CARLSBAD, Calif., July 28, 2025 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (NASDAQ: QLGN) (the “Company”) received two different communications from the staff of the Nasdaq Listing Qualifications office of the Nasdaq Stock Market, LLC. The Company received the first notice from the Nasdaq Listings Qualifications office of the Nasdaq Stock Market LLC on July 23, 2025, informing the Company that as reflected in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 filed with th ...

Carlsbad, CA, July 28, 2025 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (NASDAQ:QLGN) ("Qualigen" or the "Company"), a life sciences company focused on developing platform treatments for adult and pediatric cancers with the potential for orphan drug designations, today announced that it has entered into definitive securities purchase agreements with several institutional and accredited investors for the sale of its Series A-3 Preferred Stock. The private placement closed on July 28, 2025. The Company is ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to _____________ Qualigen Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37428 26-3474527 (State or other jurisdiction ...

CARLSBAD, Calif., July 16, 2025 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (NASDAQ: QLGN) (the “Company” or “Qualigen”) is announcing an update on patents granted in the first six months of 2025. The patent is Titled “Substitued Naphthalene Diimides and Their Use.” The patent is for the drug, which was developed by Professor Stephen Neidle and his team at the University College of London, and is licensed by Qualigen Therapeutics, QN-302. These patents cover the product and their methods of manufacturin ...

Financial Performance - The company reported total expenses of $5,761,720 for the year ended December 31, 2024, a decrease of 49.1% from $11,304,857 in 2023[181]. - The net loss attributable to Qualigen Therapeutics, Inc. for the year ended December 31, 2024, was $6,346,795, compared to a net loss of $13,417,212 in 2023, reflecting a 52.8% improvement[181]. - The company experienced a loss from operations of $5,761,720 for 2024, compared to a loss of $11,304,857 in 2023, indicating a significant reduction in operational losses[181]. - The company reported a net loss per common share of $17.55 for the year ended December 31, 2024, compared to $132.25 in 2023, showing a substantial decrease in loss per share[181]. - The company recorded a loss of approximately $0.1 million on the disposal of discontinued operations in 2024, compared to a loss of approximately $0.6 million in 2023[202]. - The company recognized a loss of approximately $358,000 due to the issuance of new convertible debt in 2024, with no such loss reported in 2023[192]. Expense Management - General and administrative expenses decreased from $6.1 million in 2023 to $4.2 million in 2024, primarily due to a $0.8 million decrease in stock-based compensation and a $0.9 million decrease in payroll expenses[183]. - Research and development expenses decreased from $5.2 million in 2023 to $1.2 million in 2024, mainly due to a $2.9 million decrease in costs related to QN-302 and a $1.0 million decrease for Pan-RAS[184]. - The company implemented expense controls and slowed the development of therapeutic products starting in Q2 2024 due to financial constraints[167]. Cash Flow and Financial Position - As of December 31, 2024, the company had approximately $1.2 million in cash and net accounts payable exceeding $1.6 million, indicating a weak financial position[203]. - The company expects cash balances to fund operations only into the third quarter of 2025, raising substantial doubt about its ability to continue as a going concern[205]. - Operating activities used $6.3 million of cash in 2024, primarily due to a net loss of $6.3 million, compared to $10.3 million used in 2023[220][221]. - Net cash used by investing activities was approximately $1.9 million in 2024, primarily due to the issuance of $2.3 million in notes receivable to Marizyme[222]. - Net cash provided by financing activities was approximately $9.0 million in 2024, resulting from $4.6 million in proceeds from the sale of Series A-2 Preferred Stock and $3.1 million from the sale of common stock[224][226]. - The company reported a net increase in cash and restricted cash of $772,805 in 2024, compared to a decrease of $6,638,320 in 2023[219]. Agreements and Collaborations - The company advanced a total of $2,257,400 to Marizyme, Inc. during the year ended December 31, 2024, with accrued interest of $113,292 recognized[177]. - The company entered into a Co-Development Agreement with Marizyme, agreeing to pay up to $1,750,000 in funding and a $200,000 exclusivity fee[164]. - A Co-Development Agreement with Marizyme, Inc. includes a Funding Payment of up to $1,750,000 and an Exclusivity Fee of $200,000, with a 33% royalty on Net Sales of DuraGraft capped at double the Funding Payment[215]. - The company entered into a License Agreement with UCL Business Limited for a genomic quadruplex (G4)-selective transcription inhibitor drug development program, with an obligation to pay $100,000 upon the first patient dosing of QN-302[214]. Research and Development Focus - The company’s lead program, QN-302, is focused on treating cancers with a strong binding affinity to G-quadruplexes prevalent in cancer cells[162]. - The company’s Pan-RAS program targets mutated RAS genes, potentially effective in treating about 25% of all cancers, including pancreatic, colorectal, and lung cancers[163]. Credit and Liabilities - The estimated expected credit losses on the Marizyme Notes as of December 31, 2024, is $360,000, reflecting the uncertain nature of the debtor's financial condition[179]. - The company incurred a $0.4 million loss in expected credit losses on Marizyme Notes Receivable in 2024, with no credit losses reported in 2023[185]. - The estimated fair value of warrant liabilities increased to $0.3 million in 2024 from $0.1 million in 2023, resulting in a $0.4 million gain due to changes in fair value[186]. - The Marizyme Notes bear an interest rate of 18% per annum, with the option for Marizyme to pre-pay without penalty[217]. - The company recognized a non-cash loss on issuance of convertible debt of approximately $0.4 million in 2024[220]. Other Financial Activities - The company settled $395,000 of outstanding accounts payable for a gain of approximately $348,000 in 2024, with no similar settlements in 2023[198]. - The company has entered into various contracts for clinical trials and product development, which are generally cancelable on notice[218].

