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Intact Financial Corporation Announces Agreement with Cornerstone Investors to Finance a Portion of the Purchase Price of the Possible Offer for RSA Insurance Group PLC (“RSA”)

Canada NewsWire

TORONTO, Nov. 12, 2020 /CNW/ – Further to the announcement on November 5, 2020 relating to the possible offer for RSA by Intact Financial Corporation (TSX: IFC) (“Intact” or the “Company”) and Tryg A/S (“Tryg”) (together the “Consortium”), Intact announced today that it has entered into subscription agreements with subsidiaries of each of Caisse de dépôt et placement du Québec (“CDPQ”), Canada Pension Plan Investment Board (“CPP Investments”) and Ontario Teachers’ Pension Plan Board (“Ontario Teachers'”) for the aggregate issuance of 23.8 million subscription receipts at a price of $134.50 per subscription receipt for gross proceeds of $3.2 billion. CDPQ, CPP Investments, and Ontario Teachers’ are committing $1.5 billion, $1.2 billion, and $0.5 billion, respectively. Completion of the offering is conditional upon the Consortium announcing a firm offer for RSA. Additional information on the proposed transaction is available at Intact’s website at https://www.intactfc.com/English/investors/.

Each subscription receipt will entitle the holder to receive one common share of Intact as well as a commitment fee upon closing of the acquisition of RSA. The completion of the offering is subject to approval of the Toronto Stock Exchange and other customary closing conditions.

The subscription receipts and the common shares of Intact have not been, and will not be, registered under the U.S. Securities Act, or the securities laws of any state of the United States and may not be offered, sold or delivered, directly or indirectly, within the United States, except in certain transactions exempt from, or not subject to, the registration requirements of the U.S. Securities Act and applicable state securities laws. This press release does not constitute an offer to sell or a solicitation of an offer to buy any of these subscription receipts within the United States.

About Intact

Intact Financial Corporation is the largest provider of property and casualty (P&C) insurance in Canada and a leading provider of specialty insurance in North America, with over $11 billion in total annual premiums. The Company has approximately 16,000 employees who serve more than five million personal, business and public sector clients through offices in Canada and the U.S.

In Canada, Intact distributes insurance under the Intact Insurance brand through a wide network of brokers, including its wholly-owned subsidiary BrokerLink, and directly to consumers through belairdirect. Frank Cowan Company, a leading MGA, distributes public entity insurance programs including risk and claims management services in Canada.

In the U.S., Intact Insurance Specialty Solutions provides a range of specialty insurance products and services through independent agencies, regional and national brokers, wholesalers and managing general agencies. Products are underwritten by the insurance company subsidiaries of Intact Insurance Group USA, LLC.

About Caisse
de dépôt et placement du Québec

Caisse de dépôt et placement du Québec (CDPQ) is a long-term institutional investor that manages funds primarily for public and para-public pension and insurance plans. As at June 30, 2020, it held CA$333.0 billion in net assets. As one of Canada’s leading institutional fund managers, CDPQ invests globally in major financial markets, private equity, infrastructure, real estate and private debt. For more information, visit www.cdpq.com, follow us on Twitter @LaCDPQ or consult our Facebook or LinkedIn pages.

About Canada Pension Plan Investment Board

Canada Pension Plan Investment Board (CPP Investments™) is a professional investment management organization that invests around the world in the best interests of the more than 20 million contributors and beneficiaries of the Canada Pension Plan. In order to build diversified portfolios of assets, investments in public equities, private equities, real estate, infrastructure and fixed income are made by CPP Investments. Headquartered in Toronto, with offices in Hong Kong, London, Luxembourg, Mumbai, New York City, San Francisco, São Paulo and Sydney, CPP Investments is governed and managed independently of the Canada Pension Plan and at arm’s length from governments. At June 30, 2020, the Fund totalled C$434.4 billion. For more information, please visit www.cppinvestments.com or follow us on LinkedIn, Facebook or Twitter.

About Ontario Teachers’ Pension Plan

The Ontario Teachers’ Pension Plan Board (Ontario Teachers’) is the administrator of Canada’s largest single-profession pension plan, with $204.7 billion in net assets (all figures at June 30, 2020 unless noted). It holds a diverse global portfolio of assets, approximately 80% of which is managed in-house, and has earned an annual total-fund net return of 9.5% since the plan’s founding in 1990. Ontario Teachers’ is an independent organization headquartered in Toronto. Its Asia-Pacific regional offices are in Hong Kong and Singapore, and its Europe, Middle East & Africa region office is in London. The defined-benefit plan, which is fully funded as at January 1, 2020, invests and administers the pensions of the province of Ontario’s 329,000 active and retired teachers. For more information, visit otpp.com and follow us on Twitter @OtppInfo.

Forward-looking statements

Certain of the statements included in this press release about the proposed cornerstone private placement, the proposed acquisition of RSA (the “Acquisition”) or any other future events or developments constitute forward-looking statements. The words “may”, “will”, “would”, “should”, “could”, “expects”, “plans”, “intends”, “trends”, “indications”, “anticipates”, “believes”, “estimates”, “predicts”, “likely”, “potential” or the negative or other variations of these words or other similar or comparable words or phrases, are intended to identify forward-looking statements. Unless otherwise indicated, all forward-looking statements in this press release are made as of November 12, 2020, and are subject to change after that date.

Forward-looking statements are based on estimates and assumptions made by management based on management’s experience and perception of historical trends, current conditions and expected future developments, as well as other factors that management believes are appropriate in the circumstances. In addition to other estimates and assumptions which may be identified herein, estimates and assumptions have been made regarding, among other things, the receipt of all requisite approvals in a timely manner and on terms acceptable to the Company, the realization of the expected strategic, financial and other benefits of the Acquisition, and economic and political environments and industry conditions. However, the completion of the Acquisition is expected to be subject to customary closing conditions, termination rights and other risks and uncertainties, including, without limitation, regulatory approvals, and there can be no assurance that the Acquisition will be completed. There can also be no assurance that if the Acquisition is completed, the strategic and financial benefits expected to result from the Acquisition will be realized. Many factors could cause the Company’s actual results, financial performance or condition, or achievements to differ materially from those expressed or implied by the forward-looking statements herein, including, without limitation, the following factors:

