Tag: Business

Equity Commonwealth and Monmouth Real Estate amend merger agreement to increase value of offer

Post author By Michelle Dryden
Post date August 16, 2021
No Comments on Equity Commonwealth and Monmouth Real Estate amend merger agreement to increase value of offer

Enhanced Consideration with 0.713x Exchange Ratio and Option to Receive Cash

Offers Monmouth Shareholders a Combination of Certainty and Opportunity for Future Upside

Total Value Represents 23.1% Premium Over Monmouth’s 30-Day Average Unaffected Trading Price as of December 18, 2020

Shareholders Urged to Vote “FOR” the Amended Transaction on the WHITE Proxy Card

CHICAGO & HOLMDEL, N.J. — (BUSINESS WIRE) — Equity Commonwealth (NYSE: EQC) and Monmouth Real Estate Investment Corporation (NYSE: MNR), or Monmouth, today announced that they have entered into an amendment to the definitive merger agreement (as amended, the “Merger Agreement”) between the two companies. Under the terms of the Merger Agreement, Equity Commonwealth revised its offer to pay a total value of $19.00 per share in a combination of cash and stock at the election of Monmouth shareholders and based on EQC’s closing price of $26.65 per share on August 13, 2021. Total consideration for the transaction is $3.4 billion, including the assumption of $857 million of mortgage debt, and the repayment of the $550 million of Monmouth’s 6.125% Series C Redeemable Preferred Stock and Monmouth’s outstanding line of credit and term loan.

The new cash component provides greater certainty of value and an opportunity for liquidity for Monmouth’s shareholders. The revised offer increases the exchange ratio from 0.67x to 0.713x, representing a 6.4% premium over the previous all-stock offer and a 23.1% valuation premium to Monmouth’s 30-day average unaffected trading price as of December 18, 2020.

“Our revised offer provides Monmouth shareholders with the option to elect to receive consideration in cash, but also provides a tax-deferred option to remain invested in the future upside of our business,” said David Helfand, President, Chief Executive Officer and Trustee of Equity Commonwealth. “We will continue to have significant balance sheet capacity, of over $4 billion, for future industrial investments.”

Monmouth shareholders will have the option to elect to receive, for each Monmouth common share, either (i) $19.00 of cash or (ii) 0.713 shares of EQC stock. Pursuant to the terms of the Merger Agreement, the aggregate cash consideration will be $641 million and the transaction will result in the issuance of 46.2 million EQC common shares. In the event Monmouth shareholders, in the aggregate, elect to receive in excess of $641 million in cash or 46.2 million EQC shares, the cash and stock consideration will become subject to proration. Depending on the extent of proration, a Monmouth shareholder electing the cash consideration will receive no less than $6.50 in cash for each Monmouth common share with the balance paid in EQC common shares. A Monmouth shareholder electing the stock consideration will receive no less than 0.469 shares of EQC common shares, representing a value of $12.50 per share based on EQC’s closing share price of $26.65 on August 13, 2021, with the balance paid in cash.

“Over Monmouth’s more than 50-year history, and particularly over the last several months as part of our robust strategic alternatives process, Monmouth’s Board and management team have successfully maximized value for shareholders,” said Michael P. Landy, President and CEO of Monmouth. “The Monmouth Board is pleased to unanimously support this improved transaction, which provides greater value and optionality to address the preferences of our diverse shareholder base. With this revised agreement, Monmouth shareholders will have the option to choose a superior, immediate cash premium, or tax-efficient equity consideration enabling them to participate in the value and cash flow upside of the combined platform. We are confident that together with EQC, our combined company will be a market leading industrial REIT well-positioned for sustainable growth and long-term value creation.”

The revised transaction structure, with the issuance of fewer EQC common shares, is expected to result in significant improvement in per share earnings metrics for the combined company as compared to earnings under the original all-stock transaction. In addition, the dividend per share is expected to be higher under the revised transaction due to fewer EQC common shares outstanding post transaction. It is anticipated that the transaction will be tax-deferred to Monmouth common shareholders to the extent they receive common stock as consideration. In connection with the revised offer, the termination fee will increase by approximately $10 million to $72 million.

Equity Commonwealth and Monmouth shareholders are expected to own approximately 73% and 27%, respectively, of the pro forma company following the close of the transaction.

Transaction Timing & Approval

The Board of Trustees of Equity Commonwealth and the Board of Directors of Monmouth Real Estate have each unanimously approved the amended Merger Agreement.

The virtual special meetings of EQC shareholders and MNR shareholders previously scheduled to be held on August 24, 2021 at 10:00 a.m. and 11:00 a.m. Eastern Time, respectively, have been rescheduled for August 31, 2021 at 10:00 a.m. and 11:00 a.m. Eastern Time, respectively. MNR shareholders wishing to participate in the live webcast of the MNR Special Meeting must pre-register at www.cesonlineservices.com/mnr21_vm by 11:00 a.m., Eastern Time, on August 30, 2021.

Both Monmouth and EQC shareholders are encouraged to submit a WHITE proxy card or voting instruction form to vote their common shares as promptly as possible. For specific instructions on how to vote shares, please review the applicable instructions that are set forth in the joint proxy statement/prospectus. Shareholders who have questions about the merger or how to submit their proxy, should contact EQC’s proxy solicitor D.F. King & Co., Inc., at (877) 783-5524 or Monmouth’s proxy solicitor, Okapi Partners LLC, at (877) 796-5274.

Common shareholders of Equity Commonwealth and Monmouth will soon receive an amendment to the joint proxy statement/prospectus which will contain important information about the amended Merger Agreement. In addition, Monmouth shareholders will separately receive an election form to enable them to indicate the form of consideration they wish to receive for their Monmouth shares. Monmouth shareholders who do not indicate a preference will be deemed to have elected to receive EQC common shares. The deadline for cash or stock elections by Monmouth common shareholders will be 5 p.m., Eastern Time, on September 9, 2021. Regardless of their election regarding cash or stock consideration, shareholders are encouraged to submit a WHITE proxy card or voting instruction form to vote their common shares as promptly as possible.

The transaction is currently expected to close September 9, 2021, subject to customary closing conditions, including approval by the common shareholders of both Equity Commonwealth and Monmouth.

Advisors

Goldman Sachs & Co. LLC is acting as financial advisor and Fried, Frank, Harris, Shriver and Jacobson LLP is serving as legal advisor to Equity Commonwealth. J.P. Morgan Securities LLC and CS Capital Advisors, LLC are acting as financial advisors and Stroock & Stroock & Lavan LLP is serving as legal advisor to Monmouth.

