QLGN Qualigen Therapeutics Inc.

1.7
-0.05  -3%
Previous Close 1.75
Open 1.67
52 Week Low 0.9295
52 Week High 4.66
Market Cap $49,499,070
Shares 29,117,100
Float 28,886,103
Enterprise Value $38,939,011
Volume 6,650,663
Av. Daily Volume 6,173,574
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Upcoming Catalysts

Drug Stage Catalyst Date
QN-165 (AS1411)
COVID-19
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
QN-247
Acute myeloid leukemia
Phase 1
Phase 1
Phase 1 trial to commence in 2023.
RP-G28
Lactose intolerance
Phase 3
Phase 3
Phase 3 data failed to meet primary endpoint - September 12, 2019.

Latest News

    • Quarterly revenues increased 38% to approximately $1.2 million, compared to approximately $0.8 million in the same quarter of the previous year

    • Year-to-date revenues increased 30% to $4.2 million, compared to $3.2 million in the same nine-month period of the previous year

    • Cash equivalents of approximately $12.3 million as of September 30, 2021

    CARLSBAD, Calif., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (NASDAQ:QLGN), a biotechnology company focused on developing novel therapeutic products for the treatment of adult and pediatric patients with rare cancers, as well as maintaining and expanding its flagship FastPack® diagnostic platform, today announced its financial results for the third quarter and nine months ended September…

    • Quarterly revenues increased 38% to approximately $1.2 million, compared to approximately $0.8 million in the same quarter of the previous year



    • Year-to-date revenues increased 30% to $4.2 million, compared to $3.2 million in the same nine-month period of the previous year



    • Cash equivalents of approximately $12.3 million as of September 30, 2021



    CARLSBAD, Calif., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (NASDAQ:QLGN), a biotechnology company focused on developing novel therapeutic products for the treatment of adult and pediatric patients with rare cancers, as well as maintaining and expanding its flagship FastPack® diagnostic platform, today announced its financial results for the third quarter and nine months ended September 30, 2021.

    "We are very encouraged by what we believe to be a strong quarter, with a 38% increase in year-over-year revenue," commented Michael S. Poirier, Qualigen's Chairman, CEO, and President. "As the country emerges from the pandemic and visits to medical offices are on the rise, we have experienced a corresponding recovery in our FastPack test kit sales. We continue to be encouraged by this increase."

    "In the meantime, we continue efforts to develop our therapeutics business, which is focused on novel approaches to rare cancers. We look forward to sharing news on those programs soon," added Mr. Poirier."

    Third Quarter 2021 Financial Highlights

    Revenues for the three months ended September 30, 2021 were $1.2 million compared to approximately $0.8 million in the same quarter of the previous year. Qualigen's revenues are primarily generated from sales of diagnostic tests. The increased revenue was primarily due to a continued recovery from the effects of the COVID-19 pandemic versus the same quarter of the prior year.

    Revenues for the nine-month period ended September 30, 2021 were $4.2 million compared to $3.2 million in the same nine-month period of the previous year. This increase was also primarily due to an increase in diagnostic product sales, reflecting recovery from the effects of the COVID-19 pandemic, as well as recognition of license revenue from Yi Xin Zhen Duan Jishu (Suzhou) Ltd. under a Technology Transfer Agreement during the first quarter, which had no counterpart during the prior year.

    For the three months ended September 30, 2021, Qualigen reported a net loss of $2.9 million, or $0.10 per share, compared to a net loss of $8.1 million, or $0.41 per share, for the corresponding period in 2020. Net loss for the three-month 2020 period included non-cash charges of $4.4 million related to the change in fair value of warrant liabilities, compared to a non-cash gain of $1.9 million related to the change in fair value of warrant liabilities in the current period.

    For the nine months ended September 30, 2021, the Company reported a net loss of $11.8 million, or $0.41 per share, compared to a net loss of $27.6 million, or $2.41 per share, in the corresponding nine-month period in 2020. Net loss for the nine-month 2020 period included non-cash charges of $20.6 million related to the change in fair value of warrant liabilities, compared to a non-cash gain of $6.1 million related to the change in fair value of warrant liabilities in the current period.

    License revenue during the nine months ended September 30, 2021 was approximately $0.5 million, due to the recognition of revenue from the Yi Xin transaction.

