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United Therapeutics Announces Submission of Tyvaso DPI™ New Drug Application to FDA

NDA submission includes both pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease indications

Priority review voucher applied to the NDA submission

PR Newswire

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., April 19, 2021 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) today announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Tyvaso DPI™, a novel dry powder inhalation formulation of treprostinil, for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1 pulmonary hypertension) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3 pulmonary hypertension). There are approximately 45,000 treated PAH patients in the U.S. and United Therapeutics estimates at least 30,000 treatable PH-ILD patients in the U.S.

The submission includes the results of the recently-completed BREEZE clinical study evaluating the use of Tyvaso DPI in PAH patients transitioning from Tyvaso® (treprostinil) Inhalation Solution, along with additional pharmacokinetic data from a study in healthy volunteers.

“In the BREEZE and pharmacokinetic studies, Tyvaso DPI demonstrated safety, tolerability, and a comparable pharmacokinetic profile to nebulized Tyvaso Inhalation Solution,” said Leigh Peterson, Ph.D., Senior Vice President, Product Development at United Therapeutics. “If approved by the FDA, we expect Tyvaso DPI will provide an advancement in the delivery of inhaled treprostinil therapy.”

“Since our founding, we’ve worked hard to ensure our patients have ample choices to deliver treprostinil in various ways to suit their individual needs,” said Gil Golden, M.D., Ph.D., Chief Medical Officer of United Therapeutics. “If approved, Tyvaso DPI will enable patients to go about their day with just a small breath­-actuated, dry powder inhaler that easily fits inside a pocket and requires no batteries or external power source to operate.”

“We’re excited for the potential for Tyvaso DPI to be one of our next product launches, assuming a timely approval in December of this year,” said Michael Benkowitz, President and Chief Operating Officer of United Therapeutics. “The patient choice afforded by Tyvaso DPI, if approved, will help us achieve our goal of doubling the number of patients on Tyvaso therapy by the end of 2022. We remain committed to investigating, innovating, and delivering multiple therapies and treatments designed to help our patients manage their conditions.”

United Therapeutics has applied a priority review voucher to the NDA that could provide for an FDA decision by December 2021. The FDA must first accept the application for review and issue a formal decision date in accordance with the Prescription Drug User Fee Act.

Tyvaso DPI is an investigational therapy that is not approved for any use in any country or indication and the Tyvaso DPI tradename is pending final FDA review. United Therapeutics expects to present data from the BREEZE study and the pharmacokinetic study in healthy volunteers at upcoming medical conferences and in forthcoming scientific publications.

About Tyvaso DPI™
Tyvaso DPI™ is an investigational drug-device combination therapy comprised of a dry powder formulation of treprostinil and a small, portable, dry powder inhaler. If approved, Tyvaso DPI is expected to provide a more convenient method of administration compared with traditional nebulized Tyvaso® therapy. United Therapeutics is developing Tyvaso DPI under a collaboration and license agreement with MannKind Corporation (Nasdaq: MNKD). Tyvaso DPI incorporates the dry powder formulation technology and Dreamboat® inhalation device technology used in MannKind’s Afrezza® (insulin human) Inhalation Powder product, which was approved by the FDA in 2014.

United Therapeutics and MannKind are also developing BluHale®, a Bluetooth-connected accessory for the Tyvaso DPI inhaler with a companion mobile application intended to help the patient track information about inhaler use.

About TYVASO® (treprostinil) Inhalation Solution

INDICATION

TYVASO (treprostinil) is a prostacyclin mimetic indicated for the treatment of:

  • Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).

    The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities.

    While there are long-term data on use of treprostinil by other routes of administration, nearly all controlled clinical experience with inhaled treprostinil has been on a background of bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase type 5 inhibitor). The controlled clinical experience was limited to 12 weeks in duration.

  • Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%).

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • TYVASO is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, TYVASO may produce symptomatic hypotension.
  • TYVASO inhibits platelet aggregation and increases the risk of bleeding.
  • Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (e.g., gemfibrozil) may increase exposure (both Cmax and AUC) to treprostinil. Co-administration of a CYP2C8 enzyme inducer (e.g., rifampin) may decrease exposure to treprostinil. Increased exposure is likely to increase adverse events associated with treprostinil administration, whereas decreased exposure is likely to reduce clinical effectiveness.

DRUG INTERACTIONS/SPECIFIC POPULATIONS

  • The concomitant use of TYVASO with diuretics, antihypertensives, or other vasodilators may increase the risk of symptomatic hypotension.
  • Human pharmacokinetic studies with an oral formulation of treprostinil (treprostinil diolamine) indicated that co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor, gemfibrozil, increases exposure (both Cmax and AUC) to treprostinil. Co-administration of the CYP2C8 enzyme inducer, rifampin, decreases exposure to treprostinil. It is unclear if the safety and efficacy of treprostinil by the inhalation route are altered by inhibitors or inducers of CYP2C8.
  • Limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. However, pulmonary arterial hypertension is associated with an increased risk of maternal and fetal mortality. There are no data on the presence of treprostinil in human milk, the effects on the breastfed infant, or the effects on milk production.
  • Safety and effectiveness in pediatric patients have not been established.
  • Across clinical studies used to establish the effectiveness of TYVASO in patients with PAH and PH–ILD, 268 (47.8%) patients aged 65 years and over were enrolled. The treatment effects and safety profile observed in geriatric patients were similar to younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of hepatic, renal, or cardiac dysfunction, and of concomitant diseases or other drug therapy.

