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Sealy Purchases Off-Market Class A Warehouse in Kansas City

Dallas, TX, April 21, 2021 (GLOBE NEWSWIRE) — Sealy & Company, a fully-integrated commercial real estate investment and operating company and recognized leader in the industrial real estate market, announces the acquisition of a distribution warehouse totaling 210,504 SF in Kansas City, Missouri. The off-market transaction was made for an undisclosed amount.

Marking the second transaction for the company in one week, the acquisition of Lone Elm Commerce Center brings Sealy & Company’s holdings in the Kansas City market to over 1.3 million square feet. Rounding out the firm’s top markets by volume at number five, this top-tier market is attractive for numerous reasons including its centralized location, significant highway and railway infrastructure, and affordable cost of labor.

The newly acquired Class A distribution center features specifications targeting the under-served user pool in need of space within 50,000 – 100,000 square feet. With the opportunity and flexibility to demise the large warehouse into multiple spaces, Sealy may better serve a variety of potential users to accompany its existing tenants within the property.

Situated on twelve acres, the modern building features expansive parking, loading docks, vast paved outdoor storage, and a high-efficiency rooftop. These amenities, along with the aesthetically enhanced office storefront and surrounding windows, attracted Sealy to this contemporary asset.

“The Johnson Country submarket in which this property is located is known for its high-quality concentration of newer industrial inventory along the I-35 corridor, and this property is no exception. This property was built in 2018, and its modern specifications are ideal for current and new tenants. This is a great addition to our portfolio,” says Jason Gandy, Managing Director of Investment Services for Sealy & Company.

Sealy & Company purchased the property from Heise-Meyer, LLC with the help of brokers Mark Long and John Hassler of Newmark.

For more news and information regarding Sealy & Company, please visit the company’s website at www.Sealynet.com.

 About Sealy & Company

Sealy & Company, a fully-integrated commercial real estate investment and operating company, is a recognized leader in acquiring, developing, and redeveloping regional distribution warehouses, industrial/flex, and other commercial properties.  Sealy provides a full-service platform for high-net-worth individuals and institutional investors through our development, management, and brokerage divisions. Sealy & Company has an exceptional team of over 100 employees, located in five offices, with corporate offices in Dallas, TX and Shreveport, ­LA. 

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Kayte Hollowell
Sealy & Company
3186983112
[email protected]

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Revolution Medicines Announces Dosing of First Patient in Phase 1/1b Clinical Study of RMC-5552 in Patients with Advanced Solid Tumors

First-in-Class Bi-steric mTORC1 Inhibitor Advances into Clinical Development

Newly Issued U.S. Patent Further Strengthens RMC-5552 IP Portfolio

REDWOOD CITY, Calif., April 21, 2021 (GLOBE NEWSWIRE) — Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage precision oncology company focused on developing targeted therapies to inhibit frontier targets in RAS-addicted cancers, today announced dosing of the first patient in a multicenter Phase 1/1b clinical trial evaluating RMC-5552, the company’s investigational first-in-class bi-steric mTORC1 inhibitor as a monotherapy. The trial is an open-label dose-escalation and dose-expansion study designed to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetics of RMC-5552 in patients with advanced relapsed/refractory solid tumors. Results from this study will inform Revolution Medicines’ identification of the maximum tolerated dose (MTD) and selection of recommended Phase 2 dose and schedule (RP2DS) for further evaluation of the compound.

RMC-5552 is a potent and selective inhibitor of mTORC1 that is being developed as an anticancer therapeutic for patients with solid tumors that have hyperactivation of the mTOR pathway, including certain RAS-addicted cancers. The compound is designed to inhibit mTORC1 and preserve the natural tumor suppressive activity of 4EBP1, without the undesired inhibition of mTORC2. RMC-5552 has demonstrated antitumor activity in a wide variety of preclinical models. Revolution Medicines has also reported in vivo data demonstrating that RMC-5552 may increase antitumor activity in combination with KRASG12C inhibitors in lung and colon cancers harboring KRAS mutations and co-mutations in the mTOR signaling pathway that can cause resistance to single agent RAS inhibition.  

“The initiation of the RMC-5552 clinical program is the first step in the evaluation of our first-in-class, bi-steric mTORC1 inhibitor as a RAS Companion Inhibitor for the treatment of tumors driven by co-occurring RAS mutations and genomic activation of the mTORC1 pathway, which account for a significant proportion of RAS-addicted cancers,” said Steve Kelsey, M.D., president, research and development at Revolution Medicines. “These co-occurring mutations may contribute to resistance to single-agent RAS inhibitors, and the potential to add RMC-5552 to RAS-directed therapies aligns nicely with our strategy of developing rational, biomarker-driven drug combinations that can achieve maximum clinical benefit in patients with RAS-driven cancers. We also look forward to evaluating RMC-5552 in selected indications where mTORC1 is activated independently of RAS.”

New Patent Issuance for RMC-5552 and Related Compounds

In additional news regarding the RMC-5552 program, Revolution Medicines today announced that the United States Patent and Trademark Office has issued U.S. Patent No. 10,980,889. This patent provides, in part, composition of matter protection for RMC-5552, as well as related compounds in the company’s proprietary series of selective mTORC1 inhibitors.

About mTORC1

The mTOR Complex 1 (mTORC1) is a central node within the mTOR signaling pathway and a critical regulator of metabolism, growth and proliferation in cancer cells. Oncogenic mutations of genes upstream of mTOR, including PI3 kinase, PTEN, and STK11, can drive abnormal activation of mTORC1 and subsequent inactivation of the tumor suppressor 4EBP1. Selective inhibition of mTORC1 to reactivate 4EBP1 is a potential therapeutic strategy for patients with tumors bearing such mutations. These mutations are often co-occurring with RAS mutations in RAS-addicted tumors and combinations of mTORC1 and RAS-targeted inhibitors may be of particular benefit in this context.

About Revolution Medicines, Inc.

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. The company possesses sophisticated structure-based drug discovery capabilities built upon deep chemical biology and cancer pharmacology know-how and innovative, proprietary technologies that enable the creation of small molecules tailored to unconventional binding sites.

The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. RAS(ON) Inhibitors in development include RMC-6291 and RMC-6236, and a pipeline of research compounds targeting additional RAS variants. RAS Companion Inhibitors in development include RMC-4630, RMC-5552, and RMC-5845.


Forward Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation statements regarding the tolerability and potential efficacy of Revolution Medicines’ clinical candidates, including RMC-5552; the outcome of the company’s clinical trials, including the Phase 1/1b study of RMC-5552; identification of the MTD and selection of a RP2DS for RMC-5552; the strategy of developing drug combinations that can achieve maximum clinical benefit; and Revolution Medicines’ plans to evaluate RMC-5552 in
selected indications where mTORC1 is activated independently of RAS
. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company’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, the company’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the effects on our business of the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines’ Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 2, 2021, and its future periodic reports to be filed with the Securities and Exchange Commission. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events. 



