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The Peck Company Holdings to Participate at Benchmark Company’s 9th Annual Discovery 1×1 Investor Conference

The Peck Company Holdings to Participate at Benchmark Company’s 9th Annual Discovery 1×1 Investor Conference

Virtual Meetings to be Held on Wednesday, November 18

BURLINGTON, Vt.–(BUSINESS WIRE)–
The Peck Company Holdings, Inc. (NASDAQ: PECK) (the “Company” or “Peck”), a leading commercial solar engineering, procurement and construction (EPC) company, today announced that Jeff Peck, Chief Executive Officer, John Sullivan, Chief Financial Officer, and Michael D’Amato, Chief Strategy Officer, will participate at Benchmark Company’s 9th Annual Discovery 1×1 Investor Conference. The virtual event will take place on Wednesday, November 1 8, 2020 with virtual 1×1 investor meetings throughout the day.

To schedule a meeting with management, please contact your Benchmark Company representative or Vince Curatola at [email protected] or [email protected].

About Benchmark Company

Benchmark Company is an institutionally focused research, sales & trading and investment banking firm working to set the benchmark in promoting each client’s success.

For additional information, please visit https://www.benchmarkcompany.com.

About The Peck Company Holdings, Inc.

Headquartered in South Burlington, VT, The Peck Company Holdings, Inc. is a 2nd-generation family business founded in 1972 and rooted in values that align people, purpose, and profitability. Ranked by Solar Power World as one of the leading commercial solar contractors in the Northeastern United States, the Company provides EPC services to solar energy customers for projects ranging in size from several kilowatts for residential properties to multi-megawatt systems for large commercial and utility scale projects. The Company has installed over 125 megawatts worth of solar systems since it started installing solar in 2012 and continues its focus on profitable growth opportunities. Please visit www.peckcompany.com for additional information.

Forward Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Words or phrases such as “may,” “should,” “expects,” “could,” “intends,” “plans,” “anticipates,” “estimates,” “believes,” “forecasts,” “predicts” or other similar expressions are intended to identify forward-looking statements, which include, without limitation, earnings forecasts, effective tax rate, statements relating to our business strategy and statements of expectations, beliefs, future plans and strategies and anticipated developments concerning our industry, business, operations and financial performance and condition.

The forward-looking statements included in this press release are based on our current expectations, projections, estimates and assumptions. These statements are only predictions, not guarantees. Such forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict. These risks and uncertainties may cause actual results to differ materially from what is forecast in such forward-looking statements, and include, without limitation, the risk factors described from time to time in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.

All forward-looking statements included in this press release are based on information currently available to us, and we assume no obligation to update any forward-looking statement except as may be required by law.

Michael d’Amato

[email protected]

p802-264-2040

ClearThink

[email protected]

KEYWORDS: United States North America Vermont

INDUSTRY KEYWORDS: Alternative Energy Energy Environment Other Energy Utilities

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New Data Build on Growing Evidence Supporting TEPEZZA® (teprotumumab-trbw) Efficacy in Thyroid Eye Disease (TED), Including in Patients With Less Severe Disease and Longer Disease Duration

New Data Build on Growing Evidence Supporting TEPEZZA® (teprotumumab-trbw) Efficacy in Thyroid Eye Disease (TED), Including in Patients With Less Severe Disease and Longer Disease Duration

— Presentation during American Academy of Ophthalmology Annual Meeting (AAO 2020 Virtual) demonstrates clinical improvement in the less severe eye —

— Additional data from OPTIC 48-week follow-up study and OPTIC-X extension trial, including findings showing that the majority of TEPEZZA patients who were diplopia (double vision) responders in OPTIC at week 24 maintained their response at week 72, nearly a year off-treatment —

— Patients who received placebo during the OPTIC Phase 3 clinical trial and then received TEPEZZA in the OPTIC-X extension trial also achieved clinically significant diplopia improvement with an average of 12 months of disease, compared with six months in OPTIC —

DUBLIN–(BUSINESS WIRE)–
Horizon Therapeutics plc (Nasdaq: HZNP) today announced new TEPEZZA® (teprotumumab-trbw) data presented at the American Academy of Ophthalmology Annual Meeting (AAO 2020 Virtual), including findings suggesting benefits of TEPEZZA in the less severe eye of patients with Thyroid Eye Disease (TED), and new data from theOPTIC 48-week follow-up study and OPTIC-X clinical trial. TEPEZZA is the first and only medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of TED – a serious, progressive and vision-threatening rare autoimmune disease.1

“We continue to analyze our existing clinical trials and pursue new research to fully understand the impact TEPEZZA has on this challenging disease,” said Elizabeth H.Z. Thompson, Ph.D., group vice president, development and external search, Horizon. “Our data demonstrating the effect of TEPEZZA at varying stages of the disease, including in the less severely affected eye and in patients who have had Thyroid Eye Disease for a longer period of time, will help advance the science of Thyroid Eye Disease and instill greater understanding of the role TEPEZZA can play in improving patient outcomes.”

Compelling Response in Less Severe TED

Improvement in Fellow Eye of Patients with TED: Pooled Analyses from Teprotumumab Studies (PO305)

In patients with TED, one eye can have more severe symptoms than the other. The TEPEZZA Phase 2 clinical trial and OPTIC Phase 3 confirmatory clinical trial designated the more severely affected eye as the “study eye”.2,3 This new analysis focused specifically on efficacy of TEPEZZA in treating the less severe eye, or “fellow eye”, of patients in the TEPEZZA Phase 2 and 3 trials. Researchers analyzed the intent-to-treat (ITT) population in the Phase 2 and Phase 3 studies, defined as all patients randomized to receive TEPEZZA (n=84) and all patients randomized to receive placebo (n=87). The fellow eye was less proptotic than the study eye in both the TEPEZZA (21.61 mm vs. 23.02 mm) and placebo (21.97 mm vs. 23.15 mm) groups, indicating less severe disease. Additionally, the fellow eye, on average, demonstrated less inflammation based on the clinical activity score (CAS) than the study eye in both the TEPEZZA (CAS: 4.3 vs. 5.1 points) and placebo (CAS: 4.7 vs. 5.3 points) groups.