ADVERSE REACTIONS

  • Pulmonary Arterial Hypertension (WHO Group 1)
    In a 12-week, placebo-controlled study (TRIUMPH I) of 235 patients with PAH (WHO Group 1 and nearly all NYHA Functional Class III), the most common adverse reactions seen with TYVASO in ≥4% of PAH patients and more than 3% greater than placebo in the placebo-controlled study were cough (54% vs 29%), headache (41% vs 23%), throat irritation/pharyngolaryngeal pain (25% vs 14%), nausea (19% vs 11%), flushing (15% vs <1%), and syncope (6% vs <1%). In addition, adverse reactions occurring in ≥4% of patients were dizziness and diarrhea.

  • Pulmonary Hypertension Associated with ILD (WHO Group 3)
    In a 16-week, placebo-controlled study (INCREASE) of 326 patients with PH-ILD (WHO Group 3), adverse reactions were similar to the experience in studies of PAH.

Please see Full Prescribing Information, the TD-100 and TD-300 TYVASO® Inhalation System Instructions for Use manuals, and other additional information at www.tyvaso.com or call 1–877–UNITHER (1-877-864-8437).

United Therapeutics: Enabling Inspiration
United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our obsession with quality and innovation, the power of our brands, our entrepreneurial culture, and our bioinformatics leadership. We also believe that our determination to be responsible citizens – having a positive impact on patients, the environment, and society – will sustain our success in the long term.

Through our wholly owned subsidiary, Lung Biotechnology PBC, we are focused on addressing the acute national shortage of transplantable lungs and other organs with a variety of technologies that either delay the need for such organs or expand the supply. Lung Biotechnology is the first public benefit corporation subsidiary of a public biotechnology or pharmaceutical company.

Please visit unither.com to learn more.

Forward-looking Statements
Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements relating to the potential for the approval of Tyvaso DPI and the timing of any such approval, its potential benefits to patients, our goal of doubling the number of patients being treated with Tyvaso by 2022, our ability to create value and sustain our success in the long-term, as well as our efforts to develop technologies that either delay the need for transplantable organs or expand the supply of transplantable organs. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of April 19, 2021, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason.

TYVASO is a registered trademark of United Therapeutics Corporation.

TYVASO DPI is a trademark of United Therapeutics Corporation.

AFREZZA, BLUHALE, and DREAMBOAT are registered trademarks of MannKind Corporation.

For Further Information Contact:
Dewey Steadman at (202) 919-4097
Email: [email protected]   

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SOURCE United Therapeutics Corporation

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Treatment.com to Commence Trading on the Canadian Securities Exchange Today

Canada NewsWire

VANCOUVER, BC, April 19, 2021 /CNW/ – Treatment.com (CSE: TRUE) announced today its common shares have been approved for listing on the Canadian Securities Exchange (CSE) and will begin trading under the symbol “TRUE”.

“We are a fast-growing technology company fueling innovation in the healthcare industry. Our mission is to keep everyone healthy. Our team has spent years developing the smartest AI health assessment trained to think like a doctor and worked with world-class consumer research agencies to inform our first product, Cara,” said John Fraser, CEO of Treatment.com. “We thank our doctors, researchers and engineers for their groundbreaking work and look forward to trading on the CSE to achieve our ambitious growth plans.”

About Treatment.com

Treatment.com is a disruptive healthcare technology startup that is harnessing the power of AI to help Canadians improve their health through personalized recommendations and insights. Based in Vancouver, the company spent the last five years working with a team of world-class doctors, engineers, mathematicians, and AI specialists to develop a complex AI engine that leverages the most robust, personalized data to generate highly predictive and accurate insights. Treatment.com is the parent company of Cara. This summer, Cara will be empowering Canadians to take control of their health with the launch of an innovative mobile app powered by this exclusive AI engine.

For more investor information on Treatment.com please visit https://treatment.com/investors/.

Forward Looking Statement

This news release contains forward-looking statements relating to the future operations of Treatment.com, International, Inc. (Treatment) and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, statements regarding the future plans and objectives of Treatment, are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from Treatment’s expectations include other risks detailed from time to time in the filings made by Treatment with securities regulators.

The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of Treatment. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and Treatment will only update or revise publicly the included forward-looking statements as expressly required by Canadian securities law.

SOURCE Treatment.com

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IDEAYA Biosciences Announces Agenda for Inaugural Synthetic Lethality Investor Day on Tuesday, April 20, 2021

PR Newswire

SOUTH SAN FRANCISCO, Calif., April 19, 2021 /PRNewswire/ — IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced the agenda for its inaugural Synthetic Lethality Investor Day. The event will be held virtually on Tuesday, April 20, 2021, at 1:00 pm – 3:00 pm ET (10:00 am – 12:00 noon PT). The agenda will include scientific presentations from IDEAYA, GlaxoSmithKline (GSK) and several key opinion leaders.