  • expected regulatory processes and outcomes in connection with the Company’s business;
  • the Company’s ability to implement its strategy or operate its business as management currently expects;
  • the Company’s ability to accurately assess the risks associated with the insurance policies it writes;
  • unfavourable capital market developments or other factors, including the impact of the COVID-19 pandemic and related economic conditions, which may affect the Company’s investments, floating rate securities and funding obligations under its pension plans;
  • the cyclical nature of the P&C insurance industry;
  • management’s ability to accurately predict future claims frequency and severity, including in the high net worth and personal auto lines of business;
  • government regulations designed to protect policyholders and creditors rather than investors;
  • litigation and regulatory actions, including with respect to the COVID-19 pandemic;
  • periodic negative publicity regarding the insurance industry;
  • intense competition;
  • the Company’s reliance on brokers and third parties to sell its products to clients and provide services to the Company and the impact of COVID-19 and related economic conditions on such brokers and third parties;
  • the Company’s ability to successfully pursue its acquisition strategy;
  • the Company’s ability to execute its business strategy;
  • the uncertainty of obtaining in a timely manner, or at all, the regulatory approvals required to complete the Acquisition, the issuance of the subscription receipts and the issuance of the common shares issuable pursuant to the subscription agreements;
  • unfavourable capital markets developments or other factors that may adversely affect the Company’s ability to finance the Acquisition;
  • the Company’s ability to improve its combined ratio, retain business and achieve synergies and maintain market position arising from successful integration plans relating to the Acquisition, as well as management’s estimates and expectations in relation to future economic and business conditions and other factors in relation to the Acquisition and resulting impact on growth and accretion in various financial metrics;
  • its ability to otherwise complete the integration of the business acquired within anticipated time periods and at expected cost levels; 
  • the Company’s dependence on key employees and its ability to attract and retain key employees in connection with the Acquisition;
  • the Company’s ability to achieve synergies arising from successful integration plans relating to acquisitions generally;
  • the Company’s profitability and ability to improve its combined ratio in the United States;
  • the Company’s ability to retain and attract new business in connection with the Acquisition;
  • the Company’s participation in the Facility Association (a mandatory pooling arrangement among all industry participants) and similar mandated risk-sharing pools;
  • terrorist attacks and ensuing events;
  • the occurrence and frequency of catastrophe events, including a major earthquake;
  • catastrophe losses caused by severe weather and other weather-related losses, as well as the impact of climate change;
  • the occurrence of and response to public health crises including epidemics, pandemics or outbreaks of new infectious diseases, including most recently, the coronavirus (COVID-19) pandemic and ensuing events;
  • the Company’s ability to maintain its financial strength and issuer credit ratings;
  • the Company’s access to debt and equity financing;
  • the Company’s ability to compete for large commercial business;
  • the Company’s ability to alleviate risk through reinsurance;
  • the Company’s ability to successfully manage credit risk (including credit risk related to the financial health of reinsurers);
  • the Company’s ability to contain fraud and/or abuse;
  • the Company’s reliance on information technology and telecommunications systems and potential failure of or disruption to those systems, including in the context of the impact on the ability of our workforce to perform necessary business functions remotely, as well as in the context of evolving cybersecurity risk;
  • the impact of developments in technology and use of data on the Company’s products and distribution;
  • changes in laws or regulations, including those adopted in response to COVID-19 that would, for example, require insurers to cover business interruption claims irrespective of terms after policies have been issued, and could result in an unexpected increase in the number of claims and have a material adverse impact on the Company’s results;
  • COVID-19 related coverage issues and claims, including certain class actions and related defence costs could negatively impact our claims reserves;
  • general economic, financial and political conditions;
  • the Company’s dependence on the results of operations of its subsidiaries and the ability of the Company’s subsidiaries to pay dividends;
  • the volatility of the stock market and other factors affecting the trading prices of the Company’s securities, including in the context of the COVID-19 crisis;
  • the Company’s ability to hedge exposures to fluctuations in foreign exchange rates;
  • future sales of a substantial number of the Company’s common shares; and
  • changes in applicable tax laws, tax treaties or tax regulations or the interpretation or enforcement thereof.

All of the forward-looking statements included in this press release are qualified by these cautionary statements and those made in the section entitled Risk Management (Sections 22-27) of our MD&A for the year ended December 31, 2019, the section entitled Risk Management (sections 17-18) of our MD&A for the quarter ended September 30, 2020 and elsewhere in this press release. These factors are not intended to represent a complete list of the factors that could affect the Company. These factors should, however, be considered carefully. Although the forward-looking statements are based upon what management believes to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with these forward-looking statements. Investors should not rely on forward-looking statements to make decisions, and investors should ensure the preceding information is carefully considered when reviewing forward-looking statements contained herein. The Company and management have no intention and undertake no 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.

Disclaimer

This press release does not constitute or form part of any offer for sale or solicitation of any offer to buy or subscribe for any securities nor shall it or any part of it form the basis of or be relied on in connection with, or act as any inducement to enter into, any contract or commitment whatsoever.

The information contained in this press release concerning the Company does not purport to be all-inclusive or to contain all the information that an investor may desire to have in evaluating whether or not to make an investment in the Company. The information is qualified entirely by reference to the Company’s publicly disclosed information and the cautionary note regarding forward-looking statements included in this press release.

No representation or warranty, express or implied, is made or given by or on behalf of the Company or any of its the directors, officers or employees as to the accuracy, completeness or fairness of the information or opinions contained in this press release and no responsibility or liability is accepted by any person for such information or opinions. In furnishing this press release, the Company does not undertake or agree to any obligation to provide investors with access to any additional information or to update this press release or to correct any inaccuracies in, or omissions from, this press release that may become apparent. The information and opinions contained in this press release are provided as at the date of this press release. The contents of this press release are not to be construed as legal, financial or tax advice. Each investor should contact his, her or its own legal adviser, independent financial adviser or tax adviser for legal, financial or tax advice.

SOURCE Intact Financial Corporation

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LHC Group continues national expansion of hospice service with initial entry into Oklahoma

PR Newswire

LAFAYETTE, La., Nov. 12, 2020 /PRNewswire/ — LHC Group, Inc. (NASDAQ: LHCG) announced today that it has agreed to purchase Grace Hospice of Oklahoma, located in Tulsa, Okla.

This acquisition is the latest addition to LHC Group’s existing hospice footprint of more than 110 locations nationwide.

The agreement is expected to close on December 1, subject to customary closing conditions. LHC Group expects annualized revenue from this purchase of approximately $12.1 million and that it will not materially affect its 2020 diluted earnings per share. The provider will continue to operate under the Grace Hospice name.

“This is an outstanding opportunity to continue expanding our hospice service line as we make our initial entry into the state of Oklahoma,” said Keith Myers, LHC Group chairman and CEO. “Grace Hospice has achieved a remarkable reputation for service in their community, and we look forward to building on a trusted name and a record of providing high-quality hospice care to patients and families in Tulsa and across the region.”

This acquisition is the latest addition to LHC Group’s existing hospice footprint of more than 110 locations around the nation. The company plans to eventually establish home health services in the Tulsa market – in alignment with its ongoing growth strategy of co-locating other in-home healthcare services in communities and markets where there is a need and established, sensible benchmarks are met.

In-home, end-of-life hospice care helps patients live comfortably, with dignity, when a cure is no longer possible. Hospice professionals provide the emotional, spiritual, and medical support needed when patients are facing the final stages of life. Hospice care can be provided in any place a patient calls home, including nursing homes and assisted living facilities.

LHC Group is a leading national provider of in-home healthcare and hospice services and the joint venture partner of choice for almost 400 leading hospitals across the United States.


About LHC Group, Inc.

LHC Group, Inc. is a national provider of in-home healthcare services and innovations for communities around the nation, offering quality, value-based healthcare to patients primarily within the comfort and privacy of their home or place of residence. The company’s 32,000 employees deliver home health, hospice, home and community based services, and facility-based care in 35 states and the District of Columbia – reaching 60 percent of the U.S. population aged 65 and older. As the preferred joint venture partner for almost 400 leading U.S. hospitals and health systems, LHC Group works in cooperation with providers to customize each partnership and reach more patients and families with an effective and efficient model of care.


Forward-looking Statements

Certain statements and information in this press release may be deemed to contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may include, but are not limited to, statements relating to our objectives, plans and strategies, and all statements, other than statements of historical facts, that address activities, events or developments that we intend, expect, project, believe or anticipate will or may occur in the future. These statements are often characterized by terminology such as “believe”, “hope”, “may”, “anticipate”, “should”, “intend”, “plan”, “will”, “expect”, “estimate”, “project”, “positioned”, “strategy” and similar expressions, and are based on assumptions and assessments made by LHC Group’s management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. Any forward-looking statements in this press release are made as of the date hereof, and LHC Group undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in LHC Group’s most recent Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, including the sections entitled “Risk Factors”, as well LHC Group’s current reports on Form 8-K, filed with the Securities and Exchange Commission.


Contacts:

Investor Relations

Media Relations

Eric Elliott

Mark Willis

(337) 233-1307

(337) 769-0673


[email protected]


[email protected]

 

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SOURCE LHC Group, Inc.

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Valeo Pharma announces Amikacin approval in CANADA and U.S. launch of Ethacrynate Sodium

PR Newswire

  • Amikacin receives Health Canada approval, commercialization to start in first half of 2021
  • Strong start for Ethacrynate Sodium commercialization in the U.S.
  • Heightened commercial and scientific interest in Hesperco™ preceeds retail launch
  • Strong fourth quarter sales growth favourably impacted by recent launches of Yondelis and Ametop

MONTREAL, Nov. 12, 2020 /PRNewswire/ –  Valeo Pharma Inc. (CSE:VPH) (OTCQB: VPHIF) (FRANKFURT: VP2), a Canadian pharmaceutical company,  announced today that it has recently received a Notice of Compliance from Health Canada granting market authorization for Amikacin, an antibiotic used within the hospital setting. Valeo also announced that shipments of  Ethacrynate Sodium have commenced in the U.S. market.  

