RBC Global Asset Management Inc. announces final valuation of RBC Target 2020 Corporate Bond Index ETF

Canada NewsWire

TORONTO, Nov. 13, 2020 /CNW/ – RBC Global Asset Management Inc. (“RBC GAM Inc.”) today announced the final valuation of the RBC Target 2020 Corporate Bond Index ETF (TSX: RQH).

As announced earlier this year, the RBC Target 2020 Corporate Bond Index ETF will mature effective the close of business today, Friday, November 13, 2020. The final net asset value (“NAV”) per unit of the ETF is as follows:


ETF


TICKER


FINAL NAV PER UNIT

RBC Target 2020 Corporate Bond Index ETF

RQH

$19.6635

The final NAV per unit consists of the following:

Income per unit 

$0.0200

Capital per unit

$19.6435

Final NAV per unit

$19.6635

The maturity proceeds will be paid out of the ETF today to the holders of the remaining outstanding units.

The suite of RBC Target Maturity Corporate Bond ETFs includes seven ETFs with maturities ranging from 2021 to 2027. Unlike traditional ETFs, which have a perpetual life, target maturity ETFs have a specified maturity date established when the ETF is launched, enabling investors to build customized fixed income portfolios tailored to specific investment needs.

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

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

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

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

About RBC Global Asset Management

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

SOURCE RBC Global Asset Management Inc.

AAM to Present at the Barclays Global Automotive Conference on November 19

PR Newswire

DETROIT, Nov. 13, 2020 /PRNewswire/ — American Axle & Manufacturing Holdings, Inc. (AAM), (NYSE: AXL) will participate in the Barclays Global Automotive Conference on November 19. Starting at 9:20 a.m. ET, David C. Dauch, AAM’s Chairman and Chief Executive Officer, will discuss recent business developments.           

A live audio webcast will be accessible through the Investor Relations page on AAM’s website (www.aam.com). A replay of the webcast will be available following the event.

About AAM
AAM (NYSE: AXL) delivers POWER that moves the world. As a leading global tier 1 automotive supplier, AAM designs, engineers and manufactures driveline and metal forming technologies that are making the next generation of vehicles smarter, lighter, safer and more efficient. Headquartered in Detroit, AAM has approximately 20,000 associates operating at nearly 80 facilities in 17 countries to support our customers on global and regional platforms with a focus on quality, operational excellence and technology leadership. To learn more, visit aam.com.

Our presentation may contain “forward-looking” statements that are subject to risks and uncertainties described in our most recent filings on Form 10-K and Form 10-Q with the Securities and Exchange Commission, and actual results may differ materially. Our presentation also may include certain non-GAAP financial measures. Information regarding these non-GAAP measures, as well as a reconciliation of these non-GAAP measures to GAAP financial information, is available on AAM’s website (www.aam.com).

For more information:


Investor Contact:

Jason P. Parsons                                                                                       
Director, Investor Relations                                                                                        
(313) 758-2404                                                                                                          
[email protected]


Media Contact:


Christopher M. Son

Vice President, Marketing & Communications
(313) 758-4814
[email protected]

Or visit the AAM website at www.aam.com.

 

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SOURCE American Axle & Manufacturing Holdings, Inc.

Scholastic Announces Multi-Book Publishing Program With Civil Rights Trailblazer Ruby Bridges

PR Newswire

NEW YORK, Nov. 13, 2020 /PRNewswire/ — Scholastic is proud to announce a new multi-book publishing program with civil rights hero and national treasure Ruby Bridges. These three new picture books will serve as Bridges and Scholastic’s first collaboration since the 1999 publication of Through My Eyes, Bridges’ critically acclaimed and Jane Addams Children’s Book Award winning autobiography.

Scholastic is proud to announce three new picture books from civil rights hero and national treasure Ruby Bridges.

Says Ellie Berger, President and EVP of Scholastic Trade Publishing: “Ruby Bridges Day takes place on November 14, 2020 and will mark sixty years since then six-year-old Ruby Bridges became the first Black student to attend an all-white elementary school. We are honored to commemorate this anniversary by announcing that we are once again teaming up with Ruby Bridges to launch a new publishing program. Ruby Bridges is a civil rights icon and inspiration, and her modern classic Through My Eyes remains a beloved gem on Scholastic’s backlist. Each of the three new books are core to Ruby’s mission of fighting bigotry, and align with Scholastic’s commitment to equality – drawing on the remarkable framework that she has built over the last six decades. These titles will (re)introduce Ruby to kids today and be presented through her singular perspective, promising to serve young readers for generations to come.”

Kicking off this slate of new publishing in spring 2022 will be I Am Ruby Bridges, a bold and beautifully illustrated book introducing a new generation of readers to this remarkable civil rights pioneer. A companion to Through My Eyes arriving in spring 2023, Dear Ruby Bridges: Letters from Kids Speaking up for a Better World will be comprised of letters from kids that Bridges has received over the years. 2023 will also see the publication of A Talk with My Teacher, based on the relationship between Bridges and Barbara Henry, her first grade teacher.

“I am very happy that Scholastic and I are continuing our 25-year journey together,” Bridges notes. “In the hundreds of classrooms I have spoken in across this country, I’ve had the unique opportunity to see how a book can both educate and inspire our youngest minds. I often say that if we are going to make lasting change, it has to come from our young people. I look forward to bringing these new titles into the Scholastic portfolio as they believe like I do in the transformative power of storytelling.”

Ruby Bridges is a powerful storyteller whose civil rights legacy invites important conversations among children and adults,” adds Andrea Davis Pinkney, Vice President and Executive Editor at Scholastic. “Her books continue to shine a vital light on the children’s book landscape, bringing our shared mission of diversity and inclusion into sharp focus. Like all of her books, these new offerings will provide readers with the tools they need to speak with the kids in their lives about fostering racial harmony for people everywhere.”

