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 June 30, 2025 Or ☐ 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) (State or other jurisdiction of incorporation) (Commissi ...

Core Viewpoint - Qualigen Therapeutics, Inc. has received communications from Nasdaq regarding its compliance with listing requirements, specifically related to stockholder's equity, and has taken steps to regain compliance through a private placement of Series A-3 Preferred Stock [1][2]. Group 1: Nasdaq Compliance - The company was notified on July 23, 2025, that it failed to meet the $2.5 million stockholder's equity requirement as per Nasdaq Rule 5550(b)(1) [1]. - Following this, the company successfully closed a $4.5 million private placement of Series A-3 Preferred Stock, which allowed it to regain compliance with the minimum stockholders' equity requirement by July 28, 2025 [2]. - Nasdaq acknowledged receipt of the company's plan to maintain compliance with all applicable continued listing standards over the next 12 months [2]. Group 2: Financial Reporting - The company filed its Quarterly Report on Form 10-Q for the period ended March 31, 2025, by the required deadline of July 21, 2025 [2]. - A Current Report on Form 8-K will be filed later, including a pro forma balance sheet reflecting stockholders' equity in compliance with applicable requirements [4]. Group 3: Company Overview - Qualigen Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel therapeutics for cancer and infectious diseases [5]. - The company's pipeline includes QN-302, a selective G-quadruplex inhibitor for various tumor types, and QN-247, a nucleolin-targeting compound for hematologic malignancies, among others [5].

Core Points - Qualigen Therapeutics, Inc. has entered into definitive securities purchase agreements for the sale of Series A-3 Preferred Stock, raising a total of $4.5 million through the issuance of 4,500 shares at a stated value of $1,000 per share [1][2] - The Series A-3 Preferred Stock is convertible into 1,607,143 shares of common stock at a conversion price of $2.80 per share, subject to adjustments [1] - The net proceeds from this private placement will be used for working capital purposes [2] Regulatory and Compliance - The Series A-3 Preferred Stock was offered in a private placement under Section 4(a)(2) and/or Rule 506(b) of Regulation D under the Securities Act of 1933 and has not been registered under the Securities Act or applicable state securities laws [3] - The company has agreed to file a registration statement with the SEC covering the resale of the common stock underlying the Series A-3 Preferred Stock within 45 days after the closing date [4] Company Overview - Qualigen Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel therapeutics for cancer and infectious diseases, with a pipeline that includes QN-302, QN-247, and small-molecule RAS oncogene inhibitors [6]

