Golden Star Publishes 2020 Corporate Responsibility Report with Enhanced Disclosures

PR Newswire

TORONTO, April 30, 2021 /PRNewswire/ – Golden Star Resources Ltd. (NYSE American: GSS) (TSX: GSC) (GSE: GSR) (“Golden Star” or the “Company”) is pleased to announce that it has published its 2020 Corporate Responsibility Report. The report has been prepared in accordance with the Global Reporting Initiative Standards (Core option), the United Nations Global Compact reporting requirements and the Sustainability Accounting Standards Board’s (“SASB”) Metals and Mining Sustainbility Accounting Standard. The report and an ESG investor presentation are available on the Company’s website at: http://www.gsr.com/responsibility/default.aspx

2020 CORPORATE RESPONSIBILITY REPORT HIGHLIGHTS

In what was a transformative year for the Company, Golden Star implemented, in 2020, a number of major initiatives and has made significant advancements in respect of the overall sustainability performance. The Corporate Responsibility Report documents our Communication on Progress to the UN Global Compact and discusses the programs that support the Sustainable Development Goals and our progress towards alignment with the World Gold Council (“WGC”) Responsible Gold Mining Principles (“RGMPs”). The report also documents work conducted on the Investor Mining and Safety Tailings Initiative and the WGC Conflict Free Gold Standard. Key highlights of the report include:

  • Leading practices in the management of the COVID-19 pandemic resulted in minimal impact to production and, more importantly, no lives lost to COVID-19 and limited serious health outcomes across the workforce.
  • Sustained improvement in injury frequency rates across the Company was marred by a fatal incident at Prestea in March 2020.
  • Wassa was recognized as the safest mine in Ghana, receiving the Best Performer in occupational health and safety at the Ghana Mining Industry Awards.
  • Golden Star continues its leading practice performance in malaria prevention, with 2020 recording the lowest case rates and days lost to malaria on Company record.
  • The Company achieved 100% conformance with its statutory monitoring program requirements and above 99% alignment to relevant quality standards.
  • Consistent with our Inclusion and Diversity Policy launched in March 2020, the Company maintained its high rates of local content, with 99% of the workforce in Ghana being Ghanaian nationals and 59% of the workforce hailing from local host communities.
  • Female representation on the Company’s Board of Directors and senior management remained high, with Golden Star recognized in the Women Lead Here benchmark of executive gender diversity for the second year running. The gender diversity across all levels increased to 8%.
  • In 2020, the Company completed the transition to a new energy composition mix at Wassa, which improves energy supply security and provides the opportunity to flatten our energy load consumption profile. A new Genser Energy Ghana natural gas power plant provides a reliable base power supply that enables the Company to explore renewable energy options, while delivering cost savings of $8 million over the first five years.
  • Construction of a first of its type, paste backfill plant in Ghana enables the reuse of process tailings for underground mine support. This facilitates improved safety outcomes and reduces volume quantities stored on the tailings storage facilities, thus enabling overall risk reduction.
  • The major upgrade of our underground electrical supply system, using a method of cable lowering not previously used before in Africa, has been a testament to our workforce development programs and the benefit of our long running local content initiatives.


Andrew Wray, Chief Executive Officer of Golden Star, commented:

“In dealing with the challenges of an unprecendented global pandemic, we were able to demonstrate the benefits of our focus on operating responsibly and sustainably through our pandemic management controls as well as our local procurement initiatives – we were able to protect our workforce and local communities, ensure stability of our operations and maintain supply chains despite land borders being closed. Not only were we able to continue operations on a reasonably uninterrupted basis, we were able to deliver significantly higher tax revenues to the Government of Ghana which helped it to deal with the financial pressures of the pandemic.

We have always understood that value generation is inherently linked with sustainability. In 2020, we clearly enunciated the understanding that people, culture and leadership, sustainability, operational excellence, financial excellence and growth are equal drivers of success and must be pursued collectively in order to achieve our goals.

We know that good reporting is of limited value if it is not substantiated by good responsible performance. Throughout the organization, our teams have delivered a remarkable performance during 2020. The improvements in water recycling, new initiatives on diversity and inclusion, and the continued strengthening of our governance systems, all demonstrate our ongoing commitment to sustainability.”

For further information, please visit
www.gsr.com
 

Company Profile:

Golden Star is an established gold mining company that owns and operates the Wassa underground mine in the Western Region of Ghana, West Africa. Listed on the NYSE American, the Toronto Stock Exchange and the Ghanaian Stock Exchange, Golden Star is focused on delivering strong margins and free cash flow from the Wassa mine. As the winner of the Prospectors & Developers Association of Canada 2018 Environmental and Social Responsibility Award, Golden Star remains committed to leaving a positive and sustainable legacy in its areas of operation.

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SOURCE Golden Star Resources Ltd.

CSI Compressco LP Announces First Quarter 2021 Results

PR Newswire

THE WOODLANDS, Texas, April 30, 2021 /PRNewswire/ — CSI Compressco LP (“CSI Compressco,” “CCLP” or the “Partnership”) (NASDAQ: CCLP) today announced first quarter 2021 results.

First Quarter 2021 Summary:

  • Total revenues for the first quarter 2021 were $65.7 million, compared to $71.1 million in the fourth quarter 2020.
  • Compression and related services revenue increased sequentially to $54.2 million in the first quarter 2021 compared to $52.6 million in the fourth quarter 2020.
  • Net loss was $14.5 million, including $0.4 million in non-recurring charges compared to a net loss of $23.0 million in the fourth quarter 2020 which included $7.6 million in non-recurring charges.
  • Adjusted EBITDA was $21.1 million compared to $26.2 million in the fourth quarter 2020. The first quarter of 2021 Adjusted EBITDA included a $0.5 million benefit from the sale of used equipment compared to a $5.8 million benefit in the fourth quarter 2020.
  • Distributable cash flow was $4.3 million compared to $7.7 million in the fourth quarter 2020.
  • Distribution coverage ratio was 8.9x in the first quarter 2021 compared to 15.9x in the fourth quarter 2020.
  • First quarter of 2021 distribution of $0.01 per common unit will be paid on May 14, 2021.

First Quarter 2021

“In the first quarter of 2021, we saw business activity stabilize at similar levels to the fourth quarter of 2020. Revenues, EBITDA and utilization were relatively flat after adjusting for the assets sales from the fourth quarter, which is traditionally a very lumpy business. More importantly, we saw the trends throughout the quarter improve, both in actual results and in forward looking quotes and activity. While we cannot predict with certainty the rest of the year’s performance, the trends give us optimism around our original thesis that 2021 will improve as the year progresses. Our customers appear more confident in their projected activity for the rest of the year and now appear to be executing around those plans. The overall impact of this customer activity, if it continues, is that in the second half of 2021 both the contract compression business and the aftermarket services business should begin to see improving utilization and margins that improve through the rest of the year” commented John Jackson, Chief Executive Officer of CSI Compressco.

“We remain excited about the future of the Partnership and the industry overall. While the improving market trends exist, we recognize that risks around results may persist during 2021, but we are optimistic about both the near-term activity levels and long-term future of the compression industry. Capital discipline, cost management and customer service are areas we continue to aggressively pursue as these are areas we can control. We expect to deliver the highest levels of service and performance to our customers as we have the people and assets in place that allow us to execute efficiently in any environment. We believe the natural gas business has a bright future and is a critical component of the energy infrastructure both today and in the transition in the energy markets in the years ahead.”

Positive net cash provided by operating activities was $9.6 million in the first quarter, compared to $7.0 million in the fourth quarter. Distributable cash flow in the first quarter was $4.3 million, resulting in a distribution coverage ratio of 8.9x.

This press release includes the following financial measures that are not presented in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”): Adjusted EBITDA, distributable cash flow, distribution coverage ratio, free cash flow, and net leverage ratio. Please see Schedules B-E for reconciliations of these non-GAAP financial measures to the most directly comparable U.S. GAAP measures.

Unaudited results of operations for the quarter ended March 31, 2021 compared to the prior quarter and the corresponding prior year quarter are presented in the table below.           


