S100P

Initiated dosing of three patients in first cohort of Phase 1 clinical trial of QN-302 for treatment of advanced or metastatic solid tumorsPhase 1a patient recruitment ongoing; company anticipates sharing update on safety and preliminary efficacy in second quarter of 2024Expect to select lead Pan-RAS inhibitor candidate for IND enabling studies in first quarter of 2024 CARLSBAD, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, today provides a corporate update for the third quarter ending September 30, 2023 and to date: Highlights: QN-302 Announced first cohort of three patients initially dosed in the Phase 1 clinical trial of QN-302 for treatment of advanced or metastatic solid tumorsPresented scientific data on QN-302 at AACR Special Conference: Pancreatic Cancer, in October 2023: “The Pan G-Quadruplex experimental drug QN-302 in PDAC: identification of potential biomarkers for clinical studies” by Ahmed Ahmed, Tariq Arshad, and Stephen Neidle. Studies showed that increased expression of S100P and CX3CL1 correlated with human pancreatic ductal adenocarcinoma (PDAC) disease progression – both gene targets previously proposed as potential biomarkers (Poster). “Target genes in pancreatic cancer cells of the Pan G-Quadruplex clinical candidate compound QN-302 revealed by comparative transcriptome profiling” by Ahmed Ahmed, Tariq Arshad, Maria Roman-Escorza, Dan Neidle, and Stephen Neidle. Studies showed that administering QN-302 to PDAC cells produced significant changes in the pattern of down-regulated G-quadruplex (G4) genes (Poster). Partnered with TD2 for Phase 1 clinical development of QN-302 for the treatment of advanced or metastatic solid tumors. Pan-RAS Presented poster highlighting Qualigen Therapeutics’ Pan-RAS inhibitor platform at AACR Special Conference: Advances in Breast Cancer, in Oct 2023: “Pan-RAS Inhibitors to Treat Luminal B Breast Cancer” by Geoff Clark, Raphael N. Jigo, Howard Donninger. Our RAS inhibitors suppressed the interaction of RAS with its downstream mitogenic effectors and suppressed RAS signaling pathways (MAPK and RAL pathways) in Luminal B breast cell model systems (Poster). Dear Shareholders: In the third quarter to date this year, we completed our transition from a diversified life science company to a streamlined clinical stage therapeutics company focused on execution and judicious capital deployment toward our differentiated oncology pipeline for the benefit of patients worldwide. In July we announced the divestiture of our FastPack® diagnostics business for approximately $5 million in an all-cash transaction to support advancement of our therapeutics pipeline. Our team and collaborators have worked diligently to advance our QN-302 program on time and within budget. We are excited to announce the initiation of dosing of not only our first patient, but of our first cohort of three patients in the Phase 1a dose escalation portion of our clinical trial of QN-302, an investigational G4-selective transcription inhibitor. This follows the announcement of QN-302 receiving US FDA Investigational New Drug (IND) clearance to initiate the clinical trial in July and the announcement of first patient dosed last week. Our Pan-RAS inhibitor platform continues to present compelling in vivo data in multiple cancer models as we make progress toward identifying a lead candidate for IND-enabling studies under our sponsored research collaboration with the University of Louisville, Kentucky. About Our Phase 1 Clinical Trial for QN-302 As stated above, our focus in 2023 has been the swift execution of business priorities. We initiated IND-enabling studies for QN-302 in January 2022, when the technology package was exclusively in-licensed from the University College London, having been discovered and developed by Dr. Stephen Neidle’s group at the School of Pharmacy. We enlisted our CRO, TD2, and within 18 months of initiating IND-enabling studies we received IND clearance to initiate Phase 1 clinical trials by the US FDA. In January 2023 we obtained Orphan Drug Designation for the potential treatment of pancreatic cancer. Details of our Phase 1 study are as follows: Title: A Phase I, Multicenter, Open-label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacodynamics, and Pharmacokinetics of Intravenous QN-302 in Patients With Advanced or Metastatic Solid Tumors Pending the Company’s ability to secure additional capital, up to 36 patients will be enrolled in the dose escalation (Phase 1a) portion of the study. The exact number of patients to be enrolled will depend on the observed safety profile. The dose expansion (Phase 1b) cohort may enroll up to an additional 20 patients with advanced, metastatic solid tumors. The expansion cohort will further evaluate safety and assess for antitumor effect of QN-302. The primary objectives of this Phase 1a study are: To determine the MTD and the dose-limiting toxicities (DLTs) of QN-302 monotherapy in patients with advanced or metastatic solid tumors that have not responded to or have recurred following treatment with available therapies.To establish the dose of QN-302 recommended for future studies (the Recommended Phase 2 Dose [RP2D]). The secondary objectives of the Phase 1a study are: To determine the pharmacokinetics of QN-302.Explore the pharmacodynamic effects of QN-302 on selected tumor biomarkers.To observe patients for any evidence of antitumor activity of QN-302 by objective radiographic assessment. About Our Pan-RAS Inhibitor Platform We continue to build our data package for our lead optimization stage Pan-RAS inhibitor platform. Along with our team at the University of Louisville, we presented a poster in June at the American Society of Clinical Oncology’s (ASCO) 2023 Annual Meeting highlighting the ability of our pre-lead compounds to potentially overcome emerging resistance and limited clinical durability of commercially approved KRAS G12C inhibitors. This is an exciting development that we are actively exploring under our sponsored research agreement. More recently, in September our collaborator Dr. Geoff Clark presented at the American Association of Cancer Research: Advances in Breast Cancer Special Meeting describing data supporting how new pre-lead Pan-RAS candidates suppressed RAS signaling pathways (MAPK and RAL pathways) via anti-tumor activity in a breast cancer vivo model. We believe RAS continues to be a promising target. RAS is the most common cancer oncogene and activating mutations occur in one of the three human RAS gene isoforms (KRAS, HRAS, or NRAS) are present in about one-fourth of all cancers. In fact, mutant KRAS is found in 98% of pancreatic ductal adenocarcinomas, 52% of colon cancers, and 32% of lung adenocarcinomas. We believe a Pan-RAS inhibitor can complement other therapeutic approaches in development and are looking to advance potential partnerships for this compelling platform. Our goal is to select a lead compound for IND-enabling studies in the first quarter of 2024 and to present new data at major conferences throughout the year. We are proud of what our team and collaborators have accomplished in the third quarter this year and beyond. For the remainder of the fourth quarter and into 2024 our plan is to continue to execute and deploy capital judiciously on what we believe will be the highest return on investment activities without sacrificing quality, and most importantly, activities for patients who are relying on new therapeutic treatment options. We are encouraged by the feedback we have received at our two active clinical trial sites and welcome potentially adding additional sites next year. We plan to share updates with our QN-302 program and Pan-RAS inhibitor platform in Q1 next year, as well as provide an update on safety and preliminary efficacy for our Phase 1a study for QN-302 in the first half of 2024. Thank you again for your support. Sincerely,Michael S. Poirier, CEO, Chairman of the Board, and Founder About Qualigen Therapeutics, Inc. Qualigen Therapeutics, Inc. is a clinical-stage 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. 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, including the anticipated timeline for the Company’s Phase 1 clinical trial and enrolling and dosing of patients (including possibly those with solid tumors), the sharing of initial data, the ability of the Company to raise additional capital, and the timing of selection of a lead compound for IND-enabling studies of Pan-RAS. Actual events or results may differ materially from the Company's expectations. 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 Pan-RAS and QN-247) 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 preclinical study results the Company observed in animals will be borne out in human patients; 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 additional sufficient working capital to complete the development, testing and launch of the Company's prospective therapeutic products (including QN-302, Pan-RAS and QN-247). 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. For more information about Qualigen Therapeutics, Inc., please visit www.qlgntx.com. Contact:Investor Relationsir@qlgntx.com.Source: Qualigen Therapeutics, Inc.

