AS-1411

All cash deal with Chembio Diagnostics, a US Subsidiary of the French Diagnostics Company BIOSYNEX, SA, solidifies Qualigen’s strategic priority on therapeutics CARLSBAD, Calif., July 24, 2023 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a therapeutics company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, announces today that it has sold its FastPack® diagnostics business to Chembio Diagnostics, Inc., an American subsidiary of French diagnostics provider BIOSYNEX Group, a leader in the design and distribution of rapid tests. The all cash transaction, which closed on July 20, 2023, enables the Company to further streamline operations and enhance its focus with additional capital on its therapeutics pipeline, in particular QN-302, its small molecule G-Quadruplex (G4) selective transcription inhibitor, and its pre-clinical pan-RAS inhibitor platform. QN-302 has strong binding affinity to G4s prevalent in cancer cells and is being developed for the potential treatment of solid tumors including pancreatic cancer, for which it was granted Orphan Drug Designation in January. Michael Poirier, Qualigen's Chairman and CEO, commented, “We are proud of the legacy our FastPack® rapid immunodiagnostics system has established by providing patients and doctors with quality laboratory solutions for over two decades. However, as we have transitioned our focus to cancer therapeutics, it is appropriate that we re-align our priorities and resources. BIOSYNEX, with their proven track record in rapid diagnostics, has the expertise and resources to further expand FastPack’s footprint throughout the in vitro diagnostics (IVD) market worldwide. In the meantime, we now have the ability to strengthen our efforts towards advancing our cancer therapeutics portfolio and look forward to reporting further developments soon.” AboutQualigenTherapeutics,Inc. Qualigen Therapeutics, Inc. is a therapeutics company focused on developing treatments for adult and pediatric cancer. Our investigational QN-302 compound is a small molecule selective transcription inhibitor with strong binding affinity to G4s prevalent in cancer cells; such binding could, by stabilizing the G4s against “unwinding”, help inhibit cancer cell proliferation. The investigational compounds within Qualigen’s family of pan-RAS oncogene protein-protein interaction inhibitor small molecules are believed to inhibit or block the binding of mutated RAS genes’ proteins to their effector proteins, thereby leaving the proteins from the mutated RAS unable to cause further harm. In theory, such mechanism of action may be effective in the treatment of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers. Our investigational QN-247 compound inhibits nucleolin, a key multi-functional regulatory protein that is overexpressed in cancer cells; QN-247 may thereby be able to inhibit the cells’ proliferation. QN-247 has shown promise in preclinical studies for the treatment of acute myeloid leukemia (AML). About BIOSYNEX Founded in 2005, French laboratory BIOSYNEX is a leading healthcare diagnostics group, specializing in rapid tests, monitoring of biotherapy and molecular diagnostics. As a key player in the medicine of the future, promoting improved access to healthcare, BIOSYNEX offers innovative healthcare solutions to a large range of users, including laboratories, hospitals, doctors and the general public, to improve overall patient care. For the general public: the BIOSYNEX Pharma division, specialized in self-diagnostics and family health products. It markets a complete range of well established brands in the fields of prevention, diagnosis and natural care to a large network of pharmacies and parapharmacies in Europe. For professionals: the BIOSYNEX Diagnostic division, a technology based business positioned in growing sectors, develops and offers in vitro diagnostic medical devices such as rapid diagnostic tests (RDTs), molecular biology tests and point-of-care (POC) tests for screening, and diagnosis to laboratories, hospitals, doctors and nursing homes. Headquartered in Illkirch-Graffenstaden, Alsace, the BIOSYNEX Group employs over 500 people and has a presence in 95 countries. The Group generated sales of €196.6 million in 2022. Listed on Euronext Growth (FR0011005933 ALBIO), BIOSYNEX is eligible for the French PEA PM scheme. Forward-Looking Statements This news release contains forward-looking statements by Qualigen that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. These statements include those related to the Company's prospects and strategy for development of its therapeutic drug candidates. Actual events or results may differ from the Company's expectations. For example, there