Algonquin Power & Utilities Corp. Declares Fourth Quarter 2020 Common Share Dividend of U.S. $0.1551 (C$0.2019)

PR Newswire

OAKVILLE, ON, Nov. 12, 2020 /PRNewswire/ – Algonquin Power & Utilities Corp. (“APUC”) (TSX: AQN) (NYSE: AQN) announced today that the Board of Directors has declared a dividend of U.S. $0.1551 per share on its common shares, payable on January 15, 2021, to the shareholders of record on December 31, 2020, for the period from October 1, 2020 to December 31, 2020.  Shareholders receiving dividends in cash can elect to receive the dividend in Canadian dollars in the amount of C$0.2019.

The common share dividend will be paid in cash or, if a shareholder has enrolled in the shareholder dividend reinvestment plan (the “Plan”), dividends will be reinvested in additional common shares (“Plan Shares”) of APUC as per the Plan.  Plan Shares will be acquired by way of a Treasury Purchase at the average market price as defined in the Plan less a 5% discount.

Pursuant to the Income Tax Act (Canada) and corresponding provincial legislation, APUC hereby notifies its common shareholders that such dividends declared qualify as eligible dividends.

The quarterly dividends payable on common shares are declared in U.S. dollars. Beneficial shareholders (those who hold common shares through a financial intermediary) who are resident in Canada or the United States may request to receive their dividends in either U.S. dollars or the Canadian dollar equivalent by contacting the financial intermediary with whom the common shares are held. Unless the Canadian dollar equivalent is requested, shareholders will receive dividends in U.S. dollars, which, as is often the case, the financial intermediary may convert to Canadian dollars. Registered shareholders receive dividend payments in the currency of residency. Registered shareholders may opt to change the payment currency by contacting AST Trust Company (Canada) at 1-800-387-0825 prior to the record date of the dividend.

The Canadian dollar equivalent of the quarterly dividend is based on the Bank of Canada daily average exchange rate on the day before the declaration date.

About Algonquin Power & Utilities Corp., Liberty Utilities, and Liberty Power

APUC is a diversified international generation, transmission, and distribution utility with approximately $11 billion of total assets. Through its two business groups, Liberty Utilities and Liberty Power, APUC is committed to providing safe, secure, reliable, cost-effective, and sustainable energy and water solutions through its portfolio of electric generation, transmission, and distribution utility investments to over 1 million customer connections, largely in the United States and Canada.  APUC is a global leader in renewable energy through its portfolio of long-term contracted wind, solar, and hydroelectric generating facilities representing over 2 GW of installed capacity and approximately 1.4 GW of incremental renewable energy capacity under construction.

APUC is committed to delivering growth and the pursuit of operational excellence in a sustainable manner through an expanding global pipeline of renewable energy and electric transmission development projects, organic growth within its rate-regulated generation, distribution, and transmission businesses, and the pursuit of accretive acquisitions.

APUC’s common shares, Series A preferred shares, and Series D preferred shares are listed on the Toronto Stock Exchange under the symbols AQN, AQN.PR.A, and AQN.PR.D, respectively. APUC’s common shares, Series 2018-A subordinated notes and Series 2019-A subordinated notes are listed on the New York Stock Exchange under the symbols AQN, AQNA and AQNB, respectively.

Visit APUC at www.algonquinpowerandutilities.com and follow us on Twitter @AQN_Utilities.

Cision View original content:http://www.prnewswire.com/news-releases/algonquin-power–utilities-corp-declares-fourth-quarter-2020-common-share-dividend-of-us-0-1551-c0-2019-301172465.html

SOURCE Algonquin Power & Utilities Corp.

CRH Medical Corporation Announces 2020 Third Quarter Results

PR Newswire

VANCOUVER, BC, Nov. 12, 2020 /PRNewswire/ – CRH Medical Corporation (TSX: CRH) (NYSE MKT: CRHM) (“CRH” or the “Company”), today announced financial and operating results for the three months ended September 30, 2020.

Third quarter 2020 highlights:

  • Total revenue of $30.3 million, down 0.2% from third quarter 2019
  • Anesthesia services revenue of $28.0 million, up 0.1% from third quarter 2019
  • Product sales revenue of $2.4 million, down 3.4% from third quarter of 2019
  • Anesthesia patient cases of 94,052 increased 6.0% from third quarter 2019
  • Adjusted operating EBITDA of $11.8 million, down 9.3% from third quarter 2019
  • Adjusted operating shareholder EBITDA of $8.0 million, a decrease of 15.2% from third quarter 2019
  • Through the first nine months of 2020, the Company generated $24.8 million in cash from operating activities and $16.1 million in free cash flow
  • The Company also completed three acquisitions and one startup joint venture

Tushar Ramani, Chair and Chief Executive Officer of CRH, commented: “Although COVID-19 continued to exert a negative impact upon both of our business segments in the third quarter, we were encouraged by the 125% increase in anesthesia revenue and the 104% increase in O’Regan revenue as compared to Q2 2020. We remain confident in our ability to execute against our key business initiatives in order to extend and augment our growth trajectory.”

Conference Call

CRH will host a conference call to discuss its results on Friday, November 13, 2020, at 8:30 am ET (5:30 am PT). To participate in the conference, please dial 1-888-664-6392, or 1-416-764-8659 and reference confirmation #64836562. An audio replay will be available shortly after the call by dialing 1-888-390-0541 or 1-416-764-8677 and entering access code 836562#. The replay will be available for two weeks after the call.

About CRH Medical Corporation:

CRH Medical Corporation is a North American company focused on providing gastroenterologists throughout the United States with innovative services and products for the treatment of gastrointestinal diseases. In 2014, CRH became a full-service gastroenterology anesthesia company that provides anesthesia services for patients undergoing endoscopic procedures in ambulatory surgical centers. To date, CRH has completed 30 anesthesia acquisitions, and now serves 66 ambulatory surgical centers in 13 states. In addition, CRH owns the CRH O’Regan System, a single-use, disposable, hemorrhoid banding technology that is safe and highly effective in treating all grades of hemorrhoids. CRH distributes the O’Regan System, treatment protocols, operational and marketing expertise as a complete, turnkey package directly to gastroenterology practices, creating meaningful relationships with the gastroenterologists it serves. CRH’s O’Regan System is currently used in all 48 lower US states.

Non-GAAP Measures

This press release makes reference to certain non-GAAP financial measures including adjusted operating EBITDA (in total and broken down as attributable to non-controlling interest and shareholders of the Company) and adjusted operating EBITDA margin as supplemental indicators of its financial and operating performance.  Adjusted operating EBITDA is defined as operating income before interest, taxes, depreciation, amortization, stock based compensation, acquisition related expenses and asset impairment charges. Adjusted operating EBITDA margin is defined as operating earnings before interest, taxes, depreciation, amortization, stock based compensation, acquisition related expenses and asset impairment charges as a percentage of revenue. These non-GAAP measures are not recognized measures under US Generally Accepted Accounting Principles (“US GAAP”) and do not have a standardized meaning prescribed by US GAAP and thus the Company’s definition may be different from and unlikely to be comparable to non-GAAP measures presented by other companies. These measures are provided as additional information to complement US GAAP measures by providing further understanding of the Company’s results of operations from management’s perspective. Accordingly, they should not be considered in isolation nor as a substitute for analyses of the Company’s financial information reported under US GAAP. Management uses non-GAAP measures such as adjusted operating EBITDA and adjusted operating EBITDA margin to provide investors with a supplemental measure of the Company’s operating performance and thus highlight trends in the Company’s core business that may not otherwise be apparent when relying solely on US GAAP financial measures. Management also believes that securities analysts, investors and other interested parties frequently use non-GAAP measures in the evaluation of issuers. In addition, management uses these non-GAAP measures in order to facilitate operating performance comparisons from period to period, prepare annual operating budgets, and to assess its ability to meet future debt service, capital expenditure, and working capital requirements. A quantitative reconciliation of adjusted operating EBITDA, and operating EBITDA margin to the most directly comparable measures under US GAAP is presented below.

Cautionary Note Regarding Forward-looking Statements

Information included or incorporated by reference in this press release may contain forward-looking statements. This information may involve known and unknown risks, uncertainties, and other factors which may cause our actual results, performance, or achievements to be materially different from the future results, performance, or achievements expressed or implied by any forward-looking statements. Forward-looking statements, which involve assumptions and describe our future plans, strategies, and expectations, are generally identifiable by use of the words “may,” “will,” “should,” “expect,” “anticipate,” “estimate,” “believe,” “plan,” “intend” or “project” or the negative of these words or other variations on these words or comparable terminology. Certain risks underlying our assumptions are highlighted below; if risks materialize, or if assumptions prove otherwise to be untrue, our results will differ from those suggested by our forward looking statements and our results and operations may be negatively affected. Forward looking statements in this press release include statements regarding the Company’s future growth. Actual events or results may differ materially from those discussed in forward-looking statements. There can be no assurance that the forward-looking statements currently contained in this report will in fact occur. The Company bases its forward-looking statements on information currently available to it. The Company disclaims any intent or obligations to update or revise publicly any forward-looking statements whether as a result of new information, estimates or options, future events or results or otherwise, unless required to do so by law.

