Zanidatamab Clinical Data Selected for Oral Presentation at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium

Zanidatamab Clinical Data Selected for Oral Presentation at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium

VANCOUVER, British Columbia–(BUSINESS WIRE)–
Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced the selection of three abstracts for presentation at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, taking place virtually on January 15 – 17, 2021.

The presentations highlight updated clinical data for the HER2‑targeted bispecific antibody, zanidatamab, in HER2‑expressing gastroesophageal adenocarcinoma (both as monotherapy and in combination with chemotherapy) and in HER2-expressing/amplified biliary tract cancer (as monotherapy). Zymeworks is currently recruiting globally in a pivotal clinical trial in patients with HER2-amplified biliary tract cancer for which a “trial in progress” poster will also be presented during the meeting.

Oral Presentation Session

Title: Zanidatamab (ZW25) in HER2-expressing gastroesophageal adenocarcinoma (GEA): Results from a phase I study

Lead Author: Funda Meric-Bernstam, MD, UT MD Anderson Cancer Center, TX

Abstract: 164

Rapid Abstract Session: Esophageal and Gastric Cancer

Date and Time: January 15, 2021 at 11:30 am – 12:15 pm ET

Poster Presentations

The poster presentations will be available on Friday, January 15 at 8:00 am ET on the conference website as well as the Zymeworks website.

Title: Zanidatamab (ZW25) in HER2-positive biliary tract cancers (BTCs): Results from a phase I study.

Lead Author: Funda Meric-Bernstam, MD, UT MD Anderson Cancer Center, TX

Abstract: 299

Poster Session: Hepatobiliary Cancer

Title: A phase IIb, open-label, single-arm study of zanidatamab (ZW25) monotherapy in subjects with advanced or metastatic HER2-amplified biliary tract cancers (BTCs).

Lead Author: Shubham Pant, MD, UT MD Anderson Cancer Center, TX

Abstract: TPS352

Trials in Progress Poster Session: Hepatobiliary Cancer

About Zanidatamab

Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric™ platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding, and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and registration-enabling clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. The FDA has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified biliary tract cancer (BTC), and two Fast Track designations to zanidatamab, one as monotherapy for refractory BTC and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA). These designations mean zanidatamab is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as intensive FDA guidance on an efficient drug development program. Zanidatamab has also received Orphan Drug designations for the treatment of biliary tract, gastric and ovarian cancers, as well as Orphan Drug designation for the treatment of gastric cancer from the European Medicines Agency.

About Zymeworks Inc.

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics. Zymeworks’ suite of therapeutic platforms and its fully integrated drug development engine enable precise engineering of highly differentiated product candidates. Zymeworks’ lead clinical candidate, zanidatamab, is a novel Azymetric™ bispecific antibody which has been granted Breakthrough Therapy designation by the FDA and is currently in a registration-enabling clinical trial for refractory HER2-amplified biliary tract cancer as well as several Phase 2 clinical trials for HER2-positive gastroesophageal and breast cancers. Zymeworks’ second clinical candidate, ZW49, is a bispecific antibody-drug conjugate currently in Phase 1 clinical development and combines the unique design and antibody framework of zanidatamab with Zymeworks’ proprietary ZymeLink™ linker-cytotoxin. Zymeworks is also advancing a deep preclinical pipeline in oncology (including immuno-oncology agents) and other therapeutic areas. In addition, its therapeutic platforms are being leveraged through strategic partnerships with nine biopharmaceutical companies. For more information, visit www.zymeworks.com and follow us @ZymeworksInc on Twitter.

Cautionary Note Regarding Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements that relate to Zymeworks’ clinical and preclinical development of its product candidates, the potential therapeutic effects of zanidatamab, and other information that is not historical information. When used herein, words such as “will”, “may”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation, market conditions and the factors described under “Risk Factors” in Zymeworks’ Quarterly Report on Form 10-Q for its quarter ended September 30, 2020 (a copy of which may be obtained at www.sec.gov and www.sedar.com). Consequently, forward-looking statements should be regarded solely as Zymeworks’ current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee future results, events, levels of activity, performance, or achievements. Zymeworks does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

Investor Inquiries:  

Ryan Dercho, Ph.D.  

(604) 678-1388  

[email protected]  

Tiffany Tolmie  

(604) 678-1388  

[email protected]  

Media Inquiries:  

Mary Klem

(604) 678-1388  

[email protected]

KEYWORDS: North America Canada

INDUSTRY KEYWORDS: Biotechnology Health Pharmaceutical Clinical Trials Oncology

MEDIA:

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sparks & honey Launches Second Annual Cultural Apprentice Program, Furthering the Company’s Commitments to Diversity, Equity & Inclusion and Reimagining The Workplace of the Future

The Consultancy Welcomes Communications Veteran Brenda Whiteman And Mental Health Advocate Shari Foos As Cultural Apprentices

NEW YORK, Dec. 10, 2020 (GLOBE NEWSWIRE) — sparks & honey, Omnicom’s technology-based cultural consultancy, has launched its second annual Cultural Apprentice Program, an initiative designed specifically for individuals with decades of professional experience, who are ready for their next endeavor. The 16-week program aims to engage curious lifelong learners who are eager to share and build upon their accumulated professional knowledge. This year, sparks & honey welcomes Brenda Whiteman, a communications veteran and public relations specialist, and Shari Foos, a long-time marriage and family therapist and founder of The Narrative Method, as the newest apprentices. Each will work remotely with various teams across the consultancy.