can be no assurance that the Company will be able to successfully develop any drugs (including QN-302, pan-RAS and QN-247); that preclinical development of the Company's drugs (including QN-302, pan-RAS and QN-247, and the deprioritized infectious-disease drug candidate QN-165) will be completed on any projected timeline or will be successful; that any clinical trials will be approved to begin by or will proceed as contemplated by any projected timeline, or at all; that any future clinical trial data will be favorable or that such trials will confirm any improvements over other products or lack negative impacts; that any drugs will receive required regulatory approvals (or Fast Track designation or Orphan Drug status) or that they will be commercially successful; that patents will issue on the Company's owned and in-licensed patent applications; that such patents, if any, and the Company's currently owned and in-licensed patents would prevent competition; or that the Company will be able to procure or earn sufficient working capital to complete the development, testing and launch of the Company's prospective therapeutic products (including QN-302, RAS and QN-247, and QN-165). The Company's stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fail to occur or is delayed or if any actual future event otherwise differs from expectations. Additional information concerning these and other risk factors affecting the Company's business can be found in the Company's prior filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K, all of which are available at . The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. For more information about Qualigen Therapeutics, Inc., please visit . Contact: Investor Relations 760-530-6487 ir@qualigeninc.com Source: Qualigen Therapeutics, Inc.

CARLSBAD, Calif., May 02, 2023 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN Qualigen Therapeutics, Inc.), a diversified life sciences company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, while also commercializing diagnostics, today announces financial results for the fourth quarter and fiscal year ended December 31, 2022, and provides an update on the company’s therapeutics pipeline and other corporate developments. Highlights For 2022 and to Date: Therapeutics Highlights: QN-302 Secured worldwide rights to G4-selective transcription inhibitors from University College London to develop as cancer therapeuticsEngaged QN-302 inventor, Professor Stephen Neidle as a consultantCommenced Investigational New Drug (IND) enabling studiesEngaged international contract development and manufacturing organization (CDMO) Hande Sciences to conduct manufacturing scale-up for IND-enabling studiesFormed World Class Scientific Advisory Board (SAB)Pre-IND application feedback received from FDA for potential treatment of advanced or metastatic solid tumorsFDA granted Orphan Drug Designation for the intended indication of pancreatic cancerInitiated GLP toxicology studiesComposition of Matter patent for QN-302 technology granted to University College London Business, as exclusively licensed to QualigenMultitude of Scientific Posters, Abstracts, and Publications: American Association for Cancer Research (AACR) Annual Meeting, April 2022 – 3 postersAmerican Association for Cancer Research (AACR) Special Conference, September 2022 – 2 postersPeer Reviewed Journal Publication – Molecules, March 2023 The Potent G-Quadruplex-Binding Compound QN-302 Downregulates S100P Gene Expression in Cells and in an In Vivo Model of Pancreatic Cancer American Association for Cancer Research (AACR) Annual Meeting, April 2023 – 4 posters RAS Extended research collaboration with University of Louisville Research FoundationScientific Posters, Abstracts, and Publications: American Society of Clinical Oncology (ASCO) Annual Meeting, June 2022 – 2 postersThe Fourth RAS Initiative Symposium, October 2022 – 2 postersAmerican Association for Cancer Research (AACR) Special Conference: Targeting RAS, March 2023 – 2 abstracts QN-247 In vivo readout demonstrated robust efficacy and no safety signal in triple negative breast cancer modelScientific Posters, Abstracts, Publications: American Association for Cancer Research (AACR) Annual Meeting, April 2023 – 1 poster Diagnostics Highlights: FastPack Resumed sales, marketing, and distribution rights to FastPack following expiration of distribution agreement with former partner SekisuiPromoted Benedict Abugan to Vice President to lead the FastPack business and Corporate Communications NanoSynex Completed the acquisition of a majority stake in NanoSynex Ltd., an Israeli-based developer of next generation diagnostics technology. NanoSynex development is on