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 September 30, 2023 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) Delaware 001-37428 26-3474527 (State or other juris ...

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, 2023 (State or other jurisdiction of incorporation) (Commission File Number) (I.R.S. Employer Identification No.) 2042 Corte Del Nogal, Carlsbad, California 92011 (Address of principal executive offices) (Zip Code) Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT ...

Oncology and Diagnostics Development - The company is focused on developing treatments for adult and pediatric cancers and commercializing diagnostics [174]. - The lead oncology program, QN-302, is currently undergoing Good Laboratory Practice (GLP) toxicology studies [175]. - The company acquired a 52.8% interest in NanoSynex, a micro-biologics diagnostics company, through a transaction involving 2,232,861 shares of Series A-1 Preferred Stock [179]. - The FastPack System diagnostic instruments and test kits are the only commercially available products, primarily sold in the U.S. and certain European countries [181]. - The company has recognized 100% of the revenue from FastPack sales since the expiration of the distribution agreement with Sekisui on March 31, 2022 [182]. - The company entered into a License Agreement with UCL Business Limited for an exclusive worldwide in-license of a genomic quadruplex (G4)-selective transcription inhibitor drug development program, including lead and back-up compounds, preclinical data, and a patent estate [213]. Financial Performance - Net product sales increased by approximately $0.9 million, or 123%, to $1.6 million for the three months ended March 31, 2023, compared to $0.7 million for the same period in 2022 [191]. - Cost of product sales was $1.3 million, or 79% of net product sales, for the three months ended March 31, 2023, down from approximately $0.8 million, or 115% of net product sales, in the same period of 2022 [192]. - General and administrative expenses decreased from $2.9 million in Q1 2022 to $1.7 million in Q1 2023, primarily due to reductions in stock-based compensation and legal expenses [193]. - Research and development costs increased from $1.9 million in Q1 2022 to $2.1 million in Q1 2023, with 60% attributed to therapeutics and 40% to diagnostics [194]. - The company recognized a $1.1 million loss due to the voluntary conversion of convertible debt into common stock during the three months ended March 31, 2023 [201]. - As of March 31, 2023, the company had approximately $4.4 million in cash and an accumulated deficit of $107.2 million [203]. - The company expects to continue to have net losses and negative cash flow from operations, raising substantial doubt about its ability to continue as a going concern [203]. - The company experienced a $1.0 million gain in other income due to the change in fair value of warrant liabilities during the three months ended March 31, 2023 [198]. - Sales and marketing expenses increased to approximately $199,000 in Q1 2023 from approximately $138,000 in Q1 2022, primarily due to increased payroll expenses [197]. Funding and Investments - The company has committed to provide up to $10.4 million in future funding to NanoSynex based on the achievement of certain development milestones [206]. - The company funded NanoSynex approximately $2.4 million during the year ended December 31, 2022, and an additional $0.5 million for the three months ended March 31, 2023, under the Funding Agreement [223]. - The company issued an 8% Senior Convertible Debenture with an aggregate principal amount of $3,300,000 to Alpha Capital, convertible into common stock at a price of $1.32 per share [218]. - As of March 31, 2023, the remaining principal balance of the Debenture was approximately $2.2 million, with a remaining discount of approximately $1.6 million [219]. Cash Flow and Operating Activities - For the three months ended March 31, 2023, the company reported a net cash used in operating activities of $2.6 million, primarily due to a net loss of $4.1 million [227]. - The company experienced a net cash decrease of $2.7 million for the three months ended March 31, 2023, compared to a decrease of $3.9 million for the same period in 2022 [226]. - The company did not provide any cash from financing activities for the three months ended March 31, 2023, compared to approximately $4,000 in the same period in 2022 [230]. Internal Controls and Reporting - The company has identified a material weakness in internal control over financial reporting due to a lack of accounting department resources, which is being addressed through additional procedures and external consulting [234]. - The company believes that its condensed consolidated financial statements fairly represent its financial condition and results of operations despite the identified material weakness [235]. - As of March 31, 2023, the company's disclosure controls and procedures were not effective due to a material weakness identified [233]. - The internal control over financial reporting was assessed as ineffective as of December 31, 2022, due to a lack of accounting department resources and policies [234]. - The company is taking steps to remediate the identified material weakness by implementing additional procedures and utilizing external consulting resources [234]. - Despite the material weakness, the condensed consolidated financial statements fairly represent the company's financial condition in accordance with U.S. GAAP [235].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-37428 Qualigen Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 26-3474527 (State or other jurisdiction of incorporation or organization) (I.R.S ...