Additional Scholastic books about the extraordinary life of Ruby Bridges include Scholastic Reader title Ruby Bridges Goes to School: My True Storyby Ruby Bridges and picture book The Story of Ruby Bridgesby Robert Coles and George Ford (which was rereleased in fall 2020 in a special anniversary edition).

In memory of her mother, Lucille Bridges, who died on November 10, 2020, Ruby Bridges will be joined by Scholastic in establishing the Lucille Bridges Trust, which will support youth who are inspired to continue the legacy of activism. For more information about the Lucille Bridges Trust, please contact [email protected].

ABOUT RUBY BRIDGES


Ruby Bridges is a civil rights activist who at the age of six was the first Black student to integrate an all-white elementary school in New Orleans. She was born in Mississippi in 1954, the same year the United States Supreme Court handed down its landmark decision ordering the integration of public schools. Her family later moved to New Orleans, where on November 14, 1960, Bridges began attending William Frantz Elementary School, single-handedly initiating the desegregation of public education in New Orleans. Her walk to the front door of the school was immortalized in Norman Rockwell’s painting The Problem We All Live With, in Robert Coles’ book The Story of Ruby Bridges, and in the Disney movie Ruby Bridges.

She established the Ruby Bridges Foundation to provide leadership training programs that inspire youth and community leaders to embrace and value the richness of diversity. Bridges is the recipient of numerous awards, including the NAACP Martin Luther King Award, the Presidential Citizens Medal, and honorary doctorate degrees from Connecticut College, College of New Rochelle, Columbia University Teachers College, and Tulane University.  Bridges is also the author of This Is Your Time.

ABOUT SCHOLASTIC

For 100 years, Scholastic Corporation (NASDAQ: SCHL) has been encouraging the personal and intellectual growth of all children, beginning with literacy. Having earned a reputation as a trusted partner to educators and families, Scholastic is the world’s largest publisher and distributor of children’s books, a leading provider of literacy curriculum, professional services, and classroom magazines, and a producer of educational and entertaining children’s media. The Company creates and distributes bestselling books and e-books, print and technology-based learning programs for pre-K to grade 12, and other products and services that support children’s learning and literacy, both in school and at home. With 15 international operations and exports to 165 countries, Scholastic makes quality, affordable books available to all children around the world through school-based book clubs and book fairs, classroom libraries, school and public libraries, retail, and online. For more information, visit Scholastic’s Media Room at http://mediaroom.scholastic.com/.

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SOURCE Scholastic

Accenture Completes Acquisition of Avenai, Ottawa-based Business and Technology Consultancy

Canada NewsWire

Acquisition enhances Accenture’s ability to help public-sector clients with technology transformations

OTTAWA, ON, Nov. 13, 2020 /CNW/ – Accenture (NYSE: ACN) has completed the acquisition of Avenai, an Ottawa-based provider of consulting and technology services.

Avenai’s experienced consulting team will be bolstered by Accenture’s global reach in helping clients meet their broad ambitions. The deal enhances Accenture’s capacity to drive the digital modernization taking place across the public sector in Canada as many departments and agencies embrace change, rapidly move to the cloud, and improve services for Canadians.

Founded in 2012, Avenai has a strong reputation among government and commercial clients in Ottawa and Toronto. The firm supports key aspects of business change including strategy development, process improvement, IT-enabled business transformation, and organizational culture transformation.

Terms of the transaction, which Accenture announced on October 7, were not disclosed.

About Accenture

Accenture is a global professional services company with leading capabilities in digital, cloud and security. Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Interactive, Technology and Operations services—all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 506,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities. Visit us at www.accenture.com.

Forward-Looking Statements

Except for the historical information and discussions contained herein, statements in this news release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “should,” “likely,” “anticipates,” “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” “positioned,” “outlook” and similar expressions are used to identify these forward-looking statements. These statements involve a number of risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied. Many of the following risks, uncertainties and other factors identified below are, and will be, amplified by the COVID-19 pandemic. These risks include, without limitation, risks that: the transaction might not achieve the anticipated benefits for Accenture; Accenture’s results of operations have been significantly adversely affected and could in the future be materially adversely impacted by the COVID-19 pandemic; Accenture’s results of operations have been, and may in the future be, adversely affected by volatile, negative or uncertain economic and political conditions and the effects of these conditions on the company’s clients’ businesses and levels of business activity; Accenture’s business depends on generating and maintaining ongoing, profitable client demand for the company’s services and solutions including through the adaptation and expansion of its services and solutions in response to ongoing changes in technology and offerings, and a significant reduction in such demand or an inability to respond to the evolving technological environment could materially affect the company’s results of operations; if Accenture is unable to keep its supply of skills and resources in balance with client demand around the world and attract and retain professionals with strong leadership skills, the company’s business, the utilization rate of the company’s professionals and the company’s results of operations may be materially adversely affected; Accenture could face legal, reputational and financial risks if the company fails to protect client and/or company data from security incidents or cyberattacks; the markets in which Accenture operates are highly competitive, and Accenture might not be able to compete effectively; Accenture’s profitability could materially suffer if the company is unable to obtain favourable pricing for its services and solutions, if the company is unable to remain competitive, if its cost-management strategies are unsuccessful or if it experiences delivery inefficiencies or fail to satisfy certain agreed-upon targets or specific service levels; changes in Accenture’s level of taxes, as well as audits, investigations and tax proceedings, or changes in tax laws or in their interpretation or enforcement, could have a material adverse effect on the company’s effective tax rate, results of operations, cash flows and financial condition; Accenture’s ability to attract and retain business and employees may depend on its reputation in the marketplace; as a result of Accenture’s geographically diverse operations and its growth strategy to continue to expand in its key markets around the world, the company is more susceptible to certain risks; Accenture’s business could be materially adversely affected if the company incurs legal liability; Accenture’s work with government clients exposes the company to additional risks inherent in the government contracting environment; Accenture’s results of operations could be materially adversely affected by fluctuations in foreign currency exchange rates; if Accenture is unable to manage the organizational challenges associated with its size, the company might be unable to achieve its business objectives; if Accenture does not successfully manage and develop its relationships with key alliance partners or fails to anticipate and establish new alliances in new technologies, the company’s results of operations could be adversely affected; Accenture might not be successful at acquiring, investing in or integrating businesses, entering into joint ventures or divesting businesses; if Accenture is unable to protect or enforce its intellectual property rights or if Accenture’s services or solutions infringe upon the intellectual property rights of others or the company loses its ability to utilize the intellectual property of others, its business could be adversely affected; Accenture’s results of operations and share price could be adversely affected if it is unable to maintain effective internal controls; changes to accounting standards or in the estimates and assumptions Accenture makes in connection with the preparation of its consolidated financial statements could adversely affect its financial results; Accenture might be unable to access additional capital on favourable terms or at all and if the company raises equity capital, it may dilute its shareholders’ ownership interest in the company; Accenture may be subject to criticism and negative publicity related to its incorporation in Ireland; as well as the risks, uncertainties and other factors discussed under the “Risk Factors” heading in Accenture plc’s most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and other documents filed with or furnished to the Securities and Exchange Commission. Statements in this news release speak only as of the date they were made, and Accenture undertakes no duty to update any forward-looking statements made in this news release or to conform such statements to actual results or changes in Accenture’s expectations.