Findings suggest that TEPEZZA may offer benefits in patients with less severe TED:

  • At Week 24, more TEPEZZA patients were proptosis (eye bulging) responders (≥2 mm reduction) in the fellow eye than placebo patients (63.1 percent vs. 8.0 percent, p<0.001), with a mean reduction in proptosis of 2.39 mm for TEPEZZA patients and a mean increase in proptosis of 0.15 mm for placebo patients (p<0.001).
  • 30 patients (34.5 percent) in the placebo group had a worsening of proptosis at Week 24 in the fellow eye compared to 0 patients (0 percent) in the TEPEZZA group.
  • CAS in the fellow eye decreased from baseline by a mean of -3.42 points in the TEPEZZA group compared to -2.00 points in the placebo group (p<0.001) at Week 24.
  • More TEPEZZA patients (63.1 percent) than placebo patients (26.4 percent) had a CAS of 0 or 1 – signifying disease inactivation – in the fellow eye at Week 24 (p<0.001).

“We know from the clinical development program that TEPEZZA significantly reduces proptosis and Thyroid Eye Disease-related inflammation in patients with moderate-to-severe disease, and now with this new analysis of the Phase 2 and 3 data, we have evidence pointing to efficacy in patients with less severe disease as well,” said Raymond Douglas, M.D., Ph.D., study author and director of the Orbital and Thyroid Eye Disease Program, Cedars-Sinai Medical Center. “We believe this robust effect is the result of the mechanism of TEPEZZA that effectively targets the underlying molecular pathways that cause Thyroid Eye Disease.”

Additional Findings from the OPTIC 48-Week Follow-Up Study and OPTIC-X Clinical Trial

Long Term Assessment of Proptosis and Diplopia from the OPTIC Trial of Teprotumumab in Thyroid Eye Disease (PA038)

Additional data from the OPTIC Phase 3 confirmatory clinical trial and the OPTIC-X open-label extension clinical trial were also included in an abstract and presented during AAO, supplementing the topline results on proptosis response announced in July 2020. The OPTIC trial included a 24-week treatment period (treatment every three weeks for a total of eight infusions) and a 48-week off-treatment follow-up period. OPTIC-X evaluated TEPEZZA in patients who were enrolled in OPTIC and were either proptosis non-responders at Week 24 or were proptosis responders at Week 24 but flared during the 48-week off-treatment follow-up period.

New OPTIC 48-week off-treatment follow-up study findings include the following:

  • The majority of TEPEZZA patients who had at least 1 grade of diplopia (double vision) improvement at Week 24 in OPTIC maintained their response at Week 72 (11/19; 58 percent) without receiving additional TED treatment.
  • 50 percent of TEPEZZA patients (8/16) who had a diplopia score of 0 at Week 24 in OPTIC maintained a diplopia score of 0 at Week 72 without receiving additional TED treatment.

New OPTIC-X findings include the following:

  • 61 percent of patients (14/23) who received placebo during the OPTIC trial and then entered OPTIC-X and received TEPEZZA were considered diplopia responders (≥1 grade improvement) at Week 24. This is consistent with results from the OPTIC trial, where 68 percent of patients (19/28) who received TEPEZZA had a change from baseline of at least 1 grade in diplopia at Week 24. OPTIC-X patients had an average of 12 months of TED compared with six months in OPTIC.
  • Five patients who received placebo during the OPTIC trial and then entered OPTIC-X had a CAS of 0 or 1, which means they had minimal or no inflammation. Of those, 60 percent (3/5) were proptosis responders at Week 24 (≥2 mm improvement in proptosis from baseline in the study eye without deterioration in the fellow eye at Week 24).

There were no new safety concerns in OPTIC-X or the OPTIC 48-week off-treatment follow-up period, including in patients who received additional TEPEZZA treatment.

About Thyroid Eye Disease (TED)

TED is a serious, progressive and vision-threatening rare autoimmune disease.1 TED often occurs in people living with hyperthyroidism or Graves’ disease; however, it is a distinct disease that is caused by autoantibodies activating an IGF-1R-mediated signaling complex on cells within the retro-orbital space.4,5 This leads to a cascade of negative effects, which may cause long-term, irreversible damage. As TED progresses, the serious damage it can cause includes proptosis (eye bulging), strabismus (misalignment of the eyes) and diplopia (double vision) – and in some cases can lead to blindness.6,7

About TEPEZZA

INDICATION

TEPEZZA is indicated for the treatment of Thyroid Eye Disease.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Infusion Reactions: TEPEZZA may cause infusion reactions. Infusion reactions have been reported in approximately 4% of patients treated with TEPEZZA. Reported infusion reactions have usually been mild or moderate in severity. Signs and symptoms may include transient increases in blood pressure, feeling hot, tachycardia, dyspnea, headache and muscular pain. Infusion reactions may occur during an infusion or within 1.5 hours after an infusion. In patients who experience an infusion reaction, consideration should be given to premedicating with an antihistamine, antipyretic, or corticosteroid and/or administering all subsequent infusions at a slower infusion rate.

Preexisting Inflammatory Bowel Disease: TEPEZZA may cause an exacerbation of preexisting inflammatory bowel disease (IBD). Monitor patients with IBD for flare of disease. If IBD exacerbation is suspected, consider discontinuation of TEPEZZA.

Hyperglycemia: Increased blood glucose or hyperglycemia may occur in patients treated with TEPEZZA. In clinical trials, 10% of patients (two-thirds of whom had preexisting diabetes or impaired glucose tolerance) experienced hyperglycemia. Hyperglycemic events should be managed with medications for glycemic control, if necessary. Monitor patients for elevated blood glucose and symptoms of hyperglycemia while on treatment with TEPEZZA. Patients with preexisting diabetes should be under appropriate glycemic control before receiving TEPEZZA.

Adverse Reactions

The most common adverse reactions (incidence ≥5% and greater than placebo) are muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dysgeusia, headache and dry skin.

For additional information on TEPEZZA, please see Full Prescribing Information at TEPEZZAhcp.com.

