Virgin Galactic Adjusts Test Flight Schedule in Response to New State Government COVID-19 Restrictions

Virgin Galactic Adjusts Test Flight Schedule in Response to New State Government COVID-19 Restrictions

LAS CRUCES, N.M.–(BUSINESS WIRE)–
Virgin Galactic Holdings, Inc. (NYSE: SPCE), in accordance with new guidelines from the New Mexico Department of Health to disrupt the spread of the COVID-19 virus in the state, today announced that it will be minimizing its operational footprint at its New Mexico facilities.

In consultation with government officials, and as a result of these new operations restrictions, the space flight that was planned to occur between November 19-23, 2020 will be rescheduled.

Michael Colglazier, CEO, Virgin Galactic said: ‘With the health and safety of our team members in mind, and in accordance with the recent direction from the New Mexico Department of Health, we will be minimizing our New Mexico operations to the greatest degree possible. While these new restrictions cause us to adjust our flight schedule, we take this pause in stride and will be prepared to resume our pre-flight procedures and announce a new test flight window as soon as we can. Our team members at Virgin Galactic, our Future Astronauts, and our fans around the world remain incredibly excited for our upcoming spaceflight.’

About Virgin Galactic Holdings

Virgin Galactic Holdings, Inc. is a vertically integrated aerospace and space travel company, pioneering human spaceflight for private individuals and researchers, as well as a manufacturer of advanced air and space vehicles. It is developing a spaceflight system designed to offer customers a unique and transformative experience. You can find more information at https://www.virgingalactic.com/

For media inquiries:

Aleanna Crane – Vice President Communications

[email protected]

For Investor Relations inquiries:

[email protected]

KEYWORDS: United States North America Canada New Mexico

INDUSTRY KEYWORDS: Engineering Air Aerospace Transport Manufacturing Other Science Science

MEDIA:

Legend Biotech Reports Third Quarter 2020 Financial Results

Legend Biotech Reports Third Quarter 2020 Financial Results

SOMERSET, N.J.–(BUSINESS WIRE)–
Legend Biotech Corporation (NASDAQ: LEGN) (“Legend Biotech” or the “Company”), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today reported financial results for the quarter ended September 30, 2020.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201116005237/en/

Legend Biotech’s Development Pipeline (Graphic: Business Wire)

Legend Biotech’s Development Pipeline (Graphic: Business Wire)

“Legend Biotech continues to execute on our corporate strategy, advancing the development of our lead product candidate, ciltacabtagene autoleucel (cilta-cel), in collaboration with Janssen Biotech, Inc. as well as our other pipeline programs,” said Dr. Ying Huang, Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”) of Legend Biotech. “We look forward to initiation of the Biologics License Application (“BLA”) filing for cilta-cel by Janssen Biotech, Inc.”

Third Quarter 2020 & Recent Highlights

  • On November 9, 2020, Legend Biotech announced that Ms. Ye (Sally) Wang was appointed, effective November 6, 2020, as Chairwoman of the Board of Directors of Legend Biotech. The Board of Directors also named Dr. Ying Huang as CEO of Legend Biotech, effective November 6, 2020. Dr. Huang had been serving as interim CEO since September 21, 2020. Dr. Huang will continue to hold his position as CFO until such time as a successor CFO is identified.
  • On November 5, 2020, Legend Biotech announced that the Company will present new and updated data from its CARTITUDE-1 and LEGEND-2 studies at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition taking place virtually December 5-8, 2020.
  • On September 21, 2020, Legend Biotech announced that the Customs Anti-Smuggling Department of the People’s Republic of China (“PRC”) had inspected places of business in China of Legend Biotech and GenScript Biotech Corporation, Legend Biotech’s majority shareholder, in connection with what Legend Biotech understands to be an investigation relating to suspected violations of import and export regulations under the laws of the PRC (the “Investigation”) and that Dr. Fangliang Zhang, the Chairman of the Board of Directors and CEO of Legend at that time, had been placed under “residential surveillance” in the PRC. No charges have been filed against Legend Biotech, Dr. Zhang, or any of its other officers or directors, and the Company does not believe that Legend Biotech is a subject of the investigation.
  • On August 5, 2020, Legend Biotech announced that the China Center for Drug Evaluation (“CDE”) of National Medical Products Administration (“NMPA”) recommended Breakthrough Therapy Designation (“BTD”) for cilta-cel for the treatment of adults with relapsed/refractory multiple myeloma. The designation was granted on August 13, 2020, making cilta-cel the first investigational product to obtain BTD in China.

Key Upcoming Milestones

  • On Saturday, December 5, 2020, during the Myeloma session at ASH entitled: Myeloma/Amyloidosis: Therapy, excluding Transplantation: Novel Therapies Targeting B Cell Maturation Antigen in Relapsed/Refractory Multiple Myeloma, the Phase 1b/2 clinical efficacy and safety data from the CARTITUDE-1 study will be presented.
  • During the ASH Annual Meeting and Exposition, LEGEND-2 data in patients with relapsed or refractory multiple myeloma and extramedullary disease will be presented as a poster.
  • Legend Biotech’s collaboration partner Janssen Biotech, Inc. anticipates initiating the BLA submission for cilta-cel to the U.S. Food and Drug Administration (“FDA”) by the end of 2020 and submitting a marketing authorization application to the European Medicines Agency (“EMA”) in early 2021.
  • Legend Biotech expects to use data from CARTIFAN-1 study to file a regulatory submission in China in 2021.
  • Please see Legend Biotech’s comprehensive development pipeline as shown below.

Development Pipeline

The extent to which the COVID-19 pandemic may impact our business and clinical trials is highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak and social distancing regulations, travel restrictions, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.

Financial Results for the Three-month and Nine-month Periods Ended September 30, 2020

Cash and Cash Equivalents:

As of September 30, 2020, Legend Biotech had approximately $449.4 million of cash and cash equivalents and approximately $125.6 million in time deposits.

Revenue

Revenue for the three months ended September 30, 2020 was $11.7 million compared to $17.7 million for the three months ended September 30, 2019. The decrease of $6.0 million was primarily due to milestone achieved in July 2019 under the agreement with Janssen Biotech, Inc., which resulted in additional consideration being allocated to the licensing of intellectual property and the steering committee service for the three months ended September 30, 2019, net-off by additional milestone that was achieved in December 2019, which resulted in additional consideration being allocated to the steering committee service for the three months ended September 30, 2020. Revenue for the nine months ended September 30, 2020 was $34.9 million compared to $37.8 million for the nine months ended September 30, 2019. Similarly, the decrease of the nine months period in 2020 was primarily driven by additional milestone payment received from Janssen Biotech, Inc. that was achieved in July 2019, net-off by additional milestone that was achieved in December 2019, which resulted in additional consideration being allocated to the steering committee service for the nine month ended September 30, 2020. Legend Biotech has not generated any revenue from product sales to date.

Research and Development Expenses

Research and development expenses for the three months ended September 30, 2020 were $63.7 million compared to $41.9 million for the three months ended September 30, 2019. This increase of $21.8 million was primarily due to a higher number of clinical trials, a higher number of patients enrolled in those trials and a higher number of research and development product candidates in the three months ended September 30, 2020. Consistently, research and development expenses for the nine months ended September 30, 2020 was $165.2 million compared to $95.8 million for the nine months ended September 30, 2019 with a $69.4 million increase.