[Part I. Financial Information](index=3&type=section&id=PART%20I.%20Financial%20Information) [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) The company's financial statements reflect a reduced cash position, stable total assets due to an acquisition, and a narrowed net loss driven by lower R&D expenses [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights | Balance Sheet Item | September 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $6,618,141 | $17,538,272 | | Total current assets | $10,395,428 | $20,796,397 | | Intangible assets, net | $5,852,074 | $171,190 | | Goodwill | $4,896,223 | $0 | | **Total Assets** | **$22,958,832** | **$22,835,705** | | **Liabilities & Equity** | | | | Total current liabilities | $4,881,243 | $4,635,479 | | Total liabilities | $7,043,223 | $6,270,971 | | Total Stockholders' Equity | $15,915,609 | $16,564,734 | | **Total Liabilities & Stockholders' Equity** | **$22,958,832** | **$22,835,705** | - The acquisition of NanoSynex in May 2022 significantly impacted the balance sheet, adding **$4.9 million in Goodwill** and increasing Intangible Assets to **$5.9 million**[8](index=8&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Statement of Operations Summary (Three Months Ended Sep 30) | Metric | 2022 | 2021 | | :--- | :--- | :--- | | Total revenues | $1,441,065 | $1,155,065 | | Total expenses | $5,824,011 | $5,962,975 | | Loss from operations | ($4,382,946) | ($4,807,910) | | Net loss attributable to Qualigen | ($3,825,109) | ($3,037,482) | | Net loss per share | ($0.10) | ($0.10) | Statement of Operations Summary (Nine Months Ended Sep 30) | Metric | 2022 | 2021 | | :--- | :--- | :--- | | Total revenues | $3,593,628 | $4,172,496 | | Research and development | $5,059,067 | $10,091,155 | | Total expenses | $17,126,538 | $22,188,087 | | Loss from operations | ($13,532,910) | ($18,015,591) | | Net loss attributable to Qualigen | ($12,268,300) | ($13,678,278) | | Net loss per share | ($0.33) | ($0.48) | - Research and development expenses for the nine months ended Sep 30, 2022, were nearly halved to **$5.1 million** from $10.1 million in the prior-year period, significantly reducing the operating loss[10](index=10&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary (Nine Months Ended Sep 30) | Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($11,009,814) | ($11,817,410) | | Net cash provided by (used in) investing activities | $60,611 | ($124,356) | | Net cash provided by financing activities | $7,173 | $285,005 | | **Net change in cash and restricted cash** | **($10,942,030)** | **($11,656,761)** | - Cash and restricted cash decreased by **$10.9 million** during the first nine months of 2022, ending the period at **$6.6 million**[14](index=14&type=chunk)[15](index=15&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the NanoSynex acquisition, raise substantial doubt about the company's ability to continue as a going concern, and outline funding commitments - On May 26, 2022, the Company acquired a **52.8% controlling interest** in NanoSynex, Ltd, a micro-biologics diagnostics company based in Israel[19](index=19&type=chunk) - The company's cash of approximately **$6.6 million** and accumulated deficit of **$97.0 million** as of September 30, 2022, raise substantial doubt about its ability to continue as a going concern[77](index=77&type=chunk) - The company is committed to providing NanoSynex with up to **$10.4 million** in future funding, contingent on NanoSynex achieving certain development milestones[80](index=80&type=chunk)[86](index=86&type=chunk) - The fair value of warrant liabilities decreased from **$1.69 million** at the end of 2021 to **$0.67 million** as of September 30, 2022, resulting in a non-cash gain of **$1.02 million**[99](index=99&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses increased product sales, reduced R&D expenses, and reiterates substantial doubt about the company's ability to continue as a going concern [Results of Operations](index=42&type=section&id=Results%20of%20Operations) Q3 net product sales rose 25% while nine-month R&D expenses fell significantly, leading to an improved net loss for the period - Q3 2022 net product sales increased by **25% to $1.4 million** from $1.2 million in Q3 2021, mainly because the company now recognizes 100% of revenue from direct sales after the Sekisui distribution agreement expired on March 31, 2022[181](index=181&type=chunk) - For