“The approval of Amikacin adds to our portfolio of hospital specialty products, an important and growing part of our revenue stream”, said Steve Saviuk, President and CEO. “We are also pleased with the commercial uptake of Ethacrynate Sodium, our first product launched in the U.S. market.”

“Valeo experienced strong revenue growth in the fourth quarter (ended October 31st) which was aided by the recent launches of Yondelis and Ametop, they combined to contribute 20% of the quarter’s revenues,”added Saviuk. “We look for revenue growth to accelerate in the coming quarters through both organic growth and additional product launches”.

“We have also been receiving heightened commercial and scientific interest in Hesperco™, a flavonoid capsule formula that supports the body’s immune system”, continued Saviuk. “Hesperco™ is available online through our www.Hesperco.com website and will soon be available through retailers and Amazon in Canada. We are proceeding with registration of Hesperco™ in the U.S. and we are actively planning our U.S. logistics and marketing launch.”

Grant of options

The Company also announces that it has granted a total of 260,000 share options under its Share Option Plan to one consultant and one employee of the Company. Additional information concerning these grants can be found in the Form 11 – Notice of Proposed Stock Options posted on the CSE website, under the Company’s profile.

About Valeo Pharma

Valeo Pharma is a Canadian pharmaceutical company dedicated to the in-licensing and commercialization of innovative pharmaceutical products in Canada with a focus on Neurodegenerative Diseases, Oncology and Hospital Specialty Products. Headquartered in Kirkland, Quebec Valeo Pharma has all the required capabilities and the full infrastructure to register and properly manage its growing product portfolio through all stages of commercialization. For more information, please visit www.valeopharma.comand follow us on LinkedIn and Twitter.

Forward Looking Statements

This press release contains forward-looking statements about Valeo’s objectives, strategies and businesses that involve risks and uncertainties. These statements are “forward-looking” because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

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SOURCE Valeo Pharma Inc.

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Sierra Oncology to Present at 2020 Jefferies Virtual London Healthcare Conference

PR Newswire

VANCOUVER, BC, Nov. 12, 2020 /PRNewswire/ – Sierra Oncology, Inc. (SRRA), a late-stage biopharmaceutical company focused on the Phase 3 execution, registration and potential commercialization of momelotinib, a novel drug that may address serious unmet needs in myelofibrosis, today announced that President and Chief Executive Officer Stephen Dilly, MBBS, PhD, will present an overview of the company at the Jefferies Virtual London Healthcare Conference taking place November 17-19, 2020.

The presentation is scheduled for 7:20 pm GMT on Wednesday, November 18. A replay of the presentation will be available following the conference on the Investors section of Sierra’s corporate website in the Events & Webcast tab.

About Sierra Oncology

Sierra Oncology is a late stage biopharmaceutical company focused on the Phase 3 execution, registration and potential commercialization of momelotinib, a novel drug that may address serious unmet needs in myelofibrosis. Momelotinib is a selective and orally bioavailable JAK1, JAK2 & ACVR1 inhibitor with a differentiated mechanism of action that enables it to potentially address all three key drivers of myelofibrosis: anemia of inflammation, constitutional symptoms and enlarged spleen. More than 1,200 subjects have received momelotinib since clinical studies began in 2009, including more than 800 patients treated for myelofibrosis. Several of these patients remain on treatment for more than 10 years.

Sierra is enrolling symptomatic and anemic patients, who have been treated previously with a JAK inhibitor in MOMENTUM, a randomized double-blind Phase 3 clinical trial. The U.S. Food and Drug Administration has granted Fast Track designation to momelotinib.

For more information, please visit www.sierraoncology.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Sierra Oncology’s expectations from current data, anticipated clinical development activities, expected timing and success of enrollment of MOMENTUM and potential benefits of momelotinib. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk that Sierra Oncology’s cash resources may be insufficient to fund its current operating plans and it may be unable to raise additional capital when needed, the risk that disruptions and impacts of COVID-19 will be significant and lengthy, Sierra Oncology may be unable to successfully develop and commercialize momelotinib, momelotinib may not demonstrate safety and efficacy or otherwise produce positive results, Sierra Oncology may experience delays in the clinical development of momelotinib, Sierra Oncology may be unable to acquire additional assets to build a pipeline of additional product candidates, Sierra Oncology’s third-party manufacturers may cause its supply of materials to become limited or interrupted or fail to be of satisfactory quantity or quality, Sierra Oncology may be unable to obtain and enforce intellectual property protection for its technologies and momelotinib and the other factors described under the heading “Risk Factors” set forth in Sierra Oncology’s filings with the Securities and Exchange Commission from time to time. Sierra Oncology undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

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SOURCE Sierra Oncology

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AC Immune to Provide Strategy and Pipeline Update During Jefferies Virtual London Healthcare Conference

To feature discussion of the Company’s world-leading therapeutic and diagnostic candidates targeting TDP-43

LAUSANNE, Switzerland, Nov. 12, 2020 (GLOBE NEWSWIRE) — AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that it will participate in a fireside chat during the upcoming Jefferies Virtual London Healthcare Conference.

The presentation will feature an overview of the Company’s business strategy and 2021 product development objectives in alignment with AC Immune’s vision for precision medicine for neurodegenerative diseases. The discussion will also feature the Company’s early- and late-stage development pipeline with a focus on its novel antibody and diagnostic candidates addressing an emerging target in neurodegenerative diseases, TAR DNA-binding protein 43 (TDP-43).

AC Immune’s CEO, Prof. Andrea Pfeifer, Ph.D., will discuss AC Immune’s focused strategy for accelerating development of its first-/best-in-class candidates in Alzheimer’s disease, as well as key neurodegenerative and non-CNS indications, in order to maximize the value of its pipeline in 2021 and beyond. The presentation will be followed by a question and answer session and will also feature progress made in the Company’s TDP-43-targeted therapeutic and diagnostic programs, which are among the most advanced in the world. TDP-43 is an emerging neuropathology that plays a key role in AD, as well as a number of NeuroOrphan indications such as amyotrophic lateral sclerosis (ALS) and frontotemporal lobar degeneration with TDP-43 pathology (FLTD-TDP). A more recently described dementia, limbic-predominant age-related TDP-43 encephalopathy (LATE), is a highly prevalent Alzheimer’s-like dementia. TDP-43 neuropathological changes underlying LATE, are present in 20–50% of individuals over 80 years old1 and AC Immune’s therapeutic antibody and diagnostic imaging agent could be the first in the world to enable a precision medicine approach to this important disease driver.

Jefferies Virtual London Healthcare Conference
Date: November 18, 2020 | 6:45–7:15 am ET / 11:45am–12:15 pm GMT
Format: Virtual Presentation followed by Q&A
Presenter: Prof. Andrea Pfeifer, CEO, AC Immune SA

A webcast of the presentation will be available on the Events Page of AC Immune’s website.

1 2019, Nelson et al. Consensus working group report

About AC Immune SA

AC Immune SA is a Nasdaq-listed clinical-stage biopharmaceutical company, which aims to become a global leader in precision medicine for neurodegenerative diseases. The Company utilizes two proprietary platforms, SupraAntigenTM and MorphomerTM, to design, discover and develop small molecule and biological therapeutics as well as diagnostic products intended to diagnose, prevent and modify neurodegenerative diseases caused by misfolding proteins. The Company’s pipeline features nine therapeutic and three diagnostic product candidates, with six currently in clinical trials. It has collaborations with major pharmaceutical companies including Genentech, a member of the Roche Group, Eli Lilly and Company and Janssen Pharmaceuticals.

For further information, please contact:

Head of Investor Relations

Joshua Drumm, Ph.D.
AC Immune
Phone: +1 917 809 0814
Email: [email protected]		 US Media

Katie Gallagher
LaVoie Health Science
Phone: +1 617 792 3937
Email: [email protected]
   
Global Head of Communications

Judith Moore
AC Immune
Phone: +41 79 826 63 82
Email: [email protected]		 European Investors & Media

Chris Maggos
LifeSci Advisors
Phone: +41 79 367 6254
Email: [email protected]

Forward looking statements

This press release contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions “Item 3. Key Information – Risk Factors” and “Item 5. Operating and Financial Review and Prospects” in AC Immune’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. These include: the impact of Covid-19 on our business, suppliers, patients and employees and any other impact of Covid-19. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.

