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Aerie Pharmaceuticals Receives Positive CHMP Opinion for Roclanda® in the European Union

Aerie Pharmaceuticals Receives Positive CHMP Opinion for Roclanda® in the European Union

-European Commission Decision Anticipated in Approximately Two Months-

DURHAM, N.C.–(BUSINESS WIRE)–
Aerie Pharmaceuticals, Inc. (NASDAQ: AERI), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, ocular surface diseases and retinal diseases, today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of the marketing authorisation application (MAA) for Roclanda® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%. The recommended indication is the reduction of elevated intraocular pressure in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient IOP reduction.

The CHMP positive opinion is a scientific recommendation for marketing authorisation, which is referred to the European Commission for a final decision on the Company’s MAA. The final decision is expected in approximately two months and will be applicable to all European Union member states plus Iceland, Norway and Liechtenstein.

“We are delighted that the CHMP has adopted a positive opinion for Roclanda®,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie. “We look forward to the European Commission’s final decision on the MAA for Roclanda®, which is expected by early next year.”

Roclanda® is currently marketed as Rocklatan® in the United States and is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or hypertension.

About Aerie Pharmaceuticals, Inc.

Aerie is an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, ocular surface diseases and retinal diseases. Aerie’s first product, Rhopressa® (netarsudil ophthalmic solution) 0.02%, a once-daily eye drop approved by the U.S. Food and Drug Administration (FDA) for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, was launched in the United States in April 2018. In clinical trials of Rhopressa®, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage. More information about Rhopressa®, including the product label, is available at www.rhopressa.com. Aerie’s second product for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension, Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%, the first and only fixed-dose combination of Rhopressa® and the widely-prescribed PGA (prostaglandin analog) latanoprost, was launched in the United States in May 2019. In clinical trials of Rocklatan®, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage. More information about Rocklatan®, including the product label, is available at www.rocklatan.com. Aerie continues to focus on global expansion and the development of additional product candidates and technologies in ophthalmology, including for wet age-related macular degeneration and diabetic macular edema. More information is available at www.aeriepharma.com.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “exploring,” “pursuing” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements in this release include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the duration and severity of the coronavirus disease (COVID-19) outbreak, including the impact on our clinical and commercial operations, demand for our products and financial results and condition of our global supply chains; our expectations regarding the commercialization and manufacturing of Rhopressa®, Rocklatan®, Rhokiinsa® and Roclanda® or any current or future product candidates, including the timing, cost or other aspects of their commercial launch; our commercialization, marketing, manufacturing and supply management capabilities and strategies in and outside of the United States; the success, timing and cost of our ongoing and anticipated preclinical studies and clinical trials for Rhopressa® and Rocklatan®, with respect to regulatory approval outside of the United States, and any current or future product candidates; our expectations regarding the effectiveness of Rhopressa®, Rocklatan®, Rhokiinsa®, Roclanda® or any current or future product candidates; the timing of and our ability to request, obtain and maintain FDA or other regulatory authority approval of, or other action with respect to, as applicable, Rhopressa®, Rocklatan® or any current or future product candidates, including the expected timing of, and timing of regulatory and/or other review of, filings for, as applicable, Rhopressa®, Rocklatan® or any current or future product candidates; the potential advantages of Rhopressa® and Rocklatan® or any current or future product candidates; our plans to pursue development of additional product candidates and technologies; our plans to explore possible uses of our existing proprietary compounds beyond glaucoma, including development of our retina program; our ability to protect our proprietary technology and enforce our intellectual property rights; and our expectations regarding strategic operations, including our ability to in-license or acquire additional ophthalmic products, product candidates or technologies. In particular, FDA approval of Rhopressa® and Rocklatan® do not constitute FDA approval of any future product candidates, and there can be no assurance that we will receive FDA approval for any future product candidates. In addition, FDA approval of Rhopressa® and Rocklatan® and EMA approval of Rhokiinsa® do not constitute regulatory approval of Rhopressa® and Rocklatan® in other jurisdictions, including EMA approval of Roclanda®, and there can be no assurance that we will receive regulatory approval for Rhopressa® and Rocklatan® in such other jurisdictions, including EMA approval of Roclanda®. Furthermore, EMA acceptance of the MAA for Roclanda® and the CHMP opinion of Roclanda® do not constitute EMA approval of Roclanda®, and there can be no assurance that we will receive EMA approval of Roclanda®. By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics, industry change and other factors beyond our control, and depend on regulatory approvals and economic and other environmental circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. We discuss many of these risks in greater detail under the heading “Risk Factors” in the quarterly and annual reports that we file with the Securities and Exchange Commission (SEC). Forward-looking statements are not guarantees of future performance and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Media: Tad Heitmann 949-526-8747; [email protected]

Investors: Ami Bavishi 908-947-3949; [email protected]

KEYWORDS: North Carolina Europe United States North America

INDUSTRY KEYWORDS: Health Pharmaceutical Optical Clinical Trials Medical Supplies

MEDIA:

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Ra Medical Systems to Participate in A.G.P.’s Virtual Healthcare Symposium

Ra Medical Systems to Participate in A.G.P.’s Virtual Healthcare Symposium

CARLSBAD, Calif.–(BUSINESS WIRE)–
Ra Medical Systems, Inc. (NYSE: RMED) , a medical device company focusing on commercializing excimer laser systems to treat vascular and dermatological diseases, announces that management will participate in A.G.P.’s Virtual Healthcare Symposium. This event, which features one-on-one meetings, is being held Thursday, November 19, 2020.

Ra Medical management will be available for one-on-one meetings. Interested investors should contact Ra Medical President Jeffrey Kraws at [email protected] or Jody Cain at [email protected].

About Ra Medical Systems

Ra Medical Systems commercializes excimer lasers and catheters for the treatment of vascular and dermatological diseases. In May 2017 the DABRA excimer laser system received FDA 510(k) clearance in the U.S. for crossing chronic total occlusions, or CTOs, in patients with symptomatic infrainguinal lower extremity vascular disease with an intended use for ablating a channel in occlusive peripheral vascular disease. The Pharos excimer laser system is FDA-cleared and is used as a tool in the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma. DABRA and Pharos are both based on Ra Medical’s core excimer laser technology platform and deploy similar mechanisms of action. Ra Medical manufactures DABRA and Pharos excimer lasers and catheters in a 32,000-square-foot facility located in Carlsbad, Calif. The vertically integrated facility is ISO 13485 certified and is licensed by the State of California to manufacture sterile, single-use catheters in controlled environments.

At the Company:

Jeffrey Kraws

President, Ra Medical Systems

760-496-9008

[email protected]

Investors:

LHA Investor Relations

Jody Cain

310-691-7100

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: General Health Health Medical Devices

MEDIA:

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Madrigal Pharmaceuticals Highlights Presentations at The Liver Meeting Digital Experience™, The American Association for the Study of Liver Diseases Meeting November 13, 2020, Including NASH Expert Insights on the Ongoing Open Label Arm of Resmetirom 52-Week Phase 3 MAESTRO-NAFLD-1 Trial

  • Dr. Stephen Harrison will present
    Resmetirom for the Treatment of NASH: Early Data from the Phase 3 MAESTRO Clinical Trials | The Liver Meeting Digital Experience™
    , AASLD
    Product Theater
    on Friday
    ,
    November 13
    , 2020
    ,
    at 4:30 PM ET.

  • In the 100 mg open label arm of MAESTRO-NAFLD
    :

    • At
      week
      16
      ,
      MRI-PDFF
      (magnetic resonance imaging-proton density fat fraction)
      reduction
      compared to baseline
      was 53% overall
      (p<0.0001)
      and
      up to 62% in key subgroups
    • At weeks 12-24, statistically significant
      lowering of
      liver enzymes, inflammatory biomarkers and
      atherogenic lipids and lipoproteins
      were observed
    • At week 16
      ,
      compared to baseline
      ,
      a meaningful reduction
      (p=0.003)
      in
      magnetic resonance elastography (MRE)
      , a measure of liver of fibrosis and inflammation
      was
      seen

CONSHOHOCKEN, Pa., Nov. 13, 2020 (GLOBE NEWSWIRE) — Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), announced that Dr. Stephen Harrison, M.D., Medical Director for Pinnacle Clinical Research, San Antonio, Texas, and Visiting Professor of Hepatology, Oxford University, and Principal Investigator of the MAESTRO studies, will make an oral presentation today at 4:30 PM ET at The Liver Meeting Digital Experience™, The American Association for the Study of Liver Diseases Meeting, November 2020 accessible via the Product Theaters and Satellite Symposium page. Dr. Harrison’s presentation, based on data from studies with MGL-3196 (resmetirom), will also highlight key insights from three posters, which are available to registered attendees on The Liver Meeting Digital Experience™ website throughout the four-day meeting. Resmetirom is the first orally administered, small-molecule, liver-directed, truly β-selective thyroid hormone receptor (THR) agonist and is currently in Phase 3 development for the treatment of NASH patients both with biopsy-confirmed fibrosis stage 2-3 (ClinicalTrials.gov NCT03900429) and in presumed NASH subjects diagnosed non-invasively (ClinicalTrials.gov/NCT04197479).

Dr. Harrison commented, “In the MAESTRO-NASH study, using a series of readily available tests such as FibroScan, MRI-PDFF and PRO-C3 in patients with metabolic risk factors (diabetes, obesity, dyslipidemia and hypertension) we have demonstrated that, in recruiting a clinical trial, NASH with advanced fibrosis (F2-F3) may be confirmed on liver biopsy with an increasing level of confidence. The MAESTRO-NAFLD-1 study in patients with presumed NASH diagnosed non-invasively, now with 1,200 enrolled patients, is helping to build a robust safety and efficacy data set in NASH patients treated with resmetirom.”

Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal, stated, “Interim data from the ongoing open label arm of MAESTRO-NAFLD-1 confirm the safety and efficacy at a 100 mg dose of resmetirom, with 80% of patients achieving at least a 30% reduction from baseline in liver fat measured on MRI-PDFF, and more than half achieving a 50% or greater reduction in liver fat at Week 16, both of which percentage fat reductions have been associated with increased NASH resolution and reduction in liver fibrosis on subsequent liver biopsy in resmetirom treated patients. The reduction in MRE at Week 16 is novel, and consistent with potential fibrosis and inflammation reductions in patients with baseline F1-F3 fibrosis. MRE is potentially a more accurate measurement of liver fibrosis than other non-invasive measures such as FibroScan because MRE measures a larger area of the liver, and may demonstrate correlations with Week 52 liver biopsy in MAESTRO-NASH. Of note, no safety flags have been observed at the 100 mg dose in the open-label arm, consistent with earlier Phase 1 and Phase 2 data.”

Paul Friedman, M.D., Madrigal’s Chief Executive Officer, added, “The open label arm of MAESTRO-NAFLD-1 provides opportunities to observe safety and the potential benefits of resmetirom treatment on an ongoing basis in non-cirrhotic NASH and compensated NASH cirrhotic patients, with completion of the double-blind arms of the study in the next 12 months. We believe that these data will inform the results of the blinded 80 and 100 mg arms of the MAESTRO-NAFLD-1 and MAESTRO-NASH studies.”  

