Market Newsdesk

TORONTO, Nov. 13, 2020 /CNW/ – RBC Global Asset Management Inc. (“RBC GAM Inc.”) today announced November 2020 cash distributions for unitholders of RBC ETFs, as follows:

* Cash distribution per unit ($) amounts are USD for RUSB.U, RUD.U, RUBY.U, RPD.U, RID.U, and RXD.U

Unitholders of record on November 20, 2020 will receive distributions payable on November 30, 2020.

The RBC Target 2020 Corporate Bond Index ETF (RQH) is scheduled to mature effective the close of business today, and the final net asset value of RQH will be distributed to remaining unitholders on a pro rata basis.

The RBC Strategic Global Dividend Leaders ETF (RLD), RBC Strategic Global Equity Leaders ETF (RLE), RBC Quant Global Infrastructure Leaders ETF (RIG in CAD and RIG.U in USD), RBC Quant Global Real Estate Leaders ETF (RGRE in CAD and RGRE.U in USD), and RBC 6-10 Year Laddered Canadian Corporate Bond ETF (RMBO) (each a “Terminating ETF”) are scheduled to terminate effective on or about November 27, 2020. Upon termination, the final net asset value of each Terminating ETF will be announced and distributed to remaining unitholders of each respective Terminating ETF on a pro rata basis.

For further information regarding RBC ETFs, please visit www.rbcgam.com/etfs.

Commissions, management fees and expenses all may be associated with investments in exchange-traded funds (ETFs). Please read the applicable prospectus or ETF Facts document before investing. ETFs are not guaranteed, their values change frequently and past performance may not be repeated. ETF units are bought and sold at market price on a stock exchange and brokerage commissions will reduce returns. RBC ETFs do not seek to return any predetermined amount at maturity. Index returns do not represent RBC ETF returns. RBC ETFs are managed by RBC GAM Inc., a member of the RBC GAM group of companies and an indirect wholly-owned subsidiary of Royal Bank of Canada.

About RBC
Royal Bank of Canada is a global financial institution with a purpose-driven, principles-led approach to delivering leading performance. Our success comes from the 86,000+ employees who bring our vision, values and strategy to life so we can help our clients thrive and communities prosper. As Canada’s biggest bank, and one of the largest in the world based on market capitalization, we have a diversified business model with a focus on innovation and providing exceptional experiences to our 17 million clients in Canada, the U.S. and 34 other countries. Learn more at rbc.com.‎

We are proud to support a broad range of community initiatives through donations, community investments and employee volunteer activities. See how at rbc.com/community-social-impact.

About RBC Global Asset Management

RBC Global Asset Management (RBC GAM) is the asset management division of Royal Bank of Canada (RBC) and includes money managers BlueBay Asset Management and Phillips, Hager & North Investment Management. RBC GAM is a provider of global investment management services and solutions to institutional, high-net-worth and individual investors through separate accounts, pooled funds, mutual funds, hedge funds, exchange-traded funds and specialty investment strategies. The RBC GAM group of companies manage approximately $520 billion in assets and have approximately 1,400 employees located across Canada, the United States, Europe and Asia.

SOURCE RBC Global Asset Management Inc.

CHICAGO, Nov. 13, 2020 /PRNewswire/ — In celebration of America Recycles Day, Conagra Brands is honoring its employees who are keeping materials out of landfills through innovative recycling and waste reduction measures. Eight Conagra facilities across the United States and Mexico have been awarded Zero Waste Champion status for diverting more than 95 percent of waste materials from landfills. These facilities helped Conagra achieve an 84 percent companywide waste diversion rate in the 2020 fiscal year.

Conagra emphasizes a systematic and strategic approach to reduce the amount of waste its facilities generate to maximize the use of resources for the future. For unavoidable waste, comprised mainly of food and packaging materials, Conagra encourages innovative ways to donate, reuse or recycle, such as composting or diverting organic waste to animal feed. The Zero Waste Champion facilities set standards to advance the company’s zero waste efforts and serve as a model for all production facilities to follow.

“We commend our employees’ ingenuity and dedication to finding solutions that reduce landfill waste,” said Dave Biegger, executive vice president and chief supply chain officer at Conagra Brands. “Our Zero Waste Champion facilities demonstrate Conagra’s commitment to finding new ways to be more environmentally responsible and nourish the planet.”

This year’s honorees include frozen, snacks, international and grocery manufacturing facilities. The 2020 Zero Waste Champion facilities are:

• Brookston, Ind.
• Hamburg, Iowa
• Irapuato, Mexico
• Lakeview, Iowa
• Mankato, Minn.
• Maple Grove, Minn.
• Oakdale, Calif.
• Waseca, Minn.

