Market Newsdesk

CAMBRIDGE, Mass., Nov. 13, 2020 (GLOBE NEWSWIRE) — Checkmate Pharmaceuticals,Inc. (NASDAQ: CMPI) (“Checkmate”), a clinical stage biotechnology company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, today announced third quarter 2020 financial results and provided an update on recent progress.

“We are enthusiastic as we advance CMP-001 toward registration in melanoma and expand toward potential proof of concept in additional indications,” said Barry Labinger, Chief Executive Officer. “We remain on track to initiate key new clinical trials by late 2020/early 2021 as planned.”

Recent
Progress

• During SITC’s 35^th Anniversary Annual Meeting, three new data presentations were given evaluating CMP-001, Checkmate’s advanced generation Toll-like receptor 9 (TLR9) agonist. These data continue to demonstrate the clinical activity of CMP-001 in combination with anti-PD-1 antibodies in patients with melanoma.
• Checkmate is actively engaging with potential clinical sites and remains on track to initiate three Phase 2 trials combining CMP-001 with PD-1 blockade by late 2020/early 2021 for the treatment of:
  • First-line head and neck cancer
  • Anti-PD-1 refractory melanoma
  • First-line metastatic or unresectable melanoma

Third
Quarter 2020 Financial Results

• Cash and cash equivalents: Cash and cash equivalents were $137.3 million as of September 30, 2020.
• Research and development expenses
  (R&D): R&D expenses were $6.7 million for the quarter ended September 30, 2020, compared to $5.1 million for the quarter ended September 30, 2019. The increase was primarily attributable to increased headcount and clinical trial expenses in connection with increased patient enrollment in the ongoing clinical trials of CMP-001 and preparations for the initiation of planned additional clinical trials of CMP-001. These increases were partially offset by a decrease in contract manufacturing costs.
• General and administration expenses
  (G&A)
  : G&A expenses were $3.2 million for the quarter ended September 30, 2020, compared to $1.2 million for the quarter ended September 30, 2019. The increase was primarily attributable to increases in personnel and other operating expenses incurred in connection with Checkmate beginning to operate as a publicly-traded company.
• Net loss
  and comprehensive loss
  : Net loss and comprehensive loss was $9.8 million for the quarter ended September 30, 2020, compared to $6.2 million for the quarter ended September 30, 2019.

About
Checkmate
Pharmaceuticals

Checkmate Pharmaceuticals is a clinical stage biotechnology company focused on developing its proprietary technology to harness the power of the immune system to combat cancer. Checkmate’s product candidate, CMP-001, is an advanced generation TLR9 agonist delivered as a biologic virus-like particle designed to trigger the body’s innate immune system to attack tumors in combination with other therapies. Information regarding Checkmate is available at www.checkmatepharma.com.

Availability of Other Information About Checkmate

Investors and others should note that we communicate with our investors and the public using our website (www.checkmatepharma.com), our investor relations website (ir.checkmatepharma.com), and on social media (Twitter and LinkedIn), including but not limited to: investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Checkmate posts on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward Looking Statements

Various statements in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. These statements include those regarding our product candidate, including its development and therapeutic potential and the advancement of our clinical and preclinical pipeline; expectations regarding the results and analysis of data; and expectations regarding the timing, initiation, implementation and success of its planned clinical trials for CMP-001.  Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. These forward-looking statements are subject to risks and uncertainties, including those related to the development of our product candidate, including any delays in our ongoing or planned preclinical or clinical trials, positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies, the impact of the ongoing COVID-19 pandemic on our business, operations, clinical supply and plans, the risks inherent in the drug development process, the risks regarding the accuracy of our estimates of expenses and timing of development, our capital requirements and the need for additional financing, and obtaining, maintaining and protecting its intellectual property. These and additional risks are discussed in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 dated September 18, 2020, as filed with the Securities and Exchange Commission pursuant to Rule 424(b) under the Securities Act 1933, as amended, which is available on the Securities and Exchange Commission’s website at www.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.

CHECKMATE PHARMACEUTICALS
,
INC
.

SUMMARY
STATEMENT
S
OF OPERATIONS

(Unaudited)

(
I
n thousands)

	Three Months Ended  September 30,								Nine Months Ended September 30,
		2020				2019				2020				2019
Operating expenses:
Research and development	$	6,673			$	5,076			$	19,462			$	17,126
General and administrative		3,160				1,208				6,465				3,365
Total operating expenses		9,833				6,284				25,927				20,491
Loss from operations		(9,833	)			(6,284	)			(25,927	)			(20,491	)
Other income (expense), net:
Interest income		4				43				32				160
Change in fair value of convertible loan notes		—				—				(83	)			—
Total other income (expense), net		4				43				(51	)			160
Net loss and comprehensive loss	$	(9,829	)		$	(6,241	)		$	(25,978	)		$	(20,331	)

CHECKMATE PHARMACEUTICALS
,
INC
.

SUMMARY
BALANCE SHEETS

(In thousands)

(Unaudited)

		September 30,				December 31,
			2020				2019
Cash and cash equivalents		$	137,340			$	4,185
Other current assets			6,725				941
Total assets		$	144,065			$	5,126
Current liabilities		$	8,860			$	5,634
Total liabilities		$	8,860			$	5,634
Series A redeemable convertible preferred stock			—				32,482
Series B redeemable convertible preferred stock			—				64,446
Total stockholders’ equity (deficit)			135,205				(97,436	)
Total liabilities, redeemable convertible preferred stock and stockholders’ (deficit)		$	144,065			$	5,126

Investor Contact
Kleem Chaudhary
Chief Business Officer
[email protected]

Media Contact
Karen Sharma
MacDougall 
781-235-3060
[email protected]

SASKATOON, Saskatchewan, Nov. 13, 2020 (GLOBE NEWSWIRE) — GFG Resources Inc. (TSX-V: GFG) (OTCQB: GFGSF) (“GFG” or the “Company”) has announced the election of four board members at its annual meeting held on November 12, 2020.

Shareholders elected board members Patrick Downey, Arnold Klassen, Brian Booth and Brian Skanderbeg.

Voting Results for
GFG

Nominee	Votes For	% Votes For	Withheld	% Votes Withheld
Patrick Downey	33,928,214	99.895	35,600	.105
Arnold Klassen	33,925,202	99.886	38,612	.114
Brian Booth	33,928,214	99.895	35,600	.105
Brian Skanderbeg	33,888,839	99.779	74,975	.221

About GFG Resources Inc.


GFG Resources is a North American precious metals exploration company focused on district scale gold projects in tier one mining jurisdictions, Ontario and Wyoming. In Ontario, the Company owns 100% of the Pen and Dore gold projects, two large and highly prospective gold properties west of the prolific gold district of Timmins, Ontario, Canada. The Pen and the Dore gold projects have similar geological settings that host most of the gold deposits found in the Timmins Gold Camp which have produced over 70 million ounces of gold. The Company also owns 100% of the Rattlesnake Hills Gold Project, a district scale gold exploration project located approximately 100 kilometres southwest of Casper, Wyoming, U.S. The geologic setting, alteration and mineralization seen in the Rattlesnake Hills are similar to other gold deposits of the Rocky Mountain alkaline province which, collectively, have produced over 50 million ounces of gold.

