Cardiovascular Systems, Inc. to Webcast Fiscal 2021 Second-Quarter Earnings Conference Call Wednesday, February 3

Cardiovascular Systems, Inc. to Webcast Fiscal 2021 Second-Quarter Earnings Conference Call Wednesday, February 3

Live Webcast at 3:30 p.m. CT (4:30 p.m. ET)

ST. PAUL, Minn.–(BUSINESS WIRE)–
Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII) will host a live webcast of its fiscal 2021 second-quarter conference call on Wednesday, February 3, 2021, at 3:30 p.m. CT (4:30 p.m. ET). CSI management will discuss results for its fiscal second quarter ended December 31, 2020, and its financial outlook. CSI will issue a post-market earnings release prior to the call on February 3, 2021.

To access the live webcast, go to the events section of CSI’s investor relations website, https://investors.csi360.com/events-and-presentations/events-calendar/default.aspx, on the day of the conference, and click on the webcast link. A webcast replay will be available beginning at 6:30 p.m. CT the same day.

To participate in the conference call, please register online prior to the event: http://www.directeventreg.com/registration/event/5682205.

About Cardiovascular Systems, Inc.

Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s orbital atherectomy system treats calcified and fibrotic plaque in arterial vessels throughout the leg and heart and addresses many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. For additional information, please visit www.csi360.com and connect on Twitter @csi360.

Cardiovascular Systems, Inc.

Jack Nielsen

(651) 202-4919

[email protected]

KEYWORDS: Minnesota United States North America

INDUSTRY KEYWORDS: Health Surgery Cardiology Medical Devices

MEDIA:

Acorda Therapeutics Announces Agreement for Sale of Manufacturing Operations and Long-Term Global Supply Agreement for INBRIJA®, Corporate Restructuring, and Enters into “At The Market” Offering Agreement

Acorda Therapeutics Announces Agreement for Sale of Manufacturing Operations and Long-Term Global Supply Agreement for INBRIJA®, Corporate Restructuring, and Enters into “At The Market” Offering Agreement

  • $80 million up-front payment will substantially increase cash balance
  • Sale, restructuring and other operating expense reductions will reduce annual operating expenses by approximately $40 million
  • Total 2021 non-GAAP operating expense guidance expected to be $130-$140 million1
  • At The Market (ATM) offering allows the sale of common stock at aggregate value up to $15.25 million1
  • Supply agreement will ensure uninterrupted supply of INBRIJA (levodopa inhalation powder) to people with Parkinson’s

ARDSLEY, N.Y.–(BUSINESS WIRE)–
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it has entered into a definitive agreement to sell its INBRIJAmanufacturing operations in Chelsea, Massachusetts to Catalent for $80 million in cash. In connection with the sale, Acorda and Catalent have entered into a long-term global supply agreement under which Catalent will manufacture and package INBRIJA for Acorda, ensuring an uninterrupted drug supply for Acorda’s patients and continued adherence to best-in-class manufacturing quality and safety standards.

As part of the deal, Catalent will absorb all Acorda employees who work at the Chelsea facility, and certain Acorda employees at the Company’s Waltham, Massachusetts facility.

Acorda also announced a corporate restructuring to reduce costs and focus its resources on INBRIJA. In addition to the associates who will transition to Catalent, Acorda is reducing its combined Ardsley, Waltham and field headcount by approximately 16% through a reduction in force.

“Today’s announcements represent important steps in our ongoing efforts to strengthen our capital structure, enhance our operating efficiency and position Acorda to drive long-term value for our shareholders,” said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. “Through the sale of the Chelsea operations we are monetizing our excess manufacturing capacity and significantly reducing expenses. This will ensure that our patients have uninterrupted access to INBRIJA, while meaningfully improving both our balance sheet and P&L.”

“The restructuring is necessary for Acorda to have an infrastructure and expenses that are right-sized for our products and revenue. This is a difficult step for us all, not least for those who will no longer be employed at the company,” he added. “We thank them for their dedication and contributions in bringing INBRIJA and AMPYRA to the patient communities we serve. We will be providing these colleagues with severance and assistance in seeking new positions.”

Sale of Manufacturing Operations

After taking into account estimated transaction fees and other estimated expenses, Acorda’s net proceeds are expected to be approximately $70 million. In addition, Acorda expects to save approximately $10 million in annual operating expenses related to the operation of the manufacturing facility. Together, this will provide Acorda with a stronger balance sheet and additional financial flexibility to reduce debt and execute on its strategic priorities in 2021 and beyond. MTS Health Partners, L.P. is serving as exclusive financial advisor to Acorda Therapeutics on the transaction.

Completion of the transaction is subject to customary closing conditions and is expected to occur in the first quarter of 2021.

Corporate Restructuring

The Company expects to realize estimated annualized cost savings related to headcount reductions of approximately $6 million beginning in 2021. Acorda estimates that it will incur approximately $3.2 million of pre-tax charges for severance and other costs related to the restructuring, through the first quarter of 2021.

Expected Fourth Quarter and 2020 Financial Performance

  • INBRIJA Q4 2020 net revenue of approximately $9 million. Full year 2020 net revenue of approximately $24 million (unaudited).
  • AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg net revenue for Q4 2020 of approximately $25 million. Full year 2020 net revenue of approximately $98 million (unaudited).
  • The Company continues to expect full year non-GAAP 2020 operating expense of $170 – $180 million. This is a non-GAAP projection that excludes restructuring costs and share-based compensation, as more fully described below under “Non-GAAP Financial Measures.”
  • 2020 year-end cash, cash equivalents and restricted cash were approximately $102 million (unaudited). Restricted cash includes $31 million in escrow related to the 6% semi-annual interest payment, payable in cash or stock, of the Company’s 2024 convertible notes. If the Company elects to make an interest payment on such notes in stock, the cash equivalent of such interest payment will be released from escrow.
  • Final results are subject to completion of the Company’s year-end audit.