    General and administrative expenses increased slightly to $2.8 million during the three months ended September 30, 2021, from $2.7 million during the three months ended September 30, 2020. General and administrative expenses increased to $8.6 million during the nine months ended September 30, 2021 compared to $5.6 million during the same nine-month period of the prior year. This increase was primarily due to overhead expenses related to Qualigen's public-company status in contrast to the Company's private-company status during much of the 2020 period.

    Research and development expenses increased to $2.1 million during the three months ended September 30, 2021, from $0.9 million during the three months ended September 30, 2020. Research and development expenses increased to $10.1 million during the nine months ended September 30, 2021 compared to $1.7 million during the same nine-month period of the prior year. These increases were primarily due to increased spending on our pre-clinical therapeutics pipeline programs.

    As of September 30, 2021, Qualigen had $12.3 million in cash and cash equivalents. The Company believes its cash and cash equivalents are sufficient to fund its anticipated operations through late 2022.

    About Qualigen Therapeutics, Inc.

    Qualigen is a biotechnology company focused on developing novel therapeutic products for the treatment of adult and pediatric patients with rare cancers, as well as maintaining and expanding its flagship FastPack® diagnostic platform. Qualigen intends to apply for Orphan Drug Designation for several of its drug candidates. The FastPack® line of FDA-cleared and CE-Marked products has been used successfully in diagnostics for 20 years. Our therapeutics pipeline includes cancer drug compounds such as QN-247 (formerly referred to as AS1411-GNP or ALAN) and RAS-F. By combining our demonstrated ability to develop and commercialize innovative medical products with the advanced capabilities of leading cancer research centers, such as the University of Louisville, we are committed to providing exciting new therapeutic technologies to physicians and patients.

    Forward-Looking Statements

    This news release contains forward-looking statements by the Company 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 the development of 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 successfully develop any drugs (including QN-247 and RAS-F); that preclinical or clinical development of the Company's drugs (including QN-247 and RAS-F) 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; 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 (including 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; 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-247 and RAS-F); or that the Company will be able to maintain or expand market demand and/or market share for the Company's diagnostic products. The Company's stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fails 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 Form 10-K, all of which 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.

    Investor Relations:

    For further information: David Kugelman

    Atlanta Capital Partners, LLC

    (404) 856-9157 or (866) 692-6847 Toll Free - U.S. & Canada

    Tony Schor

    Investor Awareness, Inc.

    (847) 971-0922

    QUALIGEN THERAPEUTICS, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (Unaudited)

      For the Three Months Ended

    September 30,
      For the Nine Months Ended

    September 30,
     
      2021  2020  2021  2020 
    REVENUES            
    Net product sales $1,155,065  $837,714  $3,693,842  $3,153,536 
    License revenue        478,654    
    Collaborative research revenue           45,000 
    Total revenues  1,155,065   837,714   4,172,496   3,198,536 
                     
    EXPENSES                
    Cost of product sales  993,120   921,475   3,112,224   2,721,049 
    General and administrative  2,756,323   2,664,658   8,582,362   5,562,650 
    Research and development  2,083,315   870,876   10,091,155   1,706,280 
    Sales and marketing  130,217   98,045   402,347   279,151 
    Total expenses  5,962,976   4,555,054   22,188,087   10,269,130 
                     
    LOSS FROM OPERATIONS  (4,807,910)  (3,717,340)  (18,015,591)  (7,070,594)
                     
    OTHER (INCOME) EXPENSE, NET                
    Loss (gain) on change in fair value of warrant liabilities  (1,942,900)  4,395,300   (6,140,900)  20,596,700 
    Interest (income) expense, net  (6,801)  715   (36,862)  148,836 
    Other (income) expense, net  (702)  (2,447)  (3,596)  (253,719)
    Total other (income) expense, net  (1,950,403)  4,393,568   (6,181,358)  20,491,817 
                     
    LOSS BEFORE PROVISION FOR INCOME TAXES  (2,857,507)  (8,110,908)  (11,834,233)  (27,562,411)
                     
    PROVISION (BENEFIT) FOR INCOME TAXES  1,011   2,305   2,146   2,283 
                     
    NET LOSS $(2,858,518) $(8,113,213) $(11,836,378) $(27,564,694)
                     
    Net loss per common share, basic and diluted $(0.10) $(0.41) $(0.41) $(2.41)
    Weighted-average number of shares outstanding, basic and diluted  29,026,211   19,799,468   28,683,972   11,434,649 

    The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

    QUALIGEN THERAPEUTICS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (Unaudited)