Two posters include data on potential clinical biomarkers and transcriptomic data associated with QN-302’s mechanism of action CARLSBAD, Calif., Sept. 27, 2023 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, today announces the presentation of two posters on the Company’s lead compound, QN-302, at the ninth American Academy of Cancer Research (AACR) Special Conference on Pancreatic Cancer, held September 27th to 30th at the Westin Copley Place in Boston. “The data from these two posters demonstrate information that is instrumental in understanding the importance of QN-302, a G-Quadruplex (G4) targeted transcription inhibitor and its potential pro Pancreatic Cancer,” commented Tariq Arshad, M.D., M.B.A., Qualigen’s Chief Medical Officer. “The inclusion of these data at the AACR Pancreatic Cancer Research meeting provides further elucidation of our therapeutic approach in treating this devastating disease. We are delighted that QN-302's Investigational New Drug application was cleared by FDA and QN-302 is on track to enter the clinic this year.” Highlights of the posters include: Poster A081: “The Pan G-Quadruplex experimental drug QN-302 in PDAC: identification of potential biomarkers for clinical studies” by Ahmed Ahmed, Tariq Arshad, and Stephen Neidle. Studies showed that increased expression of S100P and CX3CL1 correlated with human pancreatic ductal adenocarcinoma (PDAC) disease progression – both gene targets previously proposed as potential biomarkers. Figure 1a and 1b: Western blot and RT-PCR studies on tumor material in a MIA-PACA2 xenograft mouse model at the end of 28-day dosing, with dosing 1 mg/kg BW (Twice Weekly) or QW (Once Weekly): Figure 1A Figure 1B Poster A080:“Target genes in pancreatic cancer cells of the Pan G-Quadruplex clinical candidate compound QN-302 revealed by comparative transcriptome profiling” by Ahmed Ahmed, Tariq Arshad, Maria Roman-Escorza, Dan Neidle, and Stephen Neidle. Studies showed that administering QN-302 to PDAC cells produced significant changes in the pattern of down-regulated G-quadruplex (G4) genes. Table 1: QN-302 and related chemical analogs CM03 and SOP1247 showed nanomolar potency in various cell lines, including gemcitabine-resistant MIA-PACA2 and PANC-1 cell lines, as well as significant G4 stability evident by low nanomolar binding affinity [ΔTm (°)] to G4s. These data continue to expand the Company’s understanding of the genetic associations with QN-302. In 2020, there were an estimated 95,389 people living with Pancreatic Cancer in the United States (NIH, 2023). Pancreatic cancer is a highly lethal disease and the third most common cause of cancer death in the United States. Pre-clinical in-vitro and in-vivo studies of QN-302 have shown that G4 stabilization may result in inhibition of target gene expression and cessation of cell growth in a variety of cancers, including PDAC, which represents 98% of pancreatic cancers. The AACR Special Conference on Pancreatic Cancer attracts 400-500 attendees yearly and spans basic, translational, and clinical research. This year’s program focused on incorporating numerous talks from submitted abstracts to highlight the advancements and diversity of the pancreatic cancer research field. Special sessions presented cutting-edge research, career development opportunities, and discuss key areas of research in the field. About QN-302 QN-302 is a small molecule G4-selective transcription inhibitor in Phase 1 clinical development for the treatment of G4-expressing solid tumors, such as pancreatic cancer, prostate cancer, sarcomas, and others. QN-302 stabilizes G4 complexes prevalent in the promoter region of oncogenes in many tumor types, impeding transcription of G4-containing cancer genes and may potentially offer a tumor-agnostic clinical approach to treatment. Orphan Drug Designation was granted by the FDA in January of this year for QN-302 for the intended indication of pancreatic cancer. The Company anticipates the dosing of at least 24 patients in the Phase 1 trial can be completed by the end of 2024, funded in part by proceeds received by the divestiture of the Company’s diagnostics business in July 2023. About Qualigen Therapeutics, Inc. Qualigen Therapeutics, Inc. is a clinical-stage 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. 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, including the anticipated timeline for initiating the Company’s Phase 1 clinical trial and enrolling and dosing of patients and the identification of a late in vivo candidate. Actual events or results may differ from the Company's expectations. 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 Pan-RAS and QN-247) 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, Pan-RAS and QN-247). 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@qlgntx.com. Source: Qualigen Therapeutics, Inc. Attachments Qualigen Therapeutics, Inc. Qualigen Therapeutics, Inc. Qualigen Therapeutics, Inc. Qualigen Therapeutics, Inc. Figure 1A Qualigen Therapeutics, Inc. Figure 1B Qualigen Therapeutics, Inc. Table 1