Presenters

  • Alan D’Andrea, M.D., Director, Center of DNA Damage and Repair, Dana Farber Cancer Institute of Harvard Medical School
  • William Sellers, M.D., Core Institute Member and Director of the Cancer Program of the Broad Institute of MIT and Harvard
  • Benjamin Schwartz, Ph.D., Vice President, Head of Oncology Synthetic Lethality Research Unit, GlaxoSmithKline (GSK)
  • Yujiro Hata, President and Chief Executive Officer, IDEAYA Biosciences
  • Michael Dillon, Ph.D., SVP and Chief Scientific Officer, IDEAYA Biosciences
  • Mark Lackner, Ph.D., SVP and Head of Biology and Translational Sciences, IDEAYA Biosciences
  • Matt Maurer, M.D., VP and Head of Clinical Oncology and Medical Affairs, IDEAYA Biosciences

Program Agenda (ET)

  • 1:00 pm – Welcome and Introduction
    • Yujiro Hata
  • 1:10 pm – Synthetic Lethality: Emerging Area within Precision Medicine and GSK-IDEAYA Partnership
    • Ben Schwartz (GSK)
  • 1:20 pm – IDE397: Targeting MAT2A in MTAP-Deleted Tumors
    • Bill Sellers (Broad), Mark Lackner, Matt Maurer
  • 1:50 pm – Werner Helicase (Roundtable): Compelling Synthetic Lethality Target
    • Introduction: Ben Schwartz (GSK)
    • Panelists:Bill Sellers (Broad), Mike Dillon, Ben Schwartz
    • Moderator: Yujiro Hata
  • 2:10 pm – Pol Theta: Key Target in MMEJ DNA Damage Repair Pathway
    • Alan D’Andrea (Harvard), Mike Dillon, Ben Schwartz (GSK)
  • 2:30 pm – PARG: Novel Target in Clinically Validated Pathway
    • Mike Dillon, Mark Lackner
  • 2:45 pm – Analyst Q&A / Closing
    • Yujiro Hata
  • 3:00 pm – Adjourn

Registration for the IDEAYA Synthetic Lethality Investor Day and additional information on the event is available on IDEAYA’s website at https://ir.ideayabio.com/events.

About IDEAYA Biosciences
IDEAYA is a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA’s approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies. IDEAYA is applying its early research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets. 

Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the timing, content and participants of the Synthetic Lethality Investor Day. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA’s preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA’s programs’ early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA’s ability to successfully establish, protect and defend its intellectual property, the effects on IDEAYA’s business of the worldwide COVID-19 pandemic, and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see the IDEAYA Annual Report for the year ended December 31, 2020 on Form 10-K filed on March 23, 2021 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.   

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SOURCE IDEAYA Biosciences, Inc.

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Grōv Technologies and California-Based River Ranch Dairy Enter Definitive Agreement to Build World-Class Automated Indoor Feed Production Center

— Located in Central Valley California near Tulare’s annual World Ag Expo, River Ranch Dairy will become a showcase for Grōv’s sustainable dairy feed technology —

PR Newswire

VINEYARD, Utah, April 19, 2021 /PRNewswire/ — Today, Grōv Technologies announced it has signed a definitive sales agreement with River Ranch Dairy to help further their goal of becoming more sustainable and drought resistant through the adoption of Grōv’s automated indoor feed technology. Under the terms of the agreement River Ranch will purchase an on-premises indoor vertical animal feed production center which will produce fresh Grōv HDN Superfeed™, using less than 5% of the water of traditional farming.

At the core of the Grōv-River Ranch Feed Center will be the Olympus Tower Farm platform. One Olympus Tower takes up only 857 square feet and can produce 6,000 pounds of Grōv HDN Superfeed daily, replacing between 35-50 acres of farmland, using zero herbicides or pesticides.

“Reducing both our water usage and becoming more sustainable is essential for the long-term economic health of our farm and the environment,” said Jack de Jong, River Ranch Dairy owner and operator.  “In addition to sustainability, the health and welfare of our animals is one of our top priorities. We believe feeding our animals Grōv’s clean fresh “Superfeed” wheatgrass holds the promise to boost the health and productivity of our herd.”

The River Ranch Dairy is home to 10,000 animals located in California’sCentral Valley, the highest and most concentrated milk production area in the U.S. The five-county region has over 1.3 million cows. The new Grōv-River Ranch Feed Center will be located near the annual World Ag Expo in Tulare, California, attracting over 100,000 visitors, conveniently showcasing Grōv’s technology to visitors from around the globe. 

“As changing climates and water shortages increase, dairy and beef farmers will need to be equipped with technology and science that will help them feed growing populations and also care for the health and welfare of their animals,” said Steve Lindsley, president of Grōv Technologies. “We are honored to welcome Jack, who comes from a rich heritage of dairy and Ag expertise, to the Grōv family.”

The Grōv-River Ranch Dairy Feed Center is currently in the permitting and design phase with completion anticipated later this year.

In ongoing trials conducted over the past year, dairy animals that were fed with Grōv HDN Superfeed maintained milk production while eating less dry matter, thus improving overall feed efficiency. Trials were conducted at Bateman Mosida Farms, Utah’s largest dairy.

For more information about Grōv Technologies and its Olympus Tower Farm, please visit www.grovtech.com. Grōv welcomes individuals who want to come visit their facility, as long as they follow social distancing guidelines.