About Horizon

Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the potential benefits of TEPEZZA as a treatment of less severe TED. These forward-looking statements are based on management expectations and assumptions as of the date of this press release, and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include risks associated with future clinical development, whether TEPEZZA will be adopted as a treatment for less severe TED, as well as those described in Horizon’s filings with the United States Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in those filings. Forward-looking statements speak only as of the date of this press release and Horizon does not undertake any obligation to update or revise these statements, except as may be required by law.

References

  1. Barrio-Barrio J, et al. Graves’ Ophthalmopathy: VISA versus EUGOGO Classification, Assessment, and Management. Journal of Ophthalmopathy. 2015;2015:1-16.
  2. Smith, et al. Teprotumumab for Thyroid-Associated Ophthalmology. N Engl J Med. 2017;376:1748-1761.
  3. Douglas, et al. Teprotumumab for the Treatment of Active Thyroid Eye Disease. N Engl J Med. 2020;382(4):341-352.
  4. Weightman DR, et al. Autoantibodies to IGF-1 Binding Sites in Thyroid Associated Ophthalmopathy. Autoimmunity. 1993;16(4):251–257.
  5. Pritchard J, et al. Immunoglobulin Activation of T Cell Chemoattractant Expression in Fibroblasts from Patients with Graves’ Disease Is Mediated Through the Insulin-Like Growth Factor 1 Receptor Pathway. J Immunol. 2003;170:6348-6354.
  6. Ross DS, et al. The 2016 European Thyroid Association/European Group on Graves’ Orbitopathy Guidelines for the Management of Graves’ Orbitopathy. Eur Thyroid J. 2016;5(1):9-26.
  7. McKeag D, et al. Clinical features of dysthyroid optic neuropathy: a European Group on Graves’ Orbitopathy (EUGOGO ) survey. Br J Ophthalmol. 2007;91:455-458.

Tina Ventura

Senior Vice President, Investor Relations

[email protected]

Ruth Venning

Executive Director, Investor Relations

[email protected]

U.S. Media Contacts:

Rachel Vann

Director, Product Communications

[email protected]

Ireland Media Contact:

Gordon MRM

Ray Gordon

[email protected]

KEYWORDS: California Europe Ireland United States North America

INDUSTRY KEYWORDS: Science Biotechnology Research Pharmaceutical Optical Health Hospitals Genetics

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Acadia Realty Trust to Present at NAREIT’s REITworld®: 2020 Annual Conference

Acadia Realty Trust to Present at NAREIT’s REITworld®: 2020 Annual Conference

RYE, N.Y.–(BUSINESS WIRE)–
Acadia Realty Trust (NYSE: AKR) (“Acadia” or the “Company”) today announced that it will participate in NAREIT’s REITworld®: 2020 Annual Conference, which will be held from November 17-19, 2020. Kenneth F. Bernstein, President and Chief Executive Officer, is scheduled to make a presentation on Wednesday, November 18 at 4:30 p.m. ET.

To access the Company’s live presentation, attendees are required to register for NAREIT’s REITworld®: 2020 Annual Conference, using the registration link below. The Company’s presentation materials will be posted on its website under “Investors – Presentations & Events.”

Acadia will also host individual virtual meetings with investors during the conference.

Acadia Realty Trust Webcast:

Date:

 

Wednesday, November 18, 2020

Time:

 

4:30 p.m. – 5:00 p.m. ET

Webcast link:

 

REITworld 2020 Annual Conference

Webcast replay expires: 90 days following the live webcast

Acadia’s presentation will be available live via audio webcast, which may be accessed at the above link. A replay of the webcast will be available on the Company’s website for 90 days under “Investors – Presentations & Events.”

The Company uses, and intends to use, the Investors page of its website, which can be found at www.acadiarealty.com, as a means of disclosing material nonpublic information and of complying with its disclosure obligations under Regulation FD, including, without limitation, through the posting of investor presentations that may include material nonpublic information. Accordingly, investors should monitor the Investors page, in addition to following the Company’s press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, our website is not incorporated by reference into, and is not a part of, this document.

About Acadia Realty Trust

Acadia Realty Trust is an equity real estate investment trust focused on delivering long-term, profitable growth via its dual – Core and Fund – operating platforms and its disciplined, location-driven investment strategy. Acadia Realty Trust is accomplishing this goal by building a best-in-class core real estate portfolio with meaningful concentrations of assets in the nation’s most dynamic corridors; making profitable opportunistic and value-add investments through its series of discretionary, institutional funds; and maintaining a strong balance sheet. For further information, please visit www.acadiarealty.com.