For further information, please contact:

Brian Skanderbeg, President & CEO
Phone: (306) 931-0930
or
Marc Lepage, Vice President, Business Development
Phone: (306) 931-0930
Email: [email protected]
Website: www.gfgresources.com

Stay Connected with Us

Twitter: @GFGResources
LinkedIn: https://www.linkedin.com/company/gfgresources/
Facebook: https://www.facebook.com/GFGResourcesInc/

Third Quarter Highlights

• Adjusted basic earnings per Class B share⁽³⁾ of $0.93 up 29.2%; basic earnings per Class B share of $0.86 up 21.1%; currency $0.02 per Class B share positive impact
• Sales increased 1.2% on 2.5% organic decline offset by 2.2% acquisition growth and 1.5% positive currency translation
• CCL Segment sales increased 5.5%, 4.2% organically; operating income
  ⁽¹⁾
  up 26.4%
• Checkpoint and Innovia operating income
  ⁽¹⁾
  up 5.7% and 225.8%, respectively
• Consolidated
  operating margin⁽¹⁾ of 17.9%, up 240 bps

Nine-Month Highlights

• Adjusted basic earnings per Class B share⁽³⁾ of $2.24 up 5.7%; basic earnings per Class B share of $2.15 up 2.9%; currency $0.01 per Class B share positive impact
• Sales down 3.8%, principally on declines at Avery and Checkpoint
• Consolidated operating income
  ⁽¹⁾
  down 0.5%, driven by declines of 29.0% and 32.6% for Avery and Checkpoint, respectively
• Consolidated operating margin⁽¹⁾ 15.7%, up 50 bps

TORONTO, Nov. 13, 2020 (GLOBE NEWSWIRE) — CCL Industries Inc. (TSX:CCL.A) (TSX:CCL.B) (“the Company”), a world leader in specialty label, security and packaging solutions for global corporations, government institutions, small businesses and consumers, today reported 2020 third quarter results.

Sales for the third quarter of 2020 increased 1.2% to $1,373.4 million, compared to $1,357.1 million for the third quarter of 2019, with 2.5% organic decline offset by 2.2% acquisition-related growth and 1.5% positive impact from foreign currency translation.

Operating income⁽¹⁾ for the third quarter of 2020 increased 17.4% to $246.3 million compared to $209.8 million for the comparable quarter of 2019.  Operating income⁽¹⁾ increased 16.0%, excluding currency translation. 

Restructuring and other items were a $16.2 million expense for the 2020 third quarter that included severance costs principally for the Checkpoint and Avery Segments amounting to $6.8 million and the final judgement for an Innovia pre-acquisition lawsuit that exceeded the acquisition accrual by $9.4 million. For the third quarter of 2019, restructuring and other items totaled $1.7 million primarily for severance costs associated with the CCL Segment and other acquisition transaction costs. 

Tax expense for the third quarter of 2020 was $50.6 million compared to $43.9 million in the prior year period.  The effective tax rate for the 2020 and 2019 third quarters was 25.1% and 25.7%, respectively.

Net earnings were $153.3 million for the 2020 third quarter compared to $127.7 million for the 2019 third quarter. Basic and adjusted basic earnings per Class B share⁽³⁾ for the third quarter of 2020 were $0.86 and $0.93, respectively, compared to basic and adjusted basic earnings per Class B share⁽³⁾ of $0.71 and $0.72, respectively, in the prior year third quarter. Foreign currency translation had a positive impact of $0.02 on earnings per share.

For the nine-month period ended September 30, 2020, sales and operating income⁽¹⁾ declined 3.8% and 0.5% to $3.9 billion and $610.2 million, respectively, however net earnings increased 3.0% to $383.8 million, compared to the same nine-month period in 2019. The 2020 nine-month period included results from thirteen acquisitions completed since January 1, 2019, delivering acquisition-related sales growth for the period of 1.8%. Organic sales decline was 5.9% and foreign currency translation was a 0.3% positive impact. For the nine-month period ended September  30, 2020, basic and adjusted basic earnings per Class B share⁽³⁾ were $2.15 and $2.24, respectively, compared to basic and adjusted basic earnings per Class B share⁽³⁾ of $2.09 and $2.12, respectively, in the prior year nine-month period. Foreign currency translation had a positive impact of $0.01 on earnings per share.

Geoffrey T. Martin, President and Chief Executive Officer, commented, “I am very pleased to report record quarterly earnings. This outstanding performance, in the midst of ‘once in a generation’ pandemic challenges, speaks to the resilience of our business model and the unrelenting commitment and dedication of our front line people around the world.  Supported by our global leadership team, they met diverse needs of customers, delivering industry-leading quality, service and operational improvement, while ensuring the health and safety of our entire organization during highly unusual operating conditions.”

Mr. Martin continued, “The CCL Segment posted organic sales growth of 4.2% and a 300 basis point improvement in operating margin.  CCL Secure’s performance improved significantly on favourable mix coupled with unusually strong demand for currency. Both CCL Design electronics and Healthcare & Specialty maintained second quarter momentum, as sales increased on share gains and higher consumer demand from the pandemic driving strong profit improvement. CCL Design automotive sales and profitability rebounded much faster than expected from the industry shutdown. Home & Personal Care label sales increased, especially in the United States, as high demand for skin sanitizers and cleansers significantly improved profitability. Tube sales for beauty, cosmetic and skin care products sold in travel and specialty retail stores and hair salons recovered sequentially driving higher profits but results in aerosols declined on slow demand in the United States. Sleeve sales continued to grow on share gains in North America and recovering conditions in Brazil, more than offsetting slower markets in Europe.  Pressure sensitive Food & Beverage label results declined as ‘on-premise’ demand, especially for mineral water and soft drinks, remains below normal levels. Earnings from our ventures in Russia and the Middle East were strong.  Avery ‘WePrint’ and kids’ labels direct-to-consumer franchises were strong globally but not enough to offset steep declines in event and name badging as attended sports events, concerts, trade conventions and business meetings temporarily disappeared. Back-to-school performance, while initially encouraging, faded amid a somewhat chaotic return to schools and colleges in North America. Workplace-related demand improved sequentially, but remained below prior year, especially in the United States. Cost savings contributed to a creditable 20% operating margin. Checkpoint sales declined compared to a strong prior year in the MAS business but overall profitability improved as apparel labeling demand rebounded, results aided by strong growth in RFID and cost saving initiatives.  Innovia demand softened after the second quarter pantry loading hike, but sales increased on the Polish acquisition; profitability gained  dramatically on significantly improved mix, cost savings and productivity initiatives throughout the Segment.”

Mr. Martin added, “Although October activity levels were consistent with the summer recovery period, November and December are always affected by the holiday season and even in normal circumstances, difficult to predict.  Clearly, the second wave of the virus is now impacting many parts of the world, with subsequent economic effects largely unknown. Regardless, the Company’s leadership priority is to ensure the health and safety of its employees and as necessary, adapt operations and cost structures to match activity levels as we have throughout the pandemic. Foreign currency translation could be a slight tailwind at current exchange rates for the fourth quarter compared to the same quarter in 2019.”

Mr. Martin concluded, “The Company completed the third quarter with a stronger balance sheet driven by persistent free cash flow⁽⁴⁾, reducing the Company’s net leverage ratio⁽⁵⁾ to 1.51 times adjusted EBITDA compared to 1.8 times at the end of 2020 second quarter.  Our liquidity position was robust with cash-on-hand of $760.2 million and US$1.2 billion undrawn capacity on our syndicated revolving credit facility. Given the much-improved quarterly results, projected 2020 capital spending has been revised to approximately $290 million, still less than the $350 million originally planned. The Board of Directors declared its regular quarterly dividend of $0.18 per Class B non-voting share and $0.1775 per Class A voting share, payable to shareholders of record at the close of business on December 15, 2020, to be paid on December 29, 2020.”