Investigational New Drug (IND) clearance transitions Qualigen from preclinical to clinical-stage company Company divests FastPack® diagnostics business for approximately $5 million in all cash transaction to support advancement of therapeutics pipeline CARLSBAD, Calif., Aug. 15, 2023 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, today announces financial results for the second quarter ending June 30, 2023, and provides a corporate update: Highlights For Second Quarter and To Date 2023: Therapeutics Highlights: QN-302 Received US FDA clearance to initiate Phase 1 clinical trial of QN-302 for treatment of advanced or metastatic solid tumorsPresented four posters at the American Association for Cancer Research (AACR) Annual Meeting, in April 2023: “A comparison of the activity of the quadruplex-targeting experimental drugs QN-302 and CX-5461 (Pidnarulex) in wild-type and gemcitabine-resistant pancreatic cancer cell lines” Ahmed Ahmed, Tariq Arshad, and Stephen Neidle (Poster)“The potent quadruplex-binding compound QN-302 down-regulates the S100P gene in vitro and in vivo models of pancreatic cancer: a potential therapeutic target and biomarker for PDAC” Nicole Williams, Jenny Worthington, Ahmed Ahmed, Tariq Arshad, and Stephen Neidle (Poster)“The potent quadruplex-binding compound QN-302 shows anti-tumor activity as a monotherapy in an orthotopic in vivo model of pancreatic cancer” Nicole Williams, Danielle Santos, Jenny Worthington, Ahmed Ahmed, Tariq Arshad and Stephen Neidle (Poster)“Structure-based design rules for potent quadruplex-binding compounds based on the naphthalene diimide core” Stephen Neidle (Poster) Pan-RAS Presented data at the American Society of Clinical Oncology (ASCO) Annual Meeting, in June 2023: “Impact of novel pan-RAS inhibitors on efficacy and resistance to AMG-510 and MRTX-1133 in pancreatic cancer cell lines.” Howard Donninger, Rachel Ferrill, Becca Von Baby, Joe Burlison, John O. Trent, Michael Sabo, Tariq Arshad, Geoffrey J. Clark (Poster)“A novel pan-RAS inhibitor for luminal B breast cancer.” Tariq Arshad, Howard Donninger, Mike Sabo, John Trent, Geoffrey J. Clark, Joe Burlison. This abstract can be found in the ASCO 2023 Annual Meeting Abstract Book (Abstract) QN-247 Presented one poster at the American Association for Cancer Research (AACR) Annual Meeting, in April 2023: “Nano-immunotherapy: Efficacy of nanoconjugate QN-247 in a Triple Negative Breast Cancer (TNBC) mouse model” Tariq Arshad, Stephen Fait, Guy Gammon, Andrew Hertig, Mark J. Sarno (Poster) Diagnostics Highlights: Sold 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 testsAmended our Master Funding Agreement with NanoSynex to substantially reduce or eliminate Qualigen’s future cash funding obligations Michael Poirier, Qualigen’s Chairman and CEO commented, “2023 has been a transformative year for Qualigen Therapeutics. Despite continued industry headwinds, we significantly advanced our oncology-focused pipeline within budget and timelines. To build on our momentum, the company recently achieved two major milestones: We received US FDA Investigational New Drug (IND) clearance to initiate a Phase 1 clinical trial for QN-302, a small molecule G-Quadruplex (G4)-selective transcription inhibitor for treatment of advanced or metastatic solid tumors, and we divested our FastPack® diagnostics business.” “On August 1st we received news that the FDA cleared the Company’s IND application for QN-302. Based on this clearance, the Company plans to initiate the Phase 1 clinical trial in the second half of 2023 and will enroll patients with advanced or metastatic solid tumors. This clearance is the culmination of dedicated efforts by the Qualigen team and our extensive network of collaborators, subject matter experts, and service providers and exemplifies our steadfast commitment to patients. The proposed Phase 1 trial is a multicenter, open-label, dose escalation, safety, pharmacokinetic, and pharmacodynamic study with dose expansion to evaluate safety, tolerability, and antitumor activity of QN-302 in patients with advanced solid tumors that have not responded to or have recurred following treatment with available therapies. The Company anticipates dosing of at least 24 patients in the Phase 1 trial can be completed in 2024.” “In July we divested our FastPack® diagnostics business to Chembio Diagnostics, Inc., an American subsidiary of French diagnostics provider BIOSYNEX