Three Months Ended


Mar 31, 2021


Dec 31, 2020


Mar 31, 2020


Q1-2021 v Q4-2020


Q1-2021 v Q1-2020

(In Thousands, except percentage changes)

Net loss

$

(14,465)

$

(23,025)

$

(13,630)

37

%

(6)

%

Adjusted EBITDA

$

21,085

$

26,185

$

27,762

(19)

%

(24)

%

Distributable cash flow

$

4,321

$

7,653

$

8,728

(44)

%

(50)

%

Net cash provided by operating activities

$

9,614

$

7,033

$

13,357

37

%

(28)

%

Free cash flow

$

5,135

$

757

$

6,874

578

%

(25)

%

 

As of March 31, 2021, total compressor fleet horsepower was 1,182,090 and fleet horsepower in service was 900,328 for an overall fleet utilization rate of 76.2% (we define the overall service fleet utilization rate as the service compressor fleet horsepower in service divided by the total compressor fleet horsepower). Idle horsepower equipment under repair is not considered utilized, but we do count units on standby as utilized when the client is being billed a standby service rate.

Balance Sheet

Cash on hand at the end of the first quarter was $20.9 million. No amounts were drawn nor outstanding on the Partnership’s asset-based loan at the end of the first quarter. Our debt consists of $80.7 million of unsecured bonds due in August 2022, $400.0 million of first lien secured bonds due in 2025 and $157.2 million of second lien secured bonds due in 2026. Net loss for the twelve months ended March 31, 2021 was $74.7 million. Net leverage ratio at the end of the quarter was 6.1x.

Capital Expenditures – 2021 Expectations

We expect capital expenditures for 2021 to be between $30.0 million and $40.0 million. The forecast includes between $8.0 million and $12.0 million for new fleet additions. Maintenance capital expenditures are expected to be between $20.0 million and $24.0 million. Investments in the Helix digitally enhanced compression system and other technologies are expected to be between $2.0 million and $4.0 million.

First Quarter 2021 Cash Distribution on Common Units

On April 19, 2021, the board of directors of our General Partner declared a cash distribution attributable to the quarter ended March 31, 2021 of $0.01 per outstanding common unit. This distribution equates to a distribution of $0.04 per outstanding common unit, on an annualized basis. This distribution will be paid on May 14, 2021 to each of the holders of common units of record as of the close of business on April 30, 2021. The distribution coverage ratio for the first quarter of 2021 was 8.9x.

Conference Call

CSI Compressco will host a conference call to discuss first quarter results today, April 30, 2021, at 10:30 a.m. Eastern Time. The phone number for the call is 1-866-374-8397. The conference call will also be available by live audio webcast and may be accessed through CSI Compressco’s website at www.csicompressco.com. An audio replay of the conference call will be available at 1-877-344-7529, conference number 10154468, for one week following the conference call and the archived webcast will be available through CSI Compressco’s website for thirty days following the conference call.

CSI Compressco Overview

CSI Compressco is a provider of compression services and equipment for natural gas and oil production, gathering, artificial lift, transmission, processing, and storage. CSI Compressco’s compression and related services business includes a fleet of approximately 4,900 compressor packages providing approximately 1.2 million in aggregate horsepower, utilizing a full spectrum of low-, medium- and high-horsepower engines. CSI Compressco also provides well monitoring and automated sand separation services in conjunction with compression and related services in Mexico. CSI Compressco’s aftermarket business provides compressor package reconfiguration and maintenance services. CSI Compressco’s customers comprise a broad base of natural gas and oil exploration and production, midstream, transmission, and storage companies operating throughout many of the onshore producing regions of the United States, as well as in a number of foreign countries, including Mexico, Canada and Argentina. CSI Compressco’s general partner is owned by Spartan Energy Partners.

Forward-Looking Statements

This news release contains “forward-looking statements” and information based on our beliefs and those of our general partner, CSI Compressco GP LLC. Forward-looking statements in this news release are identifiable by the use of the following words and other similar words: “anticipates,” “assumes,” “believes,” “budgets,” “could,” “estimates,” “expectations,” “expects,” “forecasts,” “goal,” “intends,” “may,” “might,” “plans,” “predicts,” “projects,” “schedules,” “seeks,” “should,” “targets,” “will,” and “would.” These forward-looking statements include statements, other than statements of historical fact, including anticipated return of standby equipment to in service, the redeployment of idle fleet compressors, joint-bidding on potential projects with Spartan, commodity prices and demand for CSI Compressco’s equipment and services and other statements regarding CSI Compressco’s beliefs, expectations, plans, prospects and other future events, performance, and other statements that are not purely historical. Such forward-looking statements reflect our current views with respect to future events and financial performance, and are based on assumptions that we believe to be reasonable, but such forward-looking statements are subject to numerous risks and uncertainties, including but not limited to: economic and operating condition that are outside of our control, including the trading price of our common units; the severity and duration of the COVID-19 pandemic and related economic repercussions and the resulting negative impact on the demand for oil and gas, operational challenges relating to the COVID-19 pandemic and efforts to mitigate the spread of the virus, including logistical challenges, remote work arrangements, and supply chain disruptions, other global or national health concerns; the current significant surplus in the supply of oil and the ability of OPEC and other oil producing nations to agree on and comply with supply limitations; the duration and magnitude of the unprecedented disruption in the oil and gas industry; the levels of competition we encounter; our dependence upon a limited number of customers and the activity levels of our customers; our ability to replace our contracts with our customers, which are generally short-term contracts; the availability of adequate sources of capital to us; our existing debt levels and our ability to obtain additional financing or refinancing; our ability to continue to make cash distributions, or increase cash distributions from current levels, after the establishment of reserves, payment of debt service and other contractual obligations; the restrictions on our business that are imposed under our long-term debt agreements; our operational performance; the credit and risk profile of Spartan Energy Partners; ability of our general partner to retain key personnel; risks related to acquisitions and our growth strategy; the availability of raw materials and labor at reasonable prices; risks related to our foreign operations; the effect and results of litigation, regulatory matters, settlements, audits, assessments, and contingencies; or potential material weaknesses in the future; information technology risks, including the risk of cyberattack; and other risks and uncertainties contained in our Annual Report on Form 10-K and our other filings with the U.S. Securities and Exchange Commission (“SEC”), which are available free of charge on the SEC website at www.sec.gov. The risks and uncertainties referred to above are generally beyond our ability to control and we cannot predict all the risks and uncertainties that could cause our actual results to differ from those indicated by the forward-looking statements. If any of these risks or uncertainties materialize, or if any of the underlying assumptions prove incorrect, actual results may vary from those indicated by the forward-looking statements, and such variances may be material. All subsequent written and verbal forward-looking statements made by or attributable to us or to persons acting on our behalf are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. Each forward-looking statement speaks only as of the date of the particular statement, and we undertake no obligation to update or revise any forward-looking statements we may make, except as may be required by law.


Reconciliation of Non-GAAP Financial Measures

The Partnership includes in this release the non-GAAP financial measures Adjusted EBITDA, distributable cash flow, distribution coverage ratio, free cash flow, and net leverage ratio. Adjusted EBITDA is used as a supplemental financial measure by the Partnership’s management to:

  • assess the Partnership’s ability to generate available cash sufficient to make distributions to the Partnership’s unitholders and general partner;
  • evaluate the financial performance of its assets without regard to financing methods, capital structure or historical cost basis;
  • measure operating performance and return on capital as compared to those of our competitors; and
  • determine the Partnership’s ability to incur and service debt and fund capital expenditures.

The Partnership defines Adjusted EBITDA as earnings before interest, taxes, depreciation and amortization, and before certain charges, including impairments, bad debt expense attributable to bankruptcy of customers, equity compensation, non-cash costs of compressors sold, gain on extinguishment of debt, write-off of unamortized financing costs, and excluding, severance and other non-recurring or unusual expenses or charges.

Distributable cash flow is used as a supplemental financial measure by the Partnership’s management, as it provides important information relating to the relationship between our financial operating performance and our cash distribution capability. Additionally, the Partnership uses distributable cash flow in setting forward expectations and in communications with the board of directors of our general partner. The Partnership defines distributable cash flow as Adjusted EBITDA less current income tax expense, maintenance capital expenditures, interest expense, and severance expense, plus non-cash interest expense.

The Partnership believes that the distribution coverage ratio provides important information relating to the relationship between the Partnership’s financial operating performance and its cash distribution capability. The Partnership defines the distribution coverage ratio as the ratio of distributable cash flow to the total quarterly distribution payable, which includes, as applicable, distributions payable on all outstanding common units, the general partner interest and the general partner’s incentive distribution rights.

The Partnership defines free cash flow as net cash provided by operating activities less capital expenditures, net of sales proceeds. Management primarily uses this metric to assess our ability to retire debt, evaluate our capacity to further invest and grow, and measure our performance as compared to our peer group of companies.