Contacts:
For Investors:
Vida Strategic Partners
Stephanie Diaz
415-675-7401
[email protected]

For Media:
Vida Strategic Partners
Tim Brons
415-675-7402
[email protected]

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Associated Capital Reports Preliminary First Quarter Book Value of $41.10 to $41.30 Per Share

Associated Capital Reports Preliminary First Quarter Book Value of $41.10 to $41.30 Per Share

GREENWICH, Conn.–(BUSINESS WIRE)–
Associated Capital Group, Inc. (“AC” or the “Company”), announced today a range of its first quarter preliminary book value of $41.10 to $41.30 per share, driven largely by changes in mark-to-market values. This compares to $40.36 per share at December 31, 2020 and $36.61 at March 31, 2020.

Assets under management were $1.495 billion at March 31, 2021 as compared to $1.473 billion at March 31, 2020.

Associated Capital will be issuing further details on its financial results in early May.

About Associated Capital Group, Inc.

Associated Capital, based in Greenwich Connecticut, is a diversified global financial services company that provides alternative investment management through Gabelli & Company Investment Advisers, Inc. (“GCIA” f/k/a Gabelli Securities, Inc.). We have also earmarked proprietary capital for our direct investment business that invests in new and existing businesses. The direct investment business is developing along three core pillars: Gabelli Private Equity Partners, LLC (“GPEP”), formed in August 2017 with $150 million of authorized capital as a “fund-less” sponsor; the SPAC business (Gabelli special purpose acquisition vehicles), launched in April 2018; and Gabelli Principal Strategies Group, LLC (“GPS”) created to pursue strategic operating initiatives.

SPECIAL NOTE REGARDING FORWARD-LOOKING INFORMATION

Our disclosure and analysis in this press release contain “forward-looking statements”. Forward-looking statements convey our current expectations or forecasts of future events. You can identify these statements because they do not relate strictly to historical or current facts. They use words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” and other words and terms of similar meaning. They also appear in any discussion of future operating or financial performance. In particular, these include statements relating to future actions, future performance of our products, expenses, the outcome of any legal proceedings, and financial results. Although we believe that we are basing our expectations and beliefs on reasonable assumptions within the bounds of what we currently know about our business and operations, the economy and other conditions, there can be no assurance that our actual results will not differ materially from what we expect or believe. Therefore, you should proceed with caution in relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance.

Douglas R. Jamieson

President & CEO

(203) 629-2726

Associated-Capital-Group.com

KEYWORDS: United States North America Connecticut

INDUSTRY KEYWORDS: Consulting Banking Professional Services Finance

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Visa Deepens Global Commitment to Environmental Sustainability with Pledge to Reach Net-zero Emissions by 2040

Visa Deepens Global Commitment to Environmental Sustainability with Pledge to Reach Net-zero Emissions by 2040

Visa marks Earth Day 2021 with industry-leading milestones, innovative partnerships and initiatives toward its vision of a sustainable future

SAN FRANCISCO–(BUSINESS WIRE)–
Visa (NYSE: V), a leading global payments technology company, announced today a new global commitment to reach net-zero emissions by 2040, and that the company achieved carbon neutrality across its operations in 2020.i Visa also outlined plans to become a climate positive company through new partnerships and expanded initiatives to support sustainable commerce and the transition to a low-carbon economy beyond the company’s own footprint.

“Visa is committed to creating a more sustainable future,” said Al Kelly, chairman and chief executive officer of Visa. “Our new net-zero commitment and enhanced efforts across our network in support of sustainable initiatives are immediate ways we will achieve our goals to help build a better future for our planet.”

Net-zero by 2040 – 10 years ahead of Paris Climate Agreement goal

As part of the commitment to reach net-zero emissions by 2040, Visa announced it is a new signatory of The Climate Pledge, an initiative co-founded by Amazon and Global Optimism, as well as a new member of the Climate Business Network, a World Wildlife Fund (WWF) initiative to accelerate action toward a net-zero future. Visa’s net-zero commitment is aligned with emerging global standards and definitions and will include efforts with suppliers to abate a significant portion of the greenhouse gas footprint of the company’s purchased goods and services. Visa also has committed to set science-based targets through the Science Based Target initiative at the 1.5 degree Celsius ambition level. These new commitments join Visa’s existing sustainability leadership, including its transition to 100 percent renewable electricity usage in 2020.

“This Earth Month Visa is using the power of our network to accelerate transformation in sustainability and economic recovery, while helping ensure that the planet and economies around the world thrive,” said Douglas Sabo, chief sustainability officer of Visa. “By prioritizing clean energy and sustainable practices, investing in environmentally innovative initiatives and engaging with corporate and civil society leaders on climate, we are committed to being a part of the global solution to climate change.”

Supporting Sustainable Commerce

Visa is expanding its initiatives to use its products, services, network, data, payments expertise and brand to support sustainable commerce and the transition to a low-carbon economy. Today, Visa announced its collaboration with the Cambridge Institute for Sustainability Leadership (CISL) to work together to identify new opportunities to apply electronic payments capabilities and the Visa network toward realizing a sustainable future. Results of the collaboration are anticipated in Summer 2021.

Visa’s collaboration with CISL complements the company’s efforts to work across its network to support a low-carbon future, including:

  • Partnerships advancing sustainable payment cards and accounts
  • Global initiatives supporting sustainable behaviors, such as in mobility and travel
  • Developing sustainable insights to support stakeholders in commerce in understanding consumer barriers and drivers of sustainable living behaviors
  • Using the brand’s platforms to inspire sustainable living among millions of consumers

Visa’s new goals and efforts to support sustainable commerce build upon the company’s existing recognized industry leadership in sustainability, including inclusion on the following: Dow Jones Sustainability North American Index, America’s Most Responsible Companies, 100 Best Corporate Citizens and 100 Most Just Companies.

For more information, please visit: https://usa.visa.com/visa-everywhere/blog/bdp/2021/04/15/sustainable-commerce-and-1618453815474.html.

About Visa Inc.

Visa is the world’s leader in digital payments. Our mission is to connect the world through the most innovative, reliable and secure payment network – enabling individuals, businesses and economies to thrive. Our advanced global processing network, VisaNet, provides secure and reliable payments around the world, and is capable of handling more than 65,000 transaction messages a second. The company’s relentless focus on innovation is a catalyst for the rapid growth of connected commerce on any device. As the world moves from analogue to digital, Visa is applying our brand, products, people, network and scale to reshape the future of commerce. For more information visit usa.visa.com/about-visa.html, usa.visa.com/visa-everywhere/blog.html and @VisaNews.

