Market Newsdesk

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TORONTO, Nov. 13, 2020 (GLOBE NEWSWIRE) — Onex Corporation (TSX: ONEX) today announced its financial results for the third-quarter and nine-months ended September 30, 2020 and an update on matters following quarter end.

“Building on our portfolio improvements last quarter, we continue to demonstrate increased momentum in our private equity and credit portfolios, resulting in a very good quarter for Onex,” said Gerry Schwartz, Chairman and Chief Executive Officer of Onex. “Earlier this quarter, I was delighted to announce Bobby Le Blanc as President of Onex, in recognition of his leadership ability and the positive role he continues to play in our success.”

Highlights

• Onex reported segment net earnings for the three months ended September 30, 2020 of $515 million ($5.39 per fully diluted share), comprised of net earnings of $492 million from its investing segment and net earnings of $23 million from its asset and wealth management segment.
• Onex reported segment net earnings for the nine-months ended September 30, 2020 of $152 million ($1.55 per fully diluted share), comprised of net earnings of $164 million from its investing segment and a net loss of $12 million from its asset and wealth management segment.
• Onex’ private equity investments generated gross returns of 14% and 9% during the three and nine-months ended September 30, 2020, respectively.
• Onex’ total shareholder capital per fully diluted share increased by approximately 10% in the third-quarter to $74.04 (C$98.76), primarily driven by net increases in Onex’ private equity and credit investments.
• In August, Onex Partners sold approximately 32.0 million shares of SIG Combibloc Group (SWX: SIGN) at a price of CHF 15.50 per share. Onex’ share of the net proceeds was $162 million as a Limited Partner in Onex Partners IV and as a co-investor.
• In August, Onex invested $35 million in Onex Partners V as part of the Fund’s investment in preferred shares of Emerald Holdings, Inc. (NYSE: EEX). This attractively valued investment supports a business with a solid collection of assets with an opportunity remaining to improve operations.
• In September, Onex invested $64 million in Onex Partners V as part of the fund’s investment in Independent Clinical Services Group Ltd.
• In October, Onex Partners agreed to make a majority investment in OneDigital, a leading U.S. provider of employee benefits insurance brokerage and retirement consulting services. The transaction values OneDigital at $2.65 billion. The new equity investment of approximately $725 million will be made by Onex Partners V, Onex’ share will be approximately $200 million.
• Onex deployed $444 million (C$595 million) during the first ten months of 2020 by repurchasing 9,780,411 Subordinate Voting Shares at an average cost per share of C$60.86.

Financial


Results

For the three-months ended September 30, 2020, total segment net earnings were $515 million ($5.39 per fully diluted share). Investing segment earnings of $492 million ($5.17 per fully diluted share) were primarily driven by net gains on Onex’ private equity and credit investments consistent with the recovery in those markets during the quarter. Third-quarter asset and wealth management segment earnings of $23 million ($0.22 per fully diluted share) were driven by management and advisory fees as well as an increase in unrealized carried interest.

For the nine-months ended September 30, 2020, total segment net earnings were $152 million ($1.55 per fully diluted share). Investing segment earnings of $164 million ($1.67 per fully diluted share) were primarily driven by a net gain on Onex’ private equity investments which reflects the overall resiliency and diversification of the operating businesses that Onex has invested in. The asset and wealth management segment loss for the nine-months ended September 30, 2020 was $12 million ($0.12 per fully diluted share) driven primarily by a net reversal of unrealized carried interest.

Enclosed are supplementary schedules and non-IFRS measures related to Onex’ consolidated net earnings for the three- and nine-months ended September 30, 2020, shareholder capital at September 30, 2020 and cash and near-cash changes for the nine-months ended September 30, 2020. The financial statements prepared in accordance with International Financial Reporting Standards (IFRS), including Management’s Discussion and Analysis of the results, are posted on Onex’ website, www.onex.com, and are also available on SEDAR at www.sedar.com. A supplemental information package with additional information is available on Onex’ website, www.onex.com.

Webcast

Onex management will host a webcast to review Onex’ third-quarter 2020 results on Friday, November 13 at 11:00 a.m. ET. The webcast will be available in listen-only mode from the Presentations and Events section of Onex’ website, https://ir.onex.com/events-and-presentations. A 90-day on-line replay will be available shortly following the completion of the event.