2021 Expense Guidance

Acorda expects that combined savings from the sale, restructuring and other operating cost reductions will reduce annual operating expenses by approximately $40 million.

The Company provided new operating expense guidance of $130 to $140 million for the full year 2021. This is a non-GAAP projection that excludes restructuring costs and share-based compensation, as more fully described below under “Non-GAAP Financial Measures.”

At The Market Offering Agreement

Acorda also entered into an At The Market (ATM) Offering Agreement with H.C. Wainwright & Co., LLC as sales agent. Pursuant to the ATM Agreement, the Company may offer and sell shares of its common stock having an aggregate value of up to $15.25 million in an at-the-market offering. The shares of common stock will be offered pursuant to the Company’s effective Registration Statement on Form S-3 (File Number 333-248738), which was declared effective by the Securities and Exchange Commission (the “SEC”) on September 17, 2020, and a prospectus supplement to be filed with the SEC.

Before investing in Acorda’s common stock, investors should carefully read the prospectus supplement and the accompanying prospectus, including the documents incorporated by reference therein and any free writing prospectus. The shares of common stock may be offered only by means of a prospectus, including a prospectus supplement, forming a part of an effective registration statement. The prospectus supplement and the accompanying prospectus may be freely obtained by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022 by email: [email protected] or by telephone: (646) 975-6996.

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

Non-GAAP Financial Measures

This press release includes financial measures that were not prepared in accordance with accounting principles generally accepted in the United States (GAAP). In particular, we have provided 2020 and 2021 operating expense guidance on a non-GAAP basis, as the guidance excludes restructuring costs and share-based compensation charges. Reconciliations of these measures to the most directly comparable GAAP financial measures are not available at this time because our analysis of our 2020 financial performance (including share-based compensation expense and other GAAP expenses) is ongoing, and because the 2021 financial measure is forward-looking in nature and the amount of compensation charges needed to reconcile this measure to the most directly comparable GAAP financial measure is dependent on future changes in the market price of our common stock and is not available at this time. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes that the presentation of these non-GAAP financial measures, when viewed in conjunction with actual GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because they exclude (i) expenses that pertain to non-routine restructurings, and (ii) non-cash charges that are substantially dependent on changes in the market price of our common stock. We believe these non-GAAP financial measures help indicate underlying trends in the Company’s business and are important in comparing current results with prior period results and understanding expected operating performance. Also, management uses these non-GAAP financial measures to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.

About Acorda Therapeutics

Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. INBRIJA® (levodopa inhalation powder) is approved for intermittent treatment of OFF episodes in adults with Parkinson’s disease treated with carbidopa/levodopa. INBRIJA is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last two weeks. INBRIJA utilizes Acorda’s innovative ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inhalation. Acorda also markets the branded AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.

Forward-Looking Statements

This press release includes forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including: we may be unable to successfully complete the sale of our manufacturing operations; we may not be able to successfully market AMPYRA, INBRIJA or any other products under development; the COVID-19 pandemic, including related quarantines and travel restrictions, and the potential for the illness to affect our employees or consultants or those that work for other companies we rely upon, could have a material adverse effect on our business operations or product sales; our ability to raise additional funds to finance our operations, repay outstanding indebtedness or satisfy other obligations, and our ability to control our costs or reduce planned expenditures and take other actions which are necessary for us to continue as a going concern; risks associated with the trading of our common stock and our reverse stock split; risks related to our workforce, including our ability to realize the expected benefits of our corporate restructuring; risks associated with complex, regulated manufacturing processes for pharmaceuticals, which could affect whether we have sufficient commercial supply of INBRIJA to meet market demand; our reliance on third-party manufacturers for the production of commercial supplies of AMPYRA, and, following the sale of our manufacturing operations, INBRIJA; third party payers (including governmental agencies) may not reimburse for the use of INBRIJA or our other products at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; competition for INBRIJA, AMPYRA and other products we may develop and market in the future, including increasing competition and accompanying loss of revenues in the U.S. from generic versions of AMPYRA (dalfampridine) following our loss of patent exclusivity; the ability to realize the benefits anticipated from acquisitions, among other reasons because acquired development programs are generally subject to all the risks inherent in the drug development process and our knowledge of the risks specifically relevant to acquired programs generally improves over time; the risk of unfavorable results from future studies of INBRIJA (levodopa inhalation powder) or from our other research and development programs, or any other acquired or in-licensed programs; the occurrence of adverse safety events with our products; the outcome (by judgment or settlement) and costs of legal, administrative or regulatory proceedings, investigations or inspections, including, without limitation, collective, representative or class action litigation; failure to protect our intellectual property, to defend against the intellectual property claims of others or to obtain third party intellectual property licenses needed for the commercialization of our products; and failure to comply with regulatory requirements could result in adverse action by regulatory agencies.

These and other risks are described in greater detail in our filings with the Securities and Exchange Commission. We may not actually achieve the goals or plans described in our forward-looking statements, and investors should not place undue reliance on these statements. Forward-looking statements made in this press release are made only as of the date hereof, and we disclaim any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

Preliminary Financial Information

The Company reports its financial results in accordance with U.S. generally accepted accounting principles. All financial information in this press release as of and for the year ended December 31, 2020 is preliminary, as financial close procedures for the year ended December 31, 2020 are not yet complete. These estimates are not a comprehensive statement of the financial condition and results of operations of the Company as of and for the year ended December 31, 2020. Actual results may differ materially from these estimates as a result of the completion of normal year-end accounting procedures and adjustments, including the performance of the Company’s internal control over financial reporting, the completion of the preparation and management’s review of the Company’s financial statements as of and for the year ended December 31, 2020 and the subsequent occurrence or identification of events prior to the filing of the financial statements to be included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020.

1 This guidance is a non-GAAP projection that excludes certain items as more fully described under “Non-GAAP Financial Measures.”