Administrative Expenses

Administrative expenses for the three months ended September 30, 2020 were $6.0 million compared to $2.0 million for the three months ended September 30, 2019. The increase of $4.0 million was primarily due to Legend Biotech’s expansion of supporting administrative functions to aid continued research and development activities. Due to the consistent business expansion, administrative expenses for the nine months ended September 30, 2020 increased by $9.3 million, which was $14.0 million compared to $4.7 million for the nine months ended September 30, 2019.

Selling and Distribution Expenses

Selling and distribution expenses for the three months ended September 30, 2020 were $9.3 million compared to $4.5 million for the three months ended September 30, 2019. This increase of $4.8 million was primarily due to increased costs associated with commercial preparation activities for cilta-cel. Driven by the same commercial preparation activities, selling and distribution expenses for the nine months ended September 30, 2020 was $25.4 million compared to $12.2 million for the nine months ended September 30, 2019.

Other Income and Gains

Other income and gains for the three months ended September 30, 2020 was $1.5 million compared to $3.0 million for the three months ended September 30, 2019. The decrease was primarily driven by net foreign exchange loss incurred, net of an increase in government grant received. Other income and gains for the nine months ended September 30, 2020 was $5.3 million compared to $6.6 million for the nine months ended September 30, 2019. The decrease of the nine months period was primarily driven by reduced average interest rate for holding of time deposits that generate interest income.

Other Expenses

Other expenses for the three months ended September 30, 2020 was $1.2 million compared to $0.002 million for the three months ended September 30, 2019. Other expenses for the nine months ended September 30, 2020 was $1.3 million compared to $0.2 million for the nine months ended September 30, 2019. The increase was primarily due to foreign exchange loss.

Loss for the Period

For the three months ended September 30, 2020, net loss was $66.5 million, or $0.25 per share, compared to a net loss of $27.8 million, or $0.14 per share, for the three months ended September 30, 2019. Net loss was $245.7 million for the nine months ended September 30, 2020 compared to $69.0 million for the nine months ended September 30, 2019.

Grant of restricted share units and share options

On September 1, 2020, we granted a total number of 777,382 restricted share units (each representing the right to receive one ordinary share) to grantees with a grant date fair market value of $16.335 per share. On September 1, 2020, we granted share options, representing the right to acquire a total number of 569,000 shares to grantees with an exercise price of $16.335 per share.

About Legend Biotech

Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of over 800 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover, develop, and manufacture cutting edge cell therapies for patients in need.

We are engaged in a strategic collaboration with Janssen Biotech, Inc. to develop and commercialize our lead product candidate, ciltacabtagene autoleucel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. This candidate is currently being studied in registrational clinical trials.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s strategies and objectives; the anticipated timing of, and ability to progress, clinical trials; the ability to make, and the timing of, regulatory submissions globally, including the BLA for cilta-cel to the U.S. FDA, the marketing authorization application (MAA) for cilta-cel to the EMA, regulatory submission filing for CARTIFAN-1 in China and the Investigational New Drug Application (IND) of LB1901, a CAR T product under development for the treatment of relapsed or refractory T-cell lymphoma (TCL), to the U.S. FDA; the ability to generate, analyze and present data from clinical trials; patient enrollment; the potential benefits of our product candidates, the status and outcome of the Investigation and its impact on the Company’s operations. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the factors discussed in the “Risk Factors” section of the prospectus filed with the Securities and Exchange Commission on June 8, 2020. Any forward-looking statements contained in this press release speak only as of the date hereof, and Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

       

LEGEND BIOTECH CORPORATION

UNAUDITED INTERIM CONDENSED

CONSOLIDATED STATEMENTS OF PROFIT OR LOSS

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2020 AND 2019

       
 

Three months ended

September 30

 

Nine months ended

September 30

 

(in thousands, US$, except per share data)

 

2020

(unaudited)

 

2019

(unaudited)

 

2020

(unaudited)

 

2019

(unaudited)

 
       

REVENUE

 

11,747

 

 

17,674

 

 

34,893

 

 

37,814

 

 

Other income and gains

 

1,519

 

 

2,987

 

 

5,315

 

 

6,649

 

 

Research and development expenses

 

(63,656

)

 

(41,917

)

 

(165,226

)

 

(95,846

)

 

Administrative expenses

 

(6,038

)

 

(1,992

)

 

(13,976

)

 

(4,704

)

 

Selling and distribution expenses

 

(9,287

)

 

(4,460

)

 

(25,389

)

 

(12,246

)

 

Other expenses

 

(1,249

)

 

(2

)

 

(1,331

)

 

(216

)

 

Fair value loss of convertible redeemable preferred shares

 

 

 

 

 

(79,984

)

 

 

 

Finance costs

 

(90

)

 

(82

)

 

(4,169

)

 

(139

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

LOSS BEFORE TAX

 

(67,054

)

 

(27,792

)

 

(249,867

)

 

(68,688

)

 

Income taxes credits / (expenses)

 

508

 

 

(5

)

 

4,217

 

 

(341

)

 

LOSS FOR THE PERIOD

 

(66,546

)

 

(27,797

)

 

(245,650

)

 

(69,029

)

 

Attributable to:

 

Equity holders of the parent

 

(66,546

)

 

(27,797

)

 

(245,650

)

 

(69,029

)

 

LOSS PER SHARE ATTRIBUTABLE TO ORDINARY EQUITY HOLDERS OF THE PARENT

 

Ordinary shares—basic

 

(0.25

)

 

(0.14

)

 

(1.08

)

 

(0.35

)

 

Ordinary shares—diluted

 

(0.25

)

 

(0.14

)

 

(1.08

)

 

(0.35

)

 

ORDINARY SHARES USED IN LOSS PER SHARE COMPUTATION

 

Ordinary shares—basic

 

264,328,630

 

 

200,000,000

 

 

226,764,437

 

 

200,000,000

 

 

Ordinary shares—diluted

 

264,328,630

 

 

200,000,000

 

 

226,764,437

 

 

200,000,000

 

 
     

LEGEND BIOTECH CORPORATION

UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

AS AT SEPTEMBER 30, 2020 AND DECEMBER 31, 2019

     
 

September 30, 2020

(Unaudited)

 

December 31,

2019

(in thousands, US$)

   

NON-CURRENT ASSETS

   

Property, plant and equipment

 

96,125

 

70,079

 

Advance payments for property, plant and equipment

 

675

 

665

 

Right-of-use assets

 

8,077

 

9,348

 

Intangible assets

 

1,042

 

519

 

 

Total non-current assets

 

105,919

 

80,611

 

 

CURRENT ASSETS

   

Inventories

 

1,513

 

1,157

 

Trade receivables

 

 

29,991

 

Prepayments, other receivables and other assets

 

24,662

 

16,777

 

Financial assets at fair value through profit or loss

 

1,175

 

 

Pledged short-term deposits

 

430

 

256

 

Time deposits

 

125,559

 

75,559

 

Cash and cash equivalents

 

449,381

 

83,364

 

 

Total current assets

 

602,720

 

207,104

 

 

Total assets

 

708,639

 

287,715

 

CURRENT LIABILITIES

   

Trade and notes payables

 

7,399

 

9,586

 

Other payables and accruals

 

67,889

 