About Onex

Founded in 1984, Onex invests and manages capital on behalf of its shareholders, institutional investors and high net worth clients from around the world. Onex’ platforms include: Onex Partners, private equity funds focused on larger opportunities in North America and Europe; ONCAP, private equity funds focused on middle market and smaller opportunities in North America; Onex Credit, which manages primarily non-investment grade debt through collateralized loan obligations, senior loan strategies and other private credit strategies; and Gluskin Sheff’s wealth management services including its actively managed public equity and public credit funds. In total, Onex has approximately $36.6 billion of assets under management, of which approximately $6.7 billion is its own shareholder capital. With offices in Toronto, New York, New Jersey and London, Onex and its experienced management teams are collectively the largest investors across Onex’ platforms.

The Onex Partners and ONCAP businesses have assets of $36 billion, generate annual revenues of $22 billion and employ approximately 149,000 people worldwide. Onex shares trade on the Toronto Stock Exchange under the stock symbol ONEX. For more information on Onex, visit its website at www.onex.com. Onex’ security filings can also be accessed at www.sedar.com.

Forward-Looking Statements

This press release may contain, without limitation, statements concerning possible or assumed future operations, performance or results preceded by, followed by or that include words such as “believes”, “expects”, “potential”, “anticipates”, “estimates”, “intends”, “plans” and words of similar connotation, which would constitute forward-looking statements. Forward-looking statements are not guarantees. The reader should not place undue reliance on forward-looking statements and information because they involve significant and diverse risks and uncertainties that may cause actual operations, performance or results to be materially different from those indicated in these forward-looking statements. Except as may be required by Canadian securities law, Onex is under no obligation to update any forward-looking statements contained herein should material facts change due to new information, future events or other factors. These cautionary statements expressly qualify all forward-looking statements in this press release.

Non-GAAP Financial Measures

This press release may contain non-GAAP financial measures which have been calculated using methodologies that are not in accordance with IFRS. The presentation of financial measures in this manner does not have a standardized meaning prescribed under IFRS and is therefore unlikely to be comparable to similar financial measures presented by other companies. Onex management believes these financial measures provide helpful information to investors. Reconciliations of the non-GAAP financial measures to information contained in the consolidated financial statements have been presented where practical.

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Jill Homenuk
Managing Director, Shareholder Relations and Communications
Tel: +1 416.362.7711

Supplementary
and
Non-IFRS Measures

Summarized Consolidated Net


Earnings


(


Loss


)

(Unaudited) ($ millions except per share amounts) Three months ended September 30 , 2020		Investing (i)			Asset and Wealth Management (i)			Total
Segment income	$	492		$	93		$	585
Segment expenses		–			(70)			(70)
Segment net earnings	$	492		$	23		$	515
Stock-based compensation recovery								3
Amortization of property and equipment and other intangible assets, excluding right-of-use assets								(12)
Integration expense								(5)
Net earnings							$	501
Segment net earnings per share(ii)	$	5.17		$	0.22		$	5.39
Net earnings per share
Basic							$	5.30
Diluted							$	5.29

(i)	Refer to the unaudited interim consolidated financial statements for segment presentation and allocation considerations.
(ii)	Calculated on a fully diluted basis.

(Unaudited) ($ millions except per share amounts) Nine months ended September 30, 2020		Investing (i)			Asset and Wealth Management (i)			Total
Segment income	$	164		$	182		$	346
Segment expenses		–			(194)			(194)
Segment net earnings (loss)	$	164		$	(12)		$	152
Stock-based compensation recovery								108
Amortization of property and equipment and other intangible assets, excluding right-of-use assets								(35)
Integration expense Impairment of goodwill								(7) (85)
Net earnings							$	133
Segment net earnings (loss) per share(ii)	$	1.67		$	(0.12)		$	1.55
Net earnings per share
Basic							$	1.36
Diluted							$	1.36

(i)	Refer to the unaudited interim consolidated financial statements for segment presentation and allocation considerations.
(ii)	Calculated on a fully diluted basis.

Shareholder Capital

(Unaudited) ($ millions except per share amounts) As at September 3 0 , 2020		Investing			Asset and Wealth Management			Total
Total segmented assets	$	6,260		$	780		$	7,040
Accounts payable and accrued liabilities		–			(33)			(33)
Accrued compensation		–			(86)			(86)
Lease and other liabilities		–			(118)			(118)
DSU hedge assets		–			(61)			(61)
Total shareholder capital (i)	$	6,2 60		$	48 2		$	6, 742
Shareholder capital per share (i)(ii)	$	6 8.74		$	5. 30		$	74.04

(i)

Shareholder capital and shareholder capital per share are non-GAAP financial measures which have been calculated using methodologies that are not in accordance with IFRS. A reconciliation of total segmented assets to shareholder capital is presented in this table. The presentation of financial measures in this manner does not have a standardized meaning prescribed under IFRS and is therefore unlikely to be comparable to similar financial measures presented by other companies. Management believes that shareholder capital is useful to investors as the metric is used, in part, to assess Onex’ performance.