SOURCE Accenture

Tenneco Announces Redemption of 4.875% Senior Secured Notes due 2022

PR Newswire

LAKE FOREST, Ill., Nov. 13, 2020 /PRNewswire/ — Tenneco Inc. (NYSE: TEN) (“Tenneco”) today announced that it will redeem all of its outstanding 4.875% Senior Secured Notes due 2022 (the “Notes”) on December 14, 2020 (the “redemption date”). The aggregate principal amount outstanding of the Notes is €415,000,000. The redemption price for the Notes will be equal to 101.21875% of the principal amount thereof, plus accrued and unpaid interest on the Notes to, but excluding, the redemption date, for a total payment to holders of €1,020.1771 per €1,000 principal amount of Notes. The Notes are currently listed on the Official List of the Luxembourg Stock Exchange and admitted to trading on the Euro MTF Market.

Tenneco intends to fund the redemption of the Notes with proceeds from its previously announced offering of senior secured notes due 2029 (the “New Notes Offering”). Tenneco’s obligation to redeem the Notes is subject to the completion of the closing of the New Notes Offering.  On and after the redemption date, the Notes will no longer be deemed outstanding, interest will cease to accrue thereon, and all rights of the holders of the Notes will cease, except for the right to receive the redemption price.

Payment of the redemption price for the Notes will be made in accordance with the applicable procedures of Euroclear Bank S.A. / N.V. and Clearstream Banking, S.A.

Wilmington Trust, National Association is the trustee for the Notes, The Bank of New York Mellon, London Branch is serving as paying agent, and The Bank of New York Mellon (Luxembourg) S.A., is acting as registrar.

This press release is for information purposes only and shall not constitute the official notice of redemption required under the indenture governing the Notes, which notice shall be provided by the Paying Agent on behalf of Tenneco.  This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, the Notes or any other securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

About Tenneco
Tenneco is one of the world’s leading designers, manufacturers and marketers of automotive products for original equipment and aftermarket customers, with 2019 revenues of $17.5 billion and approximately 78,000 team members working at more than 300 sites worldwide. Through our four business groups, Motorparts, Ride Performance, Clean Air and Powertrain, Tenneco is driving advancements in global mobility by delivering technology solutions for diversified global markets, including light vehicle, commercial truck, off-highway, industrial, motorsport and the aftermarket. Visit www.tenneco.com to learn more.

Investor inquiries:

Linae Golla

847 482-5162
[email protected]

Rich Kwas
248-849-1340
[email protected]

Media inquiries:

Bill Dawson

847 482-5807
[email protected]

 

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SOURCE Tenneco Inc.

Keeping rates low and investing in Kentucky, priorities for LG&E and KU

Promoting economic recovery and providing more energy options for customers remain key

PR Newswire

LOUISVILLE, Ky., Nov. 13, 2020 /PRNewswire/ — Throughout the ongoing pandemic, Louisville Gas and Electric and Kentucky Utilities companies’ delivery of safe, reliable service has been more important than ever. With so many customers working and learning remotely, keeping additional groceries in the refrigerator and spending more time at home, customers’ reliance on ’round-the-clock service – and LG&E and KU’s dedication to deliver – is essential.

During this time, LG&E and KU have been committed to assisting customers and communities that may be struggling. The utilities suspended late fees, convenience charges and disconnects for non-payment beginning in March; donated to COVID-19 relief efforts throughout Kentucky; encouraged economic recovery; and maintained planned infrastructure and technology enhancements to continue providing safe and reliable service.

“During these difficult times, we know our customers have depended on us more than ever before,” said Paul Thompson, LG&E and KU President and CEO. “Many of our residential customers, businesses and communities have been struggling as a result of the pandemic, and we want to ensure we are doing our part to help them succeed. For us, that means keeping the lights on and the gas flowing and providing opportunities that encourage economic recovery and new job opportunities.”


Ensuring Reliable Service

Key to LG&E and KU’s reliability and system resiliency are investments in the utilities’ electric distribution and transmission systems. These include upgraded lines; replacing aging wooden poles with steel; new circuit breakers and substation equipment; cycle-based vegetation management; and advanced technology that immediately pinpoints the location of power outages, and in many cases, limits the impacted area and automatically restores service for all other customers. As a result, within the last decade, outage frequency and duration have been reduced by 20%, preventing more than 31 million outage minutes on the distribution system alone.