Diversity, equity and inclusion are at the center of many of the initiatives sparks & honey has rolled out over the last few years, with the goal of tapping into a network of contributors with unique backgrounds, perspectives and experiences. This reflects sparks & honey’s ethos as a Learning Organization, which better prepares organizations to embrace disruption by fostering curious minds and bringing in new or overlooked expertise.

“As a Learning Organization, we take pride in continuing to master new skills and gain new knowledge. I cannot think of two more qualified, wise or experienced individuals to be sparks & honey’s new Cultural Apprentices,” said sparks & honey Founder and CEO Terry Young. “With this program, not only are our apprentices learning about sparks & honey and our approach to culture, but we as a team are able to learn from the immense experience both Brenda and Shari bring to the table.”

Cultural Editorial Apprentice Brenda Whiteman has over 30 years of experience as a writer and editor in communications. Whiteman brings her passion for human-interest stories to the Editorial team, led by Anna Sofia Martin, Editorial Director at sparks & honey. Previously, Whiteman was a member of the internal communications team in Research & Development at the Educational Testing Service (ETS) and in public relations and marketing roles at Rider University, the Credit Union Affiliates of New Jersey, Syracuse University and Mercer County Community College. In her free time, she volunteers as a PR specialist for ITIAH Angels for Learning, a global nonprofit organization dedicated to providing educational tools to women and children in impoverished communities in the Caribbean and Africa.

Shari Foos joins the team as a Culture Briefing Apprentice, working with Benjamin Grinspan, Director of Cultural Strategy at sparks & honey, who spearheads the consultancy’s weekly Culture Briefings. Foos founded The Narrative Method to address the need for genuine connection in an increasingly technological world. In addition to weekly salons, she works with universities, organizations and diverse at-risk populations. Foos is also a writer and teaches The Narrative Method as an adjunct professor at Antioch University Los Angeles.

About sparks & honey:

sparks & honey
is a technology-based cultural consultancy delivering innovative growth and transformation strategy for global organizations. With its first-of-its-kind, human and AI-powered intelligence platform Q™, sparks & honey’s comprehensive framework for understanding and predicting cultural change drives bold decision-making and business impact for today’s leaders. A disruptive force to the traditional consulting model, sparks & honey identifies emerging cultural trends and industry shifts, helping organizations stay ahead of the curve in a disruption-prone world. The company is part of the Omnicom Precision Marketing Group.

Press Contact:

Melanie Capruso
DiGennaro Communications
[email protected]

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/f80ae1bb-7fe7-47f6-a0ad-3c2827d148a4

https://www.globenewswire.com/NewsRoom/AttachmentNg/e6dba763-bd49-4559-b264-082b67f909aa



AgraFlora Provides Guidance and Grow Update for its Delta Greenhouse

VANCOUVER, British Columbia, Dec. 10, 2020 (GLOBE NEWSWIRE) — AgraFlora Organics International Inc. (“AgraFlora” or the “Company”) (CSE: AGRA) (Frankfurt: PU31) (OTCPK: AGFAF) is pleased to provide 2021 phase 1 guidance for its cannabis cultivation operations at Propagation Services Canada Inc., the Company’s flagship cultivation asset located in Delta, British Columbia (the “Delta Facility” or “PSC”).

2021 Guidance Highlights:

  • PSC to complete dry room infrastructure slated to provide capacity for ~500,000 grams of dried saleable product;
  • Projected to begin executing on wholesale transactions in May 2021;
  • Delta to grow 10,000 plants for first saleable harvest and expects to yield 50 grams per plant (Based on test 2020 test harvest);
  • PSC strategy remains to be positioned as the leader in pricing of low-cost, high THC cannabis for 2021;
  • AgraFlora to release 5 different varieties for first sale to wholesale partners

The Delta Facility will begin utilizing its recently received agriculture loan (see press release dated November 23, 2020) to complete the Phase 1 rollout of infrastructure required for saleable product. AgraFlora will commence upgrading the dry rooms at the Delta Facility to hold a capacity of 500,000 grams of dry saleable high potency varieties.

Based on the data collected from the test crop of genetics, which was harvested in Q4 of 2020, PSC will expect to cultivate 10,000 plants and aim to yield 50 grams per plant of saleable product. The grow team at the Delta Facility believes that their multi-generational experience and favorable growing environment will boost PSC to become a leader in pricing low cost, high-THC cannabis with first sales expected to commence mid Q2, 2021.

Ruben Houweling, general manager of Houweling Nurseries stated, “We are well positioned to roll out first sales in 2021 after careful review of the first test crop that was recently completed. Our well-integrated organization will look to over 5 different varieties of high potency low cost cannabis flower.”

“Our data shows that timing is right in the market for our product. Currently >20% THC cannabis flower varieties rising in value and we aim to solidify good partners for our product and also take advantage of the robust spot market,” commented the AgraFlora Board of Directors.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/09713af3-8873-4809-b15f-328d0c766160

About
AgraFlora
Organics International Inc.