(ii)

Calculated on a fully diluted basis using the treasury stock method. Fully diluted shares for shareholder capital per share were 91.1 million at September 30, 2020.

Cash and Near-Cash

The table below provides a reconciliation of the change in cash and near-cash from December 31, 2019 to September 30, 2020.

(Unaudited) ($ millions)
Cash and near-cash on hand at December 31, 2019(i)	$	1,842
Private equity realizations		582
Private equity investments		(325)
Real estate distributions		15
Net Onex Credit strategies investment activity, including warehouse facilities		(53)
Onex share repurchases, options exercised, dividends and director DSU redemption		(472)
Net other, including capital expenditures, management fees, operating costs and treasury income		12
Cash and near-cash on hand at September 30 , 20 20 (i)	$	1, 601

(i)	Includes $934 million (December 31, 2019 – $395 million) of treasury investments, $96 million (December 31, 2019 – $97 million) invested in an Onex Credit unlevered senior secured loan strategy fund and $192 million (December 31, 2019 – $190 million) of management fees.

Patient Dosing Continues in the Phase 1/2 PROPEL Trial of PR001 for Parkinson’s Disease with GBA1 Mutations

Phase 1/2 PROVIDE Trial of PR001 for Type 2 Gaucher Disease and Phase 1/2 PROCLAIM Trial of PR006 for Frontotemporal Dementia with GRN Mutations Expected to Initiate Enrollment in Fourth Quarter of 2020

PR001 Receives U.S. FDA Fast Track Designation for Neuronopathic Gaucher Disease

NEW YORK, Nov. 13, 2020 (GLOBE NEWSWIRE) — Prevail Therapeutics Inc. (Nasdaq: PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today reviewed recent clinical and business updates and reported financial results for the third quarter ended September 30, 2020.

“We’re pleased to be making significant progress across our pipeline as we seek to develop urgently needed disease-modifying gene therapy treatments for patients with neurodegenerative diseases,” said Asa Abeliovich, M.D., Ph.D., Founder and Chief Executive Officer of Prevail. “We are encouraged by the continuation of patient dosing in our Phase 1/2 PROPEL trial of PR001 for Parkinson’s disease with GBA1 mutations, and we are excited to advance our PROVIDE and PROCLAIM clinical trials for Type 2 Gaucher disease and frontotemporal dementia with GRN mutations, respectively, this year.”

Recent Business
Updates

Patient Dosing Continues in Phase 1/2 PROPEL Trial of PR001 for P
arkinson’s disease with

GBA1

mutations (PD-GBA)
: Enrollment in the Phase 1/2 PROPEL clinical trial for PD-GBA has resumed following implementation of modifications to the clinical protocol. As previously announced, Prevail elected to modify the immunosuppression regimen in the clinical protocol for PROPEL and has adapted the trial design to be open-label. The Company expects to provide the next biomarker and safety analysis on a subset of patients in the PROPEL trial by mid-2021.

Phase 1/2 PROVIDE Trial Expected to Initiate Enrollment in Fourth Quarter of 2020: Initiation of patient enrollment remains on track for the fourth quarter of 2020 for the Phase 1/2 PROVIDE clinical trial of PR001 for Type 2 Gaucher disease. The optimized immunosuppression regimen used in the amended PROPEL trial will also be implemented in the PROVIDE trial. The Company currently anticipates it will provide the next update on PR001 biomarker and safety data for neuronopathic Gaucher disease (nGD) in 2021.

Phase 1/2 PROCLAIM Trial Expected to Initiate Enrollment in Fourth Quarter of 2020: Initiation of patient enrollment remains on track for the fourth quarter of 2020 for the Phase 1/2 PROCLAIM clinical trial of PR006 for frontotemporal dementia with GRN mutations (FTD-GRN). The optimized immunosuppression regimen used in the amended PROPEL trial will also be implemented in the PROCLAIM trial. The Company currently anticipates it will provide a biomarker and safety analysis on a subset of patients in the PROCLAIM trial in 2021.

PR001 Granted U.S. FDA Fast Track Designation for
nGD
: The U.S. Food and Drug Administration (FDA) granted Fast Track designation for PR001 for the treatment of nGD. The FDA previously granted PR001 Rare Pediatric Disease designation for the treatment of nGD, and Orphan Drug designation for the treatment of patients with Gaucher disease. In addition, the FDA has granted Fast Track designation for PR001 for the treatment of PD-GBA.