POSTER PRESENTATIONS

  • #1657
    ALGORITHM FOR PREDICTING ADVANCED NASH FIBROSIS ON SCREENING BIOPSY IN RESMETIROM PHASE 3 MAESTRO-NASH CLINICAL TRIAL

    Dr. Stephen A Harrison
    1, Dr. Rebecca A. Taub2, Prof. Morten Asser Karsdal3, John Franc2, Dr. Mustafa R Bashir4, Mr. Jordan Mark Barbone2, Dr. Guy Neff5, Dr. Nadege T Gunn1 and Dr. Sam Moussa6, (1) Pinnacle Clinical Research, (2) Madrigal Pharmaceuticals, (3) Biomarkers & Research, Nordic Bioscience, (4) Department of Radiology, Duke University Medical Center, (5) Covenant Research, LLC, (6) Medical, Adobe Gastroenterology

    MAESTRO-NASH is a Phase 3 double-blind placebo-controlled serial liver biopsy study to evaluate resmetirom for the treatment of NASH with F2 or F3 fibrosis and an exploratory F1 arm. Data was assessed for the power of the screening paradigm to predict eligible NASH with fibrosis on liver biopsy. These data suggest that PRO-C3 is a marker not only of fibrosis stage in NASH but also of the level of NASH activity (inflammation and ballooning) in the NASH liver. In the absence of a liver biopsy, elevated PRO-C3 in the setting of metabolic syndrome (or FIBC3 (PRO-C3 [age, BMI, platelets, T2D]), fibroscan and MRI-PDFF may predict advanced NASH.

  • #1707
    TREATMENT WITH RESMETIROM IN PHASE 3 MAESTRO-NAFLD-1 NASH STUDY OPEN LABEL ARM: EFFECTS ON BIOMARKERS AND IMAGING
    Dr. Stephen A Harrison, Pinnacle Clinical Research, Dr. Naim Alkhouri, Arizona Liver Health, Dr. Rebecca A. Taub, Madrigal Pharmaceuticals, Dr. Guy Neff, Covenant Research, LLC, Dr. Seth J Baum, Excel Medical Clinical Trials and Dr. Mustafa R Bashir, Department of Radiology, Duke University Medical Center Data from the ongoing Open Label Arm of Madrigal’s MAESTRO-NAFLD-1 trial will be presented.

    In this 52-week Phase 3 open label study, NASH patients identified using non-invasive imaging and biomarkers were treated with resmetirom 100 mg and demonstrated rapid reduction in hepatic fat, biomarkers and atherogenic lipids after 12-16 weeks of treatment, potentially supporting use of non-invasive tests to monitor individual NASH patient response to resmetirom treatment.

  All SHBG (high)
MRI-PDFF (%)    
Baseline (%) 17.6 17.9
Relative % Change -53% -62%
p-value <0.0001 <0.0001
     
MRE (kPa)    
Baseline (>2.9, F1-F3) 3.5 3.5
Absolute Change -0.34 -0.46
p-value 0.003 0.003
  • #1675
    IMPROVEMENT OF HEALTH-RELATED QUALITY OF LIFE IS ASSOCIATED WITH
    IMPROVEMENT OF FAT FRACTION BY MRI-PDFF IN PATIENTS WITH NONALCOHOLIC
    STEATOHEPATITIS TREATED WITH RESMETIROM 
    Dr. Zobair M. Younossi, MD, MPH, FAASLD1, Maria Stepanova2, Dr. Rebecca A. Taub3, Mr. Jordan Mark Barbone3, Dr. Sam Moussa4and Dr. Stephen A Harrison5, (1) Center for Liver Disease, Department of Medicine, Inova Health System, (2) Center for Outcomes Research in Liver Diseases, Washington, DC, United States, (3) Madrigal Pharmaceuticals, (4) Medical, Adobe Gastroenterology, (5) Pinnacle Clinical Research

    A review of patient reported outcome data from resmetirom’s Phase 2 NASH study demonstrates that NASH patients treated with resmetirom who had liver fat reduction also improved some quality of life measures, particularly physical components such as bodily pain. Ongoing Phase 3 studies will assess long-term sustainability of quality of life improvements with resmetirom treatment.

About
R
esmetirom (MGL-3196)

Thyroid hormone, through activation of its β-receptor in hepatocytes, plays a central role in liver function impacting a range of health parameters from levels of serum cholesterol and triglycerides to the pathological buildup of fat in the liver. Thyroid hormone receptor (THR)-β action in the liver is key to proper function of the liver, including regulation of mitochondrial activity such as breakdown of liver fat and control of the level of normal, healthy mitochondria. Patients with NASH have reduced levels of thyroid hormone activity in the liver with resultant impaired hepatic function, in part due to the inflamed state of the liver that causes degradation of thyroid hormone.

To exploit the thyroid hormone receptor (THR)-β pathway for therapeutic purposes in cardio-metabolic and liver diseases, it is important to avoid activity at the THR-α receptor, the predominant systemic receptor for thyroid hormone that is responsible for activity outside the liver including in heart and bone. The lack of selectivity of older thyromimetic compounds, chemically-related toxicities and undesirable distribution in the body led to safety concerns. Madrigal recognized that greater selectivity for thyroid hormone receptor (THR)-β and liver targeting might overcome these challenges and deliver the full therapeutic potential of THR-β agonism. Resmetirom has been shown to be highly selective based on 1) THR-β receptor functional selectivity based on both in vitro and in vivo assays and 2) specific uptake into the liver, its site of action, virtually avoiding any uptake into tissues outside the liver. In short and long term human and animal studies, resmetirom has been confirmed to be safe and devoid of activity at the THR-α receptor and without impact on bone or cardiac parameters. Resmetirom does not impact the thyroid axis hormones, including the central thyroid axis. Madrigal believes that resmetirom is the first orally administered, small-molecule, liver-directed, truly β-selective THR agonist.

About the Phase 3 Registration Program for the Treatment of NASH
(Non-alcoholic steatohepatitis)

Analyses from the resmetirom Phase 2 NASH study demonstrate that the magnitude of liver fat reduction accurately predicts NASH resolution and liver fibrosis reduction and, specifically, that the resmetirom doses being used in Madrigal’s Phase 3 MAESTRO-NASH trial could achieve the level of fat reduction predictive of NASH resolution and fibrosis reduction [Madrigal COVID and ABSTRACT Press Release_20200414].

The Phase 3 MAESTRO-NASH trial is expected to enroll 900 patients with biopsy-proven NASH (fibrosis stage 2 or 3), randomized 1:1:1 to receive resmetirom 80 mg once a day, 100 mg once a day, or placebo. After 52 weeks of treatment a second biopsy is performed. The primary surrogate endpoint on biopsy will be NASH resolution, with at least a 2-point reduction in NAS (NASH Activity Score), and with no worsening of fibrosis. Two key secondary endpoints are liver fibrosis improvement of at least one stage, with no worsening of NASH, and lowering of LDL-cholesterol [ClinicalTrials.gov/NCT03900429].

A second 52-week Phase 3 multi-center, double-blind, randomized, placebo-controlled study of resmetirom, MAESTRO-NAFLD-1, was initiated in December 2019 in 700 patients with non-alcoholic fatty liver disease (NAFLD), presumed NASH, randomized 1:1:1 to receive resmetirom 80 mg once a day, 100 mg once a day, or placebo. MAESTRO-NAFLD-1 also includes a 100 mg resmetirom open label arm in more than 100 non-cirrhotic NASH patients and additional open-label patients with compensated NASH cirrhosis. The trial was expanded to include more than 1,200 patients, in order to significantly enhance resmetirom’s safety database and provide further opportunity to study selected patient subgroups. Unlike MAESTRO-NASH, MAESTRO-NAFLD-1 is a non-biopsy study and represents a “real-life” NASH study. NASH or presumed NASH is documented using historical liver biopsy or non-invasive techniques including FibroScan and MRI-PDFF. Using non-invasive measures, MAESTRO-NAFLD-1 is designed to provide incremental safety information to support the NASH indication as well as provide additional data regarding clinically relevant key secondary efficacy endpoints to better characterize the potential clinical benefits of resmetirom on cardiovascular and liver related endpoints. These key secondary endpoints include LDL-cholesterol, apolipoprotein B and triglyceride (TG) lowering; reduction of liver fat as determined by magnetic resonance imaging, proton density fat fraction (MRI-PDFF); and reduction of PRO-C3, a NASH fibrosis biomarker. [ClinicalTrials.gov/NCT04197479] Additional secondary and exploratory endpoints will be assessed including reduction in liver enzymes, FibroScan scores and other fibrosis and inflammatory biomarkers.

These and other data, including safety parameters, form the basis for potential subpart H submission to FDA for accelerated approval for the treatment of NASH. The original 900 patients in the MAESTRO-NASH study will continue on therapy after the initial 52-week treatment period; up to another 1,100 patients are to be added using the same randomization plan and the study is expected to continue for up to 54 months to accrue and measure clinical events, most relevantly progression to cirrhosis. 

About
R
esmetirom
’
s
P
otential to
C
onfer
C
ardiovascular
Risk Reduction
in NASH patients

Additionally, resmetirom lowers multiple atherogenic lipids, including LDL cholesterol, apolipoprotein B, triglycerides, and lipoprotein (a), as demonstrated in Phase 2, a key differentiating factor compared with other NASH therapeutics. The magnitude of reduction of these lipids support a potential indication for treatment of hyperlipidemia in NASH patients and predicts a potential for benefit on cardiovascular (CV) events in NASH patients who die most frequently of CV, not liver disease.

Because of their diabetes, dyslipidemia, hypertension, obesity in concert with an inflamed, fatty liver, NASH patients, particularly those with advanced fibrosis, are at a substantially increased CV risk compared to the general population. Resmetirom’s ability to decrease liver fat, which is an independent risk factor for CV events, and resmetirom’s effect to reduce atherogenic lipids are being further evaluated in several key secondary endpoints in both MAESTRO Phase 3 clinical studies.

About Madrigal Pharmaceuticals

Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a clinical-stage biopharmaceutical company pursuing novel therapeutics that target a specific thyroid hormone receptor pathway in the liver, which is a key regulatory mechanism common to a spectrum of cardio-metabolic and fatty liver diseases with high unmet medical need. Madrigal’s lead candidate, resmetirom, is a first-in-class, orally administered, small-molecule, liver-directed, thyroid hormone receptor (THR)-β selective agonist that is in currently in two Phase 3 clinical studies, MAESTRO-NASH and MAESTRO-NAGLD-1, designed to demonstrate multiple benefits across a broad spectrum of NASH (non-alcoholic steatohepatitis) and NAFLD (non-alcoholic fatty liver disease) patients. For more information, visit www.madrigalpharma.com.

