• VENCLEXTA® (venetoclax) plus obinutuzumab is the first chemotherapy-free, fixed-duration combination regimen approved by Health Canada for patients with previously untreated chronic lymphocytic leukemia (CLL).
• Approval is based on data from the Phase 3 CLL14 trial, which showed that patients treated with obinutuzumab plus one year of treatment with VENCLEXTA had clinically meaningful and statistically significant progression-free survival (PFS) and higher rates of undetectable minimal residual disease compared to patients receiving a standard of care chemoimmunotherapy regimen of obinutuzumab and chlorambucil.¹

 

Montreal, QC, May 5, 2020 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced today that Health Canada has approved VENCLEXTA® (venetoclax) in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL). The regimen combines six 28-day cycles of obinutuzumab with 12 cycles of VENCLEXTA.

 

“Venetoclax in combination with obinutuzumab is an effective treatment with a finite treatment duration. The approval by Health Canada is good news, especially for patients that prefer not to remain on therapy indefinitely,” explains Dr. Sue Robinson, MD, FRCPC, Professor, Division of

Hematology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia. “Based on my experience on the CLL14 clinical trial, I am looking forward to prescribing this combination regimen for older patients with previously untreated CLL and/or those who have concomitant medical problems”.

 

This is the third indication for VENCLEXTA, a first-in-class B-cell lymphoma-2 (BCL-2) inhibitor. BCL-2 is a protein that prevents cancer cells from undergoing apoptosis, the process that leads to the natural death or self-destruction of cancer cells. VENCLEXTA is also approved in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy, and as a monotherapy for the treatment of CLL in the presence or absence of 17p deletion in adult patients who have received at least one prior therapy and for whom there are no other available treatment options.¹

 

“Lymphoma Canada is pleased with the approval of VENCLEXTA in combination with obinutuzumab by Health Canada for the treatment of chronic lymphocytic leukemia. Due to the nature of the disease and its high relapse rate, it is important to offer patients effective treatment options so that they can face their cancer journey with the comfort of knowing that there are always alternatives,” says Antonella Rizza, Chief Executive Officer, Lymphoma Canada.

 

This most recent approval is based on the primary analysis (median follow up of 28 months) of the Phase 3 CLL14 clinical trial, which demonstrated clinically meaningful and statistically significant progression-free survival (PFS; the time during and after treatment without disease progression, relapse, or death) as assessed by investigators in patients treated with VENCLEXTA plus obinutuzumab compared

 

to patients who received a standard of care chemotherapy regimen of chlorambucil plus obinutuzumab (hazard ratio 0.35; 95% CI (0.23,0.53), p<0.0001, medians not yet reached).¹

 

“We are extremely proud of the Health Canada approval of VENCLEXTA in combination with obinutuzumab,” said Denis Hello, General Manager, AbbVie Canada. “This third approval for VENCLEXTA underscores our commitment to develop blood cancer treatments.”

 

CLL, which is typically a slow-progressing cancer of the bone marrow and blood², is one of the most common types of leukemia in adults. In Canada, CLL accounts for approximately 1,745 newly diagnosed cases of leukemia each year and is responsible for more than 600 deaths a year.³

 

VENCLEXTA is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the

U.S. and by AbbVie outside of the U.S.

 

About the CLL14 Trial

The randomized, multicenter, open-label, actively controlled Phase 3 CLL14 trial, which was conducted in close collaboration with the German CLL Study Group (DCLLSG), evaluated the efficacy and safety of a combined regimen of VENCLEXTA and obinutuzumab (n=216) versus obinutuzumab and chlorambucil (n=216) in patients with previously-untreated CLL and coexisting medical conditions (total Cumulative Illness Rating Scale [CIRS] score >6 or creatinine clearance <70 mL/min). The therapies were administered for a fixed duration of 12 cycles for VENCLEXTA in combination with six cycles of obinutuzumab. Cycles were comprised of 28 days. The trial enrolled 432 patients, all of whom were diagnosed according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria and were previously untreated. The primary efficacy outcome was PFS as assessed by the investigator.⁴ Key secondary endpoints included MRD-negativity in peripheral blood and bone marrow, and overall and complete response rates.^4,5

 

About AbbVie Care

Canadians prescribed VENCLEXTA can be enrolled in AbbVie Care, AbbVie’s signature care program. The program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment. For more information, please visit www.abbviecare.ca.

 

About AbbVie in Oncology

At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. AbbVie’s oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 300 clinical trials and more than 20 different tumor types.

 

About AbbVie

AbbVie is a global, research and development-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

-30-

Media:

Eileen Murphy AbbVie Canada 514-449-9788

eileen.murphy@abbvie.com

 

 

 

¹ Venclexta Product Monograph. AbbVie Corporation, Canada. https://www.abbvie.ca/content/dam/abbvie- dotcom/ca/en/documents/products/VENCLEXTA_PM_EN.pdf. Accessed April 30, 2020.