Strengthened Leadership with Board Appointment: Prevail has appointed William H. Carson, M.D., to its Board of Directors. Dr. Carson was most recently the President and CEO of Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), leading the development and regulatory approvals of Otsuka’s global compounds. Before joining Otsuka, he held several roles in the CNS Research and Development department at Bristol Myers Squibb. Dr. Carson currently serves as Chairman of the Board of Directors of OPDC and is also the Chairman of the Board of the Sozosei Foundation, a newly established Otsuka charitable organization with a main focus on decriminalization of mental illness. He is a Board Member of Excision Biotherapeutics and Trustee of the non-profit Internet2. He is a Distinguished Fellow of the American Psychiatric Association, the National Medical Association and the Executive Leadership Council. Prior to joining the pharmaceutical industry, Dr. Carson, a board-certified psychiatrist, was an Associate Professor in the Department of Psychiatry and Behavioral Sciences at the Medical University of South Carolina.

Favorable Decision Received in Alector Arbitration: Prevail announced a favorable decision in the arbitration proceeding brought in 2019 by Alector Inc. against Prevail’s Founder and Chief Executive Officer, Asa Abeliovich, M.D., Ph.D. The arbitrator rejected Alector’s claims against Dr. Abeliovich that Alector confidential information was used in connection with his work on behalf of Prevail and that Alector had rights to Prevail’s patents and patent applications. The arbitrator found that Dr. Abeliovich did not breach his confidentiality obligations to Alector under his consulting agreement. Prevail was not a party to this arbitration.

Third Quarter 2020 Financial Results

• Cash Position: Cash, cash equivalents and investments were $114.3 million as of September 30, 2020, as compared to $131.2 million and $168.1 million as of June 30, 2020 and December 31, 2019, respectively. The Company continues to anticipate that its cash runway will extend into the first half of 2022.
   
• R&D Expenses: R&D expenses were $12.3 million for the third quarter of 2020 compared to $16.8 million for the third quarter in 2019. The decrease was primarily due to a decrease of $3.9 million in external manufacturing costs due to the timing of production of clinical and preclinical supply, a decrease of $1.5 million in direct clinical trial costs, and a decrease of $0.5 million related to external preclinical studies. These decreases were partially offset by an increase of $1.4 million in employee-related costs, resulting from an increase in research and development employees hired to execute the development of our clinical-stage product candidates and preclinical pipeline.
   
• G&A Expenses: G&A expenses were $6.3 million for the third quarter of 2020, compared to $4.5 million for the third quarter of 2019. The increase was primarily due to a $1.3 million increase in employee related costs, resulting from an increase in general and administrative employees to support our expanded operations and establish capabilities to operate as a public company, a $0.8 million increase in legal fees, offset by a decrease of $0.2 million in other professional services and facilities cost.
   
• Net Loss: Net loss was $18.6 million, or $0.55 loss per share, for the third quarter of 2020, compared to $20.3 million, or $0.62 loss per share, for the third quarter of 2019.

About Prevail Therapeutics

Prevail is a gene therapy company leveraging breakthroughs in human genetics with the goal of developing and commercializing disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases. The Company is developing PR001 for patients with Parkinson’s disease with GBA1 mutations (PD-GBA) and neuronopathic Gaucher disease (nGD); PR006 for patients with frontotemporal dementia with GRN mutations (FTD-GRN); and PR004 for patients with certain synucleinopathies.

Prevail was founded by Dr. Asa Abeliovich in 2017, through a collaborative effort with The Silverstein Foundation for Parkinson’s with GBA and OrbiMed, and is headquartered in New York, NY.

Forward-Looking Statements Related to Prevail

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of these forward-looking statements include statements concerning the potential for Prevail’s gene therapy candidates to modify the course of neurodegenerative diseases; the anticipated timing of Prevail’s clinical trials of PR001 in PD-GBA and in Type 2 Gaucher disease and Prevail’s clinical trial of PR006 in FTD-GRN; the expected timing of reporting of additional interim data for a subset of patients from the PROPEL trial; and expectations regarding Prevail’s cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Prevail’s novel approach to gene therapy makes it difficult to predict the time, cost and potential success of product candidate development or regulatory approval; Prevail’s gene therapy programs may not meet safety and efficacy levels needed to support ongoing clinical development or regulatory approval; the regulatory landscape for gene therapy is rigorous, complex, uncertain and subject to change; the fact that gene therapies are novel, complex and difficult to manufacture; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises. These and other risks are described more fully in Prevail’s filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Prevail undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Pr
evail Therapeutics Inc.

