Market Newsdesk

SHANGHAI and WENZHOU, China, Nov. 16, 2020 /PRNewswire/ — Hebron Technology Co., Ltd. (“Hebron” or the “Company”) (Nasdaq: HEBT), a provider of innovative comprehensive solutions through an integration of technology, industry, and finance, today announced it has changed its name from Hebron Technology Co., Ltd. to Nisun International Enterprise Development Group Co., Ltd (“Nisun International”). In addition, the Company’s ticker symbol on the Nasdaq Capital Market has changed to “NISN” from “HEBT,” effective before market open on November 16, 2020.

“The year 2020 marks an important milestone in the Company’s evolution,” said Mr. Xiaoyun Huang, Chairman and Chief Executive Officer of Nisun International. “The name Nisun International Enterprise Development Group better reflects the transformation in the Company’s management and focus that took place in recent months. The new corporate name reflects our current core business and enables different service segments to integrate their brands into one corporate identity. With this change, we remain focused on providing our customers with the best-in-class comprehensive technology solutions and services.”

The corporate name change to Nisun International does not affect the rights of the Company’s shareholders and no action is required by shareholders with respect to the name change. The number of outstanding common shares of the Company is not affected by the name and ticker symbol changes.

About Nisun International Enterprise Development Group Co., Ltd

Nisun International Enterprise Development Group Co., Ltd (NASDAQ: NISN) provides innovative comprehensive solutions for financial institutions, small and micro businesses, and individuals in China by integrating technology, industry, and finance. Through its subsidiaries, the Company provides fintech services, consulting services, business services, and intermediary services to clients in a variety of industries. Its innovations include an open fintech ecosystem for financial institutions, a credit system, an efficient liquidity system for the agriculture sector, and financial advisory intermediary services. Nisun International’s technology-driven model deepens the link between industry and finance, serving and enabling the real economy and capturing opportunities in the new technology era. For more information, please visit http://www.fintaike.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains information about Nisun’s view of its future expectations, plans and prospects that constitute forward-looking statements. Actual results may differ materially from historical results or those indicated by these forward-looking statements as a result of a variety of factors including, but not limited to, risks and uncertainties associated with its ability to raise additional funding, its ability to maintain and grow its business both in legacy and new segments, variability of operating results, its ability to maintain and enhance its brand, its development and introduction of new products and services, the successful integration of acquired companies, technologies and assets into its portfolio of products and services, marketing and other business development initiatives, competition in the industry, general government regulation, economic conditions, dependence on key personnel, the ability to attract, hire and retain personnel who possess the technical skills and experience necessary to meet the requirements of its clients, and its ability to protect its intellectual property. Nisun encourages you to review other factors that may affect its future results in Nisun’s registration statement and in its other filings with the Securities and Exchange Commission. Nisun assumes no obligation to update or revise its forward-looking statements as a result of new information, future events or otherwise.

Contacts:

Nisun International Enterprise Development Group Co., Ltd
Investor Relations
Shaokang (Ken) Lu
Tel: +86 (21) 2357-0055
Email: [email protected]

ICR, LLC
Tel: +1 203 682 8233
Email: [email protected]

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SOURCE Hebron Technology Co., Ltd.

TOKYO and CARLSBAD, Calif., Nov. 16, 2020 /PRNewswire/ — Viasat Inc. (NASDAQ: VSAT), a global communications company, and Infostellar Inc., a Japanese Ground Segment as a Service (GSaaS) start-up, today announced it signed a Real-Time Earth (RTE) agreement. Through the collaboration, Viasat will act as a market channel lead for Infostellar services in the U.S., Infostellar will act as a Japanese market channel lead for Viasat’s growing RTE network and Viasat will become a preferred supplier of antennas for Infostellar’s expanding network of ground stations.

Viasat’s RTE network 
provides GSaaS globally to the commercial and government earth observation and remote sensing communities. The RTE service offers affordability and reduced latency through automation and geographic diversity on a pay-per-use basis. Viasat’s RTE service supports next-generation and legacy low earth orbit (LEO) satellites using the S-, X- and Ka-bands, which enables satellite operators to meet current and future data requirements.

John Williams, vice president, RTE services at Viasat, commented, “Viasat is focused on changing how data is delivered from space. For example, our RTE solution increases the value of data by tapping into our global RTE antenna network that is strategically located worldwide to reduce latency. By aligning with Infostellar, we expect to drive the RTE industry forward as we grow our network in terms of locations, like in Japan, and cloud-based GSaaS capabilities.”

Infostellar’s flagship service, StellarStation, is a cloud-based software platform that enables the virtualization of ground stations around the world to provide GSaaS to leading companies in the emerging space economy. With backing from key industry players such as, Airbus Ventures, Daiwa Energy & Infrastructure, Mitsubishi UFJ Lease & Finance, and Sony, Infostellar is poised for substantial growth in the global space arena. 

Naomi Kurahara, founder and CEO of Infostellar, added, “We are incredibly excited about the opportunity to join with Viasat in this cooperative RTE agreement. Our services and approach to the marketplace are very complementary and compatible, as are our diverse locations in key world markets. Having Viasat RTE as our market channel partner in the U.S., as well as our preferred supplier of ground stations truly positions Infostellar right at the center of the growing global GSaaS market.”

About Viasat
Viasat is a global communications company that believes everyone and everything in the world can be connected. For more than 30 years, Viasat has helped shape how consumers, businesses, governments and militaries around the world communicate. Today, the Company is developing the ultimate global communications network to power high-quality, secure, affordable, fast connections to impact people’s lives anywhere they are—on the ground, in the air or at sea. To learn more about Viasat, visit: www.viasat.com, go to Viasat’s Corporate Blog, or follow the Company on social media at: Facebook, Instagram, LinkedIn, Twitter or YouTube.

About Infostellar
Infostellar is a satellite ‘Ground Segment as a Service’ (GSaaS) provider. We provide flexible and scalable ground station services enabled by our cloud platform, ‘StellarStation’, which virtualizes ground station networks. By lowering the barriers to entry in the ground segment, Infostellar empowers newspace businesses to build better missions and improve the quality of their service. Founded in 2016, Infostellar is headquartered in Tokyo, Japan and has its European office in the UK.

For more information, visit https://www.infostellar.net/  
Logos and images can be found at https://infostellar.net/media-kit  

About StellarStation
StellarStation is a flexible, scalable, satellite ground station sharing platform. After a one-time setup, satellite operators can access any ground station across our global network. StellarStation also enables ground station owners to monetise their unused capacity by sharing it with satellite operators.
https://www.stellarstation.com/

Forward-Looking Statement
This press release contains forward-looking statements that are subject to the safe harbors created under the Securities Act of 1933 and the Securities Exchange Act of 1934. Forward-looking statements include statements about Viasat’s RTE GSaaS offering, including the benefits it provides to end-users; partnership with Infostellar; and benefits of the collaboration—including market channel access and Viasat being a preferred supplier of ground stations for Infostellar’s expanding network of ground stations. Readers are cautioned that actual results could differ materially and adversely from those expressed in any forward-looking statements. Factors that could cause actual results to differ include: our ability to successfully implement our business plan with Infostellar; risks associated with the construction, launch and operation of satellites, including the effect of any anomaly or operational failure; the impact of the COVID-19 pandemic on our business, suppliers, consumers, customers, and employees or the overall economy; contractual problems, product defects, manufacturing issues or delays, regulatory issues, and technologies not being developed according to anticipated schedules, or that do not perform according to expectations. In addition, please refer to the risk factors contained in Viasat’s SEC filings available at www.sec.gov, including Viasat’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date on which they are made. Viasat undertakes no obligation to update or revise any forward-looking statements for any reason.