2020 Third Quarter Segment Highlights

CCL

• Sales increased 5.5% to $877.0 million; 4.2% organic growth and 0.9% positive impact from currency translation and 0.4% acquisition contribution
• Regional organic sales performance: North America up low-single digit, Europe up mid-single digit, Latin America up double digit and Asia Pacific declined slightly
• Operating income⁽¹⁾ $160.8 million, 18.3% operating margin⁽¹⁾, up 300 bps
• Label joint ventures added $0.01 earnings per Class B share

Avery

• Sales decreased 14.1% to $178.4 million; 19.8% organic decline, 3.9% acquisition contribution and 1.8% positive impact from currency translation
• Operating income⁽¹⁾ $35.7 million, 20.0% operating margin⁽¹⁾, down 330 bps

Checkpoint

• Sales decreased 6.0% to $169.7 million; 8.5% organic decline, 0.7% acquisition contribution and 1.8% positive impact from foreign currency translation
• Operating income⁽¹⁾ $29.6 million, 17.4% operating margin⁽¹⁾, up 190 bps

Innovia  

• Sales increased 7.6% to $148.3 million; 8.3% organic decline, 12.8% acquisition contribution and 3.1% positive impact from foreign currency translation 
• Operating income⁽¹⁾ $20.2 million, 13.6% operating margin⁽¹⁾, up 910 bps

CCL will hold a conference call at 7:30 a.m. EST on Friday November 13, 2020, to discuss these results. The analyst presentation will be posted on the Company’s website.

To access this call, please dial:
1 (844) 347-1036 Toll Free
1 (209) 905-5911 International Dial-In Number
3498305:  Optional Conference Passcode

The press release and conference call presentation will be posted on the Company’s website on Friday, November 13, 2020 – www.cclind.com.

Audio replay service for the conference call will be available Friday, November 13, 2020, at 10:30 a.m. EST until Sunday, November 29, 2020, at 10:30 a.m. EST.

To access Conference Replay, please dial:
1 (855) 859-2056 Toll Free
1 (404) 537-3406 International Dial-In Number
Conference Passcode: 3498305

For more information on CCL, visit our website – www.cclind.com or contact:

Sean Washchuk	Senior Vice President and Chief Financial Officer	416-756-8526

Forward-looking Statements

This press release contains forward-looking information and forward-looking statements (hereinafter collectively referred to as “forward-looking statements”), as defined under applicable securities laws, that involve a number of risks and uncertainties.  Forward-looking statements include all statements that are predictive in nature or depend on future events or conditions.  Forward-looking statements are typically identified by the words “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans” or similar expressions. Statements regarding the operations, business, financial condition, priorities, ongoing objectives, strategies and outlook of the Company, other than statements of historical fact, are forward-looking statements. Specifically, this press release contains forward-looking statements regarding the continuing impact of the COVID-19 pandemic, the impact of foreign currency exchange rates for the next quarter; the levels of demand for the products of the Company’s segments for the balance of 2020; the ability of the Company to continue to adapt operations and cost structures to changing activity levels; the level of capital spending; the strength of the Company’s cash flow, income and profitability of the Company’s segments; and the Company’s expectations regarding general business and economic conditions.

Forward-looking statements are not guarantees of future performance. They involve known and unknown risks and uncertainties relating to future events and conditions including, but not limited to, the extent and duration of the adverse impact of the COVID-19 pandemic on the Company, its employees, customers, suppliers, the global economy and financial markets; the impact of competition; consumer confidence and spending preferences; general economic and geopolitical conditions; currency exchange rates; interest rates and credit availability; technological change; changes in government regulations; risks associated with operating and product hazards; and the Company’s ability to attract and retain qualified employees. Do not unduly rely on forward-looking statements as the Company’s actual results could differ materially from those anticipated in these forward-looking statements.  Forward-looking statements are also based on a number of assumptions, which may prove to be incorrect, including, but not limited to, assumptions about the following: global economic environment and consumer spending; customer demand for the Company’s products; market growth in specific sectors and entering into new sectors; the Company’s ability to provide a wide range of products to multinational customers on a global basis; the benefits of the Company’s focused strategies and operational approach; the achievement of the Company’s plans for improved efficiency and lower costs, including stable aluminum costs; trends for the CCL Segment’s Healthcare & Specialty and CCL Design electronics businesses will remain resilient and augmented; management will successfully curtail cost structures to match reduced demand levels; the ability of the Company to participate in certain government assistance programs; the Company’s expectation of the magnitude of the COVID-19 pandemic on certain of Avery Segment’s direct-to-consumer businesses; consumable sales in grocery and drug store channels will remain solid for the Checkpoint Segment; mandatory closures and other restrictions imposed by governments on businesses as a result of the latest increase in the number of COVID-19 infections will generally be more targeted and more limited in duration than the closures and restrictions previously imposed in 2020 and will have a lesser adverse economic impact; governments will continue to phase-in the re-opening of retail stores and manufacturing facilities and positively impact the results for the Checkpoint Segment; the Checkpoint Segment will successfully align its cost structure to best match the downturn in volume while positioning operations for improved profitability; demand for consumer packaging and product labels will positively impact results for the Innovia Segment; the Innovia Segment will continue to benefit from pricing, productivity initiatives, mix and stable resin costs; the availability of cash and credit;  fluctuations of currency exchange rates; fluctuations in resin prices; the Company’s continued relations with its customers; the Company’s estimated annual cost reductions; and economic conditions. Should one or more risks materialize or should any assumptions prove incorrect, then actual results could vary materially from those expressed or implied in the forward-looking statements.  Further details on key risks can be found in the 2019 Annual Report, Management’s Discussion and Analysis, particularly under Section 4: “Risks and Uncertainties” as well as the 2020 Third Quarter Report, Management’s Discussion and Analysis under Section 12 “Risks and Strategies.”  CCL Industries Inc.’s annual and quarterly reports can be found online at www.cclind.com and www.sedar.com or are available upon request.

Except as otherwise indicated, forward-looking statements do not take into account the effect that transactions or non-recurring or other special items announced or occurring after the statements are made may have on the Company’s business. Such statements do not, unless otherwise specified by the Company, reflect the impact of dispositions, sales of assets, monetizations, mergers, acquisitions, other business combinations or transactions, asset write-downs or other charges announced or occurring after forward-looking statements are made. The financial impact of these transactions and non-recurring and other special items can be complex and depends on the facts particular to each of them and therefore cannot be described in a meaningful way in advance of knowing specific facts. The forward-looking statements are provided as of the date of this press release and the Company does not assume any obligation to update or revise the forward-looking statements to reflect new events or circumstances, except as required by law.

The financial information presented herein has been prepared on the basis of International Financial Reporting Standards (IFRS) for financial statements and is expressed in Canadian dollars unless otherwise stated.