About Conagra Brands




Conagra Brands, Inc. (NYSE: CAG), headquartered in Chicago, is one of North America’s leading branded food companies. Guided by an entrepreneurial spirit, Conagra Brands combines a rich heritage of making great food with a sharpened focus on innovation. The company’s portfolio is evolving to satisfy people’s changing food preferences. Conagra’s iconic brands, such as Birds Eye®, Duncan Hines®, Healthy Choice®, Marie Callender’s®, Reddi-wip®, and Slim Jim®, as well as emerging brands, including Angie’s® BOOMCHICKAPOP®, Duke’s®, Earth Balance®, Gardein®, and Frontera®, offer choices for every occasion. For more information, visit www.ConagraBrands.com.

For all media inquiries, please contact:

Tim Wrona, Conagra Brands
312-549-5400
[email protected]

 

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SOURCE Conagra Brands, Inc.

NEW YORK, Nov. 13, 2020 /PRNewswire/ — Meredith Corporation‘s (NYSE: MDP) Martha Stewart Living marks the 30^th anniversary of the legendary brand’s magazine with its December issue featuring fresh new ideas to get into the holiday spirit with advice on entertaining, decorating, cooking, gift giving, beauty and more, as well as a look back at Martha Stewart Living’s start, its most iconic moments over the last three decades, editors’ all-time favorite recipes from the archives and some of its most popular magazine covers. 

Martha Stewart Living launched in 1990 with a mission to teach and inspire readers eager to learn from Martha and her team, who shared their expertise in everything from decorating, gardening, crafting, and organizing to cooking, baking, entertaining, and beyond. The magazine offered a pioneering personality-driven editorial approach marked by careful attention to detail, visual glossaries, thoughtful instruction, and boundless creative insights that has proven timeless and continues to resonate with its audience today. As Martha wrote in the first issue of Martha Stewart Living, “Our families and our homes are the centers of our lives. This magazine will always be filled with ways to make those homes more beautiful, more comfortable, and more full of life and light and joy for those we love.” 

The December issue of Martha Stewart Living will be on newsstands November 20. Expanded content is available online this month, with new ongoing features debuting at marthastewart.com, including photo galleries, recipe slideshows, special tribute videos and an in-depth profile celebrating Martha’s career featuring exclusive interviews with Martha, her inner circle, and celebrities Chrissy Teigen and Antoni Porowski.

Martha Stewart Living Editor in Chief Elizabeth Graves said in her December issue Editor’s Letter, “We’ve pulled out all the stops (during a pandemic, no less!) to celebrate the holidays in signature Martha style, even if our gatherings are a little smaller this December. You’ll find festive meals, sweets and treats galore, gifts to buy or DIY, and a sleighful of ways to get yourself and your home in the spirit. We also take a moment to trumpet our three-decade milestone in “30 Years of Living,” a homecoming of sorts with the talented alumni who shaped the magazine. I feel fortunate to have worked with so many of these creative minds. As for the current team, I could not be prouder of what they’ve accomplished in 2020. And from all of us, thank you, dear reader, for your support. Happy holidays, and here’s to many good things in the new year!”

Here are highlights of the December issue:

• The Sweetest Invitation: Get an up-close look inside Martha’s cocktails and cookies party at her Bedford farm.
• A Feast of Favorites: Just in time to inspire your holiday menu, the magazine’s food editors share the Living recipes they simply love—and have to make every December, such as Martha’s classic eggnog and favorite potato pancakes.
• 30 Years of Living: A highlight reel of the magazine’s history, filled with iconic images, lasting lessons, and memories from alums.
• Bundles of Joy: Handmade with love (and a few simple supplies), 12 chic DIY gifts that you’ll love to make and are sure to delight. Plus, a roundup of thoughtful, high-quality presents you can buy.
• Simply Stunning: Star-quality décor ideas that take inspiration from classic Amish and Shaker designs.

Doug Olson, President of Meredith Magazines said, “Congratulations to Martha, the original influencer, and the talented Martha Stewart Living team on this significant milestone which speaks to Martha’s singular vision and inspiring lifestyle approach that’s all about celebrating life’s special moments and elevating the everyday. Meredith is proud to partner with Martha on this beloved magazine brand.”