Forward-looking information reflects current expectations of management regarding future events and operating performance as of the date of this document. Such information involves significant risks and uncertainties, should not be read as guarantees of future performance or results, and will not necessarily be accurate indications of whether or not such results will be achieved. A number of factors could cause actual results to differ materially from the results discussed in forward-looking information, including, without limitation: Our ability to predict developments in the COVID-19 pandemic and its impact to our operations; changes to payment rates or methods of third-party payors, including United States government healthcare programs, changes to the United States laws and regulations that regulate payments for medical services, the failure of payment rates to increase as our costs increase, or changes to our payor mix, could adversely affect our operating margins and revenues; We are subject to decreases in our revenue and profit margin under our fee for service contracts and arrangements, where we bear the risk of changes in volume, payor mix, radiology, anesthesiology, and pathology benefits, and third-party reimbursement rates; We may or may not successfully identify and complete corporate transactions on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances, and such acquisitions could result in unforeseen operating difficulties and expenditures, or require significant management resources and significant charges; Our senior management has been key to our growth, and we may be adversely affected if we lose any member of our senior management; ASCs or other customers may terminate or choose not to renew their agreements with us; If we are unable to maintain or increase anesthesia procedure volumes at our existing ASCs, the operating margins and profitability of our anesthesia segment could be adversely affected; We may not be able to successfully recruit and retain qualified anesthesia service providers or other independent contractors; We may be unable to enforce the non-competition and other restrictive covenants in our agreements; We operate in an industry that is subject to extensive federal, state, and local regulation, and changes in law and regulatory interpretations; Changes in the medical industry and the economy may affect the Company’s business; Our failure to comply with U.S. federal and state fraud and abuse laws, including anti-kickback laws and other U.S. federal and state anti-referral laws, could have a material, adverse impact on our business; A significant number of our affiliated physicians could leave our affiliated ASCs; Our industry is already competitive and could become more competitive; Unfavorable economic conditions could have an adverse effect on our business; The Company may not be successful in marketing its products and services; Failure to manage third-party service providers may adversely affect our ability to maintain the quality of service that we provide; Congress or states may enact laws restricting the amount out-of-network providers of services can charge and recover for such services; Adverse events related to our product or our services may subject us to risks associated with product liability, medical malpractice or other legal claims, insurance claims, product recalls and other liabilities, which may adversely affect our operations; Our dependence on suppliers could have a material adverse effect on our business, financial condition and results of operations; We may need to raise additional capital to fund future operations; We are subject to various restrictive covenants and events of default under the Credit Facilities; The Affordable Care Act (“ACA”) and potential changes to it may have a significant effect on our business; The Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”) and potential changes to it may have a significant effect on our business; Government authorities or other parties may assert that our business practices violate antitrust laws; If regulations or regulatory interpretations change, we may be obligated to re-negotiate agreements of our anesthetists, anesthesiologists or other contractors; Despite current indebtedness levels, we may still be able to incur substantially more debt, which could further exacerbate the risks associated with increased leverage; Failure to timely or accurately bill for services could have a negative impact on our net revenue, bad debt expense and cash flow; If we or some of our suppliers fail to comply with the FDA’s Quality System Regulation and other applicable requirements, our manufacturing or processing operations could be disrupted, our sales and profitability could suffer, and we may become subject to a wide variety of FDA enforcement actions; If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, shareholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common shares; Our industry is the subject of numerous governmental investigations into marketing and other business practices which could result in the commencement of civil and/or criminal proceedings, substantial fines, penalties, and/or administrative remedies, divert the attention of our management, and have an adverse effect on our financial condition and results of operations; We may write-off intangible assets; If we are unable to manage growth, we may be unable to achieve our expansion strategy; The continuing development of our products and provision of our services depends upon us maintaining strong relationships with physicians; Significant shareholders of the Company could influence our business operations, and sales of our shares by such significant shareholders could influence our share price; We have a legal responsibility to the minority owners of the entities through which we own our anesthesia services business, which may conflict with our interests and prevent us from acting solely in our own best interests; Our common shares may be subject to significant price and volume fluctuations; Unfavorable changes or conditions could occur in the states where our operations are concentrated: We may be subject to a variety of regulatory investigations, claims, lawsuits, and other proceedings; Our anesthesia employees and third-party contractors may not appropriately record or document services that they provide; If we are unable to adequately protect or enforce our intellectual property, our competitive position could be impaired; If there is a change in federal or state laws, rules, regulations, or in interpretations of such federal or state laws, rules or regulations, we may be required to redeem our physician partners’ ownership interests in anesthesia companies under the savings clause in our joint venture operating agreements; Our employees and business partners may not appropriately secure and protect confidential information in their possession; Failure to protect our information technology infrastructure against cyber-based attacks, network security breaches, service interruptions or data corruption could significantly disrupt our operations and adversely affect our business and operating results; If securities or industry analysts do not publish research, or publish inaccurate or unfavorable research, about our business, our share price and trading volume could decline; We may be subject to criminal or civil sanctions if we fail to comply with privacy regulations regarding the protection, use and disclosure of patient information; Evolving regulation of corporate governance and public disclosure may result in additional expenses and continuing uncertainty; Anti-takeover provisions could discourage a third party from making a takeover offer that could be beneficial to our shareholders; We are an “emerging growth company” and a “smaller reporting company,” and any decision on our part to comply only with certain reduced reporting and disclosure requirements applicable to such companies could make our common shares less attractive to investors; We do not intend to pay dividends on our common shares, and, consequently, your ability to achieve a return on your investment will depend on appreciation, if any, in the price of our common shares; Tax reform could have a material adverse effect on us; Income tax audits and changes in our effective income tax rate could affect our results of operations; The patent protection for our products may expire before we are able to maximize their commercial value, which may subject us to increased competition and reduce or eliminate our opportunity to generate revenues; and We may face exposure to adverse movements in foreign currency exchange rates.

For a complete discussion of the Company’s business including the assumptions and risks set out above, see the Company’s Form 10-K Annual Report, which is available on EDGAR at www.sec.gov/edgar.shtml or on the Company’s website at www.crhmedcorp.com.

Condensed Consolidated Balance Sheets

(unaudited)


September 30,


2020


December 31,


2019

Assets

Current assets:

Cash and cash equivalents

$

5,099,498

$

6,568,716

Trade and other receivables, net

20,358,880

20,041,288

Income tax receivable

3,252,973

1,332,129

Loan to equity investment

1,000

Prepaid expenses and deposits

426,589

729,483

Inventories, finished goods

296,070

349,324

29,435,010

29,020,940

Non-current assets:

Property and equipment, net

201,959

251,933

Right of use asset

1,094,732

214,854

Intangible assets, net

168,325,328

163,108,193

Deferred asset acquisition costs

228,777

59,249

Investment

2,016,076

Deferred tax assets

12,945,311

10,440,100

184,812,183

174,074,329

Total assets

$

214,247,193

$

203,095,269

Liabilities

Current liabilities:

Trade and other payables

$

7,449,298

$

6,196,741

Employee benefits

786,115

992,845

Income tax payable

28,589

Current portion of lease liability

241,742

125,555

Deferred consideration

1,868,052

Earn-out obligation

686,973

1,063,060

Contract payable – CMS Advance

1,808,952

Member loan

220,880

68,600

11,193,960

10,343,442

Non-current liabilities:

Lease liability

865,372

54,300

Contract payable – CMS Advance

91,636

Contingent liability

2,617,110

Notes payable and bank indebtedness

74,997,205

68,380,345

Deferred tax liabilities

23,786

101,822

78,595,109

68,536,467

Equity

Common stock, no par value; 71,461,684 and 71,603,584 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively

56,268,562

56,056,113

Additional paid-in capital

8,648,801

7,168,156

Accumulated other comprehensive loss

(66,772)

(66,772)

Retained earnings

7,423,053

13,154,981

Total equity attributable to shareholders of the Company

72,273,644

76,312,478

Non-controlling interest

52,184,480

47,902,882

Total equity

124,458,124

124,215,360

Total liabilities and equity

$

214,247,193

$

203,095,269

 

Condensed Consolidated Statements of Operations

(unaudited)


Three
 
months
 
ended
 
September
 
30,


Nine
 
months
 
ended
 
September
 
30,


2020


2019


2020


2019

Revenue:

Anesthesia services

$

27,983,903

$

27,966,629

$

63,561,613

$

82,685,905

Product sales

2,365,549

2,448,174

5,827,537

7,330,147

30,349,452

30,414,803

69,389,150

90,016,052

Expenses:

Anesthesia services expense

26,963,897

23,774,049

70,580,981

69,804,891

Product sales expense

1,080,861

1,089,316

3,025,258

3,441,207

Corporate expense

2,219,867

1,838,812

6,344,402

4,645,347

30,264,625

26,702,177

79,950,641

77,891,445

Operating income (loss)

84,827

3,712,626

(10,561,491)

12,124,607

Net finance expense

441,967

1,125,410

1,386,007

5,696,343

(Gain) loss from equity investment

(77,278)

37,839

(416,584)

Other income

(289,669)

(5,146,488)

Income (loss) before tax

(67,471)

2,664,494

(6,838,849)

6,844,848

Income tax expense (recovery)

(376,237)

565,165

(1,584,165)

736,052

Net and comprehensive income (loss)

$

308,766

$

2,099,329

$

(5,254,684)

$

6,108,796

Attributable to:

Shareholders of the Company

$

(337,954)

$

982,368

$

(5,324,264)

$

2,552,084

Non-controlling interest

646,720

1,116,961

69,580

3,556,712

$

308,766

$

2,099,329

$

(5,254,684)

$

6,108,796

Earnings (loss) per share attributable to shareholders

Basic

$

(0.005)

$

0.014

$

(0.074)

$

0.036

Diluted

$

(0.005)

$

0.013

$

(0.074)

$

0.035

Weighted average shares outstanding:

Basic

71,506,045

71,831,356

71,558,371

71,845,812

Diluted

71,506,045

72,799,142

71,558,371

73,023,144

 

Condensed Consolidated Statements of Cash Flows

(unaudited)


Three months ended


September 30,


Nine months ended


September 30,


2020


2019


2020


2019

Operating activities:

Net income (loss)

$

308,766

$

2,099,329

$

(5,254,684)

$

6,108,796

Adjustments for:

Depreciation of property, equipment and intangibles

10,760,397

8,555,909

29,686,467

25,974,283

Stock-based compensation

652,967

706,479

1,900,960

280,348

Unrealized foreign exchange

6,144

(50)

7,745

726

Deferred income tax recovery

(968,387)

(776,300)

(2,358,260)

(2,749,616)

Change in fair value of contingent consideration

(96,294)

181,805

(376,087)

2,771,238

Accretion on contingent consideration and deferred

   consideration

15,925

10,145

32,833

123,305

Amortization of deferred financing fees

90,411

65,091

269,424

195,273

(Gain) loss from equity investment

(77,278)

37,839

(416,584)

Change in current tax receivable

(1,699,529)

(17,826)

(2,174,418)

(154,474)

Change in trade and other receivables

(820,666)

(182,433)

(317,593)

(102,733)

Change in prepaid expenses

102,542

(59,218)

302,894

268,162

Change in inventories

(31,017)

153,837

53,254

45,309

Change in trade and other payables, including contract

   payable

(640,539)

(83,936)

3,192,069

91,726

Change in employee benefits

135,957

135,609

(206,730)

234,120

Net cash provided by operating activities

7,816,677

10,711,163

24,795,713

32,669,879

Financing activities

Proceeds from (repayment of) member loans

(28,100)

(14,375)

152,280

(18,375)

Equity investment loan

(1,000)

(1,000)

Repayment of short-term advances

(26,783)

Payment of deferred consideration

(64,827)

(1,896,850)

(1,100,000)

Payment of contingent consideration

(4,795,822)

Repayment of notes payable and bank indebtedness

(1,500,000)

(5,625,000)

(9,500,000)

(13,175,000)

Proceeds from bank indebtedness

11,006,750

7,000,000

16,006,750

11,300,000

Proceeds from exercise of stock options

6,753

10,680

426,366

Payment of deferred financing fees

(125,000)

(159,314)

Distributions to non-controlling interest

(3,952,150)

(3,615,819)

(8,688,260)

(11,804,480)

Repurchase of shares for cancellation

(296,600)

(1,109,170)

(652,165)

(3,982,914)

Acquisition of equity interest from non-controlling interest

(7,018,658)

(9,434,009)

Net cash provided by (used in) financing activities

5,039,073

(10,376,269)

(4,727,879)

(32,611,017)

Investing activities

Acquisition of property and equipment

(10,957)

(4,834)

(32,829)

(45,681)

Deferred asset acquisition costs

56,488

38,437

(191,934)

(440)

Distribution received from equity investment

92,400

92,400

Purchase adjustment relating to anesthesia service providers

   acquired in prior periods

4,366,000

4,366,000

Acquisition of cost investment

(2,016,076)

(2,016,076)

Acquisition of anesthesia services providers

(11,024,903)

(2,174,003)

(19,296,746)

(9,204,437)

Net cash provided by (used in) investing activities

(12,995,448)

2,318,000

(21,537,585)

(4,792,158)

Effects of foreign exchange on cash and cash equivalents

2,134

(270)

533

1,395

Decrease in cash and cash equivalents

(137,564)

2,652,624

(1,469,218)

(4,731,901)

Cash and cash equivalents, beginning of period

5,237,062

2,562,420

6,568,716

9,946,945

Cash and cash equivalents, end of period

$

5,099,498

$

5,215,044

$

5,099,498

$

5,215,044

 

Adjusted EBITDA Reconciliation

(in thousands, unaudited)


Three Months Ended


Nine Months Ended


September 30,


September 30,


(USD in thousands)


2020


2019


2020


2019


Net and comprehensive income (loss)

$

309

$

2,099

$

(5,254)

$

6,109

Net finance expense

442

1,125

1,386

5,696

(Gain) loss on equity investment

(77)

38

(416)

Income tax expense (recovery)

(376)