About Equity Commonwealth

Equity Commonwealth (NYSE: EQC) is a Chicago based, internally managed and self-advised real estate investment trust (REIT) with commercial office properties in the United States. EQC’s portfolio is comprised of 4 properties totaling 1.5 million square feet.

About Monmouth

Monmouth Real Estate Investment Corporation (NYSE: MNR), founded in 1968, is one of the oldest public equity REITs in the world. Monmouth specializes in single tenant, net-leased industrial properties, subject to long-term leases, primarily to investment grade tenants. Monmouth is a fully integrated and self-managed real estate company, whose property portfolio consists of 121 properties, containing a total of approximately 24.7 million rentable square feet, geographically diversified across 32 states.

Regulation FD Disclosures

We use any of the following to comply with EQC and MNR disclosure obligations under Regulation FD: press releases, SEC filings, public conference calls, or EQC and MNR websites. We routinely post important information on our websites at www.eqcre.com and www.mreic.reit, including information that may be deemed to be material. We encourage investors and other interested parties to monitor these distribution channels for material disclosures.

No Offer or Solicitation

This communication is not intended to and does not constitute an offer to sell or the solicitation of an offer to buy, sell or solicit any securities or any proxy, vote or approval in any jurisdiction pursuant to or in connection with the proposed merger or otherwise, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be deemed to be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Additional Information and Where to Find It

In connection with the proposed merger, EQC has filed a registration statement on Form S-4 with the SEC, which became effective on July 23, 2021, to register the common shares of beneficial interest of EQC to be issued pursuant to the merger with Monmouth Real Estate Investment Corporation (“MNR”). The registration statement includes a joint proxy statement/prospectus which has been filed by EQC and MNR with the SEC and has been sent to the common shareholders of EQC seeking their approval of the share issuance and to the common shareholders of MNR seeking their approval of the merger (the “joint proxy statement/prospectus”). EQC and MNR intend to file with the SEC and send to their respective common shareholders an amendment to the joint proxy statement/prospectus describing the amended terms of the merger. EQC and MNR may also file other documents regarding the proposed merger and share issuance with the SEC. Shareholders are urged to read the joint proxy statement/prospectus and the amendment thereto, as well as any other amendment or supplement thereto and any other relevant documents filed with the SEC in connection with the proposed merger, when they become available, because they will contain important information about EQC, Monmouth and the proposed mergers. Investors and security holders will be able to obtain free copies of the registration statement and joint proxy statement/prospectus and other documents filed with the SEC, when they become available, through the website maintained by the SEC at www.sec.gov. Copies of documents filed with the SEC will also be available free of charge from EQC and Monmouth using the sources indicated below.

Participants in the Solicitation

Equity Commonwealth and Monmouth and certain of their respective directors and executive officers and other employees may be deemed to be participants in the solicitation of proxies in connection with the proposed merger under the rules of the SEC. Investors may obtain information regarding the names, affiliations and interests of directors and executive officers of Equity Commonwealth in Equity Commonwealth’s proxy statement for its 2021 annual meeting of shareholders, which was filed with the SEC on April 27, 2021, as well as in its other filings with the SEC. Information about Monmouth’s directors and executive officers is available in Monmouth’s Annual Report on Form 10-K for Monmouth’s fiscal year ended September 30, 2020, filed with the SEC on November 23, 2020, and in other documents filed by Monmouth with the SEC. Other information regarding participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, is included in the registration statement on Form S-4, the solicitation statement / prospectus and other relevant materials filed or to be filed with the SEC regarding the proposed merger (if and when they become available). You may obtain free copies of these documents at the SEC’s website at www.sec.gov. Copies of documents filed with the SEC will also be available free of charge from Equity Commonwealth and Monmouth using the sources indicated below.

Forward-Looking Statements

Some of the statements contained in this press release constitute forward-looking statements within the meaning of the federal securities laws, including, but not limited to, statements regarding consummating the merger, asset sales and other transactions described herein and the timing thereof. Any forward-looking statements contained in this press release are intended to be made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar expressions concerning matters that are not historical facts. In some cases, you can identify forward-looking statements by the use of forward-looking terminology such as “may,” “will,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” or the negative of these words and phrases or similar words or phrases which are predictions of or indicate future events or trends and which do not relate solely to historical matters. You can also identify forward-looking statements by discussions of strategy, plans or intentions.

The forward-looking statements contained in this press release reflect Equity Commonwealth’s and Monmouth’s current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances regarding Equity Commonwealth and Monmouth that may cause actual results to differ significantly from those expressed in any forward-looking statement, including, without limitation, (i) inability to complete the proposed merger because, among other reasons, one or more conditions to the closing of the proposed merger may not be satisfied or waived; (ii) uncertainty as to the timing of completion of the proposed merger; (iii) potential adverse effects or changes to relationships with Equity Commonwealth’s or Monmouth’s respective tenants, employees, service providers or other parties resulting from the announcement or completion of the proposed merger; (iv) the outcome of any legal proceedings that may be instituted against the parties and others related to the merger agreement; (v) possible disruptions from the proposed merger that could harm Equity Commonwealth’s or Monmouth’s respective business, including current plans and operations; (vi) unexpected costs, charges or expenses resulting from the proposed merger; (vii) uncertainty of the expected financial performance of Equity Commonwealth following completion of the proposed merger, including the possibility that the benefits anticipated from the proposed merger will not be realized or will not be realized within the expected time period; (viii) legislative, regulatory and economic developments; and (ix) unpredictability and severity of catastrophic events, including, but not limited to, acts of terrorism, outbreak of war or hostilities and epidemics and pandemics, including COVID-19, as well as Equity Commonwealth’s or Monmouth’s management’s response to any of the aforementioned factors. These factors should not be construed as exhaustive and should be read in conjunction with other risk factors and cautionary statements that are included in Equity Commonwealth’s and Monmouth’s SEC filings. Equity Commonwealth and Monmouth do not guarantee that the transactions and events described will happen as described (or that they will happen at all).

While forward-looking statements reflect good faith beliefs, they are not guarantees of future performance. Equity Commonwealth and Monmouth disclaim any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, of new information, data or methods, future events or other changes.