70,854

 

Lease liabilities

 

1,445

 

1,027

 

Contract liabilities

 

46,789

 

46,294

 

 

Total current liabilities

 

123,522

 

127,761

 

 

NON-CURRENT LIABILITIES

   

Contract liabilities

 

245,641

 

277,765

 

Lease liabilities

 

2,543

 

5,058

 

Government grants

 

2,033

 

 

 

Total non-current liabilities

 

250,217

 

282,823

 

 

Total liabilities

 

373,739

 

410,584

 

 

EQUITY

   

Share capital

 

26

 

20

 

Reserves / (deficits)

 

334,874

 

(122,889

)

 

Total ordinary shareholders’ equity / (deficit)

 

334,900

 

(122,869

)

 

Total equity / (deficit)

 

334,900

 

(122,869

)

 

Total liabilities and equity

 

708,639

 

287,715

 

     

LEGEND BIOTECH CORPORATION

UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2020 AND 2019

     

 

 

Three months ended

September 30

 

Nine months ended

September 30

(in thousands, US$)

 

2020

(Unaudited)

 

2019

(Unaudited)

 

2020

(Unaudited)

 

2019

(Unaudited)

LOSS BEFORE TAX

 

(67,054

)

 

(27,792

)

 

(249,867

)

 

(68,688

)

CASH FLOWS (USED IN)/GENERATED FROM OPERATING ACTIVITIES

 

(64,375

)

 

19,947

 

 

(167,056

)

 

(23,078

)

CASH FLOWS USED IN INVESTING ACTIVITIES

 

(58,623

)

 

(21,194

)

 

(85,334

)

 

(172,103

)

CASH FLOWS FROM/(USED IN) FINANCING ACTIVITIES

 

9,663

 

 

(154

)

 

618,221

 

 

21,346

 

 

NET (DECREASE)/INCREASE IN CASH AND CASH EQUIVALENTS

 

(113,335

)

 

(1,401

)

 

365,831

 

 

(173,835

)

Effect of foreign exchange rate changes, net

 

325

 

 

(44

)

 

186

 

 

(55

)

Cash and cash equivalents at beginning of the period

 

562,391

 

 

37,721

 

 

83,364

 

 

210,166

 

 

CASH AND CASH EQUIVALENTS AT END OF THE PERIOD

 

449,381

 

 

36,276

 

 

449,381

 

 

36,276

 

 

ANALYSIS OF BALANCES OF CASH AND CASH EQUIVALENTS

       

Cash and bank balances

 

575,370

 

 

147,592

 

 

575,370

 

 

147,592

 

Less: Pledged short-term deposits

 

430

 

 

255

 

 

430

 

 

255

 

Time deposits

 

125,559

 

 

111,061

 

 

125,559

 

 

111,061

 

 

Cash and cash equivalents as stated in the statement of financial position

 

449,381

 

 

36,276

 

 

449,381

 

 

36,276

 

 

Cash and cash equivalents as stated in the statement of cash flows

 

449,381

 

 

36,276

 

 

449,381

 

 

36,276 

 

Media and Investor Relations:

Jessie Yeung, Head of Corporate Finance and Investor

Relations, Legend Biotech [email protected] or

[email protected]

Surabhi Verma, Manager of Investor

Relations and Corporate Communications, Legend Biotech [email protected] or

[email protected]

For Medical Affairs inquiries, please contact:

Tonia Nesheiwat, Executive Director, Medical Affairs, Legend Biotech USA Inc.

[email protected] or [email protected]

KEYWORDS: United States North America New Jersey

INDUSTRY KEYWORDS: Biotechnology Pharmaceutical Health

MEDIA:

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Legend Biotech’s Development Pipeline (Graphic: Business Wire)

Mesa Air Group Completes Second Closing On Secured Loan Facility, Receiving an Additional $152 Million

PHOENIX, Nov. 16, 2020 (GLOBE NEWSWIRE) — Mesa Air Group, Inc. (NASDAQ: MESA) today announced that it has completed a second closing through its previously disclosed five-year Loan and Guarantee Agreement under the Coronavirus Air, Relief, and Economic Security Act (CARES Act).

The Loan Agreement provided a secured term loan facility of up to $200 million. On October 30, 2020, Mesa borrowed $43 million under the facility and today, completed a second closing to borrow an additional $152 million. These funds may be used for general corporate purposes and operating expenses, to the extent permitted by the CARES Act.

“I’d like to again express my sincere gratitude to everyone involved in making this deal happen. Our people have been working very hard to ensure Mesa and its employees are prepared to weather this storm”, said Jonathan Ornstein, Chairman and Chief Executive Officer. “These additional funds will substantially benefit our airline and the communities we serve as we continue to navigate the obstacles created by the pandemic”.

In connection with the additional $152 million drawn under the facility, Mesa issued warrants to the U.S. Treasury to purchase 3,819,095 shares of common stock, no par value. The Warrants have a five-year term from the date issued, were issued pursuant to the Warrant Agreement, and have substantially identical terms to the warrants issued on the initial closing.

About Mesa Air Group, Inc.

Headquartered in Phoenix, Arizona, Mesa Air Group, Inc. is the holding company of Mesa Airlines, a regional air carrier providing scheduled passenger service to 101 cities in 39 states, the District of Columbia, Canada and Mexico. As of October 31st, 2020, Mesa operated a fleet of 146 aircraft with approximately 342 daily departures and 3,200 employees. Mesa operates all of its flights as either American Eagle, United Express, or DHL Express flights pursuant to the terms of capacity purchase agreements entered into with American Airlines, Inc., United Airlines, Inc., and DHL.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the benefits to Mesa of the additional funds borrowed under the secured term loan facility with the U.S. Treasury and its ability to navigate the obstacles created by the pandemic. All forward-looking statements in this release are made as the date hereof and are based on information available to Mesa as of such date. These forward-looking statements represent the judgment of the Company, as of the date of this release, and the Company disclaims any intent or obligation to publicly update or review any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.

Investor Relations
Brian Gillman
[email protected]

Media
Matt Harris
[email protected]



Can-Fite Presented NASH Phase II Namodenoson Data at a Late Breaking Session of the American Association for the Study of Liver Diseases (AASLD) Conference

Can-Fite Presented NASH Phase II Namodenoson Data at a Late Breaking Session of the American Association for the Study of Liver Diseases (AASLD) Conference

Dr. Safadi, the study’s Principal Investigator: “Namodenoson’s very impressive study data may result in a promising drug for the treatment of NAFLD/NASH due to the combination of good efficacy and favorable safety.”

PETACH TIKVA, Israel–(BUSINESS WIRE)–Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced that Dr. Rifaat Safadi, Principal Investigator of the Company’s Phase II study of Namodenoson in the treatment of NAFLD/NASH delivered a late-breaking oral presentation at the AASLD conference, The Liver Meeting Digital Experience™ 2020.

Titled “A Phase 2, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study Of The Efficacy And Safety Of Namodenoson (CF102), An A3 Adenosine Receptor (A3AR) Agonist, In Treating Non-Alcoholic Fatty Liver Disease (NAFLD) And Non-Alcoholic Steatohepatitis (NASH)” the oral presentation was given on Sunday, November 15 by Dr. Safadi, Head of the Liver Unit, Gastroenterology and Liver Diseases, Division of Medicine at Hadassah Medical Center, Professor of Internal Medicine, Bowel, Liver Disease, and Metabolic Syndrome at Hebrew University in Israel.