In the issue, renowned chefs, tastemakers and friends pay tribute to Martha by sharing their favorite memories, learnings, and insights on what they admire most. Here are a few:

• “Martha is just curious about the world, always asking questions and learning from people around her—and she loves food as much as I do. She ‘lives young.’ I think she’s even more of a millennial than I am!” —José Andrés, chef and founder of World Central Kitchen
• “Martha and I have homes next door to each other, and sometimes we greet each other on horseback in our adjoining woods. Our friendship has continued since we first worked together in 1983.” —Ralph Lauren
• “I’d like to thank Martha for putting some of the enchantment back into housekeeping and for exemplifying a new domesticity that we’re going to need lots more of in the 21st century: committed, inventive, sustainable, and truly beautiful.” —chef, author, and activist Alice Waters
• “What I have learned from Martha is her genuine care for the tiniest particulars, things that to most might seem unimportant. She is the hardest worker I have known, with determination to achieve her goals and succeed on every count.” —chef Daniel Boulud
• “Martha was the first food guest in the early days of The Tonight Show Starring Jimmy Fallon. She made a sandwich on-air and handed it to me. I didn’t even want to eat it. I wanted to sneak it into my dressing room and preserve it.” —Questlove, drummer and joint front man for the Roots
• “Just because it hasn’t been done is no reason not to do it. Martha showed us that you could break down barriers and do it your own way.” —Susan Spungen, renowned food stylist, cookbook author and founding food editor of Martha Stewart Living
• “Martha is an American icon. She’s one of those people who are instantly recognizable by a single name. Her reach extends to all of America, not only within the food world. She was the first person to give me a platform by including me on her show in the ’90s, when I came here from Sweden.” —chef Marcus Samuelsson

Since launching 30 years ago, the Martha Stewart Living magazine brand has grown to encompass digital, video, social and e-commerce offerings, with an audience of over 12 million digital users, 10 million social followers and more than 7 million magazine readers.* The brand is celebrating its 30th across its social media channels all month long at https://www.instagram.com/marthastewart and https://www.facebook.com/marthastewart/ with hashtag #30YearsofLiving.

As Martha reflects in this issue’s “From Martha” column, “I will be forever proud of the abundance of ideas in our pages, of the many thousands of recipes and projects our readers have used and enjoyed. We created this magazine for everyone, because good living can be learned, honed, and enjoyed by all. I want to thank you for taking pleasure in what we’ve accomplished, and for staying with us, whether you have been a reader from the beginning or discovered the magazine more recently. And to my cherished employees and colleagues, who shared my long-ago vision that beautiful how-to information could transform your life for the better, another thank-you. This anniversary is a collective dream come true.”

*Sources: Google Analytics (October 2020), AAM and internal reporting

ABOUT MARTHA STEWART LIVING
Martha Stewart Living has elevated the everyday of consumers for 30 years now. From expert advice to original ideas, the brand always provides its audience with inspiration to live a more beautiful life. With more than 7 million magazine readers, 12 million digital users monthly, and a social following of more than 10 million, Martha Stewart Living attracts a vast audience of curious and enthusiastic consumers. Martha Stewart Living is produced by Meredith Corporation (NYSE: MDP).

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SOURCE Meredith Corporation

THOMASVILLE, Ga., Nov. 13, 2020 /PRNewswire/ — Flowers Foods, Inc. (NYSE: FLO), producer of Nature’s Own, Dave’s Killer Bread, Wonder, Tastykake, and other bakery foods, today announced that its board of directors has declared a quarterly dividend of $0.20 per share, an increase of 5.3% over the same quarter last year. This is the 73rd consecutive quarterly dividend paid by the company and is payable on December 11, 2020 to shareholders of record on November 27, 2020.

About Flowers Foods

Headquartered in Thomasville, Ga., Flowers Foods, Inc. (NYSE: FLO) is one of the largest producers of packaged bakery foods in the United States with 2019 sales of $4.1 billion. Flowers operates bakeries across the country that produce a wide range of bakery products. Among the company’s top brands are Nature’s Own, Dave’s Killer Bread, Wonder, and Tastykake. Learn more at www.flowersfoods.com.

