On August 14, 2020 Lee’s Pharmaceutical Holdings Limited ("Lee’s Pharm" or the "Group", Stock Code: 950), an integrated research-driven and market-oriented pharmaceutical group in China, reported that it is anticipated that the Group’s will record a significant increase in its net profit attributable to the Shareholders for the six months ended 30 June 2020 (Press release, Lee’s Pharmaceutical, AUG 14, 2020, View Source [SID1234563670]).

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The Board of directors of the Company based on the preliminary assessment of the Group’s unaudited financial information currently available, it is anticipated that the unaudited net profit attributable to the Shareholders for the six months ended 30 June 2020 will increase by about 150%, as compared to that of for the six months ended 30 June 2019.

The Board considers that the improvement of the Group’s interim results was mainly attributable to an one-off compensation income recognised by the Company upon the early termination of the product license of Zanidip during the period under review; and the absence of considerable intangible assets impairment during the period under review, as compared to the non-recurring loss of approximately HK$108 million incurred in the same period last year by China Oncology Focus Limited, a 65%-owned subsidiary of the Group, which arose from the impairment of its intangible asset after the discontinuation of a Phase 3 clinical trial of Pexa-Vec for advanced liver cancer.

In recent years, the Group has made it a strategy to enhance in-house development capability and control over its assets, evidenced by the approval of generic Treprostinil in March 2020 to replace original product Remodulin for sales and marketing in China in which the switch has proved to be beneficial to both pulmonary arterial hypertension (PAH) patients in China and the Group. Given the availability of several generic lercanidipines in China, the Group believes that divesture of this product at this juncture not only brings short term financial benefit but also paves the way for the Group to launch its generic version in the near future for long term prosperity.

Dr. Benjamin Li, Executive Director and Chief Executive Officer of the Group, said, "As mentioned earlier this year, the volatile and complicated macroeconomic and geopolitical environment has already brought up inflationary, foreign currency and other issues and such tension may not be eased in the near future. Together with the COVID-19 pandemic which could remain for a longer period of time, the Group foresees the challenging environment will be persisted throughout this year. Nevertheless, the Group will stay focus on its new drug development, sales organisation reform and expansion, and cost containment, and firmly believes that all these works to be done will eventually drive growth therefor and will eventually create more value for the shareholders."

On August 14, 2020 Izabela Podgorski, Ph.D., co-leader of the Prostate Cancer Research Team at the Barbara Ann Karmanos Cancer Institute and associate professor of Pharmacology at Wayne State University (WSU) School of Medicine reported has recently obtained a new five-year, $2,028,733 million RO1 grant from the National Institutes of Health/National Cancer Institute to continue her studies into the ways that prostate cancer cells are affected by bone marrow fat and how they adapt and survive in bone in an effort to identify new ways of treating metastatic prostate cancer (Press release, Karmanos Cancer Institute, AUG 14, 2020, View Source [SID1234563669]). The grant number is CA251394-01. Dr. Podgorski was the first researcher to suggest a link between bone marrow fat cells (adipocytes) and metastatic prostate cancer in 2010.

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Her new study hypothesizes that tumor cell and bone marrow adipocyte interactions enhance prostate cancer metastatic progression, while simultaneously reducing the tumor cells’ response to current treatments.

"Bone by itself is a very harsh microenvironment that is difficult to treat," she said. "For a long time, people thought bone marrow fat cells were just energy storage units. We knew they were abundant in adult bones and that their numbers prematurely increased with obesity and metabolic diseases. But we had no idea what role, if any, they played in metastatic prostate cancer. In the past few years our studies, and others, began to reveal that when you have tumor cells in the bone marrow, they trigger some changes in the metabolism of adipocytes, and those changes ultimately help the tumor cells to survive and escape therapy."

Adipocytes are cells specialized for the storage of fat. Those cells expel lipids, which are fatty acids.