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Been Swindled? PissedConsumer.com Tells How to Get Satisfaction

A consumer advocacy and review platform,

PissedConsumer.com

, offers consumers five steps for resolving sticky issues with companies.

NEW YORK, Nov. 12, 2020 (GLOBE NEWSWIRE) — A complaint resolution and consumer advocacy website, PissedConsumer.com, explains to consumers the common ways of how they can seek solutions with companies and improve their satisfaction. Expertise based on consumer data and latest submitted reviews which were resolved through their platform.

“Too often customers don’t get what they expect from the company,” said Joanna Simpson of PissedConsumer.com. “By outlining basic steps for getting satisfaction, we want to help consumers resolve issues. They can reach out to the company, get back their money, eliminate frustration, and avoid making the same mistake again.”

Basic steps to follow for getting satisfaction:

  1. Reach out to the company directly. Check your confirmation email and their website for a phone number. Look into your account and see what customer service can do to help you. 
  2. Look up for contacts elsewhere and see who can help you reach out to the company. Sources like PissedConsumer have elusive contact information that you can use.
  3. Post a written complaint. Platforms like PissedConsumer gather statistics and consumer-related data, which help to drive the attention of the community, the company, and media.
  4. Read what others have written and check comments. When a complaint is echoed across PissedConsumer.com, the company is likely to respond. In some cases, you’ll find replies that lead to resolved issues.
  5. Join others to be heard. The benefit of resources like PissedConsumer is it unites people with similar complaints.

As suggested by PissedConsumer.com, consumers have power in the marketplace. To use it the right way, follow these simple tips:

  • Be nice and polite with the customer service representatives no matter what. If they fail to respond, proceed with your complaint further.
  • Use sources with reviews to highlight your issue and find shoppers and consumers who, like you, have been fleeced, hoodwinked, swindled, or taken advantages of. 
  • Talk to others, take action together, and draw public concern, especially when your case involves high sums of money, hundreds of people, and potential safety concerns.

About PissedConsumer.com

PissedConsumer.com is a consumer advocacy website where people can share their stories, experiences, and opinions about companies, products and services.

For more information about PissedConsumer or explore the latest resolved consumer issues, please visit PissedConsumer.com.

Contact:

Web: https://www.pissedconsumer.com/contact.html

email: [email protected]

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Greenlane Announces Revised Q3 2020 Conference Call Timing

BOCA RATON, Fla., Nov. 12, 2020 (GLOBE NEWSWIRE) — Greenlane Holdings, Inc. (“Greenlane” or “the Company”) (Nasdaq: GNLN), one of the largest global sellers of premium cannabis accessories and specialty vaporization products, today announced that it will reschedule its conference call to discuss the results for its third quarter ended September 30, 2020 (“Q3 2020”) to the week of November 16, 2020. Greenlane has chosen to reschedule its planned call as it works to finalize tax entries related to its European operations. The Company will provide the revised quarterly conference date and pertinent call details in due course.

About Greenlane Holdings, Inc.

Greenlane (NASDAQ: GNLN) is the leading global platform for the development and distribution of premium cannabis accessories and lifestyle products. The company operates as a powerful house of brands, third-party brand accelerator, and omni-channel distribution platform. Greenlane serves the global markets with an expansive customer base of more than 11,000 retail locations, including licensed cannabis businesses, smoke shops, and specialty retailers. As a pioneer in the cannabis space, Greenlane is the partner of choice for many of the industry’s leading brands, including PAX Labs, Storz & Bickel (Canopy-owned), Cookies, Grenco Science, and DaVinci. Greenlane also proudly owns and operates a diverse brand portfolio including packaging innovator Pollen Gear™, the K.Haring Glass Collection by Higher Standards, Marley Natural™, and VIBES™ rolling papers. Higher Standards, Greenlane’s flagship brand, offers both a high-end product line and immersive retail experience with groundbreaking stores in both New York City’s Chelsea Market and Malibu, California. Greenlane also owns and operates both Vapor.com and VapoShop.com, two industry-leading, direct-to-consumer e-commerce platforms in North America and Europe, respectively. For additional information, please visit: https://gnln.com/.

Forward Looking Statements

Certain matters within this press release are discussed using forward-looking language as specified in the Private Securities Litigation Reform Act of 1995, and, as such, may involve known and unknown risks, uncertainties and other factors that may cause the actual results or performance to differ from those projected in the forward-looking statements. These forward-looking statements include, among others: comments relating to the current and future performance of the Company’s business; the impact of the ongoing COVID-19 pandemic on the Company’s business; growth in demand for the Company’s products; growth in the market for cannabis and nicotine; the Company’s marketing and commercialization efforts; and the Company’s financial outlook and expectations. For a description of factors that may cause the Company’s actual results or performance to differ from its forward-looking statements, please review the information under the heading “Risk Factors” included in the Company’s most recent Annual Report on Form 10-K for the year ended December 31, 2019 and the Company’s other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Additional information will also be set forth in Greenlane’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to Greenlane on the date hereof. Greenlane undertakes no duty to update this information unless required by law.

Media Contact

MATTIO Communications
[email protected]

Investor Contact:

Rob Kelly
Investor Relations, MATTIO Communications
[email protected]
1-416-992-4539 

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Surrozen to Present at the Stifel 2020 Virtual Healthcare Conference

SOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) — Surrozen Inc., a biotechnology company pioneering a new class of targeted regenerative antibodies, today announced that Craig Parker, president and chief executive officer of Surrozen, will be presenting at the Stifel 2020 Virtual Healthcare Conference. The presentation will begin at 10:40 a.m. Eastern on Monday November 16th, 2020. The public may access the event live via webcast at: https://wsw.com/webcast/stifel27/surr/2139584

About Wnt Signaling

Wnt signaling plays key roles in the control of development, homeostasis, and regeneration of many essential organs and tissues, including liver, intestine, lung, kidney, central nervous system, cochlea, bone, and others. Modulation of Wnt signaling pathways has potential for treatment of degenerative diseases and tissue injuries. There are 19 Wnt ligands (Wnts) in mammals, and they signal through Frizzled receptors 1-10 and co-receptors LRP5 or 6, two families of receptors. Endogenous Wnts bind to multiple Frizzled receptors and are heavily modified post-translationally, making them difficult to manufacture consistently. R-spondin stabilizes Frizzled receptors, enhancing the body’s response to endogenous Wnts. 

About Surrozen’s Proprietary Antibody Platforms and Harnessing Wnt Signaling

Since its founding in 2016, Surrozen has developed two proprietary platforms to selectively modulate the Wnt pathway for the potential treatment of injury and disease. Surrozen Wnt-mimetics, also referred to as SWAP (Surrozen Wnt signal activating proteins), are bi-specific full-length human (IgG) antibodies that directly activate the canonical Wnt signaling pathway in target tissue. Surrozen R-spondin-mimetics, also referred to as SWEETS (Surrozen Wnt signal enhancers engineered for tissue specificity), are antibody-based molecules that enhance Wnt signaling by stabilizing Frizzled receptors on targeted cells.

About Surrozen Preclinical Candidates

SZN-043 is the first development candidate designed using Surrozen’s SWEETS platform. In preclinical animal models of liver injury and fibrosis, SZN-043 has been shown to selectively activate Wnt signaling in the liver, stimulate hepatocyte proliferation, improve synthetic function, and reduce fibrosis. Surrozen will develop SZN-043 for severe liver diseases, including severe alcoholic hepatitis and decompensated cirrhosis.

SZN-1326 is the first development candidate designed using Surrozen’s SWAP platform. SZN-1326 targets the Wnt-signaling pathway in the intestinal epithelium. In preclinical animal models of acute and chronic colitis, SZN-1326 has been shown to activate Wnt signaling in the intestine, stimulate intestinal epithelial regeneration, and reduce disease activity. Surrozen will develop SZN-1326 for moderate to severe inflammatory bowel disease.