Financial Information

CCL Industries Inc. Consolidated condensed interim statements of financial position Unaudited
In millions of Canadian dollars
	As at September 30, 2020				As at December 31, 2019
Assets
Current assets
Cash and cash equivalents	$	760.2			$	703.6
Trade and other receivables		971.3			849.2
Inventories		552.8			481.6
Prepaid expenses		38.2			36.6
Income taxes recoverable		18.4			34.0
Derivative instruments		0.2			–
Total current assets		2,341.1			2,105.0
Non-current assets
Property, plant and equipment		1,884.2			1,818.2
Right-of-use assets		163.3			146.5
Goodwill		1,907.7			1,794.4
Intangible assets		1,025.1			1,028.7
Deferred tax assets		32.6			30.8
Equity-accounted investments		63.3			62.0
Other assets		29.0			34.5
Derivative instruments		17.9			17.9
Total non-current assets		5,123.1			4,933.0
Total assets	$	7,464.2			$	7,038.0
Liabilities
Current liabilities
Trade and other payables	$	1,094.2			$	1,035.6
Current portion of long-term debt		63.9				38.8
Lease liabilities		35.5				35.3
Income taxes payable		44.0				38.1
Derivative instruments		–				0.2
Total current liabilities		1,237.6				1,148.0
Non-current liabilities
Long-term debt		2,186.9				2,234.8
Lease liabilities		124.8				110.9
Deferred tax liabilities		268.2				245.4
Employee benefits		401.3				364.9
Provisions and other long-term liabilities		11.6				11.4
Derivative instruments		58.7				24.9
Total non-current liabilities		3,051.5				2,992.3
Total liabilities		4,289.1				4,140.3
Equity
Share capital		370.0				365.5
Contributed surplus		91.7				81.5
Retained earnings		2,811.3				2,540.0
Accumulated other comprehensive loss		(97.9	)			(89.3	)
Total equity attributable to shareholders of the Company		3,175.1				2,897.7
Total liabilities and equity	$	7,464.2			$	7,038.0

CCL Industries Inc. Consolidated condensed interim income statements Unaudited
	Three Months Ended September 30								Nine Months Ended September 30
In millions of Canadian dollars, except per share information		2020				2019				2020				2019
Sales	$	1,373.4			$	1,357.1			$	3,891.7			$	4,043.4
Cost of sales		954.4				967.4				2,774.6				2,882.4
Gross profit		419.0				389.7				1,117.1				1,161.0
Selling, general and administrative expenses		185.0				198.0				537.2				594.8
Restructuring and other items		16.2				1.7				21.8				5.2
Earnings in equity-accounted investments		(2.5	)			(1.1	)			(5.5	)			(3.4	)
		220.3				191.1				563.6				564.4
Finance cost		15.4				18.8				46.4				59.9
Finance income		(0.6	)			(0.9	)			(1.9	)			(2.7	)
Interest on lease liabilities		1.6				1.6				4.9				4.9
Net finance cost		16.4				19.5				49.4				62.1
Earnings before income tax		203.9				171.6				514.2				502.3
Income tax expense		50.6				43.9				130.4				129.7
Net earnings for the period	$	153.3			$	127.7			$	383.8			$	372.6
Basic earnings per Class B share	$	0.86			$	0.71			$	2.15			$	2.09
Diluted earnings per Class B share	$	0.86			$	0.71			$	2.14			$	2.08

CCL Industries Inc. Consolidated condensed interim statements of cash flows Unaudited
	Three Months Ended September 30								Nine Months Ended September 30
In millions of Canadian dollars		2020				2019				2020				2019
Cash provided by (used for)
Operating activities
Net earnings	$	153.3			$	127.7			$	383.8		$		372.6
Adjustments for:
Property, plant and equipment depreciation		62.2				58.3				185.2				174.9
Right-of-use assets depreciation		10.6				9.8				31.1				28.9
Intangibles amortization		14.3				14.0				43.1				42.4
Earnings in equity-accounted investments, net of dividends received		(2.5	)			(0.5	)			(2.0	)			(0.1	)
Net finance costs		16.4				19.5				49.4				62.1
Current income tax expense		45.6				42.0				112.6				107.2
Deferred tax expense		5.0				1.9				17.8				22.5
Equity-settled share-based payment transactions		3.5				13.5				11.0				27.0
Gain on sale of property, plant and equipment		–				(1.4	)			(2.5	)			(2.4	)
		308.4				284.8				829.5				835.1
Change in inventories		19.8				9.5				(62.9	)			(2.8	)
Change in trade and other receivables		(33.6	)			11.6				(100.4	)			(17.4	)
Change in prepaid expenses		(3.2	)			(1.3	)			(0.9	)			(5.0	)
Change in trade and other payables		5.6				(10.3	)			14.4				(168.4	)
Change in income taxes receivable and payable		1.7				(1.2	)			6.6				(6.3	)
Change in employee benefits		5.4				9.2				16.2				2.1
Change in other assets and liabilities		7.2				(10.4	)			(27.7	)			(16.4	)
		311.3				291.9				674.8				620.9
Net interest paid		(3.1	)			(11.4	)			(35.1	)			(49.6	)
Income taxes paid		(30.5	)			(22.3	)			(88.3	)			(90.5	)
Cash provided by operating activities		277.7				258.2				551.4				480.8
Financing activities
Proceeds on issuance of long-term debt		14.9				8.3				875.3				121.7
Repayment of long-term debt		(52.4	)			(23.6	)			(955.9	)			(139.6	)
Payment of lease liabilities		(10.3	)			(9.4	)			(34.0	)			(27.3	)
Proceeds from issuance of shares		0.4				1.9				3.7				13.0
Dividends paid		(32.1	)			(30.3	)			(96.4	)			(90.8	)
Cash used for financing activities		(79.5	)			(53.1	)			(207.3	)			(123.0	)
Investing activities
Additions to property, plant and equipment		(47.5	)			(74.8	)			(204.6	)			(285.8	)
Proceeds on disposal of property, plant and equipment		0.2				1.9				14.3				6.4
Business acquisitions and other long-term investments		(10.9	)			(0.1	)			(111.2	)			(33.2	)
Cash used for investing activities		(58.2	)			(73.0	)			(301.5	)			(312.6	)
Net increase in cash and cash equivalents		140.0				132.1				42.6				45.2
Cash and cash equivalents at beginning of period		619.4				481.5				703.6				589.1
Translation adjustment on cash and cash equivalents		0.8				(12.3	)			14.0				(33.0	)
Cash and cash equivalents at end of period	$	760.2			$	601.3			$	760.2		$		601.3

CCL Industries Inc. Segment Information Unaudited
In millions of Canadian dollars
	Three Months Ended September 30												Nine Months Ended September 30
	Sales						Operating Income						Sales						Operating Income
		2020			2019			2020			2019			2020			2019			2020			2019
CCL	$	877.0		$	831.2		$	160.8		$	127.2		$	2,497.4		$	2,513.8		$	416.4		$	386.2
Avery		178.4			207.6			35.7			48.4			483.4			568.5			86.3			121.6
Checkpoint		169.7			180.5			29.6			28.0			446.2			531.3			48.1			71.4
Innovia		148.3			137.8			20.2			6.2			464.7			429.8			59.4			34.1
Total operations	$	1,373.4		$	1,357.1		$	246.3		$	209.8		$	3,891.7		$	4,043.4		$	610.2		$	613.3
Corporate expense								(12.3	)		(18.1	)								(30.3	)		(47.1	)
Restructuring and other items								(16.2	)		(1.7	)								(21.8	)		(5.2	)
Earnings in equity-accounted investments								2.5			1.1									5.5			3.4
Finance cost								(15.4	)		(18.8	)								(46.4	)		(59.9	)
Finance income								0.6			0.9									1.9			2.7
Interest on lease liabilities								(1.6	)		(1.6	)								(4.9	)		(4.9	)
Income tax expense								(50.6	)		(43.9	)								(130.4	)		(129.7	)
Net earnings							$	153.3		$	127.7								$	383.8		$	372.6