Safe Harbor Statement

Certain statements in this press release 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 and Exchange Act of 1934, as amended. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations are generally identifiable by use of the words “may,” “will,” “should,” “expect,” “anticipate,” “estimate,” “believe,” “intend” or “project,” or the negative thereof, or other variations thereon or comparable terminology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause our actual results and financial performance to be materially different from future results and financial performance expressed or implied by such forward-looking statements, including, but not limited to: (i) economic, political and social uncertainty surrounding the COVID-19 pandemic, including (a) the effectiveness or lack of effectiveness of governmental relief in providing assistance to large and small businesses, including the Company’s tenants, that have suffered significant declines in revenues as a result of mandatory business shut-downs, “shelter-in-place” or “stay-at-home” orders and social distancing practices, as well as individuals adversely impacted by the COVID-19 pandemic, (b) the duration of any such orders or other formal recommendations for social distancing and the speed and extent to which revenues of the Company’s retail tenants recover following the lifting of any such orders or recommendations, (c) the potential impact of any such events on the obligations of the Company’s tenants to make rent and other payments or honor other commitments under existing leases, (d) to the extent we were seeking to sell properties in the near term, significantly greater uncertainty regarding our ability to do so at attractive prices, (e) the potential adverse impact on returns from development and redevelopment projects, and (f) the broader impact of the severe economic contraction and increase in unemployment that has occurred in the short term and negative consequences that will occur if these trends are not quickly reversed; (ii) the ability and willingness of the Company’s tenants (in particular its major tenants) and other third parties to satisfy their obligations under their respective contractual arrangements with the Company; (iii) macroeconomic conditions, such as a disruption of or lack of access to the capital markets; (iv) the Company’s success in implementing its business strategy and its ability to identify, underwrite, finance, consummate and integrate diversifying acquisitions and investments; (v) changes in general economic conditions or economic conditions in the markets in which the Company may, from time to time, compete, and their effect on the Company’s revenues, earnings and funding sources; (vi) increases in the Company’s borrowing costs as a result of changes in interest rates and other factors, including the potential phasing out of the London Interbank Offered Rate after 2021; (vii) the Company’s ability to pay down, refinance, restructure or extend its indebtedness as it becomes due; (viii) the Company’s investments in joint ventures and unconsolidated entities, including its lack of sole decision-making authority and its reliance on its joint venture partners’ financial condition; (ix) the Company’s ability to obtain the financial results expected from its development and redevelopment projects; (x) the ability and willingness of the Company’s tenants to renew their leases with the Company upon expiration, the Company’s ability to re-lease its properties on the same or better terms in the event of nonrenewal or in the event the Company exercises its right to replace an existing tenant, and obligations the Company may incur in connection with the replacement of an existing tenant; (xi) the Company’s liability for environmental matters; (xii) damage to the Company’s properties from catastrophic weather and other natural events, and the physical effects of climate change; (xiii) uninsured losses; (xiv) the Company’s ability and willingness to maintain its qualification as a REIT in light of economic, market, legal, tax and other considerations; (xv) information technology security breaches, including increased cybersecurity risks relating to the use of remote technology during the COVID-19 pandemic; and (xvi) the loss of key executives. The risks described above are not exhaustive and additional factors could adversely affect the Company’s business and financial performance, including the risk factors discussed under the section captioned “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, and other periodic or current reports the Company files with the SEC. Any forward-looking statements in this press release speak only as of the date hereof. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or change in the events, conditions or circumstances on which such forward-looking statements are based.

Sunny Holcomb

(914) 288-8100

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Professional Services Residential Building & Real Estate Commercial Building & Real Estate Finance Construction & Property REIT Banking

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Lantheus Holdings Announces FDA Clearance for AI-Enabled Automated Bone Scan Index (aBSI) in Prostate Cancer on GE Healthcare’s Xeleris Platform

Lantheus Holdings Announces FDA Clearance for AI-Enabled Automated Bone Scan Index (aBSI) in Prostate Cancer on GE Healthcare’s Xeleris Platform

NORTH BILLERICA, Mass.–(BUSINESS WIRE)–
Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc., and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the use of Lantheus’ artificial intelligence enabled automated bone scan index (aBSI) product on GE Healthcare’s Xeleris platform.

“Lantheus is delighted by the U.S. approval of our digital AI solution for prostate cancer, aBSI, on GE Healthcare’s platform. As a leading multinational medical technology company with deep experience in medical imaging and diagnostics, GE Healthcare presents the ideal attributes to provide global access to this unique digital solution,” said Etienne Montagut, Sr. Vice President of Corporate Development. “aBSI has demonstrated clinical value in quantifying and managing disease progression in advanced prostate cancer patients with the potential to support critical clinical decisions. Lantheus will continue to develop AI solutions to augment and expand the utility of imaging diagnostics for precision medicine in oncology,” Mr. Montagut added.

In October 2019, the Company entered into a global software licensing agreement with GE Healthcare for the rights to aBSI, a vendor neutral stand-alone platform that is enabled with artificial intelligence, which has been trained to automate the detection of hotspots in bone indicative of metastatic disease and calculate the aBSI. The platform offers a fast and reliable alternative to manual interpretation of bone scan images of metastatic prostate cancer. Recent investigations have demonstrated the clinical utility of aBSI as a prognostic and a response imaging biomarker in patients with metastatic prostate cancer.1,2

“The pandemic has proven that data, analytics, AI and connectivity will only become more central to delivering care,” said Erez Levy, General Manager, Nuclear Medicine, GE Healthcare. “For GE Healthcare, that means continuing to advance intelligent and innovative technologies, like aBSI, and deliver precision health to promote better patient outcomes around the world.”

Under the terms of the non-exclusive agreement, GE Healthcare acquired from Lantheus the software license for aBSI for integration into GE Healthcare’s Xeleris platform, excluding the use of aBSI in Japan. Under the agreement with GE Healthcare, Lantheus will receive tiered licensing fees per license sold.

About aBSI

The aBSI product is vendor neutral stand-alone software as a medical device which calculates the automated bone scan index in Technetium-99m bone scintigraphy. aBSI received FDA clearance in 2019 (K191262). The product is enabled with a neural network that has been trained to automate the detection of hotspots and calculate the aBSI value.

About Lantheus Holdings, Inc.

Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc., and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.

About GE Healthcare

GE Healthcare is the $16.7 billion healthcare business of GE (NYSE: GE). As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.

Safe Harbor for Forward-Looking and Cautionary Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as “anticipate,” “believe,” “confident,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “will” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) the market receptivity to aBSI and to GEHC’s XELERIS platform; (ii) the intellectual property protection of aBSI; and (iii) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).

_________________

1 Armstrong AJ, Anand A, Edenbrandt L,et al. Phase 3 Assessment of the Automated Bone Scan Index as a Prognostic Imaging Biomarker of Overall Survival in Men With Metastatic Castration-Resistant Prostate Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018 Jul 1;4(7):944-951.