      September 30,  December 31, 
      2021  2020 
    ASSETS        
    Current Assets        
    Cash and cash equivalents $12,319,809   23,976,570 
    Accounts receivable, net  633,550   615,757 
    Inventory, net  1,178,007   953,458 
    Prepaid expenses and other current assets  1,601,512   2,678,894 
    Total current assets  15,732,878   28,224,679 
    Right-of-use asset  264,140   430,795 
    Property and equipment, net  208,958   247,323 
    Equipment held for lease, net  2,693   17,947 
    Intangible assets, net  177,562   187,694 
    Other assets  18,334   18,334 
    Total Assets $16,404,564  $29,126,772 
             
    LIABILITIES AND STOCKHOLDERS' EQUITY        
    Current liabilities        
    Accounts payable $908,703  $500,768 
    Accrued expenses and other current liabilities  1,799,431   746,738 
    Notes payable, current portion     131,766 
    Deferred revenue, current portion  270,761   486,031 
    Operating lease liability, current portion  278,901   254,739 
    Warrant liabilities  2,169,200   8,310,100 
    Total current liabilities  5,426,996   10,430,142 
    Notes payable, net of current portion     6,973 
    Operating lease liability, net of current portion  24,993   236,826 
    Deferred revenue, net of current portion  106,493   158,271 
    Total liabilities  5,558,482   10,832,212 
             
    Stockholders' equity        
    Series Alpha convertible preferred stock, $0.001 par value; 7,000 shares authorized; 180 shares issued and outstanding as of September 30, 2021 and December 31, 2020  1   1 
    Common stock, $0.001 par value; 225,000,000 shares authorized; 29,082,069 and 27,296,061 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively  29,082   27,296 
    Additional paid-in capital  89,500,869   85,114,755 
    Accumulated deficit  (78,683,870)  (66,847,492)
    Total Stockholders' Equity  10,846,082   18,294,560 
    Total Liabilities & Stockholders' Equity $16,404,564  $29,126,772 

    The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.



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  1. CARLSBAD, Calif., Oct. 19, 2021 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (NASDAQ:QLGN), a biotechnology company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, today announces the publication of a study in the peer-reviewed, open-source journal, Diagnostics, validating the Company's point of care FastPack® IP ("FastPack") diagnostic test as comparable to an industry-leading laboratory method in determining thyroid stimulating hormone (TSH) levels in blood.

    This study, which was supported by the Company's marketing partner, SEKISUI Diagnostics, provides further validation behind years of in-the-field evidence demonstrating the accuracy and reliability of FastPack…

    CARLSBAD, Calif., Oct. 19, 2021 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (NASDAQ:QLGN), a biotechnology company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, today announces the publication of a study in the peer-reviewed, open-source journal, Diagnostics, validating the Company's point of care FastPack® IP ("FastPack") diagnostic test as comparable to an industry-leading laboratory method in determining thyroid stimulating hormone (TSH) levels in blood.

    This study, which was supported by the Company's marketing partner, SEKISUI Diagnostics, provides further validation behind years of in-the-field evidence demonstrating the accuracy and reliability of FastPack compared to laboratory tests for the same application, but while also providing patients and providers the speed and convenience of a point-of-care context.

    "The FastPack technology has successfully been utilized for over two decades, and up-to-date real-world clinical evidence is an important pillar in our understanding of its accuracy and utility in the market. This study, which was conducted in a cohort of 100 subjects in Foggia, Italy, corroborates what endocrinologists, diabetologists, and general and internal medicine clinicians have experienced for many years – that FastPack IP provides an easy-to-use, rapid, reproducible – and highly accurate – test for TSH levels, which is essential for prescribing and assessing treatments," commented Michael Poirier, Qualigen's Chief Executive Officer.

    The Diagnostics study, titled "Comparison between an Emerging Point-of-Care Tool for TSH Evaluation and a Centralized Laboratory-Based Method in a Cohort of Patients from Southern Italy"1 demonstrated a strong correlation between the FastPack TSH results and those taken from laboratory analysis. Further, the subjects who participated in the study were accustomed to undergoing TSH testing 3-5 times per year and expressed complaints about the time required to receive laboratory results. All patients who participated in the study noted the advantage of the shorter time-to-result that FastPack provides.

    The study protocol required investigators to take serum from 72 patients and 28 control subjects who provided a single blood withdrawal at a central laboratory to assess TSH values by means of FastPack compared to the ACCESS2 Beckman Coulter instrument. Investigators were able to readily obtain results much faster by FastPack (within about 15 minutes) as opposed to the 2-day response time required by Beckman ACCESS2.