[PART I. Financial Information](index=3&type=section&id=PART%20I.%20Financial%20Information) This section presents the unaudited condensed consolidated financial statements, management's discussion and analysis, market risk disclosures, and controls and procedures for the reporting period [Condensed Consolidated Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) For the quarter ended March 31, 2025, the company reported a net loss of $2.6 million, an increase from the $2.1 million loss in the same period last year, with significant deterioration in financial health and a going concern warning [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, the company's financial position weakened significantly compared to December 31, 2024, with cash and cash equivalents decreasing by over 97% and total stockholders' equity collapsing to $33,134 Condensed Consolidated Balance Sheets (Unaudited) | | March 31, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | **Current Assets** | | | | Cash and cash equivalents | $30,210 | $1,174,608 | | Total current assets | $2,845,538 | $4,684,519 | | **Total Assets** | **$2,847,538** | **$4,686,519** | | **Current Liabilities** | | | | Total current liabilities | $2,814,404 | $2,007,483 | | **Total Stockholders' Equity (Deficit)** | **$33,134** | **$2,679,036** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended March 31, 2025, the company reported a net loss of $2.65 million, an increase from $2.03 million in the prior year, driven by a 136% surge in general and administrative expenses Condensed Consolidated Statements of Operations (Unaudited) | | For the Three Months Ended March 31, ($) | | :--- | :--- | :--- | | | **2025** | **2024** | | General and administrative | $2,494,532 | $1,057,364 | | Research and development | $33,167 | $364,385 | | **Loss from Operations** | **$(2,724,699)** | **$(1,421,749)** | | **Net Loss** | **$(2,646,172)** | **$(2,032,751)** | | Net loss attributable to Qualigen | $(2,646,172) | $(2,092,768) | | Total net loss per common share, basic and diluted | $(1.82) | $(17.60) | | Weighted-average number of shares outstanding | 1,456,714 | 118,876 | [Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20(Deficit)) During the first quarter of 2025, total stockholders' equity decreased from $2.68 million to just $33,134, primarily due to the $2.65 million net loss for the period Changes in Stockholders' Equity (Deficit) for Q1 2025 | | Amount ($) | | :--- | :--- | | Balance at December 31, 2024 | $2,679,036 | | Conversion of Series A-2 preferred shares | $0 | | Stock-based compensation | $269 | | Net loss | $(2,646,172) | | **Balance at March 31, 2025** | **$33,134** | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the three months ended March 31, 2025, net cash used in operating activities was $1.6 million, a significant increase from $0.8 million in the prior-year period, leading to a critically low cash balance of $30,210 Condensed Consolidated Statements of Cash Flows (Unaudited) | | For the Three Months Ended March 31, ($) | | :--- | :--- | :--- | | | **2025** | **2024** | | Net cash used in operating activities | $(1,589,396) | $(783,586) | | Net cash used in investing activities | $(305,000) | $0 | | Net cash provided by financing activities | $750,000 | $475,000 | | **Net change in cash and cash equivalents** | **$(1,144,396)** | **$(308,586)** | | Cash and cash equivalents - beginning of period | $1,174,608 | $401,803 | | **Cash and cash equivalents - end of period** | **$30,210** | **$93,217** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail significant events and accounting policies, including a going concern warning, the issuance of $0.8 million in short-term promissory notes, a lawsuit for $503,000 in unpaid fees, and subsequent borrowings of $2.5 million - The company's financial condition raises **substantial doubt about its ability to continue as a going concern** for the next year, with only **$30,000 in cash** and an accumulated deficit of **$125.7 million** as of March 31, 2025[51](index=51&type=chunk)[53](index=53&type=chunk) - In Q1 2025, the company issued **$0.8 million in short-term promissory notes**, which are unsecured and mature in six months, including a potential default penalty of **$0.3 million**[85](index=85&type=chunk) - On January 29, 2025, LifeSci Capital LLC filed a lawsuit against the company, claiming **$503,483 in unpaid fees**, which the company disputes and is defending[91](index=91&type=chunk) - Subsequent to March 31, 2025, the company borrowed an additional **$2.5 million** through short-term notes and convertible debt, and advanced another **$1.2 million** to Marizyme[149](index=149&type=chunk)[150](index=150&type=chunk)[151](index=151&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus as an early-clinical-stage therapeutics company with programs in adult and pediatric cancer, highlighting its weak financial position, recurring losses, and reliance on raising additional capital [Overview](index=33&type=section&id=Overview) Qualigen is an early-clinical-stage therapeutics company developing cancer treatments, including QN-302 and a Pan-RAS program, but has slowed development and implemented expense controls due to its financial situation - The company's lead program is **QN-302**, an investigational small molecule for cancers like pancreatic cancer[159](index=159&type=chunk) - The preclinical **Pan-RAS program** consists of small molecules designed to inhibit mutated RAS genes' proteins, potentially treating about a quarter of all cancers[160](index=160&type=chunk) - A co-development agreement with Marizyme entitles Qualigen to a **33% royalty on net sales of DuraGraft™**, capped at twice the funding provided by Qualigen[161](index=161&type=chunk) - The company slowed development of its therapeutic products beginning in Q2 2024 due to its financial situation and has implemented **dramatic expense controls**[162](index=162&type=chunk) [Results of Operations](index=36&type=section&id=Results%20of%20Operations) Comparing Q1 2025 to Q1 2024, general and administrative expenses increased by $1.4 million (135%) due to fundraising, while research and development expenses decreased by $0.3 million (90%) as activities were slowed Comparison of Operating Expenses (Q1 2025 vs Q1 2024) | Expense Category | Q1 2025 ($) | Q1 2024 ($) | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | General and administrative | $2,494,532 | $1,057,364 | +$1,437,168 | +135.9% | | Research