Copyright © 2020 Viasat, Inc. All rights reserved. Viasat, the Viasat logo and the Viasat signal are registered trademarks of Viasat, Inc. All other product or company names mentioned are used for identification purposes only and may be trademarks of their respective owners.

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SOURCE Viasat, Inc.

NEW YORK, Nov. 16, 2020 /PRNewswire/ — Q BioMed Inc. (OTCQB: QBIO), announces that it has received a patent from the U.S. Patent and Trademark Office for its Uttrocide-B molecule. The Patent is titled “Uttroside-B and Derivatives Thereof as Therapeutics for Hepatocellular Carcinoma”. Q BioMed has the exclusive rights to the technology through an agreement with the Rajiv Gandhi Centre for Biotechnology, an Autonomous Institute under the Department of Biotechnology, Government of India and the Oklahoma Medical Research Foundation. The Method Of Use patent covers the use of a novel pharmaceutical for the treatment of hepatocellular carcinoma. International and additional U.S. claims are currently under prosecution for the technology which addresses a severe unmet need for a safe and effective drug to treat hepatocellular carcinoma (HCC), the most common form of liver cancer.

“This patent allowance in the U.S. comes at an opportune time as we are scaling up manufacturing and preparing Uttroside-B for an investigational new drug (IND) application with the U.S. FDA. Upon the FDA’s clearance, we anticipate initiating proof of concept studies by the end of next year,” stated Q BioMed CEO Denis Corin.

Uttroside-B has shown ten times the potency against HCC as compared to the current standard of care drug in early pre-clinical investigation. Currently, there are only two approved first-line therapies for HCC. Challenges with current treatments include patients becoming resistant to the specific drugs, adverse side effects, and high costs. An estimated 700,000 people are diagnosed with HCC each year, with the global market for liver cancer drugs expected to grow to $3.9 billion by 2027.

About Q BioMed Inc.

Q BioMed Inc. is a biotech acceleration and commercial stage company focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets the strategic resources, developmental support, and expansion capital needed to ensure they meet their developmental potential, enabling them to provide products to patients in need‏.

Please visit http://www.QBioMed.com and sign up for regular updates.

Q BioMed Media Contact:

Denis Corin

CEO

Investor Relations:

Keith Pinder

+1(404) 995-6671
[email protected]

Forward-Looking Statements:

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions, or circumstances on which any such statement is based, except as required by law.

 

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SOURCE Q BioMed Inc.

HOUSTON, Nov. 16, 2020 /PRNewswire/ — Orbital Energy Group, Inc. (Nasdaq: OEG) (“Orbital Energy” or the “Company”) today reported unaudited financial results for the three and nine months ended September 30, 2020.

Financial and Operating Highlights:

• Reported total revenues of $13.6 million for the third quarter of 2020, compared to $6.1 million for the third quarter of 2019, an increase of 124%, primarily attributable to the addition of Reach Construction Group (“Reach”) and the Company’s Orbital Power Services group;
• Gross profit was $2.4 million for the third quarter of 2020, compared to $1.4 million for the third quarter of 2019 with the improvement mainly due to increased revenues; this improvement is expected to persist throughout the remainder of 2020 and into 2021;
• Gross margin was 17.3% for the third quarter of 2020, compared to 23.4% for the third quarter of 2019;
• Operating loss was $6.3 million for the third quarter of 2020, compared to $3.7 million in the prior year period, mainly due to higher SG&A expenses associated with Orbital Power Services and the addition of Reach during the second quarter;
• Held Cash and cash equivalents of $4.1 million and Restricted cash of $3.6 million as of September 30, 2020; and
• Total backlog was $52.0 million at September 30, 2020, up from $46.4 million at June 30, 2020, reflecting backlog growth at both Reach Construction and Orbital Power Services.

Commentary

“In the third quarter, we continued our evolution into a diversified infrastructure services provider,” said Jim O’Neil, vice chairman and CEO of Orbital Energy. “Our recently acquired solar engineering, procurement, and construction services company, Reach Construction Group, is engaged for multiple, utility scale solar programs starting in the fourth quarter and has a robust pipeline of additional project opportunities. Further, our new Orbital Power Services division, which focuses on electric transmission and distribution services, keeps gaining traction and increasing industry recognition. This resulted in several storm-related projects, which generated additional revenues for us in the third quarter and has extended into the fourth quarter.”

Mr. O’Neil added, “As utilities continue to integrate renewable generation into their transmission and distribution systems, we believe it is imperative that infrastructure providers have the technology, expertise and construction resources they need to conduct these multi-faceted projects while adhering to increasing environmental, social and governance (ESG) standards. Looking ahead, we expect customer activity will continue to increase, as conditions improve since the onset of COVID-19 and renewable energy trends drive utilities’ capital investment plans. We believe Orbital Energy Group is well suited to meet these needs, with our ability to offer a diverse service offering for these growing industry demands.”

Conference Call

Management will host a conference call today, November 16, 2020 at 8:30 AM ET to discuss these results as well as recent corporate developments. After management’s opening remarks, there will be a question and answer period. To access the call, please dial (888) 734-0328 and provide conference ID 6598596. For international callers, please dial (678) 894-3054. The live webcast of the conference call and accompanying slide presentation can be accessed through the ‘Events & Presentations’ page of the Orbital Energy Investor Relations website (www.orbitalenergygroup.com).

For those unable to attend the live call, a telephonic replay will be available until December 2, 2020. To access the replay of the call dial (855) 859-2056 or (404) 537-3406 and provide conference ID 6598596. An archived copy of the webcast and slide presentation will also be available on the ‘Events & Presentations’ page of the Orbital Energy Investor Relations website.

About Orbital Energy Group

Orbital Energy Group, Inc. (Nasdaq: OEG), formerly known as CUI Global, Inc., is creating a diversified infrastructure services platform through the acquisition and development of innovative companies. Orbital Energy’s group of businesses includes: Orbital Gas Systems, Inc., Orbital Power Services and Orbital Solar Services. Orbital Gas Systems is a 30-year leader in innovative gas solutions, serving the energy, power and processing markets through the design, installation and commissioning of industrial gas sampling, measurement and delivery systems. Orbital Power Services provides engineering, construction, maintenance and emergency response solutions to the power, utilities and midstream markets. Orbital Solar Services provides engineering, procurement and construction (“EPC”) expertise in the renewable energy industry and established relationships with solar developers and panel manufacturers in the utility scale solar market. As a publicly traded company, Orbital Energy is dedicated to maximizing shareholder value. But most important, our commitment to conduct business with a high level of integrity, respect, and philanthropic dedication allows the organization to make a difference in the lives of their customers, employees, investors and global community.