² Lymphoma Canada. Chronic lymphocytic leukemia. www.lymphoma.ca/lymphoma/lymphoma-101/types- lymphoma/cll. Accessed May 2020.

³ Canadian Cancer Statistics. Chronic lymphocytic leukemia statistics. www.cancer.ca/en/cancer- information/cancer-type/leukemia-chronic-lymphocytic-cll/statistics/?region=on. Accessed May 2020.

⁴ Fischer K, et al. Effect of fixed-duration venetoclax plus obinutuzumab (VenG) on progression-free survival (PFS), and rates and duration of minimal residual disease negativity (MRD–) in previously untreated patients (pts) with chronic lymphocytic leukemia (CLL) and comorbidities. Presented at the 2019 American Society of Clinical Oncology Annual Meeting: June 4, 2019; Chicago.

⁵ N Engl J Med 2019;380:2225-36. DOI: 10.1056/NEJMoa1815281

— Non-plant-touching entity to commercialize Vireo’s intellectual property portfolio

TORONTO, April 9, 2020 /PRNewswire/ — Field Trip Psychedelics Inc. (“Field Trip” or the “Company“), the world’s first mental wellness company focused exclusively on psychedelics and psychedelic-enhanced psychotherapy, today announced the creation of Field Trip Discovery, the company’s newly formed drug development division.

Appointment of Dr. Nathan Bryson, Chief Science Officer

Field Trip Discovery will be led by Dr. Nathan Bryson, Field Trip’s recently hired Chief Science Officer. Dr. Bryson, who holds his PhD in Chemistry and Postdoctoral Associate Degree from Massachusetts Institute of Technology, has three decades of hands-on research and development experience in the biotechnology and pharmaceutical industries where he has overseen innovation, clinical development, regulatory, quality, global supply chain and medical affairs. Prior to joining Field Trip, Dr. Bryson was the Chief Science Officer for Acerus Pharmaceuticals, a Canadian pharmaceutical company with a portfolio of sexual and reproductive health prescription products. Before Acerus, Dr. Bryson previously served as Chief Science Officer at Cynapsus Therapeutics, a pharma-biotech company that was acquired by Sunovion Pharma, and at Cannasat Therapeutics, a pharmaceutical company developing novel cannabinoid therapeutics of THC and CBD.

Appointment of Dieter Weinand and Helen Boudreau to Board of Directors

The Company is also pleased to announce the appointment of Dieter Weinand and Helen Boudreau to the Board of the Directors, who along with Dr. Michael Ehlers, the Company’s Senior Strategy Advisor, will be supporting Dr. Bryson in the strategic direction of Field Trip Discovery.

Mr. Weinand is the former President, CEO and Chairman of the Board of Bayer Pharmaceuticals, AG and has 30 years of experience in senior executive roles with a number of pharmaceutical companies, including Sanofi, Otzuka and Pfizer. He has a demonstrated ability to recognize opportunity, create a vision and strategy, and mobilize organizations behind successful execution.  Mr. Weinand has launched and marketed some of the industry’s most successful products, including Lipitor, Neurontin, Abilify, and Cipro.

Ms. Boudreau joins the Company’s Board of Directors after most recently serving as Chief Operating Officer for the Bill & Melinda Gates Medical Research Institute. Prior to that role, Ms. Boudreau served as CFO for biotech companies Proteostasis Therapeutics and FORMA Therapeutics. Previously, Ms. Boudreau spent 16 years at Novartis and Pfizer, serving in strategy and senior finance roles, including Global CFO, Oncology business unit, CFO US Corporate, VP Investor Relations, VP Finance, Customer Business Unit and Commercial Operations, and VP Finance Global R&D. She has contributed to successful product launches, driven sales growth and increased profitability, integrated mergers & acquisitions, and provided leadership across Finance, IT, HR, Strategic Sourcing, Facilities, and Innovation, Quality and Process improvement.

“One of our core priorities at Field Trip is to advance the science and understanding of psychedelic compounds through evidence-based research,” said Ronan Levy, Executive Chairman of Field Trip Psychedelics. “And with the COVID-19 pandemic likely to create one of the greatest mental health challenges the world has ever seen, the need to legitimize the use of these molecules is more urgent than ever. The creation of Field Discovery led by Dr. Bryson, and supported by the many years of operational and executive experience of Dieter and Helen, in conjunction with the technical and scientific knowledge of Mike Ehlers, will help us do just that.”

“The impressive gains in the understanding of brain function, combined with the maturation and development of legitimate research in the field, is demonstrating incredible promise for  therapeutic use of psychedelic molecules like psilocybin and MDMA,” commented Dr. Bryson. “I’m excited to join the Field Trip team. Their commitment to scientific and research excellence in psychedelics, combined with its multidisciplinary structure creates numerous synergies and a dynamic environment, which will greatly advance the understanding and applications of psychedelics and their therapeutic potential. And the need for these advances is more important than ever right now.”