The Partnership defines net leverage ratio as net debt (the sum of the carrying value of long-term and short-term debt on its consolidated balance sheet, less cash, excluding restricted cash on the consolidated balance sheet and excluding outstanding letters of credit) divided by Adjusted EBITDA for calculating net leverage (Adjusted EBITDA as reported externally adjusted for certain items to comply with its credit agreement) for the trailing twelve-month period. Management primarily uses this metric to assess the Partnership’s ability to borrow, reduce debt, add to cash balances, pay distributions, and fund investing and financing activities.

These non-GAAP financial measures should not be considered an alternative to net income, operating income, cash flows from operating activities or any other measure of financial performance presented in accordance with U.S. GAAP. These non-GAAP financial measures may not be comparable to Adjusted EBITDA, distributable cash flow, free cash flow or other similarly titled measures of other entities, as other entities may not calculate these non-GAAP financial measures in the same manner as CSI Compressco. Management compensates for the limitation of these non-GAAP financial measures as an analytical tool by reviewing the comparable U.S. GAAP measures, understanding the differences between the measures and incorporating this knowledge into management’s decision-making process. Furthermore, these non-GAAP measures should not be viewed as indicative of the actual amount of cash that CSI Compressco has available for distributions or that the Partnership plans to distribute for a given period, nor should they be equated to available cash as defined in the Partnership’s partnership agreement.

 



Schedule A – Income Statement



Results of Operations (unaudited)


Three Months Ended


Mar 31, 2021


Dec 31, 2020


Mar 31, 2020

(In Thousands, Except per Unit Amounts)

Revenues:

Compression and related services

$

54,239

$

52,568

$

65,765

Aftermarket services

11,001

12,721

17,970

Equipment sales

470

5,835

1,700

Total revenues

$

65,710

$

71,124

$

85,435

Cost of revenues (excluding depreciation and amortization expense):

Cost of compression and related services

$

26,426

$

26,707

$

31,608

Cost of aftermarket services

9,517

10,951

16,245

Cost of equipment sales

317

5,540

1,883

Total cost of revenues

$

36,260

$

43,198

$

49,736

Depreciation and amortization

18,530

20,561

19,670

Impairments of long-lived assets

6,493

Selling, general, and administrative expense

9,594

7,991

9,090

Interest expense, net

13,898

13,833

13,169

Other (income) expense, net

324

(783)

440

Loss before taxes and discontinued operations

$

(12,896)

$

(20,169)

$

(6,670)

Provision for income taxes

1,507

1,273

196

Loss from continuing operations

$

(14,403)

$

(21,442)

$

(6,866)

Loss from discontinued operations, net of taxes

$

(62)

(1,583)

(6,764)

Net loss

$

(14,465)

(23,025)

(13,630)

Net loss per basic and diluted common unit

$

(0.30)

$

(0.49)

$

(0.28)

 







Schedule B – Reconciliation of Net Loss to Adjusted EBITDA, Distributable Cash Flow and Distribution Coverage Ratio

The following table reconciles net loss to Adjusted EBITDA, distributable cash flow and distribution coverage ratio for the three-month periods ended March 31, 2021, December 31, 2020 and March 31, 2020:



Results of Operations (unaudited)


Three Months Ended


Mar 31, 2021


Dec 31, 2020


Mar 31, 2020

(In Thousands, except Ratios)

Net loss

$

(14,465)

$

(23,025)

$

(13,630)

Interest expense, net

13,898

13,833

13,169

Provision for income taxes

1,507

1,273

196

Depreciation and amortization

18,530

20,561

19,670

Impairments of fixed assets and inventory

6,493

Non-cash cost of compressors sold

360

5,568

1,809

Equity compensation

833

345

324

Bond exchange expenses

115

Severance

114

194

272

Provision for income taxes, depreciation, amortization and

impairments attributed to discontinued operations

5,625

Other

308

828

327

Adjusted EBITDA

$

21,085

$

26,185

$

27,762

Less:

Current income tax expense

1,102

1,650

204

Maintenance capital expenditures

3,440

4,125

6,490

Interest expense

13,898

13,833

13,169

Severance and other

422

1,022

599

Plus:

Non-cash items included in interest expense

2,098

2,098

1,428

Distributable cash flow

$

4,321

$

7,653

$

8,728

Cash distribution attributable to period

$

484

$

480

$

478

Distribution coverage ratio

8.9

x

15.9

x

18.3

x

 



Schedule C – Reconciliation of Net Cash Provided by Operating Activities Operations to Free Cash Flow

The following table reconciles net cash provided by operating activities to free cash flow for the three-month periods ended March 31, 2021, December 31, 2020 and March 31, 2020:



Results of Operations (unaudited)


Three Months Ended


Mar 31, 2021


Dec 31, 2020


Mar 31, 2020

(In Thousands)

Net cash provided by operating activities

$

9,614

$

7,033

$

13,357

Capital expenditures, net of sales proceeds

(4,479)

(6,276)

(6,483)

Free cash flow

$

5,135

$

757

$

6,874

 







Schedule D – Reconciliation to Adjusted EBITDA Margin (unaudited)


Three Months Ended


Mar 31, 2021


Dec 31, 2020


Mar 31, 2020


Consolidated

(In Thousands, except Margin %)

Revenue

$

65,710

$

71,124

$

85,435

Loss before taxes and discontinued operations

$

(12,896)

$

(20,169)

$

(6,670)

Adjusted loss margin before taxes and discontinued operations

(19.6)

%

(28.4)

%

(7.8)

%

Adjusted EBITDA (Schedule B)

$

21,085

$

26,185

$

27,762

Adjusted EBITDA Margin

32.1

%

36.8

%

32.5

%

 



Schedule E – Reconciliation of Net Loss to Adjusted EBITDA for Net Leverage Ratio Calculation (unaudited)

(in thousands, except ratios)


Twelve Months Ended


Mar 31, 2021

Net loss

$

(74,675)

Interest expense, net

55,197

Provision for income taxes

4,491

Depreciation and amortization

79,155

Impairments and other charges

15,470

Non-cash cost of compressors sold

11,363

Equity Compensation

1,898

Financing Fees

4,892

Severance

1,876

Other

2,419

Adjusted EBITDA

$

102,086

EBITDA adjustments to comply with Credit Agreement

(490)

Adjusted EBITDA for Net Leverage Calculation

$

101,596


Debt Schedule


Mar 31, 2021

7.25% Senior Notes

80,722

7.50% First Lien Notes

400,000

10.00%/10.75% Second Lien Notes

157,162

Asset Based Loan

Letters of Credit

1,779

Cash on Hand

(20,928)


Net Debt


$


618,735


Net Leverage Ratio (Net Debt/Adjusted EBITDA for Net Leverage Calculation)


6.1x

 



Schedule F – Balance Sheet


March 31,

2021


December 31,

2020

 (in thousands)


(Unaudited)

ASSETS

Current assets:

Cash and cash equivalents

$

20,928

$

16,577

Trade accounts receivable, net of allowances for doubtful accounts of $1,283 as of March 31, 2021 and $1,333 as of December 31, 2020

47,692

43,837

Inventories

32,683

31,188

Prepaid expenses and other current assets

7,961

5,184

Current assets associated with discontinued operations

32

39

Total current assets

109,296

96,825

Property, plant, and equipment:

Land and building

13,259

13,259

Compressors and equipment

980,406

975,375

Vehicles

7,675

7,692

Construction in progress

11,851

12,763

Total property, plant, and equipment

1,013,191

1,009,089

Less accumulated depreciation

(473,065)

(457,688)

Net property, plant, and equipment

540,126

551,401

Other assets:

Intangible assets, net of accumulated amortization of $31,452 as of
March 31, 2021 and $30,711 as of December 31, 2020

24,316

25,057

Operating lease right-of-use assets

30,575

32,637

Deferred tax asset

10

10

Other assets

3,861

4,036

Total other assets

58,762

61,740

Total assets

$

708,184

$

709,966

LIABILITIES AND PARTNERS’ CAPITAL

Current liabilities:

Accounts payable

$

23,109

$

19,766

Accrued liabilities and other

45,807

36,070

Amounts payable to affiliates

3,291

3,234

Current liabilities associated with discontinued operations

279

345

Total current liabilities

72,486

59,415

Other liabilities:

Long-term debt, net

638,662

638,631

Deferred tax liabilities

1,869

1,478

Long-term affiliate payable

11,477

Operating lease liabilities

22,472

24,059

Other long-term liabilities

1,110

11,716

Total other liabilities

675,590

675,884

Commitments and contingencies

Partners’ capital:

General partner interest

(1,094)

(885)

Common units (47,971,240 units issued and outstanding at March 31, 2021 and 47,352,291 units issued and outstanding at December 31, 2020)