The double-blind, placebo-controlled, dose-finding efficacy and safety study enrolled 60 patients with NAFLD with or without NASH. Patients with evidence of an active inflammation were treated twice daily with 12.5 mg (n=21) or 25 mg (n=19) of oral Namodenoson vs. placebo (n=20). The patients were treated for 12 weeks and followed-up until week 16. As a result of the study, 25 mg was determined to be the optimal dose.

Data presented during the oral presentation included:

  • Anti-Inflammatory effect – a significant decrease in the liver enzymes ALT and AST and significant improvement in the positive cytokine adiponectin was recorded in the Namodenoson 25 mg treated group
  • Reduced liver fat content – manifested by a significant reduction in % of liver fat volume assessed by MRI-PDFF and a decrease in the Controlled Attenuation Parameter (CAP – score ≥ 331) measured by FibroScan in the Namodenoson 25 mg group
  • Decrease in FIB-4 and FAST – non-invasive tests showed anti-fibrosis effect in Namodenoson 25 mg group
  • Decrease in body weight – a linear decrease in body weight was recorded in the 25 mg and 12.5 mg Namodenoson groups with a better effect in the higher dose
  • Safety – Namodenoson continued to have a safe profile and was very well tolerated with no drug emergent severe adverse effects and no hepatotoxicity

“We were very pleased that the AASLD accepted our late breaking abstract for an oral presentation, a prominent platform through which we shared these important study results with the leading scientists and health care professionals committed to preventing and curing liver diseases. We thank Dr. Safadi for delivering the presentation,” stated Can-Fite CEO Dr. Pnina Fishman.

Dr. Safadi added, “Namodenoson’s very impressive study data may result in a promising drug for the treatment of NAFLD/NASH due to the combination of good efficacy and favorable safety.”

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, inflammatory disease and COVID-19. The Company’s lead drug candidate, Piclidenoson, is currently in a Phase III trial for rheumatoid arthritis/psoriasis and a Phase II study in the treatment of moderate COVID-19. Can-Fite’s liver drug, Namodenoson, is headed into a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and successfully achieved its primary endpoint in a Phase II trial for the treatment of non-alcoholic steatohepatitis (NASH). Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Forward-Looking Statements

This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, market risks and uncertainties, its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, Can-Fite or its representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, various filings made by Can-Fite with the U.S. Securities and Exchange Commission, press releases or oral statements made by or with the approval of one of Can-Fite’s authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause Can-Fite’s actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause Can-Fite’s actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements. Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the impact of the COVID-19 pandemic; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; statements as to the impact of the political and security situation in Israel on our business; and risks and other risk factors detailed in Can-Fite’s filings with the SEC and in its periodic filings with the TASE. In addition, Can-Fite operates in an industry sector where securities values are highly volatile and may be influenced by economic and other factors beyond its control. Can-Fite does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.

Can-Fite BioPharma

Motti Farbstein

[email protected]

+972-3-9241114

KEYWORDS: United States North America Israel Middle East New York

INDUSTRY KEYWORDS: Professional Services Health Finance General Health Clinical Trials Pharmaceutical Biotechnology

MEDIA:

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Provectus Biopharmaceuticals Announces Presentation of PV-10® Pancreatic Cancer Data at 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting

KNOXVILLE, TN, Nov. 16, 2020 (GLOBE NEWSWIRE) — Provectus (OTCQB: PVCT) today announced that H. Lee Moffitt Cancer Center (Moffitt) presented non-clinical data from ongoing research on investigational autolytic cancer immunotherapy PV-10, an injectable formulation of Provectus’ proprietary small molecule rose bengal disodium (RBD), as a single-agent and in combination with gemcitabine chemotherapy for the treatment of pancreatic cancer at the Society for Immunotherapy of Cancer’s (SITC) 35th Anniversary Annual Meeting & Pre-Conference Programs (SITC 2020), held online from November 9-14, 2020.

RBD selectively accumulates in the lysosomes of cancer cells upon contact, disrupts these lysosomes, and causes the cancer cells to die. Intralesional (IL) (aka intratumoral) administration of PV-10 causes acute destruction of injected tumors, resulting in the release of danger-associated molecular pattern molecules (DAMPs) and tumor antigens. These signaling factors may initiate an immunologic cascade, where the innate immune system response may facilitate systemic anti-tumor immunity by the adaptive immune system. PV-10-mediated DAMP release may activate CD8+ T cells, CD4+ T cells, and NKT cells.

Moffitt’s poster presentation, authored by Innamarato et al. and entitled “Intralesional injection of rose bengal augments the efficacy of gemcitabine chemotherapy against pancreatic tumors,” concluded:

  • PV-10 kills human and murine pancreatic tumor cells in vitro,
  • The combination therapy of PV-10 and gemcitabine reduces the growth rate of murine Panc02 tumors in vivo,
  • Immunogenic Panc02OVA tumors are more sensitive in vivo to single-agent PV-10,
  • The combination therapy reduces the growth of non-injected bystander Panc02OVA tumors in vivo, and
  • Reduced tumor growth after PV-10 treatment is associated with the release of DAMPs.

PV-10-mediated DAMP-release has been demonstrated in three different cancers, varying from immunologically “cold” to “hot” tumor types:

Dominic Rodrigues, Vice Chair of the Company’s Board of Directors said, “We are grateful to the leadership and researchers of the Pilon-Thomas Lab at Moffitt Cancer Center for their translational investigation of cancer immunotherapy PV-10 in melanoma, breast cancer, and now pancreatic cancer. The non-clinical results presented at this year’s annual meeting of the Society for Immunotherapy of Cancer demonstrate that intralesional administration of PV-10 can enhance the efficacy of gemcitabine chemotherapy against pancreatic tumors.”

Mr. Rodrigues added, “A key aspect of our drug development strategy for intralesional administration of PV-10 in solid tumor cancers is targeting disease indications where there is high unmet need among patients, limited activity from approved therapies, and the opportunity to display the contribution of PV-10’s functional immune response to successful patient treatment outcomes. Pancreatic cancer is a deadly disease for which PV-10 could enhance standard of care chemotherapy.”

A copy of the poster presentation is available on Provectus’ website at https://www.provectusbio.com/media/docs/publications/Panc-PV10-Poster-SITC-2020-2.pdf.

About Rose Bengal Disodium

RBD is 4,5,6,7-tetrachloro-2′,4′,5′,7′-tetraiodofluorescein disodium, a halogenated xanthene and Provectus’ proprietary lead molecule. The Company manufactures cGMP RBD using a patented process designed to meet stringent modern global quality requirements for pharmaceuticals and pharmaceutical ingredients.

An IL formulation (i.e., by direct injection) of cGMP RBD drug substance, cGMP PV-10, is being developed as an autolytic immunotherapy drug product for solid tumor cancers. By targeting tumor cell lysosomes, RBD treatment may yield immunogenic cell death in solid tumor cancers that results in tumor-specific reactivity in circulating T cells, including a T cell mediated immune response against treatment refractory and immunologically cold tumors.1,2,3 Adaptive immunity can be enhanced by combining immune checkpoint blockade (CB) with RBD.4 IL PV-10 is undergoing clinical study for relapsed and refractory adult solid tumor cancers, such skin and liver cancers.