Contacts

Equity Commonwealth – Investors & Media
Sarah Byrnes

(312) 646-2801

ir@eqcre.com

Monmouth – Investors
Becky Coleridge

(732) 577-9996

mreic@mreic.com

Monmouth – Media
Andrew Siegel / Kara Brickman

Joele Frank

(212) 355-4449

Tags Business, New Jersey

Local News Science

Rocket Pharmaceuticals announces FDA lifts clinical hold on Danon Disease trial of RP-A501

Post author By Michelle Dryden
Post date August 16, 2021
No Comments on Rocket Pharmaceuticals announces FDA lifts clinical hold on Danon Disease trial of RP-A501

— Initiation of Pediatric Patient Dosing of RP-A501 Expected in Q3 —

— Comprehensive Clinical Update from Phase 1 Clinical Trial Planned for Q4 —

CRANBURY, N.J. — (BUSINESS WIRE) — Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, today announces that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Company’s Phase 1 clinical trial of RP-A501 for the treatment of Danon Disease, allowing patient enrollment to resume. The hold was removed after the Company addressed the FDA’s requests to modify the trial protocol and other supporting documents with revised guidelines for patient selection and management. The Company has initiated steps to resume the program as soon as possible and expects to commence dosing in the low-dose (6.7e13 vg/kg) pediatric patient cohort in the third quarter.

“We are grateful for the collaboration between the FDA and our team in reaching agreement on protocol updates allowing us to resume patient enrollment in our Danon Disease trial. We look forward to progressing this critical work on behalf of all Danon patients,” said Gaurav Shah, M.D., Chief Executive Officer of Rocket Pharma. “We are moving as quickly as possible to resume dosing and commence treatment this quarter. Additionally, given the activity observed among young adults in our low-dose cohort, in agreement with the FDA, we are now proceeding with the pediatric cohort. This is another important step forward as we believe the pediatric Danon population has the potential to realize the maximum benefit from our Danon Disease gene therapy program. We continue to anticipate reporting updated longer-term data from the low-dose (6.7e13 vg/kg) and higher-dose (1.1e14 vg/kg) young adult cohorts in the fourth quarter.”

Rocket’s Danon Disease program was placed on clinical hold by the FDA in May of 2021 to modify the study protocol and other supporting documents with revised guidelines for patient selection and safety management. No new drug-related safety events were observed in the low-dose or higher-dose young adult cohorts as part of the clinical hold or during the hold.

The non-randomized, open-label Phase 1 trial is designed to enroll both pediatric and young adult male patients to assess the safety and tolerability of a single intravenous (IV) infusion of RP-A501. Additional outcome measures include cardiomyocyte and skeletal muscle transduction by gene expression, histologic correction via endomyocardial biopsy and clinical stabilization via cardiac imaging and functional cardiopulmonary testing.

About RP-A501

RP-A501 is an investigational gene therapy product being developed for Danon Disease and the first potential gene therapy for monogenic heart failure. It consists of a recombinant adeno-associated serotype 9 (AAV9) capsid containing a functional version of the human LAMP2B transgene (AAV9.LAMP2B). RP-A501 is currently being evaluated in an ongoing Phase 1 clinical trial, in which the Company observed preliminary activity data of RP-A501 as well as a favorable tolerability profile.

About Danon Disease

Danon Disease is a rare X-linked inherited disorder caused by mutations in the gene encoding lysosome-associated membrane protein 2 (LAMP-2), an important mediator of autophagy. This results in accumulation of autophagosomes and glycogen, particularly in cardiac muscle and other tissues, which ultimately leads to heart failure, and for many male patients, death during adolescence or early adulthood. It is estimated to have a prevalence of 15,000 to 30,000 patients in the U.S. and the Europe. The only available treatment option for Danon Disease is cardiac transplantation, which is associated with substantial complications and is not considered curative. There are no specific therapies available for the treatment of Danon Disease.

About Rocket Pharmaceuticals, Inc.

Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) (“Rocket”) is advancing an integrated and sustainable pipeline of genetic therapies that aim to correct the root cause of complex and rare childhood disorders. The company’s platform-agnostic approach enables it to design the best potential therapy for each indication, creating potentially transformative options for patients afflicted with rare genetic diseases. Rocket’s clinical programs using lentiviral vector (LVV)-based gene therapy are for the potential treatment of Fanconi Anemia (FA), a difficult to treat genetic disease that leads to bone marrow failure and potentially cancer, Leukocyte Adhesion Deficiency-I (LAD-I), a severe pediatric genetic disorder that causes recurrent and life-threatening infections which are frequently fatal, Pyruvate Kinase Deficiency (PKD) a rare, monogenic red blood cell disorder resulting in increased red cell destruction and mild to life-threatening anemia and Infantile Malignant Osteopetrosis (IMO), a bone marrow-derived disorder. Rocket’s first clinical program using adeno-associated virus (AAV)-based gene therapy is for Danon disease, a devastating, pediatric heart failure condition. For more information about Rocket, please visit www.rocketpharma.com.

Rocket Cautionary Statement Regarding Forward-Looking Statements

Various statements in this release concerning Rocket’s future expectations, plans and prospects, including without limitation, Rocket’s expectations regarding its guidance for 2021 in light of COVID-19, the safety and effectiveness of product candidates that Rocket is developing to treat Fanconi Anemia (FA), Leukocyte Adhesion Deficiency-I (LAD-I), Pyruvate Kinase Deficiency (PKD), Infantile Malignant Osteopetrosis (IMO) and Danon Disease, the expected timing and data readouts of Rocket’s ongoing and planned clinical trials, Rocket’s plans for the advancement of its Danon Disease program following the lifting of the FDA’s clinical hold and the safety, effectiveness and timing of related pre-clinical studies and clinical trials, may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward-looking statements, which often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “will give,” “estimate,” “seek,” “will,” “may,” “suggest” or similar terms, variations of such terms or the negative of those terms. Although Rocket believes that the expectations reflected in the forward-looking statements are reasonable, Rocket cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Rocket’s ability to monitor the impact of COVID-19 on its business operations and take steps to ensure the safety of patients, families and employees, the interest from patients and families for participation in each of Rocket’s ongoing trials, our expectations regarding the delays and impact of COVID-19 on clinical sites, patient enrollment, trial timelines and data readouts, our expectations regarding our drug supply for our ongoing and anticipated trials, actions of regulatory agencies, which may affect the initiation, timing and progress of pre-clinical studies and clinical trials of its product candidates, Rocket’s dependence on third parties for development, manufacture, marketing, sales and distribution of product candidates, the outcome of litigation, and unexpected expenditures, as well as those risks more fully discussed in the section entitled “Risk Factors” in Rocket’s Annual Report on Form 10-K for the year ended December 31, 2020, filed March 1, 2021 with the SEC. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and Rocket undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

Media
Kevin Giordano

Director, Corporate Communications

kgiordano@rocketpharma.com

Investors
Mayur Kasetty, M.D.