(24,462)

(10,055)

Accumulated other comprehensive income (loss)

(14,336)

(14,393)

Total partners’ capital

(39,892)

(25,333)

Total liabilities and partners’ capital

$

708,184

$

709,966

 

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SOURCE CSI Compressco LP

PYC Therapeutics Highlights Continued Progress of Ocular and CNS Pipeline Programs and U.S. Expansion in First Quarter Update

Lead Candidate VP-001 for Treatment of Retinitis Pigmentosa Type 11 Moves Closer to Clinical Development; Larger Animal Model Readouts on Track for 2021, with IND Submission Expected in mid 2022

First Preclinical Study in the CNS Shows Company’s PPMO Technology Can Be Successfully Applied Across High Value Target Tissues Beyond The Eye; Company Expects to Nominate CNS Candidate This Year

Three U.S.-Based, Biopharma Industry Leaders Join Company to Drive Clinical Translation of Pipeline Programs, Including a Chief Development Officer and Board Directors; More Executive Appointments Expected in the Coming Months

PR Newswire

NEW YORK and PERTH, Australia, April 30, 2021 /PRNewswire/ — PYC Therapeutics (ASX: PYC), a biotechnology company developing a new generation of precision RNA therapeutics to change the lives of patients with inherited diseases, today announced a first quarter update highlighting the progress of its development pipeline, growth of its U.S. operations and upcoming milestones.

“PYC has had an exciting quarter of progress against our Company objectives. We have achieved continued validation of our PPMO technology in our lead candidate VP-001 for retinitis pigmentosa type 11, further development of our ocular pipeline as well as PYC’s first set of preclinical data from our CNS discovery efforts demonstrating superior delivery of RNA therapeutic throughout the brain and spinal cord. The potential of our pioneering PPMO technology is vast and we look forward to advancing this technology to provide solutions for patients with inherited ocular and neurodegenerative diseases for whom treatment options are either limited or unavailable today,” said Sahm Nasseri, U.S. Chief Executive Officer of PYC Therapeutics. “This quarter, we also expanded our U.S. operations with key leadership appointments and engagements with the U.S. biotech ecosystem, underscoring the significant steps we are taking towards our transformational goal of becoming a multi-asset clinical stage biotechnology company. PYC is well positioned to maintain this momentum into the second quarter of 2021 with important larger animal studies commencing for VP-001, deeper development of VP-002 and into the balance of 2021 with continued development of our pipeline in both the eye and the CNS.”

“This is a transformational time for PYC. For some time, we’ve had significant excitement in our PPMO technology’s potential for impact in treating numerous genetic and acquired diseases and it’s truly humbling to see that excitement being translated into results through both our lead program development, and our technology’s continued validation,” commented Alan Tribe, Chairman of PYC Therapeutics. 


Recent Achievements


Inherited Ocular Diseases:

 

  • Demonstrated key functional improvement in patient-derived models for VP-001, PYC’s lead candidate for the treatment of retinitis pigmentosa type 11 (RP11), building further confidence that VP-001 will have meaningful clinical impact for patients. The Company announced preclinical results in March showing that VP-001 restored function of the retinal pigment epithelium (RPE), the structure that provides the critical blood-retinal barrier in healthy eyes and is compromised in patients with RP11. VP-001 is the first and only treatment to demonstrate restoration of this crucial barrier function in patient-derived models1, a critical readout that demonstrates correction of an underlying pathology in the disease, and one that differentiates VP-001 from adeno-associated virus (AAV) delivered DNA therapies. These results build on PYC’s additional preclinical research last year demonstrating the effectiveness of VP-001 in preclinical models to upregulate PRPF31, the critical protein deficient in patients with RP11. PYC expects to report results from important larger animal tolerability studies in the middle of 2021, with the goal of submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in mid 2022.
  • Progressed development of VP-002 for the treatment of autosomal dominant optic atrophy (ADOA). There is currently no approved therapy for ADOA, a disease affecting approximately 30 thousand patients in the western world, with an estimated 9 to 16 thousand of which could potentially be addressable by VP-0022. PYC expects to report results from patient-derived models in the first half of 2021. These results when combined with the validation of PYC’s PPMO technology in the eye, anticipated from VP-001’s larger animal studies starting in late 1H 2021, will form a strong basis for the VP-002 program. The data being generated have the potential to enable a streamlined development and regulatory pathway for VP-002. PYC anticipates to share additional VP-002 efficacy and safety data across the balance of 2021.
  • Advanced our ocular pipeline including proof of concept work with PYC-001 for the treatment of diabetic retinopathy (DR). PYC is cultivating a rich pipeline of novel development candidates to address additional ocular diseases. The Company expects to unveil additional development candidates for the treatment of high unmet need ocular indications during 2021.


Central Nervous System (CNS) Diseases

:

  • Demonstrated superior ability of PPMO technology to deliver high levels of RNA therapeutic throughout the brain. In April, PYC announced preclinical results demonstrating its PPMO technology has significant potential to provide therapies for patients with neurodegenerative diseases. This is an important expansion of the application of PYC’s technology beyond the eye. The Company expects to nominate a candidate targeting a high unmet need neurodegenerative condition in 2021. Delivery is important for neurodegenerative disease medicines because insufficient depth of penetration and delivery to target cells has been a cause in preventing drugs from having a meaningful impact without causing significant toxicity. Superior delivery and a better short- and long-term safety profile in preclinical models for PYC’s PPMOs could translate to a higher probability of clinical success and ultimately the creation of truly differentiated and meaningful medicines for CNS patients with significant unmet need. Over 50 million people globally suffer from a neurodegenerative disease, with over 3 million people suffering from rarer neurodegenerative disease such as amyotrophic lateral sclerosis (ALS) or Huntington’s disease3. PYC’s PPMO technology is uniquely placed to intervene meaningfully in the RNA dysregulation that characterizes many of these disease processes.


Corporate Initiatives:

 

  • Expanded U.S.-based management team, including independent Directors, with biopharma industry veterans with expertise in ocular, RNA and other therapeutic development. PYC appointed Glenn Noronha, PhD, as Chief Development Officer, joining the U.S.-based management team of Sahm Nasseri, U.S. CEO, and Kaggen Ausma, Chief Business Officer, who relocated to the U.S. in early 2021 from Perth. Dr. Noronha oversees PYC’s translational clinical development, regulatory, manufacturing and preclinical development activities, laying the foundation for VP-001 to advance into the clinic and to initiate evaluation in patients with RP11. PYC also appointed two U.S.-based Board Directors, Jason Haddock and Michael Rosenblatt, MD, who bring decades of combined experiences and integral knowledge in biotechnology clinical development and financial and commercial operations.
  • Continued to grow U.S. development capabilities and access to capital markets. A key enabler for PYC to unlock the full potential of its PPMO technology has been to deeply engage with the U.S. biotech ecosystem in order to access critical drug development capabilities and also to establish PYC as an RNA therapeutics leader amongst potential partners and sophisticated biotech focused investors. In the first quarter, PYC’s management was invited to present alongside other industry leaders at several healthcare and investor conferences. The Company expects to establish a West Coast location for its U.S. corporate headquarters this year, which will complement the continued drug discovery and scientific research hub in Perth.
  • Holds strong cash position to support program discovery and development and continued U.S. expansion. PYC ended March 2021 with $41 million in cash and cash equivalents. Based on its current operating plans, and considering the Australian R&D tax rebate, this provides the Company with a multi-year cash runway enabling a very strong foundation for execution of both Corporate and Program objectives.

“We continue to execute on the strategic goals we laid out to advance our transformation from an Australia-based discovery-focused organization into an Australia and U.S.-based multi-asset clinical stage biotechnology company,” continued Mr. Nasseri, U.S. CEO of PYC. “We look forward to sharing continued progress this year, including achieving our preclinical data milestones for all three of our defined programs in ocular diseases and announcing our CNS candidate, as we further validate our PPMO technology platform across indications to develop treatments for patients with a range of significant unmet needs.”

About PYC Therapeutics
PYC Therapeutics (ASX: PYC) is a development-stage biotechnology company pioneering a new generation of RNA therapeutics that utilize PYC’s proprietary library of naturally derived cell penetrating peptides to overcome the major challenges of current genetic medicines. PYC believes its PPMO (Peptide conjugated Phosphorodiamidate Morpholino Oligomer) technology enables a safer and more effective RNA therapeutic to address the underlying drivers of a range of genetic diseases for which no treatment solutions exist today. The Company is leveraging its leading-edge science to develop a pipeline of novel therapies including three preclinical stage programs focused on inherited eye diseases and preclinical discovery efforts focused on neurodegenerative diseases. PYC’s discovery and laboratory operations are located in Australia, and the Company recently launched an expansion into the U.S. for its preclinical, clinical, regulatory and corporate operations.  For more information, visit pyctx.com, or follow us on LinkedIn and Twitter.