Tierney Saccavino

(917) 783-0251

[email protected]

KEYWORDS: New York Massachusetts United States North America

INDUSTRY KEYWORDS: Biotechnology Manufacturing Other Manufacturing Health Pharmaceutical

MEDIA:

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OpSens Announces First Quarter Fiscal 2021 Financial Results

Canada NewsWire

QUEBEC CITY, Jan. 13, 2021 /CNW Telbec/ – OpSens Inc. (“OpSens” or the “Company”) (TSX: OPS) (OTCQX: OPSSF), a medical device cardiology-focused company delivering diagnostic and treatment solutions based on its proprietary optical technology, today reported its financial results for the first quarter of fiscal 2021, ended November 30, 2020.

First Quarter Financial Highlights

  • Total revenue of $8.3 million, an increase of 19%, compared with $7.0 million for the first quarter of fiscal 2020;
  • FFR and dPR sales of $5.3 million, an increase of 23%, compared with $4.3 million for the first quarter of fiscal 2020;
  • Net income of $0.6 million, an improvement of $2.5 million, compared with the first quarter of fiscal 2020;
  • Cash and cash equivalents were $12.2 million as of November 30, 2020 ($10.9 million as of August 31, 2020).

Recent Developments

  • Awarded 3-year contract in October 2020 with major American group purchasing organization (“GPO”) to provide access to the OptoWire to their member hospitals across the United States;
  • Progress in the development of a guidewire for transcatheter aortic valve replacement (TAVI or TAVR) procedures.

Management Commentary

“I am pleased with the financial results of the first quarter of fiscal 2021, as we achieved solid double-digit top- and-bottom line growth. These positive results reflect the continued confidence of our customers and partners in our team, products and technologies,” said Louis Laflamme, President and CEO of OpSens. “During the first quarter, we made strong progress to increase the adoption of the OptoWire in the coronary artery stenosis measurement market, particularly in the United States where we executed our first group purchasing agreement. We are in discussions with others and believe this, coupled with the introduction of the OptoWire III, will be key to the expansion of the OptoWire going forward.”

Financial Results – Quarter ended November 30, 2020

Total revenue was $8.3 million, an increase of 19% in the first quarter of 2021 compared with $7.0 million in the first quarter of 2020.

Sales of products for the measurement of coronary artery stenosis (Fractional Flow Reserve (“FFR”) and diastolic pressure ratio (“dPR”)) were $5.3 million in the first quarter of 2021 compared with $4.3 million in the same period in 2020, an increase of 23%. The increase in sales is primarily the result of growth in the Japanese, American, European, and Canadian markets despite several cardiology laboratories operating at reduced levels due to COVID-19.

Sales of optical medical systems, including the Company’s 5-year supply agreement for ventricular assist device sensors, were $2.0 million in the first quarter of 2021 compared with $2.2 million in the first quarter of 2020.

Industrial sales increased 89% to $1.0 million during the first quarter of 2021 due to overall increase of activities in aeronautic and power electronics applications.

Operating expenses in the first quarter of fiscal 2021 were $4.4 million, down $1.2 million compared with $5.6 million in the first quarter of 2020. The improvement in operating expenses is attributable to a decrease in sales and marketing expenses.

Net income was $0.6 million in the first quarter of 2021 compared with a net loss of $1.9 million in the first quarter of 2020. The $2.5 million improvement is due to a $0.8 million increase in gross margin, a $1.2 million improvement in operating costs, and a $0.5 million subsidy from the Canadian government.

OpSens had a cash and cash equivalents of $12.2 million as of November 30, 2020 ($10.9 million as of August 31, 2020).

Table A

Consolidated statement of results

(In thousands of Canadian dollars, except for information per share)


For the quarter ended
November 30, 2020


For the quarter ended
November 30, 2019


$


$

Revenues

Sales

Medical


7,336

6,461

Industrial


1,000

528


8,336

6,989

Cost of Sales


3,664

3,079

Gross margin


4,672

3,910

Gross margin (%)


56%

56%


Operating Expenses

Administration


1,469

1,475

Sales and marketing


1,588

2,850

R&D


1,295

1,296


4,352

5,621

Other income


(490)

Financial expenses


216

160

Net earnings (loss) and comprehensive income (loss)


594

(1,871)

Net earnings (loss) per share – Basic and diluted


0.01

(0.02)

Table B

CONSOLIDATED BALANCE SHEET HIGHLIGHTS

(in thousands of Canadian dollars)


As at


As at


November 30, 2020


August 31,
 2020


$


$

Cash and cash equivalents


12,158

10,884

Trade and other receivables


3,777

4,041

Inventories


6,989

6,505

Total Current Assets


24,202

22,543

Property, plant, and equipment


3,048

3,230

Intangible assets


1,682

1,622

Right-of-use assets


4,368

4,513

Total Assets


33,300

31,908

Current liabilities


6,723

5,655

Long-term debt


6,348

6,608

Lease liabilities


4,213

4,298

Total Liabilities


17,284

16,561

Shareholders’ equity


16,016

15,347

 

About OpSens Inc. (www.OpSens.com or www.OpSensmedical.com)

OpSens focuses mainly on coronary artery stenosis measurement in interventional cardiology. The Company offers an advanced optical-based pressure guidewire that aims at improving the clinical outcome of patients with coronary artery disease. Its flagship product, the OptoWire, is a second-generation fiber optic pressure guidewire designed to provide the lowest drift in the industry and excellent lesions access. The OptoWire has been used in the diagnosis and treatment of over 100,000 patients in more than 30 countries. It is approved for sale in the United States, European Union, Japan, and Canada.

OpSens is also involved in industrial activities in developing, manufacturing, and installing innovative fiber optic sensing solutions for critical applications.

Forward-looking statements contained in this press release involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, and achievements of OpSens to be materially different from any future results, performance or achievements expressed or implied by the said forward-looking statements.