This release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are identified by words such as “will,” “plans,” “is expected,” and other similar expressions. Examples of forward-looking statements include, but are not limited to, statements we make regarding the timing and likelihood of taking actions related to our strategy, plans for future climate initiatives and goals, and the potential impact of our actions. By their nature, forward-looking statements: (i) speak only as of the date they are made; (ii) are not statements of historical fact or guarantees of future performance; and (iii) are subject to risks, uncertainties, assumptions or changes in circumstances that are difficult to predict or quantify. Therefore, actual results could differ materially and adversely from Visa’s forward-looking statements due to a variety of factors, including those contained in our Annual Report on Form 10-K for the fiscal year ended September 30, 2020, and our other filings with the U.S. Securities and Exchange Commission. You should not place undue reliance on such statements. Except as required by law, we do not intend to update or revise any forward-looking statements as a result of new information, future developments or otherwise.

i This carbon neutrality achievement covers greenhouse gas emissions footprint from Visa’s Scope 1 (owned source), Scope 2 (purchased electricity) and business travel and employee commuting elements of Scope 3 (value chain) emissions. Scopes 1, 2 and 3 are as defined by the Greenhouse Gas Protocol of the World Resources Institute (WRI) and the World Business Council for Sustainable Development (WBCSD).

Visa Media

Lindy Mockovak

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Environment Technology Finance Banking Other Technology Professional Services Software Alternative Energy Energy Data Management

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Applied DNA Provides Preliminary Estimated Fiscal Second Quarter 2021 Revenue Range and Business Update

Applied DNA Provides Preliminary Estimated Fiscal Second Quarter 2021 Revenue Range and Business Update

– Anticipates Revenues in the Range of $2.5 Million to $2.7 Million Driven by COVID-19 Testing and Diagnostics Sales –

– Announces Full Loan Forgiveness under Paycheck Protection Program –

– NYS Department of Health Completes Re-Inspection of ADCL –

STONY BROOK, N.Y.–(BUSINESS WIRE)–
Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today provided a preliminary estimated revenue range for the fiscal second quarter ended March 31, 2021 and a business update. The Company expects revenues for its fiscal second quarter to be in the range of $2.5 million to $2.7 million. This compares to revenues of $1.6 million in the fiscal first quarter of 2021 and $552 thousand in the fiscal second quarter of 2020. The sequential growth in quarterly revenues was driven principally by demand for safeCircle™, the Company’s pooled COVID-19 surveillance testing program, and from sales of its Linea™ COVID-19 Assay Kit (the “Assay Kit”).

Concurrently, the Company announced that it had received notification during the fiscal quarter that a loan of approximately $847 thousand received in May 2020 under the Paycheck Protection Program of the Coronavirus Aid, Relief, and Economic Security Act was fully forgiven. As a result of the full forgiveness of the loan, the Company is debt-free.

These preliminary unaudited results are based on management’s initial analysis of operations for the second fiscal quarter of 2021 ended March 31, 2021 and are subject to review and revision. The Company expects to issue full financial results for the second fiscal quarter of 2021 in mid-May 2021.

Dr. James A. Hayward, president and CEO, stated, “We are pleased to preliminarily report a second consecutive quarter of revenue growth that was driven primarily by the continued adoption of safeCircle as the surveillance testing component of clients’ COVID-19 ‘normalization’ strategies. The high sensitivity of our Assay Kit that powers safeCircle and its resultant ability to detect asymptomatic infections, coupled with the favorable economics of pooled testing, offers compelling value to communities that continue to see significant transmission alongside expanding vaccine eligibility. As such, under-vaccinated populations and organizations implementing reopening compliance strategies are target market segments for us and we are evolving our sales strategy to match.

“Our diagnostics business model has been made more resilient through product diversification and service improvements to develop adjacent revenue streams. In particular, the launch of our Selective Genomic Surveillance™ (SGS™) Mutation Panel (SGS Panel) is coincident with the rising need for tools to supplement and strengthen the nation’s genomic sequencing capacity. Our SGS Panel can quickly and cost-effectively identify COVID-19 mutations and potentially influence vaccine/booster or therapeutics design. We also continued to demonstrate the potential for our LinearDNA platform as an alternative to plasmids to produce nucleic acid-based therapies, notably reporting compelling positive preliminary Phase I results for our LinearDNA COVID-19 vaccine candidate in felines,” concluded Dr. Hayward.

Business Update

Applied DNA Clinical Labs, LLC (ADCL)

  • Resubmitted for and completed a re-inspection of its facility by the New York State Department of Health (DoH) Clinical Laboratory Evaluation Program (CLEP) as a requisite for Clinical Laboratory Improvement Amendments (CLIA) certification. If granted, CLIA certification would enable ADCL to serve as a diagnostic laboratory that would allow for it to conduct diagnostic COVID-19 testing utilizing its Assay Kit. The Company offers no timeline to a CLIA determination by the DoH. CLIA certification would also potentially allow ADCL to develop an additional revenue stream through the development and commercialization of a broad-array of diagnostic tests, including laboratory-developed tests (LDTs), that once approved by the applicable regulatory authority, could be offered by ADCL;
  • Secured an LSL (Limited Service Laboratory) registration from DoH to conduct COVID-19 diagnostic testing using third-party EUA-authorized, CLIA-waived COVID-19 testing platforms. The LSL enables ADCL to offer faster turnaround times on confirmatory diagnostic tests to safeCircle clients and capture testing revenues for diagnostic tests currently being conducted by third-party clinical labs.
  • Nearing completion of an upgrade of space and equipment within the Company’s Stony Brook, NY facility intended for diagnostic testing and cGMP (current Good Manufacturing Practice standards and procedures) capacity for LinearDNA production and processing.

LineaRx

  • Continued execution on a phased approach towards higher standards of cGMP, including upgrades in space and equipment noted above to support human therapeutic trials, veterinary therapeutics, and the subsidiary’s biotherapeutic CRO customers seeking to move into human clinical trials using LinearDNA.

About safeCircle™

ADCL’s pooled surveillance testing program, known as safeCircle, utilizes frequent, high-sensitivity pooled testing to help prevent virus spread by quickly identifying infections within a community, school, or workplace. safeCircle provides 24-hour results using real-time PCR (RT-PCR) testing.

Click through to learn more about how safeCircle can help your community, school, and workplace: safeCircle

About the Linea™COVID-19 Assay Kit and Pooled Surveillance Testing

The Linea™COVID-19 Assay Kit is authorized by FDA EUA for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens, including anterior nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider. The scope of the LineaCOVID-19 Assay Kit EUA, as amended, is expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated or until the EUA’s prior termination or revocation. The diagnostic kit has not been FDA cleared or approved, and the EUA’s limited authorization is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

The Company is offering surveillance testing in compliance with current CDC, FDA, and CMS guidances. The use of saliva and pooled sampling for surveillance testing, which has been internally validated by the Company in compliance with current surveillance testing guidances, is not included in the Company’s EUA authorization for the LineaCOVID-19 Assay Kit. The Selective Genomic Surveillance (SGS) Mutation Panel (the “SGS Panel”) is for Research Use Only (RUO) and shall not be used for clinical diagnostic purposes. The SGS Panel has not been approved or authorized to diagnose, ameliorate and/or detect any disease by any U.S. or international regulatory authority.

About Applied DNA Sciences

Applied DNA is commercializing LinearDNA™, its proprietary, large-scale polymerase chain reaction (“PCR”)-based manufacturing platform that allows for the large-scale production of specific DNA sequences.