About Grōv Technologies, LLC  
Grōv Technologies is pioneering automated controlled environment agriculture (CEA) science and technology to help meet the demands of global food security. The company has developed enterprise scale systems and growing protocols to consistently produce high-density nutrient feed, or HDN Superfeed™. Grōv enables operators to sustainably grow feed, improve animal health, produce better products and increase profits. Grōv is wholly owned by Nu Skin Enterprises, Inc. (NYSE: NUS), which empowers innovative companies with sustainable solutions, opportunities, technologies, and life-improving values.

Grōv™, Grōv HDN Superfeed™ and Olympus Tower Farm™, are trademarks of Grōv Technologies™. 

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SOURCE Grōv Technologies

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American Homes 4 Rent Announces $1.25 Billion Sustainability-Linked Revolving Credit Facility

PR Newswire

CALABASAS, Calif., April 19, 2021 /PRNewswire/ — American Homes 4 Rent (NYSE: AMH) (the “Company”), a leading provider of high-quality single-family homes for rent, today announced that the Company and its operating partnership, American Homes 4 Rent, L.P. (the “Borrower”), successfully closed a $1.25 billion, sustainability-linked revolving credit facility (the “Credit Facility”), amending its existing $800 million revolving credit facility. The amended revolving credit facility provides for expanded borrowing capacity to continue to support the Company’s growth initiatives, reflects a more favorable pricing grid based on current market conditions, and includes a sustainability component based upon third-party performance measures through which overall pricing can further improve if the Company meets certain targets. 

“We are pleased to announce the closing of our upsized credit facility which reflects our continued strategic focus on outsized external growth as well as dedication to sustainability and sound ESG principles,” stated Chris Lau, American Homes 4 Rent’s Chief Financial Officer. “Our flexible balance sheet and access to investment grade capital continue to be a key differentiator for American Homes 4 Rent.  We appreciate the strong support from our bank group and believe the closing of our upsized credit facility reflects their confidence in our future.”

The amended revolving credit facility has an initial maturity date of April 15, 2025 and may be extended for up to one year through the exercise of two six-month extension options at the Borrower’s option if certain conditions are met. As of April 15, 2021$80 million was outstanding under the existing revolving credit facility.

The interest rate on the amended revolving credit facility is at either LIBOR plus a margin ranging from 0.725% to 1.45% or a base rate (determined according to the greater of a prime rate, federal funds rate plus 0.5% or daily LIBOR rate plus 1.0%) plus a margin ranging from 0.00% to 0.45%. In each case the actual margin is determined based on the Company’s credit ratings in effect from time to time.

A total of 15 lenders participated in the Company’s Credit Facility, including Wells Fargo Bank, National Association as Administrative Agent and JPMorgan Chase Bank, N.A. as Syndication Agent. Additional lenders include Bank of America, N.A., PNC Bank, National Association, Raymond James Bank, N.A., Bank of Montreal, Mizuho Bank, LTD., Morgan Stanley Bank, N.A., The Bank of Nova Scotia, U.S. Bank National Association, Citibank, N.A., Regions Bank, City National Bank, Associated Bank, N.A., and BBVA USA as the Sustainability Agent. Wells Fargo Securities, LLC, JPMorgan Chase Bank, N.A., and BofA Securities, Inc. were the Joint Lead Arrangers and Joint Book Runners, and PNC Capital Markets LLC and Raymond James Bank, N.A. were Joint Lead Arrangers.


About American Homes 4 Rent

American Homes 4 Rent (NYSE: AMH) is a leader in the single-family home rental industry and “American Homes 4 Rent” is fast becoming a nationally recognized brand for rental homes, known for high-quality, good value and tenant satisfaction. We are an internally managed Maryland real estate investment trust, or REIT, focused on acquiring, developing, renovating, leasing, and operating attractive, single-family homes as rental properties. As of December 31, 2020, we owned 53,584 single-family properties in selected submarkets in 22 states.

Additional information about American Homes 4 Rent is available on our website at www.americanhomes4rent.com.

Contacts:
American Homes 4 Rent
Investor Relations
Anne McGuinness
Phone: (855) 794-2447
Email: [email protected]

American Homes 4 Rent
Media Relations
Megan Grabos
Phone: (805) 413-5088
Email: [email protected]

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SOURCE American Homes 4 Rent

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Equinor ASA: Notice of annual general meeting on 11 May 2021

The annual general meeting of Equinor ASA (OSE: EQNR, NYSE: EQNR) will be held on 11 May 2021 at 16:00 (CEST).

Due to the Covid-19 situation, the annual general meeting will be held as a digital meeting with electronic voting. Please refer to the attached guide for online participation. It is also possible to vote in advance, or attend the meeting by proxy.

Please see further detailed information under “Participation” in the notice of the annual general meeting.

The full notice, agenda and appendices are attached hereto. Further information is also to be found on www.equinor.com/agm

Investor contact:

Erik Gonder
+ 47 99562611
[email protected]

This information is subject to the disclosure requirements pursuant to Section 5-12 the Norwegian Securities Trading Act

Attachment



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Verit Advisors® Team Members Will Speak at the Employee Ownership Conference

Chicago, IL, April 19, 2021 (GLOBE NEWSWIRE) — Verit Advisors® will participate in the NCEO (National Center for Employee Ownership) Employee Ownership Conference virtually, April 20 and 21, 2021. This annual conference is a premier gathering on employee ownership.