Group for [give price, including amount received at closing, escrow amount and timing of escrow release]. We are proud of the legacy our FastPack® rapid immunodiagnostics system has established by providing patients and doctors with high quality laboratory solutions for over two decades. This all-cash sale enhances our business focus while providing additional capital for our therapeutics pipeline, in particular our clinical-stage QN-302 program and our preclinical Pan-RAS inhibitor platform. Going forward, we will maintain streamlined operations that will reduce overhead expenses as an out-sourced virtual model.” “In parallel with QN-302 clinical development, we continue to advance compounds within our Pan-RAS therapeutic platform. We are on track to identify a late in vivo stage candidate by the end of the year, which we will advance into IND-enabling studies by 2024. We are very encouraged by the interest we received at the ASCO Annual Meeting this June regarding our poster presentation on the impact of novel pan-RAS inhibitors on efficacy and resistance to AMG-510 and MRTX-1133 in pancreatic cancer cell lines. We believe a pan-RAS approach may overcome KRAS G12C resistance that effects depth and duration of responses in current offerings, and we will continue to build our data package with our collaborators in the second half of this year.” “We are looking forward to initiating our Phase 1 clinical trial of QN-302 in the second half of this year and potentially providing a treatment option in the future to patients who have not responded to or have relapsed following treatment with available therapies. Along with the encouraging data presented on our Pan-RAS platform, our therapeutics direction is taking shape, and is an exciting time for Qualigen and our stakeholders,” concluded Mr. Poirier. Financial Highlights Revenues from product sales for the quarter ended June 30, 2023 were approximately $1.6 million compared to approximately $1.4 million for the same period of 2022, an increase of $0.2 million or 14%, due to growth in sales volumes and higher average unit selling prices. Cost of product sales were $1.0 million, or 62% of product sales, compared to $1.1 million, or 77% of product sales for the same period of 2022. The improvement was primarily due to a reduction in force implemented in January 2023. General and administrative expenses remained at $2.7 million for the quarter, compared to the same period of 2022. Research and development costs decreased from $1.5 million for the three months ended June 30, 2022 to $1.3 million for the three months ended June 30, 2023. Of the $1.3 million of research and development costs for the three months ended June 30, 2023, approximately $1.2 million (89%) was attributable to therapeutics and $0.2 million (11%) was attributable to diagnostics. Of the $1.5 million of research and development costs for the three months ended June 30, 2022, $1.1 million (73%) was attributable to therapeutics and $0.4 million (27%) was attributable to diagnostics. The $0.1 million increase in therapeutics research and development costs was primarily due to a $0.5 million increase in QN-302 pre-clinical research and development costs, offset by a decrease of pre-clinical research and development costs of $0.4 million for QN-247. The $0.2 million decrease in diagnostics research and development costs was primarily due to a $0.2 million decrease in stock-based compensation expense and a $0.1 million decrease in payroll expenses related to FastPack due to the January 2023 reduction in force, offset by an increase of $0.1 million in research and development expenses for NanoSynex. Sales and marketing expenses were approximately $0.2 million for the quarter ended June 30, 2023, a decrease of $0.1 million or 45%, compared to the quarter ended June 30, 2022, primarily due to the January 2023 reduction in force. For the quarter ended June 30, 2023, the Company reported a net loss attributable to Qualigen Therapeutics, Inc. of approximately $3.5 million, or $0.69 per common share basic and diluted, compared to a net loss of approximately $4.1 million, or $1.12 per common share basic and diluted, for the corresponding period in 2022. About Qualigen Therapeutics, Inc. Qualigen Therapeutics, Inc. is a clinical-stage 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. 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, including the anticipated timeline for initiating the Company’s Phase 1 clinical trial and enrolling and dosing of patients and the identification of a late in vivo candidate. Actual events or results may differ from the Company's expectations. 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 Pan-RAS and QN-247) 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, Pan-RAS and QN-247). 