Forward-Looking Statements

This communication contains “forward-looking statements”
made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that are based on our beliefs and assumptions and on information currently available to us
, but are subject to factors beyond our control
. Forward-looking statements include but are not limited to statements or references concerning: our clinical trials
;
research and development activities
;
the timing and results associated with the future development of our lead product candidate, MGL-3196 (resmetirom); our primary and secondary study endpoints for resmetirom and the potential for achieving such endpoints and projections; optimal dosing levels for resmetirom; projections regarding potential future NASH resolution, safety, fibrosis treatment, cardiovascular effects
,
lipid treatment
or biomarker effects
with resmetirom;
the predictive power
of
liver fat reduction on NASH resolution with fibrosis reduction
or improvement; the achievement of enrollment objectives concerning patient number, safety database and/or timing for our studies; the predictive power of liver fibrosis reductionwith resmetirom using non-invasive tests, including the use of MRE; the predictive power of non-invasive tests generally, including for purposes of recruiting a NASH clinical trial; potential NASH or NAFLD patient risk profile benefits with resmetirom; and our possible or assumed future results of operations and expenses, business strategies and plans, capital needs and financing plans, trends, market sizing, competitive position, industry environment and potential growth opportunities, among other things. Forward-looking statements: reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events; include all statements that are not historical facts; and can be identified by terms such as “allow,” “anticipates,” “be,” “believes,” “continue,” “could,” “demonstrates,” ”design,” “estimates,” “expects,” “forecasts,” “future,” “goal,” “hopeful,” ”inform,” “intends,” “may,” “might,” “plans,” “potential,” “predicts,” ”predictive,” “projects,” “seeks,” “should,” “will,” “would” or similar expressions and the negatives of those terms. Although management presently believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements.

Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to
:
our clinical development of resmetirom
;
enrollment uncertainties,
generally and in relation to COVID-19 shelter-in-place and social distancing measures and individual precautionary measures that may be implemented or continued for an uncertain period of time;
outcomes or trends from competitive studies
;
future topline data timing or results;
the risks of achieving potential benefits in stud
ies
that includes substantially more patients than our prior stud
ies;
the timing and outcomes of clinical studies of resmetirom
;
and the uncertainties inherent in clinical testing. Undue reliance should not be placed on forward- looking statements, which speak only as of the date they are made. Madrigal undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Madrigal’s filings with the U.S. Securities and Exchange Commission for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied.
We specifically discuss these risks and uncertainties in greater detail in the section entitled “Risk Factors” in our Annual Report on Form 10-K for
the year ended December 31, 2019
and our Quarterly Report on Form 10-Q for the period ended
June
30, 2020
, as well as in our other filings with the SEC.

Investor Contact:

Marc Schneebaum, Madrigal Pharmaceuticals, Inc. [email protected]

Media Contact:

Mike Beyer, Sam Brown Inc. [email protected] 312 961 2502

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Walker & Dunlop Provides Financing for 170-Unit Multifamily Property in Suburban Pennsylvania

PR Newswire

BETHESDA, Md., Nov. 13, 2020 /PRNewswire/ — Walker & Dunlop, Inc. announced today that it structured $20,400,000 in financing for Fox Ridge Apartments, a 170-unit multifamily community in Lebanon, Pennsylvania. The team arranged the refinancing on behalf of repeat-client, Boyd/Wilson, who has completed over $75 million in financing through Walker & Dunlop within the last six months.

Walker & Dunlop’s Philadelphia Capital Markets team, including Managing Directors, John Banas and Kris Wood, as well as Analysts John Wilson, Rhett Saltiel, and Erik DiGirolamo arranged the permanent financing through Fannie Mae. The team structured the deal with six years of interest-only payments and an attractive fixed rate for the ten-year loan term. 

Mr. Banas commented, “With nearly 40 years of experience in commercial real estate development and property and construction management, Boyd/Wilson is an extremely strong family-run business with an excellent understanding of the Pennsylvania market. We’re pleased to have completed another assignment with their team.”

Located in the scenic South Lebanon Township, Fox Ridge Apartments caters to young professionals and families alike. The property is just minutes from outdoor parks, restaurants, and shopping as well as desirable schools, which include Cedar Crest High School, Cedar Crest Middle School, and South Lebanon Elementary. The community also provides residents with ease of access to several neighboring cities, including Harrisburg, Lancaster, and Reading, which are approximately 30 miles away, and York, which is 40 miles away. Fox Ridge features distinct craftsmen architecture with modern community amenities, such as a clubhouse, a fitness room, pet stations, and ample green space. Each unit includes decks or patios and premium fixtures and finishes.

Walker & Dunlop is a leader in multifamily lending, ranking as the largest Fannie Mae DUS® multifamily lender and the 3rd largest Freddie Mac Optigo® lender by volume in 2019. For information about Walker & Dunlop’s view on the apartment market, including expert perspectives on markets, leadership, and the road ahead, visit our Driven by Insight information center.

About Walker & Dunlop

Walker & Dunlop (NYSE: WD), headquartered in Bethesda, Maryland, is one of the largest commercial real estate finance companies in the United States. The company provides a comprehensive range of capital solutions for all commercial real estate asset classes, as well as investment sales brokerage services to owners of multifamily properties. Walker & Dunlop is included on the S&P SmallCap 600 Index and was ranked as one of FORTUNE Magazine’s Fastest Growing Companies in 2014, 2017, and 2018. Walker & Dunlop’s 900+ professionals in 40 offices across the nation have an unyielding commitment to client satisfaction.

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/walker–dunlop-provides-financing-for-170-unit-multifamily-property-in-suburban-pennsylvania-301172565.html

SOURCE Walker & Dunlop, Inc.

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Eldorado Gold Provides Update on Exploration Projects

VANCOUVER, British Columbia, Nov. 13, 2020 (GLOBE NEWSWIRE) — Eldorado Gold Corporation (“Eldorado” or “the Company”) is pleased to provide results from brownfields exploration drilling programs in Quebec, Greece, and Turkey, including an update on the newly-discovered Ormaque zone at Lamaque. Additionally, the Company is providing a brief update on COVID-19.

Highlights in this release include:

  • At Lamaque, new high-grade drill intercepts from the C2, C6 and C7 zones highlight the resource growth potential of the Triangle deposit; in addition, numerous new intercepts continue to grow the recent Ormaque zone discovery.
  • At Efemcukuru, drill results have confirmed continuity of high gold grades within mineralized shoots at the Kokarpinar Middle and Kokarpinar South target areas, advancing this vein system to resource conversion drilling stage.
  • At Stratoni, a new discovery of a lower massive sulfide lens of over 20 metres estimated true thickness just below current mine development provides significant resource growth potential, to be further tested in the upcoming surface exploration drilling program.

“These results from our brownfields programs continue to demonstrate the outstanding exploration potential at our operations”, said George Burns, President and CEO. “I am particularly pleased with the outcome of the step out drilling at C2, C6 and C7, which highlight the potential for further expansion of the Triangle deposit, and with the new results from the Ormaque zone.  In Turkey, we had solid results at Efemcukuru and we continue to focus on extending the life of that asset through further exploration.”

Lamaque: Triangle Deposit

The 2020 exploration drilling program at the Triangle deposit is focused on resource expansion in the lower deposit, particularly in the C6 and C7 zones and their splays. 17,822 metres of drilling have been completed year to date to the end of October, including 6 drillholes from surface and 13 drillholes from underground platforms at the Triangle mine (Figure 1). New results, including several previously unreleased intercepts from late 2019 are summarized in Table 1 and are shown on longitudinal sections of the C6-20 and C7 zones in Figures 2 and 3*.

These include:

  • At C2, drillhole TM-20-333A intersected 3.0m @ 6.84 g/t Au approximately 200 metres east of the current resources. A second drillhole on C2 (TU-325-094) intersected 3.1m @ 15.99 g/t Au (21.37 g/t Au uncapped) in a stepout approximately 50 m east of the current resources. Additional drilling is currently ongoing to further test extensions of C2.
  • At C6, new high-grade intercepts highlight the potential of the C6-20 splay zone, including 2.9m @ 16.18g/t Au (20.76 g/t Au uncapped; drillhole TU-0325-094) and 2.4m @ 9.05g/t Au (53.03 g/t Au uncapped; drillhole TM-19-330W01). The latter drillhole also intersected 3.6m @ 13.61 g/t Au within the C6-60 splay zone.
  • At C7, drilling has mainly targeted step-outs along the high-grade eastern edge of the deposit. Results to date include intercepts of 3.15 m @ 17.00 g/t Au (53.05 g/t Au uncapped; drillhole TM-19-330) and 3.5m @ 11.33 g/t Au (13.06 g/t Au uncapped; drillhole TU-0325-094). Results from an additional 8 drillholes completed in 2020 are pending.

*Gold grades for
drillhole
intervals listed in this release are capped at 40 g/t Au for Triangle deposit holes and 70 g/t Au for the
Ormaque
zone. Drill hole intercepts are
drillhole
lengths
;
where sufficient geological control exists, estimated true thicknesses of mineralized zones are listed in Tables 1 and 2.

Resource expansion drilling is ongoing with one underground rig and two surface rigs currently active. Additionally, resource conversion drilling of Triangle inferred resources is now complete for nearly all of C4 and the upper two-thirds of C5. Two underground drill rigs are continuing delineation drilling on the remainder of the inferred resources at C5.

Figure 1: Vertical section through the Triangle deposit showing outlines of mineralized zones, current extent of underground development, and traces of drillholes reported in this news release.
https://www.globenewswire.com/NewsRoom/AttachmentNg/56f13b70-128a-4e6a-9e4f-5baf256cb740

Figure 2: Longitudinal section through the C6-20 mineralized zone at Triangle showing locations of drillholes referenced in this news release and outline of September 2019 resource.
https://www.globenewswire.com/NewsRoom/AttachmentNg/e223e897-66f5-4478-8aaf-8fd0731d0d01

Figure 3: Longitudinal section through the C7 mineralized zone at Triangle showing locations of drillholes referenced in this news release and outline of September 2019 resource.
https://www.globenewswire.com/NewsRoom/AttachmentNg/6895ef68-eace-44f0-8083-8f9e4d8b7213

Lamaque:
Ormaque
Zone

2020 drilling to date at the recently-discovered Ormaque zone totals 12,236 metres in 16 drillholes. The zone has now been defined over an area measuring approximately 650 metres east-west by 400 metres north-south, and to a depth of 550 metres (Figure 4). The zone remains open to the north, east, and at depth.

Significant assay results from the Ormaque zone since the discovery was announced in January 2020 are listed in Table 2 below and include:

  • 15.85m @ 7.47 g/t Au (8.95 g/t Au uncapped) in drillhole LS-19-021; this intercept is within a wider zone of veining roughly 30 meters thick. It is one of the deepest intersections to date at Ormaque and highlights potential extensions of the zone at depth and to the east.

  • 6.30m @ 17.48 g/t Au (29.06 g/t Au uncapped) in drillhole LS-20-028, is also on the east side of the deposit and corresponds to the extension of the previously reported wide intercept in drillhole LS-19-009 (27.3m @ 10.20 g/t Au.)

  • 6.60m @ 34.52 g/t Au (64.63 g/t Au uncapped) in drillhole LS-20-030A is associated with a strong concentration of breccia veins with associated tourmaline alteration.

Drilling since the discovery was announced in January 2020 includes both stepout holes to the east and infill holes to better establish continuity of the thick high-grade intercepts. The numerous high-grade intercepts from this drilling are associated with extensional and hybrid extension-shear quartz-carbonate-tourmaline veins and adjacent tourmaline-altered wall rocks. Vein contact measurements from oriented drillcore, together with correlations between drillhole intercepts, indicate that most of the mineralized zones dip gently to moderately to the west-south-west. The vein system occurs within the “C porphyry” diorite (the same host rock as the Sigma mine), and is spacially associated with steeply NNW-dipping ductile-brittle shear zones, which are themselves weakly mineralized.

