly $5 Million
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Hello Everyone,
We are seeing some pain in the markets given the current situation with tariffs and economic uncertainty around the world. The Nasdaq has taken a sizeable dip since February and the Dow is down significantly from its highs in January. However, we always say that there are opportunities in any market that can deliver. All you have to do is look at the 5,10,20 year charts and you can come to the conclusion that this is temporary. Here is a little fun fact for you that I am sure you are not aware of; Since 1957, the S&P 500 has hit a new record high on average about every 14 trading days. Sounds like a long term strategy that can’t lose baring a cataclysmic event.
We know that the market will be back in Bull Mode eventually, we just don’t know when.
Let’s take a look at a company that has been bucking the trend lately.
Pull up QLGN and let’s get it on your radar for Monday’s session.
QLGN has some momentum behind it right now and has closed green 8 of the last 10.
What is interesting about the momentum and the roughly 30% move over the past 2 weeks is that it seems to be occurring organically with no recent news pushing this one north.
Qualigen Therapeutics, Inc. is an early-clinical-stage biotechnology company. Until the sale of its diagnostic business in 2023 when Qualigen sold its FastPack® diagnostics business to Chembio Diagnostics, Inc., an American subsidiary of French diagnostics provider BIOSYNEX Group, a leader in the design and distribution of rapid tests, Qualigen had a 20+ year history developing, marketing and selling medical devices in the United States and internationally. Their investigational QN-302 compound is a small molecule selective transcription inhibitor with strong binding affinity to G4s prevalent in cancer cells; such binding could, by stabilizing the G4s against “unwinding,” help inhibit cancer cell proliferation. QN-302 is currently in a Phase 1a clinical trial. The preclinical compounds within Qualigen’s family of Pan-RAS oncogene protein-protein interaction inhibitor small molecules are believed to inhibit or block the binding of mutated RAS genes’ proteins to their effector proteins, thereby leaving the proteins from the mutated RAS unable to cause further harm. In theory, such mechanism of action may be effective in the treatment of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers.
QLGN is working with prominent investigators at University College London and the University of Louisville.
QLGN says it’s lead compound, QN-302, is “a small molecule selective transcription inhibitor with strong binding affinity to G4s prevalent in cancer cells.”
It notes that “such binding could, by stabilizing the G4s against ‘unwinding,’ help inhibit cancer cell proliferation.”
The compound has received arom the FDA for the intended indication of pancreatic cancer
QLGN has concluded that “Mice treated with QN-302 have shown longer survival duration and greater tumor shrinkage in pancreatic cancer in vivo xenograft and genetic models vs. historically standard of care gemcitabine.”
Right now, the company is putting QN-302 through a Phase 1 trial for treatment of advanced or metastatic solid tumors, and it has initially dosed four patients.
The company has done posters, publications, and presentations at 2022, 2023, and 2024 annual and special meetings of the American Association for Cancer Research (AACR).
QLGN’s other major candidate is its Pan-RAS Inhibitor Platform.
The compathat “RAS is the most common cancer oncogene [a mutated gene that can cause cancer], present in more than 30% of all cancers”
QLGN has a family of investigational compounds that “are believed to inhibit or block the binding of mutated RAS genes’ proteins to their effector proteins.”
PIPELINE
About QN-302
QN-302, a novel tetra-substituted naphthalene diimide derivative invented and initially developed at University College London, is a potent binder to quadruplex (G4) sequences in the promoters of cancer genes, with 1-2 nM anti-proliferative activity in human pancreatic cancer (PDAC) cell lines. QN-302 has significant anti-tumor activity in xenograft, orthotopic and genetic (KPC) models of PDAC and retains high activity in gemcitabine-resistant PDAC cell lines. The drug is bio-available and well tolerated at therapeutic doses in the various animal models.