	Total Assets						Total Liabilities						Depreciation and Amortization						Capital Expenditures
	September 30			December 31			September 30			December 31			Nine Months Ended September 30						Nine Months Ended September 30
		2020			2019			2020			2019			2020			2019			2020			2019
CCL	$	3,803.7		$	3,634.3		$	1,038.3		$	964.1		$	173.4		$	165.8		$	150.0		$	230.8
Avery		729.0			638.2			237.9			236.7			19.7			17.8			14.9			10.5
Checkpoint		995.1			934.1			497.3			486.8			28.6			28.0			17.5			20.8
Innovia		1,155.6			1,090.8			302.4			261.7			36.5			33.4			22.2			23.4
Equity-accounted investments		63.3			62.0			–			–			–			–			–			–
Corporate		717.5			678.6			2,213.2			2,191.0			1.2			1.2			–			0.3
Total	$	7,464.2		$	7,038.0		$	4,289.1		$	4,140.3		$	259.4		$	246.2		$	204.6		$	285.8

Non-IFRS Measures

The Company measures the success of its business using a number of key performance measures, certain of which are not in accordance with IFRS. These non-IFRS measures do not have standardized meanings and may not be comparable to similar-named measures presented by other issuers. The non-IFRS measures should not be considered as an alternative to or replacement of net earnings or other measures of performance under IFRS.

⁽¹⁾ Operating income and operating income margin are non-IFRS financial measures used to assist in understanding the profitability of the Company’s business units. Operating income is defined as earnings before corporate expenses, net finance cost, goodwill impairment loss, earnings in equity-accounted investments, restructuring and other items, and taxes. Operating income margin, also known as return on sales, is defined as operating income over sales.

⁽²⁾ Adjusted EBITDA is a non-IFRS financial measure used extensively in the packaging industry and other industries to assist in understanding and measuring operating results. Adjusted EBITDA is also considered as a proxy for cash flow and a facilitator for business valuations. This non-IFRS financial measure is defined as earnings before net finance cost, taxes, depreciation and amortization, goodwill impairment loss, non-cash acquisition accounting adjustments to inventory, earnings in equity-accounted investments and restructuring and other items.  The Company believes that this is an important measure as it allows management to assess the ongoing business without the impact of net finance cost, depreciation and amortization and income tax expenses, as well as non-operating factors and one-time items.  As a proxy for cash flow, it is intended to indicate the Company’s ability to incur or service debt and to invest in property, plant and equipment, and it allows management to compare the business to those of the Company’s peers and competitors who may have different capital or organizational structures. Adjusted EBITDA is tracked by financial analysts and investors to evaluate financial performance and is a key metric in business valuations.  Adjusted EBITDA is considered an important measure by lenders to the Company and is included in the financial covenants included in the senior notes and bank lines of credit.

Unaudited (In millions of Canadian dollars)
	Three months ended September 30								Nine months ended September 30
		2020				2019				2020				2019
Net earnings	$	153.3			$	127.7			$	383.8			$	372.6
Corporate expense		12.3				18.1				30.3				47.1
Earnings in equity-accounted investments		(2.5	)			(1.1	)			(5.5	)			(3.4	)
Finance cost, net		16.4				19.5				49.4				62.1
Restructuring and other items		16.2				1.7				21.8				5.2
Income taxes		50.6				43.9				130.4				129.7
Operating income(1)	$	246.3			$	209.8			$	610.2			$	613.3
Less: Corporate expense		(12.3	)			(18.1	)			(30.3	)			(47.1	)
Add: Depreciation and amortization		87.1				82.1				259.4				246.2
Adjusted EBITDA	$	321.1			$	273.8			$	839.3			$	812.4

⁽³⁾ Adjusted basic earnings per Class B share is an important non-IFRS measure to assist in understanding the ongoing earnings performance of the Company excluding items of a one-time or non-recurring nature.  It is not considered a substitute for basic net earnings per Class B share but it does provide additional insight into the ongoing financial results of the Company.  This non-IFRS financial measure is defined as basic net earnings per Class B share excluding gains on business dispositions, goodwill impairment loss, non-cash acquisition accounting adjustments to inventory, restructuring and other items, and tax adjustments.

Reconciliation of Basic Earnings per Class B Share to Adjusted Basic Earnings per Class B Share

Unaudited

	Three months ended September 30								Nine months ended September 30
		2020				2019				2020				2019
Basic earnings per Class B Share	$	0.86			$	0.71			$	2.15			$	2.09
Net loss from restructuring and other items		0.07				0.01				0.09				0.03
Adjusted Basic Earnings per Class B Share	$	0.93			$	0.72			$	2.24			$	2.12

 ⁽⁴⁾ Free Cash Flow from Operations is a measure indicating the relative amount of cash generated by the Company during a period and available to fund dividends, debt repayments and acquisitions. It is calculated as cash flow from operations less capital expenditures, net of proceeds from the sale of property, plant and equipment.

The following table reconciles the measure of free cash flow from operations to IFRS measures reported in the consolidated condensed interim statements of cash flows for the period ended as indicated.

Free Cash Flow from Operations Unaudited (In millions of Canadian dollars)	Nine months ended September 30, 2020
Cash provided by operating activities	$	551.4
Less: Additions to property, plant and equipment		(204.6	)
Add:  Proceeds on disposal of property, plant and equipment		14.3
Free Cash Flow from Operations	$	361.1

⁽⁵⁾ Leverage ratio is a measure that indicates the Company’s ability to service its existing debt.  Leverage ratio is calculated as net debt divided by Adjusted EBITDA.

	September 30, 2020
Unaudited (In millions of Canadian dollars)
Current portion of long-term debt	$	63.9
Current lease liabilities		35.5
Long-term debt		2,186.9
Long-term lease liabilities		124.8
Total debt	$	2,411.1
Cash and cash equivalents		(760.2	)
Net debt	$	1,650.9
Adjusted EBITDA for 12 months ending September 30, 2020    (see below)		1,094.1
Leverage Ratio		1.51
Adjusted EBITDA for 12 months ended December 31, 2019	$	1,067.2
less: Adjusted EBITDA for nine months ended September 30, 2019		(812.4	)
add: Adjusted EBITDA for nine months ended September 30, 2020		839.3
Adjusted EBITDA for 12 months ended September 30, 2020	$	1,094.1

Supplemental Financial Information

Sales Change Analysis

Revenue Growth Rates (%)

	Three Months Ended September 30, 2020								Nine Months Ended September 30, 2020
	Organic		Acquisition		FX				Organic		Acquisition		FX
	Growth		Growth		Translation		Total		Growth		Growth		Translation		Total
CCL	4.2	%	0.4	%	0.9	%	5.5	%	(0.9	%)	0.4	%	(0.2	%)	(0.7	%)
Avery	(19.8	%)	3.9	%	1.8	%	(14.1	%)	(19.6	%)	3.1	%	1.5	%	(15.0	%)
Checkpoint	(8.5	%)	0.7	%	1.8	%	(6.0	%)	(17.3	%)	0.6	%	0.7	%	(16.0	%)
Innovia	(8.3	%)	12.8	%	3.1	%	7.6	%	(3.4	%)	9.9	%	1.6	%	8.1	%
Total	(2.5	%)	2.2	%	1.5	%	1.2	%	(5.9	%)	1.8	%	0.3	%	(3.8	%)