About Surrozen

Surrozen is a biotechnology company pioneering a new class of targeted regenerative antibodies to repair a broad range of tissues and organs damaged by serious disease. Surrozen is designing tissue-specific antibodies that engage the body’s own biological repair mechanisms resulting in a broad pipeline of disease-specific therapies to help patients across multiple disease areas, including severe liver diseases, inflammatory bowel disease, retinopathies, hearing loss, lung and airway diseases, and certain neurological disorders. For more information, please visit surrozen.com.

Investors/Partners/Media:

Reza Afkhami
VP, Corporate Development and Strategy
Surrozen, Inc.
[email protected]

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Corvus Gold Identifies New High-Grade Center at Mother Lode Deposit with 83.9 Metres @ 2.7 g/t Gold Including 12.7 Metres @ 8.5 g/t Gold & 30.4 g/t Silver

VANCOUVER, British Columbia, Nov. 12, 2020 (GLOBE NEWSWIRE) — Corvus Gold Inc. (“Corvus” or the “Company”) – (TSX: KOR, NASDAQ: KOR) announces it has received results from the north end of the Mother Lode deposit which has intersected a previously unknown new high-grade center of mineralization within the Main and CIZ target areas (Figure 1). This new high-grade zone extends from the Main Zone down into the CIZ target and is associated with a steeply west dipping feeder structure (Table 1). The first core hole (ML20-159CT) into this new feeder zone, intersected 83.9m @ 2.7 g/t gold and 6.8 g/t silver including 12.7m @ 8.5 g/t gold and 30.4 g/t silver (Figure 2). This new high-grade feeder is not part of the previously announced mineral resource estimate and represents a new expansion of the Mother Lode deposit.

The discovery of the new northern high-grade feeder zone appears again to be directly related to an intrusive dike and associated breccia zone, where hole ML20-159CT had a 1.96m wide dike/breccia intercept that ran 31.34 g/t gold. We are now designing follow up holes to chase this key mineralizing further at depth. Unfortunately, hole ML20-158CT was lost at the top of the Main Zone and did not test the new northern feeder zone at depth below hole ML20-159CT. A follow-up to hole ML20-158CT is currently being planned.

Hole ML20-135CT was drilled to test the West Target for the down dropped western part of the Mother Lode deposit. Hole ML20-135CT deviated during the drilling process and the West target was never intersected in the area of the main mineralizing structure and only low-grade gold was returned.

Jeffrey Pontius, President and CEO of Corvus, said, “The discovery of yet another high-grade feeder zone at Mother Lode is an important development as it is outlines what could be an additional area of gold mineralization. As we have seen in other, large Nevada gold Districts, these deeper, high-grade zones can lead to a completely new series of gold zones. When we look at the potential of the Eastern Bullfrog District with discoveries like Mother Lode, Lynnda Strip, Silicon and C-Horst, there is potential for the development of a large-scale production area. Corvus has key discoveries and a large land package in this part of the District and with its multiple deposits in the western part of the District, has emerged as a leading District developer for the future.”




Table 1:


Mother Lode


–


Mineral Resource Expansion Phase-4


Results


(Reported intercepts are not true widths as there is currently insufficient data to calculate true orientation in space. Mineralized intervals are calculated using a 0.3 g/t cut-off unless otherwise indicated below)

Drill Hole # from (m) to (m) Interval (m) Gold (g/t) Silver (g/t) Comment
ML
20
-1
35CT

AZ 085 dip-80		 585.22 596.49 11.27 0.23 0.18 Upper Oxide Zone

hole missed target

ML
20
-1
58CT

AZ 085 dip-70		 405.61 423.98 18.37 1.76 2.75
Main Zone
inc 407.72 423.98 16.26 1.86 2.18 1 g/t cut

ML
20
–
159CT

AZ 080 dip-65		 405.61 423.98 18.37 1.76 2.75
Main Zone
  289.56 297.79 8.23 1.13 0.47 1 g/t cut
  326.87 410.80 83.93 2.70 6.82  
  335.50 338.58 3.08 1.42 5.34 1 g/t cut
inc   342.35 401.72 59.37 3.52 8.84 1 g/t cut
inc   384.60 397.30 12.70 8.52 30.4 2 g/t cut
inc   395.35 397.31 1.96 31.34 61.49 20 g/t cut
  438.30 445.62 7.32 0.32 2.76 CIZ

0.1 g/t cut
  450.19 457.81 7.62 0.37 1.12 CIZ

0.1 g/t cut















Addition to the Board of Directors

The Company is also pleased to announce the addition of Peggy Wu, the Company’s current CFO, to the Board of Directors. Her addition adds further insight to a diverse and experienced Board. Peggy is a Chartered Professional Accountant (CPA) with strong working knowledge of IFRS and US GAAP reporting requirements in the US and in Canada. She was formerly the CFO for Balmoral Resources Ltd. prior to the acquisition by Wallbridge Mining Company Ltd. and will continue as CFO for Corvus. Given her role as CFO, Ms. Wu will not be considered an independent director.


Figure 1 Location Map


:


Mother Lode drill holes


ML20-135CT,


ML20-158CT


&


ML20-159CT:
https://www.globenewswire.com/NewsRoom/AttachmentNg/a3cee3f5-7d52-4cc4-a121-b5025d58578f


Figure 2: Photo of hole ML20-159CT high-grade zone (1.5m @


20.67


g/t gold) at the top of the CIZ target, within brecciated structural zone in carbonates:
https://www.globenewswire.com/NewsRoom/AttachmentNg/283880f8-c4ae-42e8-9f79-323d9d011f4d

Qualified Person and Quality Control/Quality Assurance

Jeffrey A. Pontius (CPG 11044), a qualified person as defined by National Instrument 43-101 – Standards of Disclosure for Mineral Projects (“NI 43-101”), has supervised the preparation of the scientific and technical information that forms the basis for this news release and has reviewed and approved the disclosure herein. Mr. Pontius is not independent of Corvus, as he is the CEO & President and holds common shares and incentive stock options.

Carl E. Brechtel, (Nevada PE 008744 and Registered Member 353000 of SME), a qualified person as defined by NI 43-101, has coordinated execution of the work outlined in this news release and has also reviewed and approved the disclosure herein. Mr. Brechtel is not independent of Corvus, as he is the COO and holds common shares and incentive stock options.

The work program at Mother Lode and North Bullfrog was designed and supervised by Mark Reischman, Corvus Gold’s Nevada Exploration Manager, who is responsible for all aspects of the work, including the quality control/quality assurance program. On-site personnel at the project log and track all samples prior to sealing and shipping. Quality control is monitored by the insertion of blind certified standard reference materials and blanks into each sample shipment. All mineral resource sample shipments are sealed and shipped to American Assay Laboratories (“AAL”) in Reno, Nevada, for preparation and assaying. AAL is independent of the Company. AAL’s quality system complies with the requirements for the International Standards ISO 9001:2000 and ISO 17025:1999. Analytical accuracy and precision are monitored by the analysis of reagent blanks, reference material and replicate samples. Finally, representative blind duplicate samples are forwarded to AAL and an ISO compliant third-party laboratory for additional quality control. Mr. Pontius, a qualified person, has verified the data underlying the information disclosed herein, including sampling, analytical and test data underlying the information by reviewing the reports of AAL, methodologies, results and all procedures undertaken for quality assurance and quality control in a manner consistent with industry practice, and all matters were consistent and accurate according to his professional judgement. There were no limitations on the verification process.

Metallurgical testing on North Bullfrog and Mother Lode samples has been performed by McClelland Analytical Services Laboratories Inc. of Sparks Nevada (“McClelland”), Resource Development Inc. of Wheatridge, CO (RDi) and Hazen Research Inc. of Golden, CO (HRi). McClelland is an ISO 17025 accredited facility that supplies quantitative chemical analysis in support of metallurgical, exploration and environmental testing using classic methods and modern analytical instrumentation. McClelland has met the requirements of the IAS Accreditations Criteria for Testing Laboratories (AC89), has demonstrated compliance with ANS/ISO/IEC Standard 17025:2005, General requirements for the competence of testing and calibration laboratories, and has been accredited, since November 12, 2012. Hazen Research Inc. (“Hazen”), an independent laboratory, has performed flotation, AAO testing and cyanide leach testing on samples of sulphide mineralization from the YellowJacket zone and Swale area of Sierra Blanca, and roasting tests on Mother Lode flotation concentrate. Hazen holds analytical certificates from state regulatory agencies and the US Environmental Protection Agency (the “EPA”). Hazen participates in performance evaluation studies to demonstrate competence and maintains a large stock of standard reference materials from the National Institute of Standards and Technology (NIST), the Canadian Centre for Mineral and Energy Technology (CANMET), the EPA and other sources. Hazen’s QA program has been developed for conformance to the applicable requirements and standards referenced in 10 CFR 830.120 subpart A quality assurance requirements, January 1, 2002. Resource Development Inc. is a state-of-the-art laboratory for metallic and industrial minerals filling a need for high quality, cost-effective, and timely technical services for the international mining industry.