the nine months ended Sep 30, 2022, R&D costs decreased significantly to **$5.1 million** from $10.1 million in the prior year, primarily due to a **$6.5 million decrease** in pre-clinical research costs for the deprioritized QN-165 COVID-19 program[202](index=202&type=chunk)[203](index=203&type=chunk) - The gain on change in fair value of warrant liabilities was **$1.0 million** for the nine months ended Sep 30, 2022, compared to a **$4.3 million gain** in the same period of 2021, with the change primarily driven by declines in the company's stock price[207](index=207&type=chunk) [Liquidity and Capital Resources](index=48&type=section&id=Liquidity%20and%20Capital%20Resources) The company's cash of $6.6 million is only sufficient to fund operations into Q3 2023, necessitating significant additional financing - The company's cash balance of **$6.6 million** as of September 30, 2022, is expected to fund operations only into the **third quarter of 2023**, raising substantial doubt about its ability to continue as a going concern[213](index=213&type=chunk) - Significant additional financing is required for planned R&D, clinical trials for QN-302, and to fund NanoSynex operations, which includes a commitment of up to **$10.4 million** based on milestones[214](index=214&type=chunk)[216](index=216&type=chunk) - Net cash used in operating activities was **$11.0 million** for the first nine months of 2022, a slight improvement from **$11.8 million** in the same period of 2021[230](index=230&type=chunk)[231](index=231&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is not required to provide market risk disclosures as it is a "smaller reporting company" - The company is not required to provide information on market risk as it qualifies as a **"smaller reporting company"**[242](index=242&type=chunk) [Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective but is remediating a previously identified material weakness in internal control over financial reporting - Management concluded that disclosure controls and procedures were **effective** as of September 30, 2022[244](index=244&type=chunk) - The company is working to remediate a **material weakness** in internal control over financial reporting identified as of December 31, 2021, which was related to a lack of accounting department resources and procedures[246](index=246&type=chunk) [Part II. Other Information](index=43&type=section&id=PART%20II.%20Other%20Information) [Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) A lawsuit with Mediant Communications Inc was settled and paid for $96,558 in April 2022 - A lawsuit with Mediant Communications Inc was settled on April 5, 2022, for an amount of **$96,558**, which has been paid[109](index=109&type=chunk) [Risk Factors](index=43&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors are reported, except for new risks associated with the acquisition of NanoSynex, Ltd - New risks have been introduced related to the **acquisition of NanoSynex, Ltd**[252](index=252&type=chunk)[253](index=253&type=chunk) - Risks include potential failure to achieve intended benefits from the acquisition, difficulties in assimilating employees, diversion of management attention, and **assumption of unforeseen liabilities**[253](index=253&type=chunk)[256](index=256&type=chunk) - The company is obligated to fund NanoSynex up to approximately **$10.4 million** over three years, subject to milestones, which will reduce liquidity and may not be achievable if the company cannot raise sufficient capital[254](index=254&type=chunk)[255](index=255&type=chunk) - A significant portion of NanoSynex's assets are recorded as **goodwill ($4.9 million)** and other intangibles (**$5.7 million**), which are subject to impairment tests and potential write-offs that could adversely affect financial results[258](index=258&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) No unregistered sales or purchases of equity securities were reported during the period - None reported for the period[259](index=259&type=chunk) [Exhibits](index=45&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the report, including required officer certifications

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, 2022 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 ...

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, 2022 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) (Commiss ...