FLO-CORP FLO-IR

Forward-Looking Statements

Statements contained in this press release that are not historical facts are forward-looking statements. Forward-looking statements relate to current expectations regarding our future financial condition, performance and results of operations and the ultimate impact of the novel strain of coronavirus (COVID-19) pandemic on our business, results of operations and financial condition, planned capital expenditures, long-term objectives of management, supply and demand, pricing trends and market forces, and integration plans and expected benefits of transactions and are often identified by the use of words and phrases such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “should,” “will,” “would,” “is likely to,” “is expected to” or “will continue,” or the negative of these terms or other comparable terminology. All forward-looking statements are subject to risks and uncertainties that could cause actual results to differ from those projected. Other factors that may cause actual results to differ from the forward-looking statements contained in this release and that may affect the company’s prospects in general include, but are not limited to, (a) the ultimate impact of the COVID-19 pandemic and measures taken in response thereto, including, among other things, temporary or ongoing bakery closures, on our business, results of operations and financial condition, which are highly uncertain and are difficult to predict, (b) general economic and business conditions and the competitive conditions in the baked foods industry, including promotional and price competition, (c) changes in consumer demand for our products, including changes in consumer behavior, trends and preferences, including health and whole grain trends, and the movement toward more inexpensive store-branded products, (d) the success of productivity improvements and new product introductions, (e) a significant reduction in business with any of our major customers including a reduction from adverse developments in any of our customer’s business, (f) fluctuations in commodity pricing, (g) energy and raw material costs and availability and hedging and counterparty risk, (h) our ability to fully integrate recent acquisitions into our business, (i) our ability to achieve cash flow from capital expenditures and acquisitions and the availability of new acquisitions that build shareholder value, (j) our ability to successfully implement our business strategies, including those strategies the company has initiated under Project Centennial, which may involve, among other things, the deployment of new systems and technology and an enhanced organizational structure; (k) our ability to integrate recent acquisitions or the acquisition or disposition of assets at presently targeted values, (l) consolidation within the baking industry and related industries, (m) disruptions in our direct-store delivery system, including litigation or an adverse ruling from a court or regulatory or government body that could affect the independent contractor classification of our independent distributors, (n) increasing legal complexity and legal proceedings that we are or may become subject to, (o) product recalls or safety concerns related to our products, and (p) the failure of our information technology systems to perform adequately, including any interruptions, intrusions or security breaches of such systems or risks associated with the planned implementation of a new enterprise resource planning system. The foregoing list of important factors does not include all such factors, nor necessarily present them in order of importance. In addition, you should consult other public disclosures made by the company, including the risk factors included in our most recently filed Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (“SEC”) and disclosures made in other filings with the SEC and company press releases, for other factors that may cause actual results to differ materially from those projected by the company. We caution you not to place undue reliance on forward-looking statements, as they speak only as of the date made and are inherently uncertain. The company undertakes no obligation to publicly revise or update such statements, except as required by law.

View original content:http://www.prnewswire.com/news-releases/flowers-foods-declares-dividend-301172773.html

SOURCE Flowers Foods, Inc.

NEW YORK, Nov. 13, 2020 /PRNewswire/ — AIkido Pharma Inc. (Nasdaq: AIKI) (“AIkido” or the “Company”) today announced the publication of positive results from a study of antiviral activity of FDA approved drugs in a peer-reviewed article in the Proceedings of the National Academy of Sciences of the United States of America (PNAS).  The publication reports studies on newly discovered antiviral compounds that were developed using a computer modeling approach.  The lead compounds were found to have broad-spectrum antiviral activity, inhibiting influenza virus, Ebola, Marburg, MERS-CoV, SARS-CoV, and SARS-CoV2, the virus that causes COVID-19.

Mr. Anthony Hayes, CEO of AIkido stated, “The results of this peer reviewed study provide encouraging data for Company’s newly licensed compounds. I am particularly excited with the data that demonstrates inhibition of SARS-CoV2 by the lead compounds.  This represents yet another solid validation of University of Maryland, Baltimore’s (UMB) antiviral platform, to which we are the exclusive licensee.  In addition, this article provides a significant amount of substantive information about the technology we have licensed from UMB.  I encourage our shareholders who want more information about the technology to review the article.”

The full article is available at https://www.pnas.org/content/early/2020/11/11/2012939117

The Company previously executed a Master License Agreement with UMB for specific antiviral compounds discovered by UMB that seek to inhibit replication of multiple viruses, including Influenza virus, SARS-CoV, SARS-CoV2, MERS-CoV, Ebolavirus and Marburg virus. The technology is covered by two patent applications already on file with the United States Patent and Trademark Office. The Company previously executed a Sponsored Research Agreement with UMB to support the development of the technology.

About AIkido Pharma Inc.

AIkido Pharma Inc. was initially formed in 1967 and is a biotechnology company with a diverse portfolio of small-molecule anti-cancer therapeutics.  The Company’s platform consists of patented technology from leading universities and researchers and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and Wake Forest University. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer, acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). In addition, we are constantly seeking to grow our pipeline to treat unmet medical needs in oncology.  The Company is also developing a broad-spectrum antiviral platform that may potentially inhibit replication of multiple viruses including Influenza virus, SARS-CoV (coronavirus), MERS-CoV, Ebolavirus and Marburg virus.