Core Viewpoint - Qualigen Therapeutics, Inc. has received a deficiency notification from Nasdaq regarding its failure to timely file its Quarterly Report on Form 10-Q for the period ended March 31, 2025, which may lead to delisting from the Nasdaq Stock Market [1][2]. Group 1 - The deficiency notification is based on Nasdaq Listing Rule 5250(c)(1), which mandates timely filing of periodic reports with the SEC [2]. - The Nasdaq Hearings Panel will consider this deficiency in its determination regarding the company's continued listing on the Nasdaq Capital Market [2][3]. - The company plans to present its compliance plan at the scheduled hearing and aims to file the Form 10-Q as soon as possible [4]. Group 2 - There is no assurance that the Panel will grant an extension or that the company will regain compliance with all listing requirements [4]. - The company is expected to address the deficiency during the hearing, and the Panel will make its decision based on the information presented [3].

Core Points - Qualigen Therapeutics, Inc. received a deficiency notification from Nasdaq for failing to timely file its Annual Report on Form 10-K for the year ended December 31, 2024 [1] - A Nasdaq Hearings Panel imposed a Discretionary Panel Monitor, which could lead to a Delist Determination Letter if compliance is not maintained [2] - The company intends to appeal the delisting decision and is working to regain compliance with Nasdaq's listing rules [3] Filing Delays - The delay in filing the 2024 Form 10-K was due to the need for the company to complete its accounting and internal control processes [4] - The company is committed to filing the 2024 Form 10-K as soon as practicable, although no specific timeline can be assured [4]

Core Viewpoint - Qualigen Therapeutics, Inc. has entered a non-binding Memorandum of Understanding (MOU) to acquire Marizyme, following a co-marketing agreement established in 2024, with the potential for rapid revenue growth beginning in 2025 [1][2][4]. Group 1: Acquisition Details - The MOU was dated March 28, 2025, and is a logical next step in the acquisition process, pending full due diligence and shareholder approval after filing an S4 [2]. - There is no assurance that the transaction will be completed or that definitive agreements will be executed [2]. Group 2: Product and Market Potential - Marizyme's DuraGraft is an FDA cleared platform technology in the Coronary Artery Bypass Graft (CABG) market, which generates over $10 billion in annual revenue [3]. - There are more than 500,000 CABG surgeries performed annually in the US, with saphenous vein graft (SVG) failure rates being a significant concern, as approximately 50% fail within 5 to 10 years [3]. - DuraGraft aims to prevent oxidative damage and slow the progression of vein graft failure, potentially increasing hospital savings by reducing repeat procedures and hospital stays [3]. Group 3: Management Statements - The CEO of Qualigen expressed excitement about the acquisition, highlighting the potential for rapid revenue growth starting in 2025 [4]. - The CEO of Marizyme noted that combining the two companies will leverage the FDA cleared DuraGraft medical device, with revenue expected by the end of fiscal 2025 [5].