track to achieve milestones in 2023 Michael Poirier, Qualigen’s Chairman and CEO commented, “Throughout 2022 we made significant progress within therapeutics and diagnostics, achieving our development timeline objectives while also gaining substantial scientific traction with our cancer therapeutics programs amid a challenging macroenvironment. “Most importantly within therapeutics, we continue to advance the preclinical development of our lead therapeutics program, QN-302, our G-quadruplex (G4) transcription inhibitor for G4-targeted solid tumors, including pancreatic cancer. Following a pre-IND, type-C interaction with the FDA at our request, we expect to submit an Investigational New Drug (IND) application around mid-year with the goal of commencing clinical trials this year. We are confident that achievement of this milestone can be transformative, as it will mark the transition of Qualigen into a clinical stage cancer therapeutics company. Meanwhile, we are progressing our discovery-stage pan RAS-targeted platform. The RAS pathway continues to be of very high interest to the scientific community and pharmaceutical industry, and we are making progress in developing our RAS platform toward identification of a lead pan-RAS candidate. “Also in 2022, we successfully resumed full responsibility for sales and marketing of our legacy FastPack business. Meanwhile, NanoSynex continues to advance its product development. We are looking forward to their completion of key milestones toward regulatory filing and commercialization of their rapid, personalized antimicrobial susceptibility test (AST). “While we continue to feel the pressure from an uncertain economic environment, in January of this year we implemented austerity measures that we believe will wisely preserve cash, while maximizing the efficiency of our operations without sacrificing either key operational requirements or development priorities. In addition to a headcount reduction of 14% of our workforce, we have also de-prioritized resourcing our QN-247 program at this time and are seeking a partner to further the development of this promising asset. We continually assess new strategic opportunities for collaboration, monetization, or other ways to capitalize on our current assets. “We remain steadfast in our vision to transition Qualigen Therapeutics to a clinical stage cancer therapeutics company in the near term with our goal to bring QN-302 into Phase 1, and to continue to develop our pan RAS-targeted platform. In the meantime, our focus is on executing our strategic plan and advancing these encouraging oncology programs toward achieving key milestones. “Thus far in 2023, we have seen validation from the scientific community regarding our cancer therapeutic pipeline programs, and we look forward to reporting future developments that we believe are catalysts to add value to our stockholders,” concluded Mr. Poirier. Financial Highlights Revenues for the year ended December 31, 2022 were approximately $5.0 million compared to approximately $5.7 million for the previous year, a decrease of $0.7 million. This decrease was primarily due to the recognition of approximately $0.6 million in license revenue from Yi Xin under the Technology Transfer Agreement for the year ended December 31, 2021, compared with no license revenue for the year ended December 31, 2022. All revenues generated during the current year were from product sales of Fast Pack diagnostics and were approximately the same as the prior year. Gross profit on product sales also remained largely unchanged from the prior year. General and administrative expenses decreased to $10.8 million the year ended December 31, 2022, as compared to $11.7 million for the prior year, primarily due to a $0.3 million decrease in professional fees, a $0.3 million decrease in payroll-related expenses, a $0.3 million decrease in insurance expenses, and a $0.3 million decrease in investor relations expenses, offset by increases of $0.2 million in legal expenses and $0.1 million in rent. Sales and marketing expenses for the year ended December 31, 2022 increased to approximately $1.0 million as compared to $0.5 million for the prior year, primarily due to an increase in payroll-related expenses as a result of the termination of the Sekisui distribution agreement. Research and development costs include therapeutic and diagnostic research and product development costs. Research and development costs decreased from approximately $11.7 million for the year ended December 31, 2021 to approximately $6.8 million for the year ended December 31, 2022. Of the $6.8 million of research and development costs for year ended December 31, 2022, $4.5 million (66%) was