Forward looking statements

Any forward-looking statements in this ASX announcement have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors, many of which are outside the Company’s control. Important factors that could cause actual results to differ materially from assumptions or expectations expressed or implied in this ASX announcement include known and unknown risks. Because actual results could differ materially to assumptions made and the Company’s current intentions, plans, expectations and beliefs about the future, you are urged to view all forward-looking statements contained in this ASX announcement with caution.  The Company undertakes no obligation to publicly update any forward-looking statement whether as a result of new information, future events or otherwise.

1 Preclincial models for Adeno-Associated Virus (AAV) delivered DNA therapies have not been demonstration in this in preclinical testing, See Brydon EM, Bronstein R, Buskin A, Lako M, Pierce EA, Fernandez-Godino R. AAV-Mediated Gene Augmentation Therapy Restores Critical Functions in Mutant PRPF31+/- iPSC-Derived RPE Cells. Mol Ther Methods Clin Dev. 2019 Nov 11;15:392-402.
Yu-Wai-Man P, et al. The prevalence and natural history of dominant optic atrophy due to OPA1 mutations. Ophthalmology. 2010 Aug;117(8):1538-46, 1546.e1; Lenaers G, Hamel C, Delettre C, et al. Dominant optic atrophy. Orphanet J Rare Dis. 2012;7:46. Published 2012 Jul 9. 6
3 GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 Parkinson included in ‘rarer disease’ to distinguish from Alzheimer’s.

CONTACTS:

INVESTORS
Deborah Elson/Matthew DeYoung
Argot Partners
[email protected]
[email protected] 

MEDIA
Leo Vartorella
Argot Partners
[email protected]

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SOURCE PYC Therapeutics

Greif, Inc. Completes the Sale of Timberlands to Weyerhaeuser Company

PR Newswire

DELAWARE, Ohio, April 30, 2021 /PRNewswire/ — Greif, Inc. (NYSE: GEF, GEF.B), a global leader in industrial packaging products and services, today announced that it has completed its previously announced sale of 69,200 acres of timberlands in southwest Alabama to Weyerhaeuser Company (NYSE: WY) for approximately $149 million in cash.

Proceeds from the sale will be used for debt repayment and will accelerate the transfer of Greif’s enterprise value from debt to equity holders in line with the Company’s stated financial priorities.

About Greif, Inc.

Greif is a global leader in industrial packaging products and services and is pursuing its vision: In industrial packaging, be the best performing customer service company in the world. The Company produces steel, plastic and fibre drums, intermediate bulk containers, reconditioned containers, flexible products, containerboard, uncoated recycled paperboard, coated recycled paperboard, tubes and cores and a diverse mix of specialty products. The Company also manufactures packaging accessories and provides filling, packaging and other services for a wide range of industries. In addition, Greif manages timber properties in the southeastern United States. The Company is strategically positioned in over 40 countries to serve global as well as regional customers. Additional information is on the Company’s website at www.greif.com. 

Contacts:
Matt Eichmann
Office: 740–549–6067
Email: [email protected]

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SOURCE Greif, Inc.

Avanos Medical, Inc. To Webcast Conference Call Discussing First Quarter 2021 Financial Results

PR Newswire

ALPHARETTA, Ga., April 30, 2021 /PRNewswire/ — Avanos Medical, Inc. (NYSE: AVNS) will webcast its conference call discussing financial results and business highlights for the first quarter 2021 on Friday, May 7 at 9 a.m. ET. The company will issue a news release detailing its results before the market opens that same day.

The conference call will be hosted by Joe Woody, chief executive officer, and Michael Greiner, senior vice president and chief financial officer.

To join the live conference call, dial 877-240-5772 in the United States. A simultaneous webcast of the call and a related presentation will be accessible via the Investors section of the Avanos Medical website, https://avanos.investorroom.com/.

   A replay of the conference call will be available May 7 at noon ET by dialing 877-344-7529 in the United States and entering passcode 10156077. It will be available for one week. A replay of the webcast also will be accessible in the Investors section of the website, approximately one hour following the completion of the conference call.


About Avanos Medical, Inc.



Avanos Medical (NYSE: AVNS) is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter. Headquartered in Alpharetta, Georgia, Avanos is committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Avanos develops, manufactures and markets its recognized brands in more than 90 countries. For more information, visit www.avanos.com and follow Avanos Medical on Twitter (@AvanosMedical), LinkedIn and Facebook.

 

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SOURCE Avanos Medical

Gage Cannabis Announces the Grand Opening of Battle Creek Dispensary and Adds Another Dispensary to Retail Portfolio

PR Newswire

Gage’s eighth retail location is currently welcoming medical patients and will serve adult-use customers in the coming weeks

DETROIT, April 30, 2021 /PRNewswire/ — Gage Growth Corp. (“Gage” or the “Company”) (CSE: GAGE), a leading high-quality craft cannabis brand and operator in Michigan, today announced the grand opening of its eighth provisioning center located in Battle Creek. This announcement comes on the heels of Gage’s recent retail expansion in February when the Company opened Cookies Kalamazoo. Patients and customers in Western Michigan will now have access to two Gage provisioning centers. Furthermore, the Company also announced the addition of a provisioning center (dispensary) to its retail portfolio.

Battle Creek Opening

Located at 48 Main Street, Battle Creek, MI, 49014, Gage Battle Creek is currently serving patients with a valid Michigan Medical Marijuana ID and expects to begin welcoming adult-use customers in the coming weeks. The newest location will carry Gage’s entire selection of products, as well as award-winning Cookies branded offerings that are exclusively available at Gage locations.

The 4,600+ square-foot location is expected to create 20+ new jobs in Battle Creek. The Company aims to build a robust cannabis business community in Michigan through its social equity program that awards $50,000 to cannabis entrepreneurs in 20 social equity cities designated by the Michigan Marijuana Regulatory Agency. The application process is open to Michigan residents year-round.

Michigan’s cannabis market continues to experience unprecedented growth, especially after sales topped $146 million in March alone, and Gage is determined to continue expanding our retail presence in order to meet this growing demand,” said Fabian Monaco, CEO of Gage. “Our Battle Creek team is eager to work with new patients and consumers, as well as community stakeholders, to showcase the mental, physical and social benefits of cannabis.”

Additional Retail Location

Gage is also pleased to announce that the Company has added another provisioning center (the “Dispensary”) to its portfolio. The addition of the Dispensary to the Company’s portfolio is aligned with the Company’s growth strategy to identify, acquire, and operate licensed cannabis provisioning centers, positioning Gage as the leading cannabis brand in the state of Michigan.

The Dispensary is expected to open within 30 calendar days with projected revenue of US$10-12 million in the next twelve months. The transaction is expected to be accretive to Gage on a revenue and Adjusted EBITDA basis.

About Gage

Gage Growth Corp. is innovating and curating the highest quality cannabis experiences possible for cannabis consumers in the state of Michigan and bringing internationally renowned brands to market. Through years of progressive industry experience, the firm’s founding partners have successfully built and grown operations with federal and state licenses, including cultivation, processing and retail locations. Gage’s portfolio includes city and state approvals for 19 “Class C” cultivation licenses, three processing licenses and 13 provisioning centers (dispensaries).

For more information about Gage Growth Corp., visit www.gagecannabis.com.

Instagram: @gagecannabis
Facebook: @gageusa
Twitter: @gagecannabisco

Gage Contact:
1-(833)-455-GAGE (4243)
[email protected]

Sources: Gage Growth Corp., Marijuana Regulatory Agency.

Non-IFRS Financial Measures

This press release refers to “Adjusted EBITDA” which is a non-IFRS financial measure. This non-IFRS financial measure does not have a standardized definition under IFRS, nor is it calculated or presented in accordance with IFRS and may not be comparable to similar measures presented by other companies. The Company defines “Adjusted EBITDA” as net income (loss) from operations, as reported, before interest and tax, adjusted to exclude extraordinary items, non-recurring items, other non-cash items, including stock-based compensation expense, depreciation and amortization, foreign exchange and acquisition related costs, if applicable.