About the North Bullfrog


& Mother Lode


Projects, Nevada

Corvus controls 100% of its North Bullfrog Project, which covers approximately 90.5 km2 in southern Nevada. The property package is made up of a number of private mineral leases of patented federal mining claims and 1,134 federal unpatented mining claims. The project has excellent infrastructure, being adjacent to a major highway and power corridor as well as a large water right. The Company also controls 445 federal unpatented mining claims on the Mother Lode project which totals approximately 36.5 km2 which it owns 100%. The total Corvus 100% land ownership now covers over 127 km2, hosting two major new Nevada gold discoveries.

About Corvus Gold Inc.

Corvus Gold Inc. is a North American gold exploration and development company, focused on its near-term gold-silver mining project at the North Bullfrog and Mother Lode Districts in Nevada. In addition, the Company controls a number of royalties on other North American exploration properties representing a spectrum of gold, silver and copper projects. Corvus is committed to building shareholder value through new discoveries and the expansion of its projects to maximize share price leverage in an advancing gold and silver market.

On behalf of
Corvus Gold Inc.

(signed) Jeffrey A. Pontius
Jeffrey A. Pontius,
President & Chief Executive Officer

Contact Information: Ryan Ko
  Investor Relations
  Email: [email protected]
  Phone: 1-844-638-3246 (toll free) or (604) 638-3246


Cautionary Note Regarding Forward-Looking Statements

This news release contains forward-looking statements and forward-looking information (collectively, “forward-looking statements”) within the meaning of applicable Canadian and US securities legislation. All statements, other than statements of historical fact, included herein including, without limitation, statements regarding the possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action; potential expansion of the deposit; the rapid and effective capture of the potential of our
Mother Lode
project; the potential for new deposits and expected increases in the system’s potential; anticipated content, commencement and cost of exploration programs; anticipated exploration program results and expansion of existing programs; the discovery and delineation of mineral deposits/resources/reserves; the potential to discover additional high grade veins or additional deposits; the growth potential of the Mother Lode project
s
; and the
potential for any mining or production at the Mother Lode
& North Bullfrog
project
s
, are forward-looking statements. Information concerning mineral resource estimates may be deemed to be forward-looking statements in that it reflects a prediction of the mineralization that would be encountered if a mineral deposit were developed and mined. Although the Company believes that such statements are reasonable, it can give no assurance that such expectations will prove to be correct. Forward-looking statements are typically identified by words such as: believe, expect, anticipate, intend, estimate, postulate and similar expressions, or are those, which, by their nature, refer to future events. The Company cautions investors that any forward-looking statements by the Company are not guarantees of future results or performance, and that actual results may differ materially from those in forward looking statements as a result of various factors, including, but not limited to, variations in the nature, quality and quantity of any mineral deposits that may be located,
variations in the market price of any mineral products the Company may produce or plan to produce, the Company’s inability to obtain any necessary permits, consents or authorizations required for its activities, the Company’s inability to produce minerals from its properties successfully or profitably, to continue its projected growth, to raise the necessary capital or to be fully able to implement its business
strategies, and other risks and uncertainties disclosed in the Company’s 20
20
Annual Information Form and latest interim Management Discussion and Analysis filed with certain securities commissions in Canada and the Company’s most recent filings with the United States Securities and Exchange Commission (the “SEC”). The Company
does not undertake to update any forward-looking
statements
, except in accordance with applicable securities laws.
All of the Company’s Canadian public disclosure filings in Canada may be accessed via

www.sedar.com

and filings with the SEC may be accessed via

www.sec.gov

and readers are urged to review these materials, including the technical reports filed with respect to the Company’s mineral properties.


Cautionary Note to US Investors

NI 43-101 is a rule developed by the Canadian Securities Administrators which establishes standards for all public disclosure an issuer makes of scientific and technical information concerning mineral projects. Unless otherwise indicated, all resource estimates contained in or incorporated by reference in this press release have been prepared in accordance with NI 43-101 and the guidelines set out in the Canadian Institute of Mining, Metallurgy and Petroleum (the “CIM”) Standards on Mineral Resource and Mineral Reserves, adopted by the CIM Council on November 14, 2004 (the “CIM Standards”) as they may be amended from time to time by the CIM.

United States investors are cautioned that the requirements and terminology of NI 43-101 and the CIM Standards differ significantly from the requirements and terminology of the SEC set forth in the SEC’s Industry Guide 7 (“SEC Industry Guide 7”). Accordingly, the Company’s disclosures regarding mineralization may not be comparable to similar information disclosed by companies subject to SEC Industry Guide 7. Without limiting the foregoing, while the terms “mineral resources”, “inferred mineral resources”, “indicated mineral resources” and “measured mineral resources” are recognized and required by NI 43-101 and the CIM Standards, they are not recognized by the SEC and are not permitted to be used in documents filed with the SEC by companies subject to SEC Industry Guide 7. Mineral resources which are not mineral reserves do not have demonstrated economic viability, and US investors are cautioned not to assume that all or any part of a mineral resource will ever be converted into reserves. Further, inferred resources have a great amount of uncertainty as to their existence and as to whether they can be mined legally or economically. It cannot be assumed that all or any part of the inferred resources will ever be upgraded to a higher resource category. Under Canadian rules, estimates of inferred mineral resources may not form the basis of a feasibility study or prefeasibility study, except in rare cases. The SEC normally only permits issuers to report mineralization that does not constitute SEC Industry Guide 7 compliant “reserves” as in-place tonnage and grade without reference to unit amounts. The term “contained ounces” is not permitted under the rules of SEC Industry Guide 7. In addition, the NI 43-101 and CIM Standards definition of a “reserve” differs from the definition in SEC Industry Guide 7. In SEC Industry Guide 7, a mineral reserve is defined as a part of a mineral deposit which could be economically and legally extracted or produced at the time the mineral reserve determination is made, and a “final” or “bankable” feasibility study is required to report reserves, the three-year historical price is used in any reserve or cash flow analysis of designated reserves and the primary environmental analysis or report must be filed with the appropriate governmental authority. The mine economics presented herein and derived from the PEA are preliminary in nature and may not be realized. The PEA is not a feasibility study. U.S. investors are urged to consider closely the disclosure in our latest reports and registration statements filed with the SEC. You can review and obtain copies of these filings at http://www.sec.gov/edgar.shtml. U.S. Investors are cautioned not to assume that any defined resource will ever be converted into SEC Industry Guide 7 compliant reserves.

This press release is not, and is not to be construed in any way as, an offer to buy or sell securities in the United States.

The United States Securities and Exchange Commission (“SEC”) limits disclosure for U.S. reporting purposes to mineral deposits that a company can economically and legally extract or produce.
Resource
estimates contained in
this
press release
are made pursuant to NI 43-101 standards in Canada and do not represent reserves under the standards of the SEC’s Industry Guide 7
.
Under the currently applicable SEC Industry Guide 7 standards, a “final” or “bankable” feasibility study is required to report reserves, the three-year historical average price is used in any reserve or cash flow analysis to designate reserves and all necessary permits and government approvals must be filed with the appropriate governmental authority.
This press release
uses the terms “M
easured R
esources”, “Indicated R
esou
rces”, and
“Inferred
R
esources”. We advise U.S. investors that while these terms are
Canadian mining terms as defined in accordance with NI 43-101, such terms are not recognized under SEC Industry Guide 7 and normally are not permitted to be used in reports and registration statements filed with the SEC. Mineral resources described in th
is press release
have a great amount of uncertainty as to their economic and legal feasibility. The SEC normally only permits issuers to report mineralization that does not constitute SEC Industry Guide 7 compliant “reserves” as in-place tonnage and grade, without reference to unit measures.
“Inferred R
esources” have a great amount of uncertainty as to their existence, and great uncertainty as to their economic and legal feasibility. It cannot be assumed that
any or all part of an Inferred R
esource will ever be upgraded to a higher category.