A north-south representative cross section through the Ormaque zone (Figure 5) shows the distribution of some of the new intercepts and preliminary interpretations of geological control on mineralized bodies.

Figure 4: Geological map of the Ormaque one and surrounding area, showing collar locations and projections of drillholes referenced in this news release and location of cross section in Figure 5.
https://www.globenewswire.com/NewsRoom/AttachmentNg/0f1c6cdb-a872-406b-94ee-8a79c6cb675f

Figure 5: Vertical north-south cross section through the Ormaque zone (Section 295730E) showing the interpreted geometry of mineralized vein systems and intercepts from several drillholes reported in this news release.
https://www.globenewswire.com/NewsRoom/AttachmentNg/bc69b6fc-f571-4bda-8562-08fcbfc5d346

Efemcukuru Mine

At the Efemcukuru mine in Turkey, 8,610 metres of exploration drilling have been completed to date in 2020 on the Kokarpinar Middle and Kokarpinar South vein systems in 28 drillholes (Figure 6), from which results have been received for 21 drillholes (Table 3). These include both delineation holes to better establish grade and continuity of existing inferred resources, and stepout drillholes from these inferred resources. At both Kokarpinar Middle and Kokarpinar South, several new drillhole intercepts contain significantly higher grades than were obtained from previous nearby drillholes and are in the current resource model (Figure 7), including:

  • At Kokarpinar South, intercepts of 2.6m @ 22.52 g/t Au (KV-731), 0.55m @ 51.60 g/t Au (KV-735) and 5.1m @ 11.33 g/t Au (KV-746).
  • At Kokarpinar Middle, intercepts of 3.25m @ 32.18 g/t Au (KV-732) and 1.95m @ 36.92 g/t Au (KV-738).

Resource expansion drilling will continue for the remainder of the year at Kokarpinar and a resource conversion drilling program is planned for 2021.

Figure 6: Geological map of the Efemcukuru mine area showing locations of exploration drillholes completed in 2020 at the Kokarpinar vein system.
https://www.globenewswire.com/NewsRoom/AttachmentNg/25aca0a1-eb12-4637-b654-93a374ad0630

Figure 7: Longitudinal section through the Kokarpinar Middle and South vein system showing drillhole results referenced in this news release, piercing points of previous drillholes and grade distribution of current inferred resource model.
https://www.globenewswire.com/NewsRoom/AttachmentNg/2d8543cd-a7f6-458b-be1d-efa1dc139bb0

Stratoni Mine

At the Stratoni mine in Greece 13 exploration drillholes (2,582 metres) have been drilled to date in 2020. Due to limited drill platform availability, all of these holes were drilled from two underground locations from which extensions to the Mavres Petres orebody were targeted and deeper stratigraphic levels in the host marble unit for new massive sulfide lenses were tested. Six of these drillholes discovered a new massive sulfide lens of substantial thickness (Table 4, Figure 8). Highlights include:

  • Drillhole MP0973 which intersected 39.0m @ 6.14% Zn, 5.28% Pb, and 128.8 g/t Ag, and
  • Drillhole MP0978, which intersected 54.9m @ 12.5% Zn, 5.0 % Pb, and 122.8 g/t Ag

This new massive sulfide lens occurs near the base of the host marble and is structurally intact with little faulting along contacts, in contrast to the faulted contacts and fault dismemberment typical of the massive sulphide lenses along the upper marble contact.

All planned holes in the underground resource expansion drilling program have now been completed and stepout drilling is scheduled to resume in mid-November 2020 from newly-permitted surface drillsites.

Figure 8: Cross section through the Mavres Petres deposit showing drillhole intercepts of the newly-discovered massive sulfide lens within the lower part of the host marble unit.
https://www.globenewswire.com/NewsRoom/AttachmentNg/063e376f-82a7-4c37-8901-3fe775bd87dc

Tables

Table 1: Summary of 2020 and Q4 2019 drillhole assay results from the Triangle Deposit. Drillholes listed are limited to those that intersected the specified zones outside of the inferred resources reported for September 30, 2019. Only intervals above a 10 gram x meter cutoff are reported. Drillhole collar locations, collar orientations, and total lengths are listed in Appendix 1.

HOLE ID FROM

(m) 		TO

(m) 		LENGTH
(m) 		TRUE
THICKNESS
(m) 		Au (g/t)
uncapped 		Au g/t

with 40
g/t cap 		Comment
C2 Zone
               
TU-0325-094 121.8 124.9 3.1 2.3 21.37 15.99  
TU-0325-095 136.5 140 3.5 2.3 4.50    
TM-20-333A 583.0 586.0 3.0 2.1 6.85 6.84  
TM-20-331A; TM-20-332; TM-20-334A Below reporting threshold in C2 shear zone Holes targeting C7
C3 and C4 Zones
TM-19-329W01 908.5 912 3.5 3.2 5.64   C4-60 Splay
TU-0184-024 464.5 467.0 2.5 2.5 17.48 12.85 C3-120 Splay
TU-0184-023 483.90 485.50 1.60   10.50   C3 Splay
TM-19-329W05 778.9 787.1 8.2 6.6 12.21    
TM-19-330; TU-0184-024; TU-0184-022; TU-0184-023; TU-0325-094; TM-20-332; TM-20-333A; TM-20-334AM01; TU-0325-095 Below reporting threshold in C4 shear zone Holes targeting C7, east of main C4 resource
C5 Zone
TM-20-334AM01 1044.0 1047.0 3.0 2.5 15.09 10.81  
and 1053.50 1060.00 6.50   2.89   Extension veins
TU-0184-022 821.10 824.00 2.90   6.08   Extension veins
TM-18-321AW06; TM-19-330; TU-0184-024; TM-19-329W05; TU-0184-022; TU-0184-023; TM-20-331A; TU-0325-094; TM-20-332; TU-0325-095 Below reporting threshold in C5 shear zone Holes targeting C7, east of main C5 resource
C6 Zone
TM-18-321AW06 1124.1 1128.9 4.8 3.0 3.15    
TU-0325-094 787.2 791.3 4.1 3.5 2.85    
and 904.35 907.25 2.9 2.5 20.76 16.18 C6-20 Splay
TM-19-329W02 1168.5 1174.7 6.2 5.3 2.95   C6-10 Splay
and 1218.5 1221.0 2.5 2.0 6.88   C6-20 Splay
TM-19-330 1134.6 1137.5 2.9 2.4 4.22    
and 1240.75 1243.85 3.1 3.0 6.71   C6-20 Splay
TM-19-330W01 1132.8 1136.4 3.6 3.1 13.15   C6-60 Splay
and 1248.9 1251.3 2.4 2.0 53.03 9.05 C6-20 Splay
TM-20-333AW01 1397.8 1418.5 20.7 17.8 5.61 5.21 C6-20 Splay
TM-18-321AW06; TM-19-330; TM-16-220W07; TM-19-329W02; TM-19-330W01; TU-0184-024; TM-19-329W05; TU-0184-022; TU-0184-023; TM-16-191W02; TM-20-331A; TM-20-334AM01 Below reporting threshold in C6 shear zone  
C7 Zone
TM-16-191W02 1182.5 1187.2 4.7 4.0 2.58    
TM-20-333A 1540.3 1543.1 2.8 2.3 4.10    
TM-20-333AW01 1536.70 1543.60 6.90 5.9 12.49    
TU-0325-094 999.9 1003.4 3.5 2.8 13.06 11.33  
TM-16-220W07 1208.3 1211.3 3 2.4 5.21    
TM-19-330 1349.5 1352.65 3.15 2.6 53.05 17.00  
TM-19-329; TM-18-321AW06; TM-16-220W06M03; TM-19-329W01; TM-18-321AW07; TM-19-329W02; TM-19-330W01; TU-0184-024; TM-19-329W05; TU-0184-022; TU-0184-023; TM-20-331A; TM-20-334AM01 Below reporting threshold in C7 shear zone  

Table 2: Summary of 2020 drillhole assay results from the Ormaque zone. Only intervals above a 20 gram x meter cutoff are reported. Drillhole collar locations, collar orientations, and total lengths are listed in Appendix 1.

HOLE ID FROM

(m) 		TO

(m) 		LENGTH
(m) 		TRUE
THICKNESS
(m) 		Au (g/t)

uncapped 		Au (g/t) with
70 g/t cap
LS-19-015 328.9 330.9 2.0 1.5 10.41  
and 354.0 359.0 5.0 3.8 14.63 13.48
and 404.9 414.45 9.55 7.2 4.50  
and 622.1 626.5 4.40 3.5 17.90 14.99
and 635.6 641.55 5.95 4.7 11.57 10.87
LS-19-017A 388.0 389.0 1.0 0.8 26.67  
and 394.0 395.0 1.0 0.8 21.18  
and 406.45 407.8 1.35 1.1 146.10 39.94
and 425.4 426.9 1.5 1.2 41.02 32.18
and 432.5 434.5 2.0 1.6 38.55 26.63
LS-19-018A 173.3 173.8 0.5 0.4 84.75 70.00
LS-19-019 287.8 290.1 2.3 2.1 13.32  
and 303.5 305.3 1.8 1.6 27.45  
and 322.0 322.5 0.5 0.5 45.31  
and 478.25 480.0 1.75 1.5 56.39 30.59
LS-19-020 240.05 242.6 2.55 1.9 11.41  
LS-19-021 395.5 399.0 3.5 3.1 6.19  
and 688.95 704.8 15.85 13.0 8.95 7.47
and 711.05 713.55 2.5 2.01 8.61  
and 719.5 725.2 5.7 4.7 5.53  
LS-19-023 153.7 155.2 1.5 1.3 13.75  
and 286.8 289.5 2.7 2.2 8.26  
and 382.5 386.2 3.7 3.0 64.69 24.14
LS-20-024 482.2 483.2 1.0 0.9 21.88  
LS-20-025 325.0 328.1 3.1 2.6 44.10 43.03
and 344.0 359.8 15.8 13.3 3.66  
including 347.6 350.2 2.6 2.2 11.28  
LS-20-026 274.1 275.9 1.8 1.6 57.76 47.23
and 294.0 294.5 0.5 0.4 71.26 70.00
and 323.6 325.5 1.9 1.7 13.63  
LS-20-027 148.5 149.8 1.3 1.2 19.64  
and 160.35 161.0 0.65 0.6 53.39  
and 365.4 370.4 5.0 4.3 11.67  
and 629.0 640.0 11.0 8.2 1.91  
LS-20-028 397.25 398.75 1.5 1.2 17.18  
and 406.85 410.0 3.15 2.5 10.57  
and 487.6 491.55 3.95 3.1 11.38  
and 510.85 517.15 6.3 4.9 29.06 17.48
and 697.8 698.80 1.0 0.7 153.02 39.87
and 719.3 720.8 1.5 1.1 17.99  
LS-20-029 164.2 164.7 0.5 0.4 41.59  
and 169.5 170.5 1.0 0.9 31.93  
and 404.95 408.35 3.4 2.9 27.23  
LS-20-030 290.0 291.0 1.0 0.9 151.45 70.00
LS-20-030A 258.8 260.4 1.6 1.4 15.53  
and 266.65 273.25 6.6 5.7 64.63 34.52
and 275.25 276.8 1.55 1.3 26.63 26.54
and 307.0 308.7 1.7 1.5 41.78 37.07
LS-20-031 297.0 301.85 4.85 4.4 5.39  
and 446.6 452.4 5.8 5.0 19.38 14.98
and 455.05 457.0 1.95 1.7 15.95  
and 715.4 716.0 0.6 0.5 39.12  
and 757.25 758.6 1.35 1.1 69.68 48.35
LS-20-032 264.7 268.5 3.8 3.8 5.94  
and 411.5 412.5 1.0 0.8 63.20 44.26
and 452.3 454.5 2.2 1.9 9.14  
and 464.0 466.0 2.0 1.6 20.24  
LS-20-033 123.0 127.25 4.25 3.8 58.81 26.03
and 193.7 208.6 14.9 13.3 14.59 7.35
LS-20-034M01 454.7 458.35 3.65 3.3 8.66  
and 465.05 466.2 1.15 1.0 47.29 36.95

Table 3: Summary of significant 2020 drillhole intersections from the Kokarpinar vein system at the Efemcukuru Mine. Only intervals above a 10 gram x meter cutoff are reported. Drillhole collar locations, collar orientations, and total lengths are listed in Appendix 1.