and development | $33,167 | $364,385 | -$331,218 | -90.9% | | Credit loss expense | $197,000 | $0 | +$197,000 | N/A | | **Total Expenses** | **$2,724,699** | **$1,421,749** | **+$1,302,950** | **+91.6%** | [Liquidity and Capital Resources](index=39&type=section&id=Liquidity%20and%20Capital%20Resources) The company's financial position is weak, with only $30,000 in cash and a $125.7 million accumulated deficit, raising substantial doubt about its ability to continue as a going concern, necessitating additional capital raises - As of March 31, 2025, the company had approximately **$30,000 in cash**, an accumulated deficit of **$125.7 million**, and is in arrears on accounts payable[184](index=184&type=chunk) - The company borrowed a total of **$3,515,000** from nine investors as short-term borrowings between January and June 2025 and plans to close a private placement in July 2025[186](index=186&type=chunk) - The company received a delisting notice from Nasdaq for late filings but was granted a continued listing subject to meeting filing deadlines for its 2024 10-K and Q1 2025 10-Q[190](index=190&type=chunk) [Cash Flows](index=41&type=section&id=Cash%20Flows) In Q1 2025, cash used in operating activities doubled to $1.6 million, reflecting a higher net loss, while investing activities used $0.3 million and financing activities provided $0.8 million, resulting in a $1.1 million decrease in cash Summary of Cash Flows (Q1 2025 vs Q1 2024) | Activity | Q1 2025 ($) | Q1 2024 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,589,399) | $(783,586) | | Net cash used in investing activities | $(305,000) | $0 | | Net cash provided by financing activities | $750,000 | $475,000 | | **Net decrease in cash** | **$(1,144,399)** | **$(308,586)** | [Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is therefore not required to provide the information for this item - As a smaller reporting company, Qualigen is **not required to provide quantitative and qualitative disclosures about market risk**[208](index=208&type=chunk) [Controls and Procedures](index=42&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were not effective as of March 31, 2025, due to material weaknesses in internal control over financial reporting, with remediation contingent upon securing additional funding - Management concluded that **disclosure controls and procedures were not effective** as of March 31, 2025[210](index=210&type=chunk) - Material weaknesses were identified, including: **lack of sufficient personnel for segregation of duties**, ineffective IT General Controls over the financial accounting system, and lack of formalized process documentation[214](index=214&type=chunk) - The company stated that it lacks the resources to employ additional personnel to remediate these weaknesses and does not foresee remediation until it receives **additional funding**[215](index=215&type=chunk) [PART II. Other Information](index=44&type=section&id=PART%20II.%20Other%20Information) This section details legal proceedings, risk factors, equity sales, defaults, and other miscellaneous information and exhibits [Legal Proceedings](index=44&type=section&id=Item%201.%20Legal%20Proceedings) The company is currently a defendant in a lawsuit filed by LifeSci Capital LLC on January 29, 2025, for alleged unpaid fees of $503,483, which the company denies and is vigorously defending - The company was sued by LifeSci Capital LLC for an alleged failure to pay **$503,483 in fees**[220](index=220&type=chunk) - The company filed its answer denying the allegations on March 17, 2025, and as of May 29, 2025, the matter is in the **discovery phase**[221](index=221&type=chunk) [Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the company's risk factors since those disclosed in its 2024 Annual Report on Form 10-K - No material changes to the Company's risk factors have occurred since the **2024 Annual Report**[223](index=223&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=44&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities and no purchases of its equity securities during the reporting period - There were **no unregistered sales of equity securities** or issuer purchases of equity securities in the quarter[224](index=224&type=chunk)[225](index=225&type=chunk) [Defaults Upon Senior Securities](index=44&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon its senior securities - None reported[225](index=225&type=chunk) [Mine Safety Disclosures](index=44&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not Applicable[225](index=225&type=chunk) [Other Information](index=44&type=section&id=Item%205.%20Other%20Information) The company reported no information for this item - None reported[225](index=225&type=chunk) [Exhibits](index=45&type=section&id=Item%206.%20Exhibits) The report lists the exhibits filed, which include the required certifications by the Chief Executive Officer and Chief Financial Officer under the Sarbanes-Oxley Act, as well as the financial statements formatted in Inline XBRL - Exhibits filed with the report include **CEO and CFO certifications** and financial data in **Inline XBRL format**[226](index=226&type=chunk)

Core Insights - Qualigen Therapeutics, Inc. has announced the granting of a patent titled "Substituted Naphthalene Diimides and Their Use" for its drug QN-302, developed by Professor Stephen Neidle and his team at University College of London [1] - The patent covers the product and its manufacturing methods, with coverage extending to over 20 countries in Europe, as well as India, China, and Russia, expiring in 2040 [2] - CEO Kevin Richardson II emphasized that the extensive patent coverage strengthens the company's position in drug development, particularly for treating pancreatic and gastrointestinal cancer [2] Patent Coverage - The granted patents cover a significant portion of the European population, with over 20 countries included [2] - Similar patent protections have been secured in India, China, and Russia, enhancing the global reach of QN-302 [2] - The expiration of these patents is set for 2040, providing long-term protection for the product [2] Company Strategy - The company plans to provide periodic updates on new patents, indicating ongoing efforts in intellectual property management [2] - The strong patent coverage is expected to facilitate the market introduction of QN-302, aimed at treating patients with specific types of cancer [2]

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]