QN-302 is being developed by Qualigen Therapeutics Inc. It was granted Orphan Drug status for Pancreatic Ductal Adenocarcinoma (PDAC) by the FDA in January 2023 and granted Investigational New Drug (IND) clearance in August 2023 by the FDA for phase 1 clinical trial in advanced or metastatic solid tumors. This trial is being conducted at two cancer centers in the USA. In this first-in-human Phase 1 dose-finding study, the study design is for QN-302 to be given once a week, intravenously over 60 min, on Day 1, Day 8, and Day 15 of a 28-Day cycle. The study is designed to use a standard oncology 3+3 dose escalation design, with enrollment of 3 patients per cohort and expansion to 6 patients in the event of a DLT (Dose Limiting Toxicity). Five patients have been enrolled to date in the trial, two with colorectal adenocarcinoma as their primary cancer. Both were subsequently withdrawn from the trial, due to non-QN-302 issues (Grade 2 anemia: disease progression). One completed one cycle of QN-302 with no serious adverse effects (SAE).
Qualigen to participate in next funding round for NanoSynex
Market size expected to reach $4.7 billion in 2027
CARLSBAD, Calif., Jan. 28, 2025 (GLOBE NEWSWIRE) — Qualigen Therapeutics, Inc. (NASDAQ: QLGN) (the “Company”)announced today they will be the first investors participating in the 2025 bridge round of funding for NanoSynex. NanoSynex will be raising up to $500,000.
“We are very excited to participate and be the first investors to commit in this round of funding for NanoSynex. The technology they are developing will help the world of Antimicrobial Susceptibility Testing (AST) by reducing the time required for tests in half, offering more robust diagnostics, which will lead to better use and not over use of the wrong antibiotics for patients globally. The Minimum Viable Product (MVP) System has numerous competitive advantages to existing tests and is priced competitively with those slower and less robust products.”, stated Kevin Richardson II, CEO of Qualigen. NanoSynex plans to be approved for the EU market in 2027 and US in 2028. The market size globally is expected to reach $4.7 billion by 2027. The US market alone is expected to reach $1.6 billion. NaoSynex also has a strong pipeline of other indications and verticals they can pursue with this technology. NanoSynex also has 4 patents protecting the technology.
Diane Abensur, CEO of NanoSynex, stated, “We are thrilled to have Qualigen’s involvement in being the first to commit to this bridge round funding. It will allow us to jump start our product development of our MVP system for AST, generation 2.0 . The need for our product and the lives we can help save by getting more timely and accurate robust diagnostics will help NanoSynex grow dramatically.”
ABOUT NANOSYNEX
NanoSynex is a MedTech company, based in Israel, that aims at providing new solutions to improve testing quality and reduce healthcare costs by speeding up diagnostic processes.
Today, NanoSynex is focused on the development and commercialization of a rapid innovative Antimicrobial Susceptibility Test (AST). The technology is based on a purely phenotypic approach and uses a microfluidic disposable test card platform and method that optimizes bacterial growth. This disruptive development was born from exciting research discoveries at the lab of Professor Shulamit Levenberg, former Dean of the Technion Institute of Technology – Biomedical Engineering Faculty.
NanoSynex’s team is composed of passionate, dedicated business executives, top-notch biomedical engineers and microbiologist team members and supported by a network of experts, including strategic alliances with future distributors, that know how to bring this revolutionary product to the market.
Marizyme Enters Into Co-Development Agreement With Qualigen Therapeutics for the Commercialization of FDA-Cleared DuraGraft(TM)
JUPITER, FL, April 16, 2024 (GLOBE NEWSWIRE) — via NewMediaWire — Marizyme, Inc. (“Marizyme”, OTCQB: MRZM) announces today a Co-Development Agreement (the “Agreement”) with Qualigen Therapeutics, Inc. (“Qualigen”) (NASDAQ:QLGN ) to advance the commercialization of Marizyme’s first-in-class FDA cleared product, DuraGraft™.
DuraGraft™ was granted a De Novo – FDA Clearance on October 4, 2023, from the U.S. Food and Drug Administration (FDA). DuraGraft™ is labeled for use as a vascular conduit solution indicated for adult patients undergoing Coronary Artery Bypass Grafting (CABG) surgeries and is intended for the flushing and storage of the saphenous vein grafts used in CABG surgery. According to the Society of Thoracic Surgeons, there are over 500,000 CABG procedures performed annually in the U.S., representing a major market for this commercial-ready product.