"Cancer cells take up those fatty acids and use them as energy," Dr. Podgorski said. "Tumor cells push the adipocytes to expel more lipids. They have this interactive relationship that supports (tumor) growth and promotes resistance to standard chemotherapy treatments, which includes docetaxel and cabazitaxel."

Men who are diagnosed with prostate cancer typically have a five-year survival rate of close to 100 percent if the cancer is contained in the original site, according to Dr. Podgorski. But if it metastasizes, the cancer cells will often migrate to a portion of the axial skeleton such as the hip, pelvis or ribs. Metastatic prostate cancer cells could also target a visceral organ such as the liver or travel to the lymph nodes.

According to Dr. Podgorski, 85 to 90 percent of men with metastatic prostate cancer have bone metastases. This lowers a man’s five-year survival rate to below 30 percent. If the tumor cells migrate to the bone and a visceral organ, it creates the most lethal scenario.

In Dr. Podgorski’s research, she and the researchers in her lab have discovered that marrow fat cells can modify normal functions of metabolic enzymes (such as PKM2) or inflammatory molecules (such as interleukin 1B). This helps tumor cells grow more robust and resist therapeutic agents. With the latest RO1 grant, she and her colleagues are striving to demonstrate that inhibiting lipid release by adipocytes will improve therapy response and uncover new molecular targets for therapy.

They are utilizing a variety of different techniques to identify these new molecules. These methods include 3D culture techniques, patient samples, mouse models, models that mix both human and mouse samples, proteomics (the study of cellular proteins) and RNA sequencing approaches. They will use these approaches to study previously unexplored mechanisms that link bone marrow adipocytes with the survival of cancer cells that also resist standard therapy.

Given the research they have already established about bone marrow adiposity, Dr. Podgorski is confident that this will provide progress in the development of new prostate cancer therapies.

"I think we have a lot of tools to answer the questions we’ve asked," she said. "We already identified potential molecules to target, including PKM2 or interleukin 1B. Fat cells change the activity of these targets in the tumor to help it live. They also affect other processes, such as iron metabolism. The design of this study promises to show that lipids supplied by fat cells in the bone marrow are key contributors to chemoresistance. The study is also likely to identify new mechanistic targets for therapy."

We congratulate Dr. Podgorski and her Karmanos and WSU collaborators on the prestigious RO1 grant, including James Granneman, Ph.D., Maik Hüttemann, Ph.D., Paul Stemmer, Ph.D., Elisabeth Heath, M.D. and Dr. Seongho Kim, Ph.D.

On August 14, 2020 ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, reported financial and operating results for the second quarter ended June 30, 2020 and provided a corporate strategic update (Press release, Thermogenesis, AUG 14, 2020, View Source [SID1234563668]).

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Second Quarter and Subsequent Achievements:

In April 2020, the Company’s 19%-owned joint venture, ImmuneCyte, acquired worldwide intellectual property for development of fully human antibody therapeutics for COVID-19, including four high-affinity monoclonal antibody drug candidates against SARS-CoV-2 and tools for screening and quantifying efficacy of such neutralizing antibodies. Results of the research related to these neutralizing antibody therapeutics were published in an article entitled, "Cross-neutralization antibodies against SARS-CoV-2 and RBD mutations from convalescent patient antibody libraries," in bioRxiv in June 2020.
On June 4, at the 2020 annual stockholder meeting, the Company received majority stockholder approval to authorize a new class of non-voting class B common stock. The Company intends to issue shares of the class B common stock to existing stockholders as a dividend payout. The class B common stock will be publicly traded under a separate ticker from its current class of common stock. The Company intends to use the class B shares as a vehicle to assist with future strategic acquisitions. The timing of the dividend will be determined by the Company at a later date.
On June 11, the Company filed patent applications for a point-of-care device which improves the speed and accuracy of its lateral flow immunoassays (LFIA) to detect COVID-19 IgM and IgG antibodies from a single drop of blood.
On June 23, Corning Incorporated’s Life Sciences Division began the commercial launch of the Company’s X-SERIES cell processing platform under the ThermoGenesis and Corning dual brand, as part of the previously announced global distribution agreement.
On June 29, the Company was added to the Russell Microcap Index.
On August 11, the Company entered into a supply agreement with BioHit Healthcare (Hefei) Co., Ltd., to market, under the ThermoGenesis brand, its SARS-CoV-2 IgM/IgG Antibody Test Kit, which has already received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Marketing activities are expected to begin on August 17, 2020.
"During the last few months, we adapted our strategy to develop and market a range of solutions to fight the global pandemic," stated Chris Xu, Ph.D., Chief Executive Officer of ThermoGenesis. "Notably, we contracted with a new manufacturer for a SARS-CoV-2 (COVID-19) IgM/IgG Antibody Test Kit which has already obtained EUA designation from the FDA and look forward to begin marketing next week. We plan to further differentiate this kit with the addition of a lateral flow immunoassay cartridge testing kit reader, now in the final stages of development, which is designed to improve the speed and accuracy of the COVID-19 antibody assay. Our research team has already filed a number of key patent applications around the reader, which allows for big data analysis, which we believe will be essential information as we continue to re-open our society and our economy."

Dr. Xu continued, "Also of note, was the commercial launch of our proprietary X-SERIES cell processing platform by our global distributor, Corning Life Sciences, under the ThermoGenesis and Corning dual brand. We remain committed to expanding our robust product line of automated cellular processing tools and services to become a market leader for cell banking and cell therapies, which will sustain our growth beyond this COVID-19 pandemic."

Jeff Cauble, Chief Financial Officer of ThermoGenesis, added, "The second quarter marked one of our best quarters for CAR-TXpress sales, up $400,000 from the prior period. This is an encouraging indication of the strength of Corning’s distribution and their ability to expand the market penetration for this product line. While this improvement was offset by a reduction in revenues for our other product lines as a result of the COVID-19 pandemic, we expect sales to return to prior levels as the health emergency subsides."

Financial Results for the Quarter Ended June 30, 2020

Net revenues. Net revenues for the three months ended June 30, 2020 were $2.2 million compared to $4.3 million for the three months ended June 30, 2019, a decrease of $2.1 million or 48%. The decrease was driven by AXP disposable sales, which declined from 1,403 cases sold in the quarter ended June 30, 2019 to 372 cases sold in the quarter ended June 30, 2020. The COVID-19 pandemic has had a significant impact on the cord blood industry, with fewer cord blood units being stored globally after the start of the pandemic. Additionally, with many countries and states on lockdown, some customers opted to consume their existing safety stock in lieu of placing new orders during the current quarter. The Company currently expects AXP disposable sales to increase back to their prior levels after the pandemic is over. Also contributing to the decrease was BioArchive device sales, as one device was sold in the quarter ended June 30, 2019 as opposed to no devices sold in the current quarter. Offsetting these decreases was an increase of $0.5 million in CAR-TXpress sales due to the distributor for this product line, Corning Incorporated, adding CAR-TXpress to its suite of products and beginning sales to their customers in the quarter ended June 30, 2020. Other revenue also increased by $267,000, driven by approximately $200,000 for COVID-19 testing kits.

Gross profit. Gross profit (loss) was $(2.6) million or (117)% of net revenues for the three months ended June 30, 2020 compared to $2.0 million or 45% of net revenues for the three months ended June 30, 2019, a decrease of $4.6 million. The loss was driven by an inventory reserve of approximately $3.6 million for the remaining on hand inventory of COVID-19 testing kits from ImmuneCyte recognized during the quarter ended June 30, 2020. Additionally, the quarter ended June 30, 2020 had 1,031 fewer cases of AXP disposables sold as compared to the same period in 2019. This resulted in approximately $1.0 million less in gross profit from AXP disposables. There was also a reduction in gross profit of approximately $75,000 due to no BioArchive devices being sold in the quarter ended June 30, 2020. The reduction in gross profit was offset by an increase in gross profit of approximately $225,000 due to increased CAR-TXpress sales in the quarter ended June 30, 2020 as compared to the same period in 2019.