Director, Business Development & Operations

investors@rocketpharma.com

Tags Business, New Jersey

Healthcare Science

FDA approves Merck’s hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor WELIREG™ (belzutifan) for the treatment of patients with certain types of Von Hippel-Lindau (VHL) disease-associated tumors

WELIREG Approved for Adult Patients With VHL Disease Who Require Therapy for Associated Renal Cell Carcinoma, Central Nervous System Hemangioblastomas, or Pancreatic Neuroendocrine Tumors, Not Requiring Immediate Surgery

WELIREG Expands Merck’s Oncology Portfolio as the First and Only Systemic Therapy Approved for These Patients With VHL Disease

KENILWORTH, N.J. — (BUSINESS WIRE) — $MRK #MERCK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved WELIREG, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. The recommended dose of WELIREG (40 mg tablets) is 120 mg once daily until disease progression or unacceptance toxicity. The approval is based on results from the open-label Study 004 trial (N=61), where the major efficacy endpoint was overall response rate (ORR) in patients with VHL-associated RCC.

WELIREG is the first HIF-2α inhibitor therapy approved in the U.S. As an inhibitor of HIF-2α, WELIREG reduces transcription and expression of HIF-2α target genes associated with cellular proliferation, angiogenesis and tumor growth.

The WELIREG label contains a boxed warning that exposure to WELIREG during pregnancy can cause embryo-fetal harm. Verify pregnancy status prior to the initiation of WELIREG. Advise patients of these risks and the need for effective non-hormonal contraception. WELIREG can render some hormonal contraceptives ineffective. WELIREG can cause severe anemia that can require a blood transfusion. Monitor for anemia before initiation of WELIREG and periodically throughout treatment. WELIREG can cause severe hypoxia that may require discontinuation, supplemental oxygen, or hospitalization. Monitor oxygen saturation before initiation of and periodically throughout treatment with WELIREG. For more information, see “Selected Safety Information” below.

“VHL disease is a rare and serious condition. Until today, there were no systemic therapies approved to help treat patients diagnosed with certain types of VHL-associated tumors,” said Dr. Eric Jonasch, principal investigator of Study 004 and professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. “The approval of WELIREG, which is based on data showing an overall response rate across three different types of VHL-associated tumors, addresses this significant unmet need by introducing a new option for physicians and their patients impacted by this disease.”

“WELIREG is the first and only approved systemic therapy for patients with certain types of VHL-associated tumors, representing an important new treatment option for patients affected by this rare condition,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “Today’s approval of WELIREG is a significant milestone and is a testament to Merck’s commitment to bring forward innovative new treatment options for more patients.”

“The approval of a non-surgical treatment option is meaningful for helping patients with certain types of VHL-associated tumors,” said Dr. Ramaprasad Srinivasan, head, Molecular Cancer Therapeutics Section, Urologic Oncology Branch, National Cancer Institute (NCI), and principal investigator on the Cooperative Research and Development Agreement (CRADA) under which the NCI served as a site in Study 004. “In Study 004, nearly half of all patients with VHL-associated renal cell carcinoma, as well as the majority of patients with VHL-associated central nervous system hemangioblastomas or pancreatic neuroendocrine tumors, who were treated with WELIREG experienced a reduction of their respective tumor size. The FDA’s approval of WELIREG marks an important step forward by introducing a systemic therapy that has the potential to improve the current treatment paradigm for patients with certain types of VHL-associated tumors.”

Merck is working to optimize production of WELIREG to allow for a sustainable supply to meet anticipated U.S. demand. Commercial supply is expected to be available by early September.

Data Supporting the Approval

The approval was based on data from Study 004 (ClinicalTrials.gov, NCT03401788), an open-label trial in 61 patients with VHL-associated RCC diagnosed based on a VHL germline alteration and with at least one measurable solid tumor (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] v1.1) localized to the kidney. Enrolled patients had other VHL-associated tumors, including CNS hemangioblastomas and pNET. CNS hemangioblastomas and pNET in these patients were diagnosed based on the presence of at least one measurable solid tumor in the brain/spine or pancreas, respectively, as defined by RECIST v1.1 and identified by an independent review committee (IRC). The study excluded patients with metastatic disease. Patients received WELIREG at a dose of 120 mg once daily until progression of disease or unacceptable toxicity. In Study 004, the median duration of exposure to WELIREG was 68 weeks (range, 8.4 to 104.7).

The study population characteristics were: median age of 41 years (range, 19 to 66), 3.3% age 65 or older; 53% male; 90% white, 3.3% Black or African American, 1.6% Asian, and 1.6% Native Hawaiian or other Pacific Islander; 82% had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 16% had an ECOG PS of 1, and 1.6% had an ECOG PS of 2; and 84% had VHL type I disease. The median diameter of RCC target lesions per central IRC was 2.2 centimeters (range, 1 to 6.1). Median time from initial radiographic diagnosis of VHL-associated RCC tumors that led to enrollment on Study 004 to the time of treatment with WELIREG was 17.9 months (range, 2.8 to 96.7). Seventy-seven percent of patients had prior surgical procedures for RCC.

The major efficacy endpoint for the treatment of VHL-associated RCC was ORR measured by radiology assessment using RECIST v1.1 as assessed by IRC. Additional efficacy endpoints included duration of response (DoR) and time to response (TTR).

In patients with VHL-associated RCC (n=61), WELIREG showed an ORR of 49% (95% CI, 36-62); all responses were partial responses. Median DoR had not yet been reached (range, 2.8+ to 22.3+ months); among responders, 56% (n=17/30) were still responding after at least 12 months. Median TTR was eight months (range, 2.7 to 19).

In patients with VHL-associated CNS hemangioblastomas (n=24), WELIREG showed an ORR of 63% (95% CI, 41-81), with a complete response rate of 4% (n=1) and a partial response rate of 58% (n=14). Median DoR had not yet been reached (range, 3.7+ to 22.3+ months); among responders, 73% (n=11/15) were still responding after at least 12 months. Median TTR was three months (range, 3 to 11).

In patients with VHL-associated pNET (n=12), WELIREG showed an ORR of 83% (95% CI, 52-98), with a complete response rate of 17% (n=2) and a partial response rate of 67% (n=8). Median DoR had not yet been reached (range, 10.8+ to 19.4+ months); among responders, 50% (n=5/10) were still responding after at least 12 months. Median TTR was eight months (range, 3 to 11).

Serious adverse reactions occurred in 15% of patients who received WELIREG, including anemia, hypoxia, anaphylaxis reaction, retinal detachment and central retinal vein occlusion (1 patient each). Permanent discontinuation of WELIREG due to adverse reactions occurred in 3.3% of patients. Adverse reactions that resulted in permanent discontinuation of WELIREG were dizziness and opioid overdose (1.6% each).