565

(1,584)

736

Other income – government assistance

(290)

(5,147)


Operating income (loss)

85

3,713

(10,561)

12,125

Amortization expense

10,735

8,528

29,604

25,892

Depreciation and related expense

26

28

83

82

Stock based compensation

653

706

1,901

280

Acquisition expenses1

57

83

87

123

Inventory write-downs

65

Other non-recurring items2

931

Other income – government assistance

290

5,147


Total adjusted operating EBITDA

$

11,845

$

13,058

$

26,324

$

39,433


Adjusted operating EBITDA


   attributable to:

Shareholders of the Company

$

7,968

$

9,392

$

17,520

$

27,819

Non-controlling interest

$

3,877

$

3,666

$

8,804

$

11,615

 

Adjusted Operating Expense Reconciliation

(in thousands, unaudited)


Three Months Ended
September 30,


Nine Months Ended
September 30,


2020


2019


2020


2019


Anesthesia services expense


26,964


23,774


70,581


69,804

Amortization expense

(10,734)

(8,527)

(29,602)

(25,890)

Depreciation and related expense

(3)

(3)

(11)

(9)

Stock based compensation

(148)

(125)

(349)

(359)

Acquisition expenses1

(57)

(83)

(87)

(123)


Anesthesia services – adjusted operating


16,022


15,036


40,532


43,424


   expense


Product sales expense


1,081


1,089


3,025


3,440

Amortization expense

(1)

(1)

(1)

(2)

Depreciation and related expense

(5)

(5)

(15)

(19)

Stock based compensation

(95)

(82)

(210)

(236)

Inventory write-downs

(65)


Product sales – adjusted operating expense


980


1,002


2,733


3,186


Corporate expense


2,220


1,839


6,345


4,645

Amortization expense

Depreciation and related expense

(18)

(20)

(57)

(55)

Stock based compensation

(410)

(500)

(1,343)

313

Other non-recurring items

(931)


Corporate – adjusted operating expenses


1,792


1,319


4,945


3,974


Total operating expense


30,265


26,702


79,951


77,891


Total adjusted operating expense


18,794


17,357


48,211


50,583

 

Cision View original content:http://www.prnewswire.com/news-releases/crh-medical-corporation-announces-2020-third-quarter-results-301172464.html

SOURCE CRH Medical Corporation

Algonquin Power & Utilities Corp. Declares Fourth Quarter 2020 Preferred Share Dividends

PR Newswire

OAKVILLE, ON, Nov. 12, 2020 /PRNewswire/ – Algonquin Power & Utilities Corp. (“APUC”) (TSX: AQN) (TSX: AQN.PR.A) (TSX: AQN.PR.D) (NYSE: AQN) announced today that the Board of Directors of APUC has declared the following preferred share dividends:

  1. C$0.32263 per Preferred Share, Series A, payable in cash on December 31, 2020 to Preferred Share, Series A holders of record on December 15, 2020, for the period from September 30, 2020 to, but excluding, December 31, 2020.

  2. C$0.31819 per Preferred Share, Series D, payable in cash on December 31, 2020 to Preferred Share, Series D holders of record on December 15, 2020, for the period from September 30, 2020 to, but excluding, December 31, 2020.

Pursuant to the Income Tax Act (Canada) and corresponding provincial legislation, APUC hereby notifies its Series A Preferred Shareholders and its Series D Preferred Shareholders that such dividends declared qualify as eligible dividends.

About Algonquin Power & Utilities Corp., Liberty Utilities, and Liberty Power

APUC is a diversified international generation, transmission, and distribution utility with approximately $11 billion of total assets. Through its two business groups, Liberty Utilities and Liberty Power, APUC is committed to providing safe, secure, reliable, cost-effective, and sustainable energy and water solutions through its portfolio of electric generation, transmission, and distribution utility investments to over 1 million customer connections, largely in the United States and Canada.  APUC is a global leader in renewable energy through its portfolio of long-term contracted wind, solar, and hydroelectric generating facilities representing over 2 GW of installed capacity and approximately 1.4 GW of incremental renewable energy capacity under construction.

APUC is committed to delivering growth and the pursuit of operational excellence in a sustainable manner through an expanding global pipeline of renewable energy and electric transmission development projects, organic growth within its rate-regulated generation, distribution, and transmission businesses, and the pursuit of accretive acquisitions.

APUC’s common shares, Series A preferred shares, and Series D preferred shares are listed on the Toronto Stock Exchange under the symbols AQN, AQN.PR.A, and AQN.PR.D, respectively. APUC’s common shares, Series 2018-A subordinated notes and Series 2019-A subordinated notes are listed on the New York Stock Exchange under the symbols AQN, AQNA and AQNB, respectively.

Visit APUC at www.algonquinpowerandutilities.com and follow us on Twitter @AQN_Utilities.

Cision View original content:http://www.prnewswire.com/news-releases/algonquin-power–utilities-corp-declares-fourth-quarter-2020-preferred-share-dividends-301172463.html

SOURCE Algonquin Power & Utilities Corp.

Alexco Announces Third Quarter 2020 Results and Provides Operations Update

PR Newswire

(All amounts in CDN$ unless otherwise indicated)

VANCOUVER, BC, Nov. 12, 2020 /PRNewswire/ – Alexco Resource Corp. (NYSE American: AXU) (TSX: AXU) (“Alexco” or the “Company”) today reports financial results for the three month period ended September 30, 2020 (“Q3 2020”) and provides comments on capital development progress at Keno Hill in anticipation of initial silver (“Ag”) concentrate production in Q4 2020. For Q3 2020, Alexco reported an operating loss of $5.4 million (“M”), or $0.04 per share. Aa at September 30, 2020, the Company had $39.8 M in cash and cash equivalents, and net working capital of $38.0 M.


Key Financial Metrics



(Expressed in 000’s of Canadian dollars,
except per share and share amounts)



For the Three Month Period
Ended September 30,


For the Nine Month Period
Ended September 30,


2020

2019


2020

2019

Revenues – Reclamation Management Revenue

$


795

555

$


2,233

1,703

Operating Loss

$


(5,356)

(1,947)

$


(10,728)

(7,330)

Adjusted Loss Before Taxes1

$


(5,514)

(1,975)

$


(10,683)

(7,758)

Cash and cash equivalents

$


39,751

10,551

$


39,751

10,551

Net Working Capital1

$


37,998

10,090

$


37,998

10,090

Adjusted Net Loss from Continued Operations1

$


(3,265)

(2,043)

$


(7,295)

(8,435)

Net Loss from Continued Operations2

$


(15,241)

(2,234)

$


(22,753)

(2,139)


Shareholders

Basic and Diluted Net Loss from Continued Operations per Common Share  

$


(0.11)

(0.02)

$


(0.18)

(0.02)

Adjusted Basic and Diluted Net Loss from Continued Operations per Common Share1 

$


(0.02)

(0.02)

$


(0.06)

(0.07)


1.


See Non-GAAP measures on page 14 of the MD&A
for the three and nine month periods ended September 30, 2020
.


2.


Net loss includes non-cash adjustments related to an embedded derivative.


Q3 2020 Highlights


Corporate

  • The Corporation’s cash and cash equivalents as at September 30, 2020 totaled $39.8 M compared to $6.8 M as at December 31, 2019, while net working capital totaled $38.0 M compared to $10.1 M as at December 31, 2019. The Corporation’s restricted cash and deposits as at September 30, 2020 totaled $2.9 M compared to $2.8 M as at December 31, 2019.
  • Alexco reported an operating loss of $5.5 M for Q3 2020, compared to a loss of $1.9 M for Q3 2019. The increase in operating loss is primarily a result of an increase in mine site rehabilitation and dewatering work at the Bellekeno mine in preparation for initial ore production in Q4 2020 and expensed refurbishment work at the Keno Hill mill in preparation for mill commissioning in Q4 2020.
  • On July 7, 2020 the Corporation completed an equity financing and issued 10,994,000 common shares at a price of $2.73 per share for aggregate gross proceeds of $30 M.
  • On August 5, 2020 Alexco entered into an amended and restated agreement with Wheaton with respect to the streaming agreement between the two companies (see press release dated June 24, 2020, entitled “Alexco Moves Forward to Production at Keno Hill”).


Mine Operations and Exploration

  • On July 23, 2020, the Company received the final amended and renewed water use license (“WUL”) for the Keno Hill Silver District (“Keno Hill” or the “District”) from the Yukon Water Board. The WUL authorizes Alexco to source and use water, as well as deposit designated waste streams into approved facilities in and around planned production centers at the Bellekeno, Flame & Moth and Bermingham mines, and the mill facility.
  • Progress on site-wide capital projects including mill modifications and infrastructure improvements continues to be on pace for completion with mill commissioning and production of silver (“Ag”) concentrate in Q4 2020. A concentrate off-take provider has been selected and agreements are being finalized.
  • The Company’s 2020 surface exploration program that commenced on July 17, 2020 has been extended to include a total of approximately 7,500 meters (“m”) core drilling in at least 12 holes, exclusively testing for deeper mineralization in the Bermingham mine area. Drilling will continue until late November.

Clynt Nauman, Alexco’s Chairman and Chief Executive Officer, commented, “During the third quarter we made significant progress at Keno Hill. I am pleased to report that we are already placing ore from the Bellekeno mine on the coarse ore pad in anticipation of mill commissioning in the very near future. Separately, underground development at the Flame & Moth and Bermingham mines continues to advance and remain on track to provide development ore in Q1 2021. Upgrades to surface infrastructure and the District Mill are nearing completion, and mill circuits have been successfully wet-tested. We are continuing with our mine optimization studies with respect to underground development efficiencies and improved NSR values for ore both within the PFS mine plan as well as adjacent mineralization. We expect to complete and report on this work in the first half of 2021.” Mr. Nauman continued, “Our exploration program at the Bermingham ‘deep’ target will be wrapping up this month and we look forward to sharing the results when they become available”.


Capital Development and Operations

On June 24, 2020, the Company announced that it is moving forward to finalize development of its mines at Keno Hill, with a goal of mill commissioning and Ag concentrate production in Q4 2020. The Company is making steady progress towards its initial production goal with mine site development activities, recruitment of key personnel, delivery of mine equipment, refurbishment of the mill, and completion of surface infrastructure projects continuing into Q4 2020.

In the mill, installation of cyclones, the addition of a new tailings filter press and modification to the fine ore feeder is complete. Other mill improvement projects underway include installation of a second ball mill, construction of a crusher enclosure and ventilation system and installation of two concentrate regrind mills. Other surface construction activities nearing final completion include the expansion of the camp accommodation complex including two new bunkhouse units, an upgraded administration complex, and employee dry and wash facilities.

Underground refurbishment projects at the Flame & Moth and Bermingham mines are complete and primary ramp development continues at both mines. Delivery and commissioning of the major pieces of new underground mine equipment is largely complete. The new fleet includes four (4) CAT R1300 3.5 yard scoops, two (2) CAT AD22 20 tonne haul trucks, two (2) Atlas Copco 282 twin boom jumbos, two (2) MacLean SSB bolters and other support gear. Development and long-hole extraction of ore from two underground levels continues at the Bellekeno mine with ore from these activities being delivered to the mill coarse ore pad. At the Flame & Moth mine, advance of the primary ramp is continuing with approximately 140 m of primary ramp required to reach the first level access point on the 835 level followed by 100 m of level access to cross cut the ore. At the Bermingham mine, development of the vent raise access level is underway prior to mobilization of the contract raise development crew within the next month.