HOLE ID FROM

(m) 		TO

(m) 		LENGTH
(m) 		TRUE
THICKNESS
(m) 		Au (g/t) Ag (g/t)
Kokarpinar
South
KV-731 206.75 210.7 3.95 3.6 2.51 27.6
and 278.25 282.15 2.6 2.4 22.52 22.6
KV-733 301.7 303.95 2.25 2.0 6.19 3.8
KV-735 309.2 309.75 0.55 0.5 51.60 23.0
and 314.75 324.7 9.95 9.1 2.76 5.7
KV-740 339.8 343.6 3.8 2.8 3.08 5.6
KV-743 274.65 280.95 6.3 5.8 3.69 2.0
KV-746 263.4 268.5 5.1 4.8 11.33 7.1
KV-748 301.6 306.8 5.2 4.9 2.86 4.4
KV-737, KV-747, KV-749, KV-750 Below reporting threshold
Kokarpinar
Middle
KV-732 235.95 239.2 3.25 2.1 32.18 28.5
KV-738 276 277.95 1.95 1.0 36.92 25.0
KV-730; KV-734; KV-736; KV-739; KV-741; KV-742; KV-744; KV-745 Below reporting threshold

Table 4: Summary of 2020 drillhole assay results from the Stratoni Mine.  

HOLE ID FROM

(m) 		TO

(m) 		LENGTH
(m) 		TRUE
THICKNESS
(m) 		Zn

(%) 		Pb

(%) 		Ag (g/t) Comment
MP0947 210.2 212.0 1.8 1.8 15.7 18.5 421.7 Upper marble contact lens
MP0949 217.1 226.5 9.4 7.2 10.3 13.6 300.4 Upper marble contact lens
MP0960 32.4 34.6 2.2 2.2 19.1 14.3 331.5 Upper marble contact lens
MP0965 44 45 1.0 1.0 10.7 14.4 262.0 Upper marble contact lens
and 103.1 104.2 1.1 1.1 16.9 11.6 268.0 Footwall marble lens
and 109.1 116.3 7.2 6.5 13.6 10.4 231.1 Footwall marble lens
MP0967 51.1 56.2 5.1 4.5 3.5 4.5 99.3 Upper marble contact lens
MP0970 52.3 53.9 1.6 1.4 6.6 4.7 104.0 Upper marble contact lens
and 56.4 58.1 1.7 1.4 12.6 5.0 119.7 Footwall marble lens
and 69.7 72.2 2.5 2.2 22.2 8.1 210.7 Footwall marble lens
MP0973 70.4 78.7 8.3 5.0 8.0 10.6 258.6 Mineralized Stratoni fault gouge
and 109.1 114.8 5.7 4.0 13.1 14.5 316.6 Footwall marble lens
and 118.3 157.3 39.0 23.0 6.1 5.3 128.8 Footwall marble lens
MP0976A 74.2 90.9 16.7 11.8 4.6 3.4 86.9 Upper marble contact lens
and 133.4 143.5 10.1 7.1 7.9 1.6 38.6 Footwall marble lens
MP0978 67.3 77.3 10.0 7.1 6.9 2.5 65.6 Mineralized Stratoni fault gouge
and 103.0 157.9 54.9 38.8 12.5 5.0 122.8 Footwall marble lens
and 160.0 163.6 3.6 3.6 4.6 0.4 11.4 Footwall marble lens
MP0980 62.6 73.6 11.0 7.7 2.9 1.6 42.4 Upper marble contact lens
and 78.2 79.5 1.3 1.3 3.1 2.7 59.0 Footwall marble lens
and 87.5 89.5 2.0 2.0 5.2 1.3 31. Footwall marble lens
MP0943, MP0950, MP0982 No significant massive sulfide intercepts

COVID-19 Update

As COVID-19 cases have surged globally in recent weeks, Eldorado remains vigilant in enforcing health and safety protocols at all of its sites with strict tracking and testing measures in place to protect the health, safety and wellbeing of its workforce, their families and neighboring communities. 

Operations at the Company’s sites have continued largely without disruption since the outbreak of COVID-19 earlier this year.

The Company has recently experienced a short-term reduction in operations at its Olympias site caused by limited workforce availability due to COVID-19, and the current temporary suspension of operations at its Stratoni facility.

The Company is working to mitigate the potential impact of COVID-19 at all of its sites, including those in Greece, and undertaking prudent and appropriate health and safety measures to allow the Company to continue to operate safely and in observance of government-mandated COVID-19 measures.

About Eldorado Gold

Eldorado is a gold and base metals producer with mining, development and exploration operations in Turkey, Canada, Greece, Romania, and Brazil. The Company has a highly skilled and dedicated workforce, safe and responsible operations, a portfolio of high-quality assets, and long-term partnerships with local communities. Eldorado’s common shares trade on the Toronto Stock Exchange (TSX: ELD) and the New York Stock Exchange (NYSE: EGO).

Contact

Investor Relations

Peter Lekich, Manager Investor Relations
604.687.4018 or 1.888.353.8166
[email protected]

Media

Louise Burgess, Director Communications and Government Relations
604.601.6679 or 1.888.363.8166
[email protected]


Qualified Persons

Dr. Peter Lewis
P.Geo
., Eldorado’s Vice President, Exploration, is the qualified person as defined by National Instrument 43-101 Standards of Disclosure for Mineral Projects (“NI 43-101”) responsible for, and has approved the scientific and technical disclosure of the exploration results contained in this press release.  Eldorado operates its exploration programs according to industry best practices and employs rigorous quality assurance and quality control procedures. All results are based on half-core samples of diamond drill core. For Lamaque, drill core samples
were  prepared
and analyzed at
Bourlamaque
Laboratories in Val d’Or, Quebec. 
Drillcore
samples
f
or Efemcukuru were prepared at the Company’s sample preparation lab in
Cannakale
, Turkey and analyzed at ALS Minerals laboratory in Izmir, Turkey.  All Au assays are based on fire assay analysis of a
30 gm
charge followed by an atomic adsorption finish.  Samples with Au grades above 5.0 g/t at the Lamaque project and 10.0 g/t at other projects were re-assayed and completed with a gravimetric finish.  Zn and Pb grades at
Mavres
Petres
were determined from an aqua regia digestion with an ICP-AES finish. Certified standard reference materials, field duplicate and blank samples were inserted regularly and were closely monitored to ensure the quality of the data.


Cautionary Note about Forward-looking Statements and Information

Certain of the statements made and information provided in this press release are forward-looking statements or information within the meaning of the United States Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws. Often, these forward-looking statements and forward-looking information can be identified by the use of words such as “plans”, “expects”,  “is expected”, “budget”, “continue”, “projected”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, or “believes” or the negatives thereof or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved.

Forward-looking statements or information contained in this release include, but are not limited to, statements or information with respect to:
the duration, extent and other implications of COVID-19 and any restrictions and suspensions with respect to
our
operations; our expectations regarding establishment of resources through our continued exploration programs, the timing and quantity of annual gold production; our strategy with respect to non-core assets;; timing of drilling activities at the Stratoni mine;
mineral reserves and resources, our guidance and outlook, including expected production and recoveries of gold, planned capital and exploration expenditures; our expectation as to our future financial and operating performance, expected metallurgical recoveries, gold price outlook; and our strategy, plans and goals, including our proposed exploration, development, construction, permitting and operating plans and priorities, including timelines and schedules.

Forward-looking statements and forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements or information. 

We have made certain assumptions about the forward-looking statements and information, including assumptions about
: how the world-wide economic and social impact of COVID-19 is managed and the duration and extent of the impact of the COVID-19 pandemic on our operations, the results of our exploration programs,;
mineral reserves and resources and metallurgical recoveries, the geopolitical, economic, permitting and legal climate that we operate in; the future price of gold and other commodities;
the global concentrate market;
exchange rates; anticipated costs and expenses; production, the impact of acquisitions, dispositions, suspensions or delays on our business and the ability to achieve our goals.  In particular, except where otherwise stated, we have assumed a continuation of existing business operations on substantially the same basis as exists at the time of this release.

Even though our management believes that the assumptions made and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking statement or information will prove to be accurate. Many assumptions may be difficult to predict and are beyond our control.  

Furthermore, should one or more of the risks, uncertainties or other factors materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information.  These risks, uncertainties and other factors include, among others
: global outbreaks of infectious diseases, including COVID-19; timing and cost of construction,
geopolitical and economic climate (global and local), risks related to the updating of our resource and reserve models and life of mine plans; mineral tenure and permits; gold and other commodity price volatility;
information technology systems risks; continued softening of the global concentrate market,
recoveries of gold and other metals; results of test work; revised guidance; risks regarding potential and pending  litigation and arbitration proceedings relating to the Company’s, business, properties and operations; expected impact on reserves and the carrying value; mining operational and development risk
; financing risks
; foreign country operational risks; risks of sovereign investment; regulatory risks and liabilities including, regulatory environment and restrictions, and environmental regulatory restrictions and liability; discrepancies between actual and estimated production, mineral reserves and resources and metallurgical testing and recoveries; additional funding requirements; currency fluctuations; community and non-governmental organization actions; speculative nature of gold exploration;
dilution; share price volatility and the price of our common shares;
competition; loss of key employees; and defective title to mineral claims or properties, as well as those risk factors discussed in the sections titled “Forward-Looking Statements” and “Risk factors in our business” in the Company’s  most recent Annual Information Form & Form 40-F. The reader is directed to carefully review the detailed risk discussion in our most recent Annual Information Form filed on SEDAR
and EDGAR
under our Company name, which discussion is incorporated by reference in this release, for a fuller understanding of the risks and uncertainties that affect the Company’s business and operations.

Forward-looking statements and information
is
designed to help you understand management’s current views of our near and longer term prospects, and it may not be appropriate for other purposes.

There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.  Accordingly, you should not place undue reliance on the forward-looking statements or information contained herein.  Except as required by law, we do not expect to update forward-looking statements and information continually as conditions change and you are referred to the full discussion of the Company’s business contained in the Company’s reports filed with the
securities
regulatory authorities in Canada and the U.S.