Dosage interruptions of WELIREG due to an adverse reaction occurred in 39% of patients. Adverse reactions that required dosage interruption in >2% of patients were fatigue, decreased hemoglobin, anemia, nausea, abdominal pain, headache and influenza-like illness. Dose reductions of WELIREG due to an adverse reaction occurred in 13% of patients. The most frequently reported adverse reaction that required dose reduction was fatigue (7%).

The most common adverse reactions (≥25%), including laboratory abnormalities, that occurred in patients treated with WELIREG were decreased hemoglobin (93%), anemia (90%), fatigue (64%), increased creatinine (64%), headache (39%), dizziness (38%), increased glucose (34%) and nausea (31%).

About Von Hippel-Lindau Disease

The incidence of von Hippel-Lindau (VHL) syndrome is estimated to be one in 36,000 individuals. This is a rare genetic disease with an estimated incidence of 10,000 people in the U.S. Patients with VHL disease are at risk for benign blood vessel tumors as well as some cancerous ones, including renal cell carcinoma.

WELIREG™ (belzutifan) Indication in the U.S.

WELIREG (belzutifan) is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.

Selected Safety Information

Warning: Embryo-Fetal Toxicity

Exposure to WELIREG during pregnancy can cause embryo-fetal harm. Verify pregnancy status prior to the initiation of WELIREG. Advise patients of these risks and the need for effective non-hormonal contraception as WELIREG can render some hormonal contraceptives ineffective.

Anemia

WELIREG can cause severe anemia that can require blood transfusion. In Study 004, anemia occurred in 90% of patients and 7% had Grade 3 anemia. In Study 001, a clinical trial in patients with advanced solid tumors (n=58) treated at the recommended dose, anemia occurred in 76% of patients and 28% had Grade 3 anemia.

Monitor for anemia before initiation of and periodically throughout treatment. Closely monitor patients who are dual UGT2B17 and CYP2C19 poor metabolizers due to potential increases in exposure that may increase the incidence or severity of anemia.

Transfuse patients as clinically indicated. For patients with hemoglobin <9g/dL, withhold WELIREG until Hb≥9g/dL, then resume at reduced dose or permanently discontinue depending on the severity of anemia. For life threatening anemia or when urgent intervention is indicated, withhold WELIREG until hemoglobin ≥9g/dL, then resume at a reduced dose or permanently discontinue.

The use of erythropoiesis stimulating agents (ESAs) for treatment of anemia is not recommended in patients treated with WELIREG.

Hypoxia

WELIREG can cause severe hypoxia that may require discontinuation, supplemental oxygen, or hospitalization. In Study 004, hypoxia occurred in 1.6% of patients. In Study 001, a clinical trial in patients with advanced solid tumors (n=58) treated at the recommended dose, hypoxia occurred in 29% of patients; 16% were Grade 3 hypoxia.

Monitor oxygen saturation before initiation of and periodically throughout treatment. For decreased oxygen saturation with exercise (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg), consider withholding WELIREG until pulse oximetry with exercise is greater than 88%, then resume at the same or a reduced dose. For decreased oxygen saturation at rest (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg) or when urgent intervention is indicated, withhold WELIREG until resolved and resume at a reduced dose or discontinue. For life-threatening or recurrent symptomatic hypoxia, permanently discontinue WELIREG. Advise patients to report signs and symptoms of hypoxia immediately to a healthcare provider.

Embryo-Fetal Toxicity

Based on findings in animal studies, WELIREG may cause fetal harm when administered to a pregnant woman.

Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose. WELIREG can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose.

Adverse Reactions

In Study 004, serious adverse reactions occurred in 15% of patients, including anemia, hypoxia, anaphylaxis reaction, retinal detachment, and central retinal vein occlusion (1 patient each).

WELIREG was permanently discontinued due to adverse reactions in 3.3% of patients for dizziness and opioid overdose (1.6% each).

The most common adverse reactions (≥25%) were decreased hemoglobin (93%), anemia (90%), fatigue (64%), increased creatinine (64%), headache (39%), dizziness (38%), increased glucose (34%), and nausea (31%).

In Study 001, a clinical trial in patients with advanced solid tumors (n=58) treated at the recommended dose, the following additional adverse reactions have been reported: edema, cough, musculoskeletal pain, vomiting, diarrhea, and dehydration.

Drug Interactions

Coadministration of WELIREG with inhibitors of UGT2B17 or CYP2C19 increases plasma exposure of belzutifan, which may increase the incidence and severity of adverse reactions. Monitor for anemia and hypoxia and reduce the dosage of WELIREG as recommended.

Coadministration of WELIREG with CYP3A4 substrates, including hormonal contraceptives, decreases concentration of CYP3A4 substrates, which may reduce the efficacy of these substrates. Coadministration of WELIREG with hormonal contraceptives may lead to contraceptive failure or an increase in breakthrough bleeding.

Lactation

Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with WELIREG and for 1 week after the last dose.

Females and Males of Reproductive Potential

WELIREG can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to initiating treatment with WELIREG.

Use of WELIREG may reduce the efficacy of hormonal contraceptives. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose.

Based on findings in animals, WELIREG may impair fertility in males of reproductive potential and the reversibility of this effect is unknown.

Pediatric Use

Safety and effectiveness of WELIREG in pediatric patients under 18 years of age have not been established.

Merck’s Focus on Cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

About Merck

For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2020 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

# # #

Please see Prescribing Information, including information for the Boxed Warning, for WELIREG (belzutifan) at https://www.merck.com/product/usa/pi_circulars/w/welireg/welireg_pi.pdf and Medication Guide for WELIREG at https://www.merck.com/product/usa/pi_circulars/w/welireg/welireg_mg.pdf.

Contacts

Media Contacts:

Melissa Moody

(215) 407-3536

Justine Moore

(908) 740-6449

Investor Contacts:

Peter Dannenbaum

(908) 740-1037

Raychel Kruper

(908) 740-2107

Tags Business, New Jersey

Business

AM Best withdraws credit ratings of Union Security Life Insurance Company of New York

Post author By Michelle Dryden
Post date August 13, 2021
No Comments on AM Best withdraws credit ratings of Union Security Life Insurance Company of New York

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance—AM Best has removed from under review with developing implications and downgraded the Financial Strength Rating to B+ (Good) from B++ (Good) and the Long-Term Issuer Credit Rating to “bbb-” (Good) from “bbb” (Good) of Union Security Life Insurance Company of New York (New York, NY). The outlook assigned to these Credit Ratings (ratings) is negative. Concurrently, AM Best has withdrawn these ratings as the company has requested to no longer participate in AM Best’s interactive rating process.