The LinearDNA platform has utility in the nucleic acid-based in vitro diagnostics and preclinical nucleic acid-based drug development and manufacturing market. The platform is used to manufacture DNA for customers as components of in vitro diagnostic tests and for preclinical nucleic acid-based drug development in the fields of adoptive cell therapies (CAR T and TCR therapies), DNA vaccines (anti-viral and cancer), RNA therapies, clustered regularly interspaced short palindromic repeats (CRISPR) based therapies, and gene therapies. Applied DNA has also established a COVID-19 diagnostic and testing offering that is in the early stages of commercialization and is grounded in the Company’s deep expertise in DNA.

The LinearDNA platform also has non-biologic applications, such as supply chain security, anti-counterfeiting and anti-theft technology. Key end-markets include textiles, pharmaceuticals and nutraceuticals, and cannabis, among others.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN,’ and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW.’

Applied DNA is a member of the Russell Microcap® Index.

Preliminary Financial Information

The preliminary information and estimates in respect of the Company’s second fiscal quarter of 2021 performance set forth herein constitute forward-looking statements, upon which you should not place undue reliance because they may prove to be materially inaccurate. The preliminary information and estimates have not been compiled or examined by the Company’s independent auditors and they are subject to revision as the Company prepares its quarterly financial statements, and as the Company’s auditors conduct their review thereof. While the Company believes that such preliminary information and estimates are based on reasonable assumptions, actual results may vary, and such variations may be material. Factors that could cause our preliminary information and estimates to differ from the information and estimates presented herein include but are not limited to: (i) additional adjustments in the calculation of, or application of accounting principles for, the financial results for the second fiscal quarter of 2021, and (ii) discovery of new information that impacts these results.

Forward-Looking Statements

The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies, and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance, the possibility that the assay kit could become obsolete or have its utility diminished, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partner’s diagnostic or therapeutic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (U.S. FDA) or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to U.S. FDA, equivalent foreign regulatory agencies and/or the New York State Department of Health, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, changes in guidances promulgated by the CDC, U.S. FDA and/or CMS relating to COVID-19 surveillance and diagnostic testing, disruptions in the supply of raw materials and supplies, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology approved for therapeutic use, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 17, 2020, and Form 10-Q filed on February 11, 2021 and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.

Investor contact: Sanjay M. Hurry, Applied DNA Sciences, 917-733-5573, [email protected]
Web:www.adnas.com

Twitter: @APDN

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Medical Supplies Health Infectious Diseases Genetics Clinical Trials Biotechnology

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Healthcare Services Group, Inc. Reports Q1 2021 Results

Healthcare Services Group, Inc. Reports Q1 2021 Results

BENSALEM, Pa.–(BUSINESS WIRE)–
Healthcare Services Group, Inc. (NASDAQ:HCSG) (the “Company”) reported for the three months ended March 31, 2021 revenue of $407.8 million and net income of $24.7 million, or $0.33 per basic and diluted common share. The Company’s Board of Directors declared a quarterly cash dividend of $0.2075 per common share, the 71st consecutive increase since the initiation of dividend payments in 2003.

Ted Wahl, Chief Executive Officer, stated, “The vaccine roll-out is proving to be a real game changer for the industry, as new COVID cases among patients and residents dropped over 90% between Q4 and Q1. Vaccinations have not only helped stabilize census but have also boosted morale for frontline caregivers and HCSG heroes, who continue their tireless efforts to protect those most vulnerable. And although the pace of census and overall industry recovery remains uncertain, immunization is a critical first step.”

Mr. Wahl continued, “We delivered outstanding operational outcomes in Q1, and I’m extremely pleased with our strong start to the year. We remain laser-focused on the elements of our business within our control: successful service execution, customer satisfaction, systems adherence and regulatory compliance.”

Mr. Wahl concluded, “Looking ahead, we will continue to closely monitor the path and pace of industry recovery and remain flexible in order to deliver the best possible outcomes on all fronts in Q2. While COVID remains a near-term headwind on revenue, some of the recent, more positive industry and customer data have provided us with improved top line visibility for potential growth opportunities in the back of the year.”

First Quarter Results

Revenue for the quarter was $407.8 million, with housekeeping & laundry and dining & nutrition segment revenues of $215.1 million and $192.7 million, respectively. Revenue included $3.9 million of COVID-19 supplemental billings, primarily related to employee pay premiums passed through to customers.

Direct cost of services was reported at $336.6 million, or 82.6%, below the Company’s historical target of 86.0%.

Housekeeping & laundry and dining & nutrition segment margins were 13.1% and 10.4%, respectively.

Selling, general and administrative (“SG&A”) was reported at $40.0 million, or 9.8%; after adjusting for the $1.3 million increase in deferred compensation, actual SG&A was $38.7 million, or 9.5%. During the quarter, SG&A was also impacted by approximately $2.0 million of legal and professional fees related to the previously announced SEC matter.

The Company reported an effective tax rate of 25.2% and expects a 2021 tax rate of 24% to 26%.

Cash flow from operations for the quarter was $3.5 million. This includes a $30.7 million decrease in accrued payroll.

Dividend & Share Repurchase

The Company’s Board of Directors declared a quarterly cash dividend of $0.2075 per common share, payable on June 25, 2021 to shareholders of record at the close of business on May 21, 2021. This represents the 72nd consecutive quarterly cash dividend payment, as well as the 71st consecutive increase since the initiation of quarterly cash dividend payments in 2003. Additionally, the Company remains authorized to repurchase 1.7 million shares of our common stock pursuant to the previous Board of Directors’ authorization and expects to repurchase up to 1.0 million shares through February 2022.

SEC Matter Update

As previously disclosed, the Securities and Exchange Commission (“SEC”) has been conducting an investigation into the Company’s earnings per share (“EPS”) calculation practices. Following receipt of a letter from the SEC in November 2017 regarding its inquiry into those practices and a subpoena in March 2018, the Company authorized its outside counsel to conduct an internal investigation, under the direction of the Company’s Audit Committee, into matters related to the SEC subpoena. This investigation was completed in March 2019, and the Company has continued to cooperate with the SEC’s investigation and document requests since then. As previously announced, the Company and the SEC have recently commenced discussions regarding a potential resolution of the investigation, which focuses on periods prior to 2018 and expects to continue to work with the SEC in working toward a final resolution.