AgraFlora Organics International Inc. is a leading cannabis company building shareholder value through the development of revenue generating operating assets in the global cannabis industry. AgraFlora is focused primarily on the Canadian cannabis industry, the world’s most advanced and regulated legal cannabis market. Flagship Canadian assets include: Edibles & Infusions, a fully automated manufacturing facility in Winnipeg, MB for white-label and consumer branded edible production; Propagation Services Canada, a large-scale commercial greenhouse in Delta, BC focused on reshaping the Canadian flower market with high-potency, low cost cannabis flower; and AAA Heidelberg, a craft focused cannabis producer in London, ON. In addition, AgraFlora’s wholly owned subsidiary Farmako GmbH is scaling towards its goal of being Europe’s leading distributor of medical cannabis. Farmako currently has active distribution operations in Germany and expects to commence active operations in the United Kingdom in 2020. For more information please visit: https://agraflora.com/.

About Propagation Services Canada

Propagation Services Canada is a joint-venture formed between AgraFlora and the Houwelings Group, one of North America’s leading producers and innovators in the greenhouse vegetable production industry. For three generations, Houwelings has been championing innovation in North American vegetable production, holding multiple patents and developing large-scale commercial greenhouses in British Colombia, California and Utah. The Houwelings Group was the first in the USA to utilize combined heat and power co-generation, and the first to develop a proprietary sealed growing technology. Through the JV, Propagation Services Canada will operate an automated greenhouse facility with an expandable footprint of up to 2,200,000 sq. ft. Propagation Services Canada is expected to commence cannabis operations and revenue in 2020 with a focus on producing high-potency cannabis at the lowest possible cost to drive margin growth and profitability.


ON BEHALF OF THE BOARD OF DIRECTORS


Brandon Boddy
Chairman & CEO
T: (604) 398-3147
 
   
For additional information: For French inquiries:
   
AgraFlora Organics International Inc. Maricom Inc.
Nicholas Konkin Remy Scalabrini
E: [email protected] E: [email protected]
T: (800) 783-6056 T: (888) 585-MARI

The CSE and Information Service Provider have not reviewed and does not accept responsibility for the accuracy or adequacy of this release.


Forward-looking Information Cautionary Statement


Except for statements of historic fact this news release contains certain “forward-looking information” within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as “plan” “expect” “project” “intend” “believe” “anticipate” “estimate” and other similar words or statements that certain events or conditions “may” or “will” occur. Forward-looking statements are based on the opinions and estimates at the date the statements are made and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking statements including but not limited to delays or uncertainties with regulatory approvals including that of the CSE. There are uncertainties inherent in forward-looking information including factors beyond the Company’s control. There are no assurances that the business plans for
AgraFlora
Organics described in this news release will come into effect on the terms or time frame described herein. The Company undertakes no obligation to update forward-looking information if circumstances or management’s estimates or opinions should change except as required by law. The reader is cautioned not to place undue reliance on forward-looking statements. Additional information identifying risks and uncertainties that could affect financial results is contained in the Company’s filings with Canadian securities regulators which are available at www.sedar.com.



Timber Pharmaceuticals Hosts Business Update Conference Call

Call to be held on Thursday, December 17th at 11:00am EST

WOODCLIFF LAKE, N.J., Dec. 10, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Timber Pharmaceuticals, Inc. (“Timber” or the “Company”) (NYSE American: TMBR), a biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today announced that it will hold a business update conference call for investors and shareholders. The call will be hosted by Timber’s Chief Executive Officer, John Koconis, and Chief Financial Officer, Joe Lucchese.

Conference Call Information

When: Thursday, December 17th at 11:00am EST

Dial in: (877) 270-2148 and ask to be joined into the Timber Pharmaceuticals call.

There will also be a live webcast of the conference call which can be accessed at:


https://services.choruscall.com/links/timberpharma201217.html

For those unable to participate in the live conference call, a replay will be archived and available on Timber’s website under the Investor Relations tab at www.timberpharma.com.

About Timber Pharmaceuticals, Inc.

Timber Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases. The Company’s investigational therapies have proven mechanisms-of-action backed by decades of clinical experience and well-established CMC (chemistry, manufacturing and control) and safety profiles. The Company is initially focused on developing non-systemic treatments for rare dermatologic diseases including congenital ichthyosis (CI), facial angiofibromas (FAs) in tuberous sclerosis complex (TSC), and localized scleroderma. For more information, visit www.timberpharma.com.

Forward-Looking Statements

This press release contains certain 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 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, competitive position, intellectual property rights, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential, “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s Form 10-Q filed on August 18, 2020 and its other filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

For more information, contact:

Timber Pharmaceuticals, Inc.
John Koconis
Chief Executive Officer
[email protected]

Investor Relations:
Stephanie Prince
PCG Advisory
(646) 762-4518
[email protected]

Media Relations:
Adam Daley
Berry & Company Public Relations
(212) 253-8881
[email protected]



Purpose Investments Highlights the Power of Being Tactical as Purpose Tactical Asset Allocation Fund Turns Five Years Old

TORONTO, Dec. 10, 2020 (GLOBE NEWSWIRE) — Purpose Investments Inc. (“Purpose”) is pleased to highlight the performance of Purpose Tactical Asset Allocation Fund (“the Fund”) as it marks the five-year anniversary of its inception. The Fund (NEO: RTA) returned an annualized 6.55% from the period of November 30, 2015 to November 30, 2020, earning the highest Morningstar Rating.*

  YTD 1-year 3-year 5-year Morningstar Rating* (5 Year)
Purpose Tactical Asset Allocation Fund Series F (PFC3901) 12.14% 11.79% 7.79% 6.55% *****

Purpose Tactical Asset Allocation Fund is a rules-based strategy which allows investors to navigate the changing landscape of the market by automating a portion of a portfolio’s asset allocation decisions. The Fund has the ability to oscillate between equities and bonds depending on the underlying market conditions. The Fund can swing from as much as 100% equities in strongly up-trending markets to 100% bonds and cash in strongly down-trending markets.