The ratings reflect Union Security Life Insurance Company of New York’s balance sheet strength, which AM Best assesses as adequate, as well as its marginal operating performance, limited business profile and appropriate enterprise risk management.

The rating downgrades reflect the diminished strategic importance of Union Security Life Insurance Company of New York to its parent, Assurant Inc., after the sale of its preneed business to CUNA Mutual Group.

This business, which was previously primarily the New York marketing arm of Assurant Employee Benefits that was sold to Sun Life Financial Inc. in 2016, is now only actively marketing a small amount of financial services business for Assurant’s Global Lifestyle Segment. Additionally, there is extremely high reinsurance leverage due to the sale of several large blocks of business via reinsurance backed by reinsurance trusts. The absolute level of capital has declined considerably from historical levels since the end of 2015, as capital formerly backing the Employee Benefits Business was released.

The negative outlooks reflect Union Security Life Insurance Company of New York’s contracting business profile, which AM Best assesses as limited.

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper use of Best’s Credit Ratings, Best’s Preliminary Credit Assessments and AM Best press releases, please view Guide to Proper Use of Best’s Ratings & Assessments.

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

Contacts

Jeff Lane
Senior Financial Analyst
+1 908 439 2200, ext. 5567
jeff.lane@ambest.com

Wayne Kaminski
Senior Financial Analyst
+1 908 439 2200, ext. 5061
wayne.kaminski@ambest.com

Christopher Sharkey
Manager, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

Jim Peavy
Director, Communications
+1 908 439 2200, ext. 5644
james.peavy@ambest.com

Tags Business, New Jersey

Education Technology

Barnes & Noble Education announces fiscal 2022 first quarter earnings release date and conference call webcast

Post author By Michelle Dryden
Post date August 13, 2021
No Comments on Barnes & Noble Education announces fiscal 2022 first quarter earnings release date and conference call webcast

BASKING RIDGE, N.J. — (BUSINESS WIRE) — Barnes & Noble Education, Inc. (NYSE: BNED) today announced the Company expects to report fiscal 2022 first quarter earnings results on Thursday, September 2, 2021, before the market opens. The Company will host an investor conference call at 8:30 a.m. Eastern Time on Thursday, September 2, 2021 to review the Company’s financial results and operations.

This call is being webcast and can be accessed at Barnes & Noble Education’s corporate website at www.bned.com. The webcast of this call will be archived and available for three months on Barnes & Noble Education’s corporate website.

ABOUT BARNES & NOBLE EDUCATION, INC.

Barnes & Noble Education, Inc. (NYSE: BNED) is a leading solutions provider for the education industry, driving affordability, access and achievement at hundreds of academic institutions nationwide and ensuring millions of students are equipped for success in the classroom and beyond. Through its family of brands, BNED offers campus retail services and academic solutions, a digital direct-to-student learning ecosystem, unparalleled best-in-class assortment of school apparel through a strategic alliance with Fanatics and Lids, wholesale capabilities and more. BNED is a company serving all who work to elevate their lives through education, supporting students, faculty and institutions as they make tomorrow a better, more inclusive and smarter world. For more information, visit www.bned.com.

Contacts

Media:
Carolyn J. Brown

Senior Vice President

Corporate Communications and Public Affairs

Barnes & Noble Education, Inc.

(908) 991-2967

cbrown@bned.com

Investors:
Andy Milevoj

Vice President

Corporate Finance and Investor Relations

Barnes & Noble Education, Inc.

(908) 991-2776

amilevoj@bned.com

Tags Business, New Jersey

Business International & World

AM Best assigns Issue Credit Rating to Group Ark Insurance Limited’s subordinated notes

Post author By Michelle Dryden
Post date August 13, 2021
No Comments on AM Best assigns Issue Credit Rating to Group Ark Insurance Limited’s subordinated notes

LONDON — (BUSINESS WIRE) — #insurance—AM Best has assigned a Long-Term Issue Credit Rating of “bbb+” (Good) to the recently issued USD 47 million floating rate subordinated notes, due 2041, of Group Ark Insurance Limited (GAIL) (Bermuda). The outlook assigned to the Credit Rating (rating) is stable. The Financial Strength Rating of A (Excellent) and the Long-Term Issuer Credit Rating of “a” (Excellent) of GAIL remain unchanged.

GAIL is using the proceeds from this 11 August 2021 issuance to support the scale-up of the Ark Insurance Holdings Limited group, including its platform at Lloyd’s and GAIL’s recently established third-party insurance and reinsurance business in Bermuda. AM Best notes that pro forma financial leverage and interest coverage metrics remain at appropriate levels for GAIL’s current ratings.

AM Best is a global credit rating agency, news publisher and data analytics provider specialising in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

Contacts

William Keen-Tomlinson
Senior Financial Analyst
+44 20 7397 4395
will.keen-tomlinson@ambest.com

Christopher Sharkey
Manager, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

Alex Rafferty, ACA
Associate Director, Analytics
+44 20 7397 0312
alex.rafferty@ambest.com

Jim Peavy
Director, Communications
+1 908 439 2200, ext. 5644
james.peavy@ambest.com

Tags Business, New Jersey

Business Technology

Cargill partners with vertical farming leader, AeroFarms, in first-of-its-kind research focused on cocoa production

Post author By Michelle Dryden
Post date August 13, 2021
No Comments on Cargill partners with vertical farming leader, AeroFarms, in first-of-its-kind research focused on cocoa production

Multi-year collaboration to use fully controlled environments to unlock plant biology, understand climate impacts and explore novel production practices

MINNEAPOLIS & NEWARK, N.J. — (BUSINESS WIRE) — As part of ongoing efforts to build a more resilient and sustainable cocoa sector, Cargill has entered a multi-year research agreement with vertical farming pioneer and leader AeroFarms aimed at improving cocoa bean yields and developing more climate-resilient farming practices.

“Environmental challenges and growing demand for cocoa products are placing increased pressure on the global cocoa supply chain,” said Niels Boetje, managing director Cargill Cocoa Europe. “Through partnerships with research institutes, universities and innovative companies like AeroFarms, we are collaborating across sectors in bold experiments to bring greater productivity and resiliency to traditional cocoa farming operations. We look forward to sharing our findings with the farmer cooperatives in our cocoa supply chain to help ensure a thriving cocoa sector for generations to come.”

This latest research collaboration brings together AeroFarms’ expertise in controlled environment agriculture, with Cargill’s extensive knowledge of cocoa agronomy and production practices. Together, the two organizations will experiment with different indoor growing technologies including aeroponics and hydroponics, light, carbon dioxide, irrigation, nutrition, plant space and pruning to identify the optimal conditions for cocoa tree growth.