For more information please visit: www.orbitalenergygroup.com 

Important Cautions Regarding Forward Looking Statements

This document contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements are subject to risks and uncertainties that could cause actual results to vary materially from those projected in the forward-looking statements. The Company may experience significant fluctuations in future operating results due to a number of economic, competitive, and other factors, including, among other things, our reliance on third-party manufacturers and suppliers, government agency budgetary and political constraints, new or increased competition, changes in market demand, and the performance or reliability of our products. These factors and others could cause operating results to vary significantly from those in prior periods, and those projected in forward-looking statements. Additional information regarding these and other factors, which could materially affect the Company and its operations, are included in certain forms the Company has filed with the Securities and Exchange Commission.

Investor Relations:
KCSA Strategic Communications
David Hanover
T: 212-896-1220
[email protected]  

 

 

 

 

 

Reconciliation of Non-GAAP Financial Measures

EBITDA, Adjusted EBITDA and Adjusted Net Income (loss) are non-GAAP financial measures and are reconciled in the table below. These non-GAAP financial measures do not represent funds available for management’s discretionary use and is not intended to represent cash flow from operations. EBITDA, Adjusted EBITDA and Adjusted Net Income (loss) should not be construed as a substitute for net loss or as a better measure of liquidity than cash flow from operating activities, which is determined in accordance with United States generally accepted accounting principles (“GAAP”). EBITDA, Adjusted EBITDA and Adjusted Net Income (loss) exclude components that are significant in understanding and assessing the company’s results of operations and cash flows. In addition, EBITDA, Adjusted EBITDA and Adjusted Net Income (loss) are not terms defined by GAAP and as a result our measure of EBITDA, Adjusted EBITDA and Adjusted Net Income (loss) might not be comparable to similarly titled measures used by other companies. However, EBITDA, Adjusted EBITDA and Adjusted Net Income (loss) are used by management to evaluate, assess and benchmark the company’s operational results and the company believes EBITDA, Adjusted EBITDA, and Adjusted Net Income (loss) are relevant and useful information which are often reported and widely used by analysts, investors and other interested parties in the Company’s industry. Accordingly, the Company is disclosing this information to permit a more comprehensive analysis of its operating performance, to provide an additional measure of performance and liquidity and to provide additional information with respect to the Company’s ability to meet future debt service, capital expenditure and working capital requirements. Adjusted Net Income (loss) eliminates the amortization expenses associated with intangible assets acquired with Orbital Gas Systems Limited, CUI-Canada and Reach Construction as well as non-cash expenses associated with impairments, Gains on sale of businesses, non-cash gains and losses related to the Company’s equity method investment in VPS and stock and stock options for compensation, royalties and services during the period.

 

 

 

 

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SOURCE Orbital Energy Group, Inc.

LOUISVILLE, Ky., Nov. 16, 2020 /PRNewswire/ — Kentucky Fried Chicken® is bringing back feelings of nostalgia this holiday season with the re-release of some of its most famous holiday buckets. Since the 1960s, KFCs around the world have created different holiday-themed buckets year after year.

In the spirit of continuing this time-honored tradition, the fried chicken chain is going retro and bringing back the iconic 1966 and 1971 U.S. holiday buckets, as well as a new, vintage-inspired design for 2020.

Both the replica designs of the 1966 and 1971 holiday buckets have been recreated down to the smallest details, including the retired tagline, “North America’s Hospitality Dish,” featured on the 1966 bucket. The new holiday bucket design for 2020 was inspired by the brand’s heritage buckets, but rounds out this year’s lineup with some modern flair.

“KFC bucket meals have been bringing people together around the dinner table for more than 60 years,” said Andrea Zahumensky, KFC U.S. CMO. “Even though the holidays may look a little different this year, we hope our holiday buckets help everyone hark back to a simpler time and bring some comfort and joy to your homes and your families throughout the season.”

KFC holiday buckets will be available in all U.S. restaurants beginning November 24. Limited quantities will be available of the 1966 and 1971 commemorative buckets. Fans can complete their holiday tablescape by collecting all three buckets in the 2020 holiday collection.

However you’re celebrating this year, you can get your favorite KFC bucket meals by visiting your local KFC restaurant or ordering ahead for delivery or pickup where available through kfc.com, DoorDash, Postmates, Uber Eats, Grubhub, Seamless.com, or the Seamless app.

KFC first introduced its now iconic bucket packaging in 1957 when Pete Harman, the owner of the first KFC franchised restaurant, purchased buckets and began advertising a bucket meal, which had 14 pieces of chicken, mashed potatoes, and gravy. Today, more than 60 million buckets of Kentucky Fried Chicken are sold in the U.S. each year.

About KFC
KFC Corporation, based in Louisville, Ky., is the world’s most popular chicken restaurant chain. KFC specializes in Original Recipe®, Extra Crispy™, Kentucky Grilled Chicken® and Extra Crispy™ Tenders, Hot Wings®, KFC Famous Bowls®, Pot Pies, freshly hand prepared chicken sandwiches, biscuits and homestyle side items. There are more than 24,000 KFC restaurants in over 145 countries and territories around the world. KFC Corporation is a subsidiary of Yum! Brands, Inc., Louisville, Ky. (NYSE: YUM). For more information, visit www.kfc.com. Follow KFC on Facebook (www.facebook.com/kfc), Twitter (www.twitter.com/kfc) and Instagram (www.instagram.com/KFC)

 

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SOURCE KFC

TOKYO, Nov. 16, 2020 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced the presentation of new data in acute myeloid leukemia (AML) at the virtual 62^nd American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 5-8, 2020.

Nine Astellas-sponsored abstracts focused on patients with AML with a positive FLT3 mutation (FLT3mut+) are being presented, comprising five oral presentations, three posters and one online-only presentation. Oral presentations include new data on the use of gilteritinib, either as monotherapy or in combination, across the FLT3mut+ AML patient spectrum – from those newly diagnosed, to relapsed or refractory patients who have been pre-treated with other tyrosine kinase inhibitors (TKIs) – as well as a secondary analysis of the Phase 3 ADMIRAL trial.  

“The research being presented at ASH will shed light on critical unmet needs and continuing progress against AML, which remains a hard-to-treat cancer in spite of continuing medical advances,” said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head, Astellas. “Several presentations will describe the effects of gilteritinib in a wide range of AML patients with a positive FLT3 mutation. We also look forward to discussing our Phase 3 LACEWING trial in progress, as well as findings from the STREAMLINE study related to real-world FLT3 testing rates in AML patients, both upon diagnosis and after relapse.”

Gilteritinib is approved as XOSPATA^® in the U.S. and selected other countries for the treatment of adult patients who have relapsed or refractory FLT3mut+ AML.