Likewise, generation reliability from LG&E and KU’s power plants is among the best in the nation as a result of the utilities’ focus on carefully planned maintenance processes and prioritized investment in equipment critical to reliable generation. The utilities’ key reliability measure of unplanned equipment downtime has been reduced or improved by approximately 50% at the utilities’ power plants over the last decade.

Across its natural gas system, LG&E is continuing to replace aging steel gas lines; making upgrades to compressor stations and underground storage facilities; and following comprehensive safety protocols that include using in-line inspection tools, robotic sensors and leak detection surveys.


Managing Costs to Keep Rates Low and Affordable

Providing safe and reliable service to customers requires significant investment and costs. While LG&E and KU have a proven track record of keeping their costs down, they must, on occasion, seek adjustments to their cost-based rates in order to continue to make the investments necessary to provide the exceptional service their customers have come to expect and require.

“We pride ourselves on providing our customers high value with award-winning service and low rates,” said Thompson. “Making the decision to request a rate adjustment in this difficult economic period was carefully considered and even delayed two months to help allow more economic recovery. However, for us to continue to provide the service on which our customers rely, we are at a point where we must ask the Kentucky Public Service Commission to review our rates based on the increasing costs to serve our customers. In addition to having more economic recovery occur before new rates would go into effect mid-2021, we hope to temper the initial increase in customer bills by also requesting approval of a $53 million ‘Economic Relief Surcredit’ that would help to mitigate the impact of the rate adjustment until mid-2022. Additionally, pending the outcome of this proceeding, it’s our goal not to request another base rate adjustment for several years.”

Despite rising costs for cybersecurity and outside labor, and the investments in the utilities’ systems, LG&E and KU will continue to deliver rates that are among the lowest in the nation. The utilities are ranked in the top quartile of peer companies for holding down costs. As a result, LG&E and KU have maintained residential rates well below the national average. LG&E’s rates are 17% lower than the national average, while KU’s rates are 22% below the national average.

If approved, taking into account the Economic Relief Surcredit, which provides immediate financial benefit, the impact on residential customer bills would be as follows:

KU residential customers using an average of 1,120 kWh per month would see an increase of $12.09 in their total monthly electric bill for the first 12 months after the ruling. When the relief credit expires in mid-2022, a KU residential customer using the same amount of energy would see their monthly bill increase approximately 76 cents.

LG&E residential electric customers using an average of 894 kWh per month would see an increase in their total monthly bill of $8.67 for the first 12 months after the ruling. An LG&E residential customer using the same amount of energy would see the additional monthly increase of $3.07 when the relief credit expires in mid-2022.

LG&E residential natural gas customers using an average of 54 Ccf per month would see an increase of $5.83 in their total monthly bill for the first 12 months following the ruling, and the additional monthly increase of 34 cents in mid-2022.


More Tailored Offerings for Customers

To help improve the environment and enable customers to better manage their bills, LG&E and KU are seeking approval for full deployment of advanced metering infrastructure, faster electric vehicle charging stations and an updated net metering tariff.

LG&E and KU are asking for permission to deploy advanced meters, also known as smart meters, without asking for an increase in rates due to the installation. Already, as part of a pilot program, 20,000 advanced meters have been installed at the request of customers, and more than 5,000 customers are on a waiting list. Advanced meters help customers better understand and manage their energy use and provide LG&E and KU information that helps reduce outages.

Throughout Kentucky, the utilities already offer 20 public electric vehicle charging stations that charge a vehicle at 12 miles to 60 miles of range per hour. To help alleviate “range anxiety,” LG&E and KU propose adding up to eight additional fast-charging stations that can provide customers with 300 miles of range per hour of charging. While just a first step, it is a key step for infrastructure development for EV deployment in Kentucky.

LG&E and KU also are asking for an adjustment in what the utilities, and ultimately all customers, must pay for excess energy created by customers with private generation systems. The adjustment will have no impact on current net metering customers for 25 years and will not impact new net metering customers who simply want to generate and offset their energy use with a private generation system. Only new net metering customers who wish to sell excess energy back to LG&E and KU will be impacted by the change.    


Timing and Ongoing Support

“We have worked to mitigate the financial impacts until the economy has a chance to rebound, and we are offering our customers programs to help them manage their bills during this most difficult time,” Thompson said. “I encourage customers having difficulty paying their utility bills to reach out to us to utilize our flexible payment options and be connected to other agencies that can provide support.”

Each year, the LG&E and KU Foundation, the companies and their employee charitable giving campaign combine to donate nearly $7 million to Kentucky nonprofit organizations that help advance our communities and support those in need.

LG&E and KU plan to file for review by the KPSC on Nov. 25. If approved, no changes would occur before mid-2021 and the full effect would not occur until mid-2022. To further assist with the economic recovery and development, the utilities are targeting this to be the last base rate adjustment for several years.

Louisville Gas and Electric Company and Kentucky Utilities Company, part of the PPL Corporation (NYSE: PPL) family of companies, are regulated utilities that serve more than 1.3 million customers and have consistently ranked among the best companies for customer service in the United States. LG&E serves 329,000 natural gas and 418,000 electric customers in Louisville and 16 surrounding counties. KU serves 558,000 customers in 77 Kentucky counties and five counties in Virginia. More information is available at http://www.lge-ku.com and www.pplweb.com.


Note to Editors: Visit our media website at www.pplnewsroom.com for additional news and background about PPL Corporation.