2 Ali A, Hoyle AP, Parker CC, et al. The Automated Bone Scan Index as a Predictor of Response to Prostate Radiotherapy in Men with Newly Diagnosed Metastatic Prostate Cancer: An Exploratory Analysis of STAMPEDE’s “M1|RT Comparison”. European Urology. 2020 Aug; 3(4): 412-419

Mark Kinarney

Senior Director, Investor Relations

978-671-8842

[email protected]

Melissa Downs

Director, Corporate Communications

646-975-2533

[email protected]

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Research Technology Medical Devices FDA Software Biotechnology Pharmaceutical Health Science Oncology

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Limestone Bank Introduces Redesigned Website & Improved Digital Experience

Limestone Bank Introduces Redesigned Website & Improved Digital Experience

LOUISVILLE, Ky.–(BUSINESS WIRE)–
Limestone Bank is excited to announce the successful launch of the new LimestoneBank.com. The complete redesign is part of the Bank’s continued efforts to bring innovative banking services to its customers. The new website provides an improved digital experience for both customers and prospective customers alike.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201113005118/en/

Limestone Bank launches new website, LimestoneBank.com. (Photo: Business Wire)

Limestone Bank launches new website, LimestoneBank.com. (Photo: Business Wire)

The website refresh includes a renewed focus on access to mobile and online banking which provides a secure and convenient way for customers to manage their accounts remotely. Limestone Bank is also proud to announce the expansion of a new service: Curbside Banking, which allows customers that prefer to visit a banking center to conduct a number of transactions from the safety and comfort of their car. This service is now available at seven of Limestone’s banking center locations, with more locations to come in the future. For more information about curbside banking services as well as a list of participating locations, visit LimestoneBank.com/Curbside-Banking.

John T. Taylor, president and chief executive officer of Limestone Bank, knows that improving the digital experience was a crucial next step in the Bank’s growth, saying, “this year has been filled with challenges and hardship for both individuals and businesses but despite all that has changed this year, the need for efficient access to banking services will always remain true, maybe now more than ever. It is our commitment to our customers to adapt to meet their needs.”

Limestone Bank is positioned to continue its ongoing efforts to modernize the traditional banking experience, without abandoning the foundation of community and service the Bank is known for. “It is our commitment to grow with our customers and their ever-evolving needs to ensure that we are providing the exceptional service our customers expect from us—whether that’s an in-person appointment, curbside, on our website, or via one of our many digital banking tools and services,” says Taylor.

Learn more about Limestone Bank’s personal and commercial banking products and services by visiting LimestoneBank.com today.

For more information, please contact Morgan Tiemann at [email protected].

About Limestone Bank, Inc.

Limestone Bank is a Louisville, Kentucky-based bank, wholly owned by Limestone Bancorp, Inc. (NASDAQ: LMST) which operates banking centers in 14 counties throughout the Commonwealth. The Bank’s markets include metropolitan Louisville in Jefferson County and the surrounding counties of Bullitt and Henry and extend south along the Interstate 65 corridor. The Bank serves south central, southern, and western Kentucky from banking centers in Barren, Butler, Daviess, Edmonson, Green, Hardin, Hart, Ohio, and Warren counties. The Bank also has banking centers in Lexington, Kentucky, the second largest city in the state, and Frankfort, Kentucky, the state capital. Limestone Bank is a traditional community bank with a wide range of personal and commercial banking products and services.

Limestone Bank

Morgan Tiemann, 502-499-4778

[email protected]

KEYWORDS: United States North America Kentucky

INDUSTRY KEYWORDS: Banking Professional Services Finance

MEDIA:

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Limestone Bank launches new website, LimestoneBank.com. (Photo: Business Wire)
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ePlus Honored with Multiple Awards Including Americas Technology Excellence Partner of the Year for Data Center at Cisco Partner Summit Digital 2020

ePlus Honored with Multiple Awards Including Americas Technology Excellence Partner of the Year for Data Center at Cisco Partner Summit Digital 2020

ePlus also secures Awards for East Region: Software Partner of the Year and Commercial Partner of the Year

HERNDON, Va.–(BUSINESS WIRE)–
ePlus inc. (NASDAQ NGS: PLUS – news) today announced that it is the recipient of a Cisco® Partner Summit Digital Geographical Region award for Americas Technology Excellence Partner of the Year: Data Center. ePlus also received area awards in the East region for Software Partner of the Year and Commercial Partner of the Year. Cisco announced the winners during its annual partner conference, this year held digitally.

Awarded to channel partners who rise to business challenges, the Cisco Partner Summit Digital Global awards are designed to recognize superior business practices and reward best-in-class methodologies. Areas of consideration include innovative processes, architecture-led successes, strategic business outcome-focused programs, seizing new opportunities, and sales approaches.

“Cisco is proud to work together with leading partners to drive digital transformation, creating powerful solutions and fresh approaches to meet the needs of our customers,” said John Moses, vice president, Americas Partner Organization at Cisco. “It is an honor to recognize ePlus with a Cisco Partner Summit Digital Geo-Region award as Technology Excellence Partner of the Year: Data Center, further underscoring its outstanding accomplishments in the Americas.”

“ePlus is honored to be recognized by Cisco for our performance and the assistance we have provided to our customers, helping them achieve positive business outcomes during quite complex and challenging times,” said Darren Raiguel, chief operating officer and president of ePlus Technology. “Our sales and services teams are providing best-in-class guidance, expertise and creativity to enable customer organizations across every industry to succeed in a new and unexpected normal. This level of attention and dedication sets us apart in the industry and we’re also proud that Cisco has recognized our excellence in these areas.”

Cisco Partner Summit Digital Geographical Regional awards reflect the top-performing partners within specific technology markets across the geographical region. All award recipients are selected by a group of Cisco Global Partner Organizations and regional executives.

ePlus is a Cisco Gold Certified Partner with Cisco Master Specializations in Networking, Security, Collaboration, Cloud Builder, and Cloud and Managed Services Master. ePlus is a member of the Cisco Lifecycle Advisor Program as well as the AppDynamics Titan Partnership Program, and holds Cisco Advanced Specializations in Data Center Architecture, Collaboration Architecture, Enterprise Networks Architecture, Service Provider Architecture, Customer Experience, and Security Architecture. In addition, ePlus holds numerous Cisco Authorized Technology Provider designations, as well as a Cisco Gold certification in the UK via its subsidiary IGXGlobal. For more information about Cisco solutions from ePlus, visit www.eplus.com/cisco.