    "We have spent many years collaborating with Qualigen and are very pleased to see the real-world clinical performance, value and utility of the FastPack platform demonstrated through this comprehensive scientific study", said Lee Lipski, Sr. VP IVD Business Unit, SEKISUI Diagnostics.

    Sales of Qualigen's FDA-approved FastPack System diagnostic instruments and test kits have exceeded $100 million since inception and have been used successfully in diagnostics for over 20 years. FastPack provides rapid and accurate immunoassay tests for prostate cancer, men's health, hormone function, PSA, testosterone, thyroid disorders, pregnancy, and Vitamin D status.

    About Qualigen Therapeutics, Inc.

    Qualigen Therapeutics, Inc. is a biotechnology company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, as well as maintaining and expanding its core FDA-approved FastPack® System, which has been used successfully in diagnostics for 20 years. Qualigen's aptamer platform, of which QN-247 is the lead candidate, inhibits nucleolin, a key multi-functional regulatory protein that is overexpressed in cancer cells, thus influencing their proliferation, survival, and metastasis. QN-247 has shown promise in pre-clinical studies for the treatment of acute myeloid leukemia (AML). Qualigen's RAS-F platform is a family of RAS oncogene protein-protein interaction inhibitor small molecules that is believed to disrupt pathways for cancer genes that cause tumor formation. 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. The RAS pathway has generated considerable interest due to recent breakthrough developments in the field and the first clinical approval earlier this year for a K-RAS directed drug. In addition to its oncology drug pipeline, Qualigen has an established diagnostics business which manufactures and distributes proprietary and highly accurate rapid blood testing systems for the management of prostate cancer and other diseases and health conditions. Qualigen's management has significant experience in drug and medical device development, manufacturing, marketing, and distribution.

    For more information about Qualigen Therapeutics, Inc. please visit www.qualigeninc.com.

    Forward-Looking Statements

    This news release contains forward-looking statements by the Company 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 the development of 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 develop any drugs (including QN-247 and RAS-F); that preclinical or clinical development of the Company's drugs (including QN-247 and RAS-F, and deprioritized infectious-disease programs such as 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; that 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 (including 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 inlicensed patents would prevent competition; 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-247 and RAS-F, and any repositioning of QN-165); or that the Company will be able to maintain or expand market demand and/or market share for the Company's diagnostic products. The Company's stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fails 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 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.

    Investor Relations:

    For further information: David Kugelman

    Atlanta Capital Partners, LLC

    (404) 856-9157 or (866) 692-6847 Toll Free - U.S. & Canada

    Tony Schor

    Investor Awareness, Inc.

    (847) 971-0922


    1 Di Cerbo, A.; Quagliano, N.; Napolitano, A.; Pezzuto, F.; Iannitti, T.; Di Cerbo, A. Comparison between an Emerging Point-of-Care Tool for TSH Evaluation and a Centralized Laboratory-Based Method in a Cohort of Patients from Southern Italy. Diagnostics 202111, 1590. https://doi.org/10.3390/diagnostics11091590.



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  2. CARLSBAD, Calif., Sept. 15, 2021 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (NASDAQ:QLGN), a biotechnology company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, announced today that CEO and Chairman Michael Poirier will present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit September 20-23, 2021.

    The presentation will provide an overview of the Company's strategy focusing primarily on its oncology drug pipeline which includes QN-247 and RAS-F assets for which Qualigen has already seen encouraging preclinical data.

    Qualigen Therapeutics, Inc. Presentation Details are as follows:

    Format: Virtual

    Presentation Webcast: www.qualigeninc.com/opco21

    Presentation…

    CARLSBAD, Calif., Sept. 15, 2021 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (NASDAQ:QLGN), a biotechnology company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, announced today that CEO and Chairman Michael Poirier will present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit September 20-23, 2021.

    The presentation will provide an overview of the Company's strategy focusing primarily on its oncology drug pipeline which includes QN-247 and RAS-F assets for which Qualigen has already seen encouraging preclinical data.

    Qualigen Therapeutics, Inc. Presentation Details are as follows:

    Format: Virtual

    Presentation Webcast: www.qualigeninc.com/opco21

    Presentation Time: Wednesday, September 22, 2021, 4:35 pm EDT. The webcast link will broadcast the presentation live, and can be viewed for 90 days thereafter.