Business Description

CCL Industries Inc. employs approximately 21,700 people operating 188 production facilities in 42 countries with corporate offices in Toronto, Canada, and Framingham, Massachusetts. CCL is the world’s largest converter of pressure sensitive and specialty extruded film materials for a wide range of decorative, instructional, functional and security applications for government institutions and large global customers in the consumer packaging, healthcare & chemicals, consumer electronic device and automotive markets. Extruded & laminated plastic tubes, aluminum aerosols & specialty bottles, folded instructional leaflets, precision decorated & die cut components, electronic displays, polymer banknote substrate and other complementary products and services are sold in parallel to specific end-use markets. Avery is the world’s largest supplier of labels, specialty converted media and software solutions for short-run digital printing applications for businesses and consumers available alongside complementary products sold through distributors, mass market stores and e-commerce retailers. Checkpoint is a leading developer of RF and RFID based technology systems for loss prevention and inventory management applications, including labeling and tagging solutions, for the retail and apparel industries worldwide. Innovia is a leading global producer of specialty, high performance, multi-layer, surface engineered films for label, packaging and security applications. The Company is partly backward integrated into materials science with capabilities in polymer extrusion, adhesive development, coating & lamination, surface engineering and metallurgy; deployed as needed across the four business segments.

NEW YORK, Nov. 13, 2020 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, will participate in a fireside chat during the Jefferies Virtual London Healthcare Conference. The fireside chat is scheduled to take place on Tuesday, November 17, 2020, at 2:20 PM ET/ 7:20 PM GMT.

A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at http://ir.tgtherapeutics.com/events.

ABOUT TG THERAPEUTICS, INC.

TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is in late stage clinical development with two investigational compounds, ublituximab and umbralisib, the combination of which is referred to as “U2”, targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. Umbralisib (TGR-1202) is an oral, once-daily dual inhibitor of PI3K-delta and CK1-epsilon. Umbralisib is currently under review by the U.S. Food and Drug Administration (FDA) for accelerated approval as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen or follicular lymphoma (FL) who have received at least two prior systemic therapies. The Company also has a fully enrolled Phase 3 clinical trial evaluating U2 in patients with treatment naïve and relapsed/refractory chronic lymphocytic leukemia (CLL), and two fully enrolled identical Phase 3 trials evaluating ublituximab monotherapy in patients with relapsing forms of multiple sclerosis (RMS). Additionally, the Company has recently brought into Phase 1 clinical development its anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), its covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor, TG-1701, as well as its anti-CD47/CD19 bispecific antibody, TG-1801. TG Therapeutics is headquartered in New York City.

CONTACT:

Jenna Bosco
Senior Vice President,
Corporate Communications
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: [email protected]

HOUSTON, Nov. 13, 2020 (GLOBE NEWSWIRE) — Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize™ liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced its financial results for the third quarter ended September 30, 2020 and provided an update on recent corporate developments.

“We made meaningful progress across our programs throughout the third quarter despite continued headwinds related to the COVID-19 pandemic. Importantly, enrollment continues in Stage 2 of our Phase 2 trial of prexigebersen (BP1001), a liposomal Grb2 antisense, as a combination treatment for patients suffering with acute myeloid leukemia (AML),” said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. “We further strengthened our intellectual property portfolio with a strategic patent providing broad protection for application of prexigebersen in the treatment of a variety of cancers in combination with front-line therapies.”

“We remain on track to initiate a Phase 1 study of prexigebersen for the treatment of solid tumors by year end. This is a particularly important advancement for Bio-Path as it marks our first-in-human study in solid tumors, an area of significant need where current treatment options are often ineffective,” continued Mr. Nielsen.

Recent Corporate


Highlights

• Receive
  d
  Notice of Allowance for Strategic Patent for Prexigebersen in
  Combination with Front
  –
  Line
  Therapies. In October, Bio-Path announced that the United States Patent and Trademark Office had issued a notice of allowance for claims related to the Company’s lead product candidate, prexigebersen, in combination with either a cytidine analogue, such as decitabine, or the Bcr-Abl tyrosine kinase inhibitors dasatinib and nilotinib. The patent provides broad protection for application of prexigebersen in the treatment of a variety of cancers in combination with front-line therapies.

• Announced First Patient Dosed in Amended Stage 2 of the Phase 2 Clinical Trial Evaluating Prexigebersen in Acute Myeloid Leukemia. In August, Bio-Path announced the enrollment and dosing of the first patient in the amended Stage 2 of the Phase 2 clinical study of prexigebersen for the treatment of AML in combination with front-line therapy decitabine and venetoclax.

Financial Results for


the


Third


Quarter


Ended


September


30


, 20


20

• The Company reported a net loss of $3.0 million, or $0.80 per share, for the three months ended September 30, 2020, compared to a net loss of $2.2 million, or $0.78 per share, for the three months ended September 30, 2019.
• Research and development expenses for the three months ended September 30, 2020 increased to $2.0 million, compared to $1.4 million for the three months ended September 30, 2019 primarily due to increased enrollment for our Phase 2 clinical trial of prexigebersen in AML, as well as increased preclinical study expenses.
• General and administrative expenses for the three months ended September 30, 2020 increased to $1.0 million, compared to $0.9 million for the three months ended September 30, 2019 primarily due to increased franchise tax expense.
• As of September 30, 2020, the Company had cash of $12.1 million, compared to $20.4 million at December 31, 2019. Net cash used in operating activities for the nine months ended September 30, 2020 was $8.4 million compared to $6.1 million for the comparable period in 2019. Subsequent to September 30, 2020, Bio-Path issued 850,000 shares of its common stock for gross proceeds of approximately $4.6 million through its at-the-market offering agreement with H.C. Wainwright.

Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these third quarter 2020 financial results and to provide a general update on the Company. To access the conference call please dial (844) 815-4963 (domestic) or (210) 229-8838 (international) and refer to the conference ID 5878804. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.

About Bio-Path Holdings, Inc.

Bio-Path is a biotechnology company developing DNAbilize®, a novel technology that has yielded a pipeline of RNAi nanoparticle drugs that can be administered with a simple intravenous infusion. Bio-Path’s lead product candidate, prexigebersen (BP1001, targeting the Grb2 protein), is in a Phase 2 study for blood cancers and prexigebersen-A, a drug product modification of prexigebersen, is under consideration by the FDA to commence Phase 1 studies in solid tumors. This is followed by BP1002, targeting the Bcl-2 protein, where it is being evaluated in lymphoma clinical studies.

For more information, please visit the Company’s website at http://www.biopathholdings.com.