Oral Presentations

Title: A Phase 1 Study of Gilteritinib in Combination with Induction and Consolidation Chemotherapy in Patients with Newly Diagnosed AML: Final Results (Abstract 24)

• Presenting author: Dr. Keith W. Pratz, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore
• Session Date/Time: Saturday, Dec. 5, 7:30 a.m. PST

Title: Phase 3, Multicenter, Open-Label Study of Gilteritinib, Gilteritinib Plus Azacitidine, or Azacitidine Alone in Newly Diagnosed FLT3 Mutated (FLT3mut+) Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Induction Chemotherapy (Trial in progress) (Abstract 27)

• Presenting author: Dr. Eunice S. Wang, Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, N.Y.
• Session Date/Time: Saturday, Dec. 5, 8:15 a.m. PST

Title: Comparison of Gilteritinib and Salvage Chemotherapy in FLT3-Mutated Acute Myeloid Leukemia on the Number Needed to Treat for Various Clinical Outcomes: A Secondary Analysis of the ADMIRAL Trial (Abstract 213)

• Presenting author: Amer M. Zeidan, Yale University School of Medicine and Yale Cancer Center, New Haven, Conn.
• Session Date/Time: Saturday, Dec. 5, noon PST

Title: Efficacy and Safety of Venetoclax in Combination with Gilteritinib for Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia in the Expansion Cohort of a Phase 1b Study (Abstract 333) (Supported by AbbVie, Astellas and Genentech)

• Presenting author: Dr. Naval G. Daver, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston
• Session Date/Time: Sunday, Dec. 6, 10:15 a.m. PST

Title: Clinical Outcomes in Patients with Relapsed/Refractory Acute Myeloid Leukemia Treated with Gilteritinib Who Received Prior Midostaurin or Sorafenib (Abstract 334)

• Presenting author: Dr. Alexander E. Perl, Abramson Cancer Center, University of Pennsylvania, Philadelphia
• Session Date/Time: Sunday, Dec. 6, 10:30 a.m. PST

Poster Presentations
Poster presentations are available online from Saturday, Dec. 5, 7 a.m. PST to Monday, Dec. 7, 3:30 p.m. PST.

Title STREAMLINE – Retrospective Cohort Study of Relapsed or Refractory (R/R) FLT3-Mutated Acute Myeloid Leukemia (AML): Real-World Treatment, Testing Patterns, and Outcomes (Abstract 2826) 

• Presenting author: Dr. Amer M. Zeidan, Yale University School of Medicine and Yale Cancer Center, New Haven, Conn.

Title: Clinical Outcomes Following Treatment with Gilteritinib or Quizartinib in Patients with Relapsed/Refractory FLT3-ITD+ Acute Myeloid Leukemia (Abstract 995) 

• Presenting author: Dr. Alexander E. Perl, Abramson Cancer Center, University of Pennsylvania, Philadelphia

Title: Pain and Opioid Use in Patients with FLT3 Mutation-Positive Relapsed/Refractory AML: A Subanalysis of Patient-Reported Outcomes from the ADMIRAL Trial (Abstract 2568) 

• Presenting author: Manasee V. Shah, Global Health Economics and Outcomes Research, Astellas

Online-Only Presentation

Title: Real-World Use of FLT3-TKIs in R/R FLT3-Mutated AML in the United States (Abstract 4413) 

Astellas-Supported Satellite Symposium 
Astellas will support the following pre-meeting Friday Satellite Symposia Live Webinar.

Title: Consensus or Controversy? Investigators Discuss Clinical Practice Patterns and Available Research Data Guiding the Management of Acute Myeloid Leukemia (Part 3 of a 4-part Series)

• Session Date/Time: Friday, Dec. 4, 3-6 p.m. PST

About Gilteritinib
Gilteritinib was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global rights to develop, manufacture and commercialize gilteritinib. Gilteritinib is available as XOSPATA^® in the U.S., Japan and selected European countries, among others, for the treatment of adult patients who have relapsed or refractory FLT3mut+ AML.¹ Gilteritinib is an FMS-like tyrosine kinase 3 (FLT3) inhibitor with demonstrated activity against FLT3-ITD, a common driver mutation that presents with a high burden and poor prognosis, and FLT3-TKD mutations.²

About XOSPATA^® (gilteritinib) in the United States
XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with an FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.³

Important Safety Information

Contraindications
XOSPATA is contraindicated in patients with hypersensitivity to gilteritinib or any of the excipients. Anaphylactic reactions have been observed in clinical trials.

Warnings and Precautions

Differentiation Syndrome (See BOXED WARNING) 3% of 319 patients treated with XOSPATA in the clinical trials experienced differentiation syndrome. Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal if not treated. Symptoms of differentiation syndrome in patients treated with XOSPATA included fever, dyspnea, pleural effusion, pericardial effusion, pulmonary edema, hypotension, rapid weight gain, peripheral edema, rash, and renal dysfunction. Some cases had concomitant acute febrile neutrophilic dermatosis. Differentiation syndrome occurred as early as 2 days and up to 75 days after XOSPATA initiation and has been observed with or without concomitant leukocytosis. If differentiation syndrome is suspected, initiate dexamethasone 10 mg IV every 12 hours (or an equivalent dose of an alternative oral or IV corticosteroid) and hemodynamic monitoring until improvement. Taper corticosteroids after resolution of symptoms and administer corticosteroids for a minimum of 3 days. Symptoms of differentiation syndrome may recur with premature discontinuation of corticosteroid treatment. If severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids, interrupt XOSPATA until signs and symptoms are no longer severe.

Posterior Reversible Encephalopathy Syndrome (PRES) 1% of 319 patients treated with XOSPATA in the clinical trials experienced posterior reversible encephalopathy syndrome (PRES) with symptoms including seizure and altered mental status. Symptoms have resolved after discontinuation of XOSPATA. A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI). Discontinue XOSPATA in patients who develop PRES.

Prolonged QT Interval XOSPATA has been associated with prolonged cardiac ventricular repolarization (QT interval). 1% of the 317 patients with a post-baseline QTc measurement on treatment with XOSPATA in the clinical trial were found to have a QTc interval greater than 500 msec and 7% of patients had an increase from baseline QTc greater than 60 msec. Perform electrocardiogram (ECG) prior to initiation of treatment with XOSPATA, on days 8 and 15 of cycle 1, and prior to the start of the next two subsequent cycles. Interrupt and reduce XOSPATA dosage in patients who have a QTcF >500 msec. Hypokalemia or hypomagnesemia may increase the QT prolongation risk. Correct hypokalemia or hypomagnesemia prior to and during XOSPATA administration.

Pancreatitis 4% of 319 patients treated with XOSPATA in the clinical trials experienced pancreatitis. Evaluate patients who develop signs and symptoms of pancreatitis. Interrupt and reduce the dose of XOSPATA in patients who develop pancreatitis.

Embryo-Fetal Toxicity XOSPATA can cause embryo-fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with XOSPATA and for at least 6 months after the last dose of XOSPATA. Advise males with female partners of reproductive potential to use effective contraception during treatment with XOSPATA and for at least 4 months after the last dose of XOSPATA. Pregnant women, patients becoming pregnant while receiving XOSPATA or male patients with pregnant female partners should be apprised of the potential risk to the fetus.

Adverse Reactions
Fatal adverse reactions occurred in 2% of patients receiving XOSPATA. These were cardiac arrest (1%) and one case each of differentiation syndrome and pancreatitis. The most frequent (≥5%) nonhematological serious adverse reactions reported in patients were fever (13%), dyspnea (9%), renal impairment (8%), transaminase increased (6%) and noninfectious diarrhea (5%).