    Virtual Meetings: One-on-one meetings will be held virtually and will be available to registered attendees. Qualigen Management will be available throughout each day September 20-22, 2021. Contact your Oppenheimer representative to register. You may also email  to register.

    About Qualigen Therapeutics, Inc.

    Qualigen Therapeutics, Inc. is a biotechnology company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation. Qualigen's aptamer platform, of which QN-247 is the lead candidate, inhibits nucleolin, a key multi-functional regulatory protein that is overexpressed in cancer cells, thus influencing their proliferation, survival and metastasis. QN-247 has shown promise in pre-clinical studies for the treatment of acute myeloid leukemia (AML). Qualigen's RAS-F platform is a family of RAS oncogene protein-protein interaction inhibitor small molecules that is believed to disrupt pathways for cancer genes that cause tumor formation. 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. The RAS pathway has generated considerable interest due to recent breakthrough developments in the field and the first clinical approval earlier this year for a K-RAS directed drug. In addition to its oncology drug pipeline, Qualigen has an established diagnostics business which manufactures and distributes proprietary and highly accurate rapid blood testing systems for the management of prostate cancer and other diseases and health conditions. Qualigen's management has significant experience in drug and medical device development, manufacturing, marketing and distribution.

    For more information about Qualigen Therapeutics, Inc. please visit www.qualigeninc.com.

    Forward-Looking Statements

    This news release contains forward-looking statements by the Company 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 the development of 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 develop any drugs (including QN-247 and RAS-F); that preclinical or clinical development of the Company's drugs (including QN-247 and RAS-F, and deprioritized infectious-disease programs such as 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; that 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 (including 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 inlicensed patents would prevent competition; 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-247 and RAS-F, and any repositioning of QN-165); or that the Company will be able to maintain or expand market demand and/or market share for the Company's diagnostic products. The Company's stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fails 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 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.

    Investor Relations:

    For further information: David Kugelman

    Atlanta Capital Partners, LLC

    (404) 856-9157 or (866) 692-6847 Toll Free - U.S. & Canada

    Tony Schor

    Investor Awareness, Inc.

    (847) 971-0922



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  3. CARLSBAD, Calif., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (NASDAQ:QLGN), a biotechnology company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, announced today that CEO and Chairman Michael Poirier will present at the H.C. Wainwright 23rd Annual Global Investment Conference September 13-15, 2021.

    The presentation will provide an overview of the Company's strategy focusing primarily on its oncology drug pipeline which includes QN-247 and RAS-F assets for which Qualigen has already seen encouraging preclinical data.

    Details for this presentation are as follows:

    Conference name: H.C. Wainwright 23rd Annual Global Investment Conference

    Format: Virtual

    Presentation…

    CARLSBAD, Calif., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (NASDAQ:QLGN), a biotechnology company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, announced today that CEO and Chairman Michael Poirier will present at the H.C. Wainwright 23rd Annual Global Investment Conference September 13-15, 2021.

    The presentation will provide an overview of the Company's strategy focusing primarily on its oncology drug pipeline which includes QN-247 and RAS-F assets for which Qualigen has already seen encouraging preclinical data.

    Details for this presentation are as follows:

    Conference name: H.C. Wainwright 23rd Annual Global Investment Conference

    Format: Virtual

    Presentation Webcast: www.qualigeninc.com/hcw2021

    Presentation Time:Webcast is viewable beginning Monday, September 13, 2021 at 7:00 AM ET, and can be viewed for 90 days thereafter.

    Virtual Meetings: Meetings are held via Zoom and will be available to registered attendees. Qualigen Management will be available for virtual one-on-one meetings throughout each day September 13-15, 2021. Attendees can register via HC Wainwright event website or by clicking HERE.

    About Qualigen Therapeutics, Inc.

    Qualigen Therapeutics, Inc. is a biotechnology company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation. Qualigen's aptamer platform, of which QN-247 is the lead candidate, inhibits nucleolin, a key multi-functional regulatory protein that is overexpressed in cancer cells, thus influencing their proliferation, survival and metastasis. QN-247 has shown promise in pre-clinical studies for the treatment of acute myeloid leukemia (AML). Qualigen's RAS-F platform is a family of RAS oncogene protein-protein interaction inhibitor small molecules that is believed to disrupt pathways for cancer genes that cause tumor formation. 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. The RAS pathway has generated considerable interest due to recent breakthrough developments in the field and the first clinical approval earlier this year for a K-RAS directed drug. In addition to an attractive oncology drug pipeline, Qualigen has an established diagnostics business which manufactures and distributes proprietary and highly accurate rapid testing systems for the management of prostate cancer and other diseases and health conditions. Qualigen is managed by a team of seasoned experts in drug and medical device development, manufacturing, marketing and distribution.