IL PV-10 is also undergoing preclinical study for relapsed and refractory pediatric solid tumor cancers, such as neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma.5,6

A topical formulation of cGMP RBD drug substance, PH-10®, is being developed as a clinical-stage immuno-dermatology drug product for inflammatory dermatoses, such as atopic dermatitis and psoriasis. RBD can modulate multiple interleukin and interferon pathways and key cytokine disease drivers.7

Oral formulations of cGMP RBD are undergoing preclinical study for relapsed and refractory pediatric blood cancers, such as acute lymphocytic leukemia and acute myelomonocytic leukemia.8,9

Oral formulations of cGMP RBD are also undergoing preclinical study as prophylactic and therapeutic treatments for high-risk adult solid tumor cancers, such as head and neck, breast, pancreatic, liver, and colorectal cancers.

Different formulations of cGMP RBD are also undergoing preclinical study as potential treatments for multi-drug resistant (MDR) bacteria, such as Gram-negative bacteria.

Tumor Cell Lysosomes as the Seminal Cancer Drug Target

Lysosomes are the central organelles for intracellular degradation of biological materials, and nearly all types of eukaryotic cells have them. Discovered by Christian de Duve, MD in 1955, lysosomes are linked to several biological processes, including cell death and immune response. In 1959, de Duve described them as ‘suicide bags’ because their rupture causes cell death and tissue autolysis. He was awarded the Nobel Prize in 1974 for discovering and characterizing lysosomes, which are also linked to each of the three primary cell death pathways: apoptosis, autophagy, and necrosis.

Building on the Discovery, Exploration, and Characterization of Lysosomes

Cancer cells, particularly advanced cancer cells, are very dependent on effective lysosomal functioning.10 Cancer progression and metastasis are associated with lysosomal compartment changes11,12, which are closely correlated (among other things) with invasive growth, angiogenesis, and drug resistance13.

RBD selectively accumulates in the lysosomes of cancer cells upon contact, disrupting the lysosomes and causing the cells to die. Provectus1,14, external collaborators5, and other researchers15,16,17 have independently shown that RBD triggers each of the three primary cell death pathways: apoptosis, autophagy, and necrosis.

Cancer Cell Autolytic Death via RBD: RBD-induced autolytic cell death, or death by self-digestion, in Hepa1-6 murine hepatocellular carcinoma (HCC) cells can be viewed in this Provectus video of the process (ethidium homodimer 1 [ED-1] stains DNA, but is excluded from intact nuclei; lysosensor green [LSG] stains intact lysosomes; the video is provided in 30-second frames, with a duration of approximately one hour). Exposure to RBD triggers the disruption of lysosomes, followed by nucleus failure and autolytic cell death. Identical responses have been shown by the Company in HTB-133 human breast carcinoma (which can be viewed in this Provectus video of the process, with a duration of approximately two hours) and H69Ar human multidrug-resistant small cell lung carcinoma. Cancer cell autolytic cell death was reproduced by research collaborators in neuroblastoma cells to show that lysosomes are disrupted upon exposure to RBD.5

Tumor Autolytic Death via RBD: RBD causes acute autolytic destruction of injected tumors (via autolytic cell death), mediating the release of DAMPs and tumor antigens; release of these signaling factors may initiate an immunologic cascade where local response by the innate immune system may facilitate systemic anti-tumor immunity by the adaptive immune system. The DAMP release-mediated adaptive immune response activates lymphocytes, including CD8+ T cells, CD4+ T cells, and NKT cells, based on clinical and preclinical experience in multiple tumor types. Mediated immune signaling pathways may include an effect on STING, which plays an important role in innate immunity.9

Orphan Drug Designations (ODDs)

ODD status has been granted to RBD by the U.S. Food and Drug Administration for metastatic melanoma in 2006, hepatocellular carcinoma in 2011, neuroblastoma in 2018, and ocular melanoma (including uveal melanoma) in 2019.

Intellectual Property (IP)

Provectus’ IP includes a family of US and international (a number of countries in Asia, Europe, and North America) patents that protect the process by which cGMP RBD and related halogenated xanthenes are produced, avoiding the formation of previously unknown impurities that exist in commercial-grade rose bengal in uncontrolled amounts. The requirement to control these impurities is in accordance with International Council on Harmonisation (ICH) guidelines for the manufacturing of an injectable pharmaceutical. US patent numbers are 8,530,675, 9,273,022, and 9,422,260, with expirations ranging from 2030 to 2031.

The Company’s IP also includes a family of US and international (a number of countries in Asia, Europe, and North America) patents that protect the combination of RBD and CB (e.g., anti-CTLA-4, anti-PD-1, and anti-PD-L1 agents) for the treatment of a range of solid tumor cancers. US patent numbers are 9,107,887, 9,808,524, 9,839,688, and 10,471,144, with expirations ranging from 2032 to 2035; US patent application numbers include 20200138942.

About Provectus

Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different disease areas based on an entirely- and wholly-owned family of small molecules called halogenated xanthenes. Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, www.clinicaltrials.gov. For additional information about Provectus, please visit the Company’s website at www.provectusbio.com.

References

1. Wachter et al. Functional Imaging of Photosensitizers using Multiphoton Microscopy. Proceedings of SPIE 4620, 143, 2002.

2. Liu et al. Intralesional rose bengal in melanoma elicits tumor immunity via activation of dendritic cells by the release of high mobility group box 1. Oncotarget 7, 37893, 2016.

3. Qin et al. Colon cancer cell treatment with rose bengal generates a protective immune response via immunogenic cell death. Cell Death and Disease 8, e2584, 2017.

4. Liu et al. T cell mediated immunity after combination therapy with intralesional PV-10 and blockade of the PD-1/PD-L1 pathway in a murine melanoma model. PLoS One 13, e0196033, 2018.

5. Swift et al. Potent in vitro and xenograft antitumor activity of a novel agent, PV-10, against relapsed and refractory neuroblastoma. OncoTargets and Therapy 12, 1293, 2019.

6. Swift et al. In vitro and xenograft anti-tumor activity, target modulation and drug synergy studies of PV-10 against refractory pediatric solid tumors. 2018 ASCO Annual Meeting, J Clin Oncol 36, 2018 (suppl; abstr 10557).

7. Krueger et al. Immune Modulation by Topical PH-10 Aqueous Hydrogel (Rose Bengal Disodium) in Psoriasis Lesions. Psoriasis Gene to Clinic, 8th International Congress, Br J Dermatol 177.

8. Swift et al. In Vitro Activity and Target Modulation of PV-10 Against Relapsed and Refractory Pediatric Leukemia. 2018 ASH Annual Meeting, Blood 132, 2018 (suppl; abstr 5207).

9. Thakur et al. Association of heat shock proteins as chaperone for STING: A potential link in a key immune activation mechanism revealed by the novel anti-cancer agent PV-10. 2020 AACR VAM II, (abstr 5393).

10. Piao et al. Targeting the lysosome in cancer. Annals of the New York Academy of Sciences. 2016; 1371(1): 45.

11. Nishimura et al. Malignant Transformation Alters Intracellular Trafficking of Lysosomal Cathespin D in Human Breast Epithelial Cells. Pathology Oncology Research. 1998; 4(4): 283.