Sales and marketing expenses. For the three months ended June 30, 2020 sales and marketing expenses were $442,000 compared to $384,000 for the three months ended June 30, 2019, an increase of $58,000 or 15%. The increase was driven by expenses related to the Company’s short-term incentive program.

Research and development expenses. Research and development expenses were $578,000 for the three months ended June 30, 2020 compared to $611,000 for the three months ended June 30, 2019, a decrease of $33,000 or 5%. The decrease was driven by development expenses for the Company’s BACS technology of approximately $100,000 which were incurred in the three months ended June 30, 2019. Those expenses were offset by increases of approximately $35,000 in development costs related to the COVID-19 cartridge reader and approximately $30,000 in expenses for the Company’s short-term incentive program which were incurred in the three months ended June 30, 2020.

General and administrative expenses. General and administrative expenses for the three months ended June 30, 2020 were $1.5 million, compared to $1.2 million for the three months ended June 30, 2019, an increase of $0.3 million or 26%. The increase is due to approximately $200,000 more for stock compensation expense in the quarter ended June 30, 2020, related to stock options granted to the Board and Company Executives during the current quarter; and approximately $100,000 in accrued expenses related to the Company’s short-term incentive program.

Interest expense. Interest expense for the three months ended June 30, 2020 was $1.3 million, as compared $1.2 million for the three months ended June 30, 2019, an increase of $103,000. The increase was driven by additional interest expense and amortization of the debt discount related to the Revolving Credit Agreement with Boyalife Asset Holding II, Inc.

Net loss. For the quarter ended June 30, 2020, the Company reported a comprehensive loss attributable to common stockholders of $6.4 million, or $(1.02) per share, based on 6,315,566 weighted average basic and diluted common shares outstanding. This compares to a comprehensive net loss of $1.3 million, or $(0.47) per share, based on 2,784,776 weighted average basic and diluted common shares outstanding for the quarter ended June 30, 2019.

Adjusted EBITDA. In addition to the results reported under US GAAP, the Company also uses a non-GAAP measure to evaluate operating performance and to facilitate the comparison of its historical results and trends. The Company uses the metric to determine operational cash flow. Adjusted EBITDA loss for the quarter ended June 30, 2020 was $4.7 million, as compared to an Adjusted EBITDA of $53,000 for the quarter ended June 30, 2019, a decrease of $4.7 million. The adjusted EBITDA decrease was primarily due to the $4.6 million decrease in gross profit in the quarter ended June 30, 2020 as compared to the same quarter in 2019, as well as approximately $175,000 more in expenses related to the Company’s short-term incentive program. A reconciliation of adjusted EBITDA loss to net loss is set forth below.

At June 30, 2020, the Company had cash and cash equivalents totaling $7.0 million, compared with $3.2 million at December 31, 2019. Working capital improved to $8.0 million at June 30, 2020 as compared to $3.2 million at December 31, 2019.

Conference Call and Webcast Information
ThermoGenesis will host a conference call today at 1:30 p.m. PT/4:30 p.m. ET. To participate in the conference call, please dial 1-844-889-4331 (domestic), 1-412-380-7406 (international) or 1-866-605-3852 (Canada). To access a live webcast of the call, please visit: View Source

A webcast replay will be available on ThermoGenesis’ website for three months by visiting the Investor page of the Company’s website at www.thermogenesis.com.

On August 14, 2020 Cardax, Inc. (OTCQB:CDXI) reported its Q2 2020 results (Press release, Cardax Pharmaceuticals, AUG 14, 2020, View Source [SID1234563667]). Highlights:

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Financial Results. Net operating loss from the same quarter last year decreased from $1,049,412 in Q2 2019 to $789,032 in Q2 2020, primarily attributed to a decrease in professional fees, salaries and wages, and selling, general, and administrative expenses. Net loss in the same period increased to $1,700,342 from $1,081,694, primarily due to amortization of non-cash discounts related to outstanding convertible notes.