    For more information about Qualigen Therapeutics, Inc. please visit www.qualigeninc.com

    Forward-Looking Statements

    This news release contains forward-looking statements by the Company 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 the development of 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 develop any drugs (including QN-247 and RAS-F); that preclinical or clinical development of the Company's drugs (including QN-247 and RAS-F, and deprioritized infectious-disease programs such as 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; that 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 (including 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 current owned and inlicensed patents would prevent competition; 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-247 and RAS-F, and any repositioning of QN-165); or that the Company will be able to maintain or expand market demand and/or market share for the Company's diagnostic products. The Company's stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fails 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 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.

    Investor Relations:

    For further information: David Kugelman

    Atlanta Capital Partners, LLC

    (404) 856-9157 or (866) 692-6847 Toll Free - U.S. & Canada

    Tony Schor

    Investor Awareness, Inc.

    (847) 971-0922



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  4. CARLSBAD, Calif.,, Aug. 17, 2021 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (NASDAQ:QLGN) today announces its intention to prioritize its focus to its oncology pipeline that includes QN-247 and RAS-F. These plans follow feedback the Company received from the United States Food and Drug Administration regarding Qualigen's investigational new drug (IND) application for one of its other compounds, QN-165, for the treatment of COVID-19 in hospitalized patients.

    "Although the FDA requested that we perform additional pre-clinical toxicity and safety pharmacology studies before proceeding with clinical trials in COVID-19 patients, we believe that, given the time horizon which these suggested studies would require, coupled with the already…

    CARLSBAD, Calif.,, Aug. 17, 2021 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (NASDAQ:QLGN) today announces its intention to prioritize its focus to its oncology pipeline that includes QN-247 and RAS-F. These plans follow feedback the Company received from the United States Food and Drug Administration regarding Qualigen's investigational new drug (IND) application for one of its other compounds, QN-165, for the treatment of COVID-19 in hospitalized patients.

    "Although the FDA requested that we perform additional pre-clinical toxicity and safety pharmacology studies before proceeding with clinical trials in COVID-19 patients, we believe that, given the time horizon which these suggested studies would require, coupled with the already very crowded COVID-19 vaccine and therapeutic landscape, the best and most prudent strategy for us at this time is to pivot to focusing primarily on our oncology pipeline that includes QN-247 and RAS-F assets for which we have already seen encouraging preclinical data," commented Michael Poirier, Qualigen's Chairman and Chief Executive Officer. "We appreciate the FDA's guidance regarding our approach to QN-165, which helps us to solidify our priority to address unmet medical needs in treating cancer patients. We look forward to sharing ongoing progress with our shareholders."

    Qualigen also today announces its second quarter and six-months 2021 financial results and provides a recap of the highlights of the 2021 second quarter.

    Highlights from the Quarter Ended June 30, 2021:

    • Q2 revenues increased 24 percent to $1.1 million, compared to $0.9 million in the same quarter of the previous year

    • First-half revenues increased 28 percent to $3.0 million, compared to $2.4 million in the same six month period of the previous year

    • Cash equivalents of approximately $15.2 million at June 30, 2021

    • Continued our license and sponsored research agreements with the University of Louisville to evaluate the use of QN-247 with G-quadruplex binders.



      • Qualigen plans to seek to obtain Orphan Drug status for QN-247 (with or without such binders) for one or more indications, such as pancreatic cancer, acute myeloid leukemia and pediatric neuroblastoma. Orphan Drug status, if obtained, would be expected to confer several advantages including faster review and increased market protection.

    • In May 2021, Qualigen announced that it had named Tariq Arshad, MD, MBA, to the newly-created position of Senior Vice President, Chief Medical Officer. Dr. Arshad brings more than 20 years of biotech and pharmaceutical experience to Qualigen.

    • In June 2021, Qualigen announced that it was added to the Russell Microcap® Index. Membership in the Russell Microcap Index means automatic inclusion in certain growth and value indexes. FTSE Russell determines membership for its indexes primarily by objective, market-capitalization rankings as well as style attributes.

    Second Quarter and Six Month Financial Highlights and Analysis

    Revenues for the three months ended June 30, 2021 were $1.1 million compared to approximately $0.9 million in the same quarter of the previous year. Our 2021 second quarter revenues were all generated from sales of diagnostic tests. This product sales improvement was due to a recovery from the effects of the COVID-19 pandemic.