7% discontinued XOSPATA treatment permanently due to an adverse reaction. The most common (>1%) adverse reactions leading to discontinuation were aspartate aminotransferase increased (2%) and alanine aminotransferase increased (2%).

The most frequent (≥5%) grade ≥3 nonhematological adverse reactions reported in patients were transaminase increased (21%), dyspnea (12%), hypotension (7%), mucositis (7%), myalgia/arthralgia (7%), and fatigue/malaise (6%).

Other clinically significant adverse reactions occurring in ≤10% of patients included: electrocardiogram QT prolonged (9%), hypersensitivity (8%), pancreatitis (5%), cardiac failure (4%), pericardial effusion (4%), acute febrile neutrophilic dermatosis (3%), differentiation syndrome (3%), pericarditis/myocarditis (2%), large intestine perforation (1%), and posterior reversible encephalopathy syndrome (1%).

Lab Abnormalities Shifts to grades 3-4 nonhematologic laboratory abnormalities in XOSPATA treated patients included phosphate decreased (14%), alanine aminotransferase increased (13%), sodium decreased (12%), aspartate aminotransferase increased (10%), calcium decreased (6%), creatine kinase increased (6%), triglycerides increased (6%), creatinine increased (3%), and alkaline phosphatase increased (2%).

Drug Interactions
Combined P-gp and Strong CYP3A Inducers Concomitant use of XOSPATA with a combined P-gp and strong CYP3A inducer decreases XOSPATA exposure which may decrease XOSPATA efficacy. Avoid concomitant use of XOSPATA with combined P-gp and strong CYP3A inducers.

Strong CYP3A inhibitors Concomitant use of XOSPATA with a strong CYP3A inhibitor increases XOSPATA exposure. Consider alternative therapies that are not strong CYP3A inhibitors. If the concomitant use of these inhibitors is considered essential for the care of the patient, monitor patient more frequently for XOSPATA adverse reactions. Interrupt and reduce XOSPATA dosage in patients with serious or life-threatening toxicity.

Drugs that Target 5HT2B Receptor or Sigma Nonspecific Receptor Concomitant use of XOSPATA may reduce the effects of drugs that target the 5HT2B receptor or the sigma nonspecific receptor (e.g., escitalopram, fluoxetine, sertraline). Avoid concomitant use of these drugs with XOSPATA unless their use is considered essential for the care of the patient.

Specific Populations
Lactation: Advise women not to breastfeed during treatment with XOSPATA and for 2 months after the last dose.

Please see Full Prescribing Information including BOXED WARNING for additional safety information.

About Astellas
Astellas Pharma Inc., is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+^® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties.

Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.

References

1. Data on file. Northbrook, IL. Astellas Pharma Inc.
2. Daver N, Schlenk RF, Russel NH, Levis MJ. (2019). Targeting FLT3 mutations in AML: review of current knowledge and evidence. Leukemia 33: 299-312.
3. XOSPATA [package insert]. Northbrook, IL: Astellas Pharma Inc.

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SOURCE Astellas Pharma Inc.

ROCKVILLE, Md., Nov. 16, 2020 /PRNewswire/ — Choice Privileges, the award-winning loyalty program from Choice Hotels International, Inc. (NYSE: CHH), is once again offering its popular annual “Members Only Madness” promotion. Now through November 21, Choice Privileges members will have the chance to unlock daily deals, including discounts on stays, deals on gift cards, as well as bonus points, when booking a trip at any Choice-branded hotel, or now at over 50 luxury all-inclusive AMResorts^®-branded properties.

Choice Privileges loyalty program members will receive a daily email alerting them of each “Members Only Madness” deal, which can also be found at CPMadness.com. Guests must be enrolled in the Choice Privileges rewards program to take advantage of this promotion, as well as enjoy other immediate program perks. Signing up is free and can be done easily in person at any Choice Hotels property, on the Choice Hotels mobile app, or online by going to www.choicehotels.com/choice-privileges.

As an added bonus during the holiday season, Choice Hotels is offering a 30% discount to all guests when booking a stay at a Choice-branded hotel on Cyber Monday, which is Monday, November 30. 

“We know this year has truly been unprecedented, so we want to thank our more than 46 million Choice Privileges members for continuing to choose to stay with us by providing them with access to exclusive perks during our Members Only Madness promotion. We hope this week filled with surprise rewards will bring a little extra holiday cheer to our incredible loyalty members,” said Jamie Russo, vice president, loyalty programs and customer engagement, Choice Hotels. “We don’t want anyone to feel left out during the holidays, so we’re doubling down on our efforts to reward this season by offering a 30% discount to all guests who book a stay with us on Cyber Monday.”   

Membership for Choice Privileges is free, offering fast rewards, including bonus points, airline miles, or credits for premium coffee and shared rides through the exclusive, one-of-a kind, Your Extras program. Choice Privileges members must book their travel directly on ChoiceHotels.com, the Choice Hotels mobile app, or by calling 800.4CHOICE.

Choice Privileges, named a top hotel loyalty program by both USA Today’s 10 Best Readers’ Choice Awards and U.S. News & World Report, announced a series of enhancements earlier this year to help provide its members with additional flexibility amid the COVID-19 pandemic. Updates include reducing the number of nights required to earn elite status; pausing the forfeiture of loyalty points until Dec. 31, 2020; and initiating upgrades, extensions and bonuses for current elite members.

Choice Hotels’ Commitment to Clean initiative and flexible cancellation policies are designed to help give guests added peace of mind when booking a Choice-branded hotel. All Choice-branded hotels are participating in Commitment to Clean, an initiative that builds upon the strong foundation of franchisees’ long-standing dedication to cleanliness with enhanced training and best practices for deep cleaning, disinfecting and social distancing.

About Choice Hotels

^®
Choice Hotels International, Inc. (NYSE: CHH) is one of the largest lodging franchisors in the world. With more than 7,100 hotels, representing nearly 600,000 rooms, in over 40 countries and territories as of September 30, 2020, the Choice^® family of hotel brands provide business and leisure travelers with a range of high-quality lodging options from limited service to full-service hotels in the upscale, midscale, extended-stay and economy segments. The award-winning Choice Privileges^® loyalty program offers members benefits ranging from everyday rewards to exceptional experiences. For more information, visit www.choicehotels.com.

© 2020 Choice Hotels International, Inc. All rights reserved.

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SOURCE Choice Hotels International, Inc.

NEW YORK, Nov. 16, 2020 /PRNewswire/ — Today, WW International, Inc. (NASDAQ: WW), has introduced myWW+ which offers a more holistic approach to weight loss and wellness that focuses on food, activity, mindset and sleep – pillars of health which have a measurable impact on success. Building on the massive success of the myWW program and through a deeply enriching, more interactive and personalized app experience, myWW+ offers members a plan that works best for them with new tools designed to make weight loss easier.

Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8814051-ww-international-launches-new-myww-plus/

In addition to featuring an all new Personal Assessment which will help people pinpoint the changes that will power their personal weight loss success, myWW+ delivers customized content powered by a smart personalization platform that uses machine learning and AI to identify the preferences of each unique member —  the more a member engages with the content and features, the more myWW+ delivers.