U.S. Investors are cautioned not to assume that any part or all of mineral deposits in these categories will ever be converted into SEC Industry Guide 7 reserves.

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Myovant Sciences Announces Corporate Updates and Financial Results for Second Quarter Fiscal Year 2020

  • FDA Priority Review of New Drug Application (NDA) for relugolix monotherapy tablet for advanced prostate cancer on track for decision by December 20, 2020 target action date
  • NDA for relugolix combination tablet for uterine fibroids accepted for FDA review with a decision expected by June 1, 2021 target action date
  • Positive one-year efficacy and safety data from Phase 3 LIBERTY program for relugolix combination therapy in women with uterine fibroids, including bone mineral density data, presented at the American Society for Reproductive Medicine (ASRM) 2020 Virtual Congress
  • Positive efficacy and safety data from Phase 3 SPIRIT program for relugolix combination therapy in women with endometriosis-associated pain presented at the ASRM 2020 Virtual Congress

BASEL, Switzerland, Nov. 12, 2020 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced corporate updates and financial results for the second quarter fiscal year 2020.

“I am very pleased with the significant progress we made during the second fiscal quarter in advancing both relugolix monotherapy tablet and relugolix combination tablet toward potential regulatory approvals, while preparing for commercialization in advanced prostate cancer, uterine fibroids, and endometriosis,” said Lynn Seely, M.D., chief executive officer of Myovant Sciences, Inc. “We have assembled a strong and highly-experienced team, spanning medical affairs, market access, commercial operations, marketing, and sales, which will enable us to rapidly and efficiently deliver relugolix monotherapy tablet to urologists, medical oncologists, and their patients, if approved, for our first commercial launch.”


Second Quarter Fiscal Year 2020 and Recent Corporate Updates

Relugolix Clinical Programs

  • Prostate Cancer:

    • Relugolix monotherapy tablet is under Priority Review by the U.S. Food and Drug Administration (FDA) and is on track for a decision by its December 20, 2020 target action date. The NDA is supported by the positive Phase 3 HERO study results, including a 97% responder rate and six positive key secondary endpoints. Relugolix also demonstrated a lower incidence of major adverse cardiovascular events compared to leuprolide acetate, the current standard of care. The Phase 3 HERO study results were published in the New England Journal of Medicine on June 4, 2020.
    • On September 29, 2020, Myovant announced results of an additional secondary endpoint of castration resistance-free survival assessed in the subgroup of men with metastatic prostate cancer from the Phase 3 HERO study of relugolix monotherapy in advanced prostate cancer. Relugolix monotherapy had a similar rate of castration resistance-free survival compared to leuprolide acetate (74% vs. 75%, respectively), and did not achieve statistical superiority (p = 0.84).
    • On October 19, 2020, Myovant presented an economic analysis of the Phase 3 HERO data at the Academy of Managed Care Pharmacy (AMCP) Nexus 2020 Virtual Meeting, demonstrating that treatment with oral relugolix may prevent one major adverse cardiovascular event for every 31 patients treated versus patients receiving leuprolide injections.
  • Uterine Fibroids:

    • In August 2020, the FDA accepted Myovant’s NDA for once-daily, oral relugolix combination tablet for the treatment of women with heavy menstrual bleeding associated with uterine fibroids, setting a target action date of June 1, 2021.
    • On September 14, 2020, Myovant announced one-year data on bone mineral density (BMD) from the Phase 3 LIBERTY program. The BMD results from the LIBERTY program demonstrated maintenance of BMD through one year and were consistent with those observed in a separate prospective observational study of untreated, age-matched women with uterine fibroids. These findings were presented at the American Society for Bone and Mineral Research (ASBMR) 2020 Annual Meeting Virtual Event, held on September 11-15, 2020.
    • On October 21, 2020, Myovant announced the presentation of data at the American Society for Reproductive Medicine (ASRM) 2020 Virtual Congress, including long-term extension data in women with symptomatic uterine fibroids. Results indicated that women experienced, on average, a 90% reduction in menstrual blood loss from baseline at one year. Additionally, 87.7% of women achieved the responder criteria for reduction in menstrual blood loss at one year, and lumbar spine and total hip BMD were maintained over one year. A poster presentation also described a validated exposure-response model simulating long-term effects of relugolix combination therapy on BMD at the lumbar spine that projected maintenance of BMD for at least three years. Other data from the LIBERTY program – including improvement in quality of life, reduction in menstrual blood loss in the first treatment cycle, and reduction in uterine fibroid-associated pain – were also presented.
    • Additional data from the Phase 1 ovulation inhibition study from 67 healthy women treated with relugolix combination therapy, resulting in 100% ovulation inhibition and 100% return to ovulation or menses after discontinuation of treatment, were also presented at the ASRM 2020 Virtual Congress.
  • Endometriosis:

    • Data from the replicate Phase 3 SPIRIT 1 and SPIRIT 2 studies were presented at the ASRM 2020 Virtual Congress on October 20, 2020 in an oral presentation named the Prize Paper by the Endometriosis Special Interest Group. Relugolix combination therapy resulted in clinically meaningful reductions in dysmenorrhea and non-menstrual pelvic pain, compared with placebo over 24 weeks of therapy (p < 0.0001) in each study. Changes in BMD over 24 weeks were minimal in the relugolix combination therapy groups.

COVID-19 Pandemic Environment

  • Myovant’s priorities during the COVID-19 pandemic are protecting the health and safety of its employees and patients while continuing its mission to redefine care for women and for men. To date, the impact of the COVID-19 pandemic on Myovant’s ability to advance its clinical studies, regulatory activities, and preparation for the potential commercialization of its product candidates has been limited, and all of Myovant’s publicly announced milestones remain on track. However, if the COVID-19 pandemic persists, and depending on the further evolution of the pandemic and its effects on Myovant’s activities, Myovant may experience more significant impacts on its business operations.


Expected Upcoming Milestones

  • Relugolix monotherapy tablet for advanced prostate cancer FDA target action date of December 20, 2020.
  • Data from the LIBERTY randomized withdrawal study expected in the first quarter of calendar year 2021.
  • One-year efficacy and safety data from the SPIRIT extension study expected in the first quarter of calendar year 2021.
  • Relugolix combination tablet for uterine fibroids FDA target action date of June 1, 2021.
  • Marketing Authorization Application (MAA) submission to European Medicines Agency (EMA) for relugolix monotherapy tablet for advanced prostate cancer in the first half of calendar year 2021.
  • NDA submission for relugolix combination tablet for the treatment of women with endometriosis-associated pain expected in the first half of calendar year 2021.
  • European Commission decision on the uterine fibroids MAA expected in 2021. If approved, this launch will be executed by Gedeon Richter, Myovant’s commercialization partner for relugolix combination tablet for the uterine fibroids and endometriosis indications in Europe and certain other international markets.
  • MAA submission to EMA for relugolix combination tablet for the treatment of women with endometriosis-associated pain expected in 2021. Gedeon Richter will be the MAA sponsor.


Second Quarter Fiscal Year 2020 Financial Summary

Research and development (R&D) expenses in the three months ended September 30, 2020, were $40.5 million compared to $50.8 million for the comparable prior year period. The decrease in R&D expenses reflects a decrease in clinical study costs as a result of the completion and continued wind down of Myovant’s Phase 3 LIBERTY, HERO, and SPIRIT studies. This decrease was partially offset primarily by increased expenses by the medical affairs organization in preparation for Myovant’s anticipated commercial launches, if approved, of relugolix monotherapy tablet for men with advanced prostate cancer and relugolix combination tablet for the women’s health indications, as well as an increase in personnel expenses.

General and administrative (G&A) expenses in the three months ended September 30, 2020, were $31.3 million compared to $16.6 million for the comparable prior year period. The increase was primarily due to increases in expenses related to commercial readiness activities, personnel-related expenses, and other general overhead expenses to support Myovant’s organizational growth and anticipated commercial launches, if approved, of relugolix monotherapy tablet for men with advanced prostate cancer and relugolix combination tablet for the women’s health indications.