    Revenues for the six month period ended June 30, 2021 were $3.0 million compared to $2.4 million in the same six month period of the previous year. This increase primarily resulted from the recognition during the first quarter of license revenue from Yi Xin Zhen Duan Jishu (Suzhou) Ltd. under a Technology Transfer Agreement, an item which had no counterpart during the prior year, as well as an increase in diagnostic product sales reflecting recovery from the effects of the COVID-19 pandemic.

    For the three months ended June 30, 2021, we reported a net loss of $5.3 million, or $0.18 per share, compared to a net loss of $18.6 million, or $2.12 per share, for the corresponding period in 2020. Net loss for the three month 2020 period included non-cash charges of $16.2 million related to a change in fair value of warrant liabilities, compared to a non-cash gain of $2.1 million from change in fair value of warrant liabilities in the current three month period.

    For the six months ended June 30, 2021, the Company reported a net loss of $9.0 million, or $0.31 per share, compared to a net loss of $19.5 million, or $2.71 per share, in the corresponding six month period in 2020. Net loss for the six month 2020 period included non-cash charges of $16.2 million related to a change in fair value of warrant liabilities, compared to a non-cash gain of $4.2 million from change in fair value of warrant liabilities in the current six month period.

    License revenue during the six months ended June 30, 2021 was approximately $0.5 million, because of the recognition of license revenue from the Yi Xin transaction.

    Research and development expenses increased to $4.5 million for the three months ended June 30, 2021, from $0.6 million for the three months ended June 30, 2020. This increase was primarily attributable to $3.4 million in expenses related to the potential application of QN-165 to treatment of COVID-19 during the quarter. Research and development expenses increased to $8.0 million for the six months ended June 30, 2021 from $0.8 million for the six months ended June 30, 2020. This increase was primarily due to $5.9 million in expenses related to the potential application of QN-165 to treatment of COVID-19, in addition to increased pre-clinical research and development costs for QN-247 and RAS as well as wind-down costs related to the withdrawn COVID-19 antibody diagnostic test and stock-based compensation expense related to our public-company status.

    General and administrative expenses increased to $3.0 million during the three months ended June 30, 2021, from $2.0 million during the three months ended June 30, 2020. General and administrative expenses increased to $5.8 million for the six months ended June 30, 2021, compared to $2.9 million during the six months ended June 30, 2020. The increases for both periods were primarily a result of overhead expenses related to our public-company status in contrast to our private-company status during most of the 2020 periods.

    As of June 30, 2021, we had $15.2 million of cash and cash equivalents.

    About Qualigen Therapeutics, Inc.

    Qualigen Therapeutics, Inc.'s cancer therapeutics pipeline includes QN-247, RAS-F, and STARS. QN-247 (formerly referred to as ALAN) is a DNA coated gold nanoparticle cancer drug candidate that has the potential to target various types of cancer with minimal side effects; the nanoparticle coating technology is similar to the core nanoparticle coating technology used in our blood-testing diagnostic products. The foundational aptamer of QN-247, QN-165, is also a drug candidate for viral-based infectious diseases. (QN-165 was formerly referred to as AS1411.) RAS-F is a family of RAS oncogene protein-protein interaction inhibitor small molecules for preventing mutated RAS genes' proteins from binding to their effector proteins; preventing this binding could stop tumor growth, especially in pancreatic, colorectal, and lung cancers. STARS is a DNA/RNA-based treatment device candidate for removal from circulating blood of precisely targeted tumor-produced and viral compounds.

    Forward-Looking Statements

    This news release contains forward-looking statements by the Company 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 the development of therapeutic drug candidates. Actual events or results may differ from the Company's expectations. For example, there can be no assurance that preclinical or clinical development of the Company's drugs (including QN-247 and RAS-F, and deprioritized infectious-disease programs such as QN-165) or therapeutic devices will be completed on any projected timeline or will be successful; that the FDA will approve any of the Company's IND applications; that any clinical trials will be approved to begin by or will proceed as contemplated by any projected timeline; that the Company will successfully develop any drugs (including QN-247 and RAS-F) or therapeutic devices; that 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 or therapeutic devices will receive required regulatory approvals (including 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 current owned and inlicensed patents would prevent competition; 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-247 and RAS-F, and any repositioning of QN-165); or that the Company will be able to maintain or expand market demand and/or market share for the Company's diagnostic products. The Company's stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fails 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 Form 10-K, all of which 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.