On Tuesday, April 20 at 12:30 EST, John Solimine, Managing Director at Verit Advisors® will join a panel on “ESOP Financing int Today’s Economy.” The presentation will provide an overview of the current credit markets and perspectives for the coming months in senior bank, non-bank and mezzanine debt markets. Mr. Solimine has over 20 years of experience in investment banking and debt capital markets. He began his career at LaSalle Bank (Bank of America), where he provided debt financing for middle-market sponsors and portfolio companies. He gained investment banking experience at Bear Stearns and Jefferies & Company in New York. He later joined Equibase Capital, a Chicago private equity firm.

Also on Tuesday at 3:45, Jake Cravens, Managing Director at Verit Advisors, will participate on a panel to discuss “Exploring a Partial ESOP Transaction.” This session will cover the financing implications of partial ESOPs, S corporation distributions, and administrative issues including considerations about balancing ownership interests and managing future repurchase obligations. It will review the pros and cons of a partial ESOP compared to a 100% ESOP transaction, as well as the broader tax advantages of ESOP transactions.” Mr. Cravens joined Verit Advisors in 2015 and leads execution on a wide range of transactions, restructuring, and advisory services including M&A, ESOPs, and strategic alternatives consulting. Jake specializes in the valuation of business enterprises and the structuring of complex ESOP transactions.

Mary Josephs, Founder and CEO of Verit Advisors, will present on Wednesday, April 21 at 2:30 on “Strategy 101: Why Employee Ownership is Not Enough.” This session will help ESOP leaders understand the importance strategic planning, taking into account the unique characteristics of ESOP capital structures, culture, and long-term objectives.  Ms. Josephs founded Verit Advisors in 2009 and has nearly three decades of experience in corporate finance. She is a nationally recognized leader and has advised structured and closed more than 300 financings for middle market companies. Ms. Josephs is a past two term board member of the NCEO.

About ESOPs

According to the NCEO, the first employee stock ownership plan (ESOP) was in 1956 and today there are about 6,700 ESOPs and equivalent plans employing more than 14 million employees in the U.S. ESOPs are spread throughout the nation and industries and range from just a few employees to more than 150,000 employees. Over a 10-year period, ESOPs have 25 percent higher job growth than comparable companies without an ESOP. These companies have 4 to 5 percent higher productivity in the year an ESOP is adopted. Employee ownership keeps businesses and jobs in state with ESOP companies 25 percent more likely to stay in business.


About Verit Advisors

Verit Advisors unites sophisticated middle market investment banking capabilities with a client centric boutique, fluent in ESOPs, debt and equity capital markets, and M&A, transaction opinions and valuation services and board advisory services. Integrity, teamwork, service, and innovation are at the heart of the organization, as the Verit Team strives to provide unparalleled advice and custom solutions to its clients. Mary Josephs founded Verit Advisors in 2009 in Chicago and has nearly three decades of experience in the world of corporate finance. Josephs and her team are considered to be the foremost experts in ESOP transactions and middle market strategic alternatives.



Pat Eichten
Verit Advisors, LLC
[email protected]

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RadNet’s Artificial Intelligence Subsidiary, DeepHealth, Announces FDA Clearance for its AI Mammography Triage Software

CAMBRIDGE, Mass. and LOS ANGELES, April 19, 2021 (GLOBE NEWSWIRE) — RadNet, Inc., (NASDAQ: RDNT) today announced that its subsidiary DeepHealth, a leading developer of artificial intelligence (AI) for mammography interpretation, has received FDA clearance for its mammography triage software Saige-Q. 

Saige-Q is a screening worklist prioritization tool that enables radiologists to more effectively manage their mammography cases with the use of artificial intelligence. DeepHealth’s powerful new AI technology automatically identifies suspicious screening exams that may need prioritized attention, allowing radiologists to optimize their workflow for efficiency and effectiveness.

“Saige-Q is built using our core artificial intelligence algorithms, described in a recent article in Nature Medicine,” said Bill Lotter, Ph.D., CTO, and co-founder of DeepHealth. “As the first FDA-cleared mammography triage product that supports 3D mammography in addition to 2D mammography, Saige-Q demonstrates high performance that is maintained across different breast densities and lesion types.”

“As our first FDA-cleared product, Saige-Q is a major milestone for our team. It represents the first step of many towards delivering the best care possible for patients through rigorous science that clinicians and patients can trust,” said Gregory Sorensen, M.D., CEO, and co-founder of DeepHealth. “We have developed an advanced algorithm to support radiologists with the significant challenge of finding breast cancer as early as possible. Saige-Q empowers radiologists to optimize how and when they read cases marked by Saige-Q as suspicious or those not marked as suspicious, enhancing their ability to deliver the best care.”

Dr. Howard Berger, President and Chief Executive Officer of RadNet, commented, “Receiving FDA clearance for our first mammography AI software algorithm is an important step in RadNet’s commitment to delivering the best quality of care for our patients. With the almost 2 million mammography exams we perform annually in our markets, we will now begin to deploy this tool, enabling our mammographers to become more accurate and productive. The efficiency gains and accuracy should be further enhanced by a more advanced diagnostic algorithm we plan to submit to the FDA for its review by year end.”