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the SEC, not limited to Risk Factors relating to its business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

Contact:

Investor Relations:      

Hayden IR
Brett Maas, Managing Partner
Phone: (646) 536-7331
Email: [email protected] 
www.haydenir.com

AIkido Pharma Inc.:   

Phone: 212-745-1373
Email: [email protected] 
www.aikidopharma.com

 

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SOURCE AIkido Pharma Inc.

CARLSBAD, Calif., Nov. 13, 2020 /PRNewswire/ — Qualigen Therapeutics, Inc. (Nasdaq: QLGN) announces that Michael Poirier, President, Chief Executive Officer and Chairman, has issued a letter to Qualigen’s stockholders. The full text is as follows:

To My Fellow Stockholders,

Since our last business update in August, Qualigen Therapeutics has made significant progress in advancing our strategic plan, including the following highlights:

AS1411. We are excited to be moving forward with our lead compound AS1411, a nucleolin-targeting DNA aptamer drug candidate for the treatment of COVID-19 and other viruses. Preclinical research conducted at the University of Louisville (UofL) has demonstrated that AS1411 has potent antiviral activity against SARS-CoV-2, the coronavirus responsible for COVID-19.  Importantly, we believe AS1411 holds potential as a broad antiviral therapeutic agent, which could significantly expand its applications and commercial potential.

In October 2020, we received a positive response to our Pre-Investigational New Drug (Pre-IND) application meeting request from the U.S. Food and Drug Administration (FDA) that is in general agreement with our planned clinical development of AS1411 for the treatment of COVID-19. We are pleased with the FDA’s response and plan to move forward with filing the IND application in order to initiate a Phase 2a clinical trial in the first half of calendar year 2021.

Like everyone else, we are heartened by news of recent advancements with COVID-19 vaccines; however, we believe there will still be a long-term and significant market opportunity for innovative therapies such as AS1411 to treat COVID-19 and other viral-based respiratory diseases.  Furthermore, we believe that the urgency placed on regulators to advance potential therapies for COVID-19, in addition to vaccines, may provide us an accelerated path to potential approval of our first drug candidate. The data and infrastructure resulting from this may, in turn, serve to streamline subsequent clinical trials for additional indications for AS1411 to combat other viruses, both currently known and those that might affect us in the future.    

In this regard, we entered into manufacturing agreements with STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec, and with IRISYS LLC in order to ensure adequate supply of AS1411 for our anticipated clinical trials. We believe that if AS1411 is approved by the FDA for commercial usage, these manufacturing agreements will help assure an efficient and large-scale rollout of this product.

Finally, to further enhance our AS1411 intellectual property portfolio, we jointly filed a U.S. provisional patent application entitled “Methods of inhibiting or treating coronavirus infection, and methods for delivering an anti-nucleolin agent” with UofL.  If AS1411 can successfully serve as a protective defense (or prophylaxis) against, as well as treat, COVID-19 or other viral-based diseases, such as seasonal influenza, this would be a very exciting usage for our technology.  We believe that for use as a prophylaxis, AS1411 could be administered by means of inhalers, nose spray or eye drops to individuals who have recently come in contact with SARS-CoV-2, or are at high risk of contracting the virus.  

ALAN, RAS-F and STARS™.  The balance of our therapeutic pipeline primarily focuses on fighting cancer, and we continue to make progress with each of our drug and device candidates.

• Expanded research agreement with UofL for ALAN cancer drug candidate. In October 2020, we announced an amended sponsored research agreement with UofL to advance ALAN (the AS1411 aptamer attached to a gold nanoparticle). UofL will perform preclinical studies on acute myeloid leukemia and we aim to file an IND and initiate a Phase 1 clinical trial later in calendar year 2021. Additionally, UofL will perform studies on other indications including glioblastoma, a malignant brain cancer that is difficult to treat because most drugs cannot pass the blood-brain membrane, and non-small cell lung cancer, which comprises approximately 85% of the 1.6 million global lung cancer cases each year.

• Signed exclusive license agreement with UofL for RAS interaction inhibitor drug candidates. In July 2020, we signed an exclusive worldwide license agreement with UofL for the intellectual property covering the RAS-F family of RAS oncogene protein-protein interaction inhibitor small molecule drug candidates. We continue to work with UofL to evaluate these compounds and identify a lead drug candidate to stop tumor growth, especially in pancreatic, colorectal and lung cancers.  Although drugs that target downstream signaling of RAS are available, they have shown limited clinical activity, most likely because RAS acts like a hub that activates multiple effectors. As such, blocking any single pathway, or even two, typically provides disappointing clinical effect. By contrast, the intended mechanism of action for the RAS-F small molecules is to inhibit or block the binding of mutated RAS to their effector proteins, thereby leaving the proteins from mutated RAS unable to cause further harm. 