Elsewhere, the Company continues to successfully recruit and onboard the mine operations team. Key managers, site supervisors and mine engineering staff are all in place and the current focus continues to be the onboarding of geologists, underground miners, and maintenance specialists. The current head count at Keno Hill is approximately 125 employees. Over 90% of the Alexco employees currently hired are from the Yukon and British Columbia including citizens of the First Nation of Na-Cho Nyak Dun.

With the significant increase in underground and district-wide operating activities at Keno Hill, the safety performance of all employees and contractors remains excellent and exemplifies the culture of safety excellence instilled at Keno Hill. The Company’s safety record has now exceeded over 7.5 years without a Lost Time Accident.

The Company’s strict COVID-19 management protocols and operating practices remain in place and are continuously reviewed to comply with the guidelines of the Yukon Chief Medical Officer.


Financial
 Report

Full details of the financial and operating results for Q3 2020 are described in Alexco’s interim condensed consolidated financial statements for the three and nine month periods ended September 30, 2020 with accompanying notes and related management’s discussion and analysis. These documents and additional information about Alexco, including its annual information form, are available on Alexco’s website at www.alexcoresource.com and on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.shtml.


Conference Call for Q3 2020 Results

Alexco is hosting an audio webcast conference call to discuss these results at 11:00 a.m. Eastern (8:00 am Pacific) on Friday, November 13, 2020. To participate in the live call, please use one of the following methods:

Dial toll free from Canada or the US:

1-800-319-4610

Dial from outside Canada or the US:

1-604-638-5340

Conference ID#:                             

Ask to join the Alexco conference call

Live audio webcast:                        


https://www.alexcoresource.com/investors/events-webcasts/ 

Participants should connect five to ten minutes before the call. The conference call will be recorded and an archived audio webcast will be available on the Company’s website at www.alexcoresource.com.

Qualified Persons

The disclosure in this news release of scientific and technical information regarding exploration projects on Alexco’s mineral properties has been reviewed and approved by Alan McOnie, FAusIMM, Vice President, Exploration, while that regarding mine development and operations has been reviewed and approved by Neil Chambers, P.Eng., Chief Mine Engineer, both of whom are Qualified Persons as defined by National Instrument 43-101 – Standards of Disclosure for Mineral Projects (“NI 43-101”).

About Alexco                                                                       

Alexco is a Canadian primary silver company that owns and operates the majority of the historic Keno Hill Silver District, in Canada’sYukon Territory, one of the highest-grade silver deposits in the world. Alexco is currently advancing Keno Hill to production and expects to start concentrate production and shipments in Q4 2020. As per Alexco’s 2020 pre-feasibility study, Keno Hill is expected to produce an average of approximately 4 million ounces of silver per year contained in high quality lead/silver and zinc concentrates. Total production over an 8-year mine life is estimated at 1.18 million tonnes of ore at an average rate of 430 tonnes per day at an average grade of 805 grams per tonne. Keno Hill retains significant potential to grow and Alexco has a long history of expanding the operation’s Mineral Resources through successful exploration.

Some statements (“forward-looking statements”) in this news release contain forward-looking information plans related to Alexco’s business and other matters that may occur in the future, made as of the date of this news release. Forward-looking statements are subject to a variety of known and unknown risks, uncertainties and other factors which could cause actual events or results to differ from those expressed or implied by the forward-looking statements. Such factors include, among others, risks related to risks and uncertainties relating to the COVID-19 pandemic including but not limited to business closures, travel restrictions,  quarantines and a general reduction in consumer activity; actual results and timing of exploration and development, mining, environmental services and remediation and reclamation activities; future prices of silver, gold, lead, zinc and other commodities; possible variations in mineral resources, grade or recovery rates; failure of plant, equipment or processes to operate as anticipated; accidents, labour disputes and other risks of the mining industry; First Nation rights and title; continued capitalization and commercial viability; global economic conditions; competition; and delays in obtaining governmental approvals or financing or in the completion of development activities. Forward-looking statements are based on certain assumptions that management believes are reasonable at the time they are made. In making the forward-looking statements included in this news release, Alexco has applied several material assumptions, including, but not limited to the circumstances surrounding the COVID-19 pandemic, although evolving, will stabilize or at least not worsen; that the extent to which COVID-19 may impact the Company, including without limitation disruptions to the mobility of Company personnel, costs associated with implementation of health and safety protocols, increased labour and transportation costs, and other related impacts, will not change in a materially adverse manner; Alexco will be able to raise additional capital as necessary, that the proposed exploration and development activities will proceed as planned, and that market fundamentals will result in sustained silver, gold, lead and zinc demand and prices. There can be no assurance that forward-looking statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Alexco expressly 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 otherwise required by applicable securities legislation.

Cision View original content:http://www.prnewswire.com/news-releases/alexco-announces-third-quarter-2020-results-and-provides-operations-update-301172461.html

SOURCE Alexco Resource Corp.

Digital Realty, Vapor IO and Hivelocity Demonstrate Core-to-Edge Bare Metal in Atlanta

Integration between Digital Realty’s PlatformDIGITAL® and Vapor IO’s Kinetic Edge enables Hivelocity to support true core-to-edge workloads on its bare metal cloud

PR Newswire

SAN FRANCISCO and AUSTIN, Texas, Nov. 12, 2020 /PRNewswire/ — Digital Realty (NYSE: DLR), a leading global provider of carrier- and cloud-neutral data center, colocation and interconnection solutions, along with Vapor IO, creators of the Kinetic Edge® platform, the first fully-integrated hardware and software platform for edge colocation, exchange and networking services, and Hivelocity, a leading provider of global bare metal cloud services, announced today the availability for developers to deploy core-to-edge workloads on Hivelocity’s bare metal edge cloud, first in Atlanta, but soon in other cities nationwide.

The multi-tier edge deployment in Atlanta builds upon Digital Realty and Vapor IO’s announcement in June, highlighting the integration of Vapor IO’s Kinetic Edge architecture with Digital Realty’s Network Hub Solution on PlatformDIGITAL®.  Hivelocity, a Digital Realty customer, was able to quickly extend its bare metal cloud to Vapor IO’s Kinetic Edge locations due to integration work already completed by Vapor IO and Digital Realty.

“Leveraging the joint solution available through Vapor IO’s Kinetic Edge and Digital Realty’s PlatformDIGITAL, we were able to lower costs and get to market quicker,” said Steve Eschweiler, COO of Hivelocity.  “By using our existing control plane in Digital Realty’s facilities to orchestrate machines in Vapor IO’s data centers at the infrastructure edge, leveraging the integrated Digital Realty Service Exchange and Kinetic Edge Exchange networks for connectivity, we were able to quickly and cost-effectively extend our bare metal cloud to the infrastructure edge, where last-mile telco networks are aggregated.” 

Separately, Hivelocity also
announced
today it has selected Vapor IO’s Kinetic Edge platform nationwide and will bring its bare metal edge cloud to the 36 U.S. cities where Vapor IO is actively deploying.

The collaboration between Vapor IO and Digital Realty combines the cloud proximity, core, regional edge, local edge and interconnection capabilities of PlatformDIGITAL® with the lastmile, low-latency, distributed architecture of the Kinetic Edge network.  This combination offers companies like Hivelocity a seamless platform for delivering core-to-edge capabilities that are the basis for many emerging edge use cases.

“We designed this joint solution to combine the data center and networking infrastructure needed to enable cloud-to-core-to-edge applications,” said Cole Crawford, founder and CEO at Vapor IO. “Hivelocity’s ability to simply and effectively extend its bare metal cloud to the edge in Atlanta is a perfect example of how we’re making it easier for joint customers to deliver low-latency edge services that tie back to their regional and core workloads.”  

For example, using Hivelocity’s bare metal cloud, a developer can deploy a multi-tier AI-based application, running low-latency inferencing in Vapor IO edge locations while training sophisticated AI models in Digital Realty’s regional edge and core facilities.

“The combination of Vapor’s Kinetic Edge and Digital Realty’s PlatformDIGITAL® is a crucial building-block for core-to-edge workloads, which we are actively supporting in Atlanta, Chicago and Dallas,” said Digital Realty Chief Technology Officer Chris Sharp. “Hivelocity’s ability to tap into this service and create a clear path to highly interconnected true core-to-edge infrastructure for their customers is precisely the simplicity we hope to provide.”  

Additional Resources:

  • Blog:  Bringing Interconnection to the Edge
  • Learn more about Digital Realty’s Network Hub solution
  • The latest megatrend and its effect on Global 2000 enterprises: Data Gravity



About Digital Realty


Digital Realty supports the world’s leading enterprises and service providers by delivering the full spectrum of data center, colocation and interconnection solutions. PlatformDIGITAL®, the company’s global data center platform, provides customers a trusted foundation and proven Pervasive Datacenter Architecture PDx™ solution methodology for scaling digital business and efficiently managing data gravity challenges.  Digital Realty’s global data center footprint gives customers access to the connected communities that matter to them with more than 280 facilities in 49 metros across 24 countries on six continents.  To learn more about Digital Realty, please visit digitalrealty.com or follow us on LinkedIn and Twitter.   

About Vapor IO

Vapor IO is developing the largest nationwide edge networking, colocation and exchange platform at the edge of the wireless and wireline networks. Serving the world’s largest carriers, operators, cloud providers, web-scale companies and other innovative enterprises, the company’s Kinetic Edge® platform combines multi-tenant colocation with software-defined interconnection and high-speed networking. The Kinetic Edge platform offers the most flexible, highly-distributed infrastructure for delivering modern, low-latency applications, and the company has deployed its Kinetic Edge in Chicago, Atlanta, Dallas, and Pittsburgh, furthering its goal to deploy over 100 data centers in 36 U.S. markets over the next two years.1Follow @VaporIO on Twitter.

About Hivelocity

Hivelocity is a leading provider of global IaaS and Edge Computing services. With a total of 32 data centers in 26 cities across four continents, Hivelocity has created one of the most geographically diverse and comprehensive edge computing platforms and infrastructures in the world. Hivelocity enables its customers to instantly deploy bare-metal servers across any of its data centers with ease. By leveraging the Hivelocity platform, users can easily manage and scale their edge computing solutions when desired.

1 Vapor, Kinetic Edge and Kinetic Edge Exchange are trademarks of Vapor IO, all rights reserved.

Media & Industry Analyst Relations

Marc Musgrove

Digital Realty
+1 (415) 508-2812
[email protected]

Jessica Gomez-Rees

For Vapor IO
+1 (415) 889-7444
[email protected]

Investor Relations

John Stewart

Digital Realty
+1 (415) 738-6500
[email protected]

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/digital-realty-vapor-io-and-hivelocity-demonstrate-core-to-edge-bare-metal-in-atlanta-301172459.html

SOURCE Digital Realty

Karyopharm Announces Publication of XPOVIO® (Selinexor) Phase 3 BOSTON Study Results in The Lancet

PR Newswire

NEWTON, Mass., Nov. 12, 2020 /PRNewswire/ — Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the results of the Phase 3 BOSTON (Bortezomib, Selinexor and Dexamethasone) study evaluating XPOVIO in patients with relapsed or refractory multiple myeloma were published online in The Lancet. The BOSTON study evaluated once weekly XPOVIO, the Company’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound, in combination with once weekly Velcade® (bortezomib) and low-dose dexamethasone against standard twice weekly Velcade in adult patients with multiple myeloma who had received one to three prior lines of therapy.