Over the course of its five years in existence as an accessible strategy, the Fund has performed well through notable periods of market declines, including major corrections in 2016, 2018 and 2020. In each major event, Purpose Tactical Asset Allocation Fund has helped protect investors’ capital by quickly becoming defensive to match market conditions.

“Purpose Tactical Asset Allocation Fund has proven its value over the course of its life and we’re thrilled to be able to step back at this point to reflect on its success,” said Greg Taylor, CIO of Purpose Investments. “The Fund is incredibly powerful, able to meaningfully improve a portfolio’s risk profile with as little as just a five percent allocation.”

Purpose Tactical Asset Allocation Fund has earned a 5-Star Morningstar rating for its strong performance within the Tactical Balanced category. It has become increasingly popular throughout the turmoil of 2020, attracting more than $400 million in assets under management. The Fund is available in both mutual fund and ETF formats, making the strategy easily accessible to Canadian investors.

“2020 has been a hard year for many investors, but it has highlighted the value of using a tactical strategy within your portfolio,” said Craig Basinger, CIO of Richardson Wealth and subadvisor of the Fund. “It’s one thing to be defensive in tough times, but it’s equally important that you appreciate over time as well. Purpose Tactical Asset Allocation Fund is doing that. But while the returns have been good, it is the defensive characteristics that have caused many investors and advisors to add the Fund to their portfolios.”

About Purpose Investments Inc.

Purpose Investments Inc. is an asset management company with more than $10 billion in assets under management. Purpose Investments has an unrelenting focus on client-centric innovation, and offers a range of managed and quantitative investment products. Purpose Investments is led by well-known entrepreneur Som Seif and is a division of Purpose Financial, an independent technology-driven financial services company.

For further information please contact:
Matt Padanyi
Purpose Investments Inc.
Tel: (877) 789-1517
Email: [email protected]

*
The Morningstar star rating is as of November 30, 2020,
Morningstar Canada. Number of funds in
the Tactical Balanced
category for the periods: 350 for YTD, 347 for 1-Year, 316 for 3-Year, 215 for 5-Year. Morningstar rates mutual funds from one to five stars based on
their performance
(after adjusting for risk) in comparison to similar funds. Within each CIFSC category, the top 10% of funds receive five stars, the next 22.5% four stars, the middle 35% three stars, the next 22.5% two stars, and the bottom 10% receive one star. Funds are rated for up to three time periods— three-, five-, and 10 years—and these ratings are combined to produce an overall rating
(minimum three years of history)
. Ratings are objective, based entirely on a mathematical evaluation of past performance
.

Commissions, trailing commissions, management fees and expenses all may be associated with investment fund investments. Please read the prospectus
and other disclosure documents
before investing.
Investment funds
are not covered by the Canada Deposit Insurance Corporation or any other government deposit insurer.
There can be no assurance that the full amount of your investment in a fund will be returned to you. If the securities are purchased or sold on a stock exchange, you may pay more or receive less than the current net asset value.
Investment funds are not guaranteed, their values change
frequently
and past performance may not be repeated
.



Entera Bio Announces FDA Approval of IND Application for EB613 – an Oral Human Parathyroid Hormone (1-34) for the Treatment of Osteoporosis

EB613 Phase 2 Placebo-Controlled, Dose-Ranging Study Ongoing in Israel with Complete 3 Month Biomarker Data expected in Q1:21 and Final Bone Mineral Density, or BMD, Data Expected in Q2:21

BOSTON and JERUSALEM, Israel, Dec. 10, 2020 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has reviewed the company’s Investigational New Drug (IND) application for EB613, orally delivered human parathyroid hormone (1-34), or PTH and informed Entera that it may proceed with its initial U.S. clinical trial. EB613 is positioned as the first potential drug candidate that could provide a patient friendly, once daily, oral, bone building (anabolic) treatment for osteoporosis patients.  

“There is a clear and compelling need for an oral PTH treatment that builds bone in patients with osteoporosis. With enrollment in the ongoing Phase 2 clinical trial of EB613 complete, we look forward to reporting the final biomarker data in the first quarter of 2021 and the final bone mineral density data from this trial in the second quarter of 2021,” stated Arthur Santora, MD, PhD Chief Medical Officer of Entera. “Subject to the successful completion of the EB613 Phase 2 clinical trial, we intend to enter into a dialogue with the FDA to discuss the design of a pivotal Phase 3 clinical trial in order to ensure we meet all of the FDA’s requirements for potential approval under the 505 (b)(2) regulatory pathway.”