Interest expense was $2.1 million in the three months ended September 30, 2020, compared to $3.8 million in the comparable prior year period. The decrease in interest expense was driven by lower interest rates associated with the Sumitomo Dainippon Pharma Loan Agreement as compared to Myovant’s previously outstanding debt obligations, which were repaid in December 2019.

Interest income in the three months ended September 30, 2020, was less than $0.1 million compared to $0.9 million for the comparable prior year period. The decrease was primarily due to decreases in interest rates and lower balances in cash equivalents and marketable securities.

Other (income) expense, net in the three months ended September 30, 2020, was income of $6.7 million compared to expenses of $0.1 million for the comparable prior year period. This was primarily the result of a foreign currency exchange gain on Myovant’s outstanding balance under the Sumitomo Dainippon Pharma Loan Agreement during the three months ended September 30, 2020 for which there was no such gain in the comparable prior year period.

Net loss for the three months ended September 30, 2020, was $67.1 million compared to $70.6 million for the comparable prior year period. On a per common share basis, net loss was $0.75 and $0.79 for the three months ended September 30, 2020, and 2019, respectively.

Capital resources: Cash, cash equivalents, marketable securities, and committed amounts available under the Sumitomo Dainippon Pharma Loan Agreement totaled $257.6 million as of September 30, 2020, and consisted of $111.3 million of cash, cash equivalents, and marketable securities and $146.3 million of available borrowing capacity under the Sumitomo Dainippon Pharma Loan Agreement.

On August 5, 2020, Myovant obtained a debt commitment letter (amended on September 29, 2020) from Sumitomo Dainippon Pharma, pursuant to which, subject to the terms and conditions set forth therein, Sumitomo Dainippon Pharma has committed to provide Myovant with an additional $200.0 million, low-interest, five-year term loan, which, subject to negotiation of a definitive agreement, will bring its total financing support for Myovant to $600.0 million. Including the additional debt commitment, cash and committed funding as of September 30, 2020 totaled approximately $460.0 million.

Conference Call
As previously announced, Myovant will hold a webcast and conference call at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) today, November 12, 2020, to discuss corporate updates and financial results for its second fiscal quarter 2020, ended September 30, 2020. Investors and the general public may access a live webcast of the call by visiting the investor relations page of Myovant’s website at investors.myovant.com. Institutional investors and analysts may also participate in the conference call by dialing 1-800-532-3746 in the U.S. or +1-470-495-9166 from outside the U.S.

The webcast will be archived on Myovant’s Investor Relations website following the call.

About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone, a hormone known to stimulate the growth of prostate cancer, and ovarian estradiol, a hormone known to stimulate the growth of uterine fibroids and endometriosis. Relugolix monotherapy tablet (120 mg) is under regulatory review in the U.S. for men with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis.

About Myovant Sciences
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Our lead product candidate, relugolix, is a once-daily, oral GnRH receptor antagonist. Relugolix monotherapy tablet (120 mg) is under regulatory review in the U.S. for men with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis. We are also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is our majority shareholder. For more information, please visit our website at www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China and the European Union. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 6,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com.

About Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company with offices in New York City and London. Sumitovant is a wholly owned subsidiary of Sumitomo Dainippon Pharma. Sumitovant is the majority shareholder of Myovant and Urovant, and wholly owns Enzyvant, Spirovant and Altavant. Sumitovant’s promising pipeline is comprised of early- through late-stage investigational medicines across a range of disease areas targeting high unmet need. For further information about Sumitovant, please visit https://www.sumitovant.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In this press release, forward-looking statements include, but are not limited to, all statements reflecting Myovant Sciences’ expectations, including those statements under the caption “Expected Upcoming Milestones”; statements and quotes regarding Myovant Sciences’ aspiration to redefine care for women and for men; statements and quotes regarding Myovant’s belief that it has assembled a strong and highly-experienced team, spanning medical affairs, market access, commercial operations, marketing and sales, which will enable it to rapidly and efficiently deliver relugolix monotherapy tablet to urologists, medical oncologists, and their patients, if approved; the commitments of Sumitomo Dainippon Pharma to Myovant, including statements regarding the expected terms of a $200 million debt facility; and the expected timing of results from Myovant Sciences’ ongoing clinical trials.

Myovant Sciences’ forward-looking statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, assumptions and other factors known and unknown that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements, including unforeseen circumstances or other disruptions to normal business operations arising from or related to the COVID-19 pandemic. Myovant Sciences cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could materially affect Myovant Sciences’ operations and future prospects or which could cause actual results to differ materially from expectations include, but are not limited to the risks and uncertainties listed in Myovant Sciences’ filings with the United States Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in Myovant Sciences’ Quarterly Report on Form 10-Q to be filed on November 12, 2020, as such risk factors may be amended, supplemented or superseded from time to time. These risks are not exhaustive. New risk factors emerge from time to time and it is not possible for Myovant Sciences’ management to predict all risk factors, nor can Myovant Sciences assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof, and, except as required by law, Myovant Sciences undertakes no obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements.

MYOVANT SCIENCES LTD.

Condensed Consolidated Statements of Operations

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

  Three Months Ended
September 30, 		  Six Months Ended
September 30,
  2020   2019   2020   2019
License and milestone revenue $ —       $ —       $ 33,333       $ —    
Operating expenses:              
Research and development (1) 40,521       50,803       84,707       101,920    
General and administrative (1) 31,316       16,603       54,144       30,755    
Total operating expenses 71,837       67,406       138,851       132,675    
Loss from operations (71,837 )     (67,406 )     (105,518 )     (132,675 )  
Interest expense —       3,788       —       7,581    
Interest expense (related party) 2,115       —       4,299       —    
Interest income (38 )     (942 )     (146 )     (1,708 )  
Other (income) expense, net (6,718 )     121       (10,287 )     (584 )  
Loss before income taxes (67,196 )     (70,373 )     (99,384 )     (137,964 )  
Income tax (benefit) expense (134 )     195       538       508    
Net loss $ (67,062 )     $ (70,568 )     $ (99,922 )     $ (138,472 )  
Net loss per common share — basic and diluted $ (0.75 )     $ (0.79 )     $ (1.12 )     $ (1.68 )  
Weighted average common shares outstanding — basic and diluted 89,744,142       88,798,398       89,523,389       82,667,061    
                               

(1) Includes the following share-based compensation expenses:

Research and development $ 3,725     $ 3,618     $ 7,749     $ 6,166  
General and administrative $ 3,199     $ 4,313     $ 6,987     $ 8,217  

MYOVANT SCIENCES LTD.

Condensed Consolidated Balance Sheets

(Unaudited, in thousands)

  September 30,
2020 		  March 31,
2020
Assets      
Current assets:      
Cash and cash equivalents $ 94,210       $ 76,644    
Marketable securities 17,086       2,997    
Prepaid expenses and other current assets 5,612       8,269    
Total current assets 116,908       87,910    
Property and equipment, net 2,808       2,497    
Operating lease right-of-use asset 10,423       11,146    
Other assets 5,634       4,373    
Total assets $ 135,773       $ 105,926    
Liabilities and Shareholders’ Deficit      
Current liabilities:      
Accounts payable $ 7,008       $ 15,334    
Interest payable (related party) —       15    
Accrued expenses 40,141       29,060    
Deferred revenue 16,667       40,000    
Operating lease liability 1,657       1,516    
Amounts due to related parties 1,284       —    
Total current liabilities 66,757       85,925    
Long-term operating lease liability 10,127       10,996    
Long-term debt, less current maturities (related party) 253,700       113,700    
Other 4,968       3,582    
Total liabilities 335,552       214,203    
Total shareholders’ deficit (199,779 )     (108,277 )  
Total liabilities and shareholders’ deficit $ 135,773       $ 105,926    
                   

Investor Contact:

Ryan Crowe
Vice President, Investor Relations
Myovant Sciences, Inc.
[email protected]

Media Contact:

Albert Liao
Director, Corporate Communications
Myovant Sciences, Inc.
[email protected]