“The results from the BOSTON study published in The Lancet demonstrate that the once-weekly regimen of XPOVIO and Velcade®, with low-dose dexamethasone (SVd) reduced the risk of disease progression or death by 30% and induced a higher rate of overall and deep responses compared to patients receiving a standard twice-weekly Velcade® and low-dose dexamethasone regimen (Vd). This was observed despite  approximately 40% less Velcade®, 25% less dexamethasone and approximately 35% fewer clinic visits on the SVd arm as compared with the standard Vd therapy arm.  Encouragingly, the efficacy of the SVd regimen was consistent and noteworthy across several key subgroups, including patients who were frail or 65 years and older, patients with high-risk cytogenetics, patients with moderate renal impairment and patients who had either prior bortezomib or lenalidomide treatment,” said Dr. Paul Richardson, MD, Clinical Program Leader and Director of Clinical Research, Jerome Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute and co-senior author of the manuscript.  

“Despite the enrollment of 50% of patients with high risk cytogenetics, a particularly difficult to treat population, the SVd regimen demonstrated a 47% improvement in progression-free survival as compared to the Vd regimen and an overall response rate of 76.4%. Additionally, the rate and severity of peripheral neuropathy, a key treatment-limiting side effect commonly seen with Velcade® therapy, was significantly lower on the SVd arm compared to the Vd arm and may lead to improved patient quality of life,” said Sundar Jagannath, MD, Director of the Center of Excellence for Multiple Myeloma and Professor of Medicine, Hematology and Medical Oncology, at the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, and an investigator in the BOSTON study.

“We are honored to have the Phase 3 BOSTON data selected for publication in such a highly esteemed medical journal and to be shared with the global oncology community,” said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. “We believe the successful outcome of this study represents an important advancement for myeloma patients and we are sincerely grateful to all of the patients and investigators who participated in the BOSTON study. While XPOVIO received accelerated FDA approval last year for patients with penta-refractory multiple myeloma, a supplemental New Drug Application requesting approval for XPOVIO as a treatment for patients with multiple myeloma who have received one prior line of therapy has been accepted by the FDA and assigned a PDUFA action date of March 19, 2021.  We are working closely with the regulatory authorities in both the U.S. and Europe to make this potential new treatment option, with a completely novel mechanism of action, available to patients as quickly as possible, if approved.”

Once-weekly SVd is a novel, effective and convenient triplet therapy that utilizes approximately 40% less Velcade® and 25% less dexamethasone and requires approximately 35% fewer clinic visits during the first 24 weeks of treatment compared to the standard Vd regimen. Because Velcade® is given as a subcutaneous injection rather than as an infusion, clinic visits may be shorter with the SVd regimen than with other non-Velcade® regimens that may be employed to treat relapsed multiple myeloma and require intravenous infusions.

The Phase 3 BOSTON Study Results as Published in the Lancet

The published BOSTON study results are based on the multi-center, Phase 3, randomized study (NCT03110562), which evaluated 402 adult patients with relapsed or refractory multiple myeloma who had received one to three prior lines of therapy. The study was designed to compare the efficacy, safety and certain health-related quality of life parameters of once-weekly selinexor in combination with once-weekly Velcade® (bortezomib) plus low-dose dexamethasone (SVd) versus twice-weekly Velcade® plus low-dose dexamethasone (Vd). The primary endpoint of the study was progression-free survival (PFS) and key secondary endpoints included overall response rate (ORR), rate of peripheral neuropathy, and others. Additionally, the BOSTON study allowed for patients on the Vd control arm to crossover to the SVd arm following objective (quantitative) progression of disease verified by an Independent Review Committee (IRC). The BOSTON study was conducted at over 150 clinical sites internationally.

Although the study had one of the highest proportions of patients with high-risk cytogenetics (~50%) as compared with other Velcade-based studies in previously treated myeloma, the median PFS in the SVd arm was 13.93 months compared to 9.46 months in the Vd arm, representing a 4.47 month (47%) increase in median PFS (hazard ratio[HR]=0.70; p=0.0075). The SVd group also demonstrated a significantly greater ORR compared to the Vd group (76.4% vs. 62.3%, p=0.0012). Patients who had received only one prior line of therapy also demonstrated a higher ORR on the SVd arm as compared to the Vd arm (80.8% vs. 65.7%, p=0.0082). Importantly, SVd therapy compared to Vd therapy showed consistent PFS benefit and higher ORR across several important subgroups.

In addition, the following results favored SVd therapy as compared to Vd therapy:

SVd therapy demonstrated a significantly higher rate of deep responses, defined as ≥ Very Good Partial Response compared to Vd therapy (44.6% vs. 32.4%) as well as a longer median duration of response (20.3 months vs. 12.9 months). Additionally, 16.9% of patients on the SVd arm achieved a Complete Response or a Stringent Complete Response as compared to 10.6% of patients receiving Vd therapy.  All responses were confirmed by an IRC.

Data at the time of analysis showed a trend toward an overall survival (OS) benefit associated with SVd therapy with fewer deaths, numerically, reported on the SVd arm (47 vs. 62). Median OS for the SVd arm had not yet been reached as of the data cut-off date of February 18, 2020, while the median OS for the Vd arm was 25.0 months. The median OS for the SVd arm will be reported once it is reached and becomes available.

Peripheral neuropathy (PN) rates were significantly lower on SVd compared to Vd (32.3% vs. 47.1%; p=0.0010). In addition, PN rates of grade ≥2 were also significantly lower in the SVd arm compared to Vd (21.0% vs. 34.3%, P=0.0013).

The most common treatment-emergent adverse events (AEs) were cytopenias, along with gastrointestinal and constitutional symptoms and were consistent with those previously reported from other selinexor studies. Most AEs were manageable with dose modifications and/or standard supportive care. The most common non-hematologic treatment-related AEs were nausea (50%), fatigue (42%), decreased appetite (35%), and diarrhea (32%) and were mostly Grade 1 and 2 events. The most common Grade 3 and 4 treatment-related AEs were thrombocytopenia (39%), anemia (16%), and fatigue (13%).

About Multiple Myeloma

According to the National Cancer Institute (NCI), multiple myeloma is one of the most common types of blood cancer in the U.S. with more than 32,000 new cases each year and over 140,000 patients living with the disease. It is most frequently diagnosed among people aged 65-74 years old. Despite recent therapeutic advances, there is currently no cure and most patients’ disease will typically progress following treatment with currently available therapies. According to the NCI, nearly 13,000 deaths due to multiple myeloma are expected in the U.S. in 2020.

About XPOVIO® (selinexor)
XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. Karyopharm has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval of selinexor in this same RRMM indication. Karyopharm’s supplemental New Drug Application (sNDA) requesting an expansion of its current indication to include the treatment for patients with multiple myeloma after at least one prior line of therapy has been accepted for filing by the FDA. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP), in liposarcoma (SEAL) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at:

Tel: +1 (888) 209-9326
Email: [email protected]

IMPORTANT SAFETY INFORMATION

Thrombocytopenia: XPOVIO can cause life-threatening thrombocytopenia, potentially leading to hemorrhage. Thrombocytopenia was reported in patients with multiple myeloma (MM) and developed or worsened in patients with DLBCL.

Thrombocytopenia is the leading cause of dosage modifications. Monitor platelet counts at baseline and throughout treatment. Monitor more frequently during the first 3 months of treatment. Institute platelet transfusion and/or other treatments as clinically indicated. Monitor patients for signs and symptoms of bleeding and evaluate promptly. Interrupt, reduce dose, or permanently discontinue based on severity of adverse reaction.

Neutropenia: XPOVIO can cause life-threatening neutropenia, potentially increasing the risk of infection. Neutropenia and febrile neutropenia occurred in patients with MM and in patients with DLBCL.

Obtain white blood cell counts with differential at baseline and throughout treatment. Monitor more frequently during the first 3 months of treatment. Monitor patients for signs and symptoms of concomitant infection and evaluate promptly. Consider supportive measures, including antimicrobials and growth factors (e.g., G-CSF). Interrupt, reduce dose, or permanently discontinue based on severity of adverse reaction (AR).

Gastrointestinal Toxicity: XPOVIO can cause severe gastrointestinal toxicities in patients with MM and DLBCL.

Nausea/Vomiting: Provide prophylactic antiemetics. Administer 5-HT3 receptor antagonists and other anti-nausea agents prior to and during treatment with XPOVIO. Interrupt, reduce dose, or permanently discontinue based on severity of ARs. Administer intravenous fluids to prevent dehydration and replace electrolytes as clinically indicated.

Diarrhea: Interrupt, reduce dose, or permanently discontinue based on severity of ARs. Provide standard anti-diarrheal agents, administer intravenous fluids to prevent dehydration, and replace electrolytes as clinically indicated.

Anorexia/Weight Loss: Monitor weight, nutritional status, and volume status at baseline and throughout treatment. Monitor more frequently during the first 3 months of treatment. Interrupt, reduce dose, or permanently discontinue based on severity of ARs. Provide nutritional support, fluids, and electrolyte repletion as clinically indicated.

Hyponatremia: XPOVIO can cause severe or life-threatening hyponatremia. Hyponatremia developed in patients with MM and in patients with DLBCL.

Monitor sodium level at baseline and throughout treatment. Monitor more frequently during the first 2 months of treatment. Correct sodium levels for concurrent hyperglycemia (serum glucose >150 mg/dL) and high serum paraprotein levels. Assess hydration status and manage hyponatremia per clinical guidelines, including intravenous saline and/or salt tablets as appropriate and dietary review. Interrupt, reduce dose, or permanently discontinue based on severity of the AR.

Serious Infection: XPOVIO can cause serious and fatal infections. Most infections were not associated with Grade 3 or higher neutropenia. Atypical infections reported after taking XPOVIO include, but are not limited to, fungal pneumonia and herpesvirus infection.

Monitor for signs and symptoms of infection, and evaluate and treat promptly.

Neurological Toxicity: XPOVIO can cause life-threatening neurological toxicities.

Coadministration of XPOVIO with other products that cause dizziness or mental status changes may increase the risk of neurological toxicity.

Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, until the neurological toxicity fully resolves. Optimize hydration status, hemoglobin level, and concomitant medications to avoid exacerbating dizziness or mental status changes. Institute fall precautions as appropriate.  

Embryo-Fetal Toxicity: XPOVIO can cause fetal harm when administered to a pregnant woman.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with a female partner of reproductive potential to use effective contraception during treatment with XPOVIO and for 1 week after the last dose.

ADVERSE REACTIONS

The most common adverse reactions in ≥20% of patients with MM are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea, and upper respiratory tract infection.

The most common ARs, excluding laboratory abnormalities, in ≥20% of patients with DLBCL are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3-4 laboratory abnormalities in ≥15% of patients included thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. Grade 4 laboratory abnormalities in ≥5% were thrombocytopenia, lymphopenia, and neutropenia.

In patients with MM, fatal ARs occurred in 9% of patients. Serious ARs occurred in 58% of patients. Treatment discontinuation rate due to ARs was 27%. The most frequent ARs requiring permanent discontinuation in ≥4% of patients included fatigue, nausea, and thrombocytopenia.

In patients with DLBCL, fatal ARs occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal AR was infection (4.5% of patients). Serious ARs occurred in 46% of patients; the most frequent serious AR was infection.  Discontinuation due to ARs occurred in 17% of patients.

USE IN SPECIFIC POPULATIONS

In MM, no overall difference in effectiveness of XPOVIO was observed in patients >65 years old when compared with younger patients. Patients ≥75 years old had a higher incidence of discontinuation due to an AR than younger patients, a higher incidence of serious ARs, and a higher incidence of fatal ARs.

Clinical studies in patients with relapsed or refractory DLBCL did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

The effect of end-stage renal disease (CLCR <15 mL/min) or hemodialysis on XPOVIO pharmacokinetics is unknown.