Conference Call and Upcoming Events

The Company will host a conference call on Wednesday, April 21, 2021, at 8:30 a.m. Eastern Time to discuss its results for the three months ended March 31, 2021. The call may be accessed via phone at 877-395-7164. The call will be simultaneously webcast under the “Events & Presentations” section of the Investor Relations page on the Company’s website, www.hcsg.com. A replay of the webcast will also be available on our website for one year following the date of the earnings call.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This release and any schedules incorporated by reference into it may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are not historical facts but rather are based on current expectations, estimates and projections about our business and industry, and our beliefs and assumptions. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “goal,” and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by us that any of our plans will be achieved. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Such forward-looking information is also subject to various risks and uncertainties. Such risks and uncertainties include, but are not limited to, risks arising from our providing services exclusively to the healthcare industry, primarily providers of long-term care; the impact of and future effects of the COVID-19 pandemic or other potential pandemics having a significant portion of our consolidated revenues contributed by one customer during the three months ended March 31, 2021; credit and collection risks associated with the healthcare industry; our claims experience related to workers’ compensation and general liability insurance (including any litigation claims, enforcement actions, regulatory actions and investigations arising from personal injury and loss of life related to COVID-19); the effects of changes in, or interpretations of laws and regulations governing the healthcare industry, our workforce and services provided, including state and local regulations pertaining to the taxability of our services and other labor-related matters such as minimum wage increases; the Company’s expectations with respect to selling, general, and administrative expense; continued realization of tax benefits arising from our corporate reorganization and self-funded health insurance program; changes in the federal corporate tax rate; the impact of the Securities and Exchange Commission investigation and related class action lawsuit; risks associated with the reorganization of our corporate structure; realization of our expectations regarding the impact of the Tax Cuts and Jobs Act on our tax rates and financial results; and the risk factors described in Part I of our Form 10-K for the fiscal year ended December 31, 2020 under “Government Regulation of Clients,” “Competition” and “Service Agreements and Collections,” and under Item IA. “Risk Factors” in such Form 10-K.

These factors, in addition to delays in payments from customers and/or customers in bankruptcy, have resulted in, and could continue to result in, significant additional bad debts in the near future. Additionally, our operating results would be adversely affected if unexpected increases in the costs of labor and labor-related costs, materials, supplies and equipment used in performing services (including the impact of potential tariffs and COVID-19) could not be passed on to our customers.

In addition, we believe that to improve our financial performance we must continue to obtain service agreements with new customers, retain and provide new services to existing customers, achieve modest price increases on current service agreements with existing customers and/or maintain internal cost reduction strategies at our various operational levels. Furthermore, we believe that our ability to sustain the internal development of managerial personnel is an important factor impacting future operating results and the successful execution of our projected growth strategies.

Healthcare Services Group, Inc. is the largest national provider of professional housekeeping, laundry and dietary services to long-term care and related health care facilities.

HEALTHCARE SERVICES GROUP, INC.

CONSOLIDATED STATEMENTS OF INCOME

(Unaudited)

(in thousands, except per share data)
 

 

For the Three Months Ended

 

March 31,

 

2021

 

2020

Revenues

$

407,751

 

449,150

 

Operating costs and expenses:

 

 

 

Cost of services provided

336,619

 

387,156

 

Selling, general and administrative

39,987

 

30,017

 

Income from operations

31,145

 

31,977

 

Other income, net:

 

 

 

Investment and other income, net

1,807

 

(5,195

)

Income before income taxes

32,952

 

26,782

 

Income tax expense

8,299

 

6,592

 

 

 

 

 

Net income

$

24,653

 

$

20,190

 

 

 

 

 

Basic earnings per common share

$

0.33

 

$

0.27

 

 

 

 

 

Diluted earnings per common share

$

0.33

 

$

0.27

 

 

 

 

 

Cash dividends declared per common share

$

0.20750

 

$

0.20250

 

 

 

 

 

Basic weighted average number of common shares outstanding

75,003

 

74,658

 

 

 

 

 

Diluted weighted average number of common shares outstanding

75,224

 

74,767

 

HEALTHCARE SERVICES GROUP, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

(in thousands)
 

 

March 31, 2021

 

December 31, 2020

Cash and cash equivalents

$

123,654

 

$

139,330

Marketable securities, at fair value

125,773

 

125,012

Accounts and notes receivable, net

252,778

 

255,474

Other current assets

69,985

 

52,587

Total current assets

572,190

 

572,403

 

 

 

 

Property and equipment, net

27,722

 

26,561

Notes receivable – long-term

31,795

 

34,417

Goodwill

51,084

 

51,084

Other intangible assets, net

17,146

 

18,187

Deferred compensation funding

46,981

 

46,825

Other assets

35,891

 

35,554

Total Assets

$

782,809

 

$

785,031

 

 

 

 

Accrued insurance claims – current

$

22,702

 

$

21,610

Other current liabilities

124,205

 

140,650

Total current liabilities

146,907

 

162,260

 

 

 

 

Accrued insurance claims – long-term

60,348

 

60,818

Deferred compensation liability

46,876

 

46,827

Other non-current liabilities

35,576

 

34,665

 

 

 

 

Stockholders’ equity

493,102

 

480,461

Total Liabilities and Stockholders’ Equity

$

782,809

 

$

785,031

 

Theodore Wahl

President and Chief Executive Officer

Matthew J. McKee

Chief Communications Officer

215-639-4274

[email protected]

KEYWORDS: United States North America Pennsylvania

INDUSTRY KEYWORDS: Nursing Health Hospitals Other Health Managed Care General Health

MEDIA:

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Posted on

Waters Corporation Continues Transformation with Planned Leadership Transitions

Waters Corporation Continues Transformation with Planned Leadership Transitions

NEWS SUMMARY:

  • Amol Chaubal named Waters Chief Financial Officer
  • Jonathan Pratt named Senior Vice President of new Waters Division
  • Jianqing Bennett named Senior Vice President of TA Instruments Division
  • Mike Harrington, Senior Vice President of Global Markets, and Ian King, Senior Vice President of Global Products, to retire

MILFORD, Mass.–(BUSINESS WIRE)–
Waters Corporation (NYSE: WAT) continues its transformation program with the announcement of several planned leadership appointments and executive retirements.

Amol Chaubal will assume the role of Senior Vice President and Chief Financial Officer, effective May 12, 2021. Mr. Chaubal joins Waters from Quanterix Corporation, a publicly traded life sciences company, where he served as Chief Financial Officer since April 2019, helping to oversee a period of strong shareholder value creation and returns. Amol brings deep experience in pharma and diagnostics and has led many transformations, including those that brought organic and inorganic growth. Michael Silveira, who has served as Interim Chief Financial Officer since January 2021, will resume his previous responsibilities as Corporate Controller and assume the role of Chief Accounting Officer, reporting to Mr. Chaubal, on May 12, 2021.