Neither TSX nor its Regulation Services Provider (as that term is defined in the policies of the TSX) accepts responsibility for the adequacy or accuracy of this release.

SOURCE OPSENS Inc.

Willow Biosciences Provides Update on Cannabigerol Research Studies and Key Personnel Appointment

PR Newswire

VANCOUVER, BC, Jan. 13, 2021 /PRNewswire/ – Willow Biosciences Inc. (“Willow” or the “Company“) (TSX: WLLW) (OTCQX: CANSF) is pleased to announce that it is undertaking two initiatives to help our customers evaluate and better understand cannabigerol (“CBG“), our first commercial cannabinoid slated for production in Q1 2021.

Willow has engaged Signum Biosciences, a leading biopharmaceutical company focused on the discovery and development of innovative consumer products, to generate a robust safety and data package for our CBG to demonstrate its safety and activity as a cosmetic ingredient.  The Company has also engaged a world-renowned regulatory consulting group to perform a comprehensive safety assessment to independently conclude that our CBG is Generally Regarded As Safe (GRAS) for use as an ingredient in food and beverage products and support future novel food submissions in multiple jurisdictions.

“The work we are doing to study the safety and activity of CBG will help to separate us from the rest of the industry,” said Trevor Peters, Willow’s President and Chief Executive Officer. “We expect to supply our customers with highly pure product and provide them with the tools they need to create a diverse set of consumer products with CBG.”

To support the above product development initiatives and further expand our knowledge of phytocannabinoids, the Company is pleased to announce the appointment of Dr. Mathias Schuetz to Vice President, Plant Science. Dr. Schuetz was previously Vice President, Research & Development.  The Company is also pleased to announce the promotion of Dr. Trish Choudhary to Vice President, Research & Development to lead our yeast strain engineering efforts. Dr. Choudhary has been with Willow since April 2019 in the role of Senior Director, Strain Engineering and has been overseeing the research and development efforts at our lab in Mountain View, California, since joining. Prior to joining Willow, Dr. Choudhary worked in senior leadership and technical roles at E-SEP Technologies and Codexis.

“Dr. Schuetz has been leading our cannabis plant research efforts with the goal of improving cannabinoid production in our yeast strains. His new title reflects his continued focus on the plant and the Company’s commitment to developing our fermentation derived cannabinoids for consumer products.  Dr. Choudhary has been the driving force behind our high throughout strain engineering efforts and is responsible for the rapid increases in performance we have achieved.  She will be a valuable addition to our executive leadership team,” said Dr. Chris Savile, Chief Operating Officer.

About Willow Biosciences Inc.

Willow is a Canadian biotechnology company based in Vancouver, British Columbia, that produces high purity, plant-derived compounds that provide building blocks for the global pharmaceutical, health and wellness, and consumer packaged goods industries. Willow’s current focus is in the production of cannabinoids for the treatment for pain, anxiety, obesity, brain disorders, among other significant indications. Willow’s science team has a proven track record of developing manufacturing technologies for high purity compounds in pain and cancer treatments. Willow’s manufacturing process creates a consistent, scalable and sustainable product that allows for the discovery and development of new life changing drugs.

Forward-Looking Statements

This news release may include forward-looking statements including opinions, assumptions, estimates and the Company’s assessment of future plans and operations, and, more particularly, statements concerning: Willow’s milestone projections, including the timing of commercialization scale-up; the results and benefits of the Company’s CBG safety initiatives; and the business plan of the Company, generally, including cannabinoid research and production. When used in this news release, the words “will,” “anticipate,” “believe,” “estimate,” “expect,” “intent,” “may,” “project,” “should,” and similar expressions are intended to be among the statements that identify forward-looking statements. The forward-looking statements are founded on the basis of expectations and assumptions made by the Company which include, but are not limited to: the success of Willow’s strategic partnerships, including the development of future strategic partnerships; the financial strength of the Company; the ability of the Company to fund its business plan using cash on hand and existing resources; the market for Willow’s products; the ability of the Company to obtain and retain applicable licences; the ability of the Company to obtain suitable manufacturing partners and other strategic relationships; and the successful implementation of Willow’s production strategy, generally. Forward-looking statements are subject to a wide range of risks and uncertainties, and although the Company believes that the expectations represented by such forward-looking statements are reasonable, there can be no assurance that such expectations will be realized. Any number of important factors could cause actual results to differ materially from those in the forward-looking statements including, but not limited to, risks associated with: the cannabinoid industry in general; the success of the Company’s research and development strategies; infringement on intellectual property; failure to benefit from partnerships or successfully integrate acquisitions; actions and initiatives of federal and provincial governments and changes to government policies and the execution and impact of these actions, initiatives and policies; import/export and research restrictions for cannabinoid-based operations; the size of the medical-use and adult-use cannabinoid market; competition from other industry participants; adverse U.S., Canadian and global economic conditions; adverse global events and public-health crises, including the current COVID-19 outbreak; failure to comply with certain regulations; departure of key management personnel or inability to attract and retain talent; and other factors more fully described from time to time in the reports and filings made by the Company with securities regulatory authorities. Please refer to the AIF and the MD&A for additional risk factors relating to Willow, which can be accessed either on Willow’s website at www.willowbio.com or under the Company’s profile on www.sedar.com.

The forward-looking statements contained in this news release are made as of the date hereof and the Company does not undertake any obligation to update publicly or to revise any of the included forward-looking statements, except as required by applicable law. The forward-looking statements contained herein are expressly qualified by this cautionary statement.

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SOURCE Willow Biosciences Inc.