attributable to therapeutics and $2.3 million (34%) was attributable to diagnostics. Of the $11.7 million of research and development costs for the year ended December 31, 2021, $10.3 million (88%) was attributable to therapeutics and $1.4 million (12%) was attributable to diagnostics. The increase in diagnostic research and development costs was primarily due to $0.9 million in R&D expenses assumed in connection with the acquisition of NanoSynex. The decrease in therapeutics research and development costs was primarily due to a decrease of $6.4 million in expenses related to the potential application of QN-165 for the treatment of COVID-19, as well as pre-clinical research and development cost decreases of $0.2 million for QN-247, a decrease in legal expenses of $0.3 million, a decrease of $0.3 million in payroll-related expenses, offset by an increase in QN-302 spending of $1.1 million and an increase in RAS expenses of $0.3 million. For the year ended December 31, 2022, the Company reported a net loss attributable to Qualigen Therapeutics, Inc. of approximately $18.6 million, or $4.85 per common share basic and diluted, compared to a net loss of approximately $17.9 million, or $6.10 per common share basic and diluted, for the corresponding period in 2021. Net cash used in operating activities was $13.2 million for the year ended December 31, 2022, as compared to $14.7 million for the corresponding period in 2021. As of December 31, 2022 the Company had approximately $7.0 million in cash. About Qualigen Therapeutics, Inc. Qualigen Therapeutics, Inc. is a diversified life sciences company focused on developing treatments for adult and pediatric cancer, as well as maintaining and expanding its core FDA-cleared FastPack® System, which has been used successfully in diagnostics for over 20 years. Our investigational QN-302 compound is a small molecule selective transcription inhibitor with strong binding affinity to G4s prevalent in cancer cells; such binding could, by stabilizing the G4s against “unwinding,” help inhibit cancer cell proliferation. The investigational compounds within our RAS family of RAS oncogene protein-protein interaction inhibitor small molecules are believed to inhibit or block the binding of mutated RAS genes’ proteins to their effector proteins, thereby leaving the proteins from the mutated RAS unable to cause further harm. In theory, such mechanism of action may be effective in the treatment of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers. Our investigational QN-247 compound inhibits nucleolin, a key multi-functional regulatory protein that is overexpressed in cancer cells; QN-247 may thereby be able to inhibit the cells’ proliferation. QN-247 has shown promise in preclinical studies for the treatment of acute myeloid leukemia (AML). In addition to our oncology drug pipeline, we have an established diagnostics business which manufactures and distributes proprietary and highly accurate rapid blood testing systems to physician offices and small hospitals for the management of prostate cancer and other diseases and health conditions. For more information about Qualigen Therapeutics, Inc., please visit www.qualigeninc.com. Forward-Looking Statements This news release contains forward-looking statements by Qualigen that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. These statements include those related to the Company's prospects and strategy for its diagnostics business and development of its therapeutic drug candidates. Actual events or results may differ from the Company's expectations. For example, there can be no assurance that the Company will be able to continue to maintain its diagnostic sales and marketing engine without interruption after resuming worldwide sales, marketing and distribution rights to FastPack from Sekisui Diagnostics, compete with others in this industry or expand market demand and/or market share for its diagnostics products, nor can there be any assurance that the Company will be able to bring the NanoSynex diagnostics technology to market or successfully develop any drugs (including QN-302, RAS and QN-247); that preclinical development of the Company's drugs (including QN-302, RAS and QN-247, and the deprioritized infectious-disease drug candidate QN-165) will be completed on any projected timeline or will be successful; that any clinical trials will be approved to begin by or will proceed as contemplated by any projected timeline, or at all; that any future clinical trial data will be favorable or that such trials will confirm any improvements over other products or lack negative impacts; that any drugs will receive required regulatory approvals (or Fast Track designation