Company Overview: Qualigen Therapeutics, Inc.

Business Focus and Programs

• Industry: Early-stage biotechnology and therapeutics company specializing in cancer treatments.
• Primary Focus: Developing therapies for adult and pediatric cancers.
• Current Programs:
  • QN-302: An investigational small molecule targeting G-quadruplexes (G4) in cancer cells. It is a transcription inhibitor designed to bind selectively to G4 structures prevalent in cancer genes, particularly promising for pancreatic cancer treatment.
    • Development Stage: Currently undergoing Phase 1a clinical trial at START Midwest (Grand Rapids, Michigan) and HonorHealth (Scottsdale, Arizona).
    • Key Milestones: FDA granted Orphan Drug Designation for pancreatic cancer; FDA cleared IND and first patient dosed in November 2023.
  • Pan-RAS: A preclinical program involving small molecules aimed at inhibiting mutated RAS proteins, which are featured in roughly 25% of all cancers (notably pancreatic, colorectal, and lung cancers). Designed to block RAS protein interaction with effectors upstream of KRAS, HRAS, and NRAS pathways.

Strategic and Business Activities

• Partnerships:
  • Marizyme, Inc.: Entered into a Co-Development Agreement in April 2024 for a vascular conduit solution called DuraGraft™.
    • Funding: Invested approximately $2.257 million (and accruing interest) to support commercialization.
    • Royalty Arrangement: Receives 33% of net sales royalties on DuraGraft, capped at twice the investment amount, starting after $500,000 U.S. sales.
    • Additional Investment: Advanced further funds ($1.5 million in early 2025).
• Business Operations:
  • Previously involved in diagnostics (FastPack® products); sold subsidiary Qualigen, Inc. in July 2023, resulting in discontinuation of diagnostics-related activities.
  • Owned a minority interest (~49.97%) in NanoSynex, an Israeli microbiological diagnostics company. NanoSynex was deconsolidated in July 2023; the investment is now accounted for under the equity method with a zero carrying value as of December 31, 2024.

Financial Highlights

• Employees: As of June 24, 2025, the company reported no employees.
• Revenue: There was no mention of revenue from product sales; revenues mainly derived from licensing, licensing milestones, and collaborative agreements.
• Net Loss:
  • For 2024: approximately $6.26 million.
  • For 2023: approximately $13.76 million.
• Funding:
  • Raised approximately $8 million in 2024 from:
    • Sale of Series A-2 Preferred Stock (~$4.6 million)
    • Sales of common stock and warrants (~$3.1 million)
    • Convertible debt (~$1.5 million)
    • Warrant exercises (~$0.4 million)
  • Borrowed $3.47 million in short-term borrowing (January-June 2025).
• Cash Position: As of December 31, 2024, approximately $1.2 million in cash.
• Market Capitalization: Based on June 30, 2024, last reported market value, approximately $1.65 million (at a stock price of $8.60 per share for about 1,635,475 shares outstanding).

Key Regulatory and Development Status

• QN-302:
  • FDA granted Orphan Drug Designation for pancreatic cancer.
  • IND cleared; first patient dosed in November 2023.
  • Ongoing Phase 1a trial.
• Pan-RAS:
  • At preclinical stages, with licensing rights from University of Louisville.
  • Aiming to inhibit RAS protein interactions to treat several cancer types.
• Intellectual Property:
  • No directly owned issued patents as of December 31, 2024.
  • Licensed patents from UCL (Q4-302) and U of L (Pan-RAS), with expiration between 2030-2040.
• Operational Status: Virtually managed; no current properties or dedicated facilities.

Summary

Qualigen Therapeutics is a biotechnology company focused on innovative cancer therapies, with lead programs targeting genetic structures (G4) relevant to pancreatic cancer, and preclinical efforts to inhibit RAS oncogenes. The company has no employees as of mid-2025, is not profitable, and faces liquidity challenges but has secured some funding and strategic partnerships to support ongoing clinical development and commercialization efforts.