“With the purchase of DeepHealth last year and the ongoing investments we are making in AI, we are dedicated to leading the transformation of our industry into utilizing machine learning to enhance patient outcomes, improve the productivity of radiologists and offer unique screening programs to health insurers which we believe will have a profound impact on population health and wellness,” Dr. Berger noted.

About RadNet, Inc.

RadNet, Inc. is the leading national provider of freestanding, fixed-site diagnostic imaging services in the United States based on the number of locations and annual imaging revenue. RadNet has a network of 331 owned and/or operated outpatient imaging centers. RadNet’s core markets include California, Maryland, Delaware, New Jersey, Arizona, Florida, and New York. In addition, RadNet provides radiology information technology solutions and other related products and services to customers in the diagnostic imaging industry. Together with affiliated radiologists, and inclusive of full-time and per diem employees and technicians, RadNet has approximately 8,200 employees.
For more information, visit www.radnet.com.

About DeepHealth, Inc.

DeepHealth, a wholly owned subsidiary of RadNet, Inc., uses machine learning to distill lifetimes of insights from medical experts into software to assist physicians. DeepHealth’s mission is to enable the best care by providing products that clinicians and patients can trust, through rigorous science and clinical integration. For more information, visit www.deep.health.


Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are expressions of our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, and anticipated future conditions, events and trends. Forward-looking statements can generally be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods.

Forward-looking statements are neither historical facts nor assurances of future performance. Because forward-looking statements relate to the future, they are inherently subject to uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not place undue reliance on any of these forward-looking statements. 


CONTACTS:

Media Contact – DeepHealth, Inc.:
Bret Baird
Chief Commercial Officer
424-832-1480
[email protected]

Media Contact – RadNet, Inc.:
Mark Stolper
Executive Vice President and Chief Financial Officer
310-445-2800
[email protected]



Posted on

Highwoods Agrees to Acquire Office Assets from Preferred Apartment Communities, Inc.

Total Investment of $769M (Including Assumed Debt) Closing Scheduled for Third Quarter 2021

Asset Strategy Market Submarket/BBD SF
150 Fayetteville Core Raleigh CBD 560,000
CAPTRUST Tower Core Raleigh North Hills 300,000
Capitol Towers Core Charlotte SouthPark 479,000
Morrocroft Centre Core Charlotte SouthPark 291,000
Galleria 75 Redevelopment Site Core Atlanta Cumberland/Galleria  
         
Office-Related Mezzanine Loan Non-Core Atlanta West Midtown  
Armour Yards Non-Core Atlanta Buckhead/Midtown  

_________________________________________

Acquisition to be Funded Primarily Through

Sales of Non-Core Assets

Expects to Return Balance Sheet Metrics to Current Levels by Mid-2022

_________________________________________

        

Plan Expected to Strengthen Long-Term Growth Trajectory

Immediately Accretive to Cash Flows

Neutral to Current FFO Run Rate; Accretive over Long-Term

_________________________________________

Conference Call: Monday, April 19

th

at 11:00 A.M. ET

(800)
756-3565
or


www.highwoods.com



_________________________________________

RALEIGH, N.C., April 19, 2021 (GLOBE NEWSWIRE) —  Highwoods Properties, Inc. (NYSE:HIW) has agreed to acquire a portfolio of office assets from Preferred Apartment Communities, Inc. (NYSE:APTS) (“PAC”). The core portfolio to be acquired consists of four Class A office assets in Charlotte and Raleigh and one mixed-use redevelopment site in Atlanta. The Company has also agreed to acquire two non-core assets: a mezzanine loan related to a recently constructed office building in Atlanta; and Armour Yards, a multi-building creative office project in Atlanta.

The Company’s total investment, including the estimated value of the non-core assets, is expected to be $769 million, which includes $28 million of near-term building improvements and $5 million of transaction costs. The transaction is expected to include, among other things, the assumption of four secured loans collateralized by the core office buildings estimated to be recorded at fair value of $403 million in the aggregate, with a weighted average effective interest rate of 3.7% and a weighted average maturity of 10.8 years. The value of the non-core assets represents less than 12% of the anticipated total investment.

The acquisition, which is subject to customary closing conditions, is scheduled to close during the third quarter of 2021. The Company is posting $50 million of earnest money deposits that are non-refundable except in limited circumstances.

The core office buildings in Charlotte and Raleigh, which encompass 1,630,000 square feet in total, were 95% leased at December 31, 2020 with rent collections of over 99% during 2020. These properties are projected to generate cash net operating income of $38.0 million and GAAP net operating income of $42.7 million in the first four quarters following closing.

The Company’s plan is to ultimately fund the acquisition primarily by accelerating the sales of existing non-core assets. The Company expects to return its balance sheet metrics to current levels by mid-2022.

Ted Klinck, President and CEO, stated, “The portfolio of properties from PAC fits perfectly with our existing BBD strategy and footprint. This high-quality portfolio gives us entry into two new BBDs that have long been on our wish list, nearly doubles our presence in Charlotte to 1.6 million square feet and further strengthens our market share in Raleigh. Further, there is long-term upside from potential synergies with our existing portfolio and an attractive redevelopment parcel in Atlanta.