Appendix 1: Collar locations and orientations and total lengths for drillholes listed in this news release

HOLE ID

 EASTING

 NORTHING

 ELEVATION

 AZIMUTH

 DIP

 LENGTH (m)

 Underground/
Surface
Lamaque Triangle Deposit
TM-16-191W02 296827 5328214 324 2 -63 1437 Surface
TM-16-220W06M03 296728 5328264 323 356 -68 1659 Surface
TM-16-220W07 296728 5328264 323 356 -68 1727 Surface
TM-18-321AW06 296826 5328214 324 351 -76 1598 Surface
TM-18-321AW07 296826 5328214 324 351 -76 1694 Surface
TM-19-329 296269 5328205 324 3 -63 1277 Surface
TM-19-329W01 296269 5328205 324 3 -63 1360 Surface
TM-19-329W02 296269 5328205 324 3 -63 1423 Surface
TM-19-329W05 296269 5328205 324 3 -63 1389 Surface
TM-19-330 296667 5328241 323 357 -70 1616 Surface
TM-19-330W01 296667 5328241 323 357 -70 2096 Surface
TM-20-331A 297019 5328248 324 5 -68 1282 Surface
TM-20-332 296880 5328191 324 4 -67 1310 Surface
TM-20-333A 296863 5327992 325 2 -72 1648 Surface
TM-20-333AW01 296863 5327992 325 2 -72 1705 Surface
TM-20-334A 296920 5328180 324 1 -74 601 Surface
TM-20-334AM01 296920 5328180 324 1 -74 1454 Surface
TU-0184-022 296536 5328357 143 1 -57 1009 Underground
TU-0184-023 296537 5328356 143 15 -56 990 Underground
TU-0184-024 296537 5328356 143 21 -52 980 Underground
TU-0325-094 296563 5328300 1 17 -63 1144 Underground
TU-0325-095 296563 5328300 1 18 -71 1042 Underground
Lamaque
Ormaque
Zone
LS-19-015 295723 5330010 324 358 -58 658 Surface
LS-19-017A 295681 5329973 324 358 -57 778 Surface
LS-19-018A 295643 5330151 325 358 -57 563 Surface
LS-19-019 295770 5330070 324 359 -57 692 Surface
LS-19-020 295642 5330249 325 4 -50 529 Surface
LS-19-021 295770 5329967 324 358 -59 754 Surface
LS-19-023 295682 5330075 324 359 -56 644 Surface
LS-20-024 295725 5329920 324 357 -60 661 Surface
LS-20-026 295558 5330030 325 358 -57 775 Surface
LS-20-027 295665 5330110 324 358 -58 679 Surface
LS-20-028 295747 5329967 324 358 -59 752 Surface
LS-20-029 295610 5330110 324 358 -58 724 Surface
LS-20-030 295725 5330070 324 358 -57 321 Surface
LS-20-030A 295725 5330070 324 358 -55 688 Surface
LS-20-031 295811 5329967 323 359 -60 845 Surface
LS-20-032 295850 5330020 324 356 -57 727 Surface
LS-20-033 295850 5330130 324 356 -57 470 Surface
LS-20-034M01 295868 5329940 324 355 -64 1010 Surface
Efemcukuru
Kokarpinar
KV-730 498542 4238767 720 165 -67 300 Surface
KV-731 498902 4238527 817 188 -57 295 Surface
KV-732 498540 4238768 720 213 -70 269 Surface
KV-733 498903 4238530 817 175 -64 314 Surface
KV-734 498541 4238768 720 169 -54 344 Surface
KV-735 498902 4238530 817 182 -72 341 Surface
KV-736 498542 4238769 720 148 -68 383 Surface
KV-737 498905 4238530 817 225 -78 359 Surface
KV-738 498544 4238765 720 249 -71 304 Surface
KV-739 498544 4238765 721 231 -65 254 Surface
KV-740 498904 4238530 817 169 -77 365 Surface
KV-741 498340 4239052 586 175 -68 309 Surface
KV-742 498340 4239051 586 173 -49 304 Surface
KV-743 498903 4238527 817 184 -50 301 Surface
KV-744 498339 4239052 586 183 -38 276 Surface
KV-745 498574 4238985 617 228 -30 362 Surface
KV-746 498902 4238529 817 193 -48 291 Surface
KV-747 498902 4238529 817 312 -66 210 Surface
KV-748 499162 4238569 749 317 -48 190 Surface
KV-749 498902 4238527 817 308 -40 193 Surface
KV-750 499162 4238570 749 322 -42 193 Surface
Stratoni
MP0943 24906 -24970 236 137 -73 190 Underground
MP0947 24905 -24970 237 88 -75 213 Underground
MP0949 24906 -24970 236 125 -78 339 Underground
MP0950 24906 -24969 236 92 -85 315 Underground
MP0960 24980 -25007 51 309 -65 126 Underground
MP0965 24980 -25008 52 238 -72 158 Underground
MP0967 24980 -25009 51 189 -71 156 Underground
MP0970 24982 -25009 52 151 -64 145 Underground
MP0973 24980 -25009 52 211 -60 196 Underground
MP0976A 24981 -25009 51 175 -57 176 Underground
MP0978 24980 -25008 52 230 -55 195 Underground
MP0980 24982 -25008 51 132 -50 154 Underground
MP0982 24982 -25008 52 110 -57 116 Underground

 



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UAE’s Telecommunications Regulatory Authority accredits Lleida.net as a certification service provider

PR Newswire

MADRID and DUBAI, UAE, Nov. 13, 2020 /PRNewswire/ — Listed technology services company Lleida.net (BME: LLN) (EPA: ALLLN) (OTCQX: LLEIF) has been accredited by the United Arab Emirates Telecommunications Regulatory Authority (TRA) to operate as a certification services provider in the country.

This accreditation is the previous step for automatic legal recognition of the electronic contracting and notification services of the company, whose titles are traded in New York, Paris and Madrid.

This recognition has been achieved through Lleida Information Technology Network Services LLC, the company’s subsidiary in the region.

“Our internationalisation policy in the Middle East is not only focused on boosting the commercialisation of our services, but also on strengthening our position as a benchmark player in the region,” explained Sisco Sapena, CEO and founder.

“TRA’s recognition of the validity of our services in the UAE is critical to further progress in this direction,” he added.

Lleida.net is, at present, the main European company in the eSignature industry.

Its electronic notification and contracting services are recognised as valid before courts and public administrations in more than 75 countries.

In 2018, Lleida.net became the first Spanish company to obtain the Eidas certification, which allows it to operate without barriers at a European level and makes its electronic certificates to be admitted by default before any European court or administration.

Likewise, the company has 187 patents in the digital signature industry, which have been granted by more than 50 countries in the five continents, including the United States, the European Union, the Gulf Cooperation Council, China, Russia, India, Mexico, Japan, Colombia, Argentina, Peru, South Africa, Nigeria, Australia or New Zealand.

Lleida.net started trading in the OTCQX Best Markets index in New York last week. On September 14th, 99.86% of the votes present at the General Shareholders Meeting expressed their approval to this IPO.

During 2020, Lleida.net became the company with the highest stock market growth in Euronext and one of the major stock market successes in the world throughout the health emergency caused by the Covid-19 pandemic.

Its shares have increased up to 940 per cent during the year.

The Paloma Project
Media, [email protected]
+356-7946-7486

 

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SOURCE Lleida.net

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Galaxy Digital Expands Global Crypto Trading Business with Acquisitions of DrawBridge Lending and Blue Fire Capital

PR Newswire

Transactions expand Galaxy Digital’s market reach and further strengthen the firm’s trading solutions portfolio, relationships with global exchanges, and lending & derivatives expertise 

NEW YORK and CHICAGO, Nov. 13, 2020 /PRNewswire/ – Galaxy Digital Holdings Ltd. (TSX: GLXY) (“Galaxy Digital” or the “Company”) today announced that it has acquired two leading cryptocurrency trading firms: DrawBridge Lending (“DrawBridge”), an innovator in digital asset lending, borrowing, and structured products, and Blue Fire Capital (“Blue Fire”), a proprietary trading firm specializing in market-making and two-sided liquidity for digital assets.

DrawBridge and Blue Fire are both pioneers in applying their teams’ institutional expertise in traditional lending, structured products, futures, and market-making to the rapidly growing cryptocurrency derivatives and lending space.

“Galaxy Digital’s mission is to bring cryptocurrency to traditional finance and vice versa. DrawBridge and Blue Fire’s market-leading capabilities will enable us to further amplify our strong position as a go-to trading desk in digital assets and more rapidly grow our innovative portfolio of trading products and services,” said Christopher Ferraro, President of Galaxy Digital. “Furthermore, these acquisitions bring in two exceptional and experienced teams who will play key roles in managing and expanding our business in the years to come.”

Galaxy Digital Trading (“GDT”) operates a 24-hour global trading model and provides institutional clients and counterparties with a broad range of trading strategies. It currently trades over $4 billion of OTC volume annually with nearly 200 active counterparties globally. 2020 has seen a broad institutional recognition of cryptocurrency use cases by investors, corporates, regulators, and governments, and as a result GDT has seen a significant increase in institutional demand for cryptocurrency-related financial products and services.

Michael Novogratz, Founder and CEO of Galaxy Digital said, “Institutional investors and corporates are becoming more knowledgeable and comfortable with digital assets and they are increasingly grasping the purpose and importance of cryptocurrency in their investment strategies. We are looking forward to seamlessly integrating DrawBridge and Blue Fire into Galaxy Digital Trading and strategically leveraging our world-class team, technology and solutions to help further meet what we believe will be an even bigger wave of institutional demand.”

“Over the past two and a half years the Galaxy Digital Trading team has been executing on a product and technology roadmap that has allowed for first-class execution, deep liquidity and an expanding set of services across spot and derivatives, including principal, agency and electronic trading,” said Peter Wisniewski, Co-Head of Galaxy Digital Trading. “These acquisitions are a continuation of this progress to date, and an important milestone as we continue to broaden our talent base and build out our differentiated capabilities, spanning fiat and digital asset lending, structured products, and prime brokerage services.”

Key Transaction Benefits:

  • Combination further expands Galaxy Digital Trading’s revenue-generating activities by immediately diversifying GDT beyond its current annual OTC trading volume of $4 billion and into: expanded derivatives and futures trading; on-exchange market making; and lending, borrowing and structured products.
  • Scales DrawBridge’s first-mover lending and structured product offerings in crypto via Galaxy Digital’s institutional market relationships and robust, publicly-audited balance sheet, while adding DrawBridge’s $150 million+ of third-party assets to Galaxy Digital.
  • Builds on DrawBridge’s strategic partnership with GDT which was formed in 2019. The companies have subsequently evaluated dozens of bespoke loans together and executed on a growing live loan book which will be expanded as a result of this transaction.
  • Amplifies Blue Fire’s best-in-class trading strategies and execution with Galaxy Digital’s broad sources of liquidity, and further enhances the combined firm’s superior relationships with key global crypto exchanges via Blue Fire’s $36 billion+ of annual notional derivatives trading volume. Drives utilization and optimization of Galaxy Digital’s balance sheet to unlock strong risk-adjusted return opportunities, as well as provide customers and counterparties with best-in-class market access and trading capital efficiency.
  • Establishes strong regional hub in Chicago for Galaxy Digital to expand agency, prime brokerage and electronic trading services, and to increase connectivity with traditional derivatives firms as they look to move into crypto markets with blue-chip partners.
  • Further strengthens Galaxy Digital Trading’s leadership team with veteran trading and lending market participants who possess proven track-records across traditional asset classes and the crypto markets.
  • DrawBridge’s CEO and Co-Founder, Jason Urban, will join Galaxy Digital as Co-Head of Galaxy Digital Trading, and will work alongside fellow Co-Head, Peter Wisniewski. Andrew Karos will join Galaxy Digital and remain CEO of Blue Fire, which will continue to operate as a wholly-owned subsidiary.
  • Provides near-term capital deployment opportunities for Galaxy Digital’s recent $50 million financing from institutional investors.