or Orphan Drug status) or that they will be commercially successful; that patents will issue on the Company's owned and in-licensed patent applications; that such patents, if any, and the Company's currently owned and in-licensed patents would prevent competition; or that the Company will be able to procure or earn sufficient working capital to complete the development, testing and launch of the Company's prospective therapeutic products (including QN-302, RAS and QN-247, and QN-165). The Company's stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fail to occur or is delayed or if any actual future event otherwise differs from expectations. Additional information concerning these and other risk factors affecting the Company's business can be found in the Company's prior filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K, all of which are available at www.sec.gov. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact: Jules AbrahamJQA Partners, Inc.917-885-7378jabraham@jqapartners.com Source: Qualigen Therapeutics, Inc. QUALIGEN THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS For the Years Ended December 31, 2022 2021 REVENUES Net product sales$4,983,556 $5,021,721 License revenue — 632,004 Total revenues 4,983,556 5,653,725 EXPENSES Cost of product sales 4,302,755 4,332,485 General and administrative 10,835,647 11,724,964 Research and development 6,837,133 11,716,718 Sales and marketing 950,420 542,594 Goodwill and fixed asset impairment 4,239,000 — Total expenses 27,164,955 28,316,761 LOSS FROM OPERATIONS (22,181,399) (22,663,036) OTHER EXPENSE (INCOME), NET Gain on change in fair value of warrant liabilities (907,203) (4,723,187)Interest (income) expense, net 26,646 (42,693)Other income, net (1,125) (5,446)Total other expense (income), net (881,682) (4,771,326) LOSS BEFORE (BENEFIT) PROVISION FOR INCOME TAXES (21,299,717) (17,891,710) (BENEFIT) PROVISION FOR INCOME TAXES (265,074) 5,427 NET LOSS (21,034,643) (17,897,137) Net loss attributable to noncontrolling interest (2,394,100) — Net loss attributable to Qualigen Therapeutics, Inc.$(18,640,543)$(17,897,137) Net loss per common share, basic and diluted$(4.85)$(6.10)Weighted—average number of shares outstanding, basic and diluted 3,840,340 2,933,487 Other comprehensive loss, net of tax Net loss$(21,034,643)$(17,897,137)Foreign currency translation adjustment 50,721 — Other comprehensive loss (20,983,922) (17,897,137)Comprehensive loss attributable to noncontrolling interest (2,394,100) — Comprehensive loss attributable to Qualigen Therapeutics, Inc.$(18,589,822)$(17,897,137) The accompanying notes are an integral part of these consolidated financial statements. QUALIGEN THERAPEUTICS, INC. CONSOLIDATED BALANCE SHEETS December 31, December 31, 2022 2021 ASSETS Current assets Cash$7,034,434 $17,538,272 Accounts receivable, net 538,587 822,351 Inventory, net 1,586,297 1,055,878 Prepaid expenses and other current assets 1,661,220 1,379,896 Total current assets 10,820,538 20,796,397 Restricted cash 5,690 — Right-of-use assets 1,422,538 1,645,568 Property and equipment, net 345,087 204,217 Intangible assets, net 5,845,702 171,190 Goodwill 625,602 — Other assets 18,334 18,334 Total Assets$19,083,491 $22,835,705 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable$857,311 $886,224 Accrued vacation 467,948 282,910 Accrued expenses and other current liabilities 1,511,856 1,510,990 R&D grant liability 780,682 — Deferred revenue, current portion 116,161 135,063 Operating lease liability, current portion 240,645 134,091 Short term debt - related party 950,722 — Warrant liabilities 788,100 1,686,200 Warrant liabilities - related party 2,834,547 — Convertible debt - related party 60,197 — Total current liabilities 8,608,169 4,635,479 Operating lease liability, net of current portion 1,301,919 1,542,564 Deferred revenue, net of current portion 49,056 92,928 Deferred tax liability 357,757 — Total liabilities 10,316,901 6,270,971 Commitments and Contingencies (Note 13) Stockholders’ equity Qualigen Therapeutics, Inc. stockholders' equity: Common stock, $0.001 par value; 225,000,000 shares authorized; 4,210,737 and 3,529,018 shares issued and outstanding as of December 31, 2022 and December 31, 2021, respectively 42,110 35,290 Additional paid-in capital 110,528,050 101,274,073 Accumulated other comprehensive income 50,721 — Accumulated deficit (103,385,172) (84,744,629)Total Qualigen Therapeutics, Inc. stockholders' equity 7,235,709 16,564,734 Noncontrolling interest 1,530,881 — Total Stockholders' Equity 8,766,590 16,564,734 Total Liabilities & Stockholders' Equity$19,083,491 $22,835,705 The accompanying notes are an integral part of these consolidated financial statements.