The Company has referenced this non-IFRS financial measure as supplemental information and believes it provides a valuable additional measure to use when analyzing the operating performance of the business. As other companies may calculate this non-IFRS measure differently than the Company, this metric may not be comparable to similarly titled measures reported by other companies. We caution readers that Adjusted EBITDA should not be substituted for determining net loss as an indicator of operating results, or as a substitute for cash flows from operating and investing activities.

Explanatory Note Regarding the Company’s Operations

References in this news release to the Company and its operations and assets are inclusive of the operations and assets of certain licensed cannabis operators that operate under the Gage brand pursuant to contractual arrangements with the Company. For additional information, please refer to the Company’s long form prospectus dated March 26, 2021 and other disclosure documents available on the Company’s profile at www.sedar.com.

Caution Regarding Cannabis Operations in the United States

Investors should note that there are significant legal restrictions and regulations that govern the cannabis industry in the United States. While legal in certain states, cannabis remains a Schedule I drug under the U.S. Controlled Substances Act, making it illegal under federal law in the United States to, among other things, cultivate, distribute or possess cannabis. Financial transactions involving proceeds generated by, or intended to promote, cannabis-related business activities in the United States may form the basis for prosecution under applicable U.S. federal money laundering legislation. Investors should carefully read the risk factors and disclosures contained in the Company’s long form prospectus dated March 26, 2021 and other disclosure documents available on the Company’s profile at www.sedar.com.

Cautionary Note Regarding Forward-Looking Information and Statements

This press release contains certain “forward-looking information” within the meaning of applicable Canadian securities legislation and may also contain statements that may constitute “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such forward-looking information and forward-looking statements are not representative of historical facts or information or current condition, but instead represent only Gage’s beliefs regarding future events, plans or objectives, many of which, by their nature, are inherently uncertain and outside of Gage’s control. Generally, such forward-looking information or forward-looking statements can be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or may contain statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “will continue”, “will occur” or “will be achieved”. The forward-looking information and forward-looking statements contained herein may include, but are not limited to, statements about the opening and financial performance of the Dispensary.

By identifying such information and statements in this manner, Gage is alerting the reader that such information and statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from those expressed or implied by such information and statements. In addition, in connection with the forward-looking information and forward-looking statements contained in this press release, Gage has made certain assumptions. Although Gage believes that the assumptions and factors used in preparing, and the expectations contained in, the forward-looking information and statements are reasonable, undue reliance should not be placed on such information and statements, and no assurance or guarantee can be given that such forward-looking information and statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information and statements. Among others, the key factors that could cause actual results to differ materially from those projected in the forward-looking information and statements are the following: unexpected costs or delays in the completion of the Company’s proposed dispensaries and other operations; negative results experienced by the Company as a result of general economic conditions or the ongoing COVID-19 pandemic; delays in the ability of the Company to obtain certain regulatory approvals; unforeseen delays or costs in the completion of the Company’s construction projects; adverse changes to demand for cannabis products; ongoing projects by competitors that may impact the relative size of the Company’s operations; adverse changes in applicable laws; adverse changes in the application or enforcement of current laws, including those related to taxation; increasing costs of compliance with extensive government regulation; changes in general economic, business and political conditions, including changes in the financial markets; and the other risks disclosed in the Company’s long form prospectus dated March 26, 2021 and other disclosure documents available on the Company’s profile at www.sedar.com.

The forward-looking information and forward-looking statements contained in this press release are made as of the date of this press release, and Gage does not undertake to update any forward-looking information and/or forward-looking statements that are contained or referenced herein, except in accordance with applicable securities laws.

Third Party Information

This press release includes market and industry data that has been obtained from third party sources, including industry publications. The Company believes that the industry data is accurate and that its estimates and assumptions are reasonable, but there is no assurance as to the accuracy or completeness of this data. Third party sources generally state that the information contained therein has been obtained from sources believed to be reliable, but there is no assurance as to the accuracy or completeness of included information. Although the data is believed to be reliable, the Company has not independently verified any of the data from third party sources referred to in this press release or ascertained the underlying economic assumptions relied upon by such sources.

SOURCE: Gage Growth Corp.

Related Links
https://gagecannabis.com

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SOURCE Gage Cannabis Co.

Puxin Limited Files Annual Report on Form 20-F for Fiscal Year 2020

PR Newswire

BEIJING, April 30, 2021 /PRNewswire/ — Puxin Limited (NYSE: NEW) (“Puxin” or the “Company”), a successful consolidator of the after-school education industry in China, today announced that it filed its annual report on Form 20-F for the fiscal year ended December 31, 2020 with the Securities and Exchange Commission (the “SEC”) on April 30, 2021. The annual report on Form 20-F, which contains its audited financial statements, can be accessed on the SEC’s website at http://www.sec.gov as well as via the Company’s investor relations website at http://ir.pxjy.com/.

The Company will provide a hard copy of its annual report containing the audited consolidated financial statements, free of charge, to its shareholders upon request. Requests should be directed to the Company’s IR Department via email at [email protected].

About Puxin Limited

Puxin Limited (NYSE: NEW, “Puxin” or the “Company”) is a successful consolidator of the after-school education industry in China. Puxin has a strong acquisition and integration expertise to effectively improve education quality and operational performance of acquired schools. Puxin offers a full spectrum of K-12 and study-abroad tutoring programs designed to help students achieve academic excellence, as well as prepare for admission tests and applications for top schools, universities and graduate programs in China and other countries. The Company has developed a business model effectively combining strategic acquisitions and organic growth achieved through successful post-acquisition integration, which has differentiated the Company from other after-school education service providers in China. For more information, please visit http://www.pxjy.com/.

Contacts

Puxin Limited
Investor Relations
Phone: +86-10-6269-8930
E-mail: [email protected]

ICA (Institutional Capital Advisory)
Mr. Kevin Yang
Phone: +86-21-8028-6033
E-mail: [email protected]

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SOURCE Puxin Limited

Boralex Announces Sale of Blendecques Cogeneration Plant to Norpaper

PR Newswire

MONTREAL and PARIS, April 30, 2021 /PRNewswire/ – Boralex Inc. (“Boralex” or the “Company”) (TSX: BLX) announced today the sale of the 12 MW Blendecques cogeneration plant, the last thermal energy asset in its French portfolio. The sale was concluded on Friday, April 30, 2021, to papermaker Norpaper, Boralex’s long-time partner in Blendecques, in Northern France, and the sole beneficiary of the thermal power produced by the plant. This will go into effect on May 1.

Boralex, a 100% green operator in Europe

As the leader in the energy transition, Boralex’s primary business is to produce renewable power. Selling this asset enables the Company to position itself as a 100% green operator in Europe. This decision is also consistent with Boralex’s strategic plan for 2023.

“By its nature, this activity is no longer aligned with our renewable production sites. This sale will enable us to focus full time on our strategic assets,” said Nicolas Wolff, Vice President and General Manager Boralex, Europe.

The plant will maintain its current operations

During the sale process, Norpaper informed Boralex that it wanted to maintain the plant’s current operations. The papermaker therefore proposed to retain the seven jobs assigned to managing the cogeneration facility. All employees involved accepted this transfer and will be joining Norpaper’s ranks as of May 1.

“We didn’t want the sale to impact employees,” said Nicolas Wolff. “The teams have my sincerest appreciation for their collaboration throughout this process. This is truly a milestone and I thank them for their commitment to Boralex over the years. The Blendecques cogeneration plant’s sale is also a testament to its quality as an asset. I wish them all the best with our long-time partner, Norpaper.”

About Boralex

Boralex develops, builds and operates renewable energy power facilities in Canada, France, the United Kingdom and the United States. A leader in the Canadian market and France’s first independent onshore wind power producer, the Corporation is recognized for its solid experience in optimizing its asset base in four power generation types – wind, hydroelectric, thermal and solar. Boralex ensures sustainable growth by leveraging the expertise and diversification developed for 30 years. Boralex’s shares are listed on the Toronto Stock Exchange under the ticker symbol BLX.

More information is available at www.boralex.com or www.sedar.com. Follow us on Facebook, LinkedIn and Twitter.

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SOURCE Boralex Inc.