ZanthoSyn Sales. Cardax net revenues from ZanthoSyn, the Company’s astaxanthin dietary supplement, increased to $134,521 in Q2 2020 from $45,391 in Q2 2019, and to $277,334 in the six-months ended June 30, 2020, from $210,363 in the same period in 2019. These increases were driven primarily driven by differences in promotional incentives and ordering patterns by the Company’s largest customer, General Nutrition Corporation ("GNC"). Sell-through decreased in these periods, primarily due to COVID-19 related impacts on GNC store sales. ("Sell-through" is defined as retail sales of ZanthoSyn to GNC customers.) The Company is also exploring additional sales channels to help expand revenues.

Funding Activities. In April 2020, the Company received a $211,300 forgivable loan through the Small Business Administration’s Paycheck Protection Program under the CARES Act, which was used primarily to support employee salaries, consistent with the focus of the legislation. In May 2020, the Company raised $460,000 through the issuance of a convertible note, $250,000 of which was used to pay off an outstanding convertible note, with the balance after issuance costs used for general working capital. An additional $225,000 was raised in July and August 2020 to date through the issuance of convertible notes to existing stockholders.

Clinical Trial Grant Submission. At the invitation of a federal government agency, Cardax submitted a grant application for a proposed 400 subject, multi-center, randomized, double-blind, placebo-controlled human clinical trial in COVID-19 with one of its astaxanthin products. The Company has also filed a patent application related to this indication. The primary endpoint of the proposed clinical trial would assess the time to recovery in hospitalized COVID-19 patients aged 65 and older.

The scientific rationale for testing astaxanthin in this indication is based on its potential to boost the immune system and reduce the extreme inflammatory response and oxidative stress that may lead to severe respiratory and coagulation complications in COVID-19 patients. Furthermore, astaxanthin has demonstrated exceptional safety in rigorous animal toxicity studies, with no evidence of immunocompromise, even at high doses.

The grant application was submitted in July 2020, and the Company does not yet know if the grant will be funded or the timing or amount of a funding award, if any.

CHASE Study. In March 2020, the Company suspended recruitment of new subjects and study visits for existing subjects due to the COVID-19 pandemic and the related governmental "stay-at-home" orders. The Company expects to resume clinical trial operations when permissible and safe to proceed. The CHASE (Cardiovascular Health Astaxanthin Supplement Evaluation) study is a randomized, double-blind, placebo-controlled trial evaluating the cardiovascular health benefits of ZanthoSyn in subjects with documented cardiovascular risk factors. In a pre-specified interim look with 40 subjects, statistically significant improvements were seen in total cholesterol, LDL cholesterol, oxidized LDL cholesterol, and blood pressure, with a strong trend in reduction of the inflammatory marker, C-reactive protein, as well as triglycerides.

The Company believes that its operations, including revenues and any public or private offerings, will continue to be affected by the ongoing COVID-19 pandemic, although the extent of the impact is uncertain at this time.

"Substantial internal effort went into preparation of the recently submitted federal grant application and we look forward to further interaction with the federal agency as it goes through the review process," said David G. Watumull, Cardax CEO. "We believe that given its excellent safety profile and strong scientific rationale, our proprietary astaxanthin product should be tested for safety and efficacy in a COVID-19 clinical trial. We also continue to diligently pursue multiple other funding opportunities for our COVID-19 program as well as for other applications. We would again like to thank our shareholders, employees, contractors, advisors, and professional service providers for all of their efforts during these difficult times. Their perseverance and commitment are key to advancing our business strategy."

Please refer to the Quarterly Report on Form 10-Q filed by the Company for additional information.

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.