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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 For the quarterly period ended September 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) (Commission File Number) FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ...

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 ...

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, 2021 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 ...

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 ...

For the quarterly period ended March 31, 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. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact name of registrant as specified in its charter) Delaware 001-37428 26-3474527 (State or other juris ...