Company Overview - Qualigen Therapeutics, Inc. is participating as the first investor in the 2025 bridge funding round for NanoSynex, which aims to raise up to $500,000 [1][2] - NanoSynex is a MedTech company based in Israel focused on developing a rapid Antimicrobial Susceptibility Test (AST) to improve testing quality and reduce healthcare costs [3][4] Technology and Market Potential - The technology being developed by NanoSynex will halve the time required for antimicrobial susceptibility testing, providing more robust diagnostics and better antibiotic usage globally [2] - The global market for AST is expected to reach $4.7 billion by 2027, with the US market projected to reach $1.6 billion [2] - NanoSynex holds four patents protecting its technology, indicating a strong competitive position in the market [2] Product Development and Future Plans - The funding from Qualigen will accelerate the development of NanoSynex's Minimum Viable Product (MVP) system for AST, referred to as generation 2.0 [3] - NanoSynex plans to seek approval for its technology in the EU market by 2027 and in the US by 2028 [2]

PART I. Financial Information [Condensed Consolidated Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) The company presents its unaudited financial statements for the nine months ended September 30, 2024, reflecting a reduced net loss, significant financing, and the impact of discontinued operations [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to $2.31 million and total liabilities rose to $4.45 million, resulting in a stockholders' deficit of $2.14 million as of September 30, 2024 Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | Sep 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $388,152 | $401,803 | | Total current assets | $2,312,994 | $1,166,767 | | **Total Assets** | **$2,312,994** | **$2,033,248** | | **Liabilities & Stockholders' Deficit** | | | | Total current liabilities | $4,453,845 | $4,136,805 | | Convertible debt | $1,090,002 | $0 | | Total Stockholders' Deficit | $(2,140,851) | $(2,103,557) | | **Total Liabilities & Stockholders' Deficit** | **$2,312,994** | **$2,033,248** | [Condensed Consolidated Statements of Operations and Other Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Other%20Comprehensive%20Loss) The company's net loss improved to $5.40 million for the nine months ended September 30, 2024, driven by significantly lower operating expenses Statement of Operations Summary (Nine Months Ended Sep 30) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Total expenses | $4,428,676 | $9,030,895 | | Loss from operations | $(4,428,676) | $(9,030,895) | | Net loss from continuing operations | $(5,303,368) | $(10,007,448) | | Net loss | $(5,403,368) | $(11,310,001) | | Net loss per common share, basic and diluted | $(24.93) | $(109.19) | [Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity%20(Deficit)) The stockholders' deficit increased slightly to $2.14 million, as the net loss was largely offset by capital raised from financing activities - The company's equity position was impacted by a **net loss of $5.4 million** for the nine months ended September 30, 2024[10](index=10&type=chunk) - Financing activities that increased additional paid-in capital included a **public offering ($3.05 million)**, monthly redemptions and voluntary conversions of convertible debt, and warrant exercises[10](index=10&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was $4.06 million, offset by $4.94 million generated from financing, resulting in a slight decrease in the cash balance Cash Flow Summary (Nine Months Ended Sep 30) | Activity | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,057,980) | $(4,632,677) | | Net cash provided by (used in) investing activities | $(900,000) | $3,980,541 | | Net cash provided by (used in) financing activities | $4,944,329 | $(440,000) | | Net change in cash and cash equivalents | $(13,651) | $(1,092,136) | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail a reverse stock split, discontinued operations, going concern doubts, significant financing activities, and a new co-development agreement - A **1-for-50 Reverse Stock Split** of the company's common stock became effective on November 5, 2024, with all share and per-share data retroactively adjusted[15](index=15&type=chunk)[149](index=149&type=chunk) - The company has **substantial doubt about its ability to continue as a going concern**, as cash balances are only expected to fund operations through Q4 2024 without additional financing[48](index=48&type=chunk) - In July 2023, the company sold its subsidiary Qualigen, Inc and deconsolidated NanoSynex, both now classified as **discontinued operations**[20](index=20&type=chunk)[21](index=21&type=chunk) - The company advanced **$1.25 million to Marizyme, Inc** via a demand promissory note bearing 18% interest as part of a co-development agreement[52](index=52&type=chunk)[114](index=114&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses its strategic focus, reduced operating expenses, and severe liquidity challenges that raise substantial doubt about its going concern status [Overview](index=27&type=section&id=Overview) The company is an early-clinical-stage firm focused on cancer therapeutics, with its lead assets being the QN-302 and Pan-RAS