    Investor Relations:

    For further information: David Kugelman

    Atlanta Capital Partners, LLC

    (404) 856-9157 or (866) 692-6847 Toll Free - U.S. & Canada

    Tony Schor

    Investor Awareness, Inc.

    (847) 971-0922

    QUALIGEN THERAPEUTICS, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (Unaudited)

      For the Three Months

    Ended June 30,
      For the Six Months

    Ended June 30,
     
      2021  2020  2021  2020 
    REVENUES                
    Net product sales $1,117,935  $904,067  $2,538,776  $2,315,823 
    License revenue        478,654    
    Collaborative research revenue           45,000 
    Total revenues  1,117,935   904,067   3,017,430   2,360,823 
                     
    EXPENSES                
    Cost of product sales  916,624   807,922   2,119,103   1,799,574 
    General and administrative  2,952,100   1,979,614   5,826,038   2,897,993 
    Research and development  4,508,466   597,345   8,007,840   835,403 
    Sales and marketing  135,543   88,844   272,129   181,106 
    Total expenses  8,512,733   3,473,725   16,225,110   5,714,076 
                     
    LOSS FROM OPERATIONS  (7,394,798)  (2,569,658)  (13,207,680)  (3,353,253)
                     
    OTHER (INCOME) EXPENSE, NET                
    Loss (gain) on change in fair value of warrant liabilities  (2,075,100)  16,201,400   (4,198,000)  16,201,400 
    Interest (income) expense, net  (12,718)  57,364   (30,061)  148,121 
    Other (income), net  (2,352)  (250,114)  (2,894)  (251,272)
    Total other (income) expense, net  (2,090,170)  16,008,650   (4,230,955)  16,098,249 
                     
    LOSS BEFORE PROVISION FOR INCOME TAXES  (5,304,628)  (18,578,308)  (8,976,725)  (19,451,502)
                     
    PROVISION (BENEFIT) FOR INCOME TAXES  605   597   1,135   (22)
                     
    NET LOSS $(5,305,233) $(18,578,905) $(8,977,860) $(19,451,480)
                     
    Net loss per common share, basic and diluted $(0.18) $(2.12) $(0.31) $(2.71)
    Weighted—average number of shares outstanding, basic and diluted  28,850,451   8,746,250   28,510,014   7,174,233 
     

    QUALIGEN THERAPEUTICS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (Unaudited)

      June 30, 2021  December 31, 2020 
    ASSETS        
    Current assets        
    Cash and cash equivalents $15,232,402  $23,976,570 
    Accounts receivable, net  766,911   615,757 
    Inventory, net  1,073,335   953,458 
    Prepaid expenses and other current assets  2,033,857   2,678,894 
    Total current assets  19,106,505   28,224,679 
    Right-of-use assets  321,076   430,795 
    Property and equipment, net  253,261   247,323 
    Equipment held for lease, net  5,821   17,947 
    Intangible assets, net  183,933   187,694 
    Other assets  18,334   18,334 
    Total Assets $19,888,930  $29,126,772 
             
    LIABILITIES AND STOCKHOLDERS' EQUITY        
    Current liabilities        
    Accounts payable $784,474  $500,768 
    Accrued expenses and other current liabilities  1,923,708   746,738 
    Notes payable, current portion     131,766 
    Deferred revenue, current portion  325,988   486,031 
    Operating lease liability, current portion  270,640   254,739 
    Warrant liabilities  4,112,100   8,310,100 
    Total current liabilities  7,416,910   10,430,142 
    Notes payable, net of current portion     6,973 
    Operating lease liability, net of current portion  98,145   236,826 
    Deferred revenue, net of current portion  112,057   158,271 
    Total liabilities  7,627,112   10,832,212 
             
    Stockholders' equity        
    Series Alpha convertible preferred stock, $0.001 par value; 7,000 shares authorized; 180 shares issued and outstanding as of June 30, 2021 and December 31, 2020  1   1 
    Common stock, $0.001 par value; 225,000,000 shares authorized; 28,902,188 and 27,296,061 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively  28,902   27,296 
    Additional paid-in capital  88,058,267   85,114,755 
    Accumulated deficit  (75,825,352)  (66,847,492)
    Total stockholders' equity  12,261,818   18,294,560 
    Total Liabilities and Stockholders' Equity $19,888,930  $29,126,772 



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