[Part I](index=3&type=section&id=Part%20I) [Item 1. Business](index=3&type=section&id=Item%201.%20Business) Qualigen Therapeutics develops cancer therapeutics and commercializes diagnostic systems, transitioning to direct FastPack sales - The company is a **diversified life sciences entity** focused on developing cancer treatments and commercializing diagnostics[18](index=18&type=chunk) - The therapeutics pipeline includes **QN-302** (G4 selective transcription inhibitor), **QN-247** (DNA coated gold nanoparticle), and **RAS-F** (RAS oncogene protein-protein interaction inhibitor)[18](index=18&type=chunk) - The **FastPack System** is the company's commercial diagnostic product line, sold in the U.S. and Europe. The distribution agreement with Sekisui Diagnostics is set to expire on **March 31, 2022**, after which Qualigen will **manage distribution directly**[20](index=20&type=chunk) Fiscal Year 2021 Revenue Breakdown | Customer | Percentage of Total Revenue | | :--- | :--- | | Sekisui | 62% | | Low T | 22% | [Product Candidates](index=5&type=section&id=Product%20Candidates) Qualigen's pipeline includes oncology candidates QN-302, QN-247, RAS-F, and the STARS device, with QN-165 deprioritized - **QN-302**: A G4 selective transcription inhibitor in-licensed from University College London, targeting cancers with high G4 prevalence, such as pancreatic ductal adenocarcinoma (PDAC). The company plans to seek **Orphan Drug status**[26](index=26&type=chunk)[27](index=27&type=chunk)[31](index=31&type=chunk) - **QN-247**: An aptamer-based drug candidate targeting nucleolin, overexpressed in cancer cells. Preclinical studies show promise for AML and potential to enhance radiation therapy. The company also plans to seek **Orphan Drug status** for indications like pancreatic cancer and AML[32](index=32&type=chunk)[34](index=34&type=chunk)[36](index=36&type=chunk) - **RAS-F**: A family of small molecule inhibitors targeting RAS oncogene protein-protein interactions, licensed from the University of Louisville, to treat RAS-driven cancers[38](index=38&type=chunk) - **STARS™**: A therapeutic device concept for removing tumor cells and viruses from blood. A U.S. patent has been issued, and the company is seeking strategic partners[42](index=42&type=chunk)[43](index=43&type=chunk) - **QN-165**: This program for treating COVID-19 has been **deprioritized** after the FDA required additional preclinical studies for its IND application. The company's strategic focus has shifted to oncology[46](index=46&type=chunk) [Strategic Partners and Sales Channels](index=8&type=section&id=Strategic%20Partners%20and%20Sales%20Channels) Qualigen partners with UCL and UofL for therapeutics, assuming direct FastPack distribution post-Sekisui agreement expiration - Key therapeutic partners include **University College London (UCL)** for QN-302 and the **University of Louisville (UofL)** for QN-247 and RAS-F[50](index=50&type=chunk)[51](index=51&type=chunk) - The primary diagnostics distribution agreement with Sekisui expires on **March 31, 2022**, after which Qualigen will take over distribution and recognize **100% of revenue** from FastPack sales[52](index=52&type=chunk)[55](index=55&type=chunk) - An agreement with Yi Xin grants exclusive rights to manufacture and sell FastPack-based products in China, with rights to expand to other global markets under specific conditions after May 2022[57](index=57&type=chunk) [Regulatory Matters](index=9&type=section&id=Regulatory%20Matters) Products face extensive FDA and international regulation, requiring device clearances and multi-phase drug clinical trials - Diagnostic products have obtained **17 FDA clearances/approvals** and **28 CE Marks** to date. No drug candidates have received regulatory approval[62](index=62&type=chunk) - In the U.S., medical devices require either **510(k) premarket notification clearance** for lower-risk devices or a more stringent **Premarket Approval (PMA)** for higher-risk (Class III) devices[64](index=64&type=chunk)[66](index=66&type=chunk) - In the EU, the company must comply with the new **Medical Device Regulation (MDR)**, which has stricter requirements for clinical evidence, labeling, and post-market reporting[68](index=68&type=chunk) - The U.S. drug approval process requires preclinical testing, an effective IND application, and successful completion of **Phase 1, 2, and 3 clinical trials** before submitting a New Drug Application (NDA) to the FDA[74](index=74&type=chunk)[78](index=78&type=chunk) [Intellectual Property](index=12&type=section&id=Intellectual%20Property) The company holds 147 patents and applications for its FastPack, STARS, and in-licensed therapeutic programs - The company holds a total of **147 issued, allowed, or pending patents and applications**, plus **35 trademark registrations or applications**[83](index=83&type=chunk) - The therapeutics patent portfolio includes **43 issued and 11 pending patents** for the QN-247 program (expiring 2032-2038), **15 pending** for the RAS program, and **11 (2 issued)** for the QN-302 program (expiring 2030-2033), all of which are in-licensed[86](index=86&type=chunk) [Item 1A. Risk Factors](index=13&type=section&id=Item%201A.