Pursuant to the Agreement, Qualigen will help support the commercial launch in the United States of DuraGraft™, including post-clearance clinical studies to advance the use of DuraGraft™ in the U.S., by providing up to $1.5 million in funding over the next several months for these purposes. In return, Qualigen will receive a share of Marizyme’s gross profit on future U.S. sales of the product, capped at a 2X return on Qualigen’s invested capital. Qualigen has also purchased an exclusive negotiation period ending May 31, 2024, for purposes of proposing and outlining a broader strategic relationship between the two companies.
David Barthel, CEO of Marizyme, stated: “This is an exciting opportunity for Marizyme to accelerate the commercialization of DuraGraft™. In addition to the non-dilutive funding that Qualigen will provide, we believe strongly in the importance of this technology and commercial potential for DuraGraft™ in the United States, and look forward to building this strategic relationship.”
Michael Poirier, CEO of Qualigen, stated: “We are thrilled to be supporting the Marizyme team. This agreement provides Qualigen with participation in an FDA-cleared commercialization project with a visible path to revenue generation in the short term. It also allows us the flexibility to broaden this relationship over the next four months.”
About Marizyme
Marizyme, Inc. is a medical technology company changing the landscape of cardiac care by delivering innovative solutions for coronary artery bypass graft (CABG) surgery. Marizyme’s first in-class product, DuraGraft™, was granted a de novo clearance on October 4, 2023, from the U.S. Food and Drug Administration (FDA). DuraGraft™, with its CE Mark, continues to drive sales growth for Marizyme internationally in Europe and Asia, and will now target the U.S. market to drive further utilization and sales.
NEWS
Qualigen to participate in next funding round for NanoSynex
Jan 28, 2025
Dec 5, 2024
Nov 25, 2024
Qualigen Therapeutics Announces $4.5 Million Private Placement of Convertible Preferred Shares
Nov 19, 2024
Shares Expected to Begin Trading on Split-Adjusted Basis on November 5, 2024
Nov 1, 2024
Qualigen Therapeutics, Inc. Announces management changes.
Sep 26, 2024
Qualigen Therapeutics, Inc. Received Extension from Nasdaq Hearings Panel
Sep 20, 2024
Sep 6, 2024
Qualigen Therapeutics, Inc. Announces Closing of $3.47 Million Public Offering
Sep 6, 2024
Qualigen Therapeutics, Inc. Announces Pricing of $3.46 Million Public Offering
Sep 5, 2024
Qualigen Therapeutics, Inc. Received Nasdaq Notice of a Delisting Determination
May 30, 2024
Apr 16, 2024
Apr 16, 2024
Apr 10, 2024
Apr 9, 2024
MANAGEMENT
Michael Poirier
CEO and Chairman
Michael S. Poirier founded Qualigen in 1996 and is its Chairman 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.
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.
Tariq Arshad MD, MBA
Senior Vice President, Chief Medical Officer
Dr. Arshad brings more than 20 years of biotech and pharmaceutical experience to Qualigen Therapeutics. He is an oncologist with expertise in both early and late stage clinical development at several leading and emergent biopharmaceutical companies, including leadership roles at Becton Dickinson, Sanofi Genzyme, Humanigen, XOMA, Merck, Genentech, and Pfizer. Dr. Arshad was Global Head of Medical Affairs and Clinical Research for Becton Dickinson BioSciences in San Jose, California where he lead a team of MDs and PHDs driving scientific strategy for a cutting-edge immuno-oncology focused portfolio.
Amy S. Broidrick
President and Chief Strategy Officer, Director
Ms. Broidrick has over 26 years experience in the biopharmaceutical industry in a variety of functions and increasing responsibility. Ms. Broidrick served from 2016 to 2020 as Senior Vice President, Global Head of Corporate Development of Viking Therapeutics, Inc., a clinical-stage biopharmaceutical company where she was responsible for building and implementing the US and global corporate and business development functions. Before that, she was Vice President, Head of Global Marketing Excellence and Business Innovation with EMD Serono (part of Merck KGaA). Earlier, she was Vice President, Head of Marketing and Commercialization at Arena Pharmaceuticals, Inc., and held roles of increasing responsibility at Merck & Co. and Pfizer (formerly GD Searle) including Global Brand Leader with worldwide P&L accountability. Ms. Broidrick holds a BA from Fairleigh Dickinson University, completed further undergraduate studies at Wroxton College in England, and performed post-graduate work at Fairleigh Dickinson.
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