• Issuance of STARS technology U.S. patent. In August 2020, the United States Patent and Trademark Office issued patent No. 10,744,258 entitled “Devices and Methods for On-Line Whole Blood Treatment” regarding our Selective Target Antigen Removal System (STARS) technology. STARS is a DNA/RNA-based treatment for the removal of viral and tumor-produced compounds from a patient’s blood. While still early in development, this technology is based on the core, commercialized science behind our FastPack® products, and could have widespread application.

FastPack® diagnostic products. As of the date of this letter, communications with the FDA concerning the requested Emergency Use Authorization for our FastPack COVID-19 antibody test indicate that our regulatory review is still in queue.  We are confident that the data we have provided to the FDA show that our test meets or exceeds the efficacy guidelines for approval of an EUA, and we are frustrated by the unusually long delay.  We still believe that a rapid, accurate, point-of-care testing system like FastPack would be beneficial as vaccines for COVID-19 – which generate antibodies for limited periods of time – begin release in 2021.     

Furthermore, we have made important strategic moves recently to advance distribution and next-generation versions of our core FastPack “laboratory in a pouch” technology.  In October 2020, we entered into a commercialization agreement with China’sYi Xin Zhen Duan Jishu (Suzhou) Ltd. for them to develop, manufacture and sell new generations of diagnostic test systems based on FastPack.  In addition, Yi Xin Zhen Duan Jishu will have rights to manufacture and sell our current generations of FastPack products in China. We were pleased to enter this agreement as it provides non-dilutive upfront funding plus potential future royalties, and China is a region we would not otherwise have entered with FastPack.

Corporate updates. In August 2020, we welcomed Amy Broidrick to our Board of Directors.  Ms. Broidrick’s background includes key roles in the successful worldwide launches and marketing of such notable drugs as VYTORIN®, Zetia® and Celebrex®. It is already evident she will be a valuable asset to Qualigen given her expertise in corporate development, marketing and business innovation with global organizations, as well as with small-cap companies.

Lastly, to fund the continued development of our pipeline, we raised $18 million in two registered-direct offerings under separate purchase agreements in July and August 2020.  With a cash balance of $14.5 million as of September 30, 2020, we believe Qualigen has the necessary capital to fund our clinical trial for AS1411 and to advance our pipeline through calendar year 2021.  Additionally, we continue to be opportunistic and evaluate strategic relationships that provide potential to enhance our pipeline in oncology and build long-term shareholder value. 

As I mentioned, we are delighted with our progress to date and are very excited about our momentum and Qualigen’s future prospects. I would like to thank our employees for their outstanding efforts and commitment, and our investors for their continued support.

Sincerely,

Michael Poirier

President, Chief Executive Officer and Chairman

Financial Results for the Fiscal Second Quarter Ended September 30, 2020

Total revenues for the three months ended September 30, 2020 were $0.8 million compared with $1.2 million for the same period in 2019, with all revenues in both periods derived from the sale of diagnostic products. The decrease was primarily due to fewer tests performed as the COVID-19 pandemic resulted in a decrease in patient non-emergency visits to physician offices, clinics and small hospitals.

General and administrative expense was $2.7 million for the three months ended September 30, 2020 compared with $0.2 million for the prior-year period. The difference is largely attributable to the addition of expenses associated with operating as a publicly traded company in the current period.

Research and development expense was $0.9 million for the three months ended September 30, 2020 compared with $0.2 million for the prior-year period. The increase is related to advancing Qualigen’s therapeutic pipeline and work on its COVID-19 antibody diagnostic test and FastPack PRO instrument.

Loss from operations for the three months ended September 30, 2020 increased to $3.7 million from $0.3 million for the prior-year period.  Net loss for the three months ended September 30, 2020 was $8.1 million, or $0.41 per share, compared with a net loss of $0.4 million, or $0.06 per share, for the same period of 2019.  Net loss for the 2020 period included non-cash charges of $4.4 million related to the change in fair value of warrant liabilities, as well as additional non-cash charges totaling $1.2 million for stock-based compensation expense.

Financial Results for the Six Months Ended September 30, 2020

Total revenues for the six months ended September 30, 2020 were $1.7 million compared with $2.7 million for the same period in 2019, with all revenues in both periods derived from the sale of diagnostic products. The decrease was primarily due to fewer tests performed as the COVID-19 pandemic resulted in a decrease in patient non-emergency visits to physician offices, clinics and small hospitals.

General and administrative expense was $4.6 million for the six months ended September 30, 2020 compared with $0.5 million for the prior-year period. The increase is largely attributable to the addition of expenses associated with operating as a publicly traded company in the current period.