Synairgen announces data from Home Cohort of SG016 Phase II trial of inhaled interferon beta in COVID-19 patients and encouraging combined data for whole SG016 trial

Press release

Synairgen plc

(‘Synairgen’ or the ‘Company’)

Synairgen
announces
data
from
Home Cohort
of
SG016
Phase II
trial
of inhaled interferon beta in COVID-19 patients
and
encouraging
combined data for
whole
SG016
trial

  • The vast majority of
    Home Cohort
    patients experienced mild disease – only two patients
    were
    hospitalised
    during the treatment period
    , both on placebo
  • Home Cohort patients successfully self-administered SNG001
  • The
    degree
    of breathlessness
    at start of treatment
    indicate
    s
    which patients should be treated with SNG001 both in hospital and at
    home
  • Analysis of
    the
    combined data from
    the
    H
    ospital and
    H
    ome
    C
    ohorts showed
    that the more
    breathless patients are
    significantly more likely (>3 fold)
    to recover on inhaled interferon beta (SNG001) than
    placebo
  • The study results r
    einforce confidence in ongoing Phase III study, with data readout on track for H2
    2021
  • Synairgen management and scientists to hold a
    30 minute

    web


    cast


    with live Q&A at


    9.00


    BST today

Southampton, UK

30
April
20
2
1
: Synairgen plc (LSE: SNG), the respiratory company developing inhaled interferon beta (IFN-beta) for the treatment of severe viral lung infections, today announces results from the Home Cohort of its SG016 Phase II trial of SNG001 in SARS-CoV-2 infected patients and data from the combined analysis of the Hospital and Home Cohorts.

SNG001 is a formulation containing IFN-beta for nebulisation, allowing it to be delivered directly into patients’ lungs. A number of studies have reported that the SARS-CoV-2 virus suppresses natural production of IFN-beta and prevents induction of anti-viral responses by infected cells. Furthermore, some people have deficiencies in antiviral IFN signalling that make them more vulnerable to spread of the virus from the nose into the lungs where it can cause severe breathing difficulties. These findings provide a rationale to deliver IFN-beta directly to the surface epithelial cells of the lungs, the primary site of virus infection in the lungs, to prevent severe lower respiratory tract illness caused by the SARS-CoV-2 virus.

The COVID-19
Phase II
s
tudy
(SG016)

Synairgen’s placebo-controlled Phase II trial evaluated SNG001 for the prevention of severe lower respiratory tract (LRT) illness caused by SARS-CoV-2, determined by evaluating change in condition measured using the WHO Ordinal Scale for Clinical Improvement (OSCI) during the dosing period (the primary endpoint). The SG016 trial involved 221 patients in two cohorts:

  • Hospital Cohort: 101 patients in the hospital setting, where patients on SNG001, compared to placebo were twice as likely to recover from severe LRT illness to the point where they had ‘no limitation of activities’ (level 1 on the OSCI) without rebound, and had reduced breathlessness.1
  • Home Cohort: 120 ‘at risk’ (aged over 65 or over 50 with a risk factor) patients in the home setting to investigate if SNG001 could prevent development of severe LRT illness.

Trial
f
indings
from
H
ome
C
ohort

In total, only two patients were admitted to hospital during the treatment period, both from the placebo group. The hospitalisation rate (approximately 3% in the placebo group) in this ‘at risk’ COVID-19 patient population was lower than had been originally anticipated, but is in line with other recent large peer-reviewed therapeutic studies. Consequently, the prevention of severe LRT illness could not be determined.
The majority of patients exhibited only mild disease which we believe compromised the possibility of showing treatment effects in the Home Cohort. We therefore decided to analyse the subset of patients with most severe symptoms. 

A post hoc analysis was conducted focusing on the 12% of patients who had significant breathlessness (marked or severe, as defined in Note a) at the time they began treatment. In these patients, the recovery to level 1 on the OSCI (‘no limitation of activities’) followed a similar pattern to that observed previously in the hospital population where SNG001 accelerated recovery. This led to an analysis of the impact of SNG001 across the Home and Hospital Cohorts in breathless patients. 

A further finding from the Home Cohort was that patients can successfully initiate treatment “remotely”, self-administering SNG001 at home without the need for a face-to-face meeting with a health care professional, reducing the burden on hospital facilities and minimising the risk of onward infection.

Overall analysis
of
SG016 trial
, combining
Hospital and Home Cohort
s
data

A combined analysis of the Hospital and Home Cohorts data was conducted to explore the impact of the different levels of breathlessness, which is one of the most prominent symptoms of COVID-19, on time to recovery.

  • An assessment of placebo patients only indicated that those with marked or severe breathlessness at time of treatment initiation had slower recovery to no limitation of activities than those patients who were not as breathless.  
  • In the Hospital Cohort (reported in July 2020) patients were 2.19 times more likely to recover to level 1 on the Ordinal Scale compared to placebo, HR 2.19, p=0.043. The addition of the 12 markedly and severely breathless Home Cohort patients changes the Hazard Ratio to 2.49, p=0.009.
  • Interestingly, not all hospitalised patients were markedly or severely breathless at time of treatment initiation. An analysis including only patients who were markedly or severely breathless at the time of treatment initiation, irrespective of whether they were in hospital or at home, showed that those treated with SNG001 (n=33) were 3.41 times more likely to recover than those on placebo (n=36) (HR 3.41 [95% confidence interval 1.47- 7.94], p=0.004).  

Richard Marsden, CEO of Synairgen, said:

I am
delighted
by the finding that SNG001 treatment led to
a threefold likelihood of recovery to ‘no limitation of activities’ in the marked
ly
/severe
ly
breathless population
compared to those on placebo
in the home
and
hospital setting
, and
that
further analyses reinforce our previous findings
.
It
increases our con
viction
in the approach we have taken to conduct
an
international Phase III
trial in
hospitalised
patients
requiring supplemental oxyge
n
,
which
is
scheduled to
read out in the second half of this year
.

“As Governments around the world
, such as India
,
look to how future outbreaks and variants may be handled
, our
virus-agnostic therapeutic could help
to
save lives, release pressure on the world’s healthcare systems
,
and
thereby
potentially mitigate
the need for economically costly lockdowns.”

Professor Tom Wilkinson
, Professor of Respiratory Medicine at the University of Southampton, commented:
“The SG016 C
OVID-19
trial of inhaled interferon beta
has been very successful. Although
the vast majority of
non-hospitalised patients had very mild symptoms, the effects of SNG001 on the small group of
markedly and
severely breathless patients
indicated
who might be benefitting most from SNG001. Assessment of breathlessness as a predictor of protracted recovery in the combined Home and Hospital Cohorts showed us that non-breathless patients have no need for the innate immune response boost that interferon beta provides, whereas the patients who were breathless
derive strong benefit from SNG001. This tells us that we should target SNG001 at C
OVID-19
patients with marked or severe breathlessness
where it has a potentially significant benefit
.

Professor Nick Francis, Professor of
Primary Care Research
at the University of Southampton, commented:

With the knowledge gained from this trial,
identifying
patients
likely
to
benefit from
SNG001 in primary care will be a relatively simple task, starting with an assessment of breathlessness. In parallel with the Phase III trial in the hospital setting
,
there is now an urgent need to assess SNG001 in the non-hospital setting, focussing entirely on breathless C
OVID-19
patients. I look forward to discussing with primary care platform study teams around the world
whether SNG001 can be included in their existing studies
.

“As a GP, I recognise the potential importance of these findings, especially for countries that are still struggling with this disease
at the moment
, and for reducing the burden for patients and the healthcare system in any future waves that may be coming our way.”

Synairgen plans to submit the findings for peer review at an upcoming medical conference or publication.

Members of the management team and scientists at Synairgen will hold a webcast for analysts, followed by a live Q&A, at 9:00 BST today. Please find a link to this webcast here.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No. 596/2014 (‘MAR’).


References

  1. The Lancet Respiratory Medicine“Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial”. Monk, P D PhD, et al., 12 November 2020, accessible here.


  2. https://investor.regeneron.com/news-releases/news-release-details/phase-3-trial-shows-regen-covtm-casirivimab-imdevimab-antibody


    .


Notes

a. Breathlessness scoring system from the Breathlessness, Cough and Sputum Scale (BCSS)

How much difficulty did you have breathing today?
0 = None – unaware of any difficulty
1 = Mild – noticeable when performing strenuous activity (e.g. running)
2 = Moderate – noticeable even when performing light activity (e.g. bedmaking or carrying groceries)
3 = Marked – noticeable when washing or dressing
4 = Severe – almost constant, present even when resting

For further enquiries, please contact:

Synairgen plc

Richard Marsden, Chief Executive Officer
John Ward, Chief Financial Officer
Tel: + 44 (0) 23 8051 2800

finnCap
(NOMAD and Joint Broker)

Geoff Nash, Kate Bannatyne, Charlie Beeson (Corporate Finance)
Alice Lane, Sunila de Silva (ECM)
Tel: + 44 (0) 20 7220 0500

Numis Securities Limited (Joint Broker)

James Black, Freddie Barnfield, Duncan Monteith
Tel: +44 (0) 20 7260 1000

Consilium Strategic Communications (Financial Media and Investor

Relations)

Mary-Jane Elliott, Jessica Hodgson, Olivia Manser
[email protected]
Tel: +44 (0) 20 3709 5700


MKC Strategies, LLC (US Media Relations)


Mary Conway
[email protected]
Tel: +1 516 606 6545


Notes for Editors

About Synairgen

Synairgen is a clinical-stage respiratory drug discovery and development company founded by University of Southampton Professors Sir Stephen Holgate, Donna Davies and Ratko Djukanovic. 