Our plan is to effectively match-fund our purchase of these trophy assets in the high-growth markets of Charlotte and Raleigh by selling a select portfolio of non-core assets. Importantly, once completed, our plan is expected to be roughly leverage-neutral, accretive to cash flows and neutral to our FFO run-rate, while improving the quality of our portfolio and providing higher growth over time.”

“We are very appreciative of the entire team at PAC who have worked so collaboratively alongside us on this transaction. They have been great to work with and we look forward to closing the transaction,” Mr. Klinck added.

The financial impacts of these planned investment activities were not included in the Company’s 2021 per share FFO outlook published on February 9, 2021. While the Company will provide an updated 2021 FFO outlook as part of its first quarter earnings release on April 27, 2021, it does not intend to update its FFO outlook to reflect the financial impacts of these planned investment activities until the closing of the acquisition.

150 Fayetteville – Raleigh (CBD)

150 Fayetteville is a 29-story, Class A officer tower encompassing 560,000 square feet in CBD Raleigh. The building was 91% leased at December 31, 2020 with a current weighted average lease term of 5.8 years. With this acquisition, the Company will own nearly 1.5 million square feet of Class A office buildings concentrated within four city blocks in CBD Raleigh, one of the city’s Best Business Districts (BBDs). The Company also owns two development sites in CBD Raleigh that can support more than 500,000 square feet of Class A office.

CAPTRUST Tower – Raleigh (North Hills)

CAPTRUST Tower is a 16-story, Class A office tower located in the heart of Raleigh’s vibrant mixed-use North Hills submarket, a new BBD for Highwoods. This 300,000 square foot building, which has a wide array of office and amenity retail customers, was 98% leased at December 31, 2020 with a current weighted average lease term of 8.3 years.

Capitol Towers – Charlotte (SouthPark)

Capitol Towers is a 479,000 square foot asset that includes two 10-story office buildings, the award-winning Legion Brewing and additional amenity retail in the vibrant and upscale SouthPark submarket of Charlotte, also a new BBD for Highwoods. Capitol Towers, which was completed between 2015 and 2017, was 98% leased on a combined basis at December 31, 2020 with a current weighted average lease term of 8.9 years.

Morrocroft Centre – Charlotte (SouthPark)

Morrocroft Centre is a 291,000 square foot, three-building office complex in the SouthPark submarket of Charlotte. Morrocroft Centre was 95% leased on a combined basis at December 31, 2020 with a current weighted average lease term of 6.1 years.

Galleria 75 – Atlanta (Cumberland/Galleria)

Galleria 75 is a mixed-use redevelopment site in the Cumberland/Galleria submarket of Atlanta, one of the city’s BBDs. The site is located less than one mile from Highwoods-owned Riverwood 100 and 200, which encompass 800,000 square feet and were 95% occupied on a combined basis at December 31, 2020. Galleria 75 can support up to 600,000 square feet of office development and 300 apartment units. The site’s two existing low-rise office buildings totaling 111,000 square feet are 90% leased to customers on short-term leases. Because Galleria 75 will be classified as a development parcel, net operating income generated from the two existing buildings, which is estimated to be approximately $1.2 million annually, will not be included in the Company’s calculation of FFO.

Non-Core Assets

The mezzanine loan is part of the financing structure used by a third party to construct 8West, a 195,000 square foot, 9-story office building on the western side of the Georgia Tech campus in Midtown Atlanta. Armour Yards is a multi-building creative office project located between Atlanta’s Buckhead and Midtown submarkets and along the future Beltline extension. Armour Yards consists of four adaptive reuse office buildings totaling 187,000 square feet that were 93% leased at December 31, 2020 as well as a 36,000 square foot, recently completed office building. As part of the transaction, PAC will separately market Armour Yards for sale to a third party. If PAC chooses not to sell Armour Yards to a third party, Highwoods will close on the acquisition of the creative office project no later than the first quarter of 2022.

Funding Plan

The Company plans to fund the initial $250 million cash portion of the purchase price with borrowings under its current $750 million unsecured revolving credit facility and an expected $200 million, six-month unsecured bridge facility from JPMorgan Chase Bank, N.A. Both facilities bear interest at LIBOR plus 90 basis points. The bridge facility, which is subject to definitive documentation and customary conditions, can be extended at the Company’s option for an additional six-month period and will contain financial and other covenants that are similar to the covenants under the Company’s revolving credit facility.

The Company’s long-term plan is to fund the acquisition primarily by accelerating the sale of $500 to $600 million of non-core assets currently owned by the Company. The Company expects to return its balance sheet metrics to current levels by mid-2022. The Company can provide no assurances, however, that it will dispose of any assets on favorable terms, or at all, because the dispositions are subject to the negotiation and execution of sale agreements and would then be subject to the buyers’ completion of satisfactory due diligence and other customary closing conditions. Approximately $250 million, or an amount equal to the cash portion of the purchase price, of the planned dispositions are expected to qualify for tax-deferred treatment under Section 1031 of the Internal Revenue Code.

Advisors

J.P. Morgan is acting as exclusive financial advisor to Highwoods. Allman Spry Davis Leggett & Crumpler, P.A. is serving as outside real estate counsel to Highwoods.

Presentation  
A presentation highlighting the planned acquisition and planned acceleration of non-core dispositions can be accessed through the link below and in the Investors section of the Company’s website at www.highwoods.com.