“As a human-centric technology company, we know how important it is for people to have a comprehensive app experience that helps them lose weight and get healthier so they can become the best version of themselves,” said Mindy Grossman, WW CEO and President. “Our myWW+ program offers a sought-after holistic wellness solution that is also highly customizable to fit your life, no matter where it takes you.”

One of the newest features with myWW+ is the Weekly Check-in – a personalized, holistic   view of your progress within the app. Members can now review how their week went and automatically receive a Progress Report to see the full picture related to food, activity, mindset and sleep.  For the upcoming week, members create an Action Plan by selecting suggested actionable goals or creating their own. Their weekly goal will be displayed to help maintain focus throughout the week. With these new tools that digitize and customize behavioral goal-setting, people will stay engaged and on track to successfully reach their goals.

“With our expertise in behavior change, we go beyond the basics of education and guidance and offer a personalized, action-oriented approach for our members,” said Gary Foster, PhD, Chief Scientific Officer, WW. “What’s particularly compelling about myWW+ is that we have been able to scale behavior change like never before by taking science-based principles and translating them into digital tools to make the weight and wellness journey easier for all of our members.”

In addition to understanding your progress and setting goals, myWW+ offers even more features focused on key wellness elements to make the weight loss journey easier and more successful, such as:

• Food: New meal planning tools, such as “Meal Planner” and “What’s In Your Fridge” (in beta) to help members customize what they want to eat throughout the week based on their eating preferences, time restrictions and the foods they have on hand.

• Activity: A redesigned activity experience gives members a new way to view and understand daily activity, weekly goals and progress over time. Members can also continue to move in ways they love with on-demand equipment-free workouts through in-app content from partners such as FitOn and Aaptiv.

• Mindset: WW now provides its science-backed mindset techniques in bite-sized audio sessions via new 5-Minute Coaching. These science-backed techniques are rooted in cognitive behavioral, acceptance-based, and positive psychology sciences and are organized by relevant categories such as Manage Eating, Help for Stress, etc.

• Sleep: WW members can track sleep (manually or synced through a wearable) to get tailored advice and learn practical, science-based strategies to improve sleep habits.

The app still includes popular features, such as food, water and activity trackers, the barcode scanner, and Connect – WW’s members-only digital community. Access to the WW app is included with all subscription-based memberships on the myWW+ program. The program is rooted in WW’s scientifically proven approach to weight loss and nutrition and grounded in the SmartPoints^® system and ZeroPoint™ foods. WW remains a category leader, having been ranked for a decade as #1 “Best for Weight Loss” by health experts in U.S. News & World Report’s Best Diets rankings.  

For more information, please visit www.ww.com.

About WW International, Inc.

WW – Weight Watchers reimagined – is a global wellness company powered by the world’s leading commercial weight management program. We inspire millions of people to adopt healthy habits for real life. Through our engaging tech-enabled experience and face-to-face group workshops, members follow our livable and sustainable program of healthy eating, physical activity, and a helpful mindset. Leveraging more than five decades of experience in building inspired communities and our deep expertise in behavioral science, we aim to democratize wellness and to deliver wellness for all. To learn more about the WW approach to healthy living, please visit ww.com. For more information about our global business, visit our corporate website at corporate.ww.com. 

For general press inquiries, contact:

[email protected]  

 

 

 

 

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SOURCE WW International Inc.

VANCOUVER, BC, Nov. 16, 2020 /PRNewswire/ – Defense Metals Corp. (“Defense Metals“) (TSXV: DEFN) (OTCQB: DFMTF) (FSE:35D) is pleased to announce that on Friday November 13, 2020, Fortress Value Acquisition Corp. (“FVAC“) held a special meeting to consider the previously announced business combination with MP Materials (“MP Materials“). MP Materials is the owner and operator of Mountain Pass, the only rare earth element mining and processing site of scale in North America¹.

The FVAC-MP Materials special meeting represents a significant milestone in the establishment of a North American critical magnet metals supply chain. If approved, the combined company created by the FVAC-MP Materials merger would have an estimated post-transaction equity value of approximately $1.5 billion². Completion of the FVAC-MP Materials merger would signal a sea-change in ongoing joint Canadian-U.S.A. government efforts towards the establishment of a North American critical metals supply chain.

Defense Metals anticipates the merger would have a positive impact on the advancement of Canadian critical metals deposits, which includes Defense Metals Wicheeda Rare Earth Element (REE) Property (Table 1).

The Wicheeda REE Project has indicated mineral resources of 4,890,000 tonnes averaging 3.02% LREO (Light Rare Earth Elements) and inferred mineral resources of 12,100,000 tonnes averaging 2.90% LREO³. Flotation pilot-plant processing of a 26-tonne bulk sample of Wicheeda REE material yielded a mineralconcentrate averaging 7.4% NdPr oxide (neodymium-praseodymium) critical magnet metals⁴.

Craig Taylor, CEO of Defense Metals, stated: “The potential completion of the Fortress-MP Materials merger signals the beginning of what Defense Metals believes will be the inevitable establishment of a North American critical metals supply chain. This merger has the potential to unlock significant value in other North American REE deposits like Wicheeda; further buoyed by recent announcements by the state of California, Province of Quebec, China and UK targeting year 2035 to ban or significantly reduce sales of internal-combustion engine vehicles. The critical magnet metals, principally NdPr, that occur at high concentration within the Wicheeda REE Deposit will position Defense Metals to capitalize on the significant growth potential of the rapidly emerging green energy-electric vehicle sector.“

Table 1. Comparison of Mountain Pass Mine and Wicheeda REE Deposit⁵

About the Wicheeda REE Property

The 1,708 hectare Wicheeda REE Property, located approximately 80 km northeast of the city of Prince George, British Columbia, is readily accessible by all-weather gravel roads and is nearby to infrastructure, including power transmission lines, the CN railway and major highways.

Geologically, the property is situated in the Foreland Belt and within the Rocky Mountain Trench, a major continental geologic feature. The Foreland Belt contains part of a large alkaline igneous province, stretching from the Canadian Cordillera to the southwestern United States, which includes several carbonatite and alkaline intrusive complexes hosting the Aley (niobium), Rock Canyon (REE), and Wicheeda (REE) deposits.

Qualified Person

The scientific and technical information contained in this news release as it relates to the Wicheeda REE Property has been reviewed and approved by Kristopher J. Raffle, P.Geo. (BC) Principal and Consultant of APEX Geoscience Ltd. of Edmonton, AB, a director of Defense Metals and a “Qualified Person” as defined in National Instrument 43-101 – Standards of Disclosurefor Mineral Projects. Mr. Raffle verified the data disclosed which includes a review of the analytical and test data underlying the information and opinions contained therein.  

About
Defense Metals Corp.

Defense Metals Corp. is a mineral exploration company focused on the acquisition of mineral deposits containing metals and elements commonly used in the electric power market, military, national security and the production of “GREEN” energy technologies, such as, high strength alloys and rare earth magnets. Defense Metals has an option to acquire 100% of the 1,708 hectare Wicheeda Rare Earth Element Property located near Prince George, British Columbia, Canada. Defense Metals Corp. trades in Canada under the symbol “DEFN” on the TSX Venture Exchange, in the United States, under “DFMTF” on the OTCQB and in Germany on the Frankfurt Exchange under “35D”.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.