Please see full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1-888-209-9326 or FDA at 1-800-FDA-1088 or

www.fda.gov/medwatch

.

About Karyopharm Therapeutics
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) is a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development, and commercialization of novel first-in-class drugs directed against nuclear export and related targets for the treatment of cancer and other major diseases. Karyopharm’s Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm’s lead compound, XPOVIO® (selinexor), received accelerated approval from the U.S. Food and Drug Administration (FDA) in July 2019 in combination with dexamethasone as a treatment for patients with heavily pretreated multiple myeloma. In June 2020, XPOVIO was approved by the FDA as a treatment for patients with relapsed or refractory diffuse large B-cell lymphoma. A Marketing Authorization Application for selinexor for patients with heavily pretreated multiple myeloma is also currently under review by the European Medicines Agency. In addition to single-agent and combination activity against a variety of human cancers, SINE compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses and wound-healing. Karyopharm has several investigational programs in clinical or preclinical development. For more information, please visit www.karyopharm.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding Karyopharm’s expectations and plans relating to XPOVIO for the treatment of patients with relapsed or refractory multiple myeloma or relapsed or refractory diffuse large B-cell lymphoma; commercialization of XPOVIO or any of its drug candidates and the commercial performance of XPOVIO; submissions to, and the review and potential approval of selinexor by, regulatory authorities, including the Company’s regulatory strategy, the anticipated availability of data to support such submissions, timing of such submissions and actions by regulatory authorities and the potential availability of accelerated approval pathways; the expected design of the Company’s clinical trials; the therapeutic potential of and potential clinical development plans for Karyopharm’s drug candidates, especially selinexor. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond Karyopharm’s control, that may cause actual events or results to differ materially from Karyopharm’s current expectations. For example, there can be no guarantee that Karyopharm will successfully commercialize XPOVIO; that regulators will agree that selinexor qualifies for conditional approval in the E.U. as a result of data from the STORM study or confirmatory approval in the U.S. or E.U. based on the BOSTON study in patients with multiple myeloma or that any of Karyopharm’s drug candidates, including selinexor, will successfully complete necessary clinical development phases or that development of any of Karyopharm’s drug candidates will continue. Further, there can be no guarantee that any positive developments in the development or commercialization of Karyopharm’s drug candidate portfolio will result in stock price appreciation. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: the risk that the COVID-19 pandemic could disrupt Karyopharm’s business more severely than it currently anticipates, including by negatively impacting sales of XPOVIO, interrupting or delaying research and development efforts, impacting the ability to procure sufficient supply for the development and commercialization of selinexor or other product candidates, delaying ongoing or planned clinical trials, impeding the execution of business plans, planned regulatory milestones and timelines, or inconveniencing patients; the adoption of XPOVIO in the commercial marketplace, the timing and costs involved in commercializing XPOVIO or any of Karyopharm’s drug candidates that receive regulatory approval; the ability to retain regulatory approval of XPOVIO or any of Karyopharm’s drug candidates that receive regulatory approval; Karyopharm’s results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies, including with respect to the need for additional clinical studies; the ability of Karyopharm or its third party collaborators or successors in interest to fully perform their respective obligations under the applicable agreement and the potential future financial implications of such agreement; Karyopharm’s ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of drug candidates by Karyopharm’s competitors for indications in which Karyopharm is currently developing its drug candidates; and Karyopharm’s ability to obtain, maintain and enforce patent and other intellectual property protection for any drug candidates it is developing. These and other risks are described under the caption “Risk Factors” in Karyopharm’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which was filed with the Securities and Exchange Commission (SEC) on November 2,, 2020, and in other filings that Karyopharm may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by law, Karyopharm expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Velcade® is a registered trademark of Takeda Pharmaceutical Company Limited.

Cision View original content:http://www.prnewswire.com/news-releases/karyopharm-announces-publication-of-xpovio-selinexor-phase-3-boston-study-results-in-the-lancet-301172456.html

SOURCE Karyopharm Therapeutics Inc.

Aileron Therapeutics Reports Third Quarter 2020 Financial Results and Business Highlights

  • Presented positive clinical proof-of-concept data from ongoing ALRN-6924 Phase 1b trial in patients with p53-mutated small cell lung cancer (SCLC) treated with topotecan in late-breaking presentation at 2020 EORTC-NCI-AACR Annual Symposium
  • Phase 1b randomized, controlled trial in patients with p53-mutated advanced non-small cell lung cancer receiving first-line platinum-based chemotherapy projected to start in the second quarter of 2021
  • Advancing long-term vision of bringing chemoprotection to all patients with p53-mutated cancers regardless of cancer type or chemotherapy
  • Novel precision medicine strategy delivers chemoprotective agent with anticancer efficacy of chemotherapy fully intact

WATERTOWN, Mass., Nov. 12, 2020 (GLOBE NEWSWIRE) — Aileron Therapeutics (NASDAQ:ALRN) today reported business highlights and financial results for the third quarter ended September 30, 2020.

“We recently achieved the critical milestone of clinical proof of concept of ALRN-6924, demonstrating a protective effect against severe anemia, thrombocytopenia and neutropenia in our ongoing Phase 1b trial of patients with p53-mutated small cell lung cancer undergoing treatment with topotecan,” said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer of Aileron. “These positive findings help inform our future clinical development strategy, which involves advancing randomized, controlled studies of ALRN-6924 in large cancer indications, including, non-small cell lung cancer, gastrointestinal cancers such as colorectal cancer, and other cancers.”

Dr. Aivado continued, “We are laying the foundation to advance our broad vision to bring chemoprotection to patients with p53-mutated cancers, which represent approximately 50% of cancer patients, regardless of cancer type or chemotherapy. We believe our approach, grounded on the principle of chemoprotection without the potential to interfere with chemotherapy’s anticancer activity, may establish ALRN-6924 as standard of care for chemoprotection among patients with p53-mutated cancers who are undergoing chemotherapy.”

Key
Third
Quarter and Recent Highlights

  • Announced
    proof-of-concept data
    from
    ongoing
    Phase 1b
    trial of ALRN-6924
    . In October 2020, Aileron announced new positive clinical data from its ongoing Phase 1b trial demonstrating clinical proof of concept that treatment with ALRN-6924 given 24 hours prior to second-line topotecan administration resulted in a protective effect against severe chemotherapy-induced bone marrow toxicities – anemia, thrombocytopenia and neutropenia – in patients with p53-mutated small cell lung cancer (SCLC). Robust and clinically meaningful protection against toxicities were observed with the 0.3 mg/kg dose of ALRN-6924. The findings were featured in a late-breaking poster presentation at the 32nd EORTC-NCI-AACR Annual (ENA 2020) Symposium on Molecular Targets and Cancer Therapeutics. The poster presentation and associated data press release can be viewed here and here, respectively. An archived webcast with company management and the study’s principal investor, Bojan Zaric, M.D., Ph.D., discussing the findings, can be found on Aileron’s website here.

    Chemotherapy is unselective, meaning it cannot distinguish between cancer cells and healthy cells. As a result, chemotherapy destroys both cancer cells and rapidly dividing healthy cells, such as bone marrow cells, hair follicle cells and skin cells, among others. ALRN-6924 is a cell-permeating peptide drug designed to work intracellularly, activating wild-type p53 to arrest cell cycling in normal, healthy cells and thereby selectively shield these cells from chemotherapy in patients who harbor p53-mutant tumors, without interrupting chemotherapy’s targeting of cancer cells.

“Chemotherapy-induced toxicities are a long-overlooked and unaddressed area of significant unmet need among the millions of cancer patients undergoing chemotherapy,” said Dr. Aivado. “For our ongoing Phase 1b trial we have focused on chemotherapy-induced bone marrow toxicities because of their severe, often life-threatening consequences for patients and also because they are the most objectively quantifiable to evaluate chemoprotection. Biologically, we believe that ALRN-6924’s ability to arrest cell cycling in normal, healthy cells has the potential to protect patients undergoing chemotherapy against a spectrum of side effects beyond bone marrow toxicities, such as hair loss, nausea, vomiting, diarrhea and fatigue.”


Upcoming Milestones

Following the achievement of clinical proof-of-concept for ALRN-6924, Aileron anticipates undertaking the following next steps to progress and expand clinical development of ALRN-6924.

  • Initiate Phase 1b randomized, controlled
    chemoprotection
    trial in patients with
    advanced
    non-small cell lung cancer
    . Aileron is planning to start a Phase 1b randomized, controlled trial of ALRN-6924 in patients with p53-mutated advanced non-small cell lung cancer who are receiving first-line platinum-based chemotherapy in the second quarter of 2021, subject to additional funding.

  • Co
    mplete
    schedule optimization part of the Phase 1b trial
    in small cell lung cancer
    to inform potential alternative dosing schedule
    for additional flexibility
    . Aileron continues to enroll patients in the schedule optimization part of the Phase 1b trial in small cell lung cancer, which is intended to determine whether ALRN-6924 given six hours prior to topotecan (“6h-schedule part”) could be an alternative dosing schedule that could provide patients and healthcare providers with additional flexibility of when to administer ALRN-6924 before topotecan. Aileron expects to report final data from the Phase 1b trial, including data from the 6h-schedule part, in the first quarter of 2021.

  • Undertake
    healthy volunteer
    study
    to support long-term clinical development
    strategy for
    ALRN-6924
    . In the fourth quarter of 2020, Aileron plans to initiate a study of ALRN-6924 in healthy volunteers to gather data to support the company’s long-term strategy to bring chemoprotection to all patients with p53-mutated cancer regardless of cancer type or chemotherapy. Specifically, the study is being conducted to characterize the time to onset, and the magnitude and duration of cell cycle arrest in human bone marrow relative to ALRN-6924 administration. This study is designed to further support Aileron’s design of future randomized, controlled studies of ALRN-6924 when given prior to various chemotherapies.


Third


Quarter


202


0


Financial Results

  • Cash Position
    : Cash, cash equivalents and investments as of September 30, 2020 were $14.1 million, compared to $18.3 million as of December 31, 2019. We expect, based on our current operating plan, that our cash, cash equivalents and investments will fund operations into the fourth quarter of 2021.

  • R
    esearch
    and
    D
    evelopmen
    t
    Expenses: Research and development expenses for the quarter ended September 30, 2020 were $2.7 million, compared to $4.5 million for the quarter ended September 30, 2019.

  • G
    eneral
    and
    Administrative
    Expenses: General and administrative expenses were $2.3 million for the quarter ended September 30, 2020, compared to $3.4 million for quarter ended September 30, 2019.

  • Net Loss
    : Net loss was $5.0 million for the quarter ended September 30, 2020, compared to $7.7 million for the corresponding period in 2019.

About Aileron Therapeutics

At Aileron, we are focused on transforming the experience of chemotherapy for cancer patients, enabling them to fight cancer without the fear or burden of chemotherapy-induced side effects. ALRN-6924, our first-in-class MDM2/MDMX dual inhibitor activating p53, is the only reported therapeutic agent in clinical development to employ a biomarker strategy, in which we exclusively focus on treating patients with p53-mutated cancers. With this unique, targeted strategy, ALRN-6924 is designed to protect multiple healthy cell types throughout the body from chemotherapy while chemotherapy continues to destroy cancer cells.

In addition to potentially reducing or eliminating multiple side effects, ALRN-6924 may also improve patients’ quality of life and help them better tolerate chemotherapy, potentially allowing patients to complete their treatment without dose reductions or delays. Our long-term vision is to bring chemoprotection to patients with p53-mutated cancers – approximately 50% of cancer patients – regardless of cancer type or chemotherapy. Visit us at aileronrx.com to learn more.