The Company also announced that Dr. Mike Harrington, Senior Vice President of Global Markets, and Ian King, Senior Vice President of Global Products, will retire following decades of service to Waters. They remain at Waters until July 2, 2021, and then will continue in consultative roles to ensure a smooth transition. Following a comprehensive search process, the Company made the following leadership appointments and organizational changes effective May 1, 2021:

  • Waters has established a dedicated Innovation Board chaired by President and CEO Dr. Udit Batra. The Innovation Board includes R&D, business development and marketing leaders from across the Company and was formed to identify unmet needs in the markets the Company serves, assess technology proof of concepts and monitor the execution of top programs.
  • Jonathan Pratt has been named Senior Vice President of the new Waters Division, comprising Global Products and Markets, bringing together commercial and R&D under one leader to drive strong cross-functional collaboration and faster decision-making to better meet customer needs. In this role, he will be responsible for Liquid Chromatography and Mass Spectrometry Instruments, consumables, informatics, sales, marketing and service. Mr. Pratt has more than 20 years of experience in life sciences and joined Waters as Senior Vice President in 2019 where he most recently served as President of TA Instruments and led the R&D and commercial teams with strong customer focus and execution.
  • Jianqing Bennett has been named Senior Vice President of TA Instruments Division, succeeding Mr. Pratt. Ms. Bennett most recently served as Senior Vice President, High Growth Markets at Beckman Coulter Diagnostics since 2017, where she helped accelerate revenue growth and market share gain by implementing commercial model changes in China and the EMEA region and driving excellence in commercial execution across all High Growth regions.

Mr. Chaubal, Mr. Pratt and Ms. Bennett will report to Dr. Batra. Kristen Garvey, Vice President of Corporate Communications, will also join the Executive Committee, reporting to Dr. Batra.

“On behalf of the entire Waters team, I want to thank Mike and Ian for their decades of service and contributions to Waters,” said Dr. Batra, Waters President and CEO. “I am personally thankful to both Mike and Ian for all they did to bring me up to speed and help our organization navigate the challenges of 2020. Over nearly 40 years with Waters, Ian has been instrumental in leading the expansion of our product pipeline and global product growth efforts. During his 34 years of service to Waters, Mike oversaw numerous transformations that enhanced Waters’ operational effectiveness and efficiency. As valued mentors to thousands of Waters employees, Mike and Ian have helped build Waters’ deep bench of talent and we wish them both all the best in retirement.”

Dr. Batra continued, “We are off to a good start with our commercial execution and now with these leadership appointments, we have set the stage to develop a competitive long-term strategy. The appointments we announced today follow an extensive search process to identify top candidates who will build on the progress we made in the fourth quarter to regain our commercial momentum and strengthen performance management. Amol, Jon, Jianqing and Kristen have strong records of leading high-performing teams and delivering results, including through transformations. We are pleased to have Amol and Jianqing join our team and look forward to benefitting from their respective financial and operating expertise as we accelerate growth and innovation to further strengthen our customer focus.”

“Jon is a seasoned leader with deep commercial expertise who knows Waters well and will help us strengthen the collaboration between our R&D and commercial operations. I also want to thank Mike Silveira for stepping in during the transition and for setting the foundation for the transformation,” concluded Dr. Batra.

Mr. Chaubal said, “Waters has a strong foundation with industry-leading profitability and strong financial flexibility. I am pleased to join the Waters team at this transformative time and look forward to partnering with Mike Silveira and the Finance team to build on the Company’s momentum and drive enhanced shareholder value.”

Ms. Bennett said, “I have long admired Waters for its commitment to innovation, strong values and tremendous talent. I am excited to lead the TA Instruments business at this pivotal time in the Company’s transformation. I look forward to working with the TA leadership team to advance our strategy and build on Waters’ record of success.”

About Amol Chaubal, Chief Financial Officer, Member of the Executive Committee as of May 12, 2021

Prior to joining Waters, Amol Chaubal was Chief Financial Officer at Quanterix since 2019. From 2017 to 2019, Mr. Chaubal was Chief Financial Officer of Global Operations at Smith & Nephew. Prior to Smith & Nephew, he served as Corporate Vice President and Head of Finance for PAREXEL’s Clinical Research Services and Access business from 2015 to 2017. Between 2013 and 2015, he was the North America Chief Financial Officer and later Regional Chief Operating Officer at Brookfield Renewable Energy Group, part of Brookfield Asset Management. Prior to Brookfield, Mr. Chaubal was Chief Financial Officer North America at Novartis Vaccines & Diagnostics and spent 11 years with Novartis in positions of increasing responsibility across Switzerland, Canada and the United States. He began his career with Procter & Gamble.

He has an MBA from INSEAD (France) and a Master’s in Chemical Engineering from Indian Institute of Technology, Mumbai.

About Jonathan Pratt, SVP, Waters Division, Member of the Executive Committee as of May 1, 2021

Jonathan Pratt served as Senior Vice President and President of TA Instruments at Waters Corporation since 2019. Prior to joining Waters, Mr. Pratt was President of Beckman Coulter Life Sciences (a Danaher operating company), where he spearheaded efforts that drove improved operating profit and revenue growth. Previously, Mr. Pratt held roles of increasing responsibility over 19 years at Pall Corporation, acquired by Danaher in 2015, including Vice President and General Manager from 2013 to 2016 and Senior Vice President of the Food and Beverage division from 2008 to 2013. Earlier in his career, Mr. Pratt served in leadership positions at Whatman (a GE company) and Monsanto UK.

Mr. Pratt also serves on the Board of SPX FLOW, Inc. where he is also a member of the Audit, Compensation and Nominating & Governance Committees.

He holds an MBA from New York University’s Stern School of Business and a B.S. in Chemistry from the University of Reading, UK.

About Jianqing Bennett, SVP, TA Instruments Division, Member of the Executive Committee as of May 1, 2021

Prior to joining Waters, Jianqing Bennett was Senior Vice President, High Growth Markets at Beckman Coulter Diagnostics (a Danaher operating company), where she was responsible for the P&L of High Growth Markets and managed the full portfolio of In-Vitro clinical core laboratory solutions. Prior to Beckman Coulter Diagnostics, she served in roles of increasing responsibility over 14 years at Carestream Health, including President of the Medical Digital Business from 2015 to 2017. Prior to Carestream Health, Ms. Bennett served in multiple roles at GE Healthcare Inc. in the U.S. from 2001 to 2003 and China from 1995 to 1999.

Ms. Bennett holds an MBA in Management Information Systems from The University of Iowa and a B.S. in Biomedical Engineering from Fudan University (Shanghai).

About Kristen Garvey, VP, Corporate Communications, Member of the Executive Committee as of May 1, 2021

Kristen Garvey has served as Vice President of Corporate Communications at Waters Corporation since 2019, leading the Company’s communication strategy across stakeholder groups and overseeing public relations, corporate branding, community involvement and executive and employee communications. From 2018 to 2019, Ms. Garvey served as Senior Director, Corporate Communications at Waters.

Prior to joining Waters, Ms. Garvey served as Senior Director, Internal Communications at Dell from 2016 to 2018. Prior to Dell, she served in a series of leadership roles in internal communications at EMC. Earlier in her career, Ms. Garvey served as a Women’s Network Advisory Board Member at the Greater Boston Chamber of Commerce and held leadership positions at Chadwick Martin Bailey and DataViz.

She earned a B.A. in Communications from the University of Massachusetts Amherst.