Else Nutrition Receives Canadian Patent for Infant & Toddler Formulation Composition

PR Newswire

VANCOUVER, BC, Jan. 13, 2021 /PRNewswire/ – ELSE NUTRITION HOLDINGS INC. (BABY.V) (BABYF) (0YL.F) (“Else” or the “Company”) the plant-based baby, toddler and children nutrition company, is pleased to update that it has been granted, and registered a Canadian patent (Registration No.:  2,898,980). The patent claims cover the formulation composition for use in an infant and/or toddler formulation.

Else, which already holds a worldwide patent covering its 100% plant-based toddler and infant formulas, has just received a grant notice from the Canadian Patent Office on the composition of its proprietary formulation, for use in a non-dairy infant and/or toddler formula. The patented composition provides the necessary proteins, amino-acids and other nutrients needed in a single food serving for a whole balanced nutrition.

“The growth of our intellectual property portfolio in the Canadian market is timely as we get set to expand our North American presence,” stated Hamutal Yitzhak, CEO and Co-Founder of Else Nutrition. “Our Plant-Based formulation has functional and meaningful applications to a wide range of potential consumer markets. While we remain laser-focused on the launch of our baby products, our IP can also help serve the rapidly growing $3 billion plant-based food market in Canada, giving consumers, nutritious Clean Label, whole food-based offerings,” she added.”

Else Nutrition already holds a global patent for its novel, whole food, plant-based formulation, with plans to extend into other geographies and market segments.

About Else Nutrition Holdings Inc.

Else Nutrition GH Ltd. is an Israel-based food and nutrition company focused on developing innovative, clean and plant-based food and nutrition products for infants, toddlers, children, and adults. Its revolutionary, plant-based, non-soy, formula is a clean-ingredient alternative to dairy-based formula. Else Nutrition (formerly INDI) won the “2017 Best Health and Diet Solutions” award at the Global Food Innovation Summit in Milan. The holding company, Else Nutrition Holdings Inc., is a publicly traded company, listed as TSX Venture Exchange under the trading symbol BABY and is quoted on the US OTC Markets QX board under the trading symbol BABYF and on the Frankfurt Exchange under the symbol 0YL. Else’s Executives includes leaders hailing from leading infant nutrition companies. Many of Else advisory board  members had past executive roles in companies such as Mead Johnson, Abbott Nutrition, Plum Organics and leading infant nutrition Societies,  and some of them currently serve in different roles in leading medical centers and academic institutes such as Boston Children’s Hospital, Pediatrics at Harvard Medical School, USA, Tel Aviv University, Schneider Children’s Medical Center of Israel, Rambam Medical Center and Technion, Israel and University Hospital Brussels, Belgium.

For more information, visit: elsenutrition.com or @elsenutrition on Facebook and Instagram.


TSX Venture Exchange

Neither the TSX Venture Exchange nor its regulation services provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.


Caution Regarding Forward-Looking Statements

This press release contains statements that may constitute “forward-looking statements” within the meaning of applicable securities legislation. Forward-looking statements are typically identified by words such as “will” or similar expressions. Forward-looking statements in this press release include statements with respect to the anticipated dates for filing the Company’s financial disclosure documents.  Such forward-looking statements reflect current estimates, beliefs and assumptions, which are based on management’s perception of current conditions and expected future developments, as well as other factors management believes are appropriate in the circumstances. No assurance can be given that the foregoing will prove to be correct. Forward-looking statements made in this press release assume, among others, the expectation that there will be no interruptions or supply chain failures as a result of COVID 19 and that the manufacturing, broker and supply logistic agreement with the Company do not terminate.  Actual results may differ from the estimates, beliefs and assumptions expressed or implied in the forward-looking statements.  Readers are cautioned not to place undue reliance on any forward-looking statements, which reflect management’s expectations only as of the date of this press release. The Company disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

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SOURCE Else Nutrition Holdings Inc.

Evolent Health Names Kim Keck To Board of Directors

Announces Cheryl Scott to Serve as Lead Independent Director

PR Newswire

WASHINGTON, Jan. 13, 2021 /PRNewswire/ — Evolent Health, Inc. (NYSE: EVH), a health care company that delivers proven clinical and administrative solutions to payers and providers, today announced that Kim A. Keck has been appointed to its Board of Directors, effective immediately and will stand for election at the Company’s 2021 annual meeting of stockholders. Ms. Keck has more than 30 years’ experience in the health care industry and currently serves as President and Chief Executive Officer of the Blue Cross Blue Shield Association (BCBSA), a national federation of 36 independent, community-based and locally operated Blue Cross and Blue Shield companies that provide health care coverage for one in three Americans. Ms. Keck will fill the seat vacated by Bruce Felt, who has decided to retire from the Board effective January 11, 2021. As part of the Board’s succession plan, independent director Cheryl Scott will serve as Lead Independent Director following Mr. Felt’s retirement.

“Kim is a highly respected leader in the health care industry and we are very pleased to welcome such a seasoned executive to our Board,” said Evolent Health Executive Chairman and Co-Founder Frank Williams. “Our company is at an important inflection point, and we look forward to Kim’s valuable perspectives and insights as we execute on our next phase of profitable growth. We also welcome Cheryl Scott into the role of Lead Independent Director.  Her independent counsel and deep industry expertise, as well as the active role she takes in engaging with all our shareholders, is key to the continued evolution of Evolent. Finally, I would like to thank Bruce Felt for his service. Bruce has been an outstanding board member and we appreciate his many significant contributions in helping guide Evolent to the strong position we are in today.”

“I am excited to join Evolent’s Board to help the Company achieve its mission of transforming the way care is delivered and experienced,” said Ms. Keck. “Evolent has a reputation as a valuable partner for payers and providers, which gives me confidence that it will be able to deliver on the opportunities still ahead. I look forward to working with its industry-leading team and my fellow independent directors to drive further growth in core services that address critical problems in health care.”

“Kim’s deep knowledge and track record within the health insurance payer community will be instrumental as we expand our core offerings in that market,” said Evolent’s Chief Executive Officer and Co-Founder Seth Blackley. “We look forward to her contributions as we continue to execute our strategy to maximize shareholder value by growing our leading clinical and administrative solutions.”