programs - The company's lead program, **QN-302**, is an investigational small molecule G4-selective transcription inhibitor currently in a Phase 1a clinical trial[158](index=158&type=chunk) - The **Pan-RAS program** is a preclinical portfolio of small molecules designed to inhibit mutated RAS oncogene protein-protein interactions[159](index=159&type=chunk) - A co-development agreement with Marizyme entitles Qualigen to a **33% royalty on net sales of DuraGraft**, capped at double the funding provided by Qualigen[161](index=161&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Operating expenses for the nine-month period decreased by 51% year-over-year, leading to an improved net loss from continuing operations of $5.3 million Operating Expense Comparison (Nine Months Ended Sep 30) | Expense Category | 2024 | 2023 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | General and administrative | $3,186,575 | $5,132,834 | $(1,946,259) | -38% | | Research and development | $1,242,101 | $3,898,061 | $(2,655,960) | -68% | | **Total expenses** | **$4,428,676** | **$9,030,895** | **$(4,602,219)** | **-51%** | - The decrease in G&A expenses was primarily due to reductions in **stock-based compensation ($0.8M)**, payroll ($0.7M), and professional fees ($0.5M)[181](index=181&type=chunk) - The decrease in R&D expenses was mainly due to reduced costs for the **QN-302 program ($2.0M)** and the RAS program ($0.8M)[182](index=182&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) The company's critical liquidity position raises substantial going concern doubts, despite recent financing efforts, and it faces a Nasdaq delisting risk - The company's cash balance of approximately $388,000 is only expected to fund operations into Q4 2024, raising **substantial doubt about its ability to continue as a going concern**[192](index=192&type=chunk)[193](index=193&type=chunk) - In the first nine months of 2024, the company raised approximately **$1.5 million from convertible debt** and net proceeds of approximately **$3.1 million from a public offering**[49](index=49&type=chunk)[195](index=195&type=chunk) - The company received a Nasdaq Panel decision granting an extension until **November 19, 2024, to regain compliance** with listing requirements, after which it may be delisted[200](index=200&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exempt from market risk disclosures as it qualifies as a smaller reporting company - The company is a **smaller reporting company** as defined by Rule 12b-2 of the Exchange Act and is not required to provide this information[222](index=222&type=chunk) [Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective due to unremediated material weaknesses in internal controls - Management concluded that **disclosure controls and procedures were not effective** as of September 30, 2024[224](index=224&type=chunk) - The ineffectiveness is due to **material weaknesses** related to an insufficient number of accounting personnel to segregate duties and a lack of effective Information Technology General Controls (ITGC)[225](index=225&type=chunk) - No changes were made to internal controls during the third quarter of 2024, and the company foresees the **weaknesses will not be remediated** until additional funding is secured[225](index=225&type=chunk)[226](index=226&type=chunk) PART II. Other Information [Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - As of the report date, the company is **not currently involved in any legal matters** that could be reasonably expected to have a material effect on its operations[101](index=101&type=chunk)[228](index=228&type=chunk) [Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred to the risk factors disclosed in the 2023 Annual Report - There have been **no material changes** to the Company's risk factors since the 2023 Annual Report[229](index=229&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company issued 64,312 unregistered common shares related to the conversion of a 2022 convertible debenture - During the nine months ended September 30, 2024, the company issued **64,312 shares of unregistered common stock** to Alpha Capital Anstalt for monthly redemptions and voluntary conversions of its 2022 Debenture[230](index=230&type=chunk) [Defaults Upon Senior Securities](index=39&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported during the period - None reported[230](index=230&type=chunk) [Mine Safety Disclosures](index=39&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not Applicable[230](index=230&type=chunk) [Other Information](index=39&type=section&id=Item%205.%20Other%20Information) No other information was reported for the period - None[230](index=230&type=chunk) [Exhibits](index=40&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the report, including financing agreements and required officer certifications - The report includes numerous exhibits detailing recent financing activities, such as the **Form of Pre-Funded Warrant, Placement Agent Warrant, and Securities Purchase Agreements**[233](index=233&type=chunk) - **Certifications from the principal executive officer and principal financial officer** pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002 are filed with the report[234](index=234&type=chunk)[235](index=235&type=chunk)