As part of the IND filing, Entera provided to the FDA data from a total of more than 70 subjects from two previously completed Phase 1 trials conducted in Israel during the development of EB613 and from an additional 35 subjects that participated in Entera’s EB612 studies in Israel, including a 4 month hypoparathyroidism trial. EB613 is currently in a dose-ranging, placebo-controlled study in postmenopausal female subjects with osteoporosis, or low BMD, that is being conducted at four leading medical centers in Israel.

About EB613

EB613 is an orally delivered human parathyroid hormone (1-34), or PTH, drug candidate positioned as the first potential once daily, oral, bone building (anabolic) treatment for osteoporosis patients. Teriparatide for injection (marketed under the brand name Forteo®) was approved in the U.S. in 2002 for the treatment of osteoporosis in men and postmenopausal women who are at high risk for having a fracture and is taken daily via a subcutaneous injection. Entera Bio completed enrollment of a 6-month phase 2 study in postmenopausal women with osteoporosis, or low BMD evaluating multiple doses of oral EB613 (and placebo) on BMD of the spine and proximal femur (hip), and anticipates reporting top-line BMD efficacy and safety results for the trial in the second quarter of 2021.

About Osteoporosis

Osteoporosis is a disease characterized by low bone mass and structural deterioration of bone tissue, which leads to greater fragility and an increase in fracture risk.  Osteoporosis is also a silent disease, often displaying no signs or symptoms until a fracture occurs, leaving the majority of patients undiagnosed and untreated, representing a high unmet medical need. The debilitating effects of osteoporosis have substantial costs and osteoporotic fractures create a significant healthcare burden. An estimated two million osteoporotic fractures occur annually in the United States, and this number is projected to grow to three million by 2025. The National Osteoporosis Foundation (NOF) has estimated that eight million women already have osteoporosis, and another approximately 44 million may have low bone mass placing them at increased risk for osteoporosis. In US women 55 years of age and older, the hospitalization burden of osteoporotic fractures and population facility-related hospital cost is greater than that of myocardial infarction, stroke, or breast cancer.

About Entera Bio

Entera is a leader in the development of orally delivered large molecule therapeutics for use in areas with significant unmet medical need where adoption of injectable therapies is limited due to cost, convenience and compliance challenges for patients. The Company’s proprietary, oral drug delivery technology is designed to address the technical challenges of poor absorption, high variability, and the inability to deliver large molecules to the targeted location in the body through the use of a synthetic absorption enhancer to facilitate the absorption of large molecules, and protease inhibitors to prevent enzymatic degradation and support delivery to targeted tissues. The Company’s most advanced product candidates, EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism are in Phase 2 clinical development. Entera also licenses its technology to biopharmaceutical companies for use with their proprietary compounds and, to date, has established a collaboration with Amgen Inc. For more information on Entera Bio, visit www.enterabio.com.

Forward Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others: changes in our interpretation of the interim data from the ongoing Phase 2 clinical trial of EB613, the timing of data readouts from the ongoing Phase 2 clinical trial of EB613, unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; a possible suspension of the Phase 2 clinical trial of EB613 for clinical or data-related reasons; the impact of COVID-19 on Entera’s business operations including the ability to collect the necessary data from the Phase 2 trial of EB613; the potential disruption and delay of manufacturing supply chains, loss of available workforce resources, either by Entera or its collaboration and laboratory partners, due to travel restrictions, lay-offs or forced closures or repurposing of hospital facilities; impacts to research and development or clinical activities that Entera is contractually obligated to provide, such as pursuant to Entera’s agreement with Amgen; overall regulatory timelines, if the FDA or other authorities are closed for prolonged periods, choose to allocate resources to review of COVID-19 related drugs or believe that the amount of Phase 2 clinical data collected are insufficient to initiate a Phase 3 trial, or a meaningful deterioration of the current political, legal and regulatory situation in Israel or the United States; the availability, quality and timing of the data from the Phase 2 clinical trial of EB613 in osteoporosis patients; the ability find a dose that demonstrates the comparability of EB613 to FORTEO in the ongoing Phase 2 clinical trial of EB613; the size and growth of the potential market for EB613 and Entera’s other product candidates including any possible expansion of the market if an orally delivered option is available in addition to an injectable formulation; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s expectations regarding its expenses, revenue, cash resources, including the amount of cash and cash equivalents as of September 30, 2020 referenced above, which has not been audited or reviewed by Entera’s independent registered public accounting firm and should be viewed in the context of all other available information regarding Entera’s results of operations, liquidity and financial condition; Entera’s ability to raise additional capital; Entera’s interpretation of FDA feedback and guidance and how such guidance may impact its clinical development plans; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Special Note Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s annual and current filings which are on file with the SEC and available free of charge on the SEC’s website at http://www.sec.gov. Additional factors may be set forth in those sections of Entera’s Quarterly Report on Form 6-K for the quarter ended September 30, 2020, filed with the SEC in the fourth quarter of 2020. In addition to the risks described above and in Entera’s annual report on Form 20-F and current reports on Form 6-K and other filings with the SEC, other unknown or unpredictable factors also could affect Entera’s results. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Entera or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Entera cautions investors not to rely too heavily on the forward-looking statements Entera makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Entera undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.