Contact: LG&E and KU Media Relations, 502-627-4999

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SOURCE Louisville Gas and Electric and Kentucky Utilities

Insmed Receives Priority Medicines (PRIME) Designation from European Medicines Agency (EMA) for Brensocatib in Patients with Non-Cystic Fibrosis Bronchiectasis (NCFBE)

PR Newswire

BRIDGEWATER, N.J., Nov. 13, 2020 /PRNewswire/ — Insmed Incorporated (Nasdaq: INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to brensocatib for the treatment of non-cystic fibrosis bronchiectasis (NCFBE). Brensocatib is a novel, first-in-class, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) being developed by Insmed for the treatment of NCFBE and other inflammatory diseases.

The EMA’s PRIME designation is designed to enhance support for the development of medicines that target unmet medical needs. To be eligible, treatment candidates must demonstrate the potential to offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options, based on early clinical data. The benefits of PRIME designation include early and enhanced interaction with the EMA to optimize development plans and the potential for accelerated assessment. More information on PRIME designation can be found on the EMA website at ema.europe.eu.

“We are very pleased that the EMA has recognized the potential for brensocatib to offer an entirely new treatment approach for NCFBE, a severe and chronic disease with significant unmet needs,” said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. “We are building on the strength of the Phase 2 WILLOW study with the initiation of a pivotal Phase 3 program for brensocatib that we hope will bring forth this urgently needed solution.”

The PRIME designation is based on positive results from the global, randomized, double-blind, placebo-controlled Phase 2 WILLOW study of brensocatib in adults with NCFBE. Insmed plans to initiate the registrational Phase 3 ASPEN trial of brensocatib in patients with NCFBE by the end of 2020. More information on this study is available at clinicaltrials.gov (NCT04594369).

In addition to PRIME designation, brensocatib has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration.

About WILLOW

WILLOW was a randomized, double-blind, placebo-controlled, parallel-group, multi-center, multi-national, Phase 2 study to assess the efficacy, safety and tolerability, and pharmacokinetics of brensocatib administered once daily for 24 weeks in patients with non-cystic fibrosis bronchiectasis (NCFBE). WILLOW was conducted at 116 sites and enrolled 256 adult patients diagnosed with NCFBE who had at least two documented pulmonary exacerbations in the 12 months prior to screening. Patients were randomized 1:1:1 to receive either 10 mg or 25 mg of brensocatib or matching placebo. The primary efficacy endpoint was the time to first pulmonary exacerbation over the 24-week treatment period in the brensocatib arms compared to the placebo arm.

About Brensocatib

Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) being developed by Insmed for the treatment of patients with non-cystic fibrosis bronchiectasis (NCFBE) and other neutrophil-mediated diseases. DPP1 is an enzyme responsible for activating neutrophil serine proteases (NSPs), such as neutrophil elastase, in neutrophils when they are formed in the bone marrow. Neutrophils are the most common type of white blood cell and play an essential role in pathogen destruction and inflammatory mediation. In chronic inflammatory lung diseases, neutrophils accumulate in the airways and result in excessive active NSPs that cause lung destruction and inflammation. Brensocatib may decrease the damaging effects of inflammatory diseases such as bronchiectasis by inhibiting DPP1 and its activation of NSPs.

About Non-Cystic Fibrosis Bronchiectasis

Non-cystic fibrosis bronchiectasis (NCFBE) is a severe, chronic pulmonary disorder in which the bronchi become permanently dilated due to a cycle of infection, inflammation, and lung tissue damage. The condition is marked by frequent pulmonary exacerbations requiring antibiotic therapy and/or hospitalizations. Symptoms include chronic cough, excessive sputum production, shortness of breath, and repeated respiratory infections, which can worsen the underlying condition. NCFBE affects approximately 340,000 to 520,000 patients in the U.S. Today, there are no approved therapies specifically targeting NCFBE in the U.S., Europe, or Japan for the treatment of patients with NCFBE.

About Insmed

Insmed Incorporated is a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases. Insmed’s first commercial product is a first-in-disease therapy approved in the United States and the European Union to treat a chronic, debilitating lung disease. The Company is also progressing a robust pipeline of investigational therapies targeting areas of serious unmet need, including neutrophil-mediated inflammatory diseases and rare pulmonary disorders. Insmed is headquartered in Bridgewater, New Jersey, with a growing footprint across Europe and in Japan. For more information, visit www.insmed.com.

Forward-looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. “Forward-looking statements,” as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “intends,” “potential,” “continues,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements.