Forward-Looking Statements

Statements in this press release about Aileron’s future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may 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 about the Company’s strategy and clinical development plans. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “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 whether Aileron’s cash resources will be sufficient to fund its continuing operations for the periods anticipated; whether the Company will obtain sufficient cash resources to conduct its planned clinical trials; whether results obtained in clinical trials will be indicative of results obtained in future clinical trials; whether Aileron’s product candidates will advance through the clinical trial process on a timely basis, or at all; whether the results of such trials will be accepted by and warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether Aileron’s product candidates will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain approval, they will be successfully distributed and marketed; what impact the coronavirus pandemic may have on the timing of our clinical development, clinical supply and our operations; and other factors discussed in the “Risk Factors” section of Aileron’s quarterly report on Form 10-Q for the period ended September 30, 2020, filed on November 12, 2020, and risks described in other filings that Aileron may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Aileron specifically disclaims any obligation to update any forward-looking statement, whether because of new information, future events or otherwise.

Investor
Contact
s: 
Media Contact:
Richard Wanstall, SVP Chief Financial Officer Liz Melone
Aileron Therapeutics 617-256-6622
617-995-0900  [email protected]
[email protected]  
   
Hans C. Vitzthum  
LifeSci Advisors, LLC.  
617-430-7578  
[email protected]  

Aileron Therapeutics, Inc.
Balance Sheet Data
(In thousands)
       
  September 30,
2020
  December 31,
2019
       
Cash, cash equivalents and investments $ 14,121     $ 18,278  
Working capital $ 10,725     $ 13,711  
Total assets $ 22,239     $ 26,473  
Accumulated deficit $ (214,296 )   $ (198,135 )
Total stockholders’ equity $ 12,458     $ 16,048  
Aileron Therapeutics, Inc.
Condensed Statement of Operations
(In thousands, except share and per share data)
               
               
  Three Months Ended September 30,     Nine Months Ended September 30,  
    2020       2019       2020       2019  
               
Revenue $     $     $     $  
Operating expenses:              
Research and development   2,684       4,475       9,241       12,953  
General and administrative   2,344       3,440       7,063       9,654  
Total Operating expenses   5,028       7,915       16,304       22,607  
Loss from operations   (5,028 )     (7,915 )     (16,304 )     (22,607 )
Gain on sale of property and equipment               66        
Interest income   5       166       77       473  
Net loss   (5,023 )     (7,749 )     (16,161 )     (22,134 )
Net loss per share — basic and diluted $ (0.13 )   $ (0.28 )   $ (0.49 )   $ (0.95 )
Weighted average common shares outstanding—basic and diluted   39,321,177       27,810,358       32,808,082       23,431,823  

Canadian Natural Resources Limited Prices C$800 Million in 3 and 7 Year Medium-Term Notes

CALGARY, Alberta, Nov. 12, 2020 (GLOBE NEWSWIRE) — Canadian Natural Resources Limited announces Limited (“Canadian Natural” or the “Company”) announces that on November 12, 2020, it priced the following medium term notes which were sold to investors in Canada:

Note / Coupon Principal Maturity Price per Note Yield to Maturity
3 year / 1.45% $500,000,000 November 16, 2023 C$99.886 1.489 %
7 year / 2.50% $300,000,000 January 17, 2028 C$99.982 2.503 %

RBC Dominion Securities Inc., BMO Nesbitt Burns Inc., Scotia Capital Inc. and TD Securities Inc. acted as joint lead agents and joint book-runners for the offering of the medium-term notes. CIBC World Markets Inc., acted as joint lead agent and AltaCorp Capital Inc., Desjardins Securities Inc., Merrill Lynch Canada Inc. and National Bank Financial Inc. acted as co-agents for the offering of the medium-term notes.

The net proceeds received by Canadian Natural from the issuance and sale of the Notes will be used primarily for refinancing Canadian Natural’s outstanding indebtedness and for general corporate purposes, which may include financing our capital expenditure program and working capital requirements. The net proceeds that are not utilized immediately may be invested in short-term marketable securities. The medium-term notes were issued under the Company’s Canadian base shelf prospectus dated July 24, 2019 that allows for the issuance of debt securities in an aggregate principal amount of up to C$3.0 billion. The offering is targeted to close on November 16, 2020, subject to customary closing conditions.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

Canadian Natural is a senior oil and natural gas production company, with continuing operations in its core areas located in  Western Canada, the U.K. portion of the North Sea and Offshore Africa.

CANADIAN NATURAL RESOURCES LIMITED

2100, 855 – 2nd Street S.W. Calgary, Alberta, T2P4J8
Phone: 403-514-7777   Email: [email protected] 
www.cnrl.com
 
 
TIM S. MCKAY

President

MARK A. STAINTHORPE
Chief Financial Officer and Senior Vice-President, Finance

JASON M. POPKO
Manager, Investor Relations

Trading Symbol – CNQ
Toronto Stock Exchange
New York Stock Exchange

Certain information regarding the Company contained herein may constitute forward-looking statements under applicable securities laws.  Such statements are subject to known or unknown risks and uncertainties that may cause actual results to differ materially from those anticipated or implied in the forward-looking statements. Refer to our website for complete forward-looking statements www.cnrl.com 

Live Webcast Invite: Accelerating the Success of Canadian Professional Service Businesses

November
17

th

, 2020, 1
2
:00pm –
1
:00pm EST


Register


Today


!

MARKHAM, Ontario, Nov. 12, 2020 (GLOBE NEWSWIRE) — It’s not enough to stay competitive — Canadian professional service companies need to get ahead of the curve to both improve productivity and accelerate success. But with client demands in flux and margins at risk, many firms are uncertain about the most sustainable path to positive professional outcomes.

Join IWI Consulting Group on November 17th, 2020 at 12:00pm EST for our newest webcast, Accelerating Success in a Volatile Business Environment. Dive into current challenges faced by the professional service industry and discover actionable solutions that can help your organization both accelerate and sustain success at scale.

Solving for Service Challenges

Competition among Canadian professional service firms are heating up as companies respond to both evolving consumer expectations and the emerging adjustments required to deliver top-tier professional services during a pandemic.

For professional service organizations, common current challenges include:

  • Manual, error-prone processes that increase total overhead
  • Management of multiple project types at scale
  • Billing complexities that negatively impact cash flow
  • Consolidation, budgeting and forecasting both in the short- and long-term
  • Lack of visibility into key data for decision-making

T
he
Impact

In our upcoming webcast, we’ll tackle these topics and showcase how the right software deployments — implemented the right way at the right time — can help reduce complexity and boost overall performance. Effective implementation can deliver substantial impact for organizations, such as

  • 90% reduction in payroll processing times
    for one staffing company
  • 12% improvement to project margins
    for a life sciences firm
  • 20-day
    reduction to monthly close timelines
    in an HR organization

While each business occupies a separate market vertical, they share a common foundation as agile, professional service enterprises. In each case, targeted application of cloud financial management solutions to address specific pain points helped these companies realize accelerated success — discover how your firm can do the same in our upcoming webcast.


Register


Today

for our professional services webcast. Can’t make it? Register today and you’ll receive a link to the recorded content
post webcast
.


Register Now

About Us
As a Sage Intacct partner with two decades of experience empowering Canadian professional service firms to improve operations and outcomes, IWI Consulting Group has built a reputation on helping companies deliver clear, measurable and consistent results.


Contact
:

John Sabaratnam

IWI Consulting Group Inc.

310 – 80 Acadia Avenue

Markham, ON L3R 9V1

Toll-Free: (866) 916-3851 ext 101

Email: [email protected]

Canacol Energy Ltd. Reports an 11% Increase in Realized Contractual Gas Sales and a Net Income of $2.6 Million in Q3 2020

CALGARY, Alberta, Nov. 12, 2020 (GLOBE NEWSWIRE) — Canacol Energy Ltd. (“Canacol” or the “Corporation”) (TSX:CNE; OTCQX:CNNEF; BVC:CNEC) is pleased to report its financial and operating results for the three and nine months ended September 30, 2020.  Dollar amounts are expressed in United States dollars, except as otherwise noted.

Highlights for the three and nine months ended September 30, 2020

(Production is stated as working-interest before royalties)

Financial and operational highlights of the Corporation include:

  • Realized contractual natural gas sales volumes increased 11% and 33% to 163 MMscfpd and 172.2 MMscfpd for the three and nine months ended September 30, 2020, respectively, compared to 146.4 MMscfpd and 129.7 MMscfpd for the same periods in 2019, respectively.  Average natural gas production volumes increased 10% and 31% to 162 MMscfpd and 171.5 MMscfpd for the three and nine months ended September 30, 2020, respectively, compared to 147.6 MMscfpd and 130.9 for the same periods in 2019, respectively.  The increase is primarily due to the pipeline expansion in late Q3 2019, offset by the decrease in sales as a result of the COVID-19 pandemic.
  • Total natural gas revenues, net of royalties and transportation expenses increased 2% and 21% to $56.3 million and $179.5 million for the three and nine months ended September 30, 2020, respectively, compared to $55.1 million and $148.2 million for same periods in 2019, respectively, mainly attributable to the increase of natural gas production due to the 2019 pipeline expansion, offset by lower spot market gas sales prices, net of transportation costs due to COVID-19.  
  • Adjusted funds from operations decreased 8% and increased 20% to $33.4 million and $109.9 million for the three and nine months ended September 30, 2020, respectively, compared to $36.4 million and $91.9 million for the same periods in 2019, respectively. Adjusted funds from operations per basic share decreased 10% and increased 17% to $0.18 per basic share and $0.61 per basic share for the three and nine months ended September 30, 2020, respectively, compared to $0.20 per basic share and $0.52 per basic share for the same periods in 2019, respectively. 
  • EBITDAX decreased 8% and increased 15% to $42.3 million and $141.6 million for the three and nine months ended September 30, 2020, respectively, compared to $46 million and $122.9 million for the same periods in 2019, respectively.
  • The Corporation realized a net income of $2.6 million and a net loss of $5.7 million for the three and nine months ended September 30, 2020, respectively, compared to a net income of $0.7 million and $8.8 million for the same periods in 2019, respectively.  The net loss realized during the nine months ended September 30, 2020 is solely due to the non-cash deferred tax expense of $39.3 million, which is primarily due to the effect of the reduction in the Colombian Peso exchange rate on the value of unused tax losses and cost pool.
  • The Corporation’s natural gas operating netback decreased 10% and 9% to $3.47 per Mcf and $3.57 per Mcf in the three and nine months ended September 30, 2020, respectively, compared to $3.86 per Mcf and $3.92 per Mcf for the same periods in 2019, respectively.  The decrease is mainly due to lower spot market gas sales prices, net of transportation costs due to COVID-19.
  • Net capital expenditures for the three and nine months ended September 30, 2020 were $26.4 million and $54.6 million, respectively. Net capital expenditures included non-cash adjustments related to decommissioning obligations and right-of-use leased assets of $0.8 million and $4.6 million for the three and nine months ended September 30, 2020, respectively.
  • On July 31, 2020, the Corporation entered into a $46 million senior unsecured revolving credit facility (the “RCF”) and a $75 million senior unsecured bridge term loan (the “Bridge Loan”) with a syndicate of banks.  The Bridge Loan is intended to be used to construct and own a pipeline from the Corporation’s operations to Medellin, Colombia (the “Project”). The Bridge Loan includes an interest rate of LIBOR + 4.25%, a two-year term, and the Corporation’s ability to repay the Bridge Loan at any time within the term without penalty.  The RCF includes an interest rate of LIBOR + 4.75%, a three-year term, and the Corporation’s ability to repay/redraw the RCF at any time within the term without penalty.  Canacol will pay a commitment fee on the Bridge Loan and RCF of 30% of the respective interest margins of 4.25% and 4.75% on any undrawn amounts throughout the term. 
  • On August 28, 2020, the Corporation withdrew the initial $25 million of the Bridge Loan, net of transaction costs of $3.1 million, which will be used for initial engineering costs and environmental licensing related to the Project.  The remaining $50 million is available to be drawn at any time up to twelve months from the closing date and is currently budgeted for Project construction materials.  The RCF remains undrawn as at September 30, 2020.
  • As at September 30, 2020, the Corporation had $93.8 million in cash and cash equivalents, $2.7 million in restricted cash and $87.8 million in working capital surplus.