Contact:

Jonathan Lieber, CFO
Tel: +001 617-362-3579
[email protected]

EHang Launches Aerial Media Solutions and Services in Europe

GUANGZHOU, China, Dec. 10, 2020 (GLOBE NEWSWIRE) — EHang Holdings Limited (Nasdaq: EH) (“EHang” or the “Company”), the world’s leading autonomous aerial vehicle (“AAV”) technology platform company, announced that the company has launched its aerial media solutions and services in the European market under the brand “DRONEPIXEL by EHang”. In a distribution partnership with the event tech company “Concept Solutions”, state-of-the-art aerial light shows are now being offered to event organizers across Europe.

While digital fireworks using drone technologies are already widespread in Asia, there are seldom providers for them in other regions of the world. After the successful expansion into the European market, EHang is now filling this gap. It was one of the first companies in the world to start business with aerial media services in its home market in China several years ago. Over a hundred of shows have been performed to date and delighted an audience of millions. In 2018 EHang received an entry in the “Guinness World RecordsTM” for the most Unmanned Aerial Vehicles (UAVs) airborne simultaneously in a light show with over 1,300 AAVs that lit up the night sky in perfect choreography. Further in 2019, it won the championship of the China’s Got Talent Show, a Chinese spin-off of the “Britain’s Got Talent”.

Compared with classic fireworks, aerial light shows do not cause any CO2 emissions and can be used repeatedly. Therefore, they represent a sustainable and modern evolution that brings fireworks into the digital age. In addition, all imaginable choreographies can be reproduced in three dimensions, making events or brands can be staged in a more dynamic way that has never been seen before. Together with the appropriate background music, live acts or laser shows, stories can be told in the night sky that can still be followed from miles away.

In order to expand rapidly in the European market, EHang entered into a sales partnership with the experienced event tech company “Concept Solutions”. The brand “DRONEPIXEL by EHang” was jointly developed with various sales channels established. The focus is on the sales platform www.drone-pixel.com, which went live today and is advertised through various channels. Interested customers will find all the information there to simply book aerial media services online. In the sense of a one-stop-shop, the comprehensive event tech offered from Concept Solutions rounds off the show design and can also be obtained directly from the platform.

“Together we want to offer digital fireworks to a broader target group and make the most modern aerial light shows simple, eco-friendly and affordable for everyone. The fascinating technology from EHang and our experience in the European market form the perfect basis for this,” said Florian Weber, CEO of Concept Solutions, in conclusion.

About EHang

EHang (Nasdaq: EH) is the world’s leading autonomous aerial vehicle (AAV) technology platform company. Our mission is to make safe, autonomous, and eco-friendly air mobility accessible to everyone. EHang provides customers in various industries with AAV products and commercial solutions: air mobility (including passenger transportation and logistics), smart city management, and aerial media solutions. As the forerunner of cutting-edge AAV technologies and commercial solutions in the global Urban Air Mobility (UAM) industry, EHang continues to explore the boundaries of the sky to make flying technologies benefit our life in smart cities. For more information, please visit www.ehang.com.

Safe Harbor Statement

This press release contains statements that may constitute “forward-looking” statements pursuant to the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “aims,” “future,” “intends,” “plans,” “believes,” “estimates,” “likely to” and similar statements. Management has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While they believe these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond management’s control. These statements involve risks and uncertainties that may cause EHang’s actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by these forward-looking statements.

Media
Contact: [email protected]

Investor
Contact: [email protected] 
In the U.S.: [email protected]
In China: [email protected]

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/37c35db7-43f9-4326-865c-0c64c8a47dac

https://www.globenewswire.com/NewsRoom/AttachmentNg/ad668f1c-6e8e-4a1e-8e43-c7330b3a1603



Quotient Limited Provides Status Update on the Initial SDS Microarray and MosaiQ Instrument for the US Market

JERSEY, Channel Islands, Dec. 10, 2020 (GLOBE NEWSWIRE) — Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company (the Company), today announced that it received a request from the U.S. Food and Drug Administration (FDA) for additional testing data regarding the 510(k) application for the Initial Serological Disease Screening Microarray (SDS) and MosaiQ instrument. The data the FDA has requested relates to specific individual performance characteristics of the assays on the microarray. In response to this request, the Company intends to re-submit its application, with the additional data requested by the FDA, in early 2021. Following that submission, the Company is targeting to receive the FDA 510(k) clearance in mid-2021.

The Company does not expect to be materially impacted by the need to submit additional data. Franz Walt, Chief Executive Officer of Quotient, explained, “We do not expect this development will delay the commercial launch of our MosaiQ platform in the US. As we always said, the commercialization of the initial SDS will only commence once the expanded Immunohematology microarray is available.”

About Quotient Limited

Building on over 30 years of experience in transfusion diagnostics, Quotient is a commercial-stage diagnostics company committed to delivering solutions that reshape the way diagnostics is practiced. MosaiQ, Quotient’s proprietary multiplex microarray technology, offers the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. MosaiQ is designed to be a game-changing solution, which Quotient believes will increase efficiencies, improve clinical practice, deliver significant workflow improvements, and operational cost savings to laboratories around the world. In response to the global effort to combat COVID-19, Quotient developed the MosaiQ COVID-19 Antibody Microarray which is CE marked and has received the U.S. FDA Emergency Use Authorization. Quotient’s operations are based in Eysins, Switzerland, Edinburgh, Scotland and Newtown, Pennsylvania.