About Galaxy Digital

Galaxy Digital is a diversified financial services and investment management company in the digital asset, cryptocurrency and blockchain technology sector. Galaxy Digital’s team has extensive experience spanning investing, portfolio management, capital markets, venture capital, asset management, and blockchain technology. Galaxy Digital currently operates four distinct business lines, which include: Trading, Asset Management, Principal Investments and Investment Banking. Galaxy Digital’s CEO and Founder is Michael Novogratz. The Company is headquartered in New York City, with offices in Chicago, San Francisco, London, Tokyo, Hong Kong, the Cayman Islands (registered office) and New Jersey. Additional information about the Company’s businesses and products is available on www.galaxydigital.io.

About DrawBridge Lending

DrawBridge Lending was founded in 2018 and is a Chicago-based, CFTC-regulated Commodity Trading Advisor (“CTA”) and Commodity Pool Operator (“CPO”) that originates structured loans with related derivatives to provide hedged financial products to institutional investors in crypto. 

About Blue Fire Capital

Blue Fire Capital, based in Chicago, was founded in 2007 and is a proprietary trading firm that specializes in crypto and providing two-sided liquidity for digital assets. Blue Fire has developed deep relationships with key crypto exchanges globally and is a leading market-maker on those trading venues.

Disclaimers

The TSX has not approved or disapproved of the information contained herein. 

This press release includes certain “forward-looking information” and “forward-looking statements” (collectively “forward-looking statements”) within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical or current fact, included herein, are forward-looking statements. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, and similar expressions, or statements that events, conditions, or results “will”, “may”, “could”, or “should” occur or be achieved. Forward-looking statements in this press release relate to, among other things, the Company’s ability to realize anticipated transaction benefits and the Company’s ability to achieve its business objectives. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. Forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. The assumptions used in the preparation of such statements, although considered reasonable at the time of preparation, may prove to be imprecise. Many factors, both known and unknown, could cause actual results, performance or achievements to be materially different from the results, performance or achievements that are or may be expressed or implied by such forward-looking statements and the parties have made assumptions and estimates based on or related to many of these factors. Such factors include, without limitation, the risks identified in the Company’s annual information form dated April 8, 2020 and available on SEDAR at www.sedar.com . Readers should not place undue reliance on the forward-looking statements and information contained in this release. The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

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SOURCE Galaxy Digital Holdings Ltd.

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ORIC Pharmaceuticals Announces Pricing of Upsized Public Offering

SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Nov. 13, 2020 (GLOBE NEWSWIRE) — ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced the pricing of an upsized underwritten public offering of 5,040,000 shares of its common stock at a price of $23.00 per share. All of the shares of common stock are being offered by ORIC. In addition, ORIC has granted the underwriters a 30-day option to purchase up to 756,000 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. The gross proceeds to ORIC from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by ORIC, are expected to be approximately $115.9 million, excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on November 17, 2020, subject to customary closing conditions.

J.P. Morgan Securities LLC, Citigroup, Jefferies LLC and Guggenheim Securities are acting as joint book-running managers for the offering. Oppenheimer & Co. Inc. is acting as lead manager for the proposed offering.

The offering is made only by means of a prospectus, copies of which may be obtained, when available, from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at (800) 831-9146; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, NY 10017, by telephone at (212) 518-9658 or by email at [email protected].

Registration statements relating to the securities have been filed with the Securities and Exchange Commission and have become effective. This press release does not constitute an offer to sell or a solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of that state or jurisdiction.

About ORIC Pharmaceuticals, Inc.

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s lead product candidate, ORIC-101, is a potent and selective small molecule antagonist of the glucocorticoid receptor, which has been linked to resistance to multiple classes of cancer therapeutics across a variety of solid tumors. ORIC-101 is currently in two separate Phase 1b trials of ORIC-101 in combination with (1) Xtandi (enzalutamide) in metastatic prostate cancer and (2) Abraxane (nab-paclitaxel) in advanced or metastatic solid tumors. ORIC’s other product candidates include (1) ORIC-533, an orally bioavailable small molecule inhibitor of CD73, a key node in the adenosine pathway believed to play a central role in resistance to chemotherapy- and immunotherapy-based treatment regimens, (2) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (3) ORIC-114, a brain penetrant inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations, being developed across multiple genetically defined cancers. Beyond these four product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the terms, timing and completion of the public offering of common stock. The forward-looking statements contained herein are based upon ORIC’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to risks and uncertainties related to market conditions and satisfaction of customary closing conditions related to the offering, and other risks. Further information regarding such risks and uncertainties may be found in ORIC’s registration statement on Form S-1 filed with the Securities and Exchange Commission (SEC) on November 10, 2020 and the preliminary prospectus included therein, as well as other documents ORIC files from time to time with the SEC, including ORIC’s Quarterly Report on Form 10-Q filed with the SEC on November 5, 2020, and ORIC’s future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and ORIC assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

For more information, please contact:

Dominic Piscitelli, Chief Financial Officer
[email protected]
[email protected]



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NTN Buzztime, Inc. Reports Third Quarter 2020 Results

PR Newswire

CARLSBAD, Calif., Nov. 13, 2020 /PRNewswire/ — NTN Buzztime, Inc. (NYSE American: NTN), reported financial results for the third quarter ended September 30, 2020. 

“Buzztime is working diligently toward closing two transformative transactions,” said Allen Wolff, CEO of NTN Buzztime. “Under the terms of the previously announced asset purchase agreement with eGames.com Holdings, LLC, we plan to sell all our assets related to our game network to eGames.com. Our goal is to preserve our compelling in-venue experience that engages patrons for Buzztime customer venues and safeguard our large and loyal player and customer base while monetizing our assets. The asset sale will strengthening our balance sheet and improve our financial position for the previously announced proposed merger with Brooklyn Immunotherapeutics LLC, which is advancing clinical development of cytokine-based therapy to enable the immune system to attack certain types of cancer cells. We believe that the proposed merger will benefit both investors of Brooklyn and stockholders of NTN Buzztime. We expect both transactions to close simultaneously in early 2021, subject to Buzztime’s stockholders approving both proposed transactions, the beneficial holders of Brooklyn’s Class A membership units approving the proposed merger, and the satisfaction of other customary closing conditions.”

Financial Results
For the third quarter 2020, total revenues were $1.5 million, up $0.7 million (or 96%) sequentially as compared to the second quarter of 2020, but down from $4.6 million in the third quarter of 2019. The decrease reflects reduced site count, primarily as a result of the termination of our relationships with Buffalo Wild Wings corporate-owned restaurants and its franchisees in November 2019, and the impact of the COVID-19 pandemic on the company’s business, as a substantial number of the bars and restaurants that subscribe to the network suspended their subscriptions for at least a portion of the current year period. Third quarter 2020 operating expense decreased to $2.9 million, from $4.9 million in the third quarter of 2019, reflecting corporate restructuring and cost reductions. Third quarter 2020 net loss attributable to common shareholders was $1.5 million, or $0.50 per share, compared to $351,000, or $0.12 per share, in the prior year quarter.  

Liquidity
Cash, cash equivalents and unrestricted cash was $1.7 million at September 30, 2020, compared to $3.2 million at December 31, 2019. In April 2020, the company received $1.6 million under the Paycheck Protection Program of the CARES Act.  In November 2020, the Small Business Administration approved the company’s application to forgive $1.1 million of such loan, leaving a note balance of $0.5 million. Also, in September 2020, the company received a bridge loan of $1.0 million from an affiliate of eGames.com in connection with entering into the asset purchase agreement with eGames.com.  Outstanding amounts under the bridge loan, if the asset sale closes, will be applied to the purchase price of the asset sale upon closing. At September 30, 2020, the principal balance of the term loan with Avidbank was $725,000, and the company had negative working capital of $137,000. For additional information regarding the company’s liquidity and capital resources, please see the quarterly report on Form 10-Q expected to be filed with the SEC later today.

About Buzztime:
Buzztime (NYSE American: NTN) delivers interactive entertainment and innovative technology that helps its customers acquire, engage and retain its patrons. Most frequently used in bars and restaurants in North America, the Buzztime tablets, mobile app and technology offer engaging solutions to establishments that have guests who experience dwell time, such as casinos, senior living, and more. Casual dining venues license Buzztime’s customizable solution to differentiate themselves via competitive fun by offering guests trivia, card, sports and arcade games. Buzztime’s platform creates connections among the players and venues and amplifies guests’ positive experiences.  Buzztime’s in-venue TV network creates one of the largest digital out of home ad audiences in the US and Canada. Buzztime hardware solutions leverages the company’s experience manufacturing durable tablets and charging systems, enabling a diverse group of businesses including corrections, point-of-sale and loyalty with product implementation.  Buzztime games have also been recently licensed by other businesses serving other markets.  For more information, please visit http://www.buzztime.com or follow us on Facebook or Twitter@buzztime.

Additional Information and Where to Find It
In connection with the proposed merger and asset sale, Buzztime filed relevant materials with the SEC, including a registration statement on Form S-4, that will serve as a proxy statement and prospectus of Buzztime and a consent solicitation statement for the beneficial holders of Brooklyn’s Class A membership units, and will be mailed or otherwise disseminated to Buzztime stockholders and to the beneficial holders of Brooklyn’s Class A membership units if and when it becomes available. INVESTORS AND SECURITY HOLDERS OF BUZZTIME AND BROOKLYN ARE URGED TO READ THESE MATERIALS CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT BUZZTIME, BROOKLYN, THE PROPOSED MERGER AND ASSET SALE, AND RELATED MATTERS. The proxy statement/prospectus/consent solicitation statement and other relevant materials (when they become available) and any other documents filed by Buzztime with the SEC, may be obtained free of charge at the SEC website at www.sec.gov. In addition, investors and security holders may obtain free copies of the documents filed with the SEC by Buzztime by directing a written request to: NTN Buzztime, Inc, 6965 El Camino Real, Suite 105-Box 517, Carlsbad, California 92009. Investors and security holders are urged to read the proxy statement/prospectus/consent solicitation statement and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed merger and asset sale.

Participants in the Solicitation
Buzztime and its directors, executive officers and certain other members of management and employees, Brooklyn and its managers and officers, and eGames.com and its managers and officers may, under SEC rules, be deemed to be participants in the solicitation of proxies from the stockholders of Buzztime with respect to the proposed merger and asset sale and related matters. Information about the directors and executive officers of Buzztime, including their ownership of shares of common stock is set forth in Buzztime’s Annual Report on Form 10-K for the year ended December 31, 2019 and Amendment No. 1 thereto, which were filed with the SEC on March 19, 2020 and April 27, 2020, respectively. Additional information regarding the persons or entities who may be deemed participants in the solicitation of proxies from Buzztime stockholders, including a description of their interests in the proposed merger and asset sale, by security holdings or otherwise, are included in the joint proxy statement/prospectus/consent solicitation statement referred to above and other relevant documents to be filed with the SEC when they become available. As described above, these documents will be available free of charge at the SEC’s website or by directing a written request to Buzztime. Neither the managers or officers of Brooklyn nor the managers or officers of eGames.com currently hold any interests, by security holdings or otherwise, in Buzztime.