HIW April 2021 Strategic Acquisitions Presentation

Conference Call
Today, Monday, April 19, 2021, at 11:00 A.M. ET, Highwoods will host a conference call to discuss the matters highlighted in this press release. For US/Canada callers, dial (800) 756-3565. A live, listen-only webcast and a subsequent replay can be accessed through the Company’s website at www.highwoods.com under the “Investors” section.

About Highwoods Properties

Highwoods Properties, headquartered in Raleigh, North Carolina, is a publicly traded (NYSE:HIW) real estate investment trust (“REIT”) and a member of the S&P MidCap 400 Index.  The Company is a fully-integrated office REIT that owns, develops, acquires, leases and manages properties primarily in the BBDs of Atlanta, Charlotte, Nashville, Orlando, Pittsburgh, Raleigh, Richmond and Tampa.  For more information about Highwoods Properties, please visit our website at www.highwoods.com.

Forward-Looking Statements

Certain matters discussed in this press release are forward-looking statements within the meaning of the federal securities laws, such as: the planned acquisition of a portfolio of office assets from PAC on the terms described in this press release; the terms of the bridge facility; the planned sales of non-core assets and expected pricing and impact with respect to such sales, including the tax impact of such sales; the anticipated total investment, projected leasing activity, estimated replacement cost and expected net operating income of acquired properties and properties to be developed; and expected future leverage of the Company. These statements are distinguished by use of the words ”will,” “expect,” “intend,” “plan,” “anticipate” and words of similar meaning. Although Highwoods believes the expectations reflected in such forward-looking statements are based upon reasonable assumptions, it can give no assurance that its expectations will be achieved.

Factors that could cause actual results to differ materially from Highwoods’ current expectations include, among others, the following: closing of the planned acquisition of a portfolio of office assets from PAC may not occur on the terms described in this press release or at all; buyers may not be available and pricing may not be adequate with respect to the planned dispositions of non-core assets; comparable sales data on which we based our expectations with respect to the sales price of the non-core assets may not reflect current market trends; anticipated G&A expense savings may not be realized; the financial condition of our customers could deteriorate; development activity by our competitors in our existing markets could result in excessive supply of properties relative to customer demand; development, acquisition, reinvestment, disposition or joint venture projects may not be completed as quickly or on as favorable terms as anticipated; we may not be able to lease or re-lease second generation space quickly or on as favorable terms as old leases; our markets may suffer declines in economic growth; we may not be able to lease our newly constructed buildings as quickly or on as favorable terms as originally anticipated; unanticipated increases in interest rates could increase our debt service costs; unanticipated increases in operating expenses could negatively impact our NOI; we may not be able to meet our liquidity requirements or obtain capital on favorable terms to fund our working capital needs and growth initiatives or to repay or refinance outstanding debt upon maturity; the Company could lose key executive officers; and others detailed in the Company’s 2020 Annual Report on Form 10-K and subsequent SEC reports.

Contact: Brendan Maiorana 
  Executive Vice President of Finance and Treasurer  
  [email protected]
  919-872-4924



Posted on

Augumenta Helps JICA Deliver Remote Learning Collaboration to Developing Countries Using Smart Glasses

A remote support solution developed by Finnish software company Augumenta helps Japanese experts continue to train researchers in Ghana and Zambia despite the pandemic

OULU, Finland, April 19, 2021 (GLOBE NEWSWIRE) — Augumenta, Ltd., today announced it was selected to supply software and systems integration services to support technical training programs for life sciences and agricultural researchers in Africa working with the Japan International Cooperation Agency (JICA). The training solution is based on the Augumenta SmartEyes system, which uses camera-equipped smart glasses to connect field workers in Africa with Japanese experts who can view the local scene and provide instructions and support in real-time.

JICA is responsible for delivering Japan’s official development assistance as an implementing agency, providing ODA Loan and Grant Aid, and executing Technical Cooperation in developing countries. With approximately 100 offices and a network of people cooperating within its numerous programs running all over the world, the organization provides, for example, technical training for participants from developing countries in a wide range of fields, such as medical, industrial, and agricultural fields.

Prior to the COVID-19 pandemic, JICA programs allowed Japanese counterparts to host experts and researchers from developing countries in Japan and thousands of Japanese experts to travel to the target countries to arrange hands-on training locally. The pandemic caused disruptions to the programs: experts have been forced to evacuate and the hosting of trainees has been suspended. Last autumn, JICA launched an open call for proposals to find solutions that enable the programs to continue operating despite travel restrictions.

The Augumenta system will initially be deployed in two African countries, Ghana and Zambia, as a tool to aid technical guidance in infectious disease control and agriculture. The SmartEyes remote collaboration solution, designed to solve remote working challenges in industrial settings, functions well in challenging environments and varying network conditions and is easy to use by workers with different skill levels.

Augumenta provides the total solution including the needed software, hardware, and support services, and is coordinating the field-testing phase. The company works in close cooperation with Iristick, which supplies the smart glasses used in the project. Iristick has extensive experience in remote assistance in general, and various types of NGO projects in developing countries in particular and brings valuable expertise to the project.

NOTE: Additional project details and statements from the involved parties can be found online: https://www.augumenta.com/library/



Media Contact:

Matt Schmidt
Small Planet Public Relations for Augumenta
Matt(at)smallplanet.pr.com