Research and development expense was $1.5 million for the six months ended September 30, 2020 compared with $0.9 million for the prior-year period. The difference is primarily related to increased spending for the therapeutic pipeline.

Loss from operations for the six months ended September 30, 2020 increased to $6.3 million from $0.8 million for the prior-year period.  Net loss for the six months ended September 30, 2020 was $26.7 million, or $1.87 per share, compared with a net loss of $1.0 million, or $0.17 per share, for the same period of 2019.  Net loss for the 2020 period included non-cash charges of $20.6 million related to the change in fair value of warrant liabilities, as well as additional non-cash charges totaling $1.6 million for stock-based compensation expense.

Qualigen had cash and cash equivalents of $14.5 million as of September 30, 2020, as a result of the $18 million in gross proceeds raised during the second quarter of fiscal year 2021. The Company believes its cash and cash equivalents are sufficient to fund its anticipated operations through calendar year 2021.

About Qualigen Therapeutics, Inc.
Qualigen Therapeutics, Inc. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack® System, which has been used successfully in diagnostics for almost 20 years. The Company’s cancer therapeutics pipeline includes ALAN (AS1411-GNP), RAS-F and STARS™. ALAN (AS1411-GNP) is a DNA coated gold nanoparticle cancer drug candidate that has the potential to target various types of cancer with minimal side effects. The foundational nucleolin-targeting DNA aptamer of ALAN, AS1411, is also being studied as a drug candidate for use in treating COVID-19 and other viral-based infectious diseases.   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. Because Qualigen’s therapeutic candidates are still in the development stage, Qualigen’s only products that are currently commercially available are FastPack System diagnostic instruments and test kits, used in physician offices, clinics and small hospitals around the world. The FastPack System menu includes rapid point-of-care diagnostic tests for cancer, men’s health, hormone function, vitamin D status and antibodies against SARS-CoV-2.  Qualigen’s facility in Carlsbad, California is FDA and ISO Certified and its FastPack product line is sold worldwide by its commercial partner Sekisui Diagnostics, LLC. For more information on Qualigen Therapeutics, Inc., please visit https://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 potential future development, testing, efficacy, approval, manufacturing and commercialization of product candidates, including the possible effectiveness of AS1411 against COVID-19 or other viral infections. Actual events or results may differ from the Company’s expectations. For example, there can be no assurance that 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 or therapeutic devices; that preclinical or clinical development of the Company’s drugs or therapeutic devices will be successful; 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 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 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; that the Company will be able to maintain or expand market demand and/or market share for the Company’s diagnostic products generally, particularly in view of COVID-19-related  deferral of patients’ physician-office visits and FastPack reimbursement pricing challenges; that adoption and placement of FastPack PRO System instruments (which are the only FastPack instruments on which the Company’s SARS-CoV-2 IgG test kits can be run) will be widespread; that the Company will be able to manufacture the FastPack PRO System instruments and SARS-CoV-2 IgG test kits successfully; that any commercialization of the FastPack PRO System instruments and SARS-CoV-2 IgG test kits will be profitable; or that the FDA will ultimately approve an Emergency Use Authorization for the Company’s SARS-CoV-2 IgG test.  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 (including events beyond the Company’s control, such as epidemics and resulting changes) can be found in the Company’s prior filings with the Securities and Exchange Commission, 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.

—Tables to Follow—

 

 

 

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SOURCE Qualigen, Inc.

CUPERTINO, Calif., Nov. 13, 2020 /PRNewswire/ — DURECT Corporation (Nasdaq: DRRX) today presented additional safety data and efficacy signals from its Phase 1b clinical trial of DUR-928 in nonalcoholic steatohepatitis (NASH) patients in a poster presentation at The AASLD Liver Meeting Digital Experience ™ (TLMdX) 2020.

“The additional safety and efficacy data presented, including improvements in multiple biomarkers of liver health such as a significant reduction in cytokeratin-18 among the patients who also experienced at least a 10% reduction in liver fat, continue to strengthen the promising profile of DUR-928 for NASH,” stated Eric Lawitz, M.D., Texas Liver Institute, University of Texas Health San Antonio and principal investigator of the study. “Together with previously reported overall global reduction from baseline of liver enzymes, liver fat, stiffness as measured by imaging and serum lipids, this additional biomarker data suggests that epigenetic modulation by DUR-928 is worthy of further study in NASH patients.”

James E. Brown, D.V.M., President and CEO of DURECT, added, “The safety and efficacy profiles demonstrated with DUR-928 not only in this NASH trial but in our Phase 2a trial in alcoholic hepatitis, demonstrate potential of this epigenetic regulator to treat multiple acute organ injury and chronic liver diseases. We look forward to continuing the evaluation of DUR-928 in our clinical studies and potentially bringing a life-saving treatment option to patients in need.”

