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)

Core Viewpoint - Qualigen Therapeutics, Inc. will implement a 1-for-50 reverse stock split effective November 5, 2024, to increase the bid price of its common stock and regain compliance with Nasdaq listing requirements [1][2]. Group 1: Reverse Stock Split Details - The reverse stock split will convert every 50 shares of pre-split common stock into one new share, reducing the number of outstanding shares from approximately 36.7 million to about 737 thousand [3]. - The number of authorized shares will remain unchanged, and stockholders entitled to fractional shares will receive cash in lieu of those shares [3][4]. - The reverse stock split will not affect the par value of the common stock [3]. Group 2: Compliance and Authorization - The reverse stock split was authorized by stockholders at the annual meeting held on October 25, 2024, with the final ratio determined by the Board of Directors [2]. - The action is intended to help the company meet the minimum bid price requirement for continued listing on The Nasdaq Capital Market [2]. Group 3: Administrative Process - The company's transfer agent, Equiniti Trust Company, LLC, will act as the exchange agent and notify stockholders of their new share count post-split [4]. - Stockholders holding shares through brokers or other nominees will have their positions adjusted automatically [4].

Core Insights - Qualigen Therapeutics, Inc. announced the immediate resignations of CEO Michael Poirier and CFO Christopher Lotz due to disagreements over the company's future direction and strategic initiatives [1] - The board appointed Campbell Becher as President and Kevin Richardson as Interim CEO and CFO, indicating a shift in leadership aimed at enhancing shareholder value [2][3] Leadership Changes - Michael Poirier resigned as CEO and Chairman, effective immediately, along with CFO Christopher Lotz, both citing disagreements with the company's strategic direction [1] - Campbell Becher was appointed as President of the company on September 25, 2024, effective immediately [2] - Kevin Richardson was appointed as Interim CEO and CFO, bringing extensive experience in leading strategic initiatives in small cap companies [3] Future Outlook - Both new leaders, Richardson and Becher, expressed enthusiasm for the company's future and potential opportunities, indicating a proactive approach to upcoming strategic initiatives [3][4]

Core Viewpoint - Univest Securities, LLC has successfully closed a registered direct offering for Qualigen Therapeutics, Inc., raising approximately $3.46 million through the sale of common stock and pre-funded warrants [1][3]. Group 1: Offering Details - The offering consists of 14,724,058 shares of common stock priced at $0.130 per share, along with pre-funded warrants exercisable for 11,972,754 shares [1][2]. - The purchase price for each pre-funded warrant is set at $0.129 per share, with an exercise price of $0.001 per share [2]. Group 2: Financial Proceeds - The total gross proceeds from the offering amount to approximately $3.46 million [3]. Group 3: Regulatory Compliance - The offering was conducted under a shelf registration statement on Form S-1, which was originally filed with the SEC on June 13, 2023, and became effective on September 4, 2024 [4]. Group 4: Company Background - Qualigen Therapeutics, Inc. is a clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancer, with investigational compounds targeting cancer cell proliferation [7].

Core Viewpoint - Qualigen Therapeutics, Inc. has successfully closed a public offering of common stock and pre-funded warrants, raising approximately $3.47 million for various corporate purposes [1][3]. Group 1: Offering Details - The company offered 14,724,058 shares of common stock at a price of $0.13 per share and pre-funded warrants to purchase up to 11,972,754 shares at a price of $0.129 per share [1]. - The pre-funded warrants are exercisable upon issuance and will remain exercisable until fully exercised [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be used for operations and general corporate purposes, including: - Accelerated payment of a $2 million Senior Note issued in July 2024 [3]. - Advancement of clinical trials and preclinical studies [3]. - General working capital [3]. - Possible expansion of the relationship with Marizyme, Inc. under a Co-Development Agreement [3]. - Potential future acquisitions [3]. Group 3: Regulatory Information - The securities were offered under a registration statement on Form S-1, which became effective on September 4, 2024 [4]. - The offering was conducted only by means of a prospectus that is part of the effective registration statement [4].

CARLSBAD, Calif., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (NASDAQ: QLGN) (the "Company") today announced the pricing of a public offering of 14,724,058 shares of common stock, par value $0.001 per share (each a "Share," and collectively, the "Shares") at a public offering price of $0.13 per Share and pre-funded warrants to purchase up to 11,972,754 Shares at a price of $0.129 per prefunded warrant with an exercise price of $0.001 per share (the "Pre-Funded Warrants"). The Pre-Funded W ...

As filed with the Securities and Exchange Commission on August 22, 2024. Registration No. 333-272623 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 5 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Qualigen Therapeutics, Inc. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 2834 26-3474527 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identifica ...