About Michael Silveira, Corporate Controller and Chief Accounting Officer, reporting to Amol Chaubal as of May 12, 2021

Prior to being appointed Interim Chief Financial Officer of Waters Corporation in January 2021, Michael Silveira served as Vice President and Corporate Controller since 2013, assuming responsibility over treasury, tax and corporate financial planning and analysis, and accounting and external reporting in 2018. From 2004 to 2013, Mr. Silveira served as Assistant Corporate Controller.

Prior to Waters, Mr. Silveira held several senior financial management positions with Astro-Med (now known as AstroNova), Textron and KPMG.

He earned a B.S. in Accounting from Providence College and is a Certified Public Accountant.

About Waters

Waters Corporation (NYSE:WAT), the world’s leading specialty measurement company, has pioneered chromatography, mass spectrometry, and thermal analysis innovations serving the life, materials, food and environmental sciences for more than 60 years. With more than 7,400 employees worldwide, Waters operates directly in 35 countries, including 14 manufacturing facilities, and with products available in more than 100 countries.

Cautionary Statement

This release contains “forward-looking” statements regarding future results and events, including statements regarding leadership transitions and the Company’s transformation program. For this purpose, any statements that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “will,” “feels”, “believes”, “anticipates”, “plans”, “expects”, “intends”, “suggests”, “appears”, “estimates”, “projects”, and similar expressions, whether in the negative or affirmative, are intended to identify forward-looking statements. Actual future results and events may differ significantly from the results and events discussed in the forward-looking statements within this release for a variety of reasons, including the factors that are discussed in the sections entitled “Forward-Looking Statements” and “Risk Factors” of the Company’s annual report on Form 10-K for the year ended December 31, 2020 as filed with the Securities and Exchange Commission (“SEC”), as updated by the Company’s subsequent filings with the SEC. The forward-looking statements included in this release represent the Company’s estimates or views as of the date of this release and should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this release. Except as required by law, the Company does not assume any obligation to update any forward-looking statements.

Waters Corporation

Bryan Brokmeier, 508-482-3448

[email protected]

Senior Director Investor Relations

Waters Corporation

Kevin Kempskie, 617-413-4333

[email protected]

Senior Director Public Relations

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Biotechnology Health Science Other Science Research

MEDIA:

Posted on

Driven Brands Holdings Inc. to Report First Quarter Results on April 28, 2021

CHARLOTTE, N.C., April 21, 2021 (GLOBE NEWSWIRE) — Driven Brands Holdings Inc. (NASDAQ: DRVN) (“Driven Brands”) will release first quarter 2021 financial results before the market opens on April 28, 2021. Following the release, Driven Brands will host a conference call at 9:00 a.m. ET to review the financial results.

The conference call will be available via live webcast on Driven Brands’ Investor Relations webpage at investors.drivenbrands.com. A webcast replay of the call will be available later the same day until July 27, 2021.

About Driven Brands

Driven Brands™, headquartered in Charlotte, NC, is the largest automotive services company in North America, providing a range of consumer and commercial automotive needs, including paint, collision, glass, vehicle repair, oil change, maintenance and car wash. Driven Brands is the parent company of some of North America’s leading automotive service businesses including Take 5 Oil Change®, Meineke Car Care Centers®, Maaco®, 1-800-Radiator & A/C®, and CARSTAR®. Driven Brands has more than 4,200 centers across 15 countries, and services over 50 million vehicles annually. Driven Brands’ network generates more than $900 million in revenue from more than $3 billion in system-wide sales.


Contacts

Shareholder/Analyst inquiries:

Rachel Webb
[email protected]
(704) 644-8125

Media inquiries:

Katie Blixt
[email protected]
(704) 644-8129



Posted on

Cerevel Therapeutics Appoints Abraham N. Ceesay as President

CAMBRIDGE, Mass., April 21, 2021 (GLOBE NEWSWIRE) — Cerevel Therapeutics, a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, today announced the appointment of Abraham N. Ceesay to the newly-created role of president, effective May 3, 2021. Mr. Ceesay brings nearly two decades of healthcare experience leading operations at a number of biopharmaceutical companies, serving most recently as chief executive officer at Tiburio Therapeutics, a privately-held biotechnology company. As president, he will be responsible for developing Cerevel’s commercial capabilities and infrastructure and will oversee corporate strategy, business development, and portfolio and program management.

“Abe brings tremendous experience and a strong track record in building outstanding commercial organizations. His strategic business expertise will ensure Cerevel is set up for success as we look ahead to introducing new therapies to patients with devastating neuroscience conditions,” said Tony Coles, M.D., chairperson and chief executive officer of Cerevel Therapeutics. “He brings exactly the broad leadership capabilities and operating experience that we need at Cerevel as we continue on our journey to become the premier neuroscience company.”

“I am thrilled to be joining such a dynamic organization, one that is positioning itself to make a tremendous difference in the lives of millions of patients struggling with Parkinson’s disease, epilepsy, schizophrenia, and other neuroscience diseases,” said Mr. Ceesay. “I look forward to joining this outstanding team to build the capabilities Cerevel needs for its next phase of growth.”

About Abraham N. Ceesay

Abraham Ceesay has nearly two decades of experience in leading biopharmaceutical companies and commercializing innovative therapeutic products. Abraham previously served as the chief executive officer at Tiburio Therapeutics, a company focused on the development of novel therapies for rare neuroendocrine tumors and endocrine diseases. At Tiburio, Abraham built a fully integrated company that led to the IND enablement of Tiburio’s lead program for a rare neuroendocrine tumor.

Prior to joining Tiburio, he served as chief operating officer at scPharmaceuticals, where he developed and led all operational and commercial aspects of the company. He was integral in raising more than $150 million in private and public capital, as well as closing the company’s initial public offering. Prior to joining scPharmaceuticals, he served as the head of commercial (sales, marketing, and commercial operations) at Keryx Biopharmaceuticals and spent four years at Ironwood Pharmaceuticals as vice president of marketing. At Ironwood, he led the launch of Linzess® and also held responsibility for the management of the U.S. P&L, leadership of the Linzess® brand team, and co-promotion collaboration with Forest Laboratories.

Previously, Abraham was at Genzyme/Sanofi, initially as a field sales specialist and ultimately as the director, Renal Global Marketing, in which capacity he led the global launch of Renvela® and held global marketing responsibility for the company’s renal franchise.

Abraham serves on the Board of Directors for Life Science Cares and Camp Harbor View. He holds a bachelor’s degree from Ithaca College and a Master of Business Administration from Suffolk University’s Sawyer School of Management.

About Cerevel Therapeutics

Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. The company is tackling diseases with a targeted approach to neuroscience that combines expertise in neurocircuitry with a focus on receptor selectivity. Cerevel Therapeutics has a diversified pipeline comprising five clinical-stage investigational therapies and several pre-clinical compounds with the potential to treat a range of neuroscience diseases, including Parkinson’s, epilepsy, schizophrenia, and substance use disorder. Headquartered in Cambridge, Mass., Cerevel Therapeutics is advancing its current research and development programs while exploring new modalities through internal research efforts, external collaborations, or potential acquisitions. For more information, visit www.cerevel.com.

Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements about our potential to become a premier neuroscience company and introduce new therapies to patients and the potential attributes and benefits of our product candidates. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties, including,
those under the heading “Risk Factors” in our Annual Report on Form 10-K filed with the SEC on March 24, 2021 and our subsequent SEC filings. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

Media Contact:

Kate Contreras
W2O/Real Chemistry
[email protected]

Investor Contact:

Matthew Calistri
Cerevel Therapeutics
[email protected]



Posted on

Trevena Announces TRV027 Selected for Study in Global REMAP-CAP Trial in COVID-19 Patients

—


REMAP-CAP is led by experts in pandemic response and builds upon a worldwide clinical trial network evaluating treatments for COVID-19


Interim review of Imperial College London TRV027 study data supports transition to larger study


REMAP-CAP trial to study TRV027 in up to 300 patients

—

CHESTERBROOK, Pa., April 21, 2021 (GLOBE NEWSWIRE) — Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that TRV027, the Company’s novel AT1 receptor selective agonist, has been selected for inclusion in an international, multi-site, adaptive, Phase 2-Phase 3 trial in COVID-19 patients.

The trial is being conducted and funded as part of REMAP-CAP (Randomised, Embedded, Multi-factorial, Adaptive Platform Trial for Community-Acquired Pneumonia), a global network of clinicians, institutions, and research facilities with the objective of evaluating treatments with the potential to reduce mortality, ICU use, and morbidity in severely ill patients with COVID-19. REMAP-CAP is financially supported by an array of governments and research organizations worldwide.

“I am pleased with the addition of TRV027 to REMAP-CAP, a globally recognized research network that is leading the search for cutting-edge COVID-19 therapies,” said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc. “TRV027 holds immense potential as a treatment for the severe multi-organ damage and blood clotting caused by COVID-19, and I look forward to supporting the investigation of our novel asset in this innovative and expansive trial.”

The trial, known as the REMAP-CAP COVID-19 ACE2 RAS Modulation Domain, is designed specifically to evaluate treatments targeting the renin-angiotensin system (RAS) and determine whether modulation of the RAS is an effective strategy for preventing multiorgan failure and mortality in hospitalized COVID-19 patients. TRV027, which is based on Nobel Prize winning technology, combats disruption within the RAS by specifically binding to and rebalancing AT1 receptor activation, blocking the damaging pathway that leads to acute lung damage and abnormal blood clotting, while activating the cellular pathway that selectively targets reparative actions that improve lung function and promote anti-inflammatory effects.

“I am excited by the opportunity to study TRV027, a novel AT1 receptor selective agonist, as part of REMAP-CAP’s investigation of innovative treatments for COVID-19,” said Anthony Gordon, M.D., Professor of Anaesthesia and Critical Care at Imperial College London and a National Institute for Health Research (NIHR) Research Professor. “REMAP-CAP’s adaptive trial design allows us to gather a plethora of data on a treatment’s efficacy – particularly in certain patient populations or when administered in conjunction with other types of therapies — and I look forward to seeing what information we can glean from TRV027 as we evaluate its performance in COVID-19 patients.”

As previously announced, TRV027 is being investigated in a proof-of-concept study by Imperial College London. A recent review of the interim data by the study’s Data Monitoring and Safety Committee (DMSC) found that there were no safety concerns with TRV027, and the DMSC supported advancing TRV027 to a larger, more extensive study with clinical efficacy outcomes. Imperial College London anticipates winding down its study in the near future and is supporting the transition of TRV027 into the REMAP-CAP COVID-19 RAS domain study. David Owen, M.D., Ph.D., the chief investigator of Imperial College London’s TRV027 study, has joined the investigator team committee for the REMAP-CAP RAS domain study.

About the REMAP-CAP COVID-19 ACE2 RAS Modulation Domain

This is an international, multi-site, randomised, Phase 2-Phase 3 adaptive clinical trial in hospitalized patients with acute illness due to suspected or proven COVID-19, including patients admitted to ICU. Four active treatments are included in the study protocol, including TRV027, with 200-300 patients expected to be enrolled in each arm. TRV027 will be administered in conjunction with an ACE inhibitor. The primary outcome is a composite of in-hospital mortality and provision of organ failure support while admitted to an ICU in the 21 days following randomization. The trial is also evaluating clinical outcomes including ICU and hospital length of stay, ventilator-free days, and organ failure-free days.

About REMAP-CAP

REMAP-CAP (Randomised, Embedded, Multi-factorial, Adaptive Platform Trial for Community-Acquired Pneumonia) is a platform trial designed by clinicians who cared for patients and conducted research during the 2009 H1N1 pandemic. Planning began in 2011. REMAP-CAP is supported by multiple government grants.

REMAP-CAP builds on the combined input of the world’s leading ICU trial networks and experts in infectious disease, immunology, critical care, emergency medicine, Bayesian statistics, and clinical trial execution. These existing networks have enrolled tens of thousands of patients into trials. They have extensive experience designing, conducting, and reporting clinical trials that enroll patients who are severely ill.

The goal of REMAP-CAP is to generate evidence that can be applied during the pandemic to reduce mortality, reduce ICU use, and reduce morbidity in severely ill patients with COVID-19 infection. For the past several years, REMAP-CAP has been recruiting patients with severe CAP in the inter-pandemic period. REMAP-CAP is currently recruiting in more than 300 sites across 21 countries. REMAP-CAP was designed to adapt to an acute pandemic need: that time came slightly over a year ago. Changes necessary for the pandemic have been approved or submitted for approval and many patients with COVID-19 have been and are being enrolled. More information can be found at https://www.remapcap.org/.

About TRV027

TRV027 is a novel AT1 receptor selective agonist that is currently being investigated by multiple institutions as a potential treatment for acute lung injury contributing to ARDS and abnormal blood clotting in COVID-19 patients. It has previously been studied in 691 individuals, has a well-characterized pharmacokinetic profile, and has demonstrated efficacy, potency, and selectivity at the AT1 receptor in nonclinical studies. In previous clinical trials, there was a low dropout rate associated with TRV027, and no significant safety issues were reported. In April 2021, the Company filed a non-provisional patent application and PCT application with the United States Patent and Trademark Office covering the use of TRV027 to treat ARDS and the prevention or treatment of abnormal clotting in COVID-19 patients.

About Trevena

Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company’s novel pipeline is based on Nobel Prize winning research and includes four differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, TRV045 for epilepsy and chronic neuropathic pain, and TRV027 for acute respiratory distress syndrome and abnormal blood clotting in COVID-19 patients.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company’s clinical trials or any future trials of any of the Company’s investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company’s assessment of the discussions with FDA, the timing of FDA’s decision on the oliceridine NDA; available funding; uncertainties related to the Company’s intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

For more information, please contact:

Investor Contact:

Dan Ferry
Managing Director
LifeSci Advisors, LLC
[email protected]
(617) 430-7576

PR & Media Contact:

Sasha Bennett
Director
Clyde Group
[email protected]
(239) 248-3409