12. Gocheva et al. Distinct roles for cysteine cathepsin genes in multistage tumorigenesis. Genes & Development. 2006; 20(5): 543.

13. Fehrenbacher et al. Lysosomes as Targets for Cancer Therapy. Cancer Research. 2005; 65 (8): 2993.

14. Wachter et al. Imaging Photosensitizer Distribution and Pharmacology using Multiphoton Microscopy. Proceedings of SPIE 4622, 112, 2002.

15. Koevary. Selective toxicity of rose Bengal to ovarian cancer cells in vitro. International Journal of Physiology, Pathophysiology and Pharmacology 4(2), 99, 2012.

16. Zamani et al. Rose Bengal suppresses gastric cancer cell proliferation via apoptosis and inhibits nitric oxide formation in macrophages. Journal of Immunotoxicology, 11(4), 367, 2014.

17. Luciana et al. Rose Bengal Acetate photodynamic therapy-induced autophagy. Cancer Biology & Therapy, 10:10, 1048, 2010.

Trademarks

PV-10® and PH-10® are registered trademarks of Provectus, Knoxville, Tennessee, U.S.A.


FORWARD-LOOKING STATEMENTS:

The information in this press release may include “forward-looking statements,” within the meaning of U.S. securities legislation, relating to the business of Provectus and its affiliates, which are based on the opinions and estimates of Company management and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “project,” “predict,” “potential,” “targeting,” “intend,” “could,” “might,” “should,” “believe,” and similar words suggesting future outcomes or statements regarding an outlook.

The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated or that such agents as products will achieve any particular revenue levels.

Due to the risks, uncertainties, and assumptions inherent in forward-looking statements, readers should not place undue reliance on these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof or as of the date specifically specified herein, and Provectus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except in accordance with applicable securities laws. The forward-looking statements are expressly qualified by this cautionary statement.

Risks, uncertainties, and assumptions include those discussed in the Company’s filings with the SEC, including those described in


Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019


and


Provectus’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2020


.

###

Contact:

Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999



K92 Mining Inc Releases Strong 2020 Q3 Financial Results, Including Record Net Cash & Throughput Following Commissioning of Stage 2 Plant Expansion

VANCOUVER, British Columbia, Nov. 16, 2020 (GLOBE NEWSWIRE) — K92 Mining Inc. (“K92” or the “Company”) (TSX-V: KNT; OTCQX: KNTNF) is pleased to announce results from its interim financial statements for the three and nine months ended September 30, 2020.

Third Quarter 2020 Highlights:

Safety

  • Strong safety record continues, with no lost time injuries and one of the best safety records in the Australasia region since start of operations.
  • Proactive and focused management of COVID-19. K92 continues to operate and has strong preventative and response plans.

Production

  • Record tonnage of 64,702 tonnes treated, a 102% increase from Q3 2019.
  • Quarterly production of 22,261 oz gold equivalent (“AuEq”) oz, comprising 21,298 oz of gold, 488,020 lbs copper and 7,127 oz silver.
  • Cash costs of US$695/oz gold and all-in sustaining costs (“AISC”) of US$834/oz gold(2).
  • Long hole stoping at the K1 and K2 Veins has continued to perform to design and has provided a notable positive impact on operational flexibility.

Financials

  • Sold 19,265 oz of gold, 487,087 lbs of copper and 7,166 oz of silver. Gold concentrate inventories of 5,859 oz as of September 30, 2020, a quarterly increase of 2,420 oz.
  • Quarterly revenue of US$35.6 million, a 70% increase from Q3 2019.
  • Operating cash flow (before working capital adjustments) of US$14.8 million or US$0.07 per share and earnings before interest, taxes, depreciation and amortization (“EBITDA”) of US$17.4 million or US$0.08 per share.
  • Net income of US$9.4 million or US$0.04 per share.
  • Balance sheet significantly strengthened during Q3, with cash increasing by US$6.5 million to US$41.2 million and debt decreasing by US$2.1 million to US$7.0 million as at September 30, 2020.

Growth

  • Successful commissioning of the Stage 2 Plant Expansion to double throughput capacity to 400,000 tonnes per year and continued development of the twin incline following the lifting of the State of Emergency in June.
  • Stage 3 Expansion Preliminary Economic Assessment announced on July 27, 2020, outlining a potential Tier 1 asset, with ~318,000 ounces per annum AuEq run-rate production at a life of mine average AISC cost of $362 per gold ounce net of by-product credits. At $1,500/oz gold, $18/oz silver and $3.00/lb copper prices, the estimate after-tax NPV5% is US$1.5 billion and is fully funded from mine cash flow. At US$1,900/oz gold prices the estimated after-tax NPV5% is US$2.0 billion.
  • Preliminary results reported from underground development on the Judd Vein #1 (“J1”), marking the first significant exploration undertaken by K92 on the near-mine infrastructure, underexplored, +2.5km strike vein system. A Phase 1 underground drill program commenced during the quarter after reporting the preliminary results.
  • Drill rigs increased to 9 at the end of the quarter and is expected to increase to 10 by year end, with plans to drill Kora, Kora South, Karempe and Judd epithermal vein systems plus the Blue Lake porphyry concurrently by year end.

For complete details of the interim consolidated financial statements and associated management’s discussion and analysis, please refer to the Company’s website or profile on SEDAR (www.sedar.com).  All amounts are in U.S. dollars unless otherwise indicated.

John Lewins, K92 Chief Executive Officer and Director, stated, “The third quarter achieved multiple important milestones in terms of both production and exploration. On production, the completion of the Stage 2 Plant Expansion commissioning represents a major step-change for Kainantu’s production capabilities, doubling mill throughput from 200,000 tpa (~550 tpd) to 400,000 tpa (~1,100 tpd). Since completing commissioning, the operation has performed well, and we expect a strong finish to 2020.

On exploration, the number of drill rigs has increased to nine and our tenth drill rig is expected to arrive by year end. The increase in drill rigs has not only provided a considerable boost to our drilling rates, but more importantly, our capacity to drill multiple targets concurrently. In late October, we announced our maiden drilling results on the Karempe Vein system, intersecting five sub-parallel veins and multiple high grade intersections including KRDD0005 recording 2.45 m at 39.82 g/t Au, 6 g/t Ag and 0.19% Cu (40.18 g/t AuEq, 2.30 m true width) on the KA1 Vein (see October 22, 2020 Press Release). Last week, we announced our first set of drilling results from our Phase 1 drill program at Judd, intersecting three sub-parallel veins systems including JDD0006 recording 7.25 m at 256.09 g/t Au, 113 g/t Ag and 0.42 % Cu (258.01 g/t AuEq, 5.30m true width) on the J1 vein (see November 9, 2020 Press Release). Both Karempe and Judd recorded mineralization similar to Kora. We have also recently commenced porphyry exploration, with the Phase 2 drill program at the Blue Lake porphyry now underway. Plans to add additional drill rigs are in progress for 2021, with an eleventh drill rig already scheduled to arrive in Q1.

Lastly, we would like to thank the extraordinary commitment of our workforce during the COVID-19 pandemic. The amount of progress achieved year to date has been outstanding. The support of all levels of government has also been a major factor.”