About ePlusinc.

ePlus is a leading consultative technology solutions provider that helps customers imagine, implement, and achieve more from their technology. With the highest certifications from top technology partners and lifecycle services expertise across key areas including security, cloud, data center, collaboration, networking and emerging technologies, ePlus transforms IT from a cost center to a business enabler. Founded in 1990, ePlus has more than 1,400 associates serving a diverse set of customers in the U.S., Europe, and Asia-Pac. The Company is headquartered at 13595 Dulles Technology Drive, Herndon, VA, 20171. For more information, visit www.eplus.com, call 888-482-1122, or email [email protected]. Connect with ePlus on Facebook, LinkedIn, Twitter and Instagram. ePlus, Where Technology Means More®.

ePlus®, Where Technology Means More®, and ePlus products referenced herein are either registered trademarks or trademarks of ePlus inc. in the United States and/or other countries. The names of other companies, products, and services mentioned herein may be the trademarks of their respective owners.

Statements in this press release that are not historical facts may be deemed to be “forward-looking statements.” Actual and anticipated future results may vary materially due to certain risks and uncertainties, including, without limitation, risks related to COVID-19, including but not limited to its possible effects on the availability of and demand for our products and services, our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19, and its impact on the economy, possible adverse effects resulting from financial market disruption and fluctuations in foreign currency rates, and general slowdown of the U.S. economy such as our current and potential customers delaying or reducing technology purchases or put downward pressure on prices, increasing credit risk associated with our customers and vendors, reduction of vendor incentive programs, and restrictions on our access to capital necessary to fund our operations; our ability to consummate and integrate acquisitions; the possibility of goodwill impairment charges in the future; significant adverse changes in, reductions in, or losses of relationships with major customers or vendors; the demand for and acceptance of, our products and services; our ability to adapt our services to meet changes in market developments; our ability to implement comprehensive plans to achieve customer account coverage for the integration of sales forces, cost containment, asset rationalization, systems integration and other key strategies; our ability to reserve adequately for credit losses; our ability to secure our electronic and other confidential information or that of our customers or partners; future growth rates in our core businesses; our ability to protect our intellectual property; the impact of competition in our markets; the possibility of defects in our products or catalog content data; our ability to adapt to changes in the IT industry and/or rapid change in product standards; our ability to realize our investment in leased equipment; our ability to hire and retain sufficient qualified personnel; and other risks or uncertainties detailed in our reports filed with the Securities and Exchange Commission. All information set forth in this press release is current as of the date of this release and ePlus undertakes no duty or obligation to update this information.

Kleyton Parkhurst, SVP

ePlus inc.

[email protected]

703-984-8150

KEYWORDS: United States North America Virginia

INDUSTRY KEYWORDS: Online Retail Data Management Retail Technology Software Networks Internet

MEDIA:

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Nicholas Financial’s Las Vegas Grand Opening

CLEARWATER, Fla., Nov. 13, 2020 (GLOBE NEWSWIRE) — Nicholas Financial, Inc. (NASDAQ: NICK) – an industry leading branch-based subprime auto lender focused on servicing the needs of the local independent dealer – announced today a grand opening celebration for our latest expansion branch office in Las Vegas, NV at 7985 W. Sunset Road, Suite 106 on November 18, 2020. The official ribbon cutting ceremony will commerce at 3:30 pm and the celebration will continue until 7:30 pm. Please contact the local office at 702-879-4815 for more information regarding the event.

“We are excited to celebrate our renewed focus on expansion with our first branch office in Las Vegas, Nevada. We are even more excited about our talented local management team,” said Doug Marohn, president and CEO of Nicholas Financial. “Expanding our branch network is a key initiative for us and an integral part of our growth strategy for Fiscal Year 2021 and beyond.

In addition to the new Las Vegas, NV office the Company has expansion efforts underway in Salt Lake City, UT, Milwaukee, WI and Columbia, SC. The company is also now licensed in Arizona, New Mexico and Texas and has recently begun initial expansion efforts in each of those states.

For more information on Nicholas, visit www.nicholasfinancial.com.

About Nicholas Financial

Nicholas Financial, Inc. (NASDAQ:NICK) is a specialized consumer finance company, operating branch-based model with offices across the United States. The Company engages primarily in acquiring and servicing automobile finance installment contracts (“Contracts”) for purchases of used and new automobiles and light trucks. Additionally, Nicholas Financial originates direct consumer loans (“Direct Loans”) and sells consumer-finance related products. For an index of Nicholas Financial, Inc’s new releases or to obtain a specific release, please visit our website at www.nicholasfinancial.

Contact: Doug Marohn
CEO
Ph #  (727)-726-0763

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Pinnace Bankshares Corporation Announces Cash Dividend

ALTAVISTA, Va., Nov. 13, 2020 (GLOBE NEWSWIRE) — Pinnacle Bankshares Corporation (“Pinnacle” or the “Company”) (OTCQX: PPBN), the one-bank holding company for First National Bank (the “Bank”), announced today that its Board of Directors declared a cash dividend of $0.14 per share on November 10, 2020, payable December 4, 2020, to shareholders of record as of November 20, 2020.

The $0.14 per share cash dividend is equal to the $0.14 dividend paid last quarter and marks the thirty-third consecutive quarter a dividend has been declared. Pinnacle previously released its third quarter 2020 earnings on November 6, 2020.

“Pinnacle is pleased to be able to provide a consistent quarterly cash dividend of $0.14 per share to its shareholders for 2020,” stated Aubrey H. Hall, III, President and Chief Executive Officer for both the Company and the Bank.   Mr. Hall further commented, “While net income through nine months of 2020 has declined as compared to the same time period of 2019, it is primarily due to higher noninterest expense associated with strategic growth initiatives including our recently completed merger with Virginia Bank Bankshares, Inc. Our current operating environment presents many challenges and uncertainties due to the negative impacts of the COVID-19 Pandemic, however, we remain pleased with Pinnacle’s overall performance and how the Company is positioned for the future.”

Pinnacle Bankshares Corporation is a locally managed community banking organization based in Central Virginia. The one-bank holding company of First National Bank serves an area consisting primarily of all or portions of the Counties of Campbell, Pittsylvania, Bedford, Amherst, and the Cities of Lynchburg, Danville and Charlottesville. The Company has a total of seventeen branches with two located in the Town of Altavista in Campbell County, where the Bank was founded. Other branch locations include three additional branches in Campbell County, one branch in the Town of Amherst in Amherst County, three branches in the City of Lynchburg and one branch in Bedford County. Seven additional branches were acquired through the Company’s merger with Virginia Bank Bankshares, Inc., including four in the City of Danville and three in Pittsylvania County. The Company also operates a loan production office located in Charlottesville. The Company plans to open another branch at the Graves Mill Plaza in Forest during 2021. First National Bank is in its 112th year of operation.


