On August 14, 2020 Qualigen Therapeutics, Inc. (NASDAQ: QLGN) (Qualigen or the Company) reported business highlights and financial results for the fiscal year 2021 first quarter, ended June 30, 2020 (Press release, Qualigen, AUG 14, 2020, View Source [SID1234563666]).

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Business highlights for the fiscal first quarter and recent weeks include the following:

Raised a total of $18 million in new equity financing. Under separate purchase agreements in July and August 2020, the Company raised a total of $18 million in cash (before expenses) from registered-direct placements of common stock and warrants with a single institutional investor. As of today, the Company has $16 million in cash and cash equivalents. The Company believes its cash and cash equivalents are sufficient to fund its operations into calendar 2022.
Signed exclusive license agreement with the University of Louisville for RAS interaction inhibitor drug candidates. In July 2020, Qualigen signed an exclusive worldwide license agreement with the University of Louisville (UofL) for the intellectual property covering the RAS-F family of RAS oncogene protein-protein interaction inhibitor small molecule drug candidates. The Company will evaluate these patent-pending compounds in order to identify a lead drug candidate for further development against one or more cancers.
Signed exclusive license agreement with the University of Louisville, with plans to develop AS1411 for the treatment of COVID-19. In June 2020, the Company signed an exclusive license agreement with the UofL to facilitate development of Qualigen’s AS1411 DNA aptamer as a drug candidate for the treatment of COVID-19, the disease caused by the novel coronavirus SARS-CoV-2.
Engaged NFL Hall of Famer Mike Haynes as advisor to the Company and spokesperson for the FastPack rapid diagnostic system. In July 2020, the Company engaged Pro Football Hall of Fame and College Football Hall of Fame inductee Mike Haynes as an advisor to the Company and as spokesperson for Qualigen’s FastPack rapid diagnostic system. Since receiving an elevated PSA test result using a FastPack immunoassay test at a 2008 Hall of Fame event sponsored by Qualigen and the American Urological Association, Mr. Haynes has been a prominent advocate for prostate cancer testing.
Commenced commercial shipments of its FastPack COVID-19 antibody test. In July 2020, Qualigen announced it began commercial shipments of its FastPack SARS-CoV-2 IgG diagnostic test for COVID-19 antibodies. This test has been submitted to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA), and previously the Company submitted an official notification to the FDA of its plans to exercise its right to commence sales while the EUA is pending.
Received U.S. patent Notice of Allowance for its STARS technology. In June 2020, the United States Patent and Trademark Office issued Qualigen a Notice of Allowance for a U.S. patent titled "Devices and Methods for On-Line Whole Blood Treatment" regarding the Company’s Selective Target Antigen Removal System (STARS) technology. STARS is a DNA/RNA-based treatment product candidate for the removal of viral and tumor-produced compounds from a patient’s blood.
Management Commentary

"I am pleased with the significant progress Qualigen has made since our May 2020 reverse recapitalization transaction to expand and advance our development programs," stated Michael Poirier, President and Chief Executive Officer of Qualigen. "We recently raised $18 million in capital, which we will use to advance our therapeutic pipeline of promising cancer and infectious disease drug candidates, including AS1411, ALAN and RAS-F, as well as to further our FastPack diagnostics platform."

First Quarter Financial Results

Total revenues for the three months ended June 30, 2020 were $0.9 million compared with $1.5 million for the same period in 2019. The decrease was primarily due to the COVID-19 pandemic resulting in a decrease in patient visits to physician offices, clinics and small hospitals, which reduced the number of FastPack tests performed. All revenues in both periods were derived from diagnostic products.

General and administrative expense was $2.0 million for the three months ended June 30, 2020 compared with $0.3 million for the prior-year period. The increase is largely attributable to one-time expenses related to the reverse recapitalization transaction and other public company expenses not incurred in the prior-year period.

Total R&D expense was $0.6 million for the three months ended June 30, 2020 compared with $0.7 million for the prior-year period. Higher expenses related to sponsored therapeutics research at the University of Louisville and COVID-19 antibody diagnostic test development were offset by the absence in the 2020 period of related-party research and development costs associated with a diagnostics development project with Sekisui Diagnostics, LLC which was terminated in May 2019.

Loss from operations for the three months ended June 30, 2020 increased to $2.6 million from a $0.5 million loss from operations for the prior-year period. Net loss for the three months ended June 30, 2020 was $18.6 million, or $2.12 per share, compared with a net loss of $0.6 million, or $0.11 per share, for the same period of 2019. Net loss for the three months ended June 30, 2020 included a non-cash charge of $16.2 million for the fair value of warrant liabilities.

Qualigen had cash and cash equivalents of $2.3 million as of June 30, 2020. Subsequent to the close of the quarter, in July and August 2020 the Company raised an additional $18 million in gross proceeds from registered-direct equity offerings.

Conference Call

Qualigen senior management will host a business update conference call and live audio webcast beginning at 4:30 p.m. Eastern time on August 18, 2020. Participants are encouraged to pre-register for the conference call using this link. Callers who pre-register will be given a conference passcode and unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. A webcast of the call may also be accessed at Qualigen’s Investor Relations page at Qualigen Business Update Conference Call. Those without internet access or unable to pre-register may dial in by calling 1-866-777-2509 (U.S.) or 1-412-317-5413 (International).

A replay of the webcast will be available beginning approximately one hour after the completion of the live conference call at Qualigen Business Update Conference Call. A dial-in replay of the call will be available until August 25, 2020 by calling 1-877-344-7529 (U.S.) or 1-412-317-0088 (International) and providing the passcode 10147089.