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws. These statements are based on management’s current expectations and accordingly are subject to uncertainty and changes in circumstances. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including the impact, risks and uncertainties related to COVID-19 and actions taken by governmental authorities or others in connection therewith, Bio-Path’s ability to raise needed additional capital on a timely basis in order for it to continue its operations, have success in the clinical development of its technologies, the timing of enrollment and release of data in such clinical studies and the accuracy of such data, limited patient populations of early stage clinical studies and the possibility that results from later stage clinical trials with much larger patient populations may not be consistent with earlier stage clinical trials, and such other risks which are identified in Bio-Path’s most recent Annual Report on Form 10- K, in any subsequent quarterly reports on Form 10-Q and in other reports that Bio-Path files with the Securities and Exchange Commission from time to time. These documents are available on request from Bio-Path Holdings or at www.sec.gov. Bio-Path disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact Information:
                        

I
nvestors

Will O’Connor
Stern Investor Relations, Inc.
212-362-1200
[email protected]   

Doug Morris
Investor Relations
Bio-Path Holdings, Inc.
832-742-1369

—


Data p


resented at the 2020


Annual Scientific Meeting of the


American College of Allergy, Asthma & Immunology (ACAAI)


—

RESEARCH TRIANGLE PARK, N.C., Nov. 13, 2020 (GLOBE NEWSWIRE) — BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced data from a cross-sectional study among patients, caregivers and physicians capturing the burden of injectable prophylactic therapy experienced by hereditary angioedema (HAE) patients and caregivers, and differences in perceptions between physicians and HAE patients.

The three abstracts were presented at the 2020 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI), which is being conducted virtually from November 13-15.

Poster presentations:

• Patient Perspectives on the Treatment Burden of Injectable Medication Administration for Hereditary Angioedema (#160)
• Prophylactic Treatment Burden: Assessment by Caregivers of Patients with Hereditary Angioedema (#161)
• Understanding Differences in Perceptions of Hereditary Angioedema Treatment Burden May Improve Patient-Physician Treatment Care Dialogue (#162)

“These data are consistent across HAE patients, caregivers and treating physicians showing many patients experience a significant treatment burden associated with current prophylactic HAE therapies. New therapies with easier routes of administration may meet a significant unmet need for HAE patients seeking improved quality of life,” said study lead Cristine Radojicic, M.D., assistant professor of medicine at Duke University School of Medicine.

Overall, the burden of treatment reported across all groups surveyed suggests an unmet need still remains in HAE clinical management. These study findings collectively highlight the opportunity to strengthen the shared decision making between patients and physicians with more effective dialogue about the burden of treatment and patients’ individual needs and preferences.

Following is a brief summary of the data from the cross-sectional study conducted via three double-blinded surveys with HAE patients (n=75), caregivers (n=30) and physicians (n=109), respectively:

• Almost nine in 10 patients with HAE report they have learned to tolerate difficult aspects of their treatment and 58 percent report they are tired of their injections. Even though patients are satisfied with their current prophylactic medications, 86 percent are still interested in a less burdensome route of administration.
• Over 50 percent of caregivers agree it was challenging to learn how to administer HAE treatment, specifically gaining comfort with using needles and learning how to self-administer. Seventy-one percent of caregivers agree that patients experience needle fatigue with their HAE prophylactic medications and an even greater proportion of caregivers believe a once-daily pill would provide the patient more freedom (86 percent), independence (85 percent), and reduce caregivers’ burden.
• Most physicians (94 percent) and patients (84 percent) agree there is a need for newer and more novel HAE treatments. In addition, 86 percent of caregivers believe that, while their patient is satisfied with current treatment, the patient would still be interested in one that is easier to administer.
• Over 70 percent of physicians surveyed believe that starting prophylaxis treatment was overwhelming, becoming comfortable with needles was intimidating, and learning how to self-administer was challenging for their patients. The study also shows that physicians tend to underestimate time required for preparation and administration of prophylaxis medications. Importantly, despite recognition of the burden with current treatments, there is discordance between patients and physicians regarding the person initiating conversations about medication challenges, suggesting an opportunity to improve the dialogue to help with an individualized approach to the management of HAE.

About BioCryst Pharmaceuticals

BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including ORLADEYO^™ (berotralstat), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB^® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company’s website at www.BioCryst.com.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst’s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: the ongoing COVID-19 pandemic, which could create challenges in all aspects of BioCryst’s business, including without limitation delays, stoppages, difficulties and increased expenses with respect to BioCryst’s and its partners’ development, regulatory processes and supply chains, negatively impact BioCryst’s ability to access the capital or credit markets to finance its operations, or have the effect of heightening many of the risks described below or in the documents BioCryst files periodically with the Securities and Exchange Commission; developing and commercializing ORLADEYO or any HAE product candidate may take longer or may be more expensive than planned; BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; BioCryst may not advance human clinical trials with product candidates as expected; the FDA, EMA, PMDA or other applicable regulatory agency may require additional studies beyond the studies planned for product candidates, may not provide regulatory clearances which may result in delay of planned clinical trials, may impose certain restrictions, warnings, or other requirements on product candidates, may impose a clinical hold with respect to such product candidates, or may withhold market approval for product candidates; product candidates, if approved, may not achieve market acceptance; BioCryst’s ability to successfully commercialize its product candidates, manage its growth, and compete effectively; risks related to the international expansion of BioCryst’s business; and actual financial results may not be consistent with expectations, including that 2020 operating expenses and cash usage may not be within management’s expected ranges. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in BioCryst’s forward-looking statements.

BCRXW

Contact:


John Bluth
+1 919 859 7910
[email protected]

Catherine Collier Kyroulis
+1 917 886 5586
[email protected]

– Seed Therapeutics to Use Proprietary “Molecular Glue” Protein Degradation Technology to Develop Potential New Medicines –

NEW YORK, Nov. 13, 2020 (GLOBE NEWSWIRE) — Seed Therapeutics (“the Company”), a global research company and subsidiary of BeyondSpring focused on discovering and developing “molecular glues” to degrade disease-causing protein previously believed to be undruggable, announced today that it has entered into a research collaboration and license agreement with Eli Lilly and Company (“Lilly”) to discover and develop new chemical entities (NCEs) that could produce therapeutic benefit through targeted protein degradation (TPD).

The TPD field allows for the targeting of hundreds of proteins that are known to be associated with human diseases but were previously thought to be undruggable. Seed Therapeutics has pioneered a strategy called “molecular glue” to induce the protein degrading machinery which is present in all cells to recognize and degrade the disease-causing protein that is not normally targeted for elimination. More importantly, Seed Therapeutics’ molecular glue program focuses on NCEs with more drug-like chemical properties, differentiated from the strategy of developing proteolysis-targeting chimeras (PROTACs).

Under the terms of the agreement, Seed Therapeutics will receive a $10 million upfront cash payment to fund research, as well as a $10 million equity investment from Lilly. Seed Therapeutics will also be eligible to receive up to approximately $780 million in potential pre-clinical and clinical development, regulatory and commercial milestones, as well as tiered royalties on net sales of products that result from the collaboration. The transaction is subject to customary closing conditions.

“This agreement further allows us to advance our pioneering platform to deliver new molecules targeting proteins that cause human diseases,” added Dr. Lan Huang, CEO of both Seed Therapeutics and BeyondSpring. “Our alliance with Lilly is the catalyst for the world-class team at Seed Therapeutics to begin developing a pipeline of TPD therapies for diseases in which common strategies have failed.”

“Our pre-clinical research and licensing collaboration with Seed Therapeutics will enable both companies to better study the potential of targeted protein degradation to support the development of future medicines,” said Dr. Utpal Singh, Ph.D., Vice President of Discovery Chemistry at Lilly.

About Seed Therapeutics

Seed Therapeutics, a subsidiary of BeyondSpring (NASDAQ: BYSI), is a global research company focused on harnessing and engineering molecules that use “molecular glue” protein degradation to attack previously believed undruggable targets. Backed by a comprehensive intellectual property portfolio, Seed Therapeutics’ mission is to positively impact human health by creating novel protein degradation therapeutics for the treatment of various severe diseases that currently have limited options for patients and their families.