Cautionary Statement Regarding Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of federal securities laws that involve significant risks and uncertainties. Any statements contained herein that are not historical facts are forward-looking and are based on current assumptions and analysis by the Company. These forward-looking statements may include, but are not limited to, statements regarding the credit quality of our asset portfolio in future periods, the expected losses of nonperforming loans in future periods, returns and capital accretion during future periods, our cost of funds, the maintenance of our net interest margin, future operating results and business performance, results of the Company’s pending merger with
Virginia Bank Bankshares, Inc. (“Virginia Bank”)
, and the potential effects of the COVID-19 pandemic and related impacts on the Company’s financial condition and results of operations. Although we believe our plans and expectations reflected in these forward-looking statements are reasonable, our ability to predict results or the actual effect of future plans or strategies is inherently uncertain, and we can give no assurance that these plans or expectations will be achieved. Factors that could cause actual results to differ materially from management’s expectations include, but are not limited to, the effectiveness of management’s efforts to improve asset quality, returns, net interest margin and collections and control operating expenses, management’s efforts to minimize losses related to nonperforming loans, management’s efforts to lower our cost of funds, the Company’s branch expansions, cyber threats, attacks or similar events, the potential adverse effects of the ongoing COVID-19 Pandemic on local and national economies and markets and any governmental or societal responses thereto, the effect of steps taken by the Company in response to the COVID-19 Pandemic, the severity and duration of the pandemic, the impact of loosening of governmental restrictions, the ability of the Company and the Bank to realize the anticipated benefits of the merger with Virginia Bank, changes in: interest rates, general economic and business conditions, including unemployment levels and slowdowns in economic growth, declining collateral values, especially real estate, the real estate market, the legislative/regulatory climate, including laws and regulations concerning taxes, banking, securities, insurance, and healthcare with which the Company and its subsidiaries must comply, including recent and potential legislative and regulatory changes in response to the COVID-19 Pandemic such as the
Coronavirus Aid, Relief and Economic Security Act (“CARES Act”)
t and the rules and regulations that may be promulgated thereunder, monetary and fiscal policies of the U.S. Government, including policies of the U.S. Treasury and the Board of Governors of the Federal Reserve System and any policies or programs implemented pursuant to the CARES Act, the quality or composition of the loan or investment portfolios, demand for loan products, deposit flows and funding costs, competition, demand for financial services in our market area and accounting principles, policies and guidelines. These risks and uncertainties should be considered in evaluating the forward-looking statements contained herein, and you should not place undue reliance on such statements, which reflect our views as of the date of this release.

CONTACT: Pinnacle Bankshares Corporation, Bryan M. Lemley, 434-477-5882 or [email protected]

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Gulf Resources Announces Conference Call to Discuss Third Quarter 2020 Results

SHOUGUANG, China, Nov. 13, 2020 (GLOBE NEWSWIRE) — Gulf Resources, Inc. (Nasdaq:GURE) (“Gulf Resources” or the “Company”), a leading manufacturer of bromine, crude salt and specialty chemical products in China, today announced that the Company will host a conference call on, November 16, 2020 at 20:00 Eastern Time to discuss its financial results for the third quarter 2020 results ended September 30, 2020.

Mr. Xiaobin Liu, CEO of Gulf Resources, will be hosting the call. The Company’s management team will be available for investor questions following the prepared remarks.

To participate in this live conference call, please dial +1 (877) 407-8031 five to ten minutes prior to the scheduled conference call time. International callers should dial +1 (201) 689-8031.

The webcasting is also available then, just simply click on the link below:
http://www.gulfresourcesinc.com/events.html

A replay of the conference call will be available two hours after the call’s completion during 11/16/2020 23:00 ET – 11/30/2020 23:00 ET. To access the replay, call +1 (877) 481-4010. International callers should call +1 (919) 882-2331. The Replay Passcode is 38847.

About Gulf Resources, Inc.
Gulf Resources, Inc. operates through three wholly-owned subsidiaries, Shouguang City Haoyuan Chemical Company Limited (“SCHC”), Shouguang Yuxin Chemical Industry Co., Limited (“SYCI”), and Daying County Haoyuan Chemical Company Limited (“DCHC”). The company believes that it is one of the largest producers of bromine in China. Elemental Bromine is used to manufacture a wide variety of compounds utilized in industry and agriculture. Through SYCI, the company manufactures chemical products utilized in a variety of applications, including oil and gas field explorations and papermaking chemical agents, and materials for human and animal antibiotics. DCHC was established to further explore and develop natural gas and brine resources (including bromine and crude salt) in China. For more information, visit www.gulfresourcesinc.com.

Forward-Looking Statements
Certain statements in this news release contain forward-looking information about Gulf Resources and its subsidiaries business and products within the meaning of Rule 175 under the Securities Act of 1933 and Rule 3b-6 under the Securities Exchange Act of 1934, and are subject to the safe harbor created by those rules. The actual results may differ materially depending on a number of risk factors including, but not limited to, the general economic and business conditions in the PRC, future product development and production capabilities, shipments to end customers, market acceptance of new and existing products, additional competition from existing and new competitors for bromine and other oilfield and power production chemicals, changes in technology, the ability to make future bromine asset purchases, and various other factors beyond its control. All forward-looking statements are expressly qualified in their entirety by this Cautionary Statement and the risks factors detailed in the company’s reports filed with the Securities and Exchange Commission. Gulf Resources undertakes no duty to revise or update any forward-looking statements to reflect events or circumstances after the date of this release.