The forward-looking statements in this press release are based upon the Company’s current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company’s actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timing discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: failure to obtain, or delays in obtaining, regulatory approvals for ARIKAYCE outside the U.S. or European Union or for the Company’s product candidates in the U.S., Europe, Japan or other markets; failure to successfully commercialize or maintain U.S. or EU approval for ARIKAYCE, the Company’s only approved product; business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises; impact of the novel coronavirus (COVID-19) pandemic and efforts to reduce its spread on the Company’s business, employees, including key personnel, patients, partners and suppliers; the risk that brensocatib does not prove effective or safe for patients in future clinical studies, including the ASPEN and STOP-COVID19 studies; uncertainties in the degree of market acceptance of ARIKAYCE by physicians, patients, third-party payors and others in the healthcare community; the Company’s inability to obtain full approval of ARIKAYCE from the FDA, including the risk that the Company will not timely and successfully complete the study to validate a PRO tool and complete the confirmatory post-marketing study required for full approval of ARIKAYCE; inability of the Company, PARI Pharma GmbH (PARI) or the Company’s other third-party manufacturers to comply with regulatory requirements related to ARIKAYCE or the Lamira® Nebulizer System; the Company’s inability to obtain adequate reimbursement from government or third-party payors for ARIKAYCE or acceptable prices for ARIKAYCE; development of unexpected safety or efficacy concerns related to ARIKAYCE or the Company’s product candidates; inaccuracies in the Company’s estimates of the size of the potential markets for ARIKAYCE or its product candidates or in data the Company has used to identify physicians, expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; the Company’s inability to create an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of ARIKAYCE or any of the Company’s product candidates that are approved in the future; failure to obtain regulatory approval to expand ARIKAYCE’s indication to a broader patient population; failure to successfully conduct future clinical trials for ARIKAYCE, brensocatib, TPIP and the Company’s other product candidates due to the Company’s limited experience in conducting preclinical development activities and clinical trials necessary for regulatory approval and its potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; risks that our clinical studies will be delayed or that serious side effects will be identified during drug development; failure of third parties on which the Company is dependent to manufacture sufficient quantities of ARIKAYCE or the Company’s product candidates for commercial or clinical needs, to conduct the Company’s clinical trials, or to comply with laws and regulations that impact the Company’s business or agreements with the Company; the Company’s inability to attract and retain key personnel or to effectively manage the Company’s growth; the Company’s inability to adapt to its highly competitive and changing environment; the Company’s inability to adequately protect its intellectual property rights or prevent disclosure of its trade secrets and other proprietary information and costs associated with litigation or other proceedings related to such matters; restrictions or other obligations imposed on the Company by its agreements related to ARIKAYCE or the Company’s product candidates, including its license agreements with PARI and AstraZeneca AB, and failure of the Company to comply with its obligations under such agreements; the cost and potential reputational damage resulting from litigation to which the Company is or may become a party, including product liability claims; the Company’s limited experience operating internationally; changes in laws and regulations applicable to the Company’s business, including any pricing reform, and failure to comply with such laws and regulations; inability to repay the Company’s existing indebtedness and uncertainties with respect to the Company’s ability to access future capital; and delays in the execution of plans to build out an additional manufacturing facility approved by the appropriate regulatory authorities and unexpected expenses associated with those plans.

The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company’s forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company’s business, please see the factors discussed in Item 1A, “Risk Factors,” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, the Company’s Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020 and June 30, 2020 and any subsequent Company filings with the Securities and Exchange Commission (SEC).

The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Contact:

Investors:

Argot Partners
Laura Perry or Heather Savelle
(212) 600-1902 
[email protected] 

Media:

Mandy Fahey 
Senior Director, Corporate Communications 
Insmed 
(732) 718-3621 
[email protected]

 

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SOURCE Insmed Incorporated

THC BioMed Releases Year End Results

PR Newswire

THC – CSE
THCBF – OTC 
TFHD – F

VANCOUVER, BC, Nov. 13, 2020 /PRNewswire/ – THC BioMed Intl Ltd. (CSE: THC) (“THC BioMed” or the “Company”) is pleased to report its financial results for the fiscal year ended July 31, 2020.

Annual Highlights:

  • Annual Revenue of $4,178,179
  • EBITDA (Earnings Before Interest Taxes, Depreciation, and Amortization) of $1,167,003

 


STATEMENT OF COMPREHENSIVE INCOME (LOSS) SUMMARY


July 31

July 31


2020

2019

Revenue


$


4,178,179

$

1,489,603

Cost of sales


(3,074,092)

(1,502,452)

Gross profit before fair value adjustments


1,104,087

(12,849)

Net change in fair value of biological assets


2,139,877

1,515,266

Gross margin


3,243,964

1,502,417

Total expenses


3,405,554

14,201,764


Net and comprehensive loss for the year


$


(161,590)

$

(12,699,347)


BALANCE SHEET SUMMARY


As at


July 31


2020

July 31

2019

Current assets


$


8,039,001

$

5,217,996

Total assets


$


21,774,654

$

18,058,337

Current liabilities


$


5,569,427

$

3,290,724

Total liabilities


$


6,901,682

$

4,603,731

Working capital


$


2,469,574

$

1,927,272

Accumulated deficit


$


27,309,521

$

28,400,635



CASH FLOW STATEMENT SUMMARY


July 31


2020

July 31

2019

Net and comprehensive loss for the year


$


(161,590)

$

(12,699,347)

Cash, end of the year


$


751,459

$

991,155


NON-IFRS EARNINGS MEASURE


July 31


2020

July 31

2019

Net and comprehensive loss for the year


$


(161,590)

$

(12,699,347)

Add back

Interest


314,237

74,616

Depreciation and amortization


1,014,356

604,692


EBITDA(1) from continuing operations


1,167,003

(12,020,039)

Accretion expense on convertible debentures


26,513

Fair value of earn out shares to be issued



3,377,877

Financing fees



4,458,153

Realized fair value changes in biological assets included in inventory sold


1,269,559

175,055

Share-based compensation


698,494

3,903,587

Unrealized gain on changes in fair value of biological assets


(3,409,436)

(1,690,321)


Adjusted EBITDA(1)


$


(247,867)

$

(1,795,688)

(1)

These non-IFRS measures are defined in the Company’s MD&A for the year ended July 31, 2020.

MANAGEMENT COMMENTARY

“Sales in Q4 improved over sales in Q3 due to the quantity of product sold. The overall selling prices for cannabis in the retail market are lower, putting pressure on Licensed Producers to improve production efficiencies. Although the quarter ended July 31, 2020 resulted in a loss of $642,989, for the year ended July 31, 2020, the net and comprehensive loss was $161,590. Our focus now is on production of our cannabis beverage shot, THC Kiss, and our Pure Cannabis Sticks which will improve our gross margin,” said THC BioMed President & CEO, John Miller.

All financial information in this press release is reported in Canadian dollars, unless otherwise indicated. This press release is intended to be read in conjunction with the Company’s Audited Consolidated Financial Statements and Management’s Discussion & Analysis for the year ended July 31, 2020, which has been filed on SEDAR (www.sedar.com).