Forward Looking Information

This news release includes certain statements that constitute “forward-looking information or statements” within the meaning of applicable securities law, including without limitation, Defense Metals’ plans for its properties/projects, the positive impact that the Mountain Pass merger and listing will have on the rare earth elements industry, the  growth potential of the green energy-electric vehicle sector, other statements relating to the technical, financial and business prospects of Defense Metals and its properties, and other matters.

Forward-looking statements address future events and conditions and are necessarily based upon a number of estimates and assumptions. These statements relate to analyses and other information that are based on forecasts of future results, estimates of amounts not yet determinable and assumptions of management. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events or performance (often, but not always, using words or phrases such as “expects” or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “estimates” or “intends”, or stating that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved), and variations of such words, and similar expressions are not statements of historical fact and may be forward-looking statements. Forward-looking statement are necessarily based upon a number of factors that, if untrue, could cause the actual results, performances or achievements of Defense Metals to be materially different from future results, performances or achievements express or implied by such statements. Such statements and information are based on numerous assumptions regarding present and future business strategies and the environment in which Defense Metals will operate in the future, including the price of metals and elements, anticipated costs and the ability to achieve goals, that general business and economic conditions will not change in a material adverse manner, that financing will be available if and when needed and on reasonable terms, and that third party contractors, equipment and supplies and governmental and other approvals required to conduct Defense Metals planned exploration activities will be available on reasonable terms and in a timely manner. While such estimates and assumptions are considered reasonable by the management of Defense Metals, they are inherently subject to significant business, economic, competitive and regulatory uncertainties and risks.

Forward-looking statements are subject to a variety of risks and uncertainties, which could cause actual events, level of activity, performance or results to differ materially from those reflected in the forward-looking statements, including, without limitation: (i) risks related to rare earth elements, and other commodity price fluctuations; (ii) risks and uncertainties relating to the interpretation of exploration results; (iii) risks related to the inherent uncertainty of exploration and cost estimates and the potential for unexpected costs and expenses; (iv) that resource exploration and development is a speculative business; (v) that Defense Metals may lose or abandon its property interests or may fail to receive necessary licences and permits;  (vi) that environmental laws and regulations may become more onerous;  (vii) that Defense Metals may not be able to raise additional funds when necessary; (viii) the possibility that future exploration, development or mining results will not be consistent with Defense Metals expectations; (ix) exploration and development risks, including risks related to accidents, equipment breakdowns, labour disputes or other unanticipated difficulties with or interruptions in exploration and development; * competition; (xi) the potential for delays in exploration or development activities or the completion of geologic reports or studies; (xii) the uncertainty of profitability based upon Defense Metals history of losses; (xiii) risks related to environmental regulation and liability; (xiv) risks associated with failure to maintain community acceptance, agreements and permissions (generally referred to as “social licence”), including local First Nations; (xv) risks relating to obtaining and maintaining all necessary government permits, approvals and authorizations relating to the continued exploration and development of Defense Metals projects; (xvi) risks related to the outcome of legal actions; (xvii) political and regulatory risks associated with mining and exploration; (xix) risks related to current global financial conditions; and (xx) other risks and uncertainties related to Defense Metals prospects, properties and business strategy. These risks, as well as others, could cause actual results and events to vary significantly.

Factors that could cause actual results to differ materially from those in forward looking statements include, but are not limited to, continued availability of capital and financing and general economic, market or business conditions, the loss of key directors, employees, advisors or consultants, adverse weather conditions, increase in costs, equipment failures, the impact of Covid-19 or other viruses and diseases on the Company’s ability to operate, failure to maintain community acceptance (including First Nations), decrease in the price of rare earth elements, litigation, failure of counterparties to perform their contractual obligations and fees charged by service providers. Investors are cautioned that forward-looking statements are not guarantees of future performance or events and, accordingly are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty of such statements. The forward-looking statements included in this news release are made as of the date hereof and Defense Metals disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities legislation.

__________________________________

¹ www.businesswire.com Fortress Value Acquisition Corp. and MP Materials Announce Effectiveness of Registration Statement for Proposed Business Combination, October 27, 2020

² www.businesswire.com MP Materials, a Leading Producer of Rare Earth Materials, to Be Listed on NYSE Through Merger with Fortress Value Acquisition Corp., July 15, 2020

³ Technical Report on the Wicheeda Property, British Columbia, effective June 27, 2020 and prepared by APEX Geoscience Ltd. (Steven J. Nicholls, B.A. Sc., MAIG and Kristopher J. Raffle, B.Sc., P.Geo.) is available under Defense Metals Corp.’s profile on SEDAR (www.sedar.com)

⁴ See Defense Metals News Release date September 23, 2020

⁵Source: www.sec.gov U.S. SEC Form S-4 for Fortress Value Acquisition Corp., September 30, 2020. Mountain Pass data are for commercial operations and Defense Metals’ current results are from large-scale pilot plant testing. There is no guarantee similar results can be achieved in a commercial production scenario. Mineral Resources that are not Mineral Reserves do not have demonstrated economic viability. There is no guarantee that any part of the mineral resources discussed herein will be converted into a mineral reserve in the future.

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SOURCE Defense Metals Corp.

IRVINE, Calif., Nov. 16, 2020 /PRNewswire/ — Allergan Aesthetics, an AbbVie company (NYSE: ABBV), is celebrating its second annual BOTOX^® Cosmetic Day on Wednesday, November 18, 2020. The event is dedicated to celebrating the iconic treatment that helped create the aesthetics industry and recognizing the loyal community of patients and healthcare providers who have helped make this brand what it is today. In addition, this is a day for both new and loyal BOTOX^® Cosmetic users to put themselves first with an exclusive one-day-only offer available while supplies last exclusively through Allē^SM, the new loyalty platform from Allergan Aesthetics.

BOTOX^® Cosmetic Day is a very special holiday for Allergan Aesthetics. The brand is dedicated to encouraging patients and providers to do something for themselves especially ahead of the holiday season.

“BOTOX^® Cosmetic Day is also all about our loyal healthcare providers. From partnering with them on product formulations and clinical trials, to patient education and treatment, our providers are at the core of everything that goes into our products,” says Carrie Strom, Senior Vice President, AbbVie, and President, Global Allergan Aesthetics. “There are ten million people considering a facial injectable treatment in the next year, and BOTOX^® Cosmetic Day serves as an opportunity to connect these consumers with healthcare providers in their area.¹ We are incredibly grateful for the knowledge and diligent work providers contribute to our brands and the entire aesthetic category. We encourage everyone to thank their providers, even if it is a virtual celebration this year.”  

On November 18, consumers who are new or existing members of Allē^SM, Allergan Aesthetics’ new loyalty program, can participate in the exclusive offer which will be announced at 9 am Pacific Time on BOTOX^® Cosmetic Day at www.BOTOXCosmeticDay.Alle.com.  