CONTACT: Gulf Resources, Inc.
Web: 

http://www.gulfresourcesinc.com
   
  Director of Investor Relations
  Helen Xu (Haiyan Xu)
  [email protected] 



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Greenwich Biosciences to Present Analysis of Three Clinical Studies of Nabiximols for People with Multiple Sclerosis Related Spasticity at the American Academy of Physical Medicine and Rehabilitation (AAPM&R) Annual Assembly

– Results from analysis of three
P
hase 3 clinical studies showed statistically significant improvement in spasticity in people with multiple sclerosis

– Treatment with nabiximols seen in this analysis was
not associated with increased muscle weakness or a notable change in preferred walking speed

CARLSBAD, Calif., Nov. 13, 2020 (GLOBE NEWSWIRE) — Greenwich Biosciences, U.S. subsidiary of GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the Group), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, will present data from an analysis of three Phase 3 clinical trials of nabiximols in spasticity among persons with multiple sclerosis (MS) at the American Academy of Physical Medicine and Rehabilitation (AAPM&R) Virtual Annual Assembly. The research will be presented live during the November 14 Research Spotlight session on Neurological Rehabilitation. The analysis showed that the statistically significant improvement in spasticity observed with nabiximols in all three trials was not accompanied by an increase in muscle weakness or decrease in preferred walking speed.

“Between 60 and 90 percent of people with multiple sclerosis report experiencing spasticity; and muscle weakness can be a serious side effect with current anti-spasticity medications,” said Francois Bethoux, MD, Director of Rehabilitation Services, The Mellen Center for Multiple Sclerosis Treatment and Research, The Cleveland Clinic Foundation, and a consultant to GW Pharmaceuticals. “Muscle weakness in MS is more than feeling weak; it represents genuine difficulty in moving and can make even daily activities like walking and dressing challenging. We are encouraged that the data from these trials showed that nabiximols not only improved patient-reported spasticity but also did not appear to increase muscle weakness or negatively affect preferred walking speed.”

Data from three randomized, placebo-controlled trials of nabiximols (GWMS0106, GWSP0604, and SAVANT) conducted in Europe were analyzed to assess the relationship between measures of spasticity and muscle strength in lower extremities or walking speed. Spasticity was evaluated using the Numerical Rating Scale (NRS) in all three trials, muscle strength using Motricity Index (MI) in GWMS0106 and GWSP0604, and mobility using timed 10-Meter Walk Test (10MWT) in GWSP0604 and SAVANT. All three trials enrolled persons with MS-related spasticity inadequately managed by current medications.

  • GWMS0106: Nabiximols significantly improved mean NRS spasticity score vs. placebo (-0.52 points; p=0.048), without significantly affecting the MI for legs (3.86, p=0.054).
  • GWSP0604: Nabiximols significantly improved mean NRS spasticity score from baseline vs. placebo (-0.84, p=0.0002), without significantly affecting the MI for legs (0.97, p=0.439) or the 10MWT results (-3.34, p=0.069).
  • SAVANT: Nabiximols significantly improved mean NRS spasticity vs. placebo (-1.9, p<0.0001), without significantly affecting the 10MWT results (-1.71, p=0.11).

The analysis included data from 184 participants in GWMS0106, 241 participants in GWSP0604, and 106 participants in SAVANT.

Nabiximols is approved by regulatory bodies in 28 countries outside the United States to treat MS spasticity. GW recently initiated the first global Phase 3 clinical trial studying nabiximols for MS spasticity that will engage patients and investigators in the United States. The first trial is one of five new pivotal studies planned for nabiximols in MS spasticity globally, with the remaining studies on track to commence later in 2020 or in 2021.

“These studies, which served as the basis for nabiximols regulatory approvals outside the U.S., provide important insights into the potential of nabiximols for people with MS-related spasticity,” said Justin Gover, GW’s Chief Executive Officer. “We are now recruiting participants for the first nabiximols Phase 3 clinical trial in the U.S. in pursuit of our goal of bringing to market the first FDA-approved medicine derived from the whole cannabis plant for the treatment of spasticity in MS.”

About Nabiximols

Nabiximols is in pivotal Phase 3 development in the United States for the treatment of MS spasticity. The U.S. commercial rights are owned by GW. In addition to MS spasticity, GW expects to develop nabiximols in Spinal Cord Injury spasticity.

Nabiximols is a complex botanical medicine formulated from extracts of the cannabis plant that contains the principal cannabinoids THC and CBD and also contains minor constituents, including other cannabinoid and non-cannabinoid plant components, such as terpenes, sterols, and triglycerides. The product is administered as an oral spray.

Nabiximols is known as Sativex® outside of the U.S. and is indicated in numerous countries as a treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.1 These approvals were based on multiple pivotal trials conducted in Europe.2 Nabiximols is currently not approved for any indication in the U.S.

About GW Pharmaceuticals plc and Greenwich Biosciences, Inc.

Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. The Company’s lead product, EPIDIOLEX® (cannabidiol) oral solution, is commercialized in the U.S. by its U.S. subsidiary Greenwich Biosciences for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients one year of age and older. This product has received approval in the European Union under the tradename EPIDYOLEX® for the adjunctive treatment of seizures associated with LGS or Dravet syndrome in conjunction with clobazam in patients two years and older and is under EMA review for the treatment of TSC. The Company has a deep pipeline of additional cannabinoid product candidates, in particular nabiximols, for which the Company is advancing multiple late-stage clinical programs in order to seek FDA approval in the treatment of spasticity associated with multiple sclerosis and spinal cord injury. The Company has additional cannabinoid product candidates in clinical trials for autism and schizophrenia. For further information, please visit www.gwpharm.com, and clinicaltrials.gov for updated trial site information and locations.

Forward-looking statement

This news release contains forward-looking statements that reflect GW’s current expectations regarding future events, including statements regarding the timing of clinical trials, the timing of regulatory filings and approvals, the timing and outcomes of regulatory or intellectual property decisions, and the clinical benefits and commercial potential of nabiximols (marketed as Sativex® outside the US).Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the risks and uncertainties which can be found in GW’s filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

U.S. Media Enquiries:

Sam Brown Inc. Healthcare Communications

  
Christy Curran

Mike Beyer

 615 414 8668

312 961 2502

1 Sativex Oralmucosal Spray, SmPC, https://www.medicines.org.uk/emc/product/602 
2 Markova et al, International Journal of Neuroscience 2019; Novotna et al, European Journal of Neurology 2011; Collin et al, European Journal of Neurology 2007