SUMMARY OF QUARTERLY RESULTS


Quarter Ended


Revenue


Net



Income (Loss)


Income (Loss)
Per Share

Q4/2020

July 31, 2020

(1)

$

990,940

$

(642,989)

$

(0.01)

Q3/2020

April 30, 2020

(1)

$

896,104

$

(295,717)

$

Q2/2020

January 31, 2020

(1)

$

1,246,625

$

88,191

$

Q1/2020

October 31, 2019

(1)

$

1,044,510

$

688,925

$

0.01

Q4/2019

July 31, 2019

$

382,096

$

(4,177,572)

$

(0.04)

Q3/2019

April 30, 2019

$

354,326

$

(4,905,797)

$

(0.03)

Q2/2019

January 31, 2019

$

474,041

$

(4,722,819)

$

(0.04)

Q1/2019

October 31, 2018

$

279,140

$

1,106,841

$

0.01


(1)

Includes excise taxes

For the quarter ended July 31, 2020, we produced 913.0 kilograms of dried marijuana and sold 238.7 kilograms at an average selling price of $3.33 per gram reflecting overall lower selling prices in the retail market.

Q4 HIGHLIGHTS

  • Revenue for the quarter increased 159% compared to the same period last year
  • Delivered our largest single sales order in the quarter ended July 31, 2020 of just over $550,000
  • Began shipment of our cannabis beverage shot, THC Kiss, to the adult recreational cannabis market
  • Filed for a U.S. trademark for the use of “THC Kiss” in the U.S. THC BioMed Ltd. owns the common-law rights and the trademark application for “THC Kiss” in Canada.
  • Began production of its Pure Cannabis Sticks; however, delivery has been delayed due to supply chain issues as a result of the general slowdown caused by COVID-19.

HIGHLIGHTS SUBSEQUENT TO JULY 31, 2020

  • Began shipment of its Pure Cannabis Sticks for the recreational market
  • Has submitted the 60-day notice period for new products to Health Canada for THC Kiss Gummies and THC Kiss Water
  • On October 21, 2020, the Company completed the first tranche of a private placement to total $1,500,000. In the first tranche, the Company issued 1,363,637 units (“Units”) at a price of $0.11 per Unit, for total proceeds of $150,000. Each Unit consists of one common share and one common share purchase warrant. Each Unit warrant entitles the holder to purchase one common share of the Company for a period of 24 months from closing at a price of $0.15 per share. Commission of 7% cash was paid and 7% broker warrants for 95,455 broker warrants were issued. The broker warrants have the same terms as the Unit warrants. The Company intends to close additional tranches in the near-term.

ABOUT THC

THC BioMed is a small batch Cannabis Act Licensed Producer of medical and recreational cannabis. It is licensed to cultivate and sell dried, extract, edible and topical cannabis. The Company is on the leading edge of scientific research and the development of products and services related to the cannabis industry.

Please visit our website for a more detailed description of our business and services available. www.thcbiomed.com 

Forward-Looking Information:

This press release may include forward-looking information within the meaning of Canadian securities legislation, concerning the business of THC BioMed Intl Ltd. (“THC”). Forward-looking information is based on certain key expectations and assumptions made by the management of THC. In some cases, you can identify forward-looking statements by the use of words such as “will,” “may,” “would,” “expect,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “likely,” “could” and variations of these terms and similar expressions, or the negative of these terms or similar expressions. Forward-looking statements in this press release are made as of the date of this press release and include that THC will focus now on production of THC Kiss and Pure Cannabis Sticks. Although THC believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because THC can give no assurance that they will prove to be correct. THC disclaims any intent or obligation to update publicly any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.


The Canadian Securities Exchange (CSE) has not reviewed and does not accept responsibility for the adequacy or the accuracy of the contents of this release.

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SOURCE THC BioMed

China Biologic Products to Report Third Quarter 2020 Financial Results

PR Newswire

BEIJING, Nov. 13, 2020 /PRNewswire/ — China Biologic Products Holdings, Inc. (NASDAQ: CBPO) (“China Biologic” or the “Company”), a leading fully integrated plasma-based biopharmaceutical company in China, today announced that the Company plans to release its third quarter 2020 financial results on Tuesday, November 24, 2020 after the market closes.

The Company’s management will hold a conference call at 7:30 a.m. ET on Wednesday, November 25, 2020, which is 8:30 p.m. Beijing Time on November 25, 2020, to discuss third quarter 2020 results. Listeners may access the call by dialing:

US:

1 888 346 8982

International:

1 412 902 4272

Hong Kong:

800 905945

Mainland China:

4001 201203

A telephone replay will be available one hour after the conclusion of the conference call through December 2, 2020. The dial-in details are:

US:

1 877 344 7529

International:

1 412 317 0088

Passcode:

10149967

A live and archived webcast of the conference call will be available through the Company’s investor relations website at http://chinabiologic.investorroom.com/.


About China Biologic Products Holdings, Inc.

China Biologic Products Holdings, Inc. (NASDAQ: CBPO) is a leading fully integrated plasma-based biopharmaceutical company in China. The Company’s products are used as critical therapies during medical emergencies and for the prevention and treatment of life-threatening diseases and immune-deficiency related diseases. China Biologic is headquartered in Beijing and manufactures over 20 different dosage forms of plasma products through its indirect majority-owned subsidiary, Shandong Taibang Biological Products Co., Ltd. and its wholly owned subsidiary, Guizhou Taibang Biological Products Co., Ltd. The Company also has an equity investment in Xi’an Huitian Blood Products Co., Ltd. Since the acquisition of TianXinFu (Beijing) Medical Appliance Co., Ltd. in 2018, China Biologic is also engaged in the sale of medical devices, primarily regenerative medical biomaterial products. The Company sells its products to hospitals, distributors and other healthcare facilities in China. For additional information, please see the Company’s website www.chinabiologic.com.