“BOTOX^® Cosmetic Day is a testament to the impact this brand has had on the aesthetic community,” said Dr. Jean Carruthers, MD, FRCSC, FRC(Ophth). “In the past three decades, I’ve personally been on the front lines of continued research for this molecule and have witnessed the exponential increase in interest in this treatment, both among patients and the medical community worldwide.² With the largest scientific and medical bibliography, BOTOX^® Cosmetic is the most widely studied treatment of its kind.³ I will continue to rely on BOTOX^® Cosmetic in my practice for its safety, efficacy and predictable results when treating my patients. I am honored to stand with my peers in the medical community and friends at Allergan Aesthetics to celebrate the one and only BOTOX^® Cosmetic.”

BOTOX^® Cosmetic is the first and only neurotoxin FDA-approved to temporarily improve the appearance of moderate to severe forehead lines, crow’s feet lines, and glabellar lines in adults, and physicians have relied on it for more than 18 years.⁴ Recognized by National Day Archives as an official holiday on the National Day Registry™, BOTOX^® Cosmetic Day is held annually on the third Wednesday in November. Visit www.BOTOXCosmeticDay.Alle.com for more information and to purchase a gift card. Limited time offer. Terms and conditions apply.

BOTOX® (onabotulinumtoxinA) Important Information

IMPORTANT SAFETY INFORMATION

BOTOX® and BOTOX® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® or BOTOX® Cosmetic:

• Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
• Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing

There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX® has been used at the recommended dose to treat Chronic Migraine, severe underarm sweating, Blepharospasm, Strabismus, or when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow’s feet lines, and/or forehead lines.

Indications
BOTOX® is a prescription medicine that is injected into muscles and used:

• To treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken
• To treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder caused by a neurologic disease who still have leakage or cannot tolerate the side effects after trying an anticholinergic medication
• To prevent headaches in adults with Chronic Migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older
• To treat increased muscle stiffness in people 2 years of age and older with spasticity
• To treat the abnormal head position and neck pain that happens with Cervical Dystonia (CD) in people 16 years and older
• To treat certain types of eye muscle problems (Strabismus) or abnormal spasm of the eyelids (Blepharospasm) in people 12 years and older

BOTOX® is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older.

BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow’s feet lines, and frown lines between the eyebrows in adults.

It is not known whether BOTOX® and BOTOX® Cosmetic are safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).

BOTOX® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles.

It is not known whether BOTOX® and BOTOX® Cosmetic are safe or effective for severe sweating anywhere other than your armpits.

It is not known if BOTOX® Cosmetic is safe or effective for use more than 1 time every 3 months.

IMPORTANT SAFETY INFORMATION (continued)
BOTOX® and BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX® or BOTOX® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Do not receive BOTOX® or BOTOX® Cosmetic if you: are allergic to any of its ingredients (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.

Do not receive BOTOX® for the treatment of urinary incontinence if you: have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing. Due to the risk of urinary retention (not being able to empty the bladder), only patients who are willing and able to initiate catheterization post treatment, if required, should be considered for treatment.

Patients treated for overactive bladder:
In clinical trials, 36 of the 552 patients had to self-catheterize for urinary retention following treatment with BOTOX® compared to 2 of the 542 treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX® 100 Units (n = 36) was 63 days (minimum 1 day to maximum 214 days) as compared to a median duration of 11 days (minimum 3 days to maximum 18 days) for patients receiving placebo (n = 2). Patients with diabetes mellitus treated with BOTOX® were more likely to develop urinary retention than nondiabetics.

Patients treated for overactive bladder due to neurologic disease:
In clinical trials, 30.6% of patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection, required catheterization for urinary retention following treatment with BOTOX® 200 Units as compared to 6.7% of patients (7/104) treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX® 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days) as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7). Among patients not using CIC at baseline, those with MS were more likely to require CIC post injection than those with SCI.

The dose of BOTOX® and BOTOX® Cosmetic is not the same as, or comparable to, any other botulinum toxin product.

Serious and/or immediate allergic reactions have been reported, including itching, rash, red itchy welts, wheezing, asthma symptoms, dizziness, or feeling faint. Get medical help right away if you experience symptoms; further injection of BOTOX® or BOTOX® Cosmetic should be discontinued.

Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX® or BOTOX® Cosmetic.

Tell your doctor if you have any breathing-related problems. Your doctor may monitor you for breathing problems during treatment with BOTOX® for spasticity or for detrusor overactivity associated with a neurologic condition. The risk of developing lung disease in patients with reduced lung function is increased in patients receiving BOTOX®.

Cornea problems have been reported. Cornea (surface of the eye) problems have been reported in some people receiving BOTOX® for their Blepharospasm, especially in people with certain nerve disorders. BOTOX® may cause the eyelids to blink less, which could lead to the surface of the eye being exposed to air more than is usual. Tell your doctor if you experience any problems with your eyes while receiving BOTOX®. Your doctor may treat your eyes with drops, ointments, contact lenses, or with an eye patch.

Bleeding behind the eye has been reported. Bleeding behind the eyeball has been reported in some people receiving BOTOX® for their Strabismus. Tell your doctor if you notice any new visual problems while receiving BOTOX®.

Bronchitis and upper respiratory tract infections (common colds) have been reported. Bronchitis was reported more frequently in adults receiving BOTOX® for upper limb spasticity. Upper respiratory infections were also reported more frequently in adults with prior breathing-related problems with spasticity. In pediatric patients treated with BOTOX® for upper limb spasticity, upper respiratory tract infections were reported more frequently. In pediatric patients treated with BOTOX^® for lower limb spasticity, upper respiratory tract infections were not reported more frequently than placebo.

Autonomic dysreflexia in patients treated for overactive bladder due to neurologic disease. Autonomic dysreflexia associated with intradetrusor injections of BOTOX® could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in patients treated with BOTOX® 200 Units compared with placebo (1.5% versus 0.4%, respectively).

Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; have plans to have surgery; had surgery on your face; weakness of forehead muscles; trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; have symptoms of a urinary tract infection (UTI) and are being treated for urinary incontinence (symptoms of a urinary tract infection may include pain or burning with urination, frequent urination, or fever); have problems emptying your bladder on your own and are being treated for urinary incontinence; are pregnant or plan to become pregnant (it is not known if BOTOX® or BOTOX® Cosmetic can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX® or BOTOX® Cosmetic passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® or BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you havereceived BOTOX® or BOTOX® Cosmetic in the past.

Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.

Other side effects of BOTOX® and BOTOX® Cosmetic include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, dry eyes; drooping eyebrows; and upper respiratory tract infection. In people being treated for urinary incontinence other side effects include: urinary tract infection, painful urination, and/or inability to empty your bladder on your own. If you have difficulty fully emptying your bladder after receiving BOTOX®, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again.

For more information refer to the Medication Guide or talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see BOTOX® full Product Information, including Boxed Warning and Medication Guide.

Please see BOTOX® Cosmetic full Product Information, including Boxed Warning and Medication Guide.

About Allergan Aesthetics


Allergan Aesthetics, an AbbVie company, develops, manufactures, and markets a portfolio of leading aesthetics brands and products. Their aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Their goal is to consistently provide customers worldwide with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. 

www.AllerganAesthetics.com

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

References

1. Data on File, Allergan; Situational Analysis, June 2020.
2. BOTOX® Prescribing Information, 2020.
3. Data on File, Allergan; Peer-Reviewed Articles, 2018.
4. BOTOX® Prescribing Information, 2020.

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SOURCE AbbVie