These findings will yield new insights, targeting factors such as faster tree growth and greater yields, accelerated development of varieties with enhanced pest and disease resistance, and unlocking the cocoa bean’s full flavor and color potential. These outcomes will help secure the future supply of cocoa beans in the face of climate change.

“AeroFarms shares a similar vision as Cargill to nourish the world in a safe, responsible and sustainable way,” said David Rosenberg, Co-Founder & CEO of AeroFarms. “We have grown over 550 different crops, and we are excited to be working on another project with them, this time focused on cocoa. At AeroFarms we think of our proprietary technology as a platform to optimize plant biology, genetics, mechanical systems, operational systems, environmental systems and digital controls, data capture and analytics. Genetics and speed breeding is one of the verticals where we focus. Applying our platform to optimize cocoa growing is one way that AeroFarms can have a broader positive impact on the world.”

Initial exploratory work has already begun at AeroFarms global headquarters in Newark, New Jersey, and will soon expand to the company’s state-of-the-art AeroFarms AgX Research & Development indoor vertical farm in Abu Dhabi, UAE, which is slated to open in early 2022.

About Cargill

Cargill’s 155,000 employees across 70 countries work relentlessly to achieve our purpose of nourishing the world in a safe, responsible and sustainable way. Every day, we connect farmers with markets, customers with ingredients, and people and animals with the food they need to thrive.

We combine 155 years of experience with new technologies and insights to serve as a trusted partner for food, agriculture, financial and industrial customers in more than 125 countries. Side-by-side, we are building a stronger, sustainable future for agriculture. For more information, visit Cargill.com and our News Center.

About Cargill’s global cocoa and chocolate business

Cargill Cocoa & Chocolate provides high quality cocoa and chocolate more sustainably throughout the world and brings our customers peace of mind, integrity and excitement. With balanced efforts on security of supply, sustainability projects and sensory expertise, we create a wide range of outstanding standardized and custom-made products and services. In addition, we provide our customers with extensive market knowledge. We grow a robust, fair and transparent supply chain, from bean to bar, eager to continuously shape industry standards. To ensure a more sustainable supply of quality cocoa beans, Cargill established our own sourcing and trading operations at origin in Brazil, Cameroon, Côte d’Ivoire, Ghana and Indonesia. Our Cargill Cocoa Promise underlines our commitment to enable farmers and their communities achieve better incomes and living standards. Our team of 4,100 passionate cocoa and chocolate experts work across 57 locations and are part of Cargill’s 155,000 colleagues around the world. For more information, visit cargillcocoachocolate.com.

About AeroFarms

Since 2004, AeroFarms has been leading the way for indoor vertical farming and championing transformational innovation for agriculture. On a mission to grow the best plants possible for the betterment of humanity, AeroFarms is a Certified B Corporation with global headquarters in Newark, New Jersey. Named one of the World’s Most Innovative Companies by Fast Company two years in a row and one of TIME’s Best Inventions in Food, AeroFarms patented, award-winning indoor vertical farming technology provides the perfect conditions for healthy plants to thrive, taking agriculture to a new level of precision, food safety, and productivity while using up to 95% less water and no pesticides ever versus traditional field farming. AeroFarms enables local production to safely grow all year round, using vertical farming for elevated flavor. In addition, through its proprietary growing technology platform, AeroFarms has grown over 550 varieties and has developed multi-year strategic partnerships ranging from government to major Fortune 500 companies to help uniquely solve agriculture supply chain needs. For additional information, visit: https://aerofarms.com/.

On March 26, 2021, AeroFarms announced a definitive business combination agreement with Spring Valley Acquisition Corp. (Nasdaq: SV). Upon the closing of the business combination, AeroFarms will become publicly traded on Nasdaq under the new ticker symbol “ARFM”. Additional information about the transaction can be viewed here: https://aerofarms.com/investors/

No Offer or Solicitation

This press release does not constitute an offer to sell or a solicitation of an offer to buy, or the solicitation of any vote or approval in any jurisdiction in connection with a proposed potential business combination among Spring Valley and AeroFarms or any related transactions, nor shall there be any sale, issuance or transfer of securities in any jurisdiction where, or to any person to whom, such offer, solicitation or sale may be unlawful. Any offering of securities or solicitation of votes regarding the proposed transaction will be made only by means of a proxy statement/prospectus that complies with applicable rules and regulations promulgated under the Securities Act of 1933, as amended (the “Securities Act”), and Securities Exchange Act of 1934, as amended, or pursuant to an exemption from the Securities Act or in a transaction not subject to the registration requirements of the Securities Act.

Forward Looking Statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “might,” “will,” “estimate,” “continue,” “contemplate,” “anticipate,” “intend,” “expect,” “should,” “would,” “could,” “plan,” “predict,” “project,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. All statements, other than statements of present or historical fact included in this press release, including those regarding Spring Valley’s proposed acquisition of AeroFarms and the Special Meeting are forward-looking statements. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the respective management of AeroFarms and Spring Valley and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of AeroFarms and Spring Valley. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; the inability of the parties to successfully or timely consummate the proposed transaction, including the risk that any regulatory approvals are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect the combined company or the expected benefits of the proposed transaction or that the approval of the stockholders of Spring Valley or AeroFarms is not obtained; failure to realize the anticipated benefits of the proposed transaction; risks related to the expansion of AeroFarms’ business and the timing of expected business milestones; the effects of competition on AeroFarms’ business; the ability of Spring Valley or AeroFarms to issue equity or equity-linked securities or obtain debt financing in connection with the proposed transaction or in the future, and those factors discussed in Spring Valley’s Annual Report on Form 10-K, Quarterly Report on Form 10-Q, final prospectus dated November 25, 2020 and definitive proxy statement/prospectus dated July 26, 2021 under the heading “Risk Factors,” and other documents Spring Valley has filed, or will file, with the SEC. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that neither Spring Valley nor AeroFarms presently know, or that Spring Valley nor AeroFarms currently believe are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Spring Valley’s and AeroFarms’ expectations, plans, or forecasts of future events and views as of the date of this press release. Spring Valley and AeroFarms anticipate that subsequent events and developments will cause Spring Valley’s and AeroFarms’ assessments to change. However, while Spring Valley and AeroFarms may elect to update these forward-looking statements at some point in the future, Spring Valley and AeroFarms specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing Spring Valley’s and AeroFarms’ assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Contacts

Media Contacts:
Kelly Sheehan, kelly_sheehan@cargill.com, 952-742-4204

Marc Oshima, marcoshima@aerofarms.com, 1-917-673-4602

AeroFarms Investor Relations Contact:
Jeff Sonnek, Jeff.Sonnek@icrinc.com, 1-646-277-1263

Tags Business, New Jersey

Business Technology

SHI Elevates Azure Expert MSP status, meeting stricter levels of criteria in recent progress audit

Post author By Michelle Dryden
Post date August 11, 2021
No Comments on SHI Elevates Azure Expert MSP status, meeting stricter levels of criteria in recent progress audit

SOMERSET, N.J. — (BUSINESS WIRE) — SHI International, one of the world’s largest technology solutions providers, reaffirmed its Azure Expert MSP status in a rigorous third-party progress audit. After being recognized by Microsoft with the Azure Expert credential in 2020, this recent progress audit raised by bar by introducing new levels of criteria that needed to be met in order for SHI to maintain its Azure expertise.