 
Mine Operating Activities
     
  Three months ended Three months ended
  September 30, 2020 September 30, 2019

Operating data
   
Head grade (Au g/t) 11.3 19.2
Gold recovery (%) 90.7% 94.1%
Gold ounces produced 21,298 18,636
Gold ounces equivalent produced (1) 22,261 19,170
Tonnes of copper produced 221 95
Silver ounces produced 7,127 5,284
     

Financial data (in thousands of dollars)
   
Gold ounces sold 19,265 15,652
Revenues from concentrate sales US$35,605 US$20,989
Mine operating expenses US$8,068 US$4,283
Other mine expenses  US$5,113 US$5,387
Depreciation and depletion US$2,702 US$2,569
     

Statistics (in dollars)
   
Average realized selling price per ounce, net US$1,815 US$1,409
Cash cost per ounce US$695 US$649
All-in sustaining cost per ounce  US$834 US$800
     

Notes:

(1) Gold equivalent for 2020 based on the following prices: gold $1,500 per ounce; silver $17.75 per ounce; and copper $2.70 per pound.  Gold equivalent for 2019 based on the following metal prices: gold $1,300 per ounce; silver $16.50 per ounce; and copper $2.90 per pound.

(2) The Company provides some non-international financial reporting standard measures as supplementary information that management believes may be useful to investors to explain the Company’s financial results.  Please refer to non-IFRS financial performance measures in the Company’s management’s discussion and analysis dated November 12, 2020, available on SEDAR or the Company’s website, for reconciliation of these measures.

K92 has not based its production decisions on mineral reserve estimates or feasibility studies, and historically such projects have increased uncertainty and risk of failure.  Mineral resources that are not mineral reserves do not have demonstrated economic viability.

Conference Call Information

K92 will host a conference call and webcast to present the 2020 Q3 Financial Results at 8:30 am (EST) on Monday, November 16, 2020.

  • Listeners may access the conference call by dialing toll-free to 1-800-319-4610 within North America or +1-604-638-5340 from international locations.
    ° The conference call will also be broadcast live (webcast) and may be accessed via the following link: http://services.choruscall.ca/links/k92mining20201116.html

Qualified Person

K92 Mine Geology Manager and Mine Exploration Manager, Mr. Andrew Kohler, PGeo, a Qualified Person under the meaning of National Instrument 43-101 – Standards of Disclosure for Mineral Projects has reviewed and approved the technical content of this news release.

On Behalf of the Company,

John Lewins, Chief Executive Officer and Director

For further information, please contact David Medilek, P.Eng., CFA at +1-604-687-7130.

NEITHER TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN POLICIES OF THE TSX VENTURE EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION: This news release includes certain “forward-looking statements” under applicable Canadian securities legislation. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. All statements that address future plans, activities, events, or developments that the Company believes, expects or anticipates will or may occur are forward-looking information, including statements regarding the realization of the preliminary economic analysis for the Kainantu Project, expectations of future cash flows, the planned plant expansion, production results, cost of sales, sales of production, potential expansion of resources and the generation of further drilling results which may or may not occur. Forward-looking statements and information contained herein are based on certain factors and assumptions regarding, among other things, the market price of the Company’s securities, metal prices, exchange rates, taxation, the estimation, timing and amount of future exploration and development, capital and operating costs, the availability of financing, the receipt of regulatory approvals, assumptions contained in the PEA, environmental risks, title disputes, failure of plant, equipment or processes to operate as anticipated, accidents, labour disputes, claims and limitations on insurance coverage and other risks of the mining industry, changes in national and local government regulation of mining operations in PNG, mitigation of the Covid-19 pandemic, continuation of the lifted state of emergency, and regulations and other matters. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. 



Weingarten Realty Continued Improvement in Cash Collections and Provides COVID-19 Update

Weingarten Realty Continued Improvement in Cash Collections and Provides COVID-19 Update

HOUSTON–(BUSINESS WIRE)–
Weingarten Realty (NYSE: WRI) provided the following business update regarding the COVID-19 pandemic for the REITworld: 2020 Investors Conference, including an update on rent collections for the third quarter and October of 2020. To view the Company’s updated investor presentation, please visit the REITworld 2020 Investor Presentation on our Webcasts & Presentations page at www.weingarten.com.

“Weingarten is well positioned to navigate the COVID pandemic. We are pleased with the increase in cash collections to 91% for the third quarter and 90% for October which we are reporting today. This demonstrates the strength of our transformed portfolio of primarily grocery-anchored centers that provide basic goods and services,” said Drew Alexander, Chairman, President and Chief Executive Officer.

For further details of the updated collections information, please refer to the Company’s REITworld 2020 investor presentation that can be found on its website at www.weingarten.com.

About Weingarten Realty Investors

Weingarten Realty Investors (NYSE: WRI) is a shopping center owner, manager and developer. At September 30, 2020, the Company owned or operated under long-term leases, either directly or through its interest in real estate joint ventures or partnerships, a total of 162 properties which are located in 15 states spanning the country from coast to coast. These properties represent approximately 31.0 million square feet of which our interests in these properties aggregated approximately 21.0 million square feet of leasable area. To learn more about the Company’s operations and growth strategies, please visit www.weingarten.com.

Forward-Looking Statements

Statements included herein that state the Company’s or Management’s intentions, hopes, beliefs, expectations or predictions of the future are “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995 which by their nature, involve known and unknown risks and uncertainties. The Company’s actual results, performance or achievements could differ materially from those expressed or implied by such statements. These risks and uncertainties include those related to the COVID-19 pandemic, about which there are still many unknowns, including the duration of the pandemic and the extent of its impact, as well as those discussed in the Company’s regulatory filings with the Securities and Exchange Commission, which include other information or factors that may impact the Company’s performance.

Projections involve numerous assumptions such as rental income (including assumptions on percentage rent), interest rates, tenant defaults, occupancy rates, volume and pricing of properties held for disposition, volume and pricing of acquisitions, expenses (including salaries and employee costs), insurance costs and numerous other factors. Not all of these factors are determinable at this time and actual results may vary from the projected results, and may be above or below the ranges indicated. The above ranges represents management’s estimate of results based upon these assumptions as of the date of this press release. Accordingly, there is no assurance that our projections will be realized.

Michelle Wiggs, Phone: (713) 866-6050

KEYWORDS: United States North America Texas

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

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Capstead Mortgage Corporation to Present Virtually and Host 1×1 Investor Meetings at Southwest IDEAS Investor Conference on November 18, 2020

Capstead Mortgage Corporation to Present Virtually and Host 1×1 Investor Meetings at Southwest IDEAS Investor Conference on November 18, 2020

DALLAS–(BUSINESS WIRE)–
Capstead Mortgage Corporation (NYSE: CMO) (“Capstead” or the “Company”) announced today that Management will participate in the virtual Southwest IDEAS Investor Conference on November 18, 2020.

Capstead’s presentation is scheduled to be available at 7:00 am CST on Wednesday, November 18, 2020 and will be accessible to registered attendees through the conference site at www.IDEASconferences.com. If interested in participating or learning more about the IDEAS conferences, please visit the IDEAS website.

Additionally, a webcast of the presentation will be available at 7:00 am CST on Monday, November 16, 2020 through the investor relations section of the Company’s website under the event calendar page of the news and market information tab at http://www.capstead.com.