Statements of Operations

(Unaudited)
(in thousands, except share and per share data)

		Three Months Ended September 30,												Nine Months Ended September 30,
		2020						2019						2020						2019
Operating Expenses:
Research and development		$	12,321					$	16,836					$	36,681					$	37,202
General and administrative			6,303						4,452						23,373						10,050
Total operating loss			(18,624	)					(21,288	)					(60,054	)					(47,252	)
Other income			—						—						210						—
Interest income, net			37						989						582						1,905
Total other income			37						989						792						1,905
Net loss		$	(18,587	)				$	(20,299	)				$	(59,262	)				$	(45,347	)
Other comprehensive income			5						—						4						—
Comprehensive loss		$	(18,582	)				$	(20,299	)				$	(59,258	)				$	(45,347	)
Net loss per share, basic and diluted		$	(0.55	)				$	(0.62	)				$	(1.77	)				$	(1.68	)
Weighted average shares outstanding, basic and diluted			33,636,651						32,864,156						33,457,768						26,950,854

Prevail Therapeutics Inc.

Balance
Sheets

(Unaudited)
(in thousands, except share and per share data)

		September 30, 2020				December 31, 2019
ASSETS
CURRENT ASSETS:
Cash and cash equivalents		$	81,732			$	168,051
Investments			9,755				—
Prepaid expenses and other current assets			4,839				6,410
Total current assets			96,326				174,461
Property and equipment, net			2,746				2,549
Investments			22,861				—
Operating lease right-of-use assets			9,023				10,001
Other long-term assets			3,068				—
Restricted cash			91				91
TOTAL ASSETS		$	134,115			$	187,102
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable		$	2,597			$	5,162
Accrued expenses and other current liabilities			8,651				5,330
Operating lease liabilities			1,500				1,341
Total current liabilities			12,748				11,833
Long-term operating lease liabilities			8,787				9,927
TOTAL LIABILITIES			21,535				21,760
COMMITMENTS AND CONTINGENCIES (Note 13)
STOCKHOLDERS’ EQUITY
Preferred stock – $0.0001 par value, 10,000,000 shares authorized as of September 30, 2020 and December 31, 2019, respectively; no shares issued as of September 30, 2020 and December 31, 2019, respectively			—				—
Common stock – $0.0001 par value, 200,000,000 shares authorized as of September 30, 2020 and December 31, 2019, respectively, 34,245,433 and 34,138,750 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively			3				3
Additional paid-in capital			255,937				249,441
Accumulated deficit			(143,364	)			(84,102	)
Accumulated other comprehensive income			4				—
Total stockholders’ equity			112,580				165,342
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY		$	134,115			$	187,102

Media Contact
:

Lisa Qu
Ten Bridge Communications
[email protected]
678-662-9166

Investor Contact
:

[email protected]

 

TEL AVIV, Israel and RALEIGH, N.C., Nov. 13, 2020 (GLOBE NEWSWIRE) — RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that Mr. Guy Goldberg, RedHill’s Chief Business Officer, will present a corporate overview and host 1-on-1 investor meetings at the German Equity Forum (Deutsches Eigenkapital Forum) 2020, one of Europe’s largest investor events, on Tuesday, November 17, 2020, at 9:30 a.m. CET.

The presentation will be available via replay for 30 days on the Company’s website: https://ir.redhillbio.com.

About RedHill Biopharma           
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs Movantik^® for opioid-induced constipation in adults¹, Talicia^® for the treatment of Helicobacter pylori (H. pylori) infection in adults², and Aemcolo^® for the treatment of travelers’ diarrhea in adults³. RedHill’s key clinical late-stage development programs include: (i) RHB-204, with a planned Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) opaganib (Yeliva^®), a first–in–class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn’s disease; (iv) RHB-102 (Bekinda^®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB–106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,”
“hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties
include
risks and uncertainties
associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates and Talicia

^®

; (v) the Company’s ability to successfully commercialize and promote Movantik

^®

, Talicia

^®

and Aemcolo

^®

; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company’s ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company’s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company’s Expanded Access Program; and (xiv) competition from other companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on
M
arch 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

Company contact: Adi Frish Chief Corporate & Business Development Officer RedHill Biopharma +972-54-6543-112 [email protected]

Media contact (U.S.): Bryan Gibb Vice President Finn Partners +1 212 529 2236 [email protected]

^{_____________
1} Full prescribing information for Movantik^® (naloxegol) is available at: www.Movantik.com.
² Full prescribing information for Talicia^® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       
³ Full prescribing information for Aemcolo^® (rifamycin) is available at: www.Aemcolo.com.

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]