Forward-Looking Statements


This press release contains 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 intended to be covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are any statements that are not statements of historical fact and may be identified by terminology such as “expect,” “intend,” “plan,” “believe,” “anticipate,” “may,” “will,” “would,” “should,” “could,” “contemplate,” “estimate,” “predict,” “potential” or “continue,” or the negative of these terms or other similar words. These forward-looking statements include, but are not limited to, statements concerning: the completion of the proposed asset sale and merger and the anticipated timing thereof, the benefits of the proposed asset sale and merger for Buzztime’s stockholders and other stakeholders. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance.

Actual results could differ materially from those stated or implied in any forward-looking statement as a result of various factors, including, but not limited to: (i) risks that the conditions to the closing of the proposed merger and/or asset sale are not satisfied, including the failure of Buzztime and Brooklyn to timely obtain the requisite stockholder and member approvals for the merger and/or asset sale and related matters, or to meet the net cash and capitalization requirements under the merger agreement, as applicable; (ii) uncertainties as to the timing of the consummation of the proposed merger and asset sale and the ability of each party to consummate the proposed merger and asset sale; (iii) risks related to Buzztime’s and Brooklyn’s ability to manage their respective operating expenses and their expenses associated with the proposed merger and asset sale, as applicable, pending closing; (iv) uncertainties related to the impact of the COVID-19 pandemic on the business and financial condition of Buzztime and the ability of Buzztime and Brooklyn to consummate the merger and Buzztime and eGames.com to consummate the asset sale; (v) Buzztime’s ability to continue to operate as a going concern if the proposed merger or asset sale is not consummated in a timely manner, or at all; (vi) the outcome of any legal proceedings that have been instituted against Buzztime, Brooklyn or others related to the merger agreement and the asset purchase agreement; (vii) the occurrence of any event, change or other circumstance or condition that could give rise to the termination of either or both of those agreements; (viii) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the proposed merger or asset sale; and (ix) those risks and uncertainties discussed in Buzztime’s reports filed with the SEC, including its most recent Annual Report on Form 10-K, its Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, as well as other documents that may be filed by Buzztime from time to time with the SEC available at www.sec.gov.

You should not rely upon forward-looking statements as predictions of future events. Buzztime cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. The forward-looking statements made in this communication speak only as of the date on which they were made. Buzztime does not undertake any obligation to update the forward-looking statements contained herein to reflect events that occur or circumstances that exist after the date hereof, except as may be required by applicable law or regulation.

IR AGENCY CONTACT:
Kirsten Chapman, LHA Investor Relations, [email protected] 415-433-3777


 

 


NTN BUZZTIME, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except par value amount)

ASSETS


September 30,


2020


December 31,


2019

Current Assets:

(unaudited)

Cash and cash equivalents

$       1,710

$       3,209

Restricted cash

—

50

Accounts receivable, net

132

1,195

Income tax receivable

13

—

Site equipment to be installed

792

1,090

Prepaid expenses and other current assets

146

526

Total current assets

2,793

6,070

Restricted cash, long-term

—

150

Operating lease right-of-use assets

5

2,101

Fixed assets, net

689

2,822

Software development costs, net

1,420

1,915

Deferred costs

85

274

Goodwill

—

696

Other assets

62

97

Total assets

$       5,054

$     14,125

LIABILITIES AND SHAREHOLDERS’ EQUITY

Current Liabilities:

Accounts payable

$           275

$           835

Accrued compensation

125

588

Accrued expenses

490

490

Sales taxes payable

14

131

Income taxes payable

—

3

Current portion of long-term debt

1,724

2,739

Current portion of obligations under operating leases

5

409

Current portion of obligations under financing leases

23

21

Current portion of deferred revenue

120

460

Other current liabilities

154

419

Total current liabilities

2,930

6,095

Long-term debt

1,625

—

Obligations under operating leases

—

2,891

Obligations under financing leases

4

20

Deferred revenue

—

2

Other liabilities

—

26

Total liabilities

4,559

9,034

Shareholders’ equity:

Series A 10% cumulative convertible preferred stock, $0.005 par value, $156 liquidation preference, 156 shares authorized; 156 shares issued and outstanding at September 30, 2020 and December 31, 2019

1

1

Common stock, $0.005 par value, 15,000 shares authorized at September 30, 2020 and December 31, 2019; 2,952 and 2,901 shares issued at September 30, 2020 and December 31, 2019, respectively

15

14

Treasury stock, at cost, 10 shares at September 30, 2020 and December 31, 2019

(456)

(456)

Additional paid-in capital

136,881

136,721

Accumulated deficit

(136,187)

(131,457)

Accumulated other comprehensive income

241

268

Total shareholders’ equity

495

5,091

Total liabilities and shareholders’ equity

$       5,054

$     14,125

 

 


NTN BUZZTIME, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(unaudited)

(In thousands, except per share data)


Three months ended


September 30,


Nine months ended


September 30,


2020


2019


2020


2019

Revenues

Subscription revenue

$    1,053

$    3,723

$    3,779

$  11,356

Hardware revenue

379

11

421

811

Other revenue

45

846

425

2,471

Total revenues

1,477

4,580

4,625

14,638

Operating expenses:

Direct operating costs (includes depreciation and amortization)

801

1,344

2,364

4,545

Selling, general and administrative

2,068

3,413

6,743

10,303

Impairment of capitalized software

—

51

238

52

Impairment of goodwill

—

—

662

—

Depreciation and amortization (excluding depreciation and amortization included in direct costs)

26

88

189

273

Total operating expenses

2,895

4,896

10,196

15,173

Operating loss

(1,418)

(316)

(5,571)

(535)

Other (expense) income, net

(82)

(16)

826

(189)

Loss before income taxes

(1,500)

(332)

(4,745)

(724)

Income tax benefit (provision)

19

(19)

23

(30)

Net loss

(1,481)

(351)

(4,722)

(754)

Series A preferred stock dividend

—

—

(8)

(8)

Net loss attributable to common shareholders

$   (1,481)

$      (351)

$   (4,730)

$      (762)

Net loss per common share – basic and diluted

$     (0.50)

$     (0.12)

$     (1.62)

$     (0.27)

Weighted average shares outstanding – basic and diluted

2,936

2,874

2,920

2,870

Comprehensive loss:

Net loss

$   (1,481)

$      (351)

$   (4,722)

$      (754)

Foreign currency translations adjustment

1

(18)

(27)

47

Total comprehensive loss

$   (1,480)

$      (396)

$   (4,749)

$      (707)

 

 


NTN BUZZTIME, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(In thousands)


Nine months ended


September 30,


2020


2019

Cash flows (used in) provided by operating activities:

Net loss

$  (4,722)

$     (754)

Adjustments to reconcile net loss to net cash (used in) provided by operating activities:

Depreciation and amortization

1,430

2,191

Provision for doubtful accounts

124

144

Amortization of operating lease right-of-use assets

161

217

Common stock issued for compensation in lieu of cash payment

61

—

Transfer of fixed assets to sales-type lease

—

7

Stock-based compensation

135

172

Gain from the asset sale of Stump! Trivia and OpinioNation

(1,225)

—

Loss from the termination of operating leases

9

—

Loss (gain) from the disposition or sale of assets

511

(5)

Loss from impairment of capitalized software

238

52

Loss from impairment of goodwill

662

—

Amortization of debt issuance costs

12

7

Changes in assets and liabilities:

Accounts receivable

939

222

Site equipment to be installed

51

475

Operating lease liabilities

(154)

(111)

Prepaid expenses and other assets

353

(66)

Accounts payable and accrued expenses

(1,405)

(196)

Income taxes

(16)

4

Deferred costs

189

84

Deferred revenue

(342)

(541)

Other liabilities

(291)

(141)

Net cash (used in) provided by operating activities

(3,280)

1,761

Cash flows used in investing activities:

Capital expenditures

(21)

(111)

Capitalized software development expenditures

(173)

(882)

Proceeds from the sale of equipment

—

29

Net cash used in investing activities

(194)

(964)

Cash flows provided by (used in) financing activities:

Net proceeds from the sale of Stump! Trivia and OpinoNation

1,226

—

Proceeds on long-term debt

2,625

—

Payment on long-term debt

(2,025)

(750)

Debt issuance costs on long-term debt

(3)

—

Principal payments on financing leases

(14)

(39)

Payment of preferred stockholder dividends

(8)

(8)

Payroll taxes remitted on net share settlement of equity awards

(36)

(29)

Net cash provided by (used in) financing activities

1,765

(826)

Effect of exchange rate on cash and cash equivalents

10

27

Net decrease in cash and cash equivalents

(1,699)

(2)

Cash, cash equivalents and restricted cash at beginning of period

3,409

2,786

Cash, cash equivalents and restricted cash at end of period

$   1,710

$   2,984

 

 

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SOURCE NTN Buzztime, Inc.

Posted on

Amesite CEO Dr. Ann Marie Sastry Scheduled to Appear on CNBC’s Squawk Box Monday at 6:45 a.m. ET

Founder of the remote learning software company to talk about the changing dynamic of the workplace, the new normal in technology, and supporting and training remote and in-person workforces

PR Newswire

ANN ARBOR, Mich., Nov. 13, 2020 /PRNewswire/ — AmesiteInc. (Nasdaq: AMST), an artificial intelligence software company providing online learning ecosystems for business, higher education, and K-12, announced today its CEO, Dr. Ann Marie Sastry, is scheduled to appear on CNBC’s Squawk Box Monday morning at 6:45 a.m. ET.  

Dr. Sastry will discuss how workplaces are adapting and what the future of work looks like, how technology is evolving to meet the changing needs of business during the pandemic, and how to best support remote and in-person workforces with highly effective virtual training.


About Amesite Inc.

Amesite is a high-tech artificial intelligence software company offering a cloud-based platform and content creation services for K-12, college, university and business education and upskilling. Amesite-offered courses and programs are branded to our customers.  Amesite uses artificial intelligence technologies to provide customized environments for learners, easy-to-manage interfaces for instructors, and greater accessibility for learners in the US education market and beyond.  The Company leverages existing institutional infrastructures, adding mass customization and cutting-edge technology to provide cost-effective, scalable and engaging experiences for learners anywhere. For more information, visit https://amesite.com.


Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended) concerning the Company, the Company’s planned online machine learning platform, the Company’s business plans, any future commercialization of the Company’s online learning solutions, potential customers, business objectives and other matters. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “believe,” “intend,” “look forward,” and other similar expressions among others. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement. Risks facing the Company and its planned platform are set forth in the Company’s filings with the SEC. Except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Media Contact: Robert Busweiler – [email protected] – 631.379.6454

Cision View original content:http://www.prnewswire.com/news-releases/amesite-ceo-dr-ann-marie-sastry-scheduled-to-appear-on-cnbcs-squawk-box-monday-at-645-am-et-301172435.html

SOURCE Amesite Inc.