Prior to becoming President and CEO of BCBSA in January 2021, Ms. Keck served as President and Chief Executive Officer of Blue Cross Blue Shield of Rhode Island since 2016.  During her leadership at BCBSRI, she advanced a vision to lead a state of health and well-being across Rhode Island, putting the Plan’s 450,000 members at the center of BCBSRI’s strategic initiatives around cost and value stewardship, convenience, and comprehensive health. Previously, Ms. Keck held several leadership roles at Aetna from 2001 to 2016, including Senior Vice President from 2010 to 2016.  Ms. Keck serves on the Board of Directors of Oak Street Health and the Blue Cross Blue Shield Association. She received a B.A. in Mathematics from Boston College and an MBA in Finance from the University of Connecticut, and is a Chartered Financial Analyst.

About Evolent Health 
Evolent Health (NYSE: EVH) delivers proven clinical and administrative solutions that improve whole-person health while making health care simpler and more affordable. Our solutions encompass total cost of care management, specialty care management, and administrative simplification. Evolent serves a national base of leading payers and providers, is the first company to receive the National Committee for Quality Assurance’s Population Health Program Accreditation, and is consistently recognized as a top place to work in health care nationally. Learn more about how Evolent is changing the way health care is delivered by visiting evolenthealth.com.

Contacts:

Chelsea Griffin

Investor Relations
919.817.8045
[email protected]  

Dan Paladino

Media Relations
571.306.3470
[email protected]

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SOURCE Evolent Health

ESSA Pharma Announces Clinical Collaboration with Janssen to Evaluate EPI-7386 Combination for Patients with Metastatic Castration-Resistant Prostate Cancer

PR Newswire

HOUSTON and VANCOUVER, BC, Jan. 13, 2021 /PRNewswire/ – ESSA Pharma Inc. (Nasdaq: EPIX) (“ESSA” or the “Company”), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today announced that the Company has entered into a clinical collaboration and supply agreement with Janssen Research & Development, LLC (Janssen) to evaluate ESSA’s first-in-class N-terminal domain androgen receptor inhibitor, EPI-7386, in combination with apalutamide as well as the combination of EPI-7386 with abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer (“mCRPC”).

Under the terms of the agreement, Janssen may sponsor and conduct up to two Phase 1/2 studies evaluating the safety, tolerability and preliminary efficacy of the combination of EPI-7386 and apalutamide as well as the combination of EPI-7386 with abiraterone acetate plus prednisone in patients with mCRPC who have failed a current second-generation antiandrogen therapy. Janssen will assume all costs associated with the studies, other than the manufacturing costs associated with the clinical drug supply of EPI-7386. The parties will form a joint oversight committee for the clinical studies, which are planned to start in 2021. ESSA will retain all rights to EPI-7386.

“We are delighted to collaborate with Janssen to explore the potential clinical role of EPI-7386 in combination with the antiandrogens apalutamide and abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer,” said Dr. David. R. Parkinson, Chief Executive Officer, ESSA Pharma Inc. “EPI-7386 binds to the androgen receptor targeting the opposite end of the androgen receptor from current therapies. In preclinical models, we have seen that combining EPI-7386 with current antiandrogens can lead to deeper and broader inhibition of androgen biology. We look forward to investigating these combination therapies and their potential to improve the treatment of prostate cancer.”

About EPI-7386
EPI-7386 is an investigational, highly-selective, oral, small molecule inhibitor of the N-terminal domain of the androgen receptor. EPI-7386 is currently being studied in a Phase 1 clinical trial (NCT04421222) in men with metastatic castration-resistant prostate cancer (“mCRPC”) whose tumors have progressed on current standard-of-care therapies. The Phase I clinical trial of EPI-7386 began in Q3 of 2020 following FDA allowance of the IND and Health Canada acceptance. The U.S. FDA has granted Fast Track designation to EPI-7386 for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment. ESSA retains all rights to EPI-7386 worldwide.

About ESSA Pharma Inc.
ESSA is a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of patients with prostate cancer. For more information, please visit www.essapharma.com and follow us on Twitter under @ESSAPharma.

About Prostate Cancer
Prostate cancer is the second-most commonly diagnosed cancer among men and the fifth most common cause of male cancer death worldwide (Globocan, 2018). Adenocarcinoma of the prostate is dependent on androgen for tumor progression and depleting or blocking androgen action has been a mainstay of hormonal treatment for over six decades. Although tumors are often initially sensitive to medical or surgical therapies that decrease levels of testosterone, disease progression despite castrate levels of testosterone can lead to metastatic castration-resistant prostate cancer (“mCRPC”). The treatment of mCRPC patients has evolved rapidly over the past ten years. Despite these advances, many patients with mCRPC fail or develop resistance to existing treatments, leading to continued disease progression and limited survival rates.

Forward-Looking Statement Disclaimer
               
This release contains certain information which, as presented, constitutes “forward-looking information” within the meaning of the Private Securities Litigation Reform Act of 1995 and/or applicable Canadian securities laws. Forward-looking information involves statements that relate to future events and often addresses expected future business and financial performance, containing words such as “anticipate”, “believe”, “plan”, “estimate”, “expect”, and “intend”, statements that an action or event “may”, “might”, “could”, “should”, or “will” be taken or occur, or other similar expressions and includes, but is not limited to, statements regarding the sponsorship by Janssen of up to two Phase 1/2 studies, Janssen’s assumption of all costs associated with the studies, the formation of a joint oversight committee, the anticipated start date in 2021 of the clinical studies and  other statements surrounding the Company’s clinical evaluation of EPI-7386.

Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of ESSA to control or predict, and which may cause ESSA’s actual results, performance or achievements to be materially different from those expressed or implied thereby. Such statements reflect ESSA’s current views with respect to future events, are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by ESSA as of the date of such statements, are inherently subject to significant medical, scientific, business, economic, competitive, political and social uncertainties and contingencies. In making forward looking statements, ESSA may make various material assumptions, including but not limited to (i) the accuracy of ESSA’s financial projections; (ii) obtaining positive results of clinical trials; (iii) obtaining necessary regulatory approvals; and (iv) general business, market and economic conditions.

Forward-looking information is developed based on assumptions about such risks, uncertainties and other factors set out herein and in ESSA’s Annual Report on Form 10-K dated December 15, 2021 under the heading “Risk Factors”, a copy of which is available on ESSA’s profile on  EDGAR at www.sec.gov, and as otherwise disclosed from time to time on ESSA’s SEDAR profile www.sedar.com.Forward-looking statements are made based on management’s beliefs, estimates and opinions on the date that statements are made and ESSA undertakes no obligation to update forward-looking statements if these beliefs, estimates and opinions or other circumstances should change, except as may be required by applicable Canadian and United States securities laws. Readers are cautioned against attributing undue certainty to forward-looking statements.

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SOURCE ESSA Pharma Inc

GFL Environmental Inc. Sets Date for Full Year 2020 Earnings Release and 2021 Outlook

PR Newswire

VAUGHAN, ON, Jan. 13, 2021 /PRNewswire/ – GFL Environmental Inc. (NYSE: GFL) (TSX: GFL) (“GFL” or the “Company”) today announced that it will release its fourth quarter and full year 2020 financial results and 2021 outlook after the market closes on Monday February 22, 2021 and will host an investor conference call related to this release on Tuesday February 23, 2021 at 8:30 am Eastern Time.  

A live audio webcast of the conference call can be accessed by logging onto the Company’s Investors page at investors.gflenv.com or by clicking here or listeners may access the call toll-free by dialing 1-844-824-3839 or 1-855-669-9657 (conference ID: 10150538) approximately 15 minutes prior to the scheduled start time. 

The Company encourages participants who will be dialing in to pre-register for the conference call using the following link: https://dpregister.com/sreg/10150538/ded9ae7a5c. Callers who pre-register will be given a conference passcode and PIN to gain immediate access to the call and bypass the live operator on the day of the call. Participants may pre-register at any time, including up to and after the call start time. For those unable to listen live, an audio replay of the call will be available until March 9, 2021 by dialing 1-844-824-3839 or 1-855-669-9657 (access code 10150538).

About GFL

GFL, headquartered in Vaughan, Ontario, is the fourth largest diversified environmental services company in North America, providing a comprehensive line of non-hazardous solid waste management, infrastructure & soil remediation and liquid waste management services through its platform of facilities throughout Canada and in 27 states in the United States.  Across its organization, GFL has a workforce of more than 15,000 employees and provides its broad range of environmental services to more than 135,000 commercial and industrial customers and its solid waste collection services to more than 4 million households. 

For further information: Patrick Dovigi, Founder and Chief Executive Officer, +1 905-326-0101, [email protected]

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SOURCE GFL Environmental Inc.

RBC and Rexall Team Up to Reward Canadians for Managing their Health and Wellness

Canada NewsWire


RBC clients can now receive additional value and savings through Rexall’s Be Well™ loyalty program

TORONTO, Jan. 13, 2021 /CNW/ – Today, Royal Bank of Canada (RBC) and Rexall have announced a new strategic partnership that will allow RBC clients to earn and receive even more value and savings, while accessing Rexall’s health and wellness resources. RBC clients will receive 50 Be Well™ points for every $1 spent on eligible purchases at Rexall when they link their eligible RBC credit and debit cards to their Be Well™ card. This will deliver 5x more value than non-RBC Be Well™ members or unlinked RBC clients.

“We’re thrilled to add Rexall to our highly successful loyalty partner program,” said Sean Amato-Gauci, Executive Vice-President, Cards, Payments & Banking, RBC. “Through our proprietary RBC Rewards loyalty program and strategic loyalty partnerships, our clients receive additional ways to instantly save and earn more RBC Rewards points. We’re proud to be partnering with Rexall, a company that shares our common values of supporting the health and wellness of our employees and clients.”

Starting today, RBC clients can visit www.rbc.com/rexall to learn more about this new program and receive instructions on how to link their eligible RBC credit and debit cards to their Be Well™ account and become a Be Well™ member.

Once linked, every time RBC clients shop at any Rexall location in Canada, scan their Be Well™ card or Be Well™ app and pay using a linked RBC card, they will receive 50 Be Well™ points for every $1 spent on eligible purchases. Plus, linked RBC clients will have exclusive access to offers and promotions created just for them.

Rexall’s Be Well™ loyalty program, which launched this past September, already has over 1.8 million members and provides access to tools and insights into managing and improving health and wellness, while also delivering value and savings. For more information about Be Well™, visit www.letsbewell.ca.

“This new offering enhances our mission of making the journey to better health and wellness easier, simpler, and more rewarding,” said Nicolas Caprio, President, Rexall. “We’re looking forward to growing our partnership with RBC to give additional tools and benefits to Canadians searching for a path to better health.”

This is just the beginning of a long-term strategic partnership between the two Canadian brands. Both RBC and Rexall will continue to work together to identify additional benefits for Canadians.

Rexall joins Petro-Canada, a Suncor business, in RBC’s growing portfolio of loyalty program partners, an innovative approach to delivering value and savings for clients. Since launching in 2017, the Petro-Canada strategic partnership has enabled clients to instantly receive 3¢ per litre on gas every time they pay with their linked RBC card as well as earn 20 per cent more Petro-Points and, if applicable, 20 per cent more RBC Rewards points. The program has already helped clients realize over $60 million in fuel savings and this number continues to grow. To learn more, visit www.rbcroyalbank.com/petro-canada.