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. For more information about Qualigen Therapeutics, Inc., please visit www.qlgntx.com. Contact:Investor Relations760-530-6487ir@qlgntx.com. Source: Qualigen Therapeutics, Inc. QUALIGEN THERAPEUTICS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND OTHER COMPREHENSIVE LOSS(Unaudited) For the Three Months Ended June 30, For the Six Months Ended June 30, 2023 2022 2023 2022 REVENUES Net product sales $1,627,031 $1,430,534 $3,234,201 $2,152,563 Total revenues 1,627,031 1,430,534 3,234,201 2,152,563 EXPENSES Cost of product sales 1,016,542 1,099,677 2,281,368 1,928,524 General and administrative 2,665,849 2,660,857 4,380,283 5,559,608 Research and development 1,326,544 1,506,227 3,448,095 3,370,972 Sales and marketing 169,223 305,103 368,337 443,426 Total expenses 5,178,158 5,571,864 10,478,083 11,302,530 LOSS FROM OPERATIONS (3,551,127) (4,141,330) (7,243,882) (9,149,967) OTHER EXPENSE (INCOME), NET Gain on change in fair value of warrant liabilities (440,294) (14,800) (1,478,967) (698,042)Interest expense (income), net 377,416 (4,824) 921,652 (11,132)Loss on voluntary conversion of convertible debt — — 1,077,287 — Loss on disposal of equipment held for lease 63,302 — 63,302 — Other income, net (5,680) 376 (10,559) 341 Loss on fixed asset disposal — — 300 — Total other expense (income), net (5,256) (19,248) 573,015 (708,833) LOSS BEFORE (BENEFIT) PROVISION FOR INCOME TAXES (3,545,871) (4,122,082) (7,816,897) (8,441,134) (BENEFIT) PROVISION FOR INCOME TAXES (38,182) 5,438 (201,959) 6,173 NET LOSS (3,507,689) (4,127,520) (7,614,938) (8,447,307) Net loss attributable to noncontrolling interest (43,484) (4,116) (304,512) (4,116) Net loss attributable to Qualigen Therapeutics, Inc. $(3,464,205) $(4,123,404) $(7,310,426) $(8,443,191) Net loss per common share, basic and diluted $(0.69) $(1.12) $(1.46) $(2.35)Net loss per common share, basic $(0.69) $(1.12) $(1.46) $(2.35)Weighted—average number of shares outstanding, basic and diluted 5,052,463 3,668,016 5,006,050 3,599,093 Weighted—average number of shares outstanding, basic 5,052,463 3,668,016 5,006,050 3,599,093 Other comprehensive loss, net of tax Net loss $(3,507,689) $(4,127,520) $(7,614,938) $(8,447,307)Foreign currency translation adjustment (56,747) 65,540 119,473 65,540 Other comprehensive loss (3,564,436) (4,061,980) (7,495,465) (8,381,767)Comprehensive loss attributable to noncontrolling interest (43,484) (4,116) (304,512) (4,116)Comprehensive loss attributable to Qualigen Therapeutics, Inc. $(3,520,952) $(4,057,864) $(7,190,953) $(8,377,651) The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. QUALIGEN THERAPEUTICS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(Unaudited) June 30, 2023 December 31, 2022 ASSETS Current assets Cash $1,341,659 $7,034,434 Accounts receivable, net 679,380 538,587 Inventory, net 1,563,399 1,586,297 Prepaid expenses and other current assets 1,278,077 1,661,220 Total current assets 4,862,515 10,820,538 Restricted cash 5,434 5,690 Right-of-use assets 1,305,970 1,422,538 Property and equipment, net 498,647 345,087 Intangible assets, net 5,833,070 5,845,702 Goodwill 625,602 625,602 Other assets 18,334 18,334 Total Assets $13,149,572 $19,083,491 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable $1,756,183 $857,311 Accrued vacation 332,617 467,948 Accrued expenses and other current liabilities 1,980,555 1,511,856 R&D grant liability 151,620 780,682 Deferred revenue, current portion 94,474 116,161 Operating lease liability, current portion 257,155 240,645 Short term debt-related party 965,155 950,722 Warrant liabilities 133,500 788,100 Warrant liabilities - related party 2,010,180 2,834,547 Convertible debt - related party 812,419 60,197 Total current liabilities 8,493,859 8,608,170 Operating lease liability, net of current portion 1,168,653 1,301,919 Deferred revenue, net of current portion 28,648 49,056 Deferred tax liability 150,369 357,757 Total liabilities 9,841,528 10,316,901 Commitments and Contingencies (Note 12) - - Stockholders’ equity Qualigen Therapeutics, Inc. stockholders’ equity: Common stock, $0.001 par value; 225,000,000 shares authorized; 5,052,463 and 4,210,737 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively 42,952 42,110 Additional paid-in capital 112,554,830 110,528,050 Accumulated other comprehensive income 131,891 50,721 Accumulated deficit (110,695,598) (103,385,172)Total Qualigen Therapeutics, Inc. stockholders’ equity 2,034,075 7,235,709 Noncontrolling interest 1,273,969 1,530,881 Total Stockholders’ Equity 3,308,044 8,766,590 Total Liabilities & Stockholders’ Equity $13,149,572 $19,083,491 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.