Outlook

In October 2020, the Corporation tested the Arandala-1 exploration well, which was drilled in late 2019. The well encountered 29.5 feet true vertical depth of net gas pay within the Porquero sandstone and was tested with a final production rate of 12.8 MMscfpd. The well is currently tied to the production manifold and ready for production.

For the remainder of 2020, the Corporation plans to commence the drilling of two additional gas exploration wells, Flauta-1 and Siku-1.

The Corporation also plans to add two new exploration and production contracts to its portfolio, the VIM-44 block, which is located in the Lower Magdalena Basin adjacent to its main gas producing area, and the VMM-47 block located in the Middle Magdalena Basin which complements its large existing gas exploration position in the basin.

The 2020 year started with national gas demand slightly above 2019 levels in the January and February 2020 time period.  In the month of April 2020, with Colombia under a country-wide lockdown related to COVID-19, the national gas demand decreased 25% relative to the same period in 2019, 721 MMscfpd versus 957 MMscfpd respectively.  Since May 2020, the national gas demand has slowly recovered as economic activity resumed following the lockdown.  In the month of October 2020, the national gas demand stood at 837 MMscfpd, down only 6% from 892 MMscfpd in October 2019.  In order to increase interruptible gas sales during the period May through to August 2020, the Corporation sold interruptible volumes at competitive prices to gain market share.  Since September 2020, with higher levels of national demand, the Corporation’s pricing for interruptible volumes has recovered.  Although the Corporation expects national gas demand to increase in 2021 from 2020 levels, given the ongoing spread of COVID-19 in Colombia, uncertainty remains with respect to both future gas demand and interruptible pricing depending upon the trajectory of the pandemic in Colombia.

Financial   Three months ended
September 30,
    Nine months ended
September 30,
  2020   2019 Change     2020   2019 Change
                       
Total natural gas, LNG and crude oil
revenues, net of royalties and
transportation expense
  $ 57,429      $ 56,634   1 %     $ 182,828        $ 153,727   19 %
                       
Adjusted Funds from operations(1)   $ 33,409      $ 36,420   (8 %)     $ 109,871        $ 91,911   20 %
Per share  – basic ($)(1)   0.18      0.20   (10 %)     0.61        0.52   17 %
Per share  – diluted ($)(1)   0.18      0.20   (10 %)     0.61        0.51   20 %
                       
Net income (loss) and comprehensive
income (loss)(2)
  $ 2,609      $ 663   294 %     $ (5,664 )     $ 8,815   n/a  
Per share – basic ($)   0.01        n/a       (0.03 )     0.05   n/a  
Per share – diluted ($)   0.01        n/a       (0.03 )     0.05   n/a  
                       
Cash flow provided by operating activities   $ 50,016      $ 36,887   36 %     $ 125,848        $ 71,169   77 %
Per share – basic ($)   0.28      0.21   33 %     0.70        0.40   75 %
Per share – diluted ($)   0.28      0.20   40 %     0.69        0.40   73 %
                       
EBITDAX(1)   $ 42,303      $ 46,037   (8 %)     $ 141,588        $ 122,867   15 %
                       
Weighted average shares outstanding –
basic
  180,980      178,273   2 %     180,942        177,736   2 %
Weighted average shares outstanding –
diluted
  181,495      180,873         181,543        179,681   1 %
                       
Capital expenditures, net dispositions   $ 26,437      $ 30,806   (14 %)     $ 54,598        $ 78,973   (31 %)
                       
                  Sep 30,
2020
        Dec 31,
2019
  Change
                     
Cash and cash equivalents               $ 93,770        $ 41,239   127 %
Restricted cash               $ 2,749        $ 4,524   (39 %)
Working capital surplus               $ 87,764        $ 50,676   73 %
Total debt               $ 416,684        $ 392,946   6 %
Total assets               $ 779,560        $ 754,062   3 %
                       
Common shares, end of period (000’s)               180,623        180,075    
                       
Operating   Three months ended
September 30,
    Nine months ended
September 30,
  2020   2019 Change     2020   2019 Change
                       
Production, before royalties(1)                      
Natural gas and LNG (MMscfpd)   162,012      147,630   10 %     171,475        130,901   31 %
Colombia oil (bopd)   317      322   (2 %)     292        365   (20 %)
Total (boepd)   28,740      26,222   10 %     30,375        23,330   30 %
                       
Realized contractual sales, before royalties(1)                      
Natural gas and LNG (MMscfpd)   162,984      146,439   11 %     172,216        129,747   33 %
Colombia oil (bopd)   347      329   5 %     281        375   (25 %)
Total (boepd)   28,941      26,020   11 %     30,494        23,138   32 %
                       
Operating netbacks(1)                      
Natural gas and LNG ($/Mcf)   3.47      3.86   (10 %)     3.57        3.92   (9 %)
Colombia oil ($/bopd)   17.04      24.34   (30 %)     16.98        25.59   (34 %)
Corporate ($/boe)   19.76      22.06   (10 %)     20.30        22.41   (9 %)

(1) Non-IFRS measures – see “Non-IFRS Measures” section within the MD&A.
(2) The net loss realized during the nine months ended September 30, 2020 is solely due to the non-cash deferred tax expense of $39.3 million, which is primarily due to the effect of the reduction in the Colombian Peso (“COP”)  exchange rate on the value of unused tax losses and cost pools. In the event that the COP strengthens in the future, as it did as at June 30, 2020, the Corporation would realize a deferred income tax recovery for the period.

This press release should be read in conjunction with the Corporation’s interim condensed consolidated financial statements and related Management’s Discussion and Analysis. The Corporation’s has filed its interim condensed consolidated financial statements and related Management’s Discussion and Analysis as at and for the three and nine months ended September 30, 2020 with Canadian securities regulatory authorities. These filings are available for review on SEDAR at www.sedar.com.

Canacol is a natural gas exploration and production company with operations focused in Colombia. The Corporation’s shares are traded on the Toronto Stock Exchange under the symbol CNE, the OTCQX in the United States of America under the symbol CNNEF and the Bolsa de Valores de Colombia under the symbol CNEC.

This press release contains certain forward-looking statements within the meaning of applicable securities law.  Forward-looking statements are frequently characterized by words such as “plan”, “expect”, “project”, “target”, “intend”, “believe”, “anticipate”, “estimate” and other similar words, or statements that certain events or conditions “may” or “will” occur, including without limitation statements relating to estimated production rates from the Corporation’s properties and intended work programs and associated timelines.  Forward-looking statements are based on the opinions and estimates of management at the date the statements are made 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.  The Corporation cannot assure that actual results will be consistent with these forward looking statements.  They are made as of the date hereof and are subject to change and the Corporation assumes no obligation to revise or update them to reflect new circumstances, except as required by law.  Information and guidance provided herein supersedes and replaces any forward looking information provided in prior disclosures.  Prospective investors should not place undue reliance on forward looking statements.  These factors include the inherent risks involved in the exploration for and development of crude oil and natural gas properties, the uncertainties involved in interpreting drilling results and other geological and geophysical data, fluctuating energy prices, the possibility of cost overruns or unanticipated costs or delays and other uncertainties associated with the oil and gas industry.  Other risk factors could include risks associated with negotiating with foreign governments as well as country risk associated with conducting international activities, and other factors, many of which are beyond the control of the Corporation.  Other risks are more fully described in the Corporation’s most recent Management Discussion and Analysis (“MD&A”) and Annual Information Form, which are incorporated herein by reference and are filed on SEDAR at www.sedar.com.  Average production figures for a given period are derived using arithmetic averaging of fluctuating historical production data for the entire period indicated and, accordingly, do not represent a constant rate of production for such period and are not an indicator of future production performance.  Detailed information in respect of monthly production in the fields operated by the Corporation in Colombia is provided by the Corporation to the Ministry of Mines and Energy of Colombia and is published by the Ministry on its website; a direct link to this information is provided on the Corporation’s website.  References to “net” production refer to the Corporation’s working-interest production before royalties.


Use of Non-IFRS Financia

l Measures – Such supplemental measures should not be considered as an alternative to, or more meaningful than, the measures as determined in accordance with IFRS as an indicator of the Corporation’s performance, and such measures may not be comparable to that reported by other companies.  This press release also provides information on adjusted funds from operations.  Adjusted funds from operations is a measure not defined in IFRS.  It represents cash provided by operating activities before changes in non-cash working capital and decommissioning obligation expenditures.  The Corporation considers funds from operations a key measure as it demonstrates the ability of the business to generate the cash flow necessary to fund future growth through capital investment and to repay debt.  Funds from operations should not be considered as an alternative to, or more meaningful than, cash provided by operating activities as determined in accordance with IFRS as an indicator of the Corporation’s performance.  The Corporation’s determination of adjusted funds from operations may not be comparable to that reported by other companies.  For more details on how the Corporation reconciles its cash provided by operating activities to adjusted funds from operations, please refer to the “Non-IFRS Measures” section of the Corporation’s MD&A. Additionally, this press release references working capital, EBITDAX and operating netback measures. Working capital is calculated as current assets less current liabilities, excluding the current portion of long-term obligations, and is used to evaluate the Corporation’s financial leverage.  EBITDAX is defined as consolidated net income adjusted for interest, income taxes, depreciation, depletion, amortization, exploration expenses and other similar non-recurring or non-cash charges.  Operating netback is a benchmark common in the oil and gas industry and is calculated as total natural gas, LNG and petroleum sales, net transportation expenses, less royalties and operating expenses, calculated on a per barrel of oil equivalent basis of sales volumes using a conversion.  Operating netback is an important measure in evaluating operational performance as it demonstrates field level profitability relative to current commodity prices. Working capital, EBITDAX and operating netback as presented do not have any standardized meaning prescribed by IFRS and therefore may not be comparable with the calculation of similar measures for other entities.

Operating netback is defined as revenues, net transportation expenses less royalties and operating expenses.

Realized contractual sales is defined as natural gas and LNG produced and sold plus income received from nominated take-or-pay contracts without the actual delivery of natural gas or LNG and the expiry of the customers’ rights to take the deliveries.


Boe


Conversion – The term “boe” is used in this news release.  Boe may be misleading, particularly if used in isolation.  A boe conversion ratio of cubic feet of natural gas to barrels oil equivalent is based on an energy equivalency conversion method primarily applicable at the burner tip and does not represent a value equivalency at the wellhead.  In this news release, we have expressed boe using the Colombian conversion standard of 5.7 Mcf: 1 bbl required by the Ministry of Mines and Energy of Colombia.  As the value ratio between natural gas and crude oil based on the current prices of natural gas and crude oil is significantly different from the energy equivalency of 5.7 Mcf:1, utilizing a conversion on a 5.7 Mcf:1 basis may be misleading as an indication of value.

For further information please contact:           
Investor Relations
South America: +571.621.1747 [email protected]
Global: +1.403.561.1648 [email protected]     
http://www.canacolenergy.com