Contact:    
China Biologic Products Holdings, Inc.
Mr. Ming Yin
Senior Vice President
Email: [email protected]

The Foote Group
Mr. Philip Lisio
Phone: +86-135-0116-6560
E-mail: [email protected]

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SOURCE China Biologic Products Holdings, Inc.

Kintara Therapeutics Announces First Fiscal Quarter 2021 Financial Results and Recent Corporate Updates

PR Newswire

SAN DIEGO, Nov. 13, 2020 /PRNewswire/ — Kintara Therapeutics, Inc. (Nasdaq: KTRA) (“Kintara” or the “Company”), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced its financial results for the first quarter ended September 30, 2020 and provided a corporate update.

“The first quarter of our fiscal year marked the beginning of a new era for the company as we completed the acquisition of Adgero,” commented Saiid Zarrabian, Kintara’s President and Chief Executive Officer. “In conjunction with this transformational milestone, we strengthened our balance sheet with a $25 million private placement to enable us to execute a timely advance of our key programs including the clinical stage of the GCAR GBM AGILE registrational study for VAL-083 and the confirmatory cutaneous metastatic breast cancer study for REM-001.”

First Quarter Highlights and Recent Developments

  • Consummated the acquisition of Adgero, a privately held biopharmaceutical company focused on the development of its late stage photodynamic therapy platform for the treatment of serious cutaneous oncology indications, which created a diversified biopharmaceutical company with a robust product pipeline targeting rare, unmet medical needs in oncology (August 2020).
  • Completed a private placement of Series C Convertible Preferred Stock for aggregate gross proceeds of approximately $25 million, or net proceeds of approximately $21.6 million (August 2020).
  • Executed a definitive agreement with the Global Coalition for Adaptive Research (GCAR) to include VAL-083 in GCAR’s Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) study, an adaptive clinical trial platform in glioblastoma multiforme (GBM). Kintara will supply GCAR with the VAL-083 drug along with the funding to support the VAL-083 arm of the GBM AGILE registrational study. In turn, GCAR will manage all operational aspects of the study, including site activation and patient enrollment (October 2020).
  • Received award notification of a Small Business Technology Transfer grant to study the use of REM-001 in the prevention of arteriovenous fistula maturation failure (AFMF), a cardiovascular-related condition that occurs in hemodialysis patients. This grant will allow Kintara to further study the use of REM-001 in the prevention of AFMF in preclinical models (July 2020).

SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR 2021 FIRST QUARTER ENDED SEPTEMBER 30, 2020

At September 30, 2020, the Company had cash and cash equivalents of approximately $22.6 million.  In August 2020, the Company completed the private placement of Series C Convertible Preferred Stock for gross proceeds of approximately $25 million, or net proceeds of approximately $21.6 million. The cash and cash equivalents at September 30, 2020, along with the proceeds from warrant exercises received subsequent to September 30, 2020, are expected to be sufficient to fund the Company’s planned operations into the fourth quarter of calendar year 2021.

For the quarter ended September 30, 2020, the Company reported a net loss of approximately $19.5 million, or $1.33 per share, compared to a net loss of approximately $1.6 million, or $0.21 per share, for the quarter ended September 30, 2019. The increase in the current quarter was largely due to the recognition of $16.0 million of non-cash expenses related to the acquisition of in-process research and development costs associated with the Adgero transaction.

 


Selected Balance Sheet Data (in thousands)


September 30,


2020


June 30,
2020

$

$

Cash and cash equivalents

22,602

2,392

Working capital

20,566

176

Total assets

23,131

2,938

Total stockholders’ equity

20,554

263

 


Selected Statement of Operations Data (in thousands, except per share data)


For the quarters ended 


September 30,


September 30,


2020


2019

$

$

Research and development

1,357

721

General and administrative

1,534

914

Merger costs

500

In-process research & development

16,094

Other loss (income)

33

(29)

Net loss for the period

19,518

1,606

Deemed dividend recognized on beneficial conversion features of Series C Preferred stock issuance

3,181

Series A Preferred cash dividend

2

2

Series B Preferred stock dividend

5

2

Net loss attributable to common stockholders

22,706

1,610

Basic and fully diluted weighted average number of shares

17,106

7,539

Basic and fully diluted loss per share

1.33

0.21

 

Kintara’s financial statements as filed with the U.S. Securities Exchange Commission can be viewed on the Company’s website at: http://ir.kintara.com/sec-filings.

ABOUT KINTARA

Located in San Diego, California, Kintara is dedicated to the development of novel cancer therapies for patients with unmet medical needs.

Kintara is developing two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs.  The two programs are VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).

VAL-083 is a “first-in-class”, small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g. NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara’s internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

Kintara is also advancing its proprietary, late-stage photodynamic therapy platform that holds promise as a localized cutaneous, or visceral, tumor treatment as well as in other potential indications. REM-001 therapy, has been previously studied in four Phase 2/3 clinical trials in patients with CMBC, who had previously received chemotherapy and/or failed radiation therapy. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

SAFE HARBOR STATEMENT

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the status of the Company’s clinical trials and the GBM AGILE study.  Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties.  The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the impact of the COVID-19 pandemic on the Company’s operations and clinical trials; the Company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company’s products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies.  These and other factors are identified and described in more detail in the Company’s filings with the SEC, including the Company’s Annual Report on Form 10-K for the year ended June 30, 2020, the Company’s Quarterly Reports on Form 10-Q, and the Company’s Current Reports on Form 8-K.

CONTACTS:

Investors:
CORE IR
516-222-2560
[email protected]

Media:

Jules Abraham

Director of Public Relations
CORE IR
917-885-7378
[email protected]

 

 

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SOURCE Kintara Therapeutics