To be acknowledged with the Azure Expert MSP status, Microsoft partners need to meet a set of strict requirements to confirm that they have the talent, technology, and services to guide customers in their cloud journey. This year, new criteria has been introduced, including maturity of practice and development of a Cloud Center of Excellence (CCoE), use of cutting-edge technology, and alignment to Microsoft methodology.

“With digital transformation and pressure for businesses to accelerate moving to the cloud, we’ve transcended our tools and processes to ensure every customer has a seamless transition,” said Cory Peters, AVP – Cloud & MSP – Advanced Solutions Group at SHI. “Our technical acumen, operational excellence, and evolution of our capabilities puts us in a unique position to be able to deliver solutions and services across complex environments for our customers.”

SHI offers multiple options for supporting or managing organizations’ Azure infrastructure. Services include a planning assessment, cost comparison, cloud adoption, and various options for organizations pursuing hybrid cloud, a data center lift and shift, and cloud backup and disaster recovery in the Azure cloud.

“This certification is an important milestone that confirms SHI’s technical knowledge, cloud skills and commitment to the Microsoft Azure platform,” said Thai Lee, President and CEO of SHI International. “It also demonstrates proven customer success and recognizes our direct engagement to Microsoft Support and Engineering groups.”

SHI’s professional support services deliver cloud architect expertise to organizations in need of technical support for design or issue resolution. The service includes a designated technical account manager for Azure customers and annual cloud architecture reviews to ensure best practices are in place.

For organizations looking for additional support, SHI’s Azure managed services can handle backups, monitoring, and day-to-day management of a customer’s environment. The service includes professional support as well as best practice configuration of Azure services, patch management, and deployment of new infrastructure.

Learn more about SHI’s Azure services.

ABOUT SHI

SHI International Corp. is a transformational technology solutions provider serving the needs of more than 15,000 corporate, enterprise, public sector and academic customer organizations around the world. It helps companies achieve business goals through the use of technologies ranging from software licensing and end user computing devices to innovative cloud and edge solutions. With over 5,000 employees worldwide, SHI is the largest Minority and Woman Owned Business Enterprise (MWBE) in the U.S.

Press Resources:

SHI Corporate Website: http://www.SHI.com
SHI Blog: http://blog.SHI.com
SHI Twitter Handle: @SHI_Intl

Contacts

For SHI International

Gregory FCA

Matt McLoughlin

610-228-2123

Tags Business, New Jersey

Business

AM Best to host webinar on insurance defense 101: What insurers need from today’s counsel

Post author By Michelle Dryden
Post date August 11, 2021
No Comments on AM Best to host webinar on insurance defense 101: What insurers need from today’s counsel

OLDWICK, N.J. — (BUSINESS WIRE) — AM Best and Best’s Insurance Professional Resources will host a complimentary webinar on Wednesday, Sept. 8, 2021, at 2:00 p.m. (EDT). A panel of insurance and legal experts examine the evolving relationship between insurers and outside counsel, including expectations for expertise, responsiveness, specialization and resources. Panelists will also review how firms can enter into or expand their presence in this vital sector of legal defense.

Panelists include:

Fred Fisher, president, Fisher Consulting Group, Inc.;
Frank Zacherl, partner, Shutts & Bowen, LLP;
Joanna Salinas, partner, Fletcher, Farley, Shipman & Salinas, LLP; and
Graham Cridland, shareholder, Ericksen Arbuthnot.

Attendees can submit questions during registration or by emailing webinars@ambest.com. The event will be streamed in video and audio formats, and playback will be available to registered viewers shortly after the event.

Contacts

John Czuba
Managing Editor, Best’s Insurance Professional Resources
+1 908 439-2200, ext. 5673
john.czuba@ambest.com

Tags Business, New Jersey

Business

AM Best upgrades credit ratings of Bondex Insurance Company

Post author By Michelle Dryden
Post date August 11, 2021
No Comments on AM Best upgrades credit ratings of Bondex Insurance Company

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance—AM Best has upgraded the Financial Strength Rating to B++ (Good) from B+ (Good) and the Long-Term Issuer Credit Rating to “bbb” (Good) from “bbb-” (Good) of Bondex Insurance Company (Bondex) (Florham Park, NJ). The outlook of these Credit Ratings (ratings) is stable.

These Credit Ratings (ratings) reflect Bondex’s balance sheet strength, which AM Best assesses as adequate, as well as its adequate operating performance, limited business profile and appropriate enterprise risk management (ERM).

Bondex’s balance sheet strength is assessed as adequate despite the company having the strongest level risk-adjusted capitalization, as measured by Best’s Capital Adequacy Ratio (BCAR). The company’s BCAR has increased over the past several years, driven by surplus growth supported by favorable underwriting results. However, various components of the balance sheet offset the strongest level BCAR such as a low level of surplus, high underwriting leverage, high reinsurance dependence and trailing liquidity metrics when compared with the industry.

Bondex’s adequate operating performance has been driven by favorable underwriting results in recent years, which has contributed to overall earnings and continued surplus growth. Despite the overall economic impact from the COVID-19 pandemic, the company produced net income in 2020 and posted solid total return metrics.

The limited business profile reflects the company’s single product line concentration in surety bonds and narrow geographic concentration with the majority of its business written in New Jersey. Offsetting these high concentrations is the company’s reputation in its market and management’s knowledge of the surety industry.

The rating upgrades reflect a change in AM Best’s assessment of Bondex’s ERM to appropriate from marginal. These upgrades follow the implementation of the company’s ERM framework and capabilities over recent years. Risk appetite and tolerances have been established and are reviewed annually by the board, along with current and emerging risks. Additionally underwriting reviews the top exposures regularly, but not less than monthly, and takes action when appropriate to reduce risk. In addition, the company has put into place an adequate reinsurance program supported by high quality reinsurers to support its surety bond business.