Forward Looking Statements

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include statements regarding the underwritten public offering, including the anticipated net proceeds to be raised in the offering and expected closing date of the offering. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially, including: market conditions; Quotient’s ability to satisfy closing conditions related to the offering; unanticipated expenses associated with the offering; and other risks set forth in Quotient’s most recent Annual Report on Form 10 K and Quarterly Report on Form 10 Q, as well as other documents that Quotient files with the Securities and Exchange Commission, including the Registration Statement on Form S 3 (File No. 333 248235), as amended by Amendment No. 1, for the offering. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Quotient disclaims any obligation to update these forward-looking statements because of new information, future events or circumstances or other factors. The Quotient logo, Quotient MosaiQ and MosaiQ are trademarks or registered trademarks of Quotient Limited or its subsidiaries in various jurisdictions.

Contact: Peter Buhler, Chief Financial Officer, [email protected]; +41 22 545 52 26



Osisko Metals Announces Equity and Royalty Financing Totaling $8.5 Million


NOT FOR DISTRIBUTION TO U.S. NEWS WIRE SERVICES


OR FOR DISSEMINATION IN THE UNITED STATES

MONTRÉAL, Dec. 10, 2020 (GLOBE NEWSWIRE) — Osisko Metals Incorporated (the “Company” or “Osisko Metals“) (TSX-V: OM; OTCQX: OMZNF; FRANKFURT: 0B51) is pleased to announce a financing package totaling $8.5 million, comprising (a) the grant of a further 0.5% net smelter returns (“NSR”) royalty to Osisko Gold Royalties Ltd (“Osisko Royalties“) on the Pine Point Project for cash consideration of $6.5 million and (b) a non-brokered private placement of up to 4.2 million units of the Company (each, a “Unit“) at a price of $0.48 per Unit for gross proceeds of up to $2 million (the “Offering“), as more particularly described below.

Royalty Financing

Osisko Metals and Osisko Royalties have agreed to amend (the “NSR Amendment“) the existing 1.5% NSR royalty held by Osisko Royalties on the Pine Point Project (see news release dated December 3, 2019). Pursuant to the NSR Amendment, Osisko Metals will grant a further 0.5% NSR royalty to Osisko Royalties on the Pine Point Project for cash consideration of $6.5 million, which will result in Osisko Royalties holding a combined 2% NSR royalty on the Pine Point Project. The 2% NSR royalty held by Osisko Royalties on the Pine Point Project is not subject to buy-back rights in favour of Osisko Metals.

Non-Brokered Unit Financing

Osisko Metals will complete a non-brokered private placement of up to 4.2 million Units at a price of $0.48 per Unit for gross proceeds of up to $2 million. Each Unit will consist of one common share of the Company (each, a “Common Share“) and one-half-of-one common share purchase warrant of the Company (each whole warrant, a “Warrant“). Each Warrant will entitle the holder thereof to acquire one Common Share at a price of $0.58 per share for a 24-month period following the closing date of the Offering.

The Offering is expected to close on or about December 20 or such other date as the Company may determine. The securities to be issued under the Offering will have a hold period of four months and one day from the closing date of the Offering in accordance with applicable securities laws.

The following “insiders” of the Company intend to subscribe for the following Units:

Insider Category Number of Units Subscription Amount
Robert Wares 10% Security Holder; Chairman, CEO and Director 1,050,000 $504,000

Osisko Mining Inc. also intends to subscribe for 1,050,000 Units as part of the Offering, representing a subscription amount of $504,000.

The net proceeds from the Offering will be used for the development of Osisko Metals’ Pine Point Project, specifically drilling and hydrogeological studies, as well as general corporate purposes.

Completion of the NSR Amendment and the Offering are conditional upon the satisfaction of certain closing conditions, including the receipt of all required regulatory approvals, including the approval of the TSX Venture Exchange.

This news release does not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of any of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful, including any of the securities in the United States of America. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “1933 Act”) or any state securities laws and may not be offered or sold within the United States or to, or for account or benefit of, U.S. Persons (as defined in Regulation S under the 1933 Act) unless registered under the 1933 Act and applicable state securities laws, or an exemption from such registration requirements is available.

About Osisko Metals

Osisko Metals Incorporated is a Canadian exploration and development company creating value in the base metal space with a focus on zinc mineral assets. The Company controls two of Canada’s premier past-producing zinc mining camps: 1) the Pine Point Project that is located in the Northwest Territories, for which the recently filed preliminary economic assessment (“PEA“) has indicated an after-tax NPV of $500 million and an IRR of 29.6%. The Pine Point Project PEA is based on current mineral resource estimates that are amenable to open pit and shallow underground mining and consist of 12.9Mt grading 6.29% ZnEq of indicated mineral resources and 37.6Mt grading 6.80% ZnEq of inferred mineral resources. For the assumptions, qualifications and limitations in the Pine Point Project PEA, please refer to the technical report entitled Preliminary Economic Assessment, Pine Point Project, Hay River, North West Territories, Canada dated July 30, 2020 (with an effective date of June 11, 2020), which has been filed on SEDAR (www.sedar.com) under Osisko Metals’ issuer profile. The Pine Point Project is located on the south shore of Great Slave Lake in the Northwest Territories, near infrastructure, paved highway access, and has 100 kilometres of viable haulage roads already in place; 2) The Bathurst Mining Camp projects are located in northern New Brunswick. The company has optioned the majority of its holding in the Bathurst Camp to Brunswick Exploration.