Data presented at The Liver Meeting further demonstrated that DUR-928 was well tolerated at all three doses (50mg, 150mg, and 600mg) with no serious adverse events reported.

Improvements in Biomarkers Data Summary (Day 28 vs Baseline)

% change from baseline at the end of dosing (median at day 28)

Biomarker Data Along With Previously Reported Improvements in Liver Enzymes, Imaging and Serum Levels (Day 28 vs Baseline)

* Indicates p-value <0.05; ** indicates p < 0.01; *** indicates p <0.001

ALT

 (
alanine aminotransferase); AST (aspartate aminotransferase); GGT (gamma-glutamyl transferase); MRI-PDFF (Magnetic Resonance Imaging – Proton Density Fat Fraction) is a non-invasive measure of the proportion of liver tissue which is composed of fat; FibroScan is a specialized ultrasound machine that measures the stiffness of liver tissue. LDL-C ( Low-Density Lipoprotein – Cholesterol); Non-HDL-C (Total cholesterol excluding High-Density Lipoprotein-Cholesterol); QD (once a day); BID (twice a day); CK-18 (cytokeritin 18)

Additionally, in subjects with baseline triglyceride (TG) levels ≥200mg/dL (n=16), there was a 24% reduction at the end of the 4-week dosing period (p<0.01). 

About DUR-928 Phase 1b Trial

The study was a randomized, open label, multi center US study to evaluate safety, pharmacokinetics and signals of biological activity of DUR-928 in NASH patients with stage 1-3 fibrosis. A total of 65 patients completed the study. DUR-928 was orally administered daily at 50 mg (n=23), 150 mg (n=21), or 600 mg (300 mg BID (n=21)). Patients in this trial were dosed daily for 4 weeks and followed up for an additional 4 weeks.

About DUR-928

DURECT’s lead drug candidate, DUR-928, is an endogenous sulfated oxysterol and an epigenetic regulator. It represents a new class of therapeutics with a unique mechanism of action. DUR-928 epigenetically modulates the expression of multiple clusters of master genes that are involved in many important cell signaling pathways, through which it stabilizes mitochondria, reduces lipotoxicity, regulates inflammatory or stress responses, and promotes cell survival.

About NASH

Nonalcoholic steatohepatitis (NASH) is the most severe and progressive form of nonalcoholic fatty liver disease (NAFLD) and the most common chronic liver disease worldwide, with an estimated prevalence of more than 10% of adults in the United States, Europe, Japan, and other developed countries, expected to double by 2030. No drug is currently approved for treatment of NAFLD or NASH.

About DURECT Corporation

DURECT is a biopharmaceutical company committed to transforming the treatment of acute organ injury and chronic liver diseases by advancing novel and potentially lifesaving therapies based on its endogenous epigenetic regulator program. DUR-928, the company’s lead drug candidate is in clinical development for the potential treatment of alcoholic hepatitis (AH), COVID-19 patients with acute liver or kidney injury, and nonalcoholic steatohepatitis (NASH). DURECT’s proprietary drug delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. One late-stage product candidate in this category is POSIMIR® (bupivacaine sustained-release solution), an investigational locally-acting, non-opioid analgesic intended to provide up to three days of continuous pain relief after surgery. For more information about DURECT, please visit www.durect.com and follow us on Twitter https://twitter.com/DURECTCorp.

DURECT Forward-Looking Statement

The statements in this press release regarding clinical development plans for DUR-928, including the potential use of DUR-928 to treat COVID-19 patients with liver or kidney injury, the potential use of DUR-928 to treat acute organ injuries, such as AH, and chronic liver diseases, such as NASH, the life saving potential of DUR-928, and the potential use of POSIMIR to provide pain relief after surgery are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, the risks that the clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, protocol changes or lack of available patients, the risk that future clinical trials of DUR-928 are not started when anticipated, take longer to conduct than anticipated, do not confirm the results from earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy or the life saving potential of DUR-928 in a statistically significant manner, the risk that the FDA will not approve POSIMIR or approve POSIMIR with a limited label, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or the Company’s other product candidates, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties and risks related to our ability to obtain capital to fund operations and expenses. Further information regarding these and other risks is included in DURECT’s Form 10-Q filed on November 3, 2020 under the heading “Risk Factors.”

NOTE: POSIMIR^® and SABER^® are trademarks of DURECT Corporation.  Other referenced trademarks belong to their respective owners.  DUR-928 and POSIMIR are investigational drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities for any indication.

 

 

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SOURCE DURECT Corporation