Synairgen is currently focused on developing its product candidate, SNG001 (inhaled interferon beta) for the treatment of COVID-19. SNG001 is potentially the first host-targeted broad-spectrum antiviral treatment delivered directly into the lungs. The Company is evaluating nebulised SNG001 in its Phase III clinical programme, which has been deemed an Urgent Public Health study by the UK’s National Institute for Health Research (NIHR). SNG001 has also been granted Fast Track status from the US Food and Drug Administration (FDA). In Phase II trials, COVID-19 patients with marked/severe breathlessness demonstrated a threefold chance of recovery when treated with SNG001 versus placebo. For more detailed information, please see the notes below.

Synairgen is quoted on AIM (LSE: SNG). For more information about Synairgen, please see www.synairgen.com

COVID-19

COVID-19, caused by the SARS-CoV-2 virus, is an ongoing global pandemic and there is widespread recognition of the urgent need for antiviral therapies, alongside vaccination programs, both for this and future pandemics. Such therapies could be used to prevent and effectively treat the severe lower respiratory tract illness that can occur with these types of diseases.

SNG001 (inhaled Interferon beta) applicability to COVID-19

Interferon beta (‘IFN-beta’) is a naturally-occurring protein, which orchestrates the body’s antiviral responses. It is used widely in the treatment of multiple sclerosis and is a safe and well tolerated drug. There is growing evidence that deficiency in IFN-beta production by the lung could explain the enhanced susceptibility in ‘at-risk’ patient groups to developing severe lower respiratory tract (lung) disease during respiratory viral infections.

Viruses, including coronaviruses such as SARS-CoV-2, have evolved mechanisms which suppress endogenous IFN-beta production, helping the virus to evade the innate immune system. The addition of exogenous IFN-beta before or during viral infection of lung cells in vitro either prevents or greatly reduces viral replication, potentially reducing the severity of infection and accelerating recovery.

Synairgen’s SNG001 is a formulation of IFN-beta-1a for direct delivery to the lungs via nebulisation. It is [pH neutral, and is free of mannitol, arginine and human serum albumin, making it] suitable for inhaled delivery direct to the site of action. Phase I and II trial data have shown that SNG001 activates lung antiviral defences as measured in sputum cells, and that SNG001 has been well tolerated in approximately 280 asthma/COPD/COVID-19 patients to-date. SNG001 has the potential to address the urgent need for antiviral therapies for COVID-19 and for future pandemic respiratory infections, alongside vaccination programmes.

In July 2020, Synairgen announced the results of its Phase II double-blind, placebo-controlled study of 101 randomised COVID-19 hospitalised patients, which showed that SNG001 given for 14 days was associated with greater odds of improvement versus placebo on the WHO Ordinal Scale for Clinical Improvement (OSCI) and more rapid recovery to the point where patients were no longer limited in their activity, with a greater proportion of patients recovering during the 28-day study period.

The results were published in The Lancet Respiratory Medicine: “Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial”. Monk, P D PhD, et al., 12 November 2020, accessible here.

The Company’s global Phase III trial (SG018) evaluating SNG001 for the treatment of hospitalised COVID-19 patients is ongoing. The trial is deemed an Urgent Public Health study by the UK’s National Institute for Health Research (NIHR). In the US, SNG001 has been granted Fast Track status from the US Food and Drug Administration (FDA). The Company is seeking further equivalent prioritisations and support from governments in participating countries.

About Southampton Clinical Trials Unit

The Southampton Clinical Trials Unit (CTU) is a National Institute for Health Research (NIHR) supported CTU with expertise in the design, conduct and analysis of interventional clinical trials. The CTU is based within the University of Southampton with offices at the University Hospital Southampton NHS Foundation Trust Southampton General Hospital site. (www.southampton.ac.uk/ctu/index.page



Pfizer and BioNTech Submit Request to Expand Conditional Marketing Authorization of COMIRNATY® in the EU to Adolescents

NEW YORK
a
nd MAINZ,
GERMANY
,
April
30
,
202
1
(GLOBE NEWSWIRE)Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a variation to the Conditional Marketing Authorization (CMA) in the European Union (EU) to the European Medicines Agency (EMA) for the Pfizer-BioNTech vaccine COMIRNATY® (BNT162b2) to request an extension of the indication for use in adolescents 12 to 15 years of age. If EMA approves the variation, the amended CMA will be valid in all 27 member states of the EU. The companies have already submitted a similar request to the U.S. Food and Drug Administration (FDA) for the Emergency Use Authorization (EUA) and plan to request additional amendments with other regulatory authorities worldwide.

This submission is based on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years. Topline results from this trial, announced on March 31, 2021, showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and robust antibody responses. In the trial, the vaccine also was generally well tolerated. Participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (jointly with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

AUTHORIZED USE IN THE EU:

COMIRNATY

®

(the Pfizer-BioNTech COVID-19 vaccine) has been granted conditional marketing authorisation by the by the European Commission to prevent coronavirus disease 2019 (COVID-19) in people from 16 years of age. The European Medicines Agency’s (EMA’s) human medicines committee (CHMP) has completed its rigorous evaluation of COMIRNATY®, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available.

IMPORTANT SAFETY INFORMATION:

  • Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.
  • The efficacy, safety and immunogenicity of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of COMIRNATY® may be lower in immunosuppressed individuals.
  • As with any vaccine, vaccination with COMIRNATY® may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their second dose of vaccine.
  • In clinical studies, adverse reactions in participants 16 years of age and older were injection site pain (> 80%), fatigue (> 60%), headache (> 50%), myalgia and chills (> 30%), arthralgia (> 20%), pyrexia and injection site swelling (> 10%) and were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age.
  • There is limited experience with use of COMIRNATY® in pregnant women. Administration of COMIRNATY® in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus.
  • It is unknown whether COMIRNATY® is excreted in human milk.
  • Interactions with other medicinal products or concomitant administration of COMIRNATY® with other vaccines has not been studied.
  • For complete information on the safety of COMIRNATY® always make reference to the approved Summary of Product Characteristics and Package Leaflet available in all the languages of the European Union on the EMA website.

The black equilateral triangle denotes that additional monitoring is required to capture any adverse reactions. This will allow quick identification of new safety information. Individuals can help by reporting any side effects they may get. Side effects can be reported to EudraVigilance or directly to BioNTech using email [email protected], telephone +49 6131 9084 0, or via the website www.biontech.de.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure Notice

The information contained in this release is as of April 30, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine program and COMIRNATY®, the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) (including qualitative assessments of available data, potential benefits, expectations for clinical trials, the potential of BNT162b2 for adolescents 12 to 15 years of age, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including the topline data outlined in this release), including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data (including the topline data outlined in this release); the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies or in larger, more diverse populations following commercialization; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data (including the topline data outlined in this release) are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program (including the topline data outlined in this release) will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when a Biologics License Application for BNT162b2 may be filed in the U.S. and whether and when other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including a potential Biologics License Application in the U.S. or any requested amendments to the emergency use or conditional marketing authorizations) or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine’s benefits outweigh its known risks and determination of the vaccine’s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine’s ultra-low temperature formulation, two-dose schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

About BioNTech

Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.

BioNTech Forward-looking Statements

This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech’s efforts to combat COVID-19; the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine; our expectations regarding the potential characteristics of BNT162b2 (COMIRNATY®) in our Phase 2/3 trial and/or in commercial use based on data observations to date; the expected timepoint for additional readouts on efficacy data of BNT162b2 in our Phase 2/3 trial; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; our contemplated shipping and storage plan, including our estimated product shelf-life at various temperatures; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimates for 2021. Any forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Annual Report on Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SEC’s website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

Pfizer Contacts:

Media Relations

Andy Widger
+44 (0)1737 330909
[email protected]

Investor Relations
Chuck Triano
+1 (212) 733-3901
[email protected]

BioNTech Contacts:

Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513
Media@biontech.de

Investor Relations
Sylke Maas, Ph.D.
+49 (0)6131 9084 1074
[email protected]