The mineral resource estimates described in this news release have been prepared in accordance with National Instrument 43-101– Standards of Disclosure for Mineral Projects by independent qualified persons (each as defined by National Instrument 43-101– Standards of Disclosure for Mineral Projects). The abovementioned mineral resources are not mineral reserves and do not have demonstrated economic viability. The quantity and grade of the reported inferred mineral resources are conceptual in nature and are estimated based on limited geological evidence and sampling. Geological evidence is sufficient to imply but not verify geological grade and/or quality of continuity. Zinc equivalency percentages are calculated using metal prices, forecasted metal recoveries, concentrate grades, transport costs, smelter payable metals and charges (see respective technical reports for details).

For further information on
this
news
release
, visit

www.osiskometals.com

or contact:

Robert Wares
Chairman & CEO
Osisko Metals Incorporated
Email: [email protected]
www.osiskometals.com

Cautionary Statement on Forward-Looking Information

This news release contains

forward-looking information

within the meaning of the applicable Canadian securities legislation that is based on expectations, estimates, projections and interpretations as at the date of this news release. The information in this news release about the closing of the Offering
and the NSR Amendment
(if at all); the demand for Units (if any); the use of proceeds of the Offering
and the NSR Amendment
;
the approval of the
TSX Venture Exchange
relating to the Offering
and the NSR Amendment
; and any other information herein that is not a historical fact may be

forward-looking information

. Any statement that involves discussions with respect to predictions, expectations, interpretations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as

expects

, or

does not expect

,

is expected

,

interpreted

,

management

s view

,

anticipates

or

does not anticipate

,

plans

,

budget

,

scheduled

,

forecasts

,

estimates

,

believes

or

intends

or variations of such words and phrases or stating that certain actions, events or results

may

or

could

,

would

,

might

or

will

be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information and are intended to identify forward-looking information. This forward-looking information is based on reasonable assumptions and estimates of management of the
Company
at the time such assumptions and estimates were made, and involves known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of
Osisko Metals
to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Such factors include,
but are not limited to,
capi
tal and operating costs varying
significantly from estimates; the preliminary nature of metallurgical test results; delays in
obtaining or failures to obtain
required governmental, environmental or other project approvals; uncertainties relating to the avai
lability and costs of financing
needed in the future; changes in equity markets; inflation; fluctuations in commodity price
s; delays in the development of
projects; the other risks involved in the mineral exploration and development industry;
and those risks set out in the
Company

s p
ublic documents filed on SEDAR (

www.sedar.com

) under Osisko Metals’ issuer profile.
Although the Company be
lieves that the assumptions and
factors used in preparing the forward-looking information in this news release are reasonabl
e, undue reliance should not be
placed on such information, which only applies as of the date of this news release, and no a
ssurance can be given that such
events will occur in the disclosed time frames or at all. The Company disclaims any intention or
obligation to update or revise
any forward-looking information, whether as a result of new information, future events or other
wise, other than as required by la
w.

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.



Large-Scale Use of Hydrogen Presents ‘Sweet Spot’ of Opportunity

NEW YORK, Dec. 10, 2020 (GLOBE NEWSWIRE) — NetworkNewsAudio – Clean Power Capital Corp. (CSE: MOVE) (US OTC: MOTNF) (FWB: 2K6A) announces the availability of a broadcast titled, “Hydrogen-Powered Vehicles Usher in New Era of Transportation.”

To hear the AudioPressRelease, please visit: The NetworkNewsAudio News Podcast

To view the full editorial, please visit: https://nnw.fm/LmeU1

A recent “Wall Street Journal” article titled “Betting on Hydrogen” reported that hydrogen currently supplies less than 5% of the world’s energy but could reach nearly one quarter of global energy consumption by 2050 and generate more than $2.5 trillion direct revenue annually. In the article, Olav Juntilla, managing director at Nomura Greentech Capital Advisors, stated, “Large-scale usage of hydrogen requires build-out and operation of not just production facilities but also compression, transportation, distribution and conversion facilities.”

This is the sweet spot for Clean Power Capital Corp. (CSE: MOVE) (FWB: 2K6A) (OTC: MOTNF) and its subsidiary PowerTap Hydrogen Fueling Corp. Operating at the intersection of technology and opportunity, PowerTap deploys state-of-the-art hydrogen production fueling and refueling technology that produces hydrogen onsite, bypassing the need for the build-out of larger expensive production facilities, gas compression, transportation, distribution or conversion facilities.

About Clean Power Capital Corp.
 

Clean Power is an investment company that specializes in investing into private and public companies opportunistically that may be engaged in a variety of industries, with a current focus in the health and renewable energy industries. In particular, the investment mandate is focused on high-return investment opportunities, the ability to achieve a reasonable rate of capital appreciation and to seek liquidity in its investments. For more information about the company, please visit www.CleanPower.Capital.

NOTE TO INVESTORS: The latest news and updates relating to MOTNF are available in the company’s newsroom at https://nnw.fm/MOTNF

About NetworkNewsWire

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