About Capstead

Capstead is a self-managed real estate investment trust, or REIT, for federal income tax purposes. The Company earns income from investing in a leveraged portfolio of residential adjustable-rate mortgage pass-through securities, referred to as ARM securities, issued and guaranteed by government-sponsored enterprises, either Fannie Mae, Freddie Mac, or by an agency of the federal government, Ginnie Mae.

Capstead’s investment strategy attempts to mitigate risks to book value by focusing on investments in agency-guaranteed residential mortgage pass-through securities, which are considered to have little, if any, credit risk and are collateralized by ARM loans with interest rates that reset periodically to more current levels.

Lindsey Crabbe

(214) 874-2339

 

KEYWORDS: United States North America Texas

INDUSTRY KEYWORDS: Construction & Property Professional Services REIT Finance

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Atkore International Is Great Place to Work Certified in 2020

Atkore International Is Great Place to Work Certified in 2020

HARVEY, Ill.–(BUSINESS WIRE)–
Atkore International Group Inc. (the “Company”) (NYSE: ATKR), a leading provider of electrical, safety and infrastructure solutions, today announced the Company has been designated as a Great Place to Work-Certified™ company. The Great Place to Work organization is the global authority on workplace culture and employee experience, and the leadership behaviors proven to deliver market-leading revenue and increased innovation.

“We are excited to receive certification as a Great Place to Work, especially in our first year of participation,” remarked Bill Waltz, Atkore President and Chief Executive Officer. “Our mission, values and culture have created a workplace that attracts the best talent. This certification helps further validate the value delivered through our focus on developing employees, supporting a diverse and inclusive culture, and driving reward and recognition at all levels of the organization.”

Company employees completed the program’s signature Trust Index© Survey that covered a variety of workplace quality experiences, including employees’ ability to perform their jobs, management credibility, respect and fairness, pride in their work and camaraderie within the organization. Rankings are based on employees’ experiences, no matter who they are or what they do. Highlights from the Company’s survey results include:

  • 89 percent believe people they are treated fairly, regardless of race.
  • 85 percent believe they are given a lot of responsibility.
  • 84 percent believe when you join the Company, you are made to feel welcome.

     

Mr. Waltz added, “At Atkore, we firmly believe that our employees are our most important asset. By developing a culture that is supportive of their needs, we are able to build an engaged and aligned team committed to achieving the organization’s goals.”

“We congratulate Atkore on their Certification,” said Sarah Lewis-Kulin, Vice President of Best Workplace List Research at Great Place to Work. “Organizations that earn their employees’ trust create great workplace cultures that deliver outstanding business results.”

About Atkore International

Atkore is forging a future where our employees, customers, suppliers, shareholders and communities are building better together – a future focused on serving the customer and powering and protecting the world.

With approximately 3,900 employees and 66 manufacturing and distribution facilities worldwide, Atkore is a leading provider of electrical, safety and infrastructure solutions. To learn more, please visit www.atkore.com.

About Great Place to Work®

Great Place to Work helps organizations quantify their culture and produce better business results by creating a high-trust work experience for all employees. Emprising®, their culture management platform, empowers leaders with the surveys, real-time reporting, and insights they need to make data-driven people decisions.

Lisa Winter

Vice President-Communications

708 225 2453

KEYWORDS: Illinois United States North America

INDUSTRY KEYWORDS: Manufacturing Other Construction & Property Commercial Building & Real Estate Construction & Property Engineering

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Change Healthcare Launches Social Determinants of Health Analytics to Help Improve Patient Outcomes

Change Healthcare Launches Social Determinants of Health Analytics to Help Improve Patient Outcomes

Innovative services help healthcare organizations better assess, select, and implement SDoH programs across diverse population health segments

NASHVILLE, Tenn.–(BUSINESS WIRE)–
Today Change Healthcare (NASDAQ: CHNG) launched an innovative national data resource that connects the circumstances of people’s lives to the care they receive. The solution, Social Determinants of Health (SDoH) Analytics, is a resource to help health systems, insurers, and life sciences organizations explore how geodemographic factors affect patient outcomes.

Scientific research has shown that 80% of health outcomes are SDoH-related. Barriers such as food and housing availability, transportation insecurity, and education inequity must be addressed to reduce health disparities and improve outcomes. Change Healthcare’s SDoH Analytics links deidentified claims with factors such as financial stability, education level, ethnicity, housing status, and household characteristics to reveal the correlations between SDoH, clinical care, and patient outcomes. The resulting dataset is de-identified in accordance with HIPAA privacy regulations.

“All the work I do—for Mayo Clinic, the COVID-19 Healthcare Coalition, and The Fight Is In Us— is predicated on equity,” said John Halamka, president, Mayo Clinic Platform. “The only way we can eliminate racism and disparities in care is to better understand the challenges. Creating a national data resource on the social determinants of health is an impactful first step.”

Healthcare organizations can now use SDoH Analytics to assess, select, and implement effective programs to help reduce costs and improve patient outcomes. Organizations can choose one of three ways to use SDOH Analytics:

  • Receive customized reports identifying SDoH factors that impact emergency room, inpatient, and outpatient visits across diverse population health segments.
  • Append existing systems with SDoH data to close information gaps and help optimize both patient engagement and outcomes.
  • Leverage a secure, hosted environment with ongoing compliance monitoring for the development of unique data analytics, models, or algorithms.

“Health systems, insurers, and scientists can now use SDoH Analytics to make a direct connection between life’s circumstances and health outcomes,” said Tim Suther, senior vice president of Data Solutions at Change Healthcare. “This helps optimize healthcare utilization, member engagement, and employer wellness programs. Medical affairs and research are transformed. And most importantly, patient outcomes improve. SDoH Analytics makes these data-driven insights affordable and actionable.”

“Healthcare providers have long known that diseases impact people differently based on various factors, a challenge that has become acutely clear during the COVID-19 pandemic,” said Michael Pencina, PhD, vice dean for Data Science and Information Technology at Duke University School of Medicine. “Access to social determinants of health data allows us to support fair and equitable care and to apply novel methodologies to new challenges. We are currently leveraging this data to help ensure that the right therapies are being used for the right patient at the right time in their treatment. And that should lead to better healthcare for all.”

Organizations can get started by visiting the SDoH Analytics site for more information.

Change Healthcare operates one of the nation’s largest datasets of deidentified claims and remittances. For details on how authorized healthcare stakeholders can use deidentified, aggregated data to help solve some of healthcare’s biggest problems, visit the Healthcare Data and Analytics Solutions site or contact the Change Healthcare sales team.

About Change Healthcare

Change Healthcare (Nasdaq: CHNG) is a leading independent healthcare technology company, focused on accelerating the transformation of the healthcare system through the power of the Change Healthcare Platform. We provide data and analytics-driven solutions to improve clinical, financial, administrative, and patient engagement outcomes in the U.S. healthcare system. Learn more at changehealthcare.com.

For more information on Change Healthcare, please visit our website, hear from our experts at Insights; Follow us on Twitter; Like us on Facebook; Connect with us on LinkedIn; and Subscribe to us on Libsyn, Apple Podcasts, Google Podcasts, and YouTube.

Katherine Wojtecki

External Communications

Change Healthcare

630-624-9142

[email protected]

KEYWORDS: United States North America Tennessee

INDUSTRY KEYWORDS: Data Management Health Technology Practice Management Software General Health

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