%20Risk%20Factors) Significant risks stem from high-risk therapeutics development, intense diagnostics competition, and internal control weaknesses [Risks Related to Our Therapeutics and Diagnostics Pipeline](index=14&type=section&id=Risks%20Related%20to%20Our%20Therapeutics%20and%20Diagnostics%20Pipeline) Therapeutics development is high-risk, requiring capital, facing uncertain approval, third-party reliance, and competition - The company's focus on developing therapeutic product candidates is a **high-risk strategy** with no guarantee of commercial, legal, operational, scientific, or financial success[94](index=94&type=chunk) - The company does not have enough working capital to fully execute its strategic plan and will need to raise **additional capital**, which may not be available on desirable terms and could lead to stockholder dilution[95](index=95&type=chunk)[96](index=96&type=chunk) - Drug and device development is a lengthy, expensive, and uncertain process. Most drug candidates fail, and there is **no guarantee of regulatory approval** for QN-302, QN-247, RAS-F, or STARS[100](index=100&type=chunk) - The company relies on third parties like UofL and CROs to conduct preclinical studies and clinical trials, and on contract manufacturers for production. Failure by these third parties to perform could significantly delay or impair development efforts[128](index=128&type=chunk)[132](index=132&type=chunk) [Risks Related to Our Diagnostics Business](index=23&type=section&id=Risks%20Related%20to%20Our%20Diagnostics%20Business) Diagnostics faces post-Sekisui transition, intense competition, and declining reimbursement rates - The company may face logistical and relationship challenges during the transition period after its distribution agreement with Sekisui expires on **March 31, 2022**[153](index=153&type=chunk)[154](index=154&type=chunk) - The FastPack system faces **heavy competition** from both large central lab systems and newer point-of-care technologies from competitors with greater resources[155](index=155&type=chunk) - Reduced Medicare and private insurer reimbursement for diagnostic tests constrains pricing and negatively impacts the diagnostics business[156](index=156&type=chunk) [Other Business Risks](index=24&type=section&id=Other%20Business%20Risks) Risks include key personnel dependence, IT failures, COVID-19 impacts, and a material weakness in internal financial controls - The company is highly dependent on its **key executive team** and its ability to attract and retain qualified personnel[159](index=159&type=chunk) - The COVID-19 pandemic significantly reduced diagnostic product sales in **2020** due to deferral of non-emergency physician visits, and future outbreaks could have similar adverse impacts[170](index=170&type=chunk)[171](index=171&type=chunk) - A **material weakness in internal controls over financial reporting** was identified in the 2021 audit, which could adversely affect the accuracy of financial reporting and investor confidence[177](index=177&type=chunk) [Item 2. Properties](index=27&type=section&id=Item%202.%20Properties) The company leases a 23,000 square foot facility in Carlsbad, California, serving as its headquarters for all operations - The company leases a **23,000 square foot facility** in Carlsbad, California for all its operations[181](index=181&type=chunk) [Item 3. Legal Proceedings](index=27&type=section&id=Item%203.%20Legal%20Proceedings) The company is in settlement negotiations after its Motion to Dismiss was granted in a lawsuit by Mediant Communications Inc - On **November 9, 2021**, Mediant Communications Inc. filed a lawsuit against the company over an alleged implied contract. The company's Motion to Dismiss was granted on **March 14, 2022**, and settlement negotiations are ongoing[346](index=346&type=chunk) [Part II](index=27&type=section&id=Part%20II) [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=27&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq under QLGN, with 692 holders and a recent warrant issuance to a consultant - Common stock is listed on the **Nasdaq Capital Market** under the symbol "**QLGN**"[184](index=184&type=chunk) - As of **March 25, 2022**, there were **692 registered holders of record** of the company's common stock[185](index=185&type=chunk) - On **December 3, 2021**, the company issued a warrant to a consultant to purchase **600,000 shares** of common stock at **$1.32 per share**, exempt from registration under Section 4(a)(2) of the Securities Act[186](index=186&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) FY2021 revenue grew to $5.7 million, but a $17.9 million net loss resulted from higher R&D and G&A [Results of Operations](index=31&type=section&id=Results%20of%20Operations) FY2021 revenues increased to $5.7 million, but operating loss widened to $22.7 million due to higher R&D and G&A Comparison of Operations (FY 2021 vs. 2020 Transition Period) | Metric | Year Ended Dec 31, 2021 (12 months) | Nine Months Ended Dec 31, 2020 (9 months) | | :--- | :--- | :--- | | **Total Revenues** | **$5,653,725** | **$2,849,561** | | Net product sales | $5,021,721 | $2,849,561 | | License revenue | $632,004 | $0 | | **Total Expenses** | **$28,316,761** | **$14,745,487** | | Cost of product sales | $4,332,485 | $2,640,148 | | General and administrative | $11,724,964 | $7,105,337 | | Research and development | $11,716,718 | $3,316,099 | | **Loss from Operations** | **($22,663,036)** | **($11,895,926)** | | (Gain) loss on warrant liabilities | ($4,723,187) | $8,310,100 | | **Net