The great majority of approved treatments for human diseases act by binding molecular targets in or outside of cells to impact target-related signaling or actions. The cellular targets of drugs and drug candidates discovered with this typical strategy are predominately proteins, the work-horse of cells that, when gone astray, contribute to disease onset and / or progression. Importantly, less than 30 percent of proteins thought to be involved in diseases are likely to be “druggable” utilizing this drug development strategy. Therapeutic development in many serious indications has, therefore, suffered due to a lack of proteins that are druggable, rather than being due to a lack of understanding the biology of the disease.

Seed Therapeutics is overcoming this challenge by developing novel therapies that aim to inhibit the function of disease-causing proteins, or proteins responsible for resistance to other therapies, by inducing specific degradation of the protein using novel E3s. This groundbreaking strategy has the potential to offer meaningful benefits to hundreds of thousands of patients suffering from serious conditions, as diverse as cancer and Alzheimer’s disease. Through ongoing collaborations with world-leading academic experts in the field, and in partnership with seasoned drug development and commercialization experts at the parent company, BeyondSpring, Seed Therapeutics is establishing a growing pipeline of novel drug candidates on a path to clinical and commercial success. To learn more about Seed Therapeutics, please visit us at seedtherapeutics.com.

About BeyondSpring

Headquartered in New York, BeyondSpring is a global, clinical-stage biopharmaceutical company focused on developing innovative immuno-oncology cancer therapies to improve clinical outcomes for patients with high unmet medical needs. BeyondSpring’s first-in-class lead immune asset, Plinabulin, is a potent antigen-presenting cell (APC) inducer. It is currently in two Phase 3 clinical trials for two severely unmet medical needs indications: one is for the prevention of chemotherapy-induced neutropenia (CIN), the most frequent cause for a chemotherapy regimen dose’s decrease, delay, downgrade or discontinuation, which can lead to suboptimal clinical outcomes. The second is for non-small cell lung cancer (NSCLC) treatment in EGFR wild-type patients. As a “pipeline drug,” Plinabulin is in various I/O combination studies to boost PD-1 / PD-L1 antibody anti-cancer effects. In addition to Plinabulin, BeyondSpring’s extensive pipeline includes three pre-clinical immuno-oncology assets.

Cautionary Note Regarding Forward-Looking Statements

This press release includes forward-looking statements that are not historical facts. Words such as “will,” “expect,” “anticipate,” “plan,” “believe,” “design,” “may,” “future,” “estimate,” “predict,” “objective,” “goal,” or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company’s future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSpring’s most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Media Contacts

Caitlin Kasunich / Raquel Cona
KCSA Strategic Communications
212.896.1241 / 212.896.1276
[email protected] / [email protected]

Waterloo, Canada, Nov. 13, 2020 (GLOBE NEWSWIRE) — The Centre for International Governance Innovation (CIGI) and Gateway House: Indian Council on Global Relations will welcome Canada and India’s top diplomats on Tuesday to discuss the growing strategic partnership between Canada and India in the era of COVID-19.

This is the third Canada-India Track 1.5 Dialogue on Innovation, Growth and Prosperity meeting. The partnership began in 2018 with the support of Prime Minister Justin Trudeau and Prime Minister Narendra Modi as an initiative to explore areas for closer cooperation between the two countries. Track 1.5 dialogues are unofficial conversations between countries that include a mix of government officials and non-governmental experts. 

Media are invited to observe the opening discussion of the meeting, featuring Canada’s Minister of Foreign Affairs, The Honourable François-Philippe Champagne, and India’s Minister of External Affairs, The Honourable Subrahmanyam Jaishankar. Please note that no questions will be taken from the audience.

WHO:

• The Honourable François-Philippe Champagne, Canada’s Minister of Foreign Affairs
• The Honourable Subrahmanyam Jaishankar, India’s Minister of External Affairs
• Rohinton P. Medhora, President, CIGI
• Manjeet Kripalani, Executive Director, Gateway House

WHEN:

Tuesday, November 17^th from 8:30 AM – 9:30 AM EST

WHERE:

A WebEx link to the virtual meeting will be provided upon registration. 

To register, please contact Rebecca MacIntyre or for more information, visit www.cigionline.org/Canada-India.

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Attachments

• GH_Logo-Regular-Stacked
• 2018-10-30 – Can-India Ottawa Meetings – AM Sessions-19 copy

Rebecca MacIntyre
Centre for International Governance Innovation
6478616800
[email protected]

NEW HAVEN, Conn., Nov. 13, 2020 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (“BTI” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced that Dr. Vimal Mehta, Founder and Chief Executive Officer of BTI, will participate in a fireside chat at the Jefferies Virtual London Healthcare Conference.

Presentation Details:

Event: Jefferies Virtual London Healthcare Conference
Date: Thursday, November 19, 2020
Time: 7:20 PM GMT/2:20 PM ET

A live webcast of the fireside chat will be accessible through the Investors section of the Company’s website at www.bioxceltherapeutics.com. Following the conference, the webcast will be archived on the Company’s website for at least 30 days.

About BioXcel Therapeutics, Inc.

BioXcel Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on drug development that utilizes artificial intelligence to identify improved therapies in neuroscience and immuno-oncology. BTI’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. BTI’s two most advanced clinical development programs are BXCL501, an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine for the treatment of agitation and opioid withdrawal symptoms, and BXCL701, an investigational, orally administered, systemic innate immunity activator in development for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors. For more information, please visit www.bioxceltherapeutics.com.

Contact Information:
BioXcel Therapeutics, Inc.
www.bioxceltherapeutics.com

Investor Relations:
John Graziano
[email protected]
1.646.378.2942

Media:
Julia Deutsch
[email protected]
1.646.378.2967

GREENWICH, Conn., Nov. 13, 2020 (GLOBE NEWSWIRE) —  

XPO Logistics, Inc
. (NYSE: XPO), a leading global provider of supply chain solutions, has been named to the 2021 FreightTech 25 as one of the transportation industry’s most technologically disruptive companies. This is the third consecutive year XPO has been recognized by FreightWaves, a leading source of information about global freight markets.

To arrive at the 25 foremost innovators, an independent panel of judges selected 100 companies from over 500 nominees to comprise the FreightTech 100. A separate panel of industry experts voted to determine the final FreightTech 25.

Mario Harik, chief information officer of XPO Logistics, said, “This unpredictable year has highlighted the critical role of technology in ensuring supply chain continuity. We thank FreightWaves for recognizing our commitment to advance the industry through innovation, with greater visibility and control of operations.”

The company recently announced two new global milestones for its XPO Connect™ digital freight marketplace: more than 65,000 carriers registered on the platform, and over 200,000 downloads of the Drive XPO™ mobile app for truck drivers.

About XPO Logistics

XPO Logistics, Inc. (NYSE: XPO) is a top ten global logistics provider of cutting-edge supply chain solutions to the most successful companies in the world. The company operates as a highly integrated network of people, technology and physical assets in 30 countries, with 1,499 locations and approximately 97,000 employees. XPO uses its network to help more than 50,000 customers manage their goods most efficiently throughout their supply chains. XPO’s corporate headquarters are in Greenwich, Conn., USA, and its European headquarters are in Lyon, France. xpo.com

Media Contact

XPO Logistics, Inc.
Joe Checkler
+1-203-423-2098
[email protected]