Please visit www.rbc.com/rexall for more information about this latest program and to link your RBC and Rexall cards today.

About RBC
Royal Bank of Canada is a global financial institution with a purpose-driven, principles-led approach to delivering leading performance. Our success comes from the 86,000+ employees who leverage their imaginations and insights to bring our vision, values and strategy to life so we can help our clients thrive and communities prosper. As Canada’s biggest bank, and one of the largest in the world based on market capitalization, we have a diversified business model with a focus on innovation and providing exceptional experiences to our 17 million clients in Canada, the U.S. and 34 other countries. Learn more at rbc.com.‎

We are proud to support a broad range of community initiatives through donations, community investments and employee volunteer activities. See how at rbc.com/community-social-impact.

About Rexall Drugstores
With a heritage dating back over a century, Rexall is a leading drugstore operator with a dynamic history of innovation and growth, dedicated to caring for Canadians’ health…one person at a time. Operating over 400 pharmacies across Canada, Rexall’s 8,500 employees provide exceptional patient care and customer service. Rexall is part of the Rexall Pharmacy Group Ltd. and a proud member of the global McKesson Corporation family. For more information, visit rexall.ca. Follow us on Twitter: @RexallDrugstore, on Instagram at @RexallDrugstoreOfficial and on Facebook at @RexallDrugstore.

SOURCE RBC Royal Bank

HiberCell and Biodesix Initiate Broad Collaboration for Companion Diagnostic Discovery, Development and Commercialization

Initial program to focus on development of a companion diagnostic for HiberCell’s novel immunotherapy, Imprime PGG, to aid in patient selection across multiple oncology programs

PR Newswire

NEW YORK and BOULDER, Colo., Jan. 13, 2021 /PRNewswire/ — HiberCell, a biotechnology company developing novel therapeutics for cancer relapse and metastasis, today announced an agreement with Biodesix, Inc. (Nasdaq: BDSX) to further the development of an enzyme-linked immunosorbent assay (ELISA) as a companion diagnostic in future registrational trials in breast cancer for Imprime PGG programs. Terms of the partnership were not disclosed.

Biodesix leverages multiple technologies with its proprietary artificial intelligence platform to discover, develop and commercialize diagnostic solutions for unmet clinical needs. Through this agreement, Biodesix will continue its leadership in clinical proteomics by developing a companion diagnostic to select patients for enrollment in HiberCell’s future registrational clinical trials. The ELISA test, which will be validated in Biodesix’s NYS CLEP-approved and CLIA-accredited lab, will be designed to test for Anti-β Glucan IgG Antibody (IgG ABA) expression in breast and melanoma serum samples to assess cancer patients’ eligibility for Imprime PGG therapy. 

“We are pleased to partner with Biodesix to further enable our patient stratification capabilities for our lead clinical asset, Imprime PGG,” said Alan C. Rigby, Ph.D., co-founder and chief executive officer of HiberCell. “We look forward to a robust collaborative effort with the Biodesix team that is initially focused on rapidly identifying patients for our Imprime PGG clinical trials, while supportive of our efforts to bring a potentially transformative portfolio of therapies to patients living with hard-to-treat recurrent metastatic disease.”

“Biodesix is excited to collaborate with HiberCell across their promising portfolio,” said Scott Hutton, president and chief executive officer of Biodesix. “Our leadership in clinical proteomics along with our comprehensive approach to diagnostic discovery, development and commercialization will help streamline and accelerate HiberCell’s ability to bring critical therapies to patients.  Working together on a companion diagnostic for the Imprime PGG program is only touching the surface of what we can do together. This approach to identifying patients for this drug is very novel and holds tremendous promise.”

About HiberCell
HiberCell is dedicated to developing therapeutic molecules that overcome foundational scientific barriers that prevent patients from living longer, cancer-free lives. The company recognizes cancer as a chronic disease and is working to develop therapies that address the most common cause of cancer mortality: relapse and metastasis. To that end, HiberCell is actively developing therapies with a focus on modulating stress mediated adaptive biology and reprogramming the immunosuppressive tumor microenvironment given their critical role in cancer recurrence and metastatic disease.

HiberCell is headquartered in New York City with a site in Roseville, Minnesota. For more information, please visit https://www.hibercell.com and follow on LinkedIn.

About Imprime PGG
Imprime PGG is a novel innate immune activator that binds and agonizes dectin-1. This functions to activate innate and adaptive immunity, reprogramming the immunosuppressive tumor microenvironment to enhance antigen presentation, T cell activation and ultimately enhance the immune response against tumors. Phase II clinical studies of Imprime PGG in combination with checkpoint inhibitors provided mechanistic proof-of-concept data including the activation of innate and adaptive immunity resulting in improved overall survival, overall response and disease control rates in metastatic triple negative breast cancer (mTNBC). HiberCell is continuing studies of Imprime PGG in metastatic breast cancer post HR failure while exploring additional cancer indications that include treatment-naïve, resectable, stage III melanoma.

About Biodesix
Biodesix is a leading diagnostic company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix is the first company to offer six non-invasive tests for patients with diseases of the lung. Biodesix launched the SARS-CoV-2 ddPCR™ test and the Platelia SARS-CoV-2 Total Ab in response to the global pandemic and virus that impacts the lung and causes COVID-19. The blood-based Biodesix Lung Reflex® strategy for lung cancer patients integrates the GeneStrat® and VeriStrat® tests to support treatment decisions with results in 72 hours, expediting time to treatment. The blood-based Nodify Lung™ nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT™ tests, evaluates the risk of malignancy in incidental pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. Biodesix also collaborates with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. For more information about Biodesix, visit biodesix.com.

HiberCell Media Contact

Danielle Cantey

Glover Park Group
[email protected]
(202) 295-0155

Biodesix Media Contact

Jordona Jackson Smith

[email protected] 
(805) 674-7347

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SOURCE HiberCell