Loss** | **($17,897,137)** | **($19,546,366)** | - Research and development costs increased sharply to **$11.7 million** in Fiscal 2021, with **88% ($10.4 million)** attributable to therapeutics, up from **$3.3 million** in the 2020 transition period[220](index=220&type=chunk) - The significant swing in 'Other Expense (Income)' was driven by the change in fair value of warrant liabilities, resulting in a **$4.7 million gain** in 2021 versus an **$8.3 million loss** in the 2020 transition period, primarily due to stock price fluctuations[226](index=226&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) The company had $17.5 million cash at year-end, sufficient for 12 months, but needs additional financing for clinical development - The company had **$17.5 million** in cash as of December 31, 2021, which is believed to be sufficient to fund operations for the subsequent **12-month period**[231](index=231&type=chunk) - Significant additional financing will be required to fully execute the business plan, particularly for clinical trials of therapeutic drug candidates[232](index=232&type=chunk) Cash Flow Summary (FY 2021 vs. 2020 Transition Period) | Cash Flow Activity | Year Ended Dec 31, 2021 | Nine Months Ended Dec 31, 2020 | | :--- | :--- | :--- | | Net cash used in Operating activities | ($14,730,742) | ($10,162,935) | | Net cash used in Investing activities | ($141,364) | ($65,094) | | Net cash provided by Financing activities | $8,433,808 | $34,051,478 | [Item 8. Consolidated Financial Statements and Supplementary Data](index=34&type=section&id=Item%208.%20Consolidated%20Financial%20Statements%20and%20Supplementary%20Data) Audited FY2021 financials show a $17.9 million net loss; warrant liability valuation is a Critical Audit Matter - The independent auditor identified the valuation of warrant liabilities as a **Critical Audit Matter**, noting the process was especially challenging due to the significant assumptions and management judgment required for the Monte Carlo simulation model[254](index=254&type=chunk)[255](index=255&type=chunk) Consolidated Balance Sheet Summary | Account | Dec 31, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | **Total Assets** | **$22,835,705** | **$29,126,772** | | Cash | $17,538,272 | $23,976,570 | | **Total Liabilities** | **$6,270,971** | **$10,832,212** | | Warrant liabilities | $1,686,200 | $8,310,100 | | **Total Stockholders' Equity** | **$16,564,734** | **$18,294,560** | - Subsequent to year-end, the company in-licensed the **QN-302 drug program** from UCL, received a Nasdaq notice for failing to meet the **$1.00 minimum bid price requirement**, and extended its RAS inhibitor research agreement with ULRF[405](index=405&type=chunk)[406](index=406&type=chunk)[410](index=410&type=chunk) - An error was identified in previously issued 2021 interim financial statements related to the accounting for exercised liability-classified warrants, resulting in a **$1.9 million overstatement** of the gain on change in fair value of warrant liabilities. This error was corrected in the annual report[403](index=403&type=chunk) [Item 9A. Controls and Procedures](index=64&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded disclosure controls were ineffective due to a material weakness in internal control over financial reporting - Management concluded that as of **December 31, 2021**, the company's disclosure controls and procedures were **not effective**[413](index=413&type=chunk) - A **material weakness** was identified in internal control over financial reporting related to a lack of accounting department resources and/or procedures to ensure proper recording and disclosure of complex items, such as warrant valuations, in compliance with U.S. GAAP[416](index=416&type=chunk) - Remediation efforts include utilizing external consulting resources with expertise in U.S. GAAP and public company reporting to assist with complex and non-recurring transactions[417](index=417&type=chunk)[418](index=418&type=chunk) [Part III](index=65&type=section&id=Part%20III) [Items 10-14](index=65&type=section&id=Items%2010-14) Information for Items 10-14 is incorporated by reference from the 2022 Proxy Statement - Information for Items 10 (Directors, Executive Officers and Corporate Governance), 11 (Executive Compensation), 12 (Security Ownership), 13 (Certain Relationships and Related Transactions), and 14 (Principal Accounting Fees and Services) is incorporated by reference from the company's definitive Proxy Statement for the 2022 Annual Meeting of Stockholders[425](index=425&type=chunk)[426](index=426&type=chunk)[427](index=427&type=chunk) [Part IV](index=66&type=section&id=Part%20IV) [Item 15. Exhibits and Financial Statement Schedules](index=66&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section provides a comprehensive index of financial statements, schedules, and exhibits - This section contains the list of financial statements filed with the report and a detailed index of all exhibits[431](index=431&type=chunk)[432](index=432&type=chunk)

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 September 30, 2021 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) (Com ...

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, 2021 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) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Securities registered pursuant to Section 12(b) of the A ...