CX3CL1

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

A researcher is one step closer to demonstrating the potential of a brain molecule called fractalkine to halt and even reverse the effects of multiple sclerosis and other neurodegenerative diseases. Researchers injected fractalkine into mice with chemically induced MS. They found the treatment increased the number of new oligodendrocytes -- vital brain and spinal cord cells that produce myelin in both embryonic and adult brains -- which are damaged during the MS autoimmune attack. A University of Alberta researcher is one step closer to demonstrating the potential of a brain molecule called fractalkine to halt and even reverse the effects of multiple sclerosis and other neurodegenerative diseases. Multiple sclerosis is an autoimmune disease in which the myelin, or fatty lining of nerve cells, is eroded, leading to nerve damage and slower signalling between the brain and the body. MS symptoms range from blurred vision to complete paralysis, and while there are treatments, the causes are not fully understood and nothing exists to reverse the disease process. More than 90,000 Canadians live with MS, according to the MS Society. In new research published in Stem Cell Reports, Anastassia Voronova, an assistant professor and Canada Research Chair in Neural Stem Cell Biology, injected fractalkine into mice with chemically induced MS. She found the treatment increased the number of new oligodendrocytes -- vital brain and spinal cord cells that produce myelin in both embryonic and adult brains -- which are damaged during the MS autoimmune attack. "If we can replace those lost or damaged oligodendrocytes, then they could make new myelin and it is believed that would halt the disease progression, or maybe even reverse some of the symptoms," Voronova says. "That's the Holy Grail in the research community and something that we're very passionate about." Voronova's earlier research tested the safety and efficacy of fractalkine in normal mice and found similar beneficial effects. Other researchers have demonstrated that fractalkine may provide protection for nerves in mouse models before the disease is induced, but this is the first time it has been tested on animals that already have the disease. Voronova and her team observed new oligodendrocytes, as well as reactivated progenitor cells that can regenerate oligodendrocytes, in the brains of the treated animals. Remyelination occurred in both the white and grey matter. The researchers also observed a reduction in inflammation, part of the damage caused by the immune system. Next steps for the treatment include testing it in other diseased mouse models, including those with neurodegenerative diseases other than MS.