About Field Trip Psychedelics Inc.
Field Trip is the world’s first mental wellness company at the forefront of the scientific re-emergence of psychedelics and psychedelic-enhanced therapies. With Field Trip Health centres opening across North America, and drug development and advanced research on plant-based psychedelics through Field Trip Discovery, we help people to heal and heighten engagement with the world.

Learn more at https://fieldtriphealth.com and https://fieldtripdiscovery.com

SOURCE Field Trip Psychedelics Inc.

Related Links

https://fieldtripdiscovery.com

NOT FOR DISSEMINATION IN THE UNITED STATES OR FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES AND DOES NOT CONSTITUTE AN OFFER OF THE SECURITIES DESCRIBED HEREIN

TORONTO, March 18, 2020 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV), a cannabis and psychedelic life sciences company, is pleased to announce that further to its press release of February 11, 2020, it has closed a private placement of 33,535,000 units (“Units”) at a price of $0.05 per Unit for gross proceeds of $1,676,750 (the “Offering”). Hampton Securities Limited acted as sole lead agent (the “Agent”) in connection with the Offering.

Each Unit consists of one common share (“Share”) in the capital of the Company and one common share purchase warrant (“Warrant”). Each Warrant entitles the holder thereof to acquire one common share of the Company (each a “Warrant Share”) at a price of $0.07 per Warrant Share at any time until March 18, 2023.

Pursuant to the Offering, Revive paid the Agent a cash commission of $150,907.50, a corporate finance fee of $22,600 and issued the Agent 3,018,150 non-transferable broker warrants (the “Broker Warrants”). Each Broker Warrant entitles the Agent to purchase one unit of the Company (each a ‎‎ “Compensation Unit”) at the price of $0.05 per Compensation Unit at any time until March 18, 2022.

Each Compensation Unit is comprised of one common share in the capital of ‎the Company and one common share purchase warrant (each a ‎‎”Compensation Unit Warrant”). Each Compensation Unit Warrant shall entitle the holder thereof to ‎purchase one common share in the capital of the Company (each a “Compensation Warrant Share”) ‎at a price of $0.07 per Compensation Warrant Share at any time until March 18, 2023.

The Company intends to use the net proceeds of the Offering for general corporate purposes.

All securities issued pursuant to the Offering are subject to a statutory hold period of four months and ‎one day.

“Given the current financial situation brought about by the COVID-19 pandemic, it is a testament to the core business of the Company in closing the Offering,” said Michael Frank, Revive’s Chief Executive Officer. “The proceeds from the Offering will enable the Company to continue and broaden its research and development initiatives. Revive has a portfolio of core IP that can address a variety of unmet medical needs.”

This press release shall not constitute an offer for the sale of securities, nor a solicitation for offers to buy securities in any jurisdiction. The securities referred to in this press release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, or state securities laws and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent U.S. federal and state registration or an applicable exemption from the U.S. registration requirements. Any public offering of securities in the United States must be made by means of a prospectus containing detailed information about the company and management, as well as financial statements.

About Revive Therapeutics Ltd.

Revive is a company focused on the research, development and commercialization of novel psychedelic and cannabinoid-based life sciences products. Revive’s cannabinoid technology is being advanced to fill the medical needs for diseases and disorders such as pain, inflammation, and wound care. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory areas such as liver disease. The company has been granted FDA orphan drug status designation for the use of CBD to treat auto-immune hepatitis (liver disease) and FDA orphan drug status designation for the use of CBD to treat ischemia and reperfusion injury from organ transplantation. With its recent acquisition of Psilocin Pharma Corp., Revive will advance Psilocybin-based therapeutics in various diseases and disorders and will prioritize development efforts to take advantage of a number of regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations.

For more information please contact:
Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel:	1 888 901 0036
Email:	mfrank@fbn.436.myftpupload.com
Website:	www.revivethera.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Offering, including the intended use of proceeds. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2019, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

Company Now Trades under Ticker AIKI

News Provided by PR Newswire via QuoteMedia

– CAD $10.5 million financing to increase retail sell through in key medical only markets –

– Management provides update regarding recent strategic initiatives –

MINNEAPOLIS , March 10, 2020 /CNW/ — Vireo Health International, Inc. (“Vireo” or the “Company”) (CNSX: VREO; OTCQX: VREOF), the science-focused multi-state cannabis company with active operations in exclusively medical-only markets and licenses in 10 states and the commonwealth of Puerto Rico , today announced it has closed the first tranche of a non-brokered private placement offering (the “Offering”) of 13,651,574 units of the Company (the “Units”). The Offering was authorized at a price per Unit of CAD $0.77 for up to a total amount of U.S. $10,000,000.

“This financing reflects the confidence of the capital markets in the potential growth of sales and margin for Vireo,” said Executive Chairman, Bruce Linton . “There are significant opportunities across our existing footprint to leverage increasing scale to improve sales growth and operating performance, especially considering that we anticipate as many as seven of our medical-only state markets could enact recreational-use legislation over the near- to mid-term future.”

“As a smaller, nimbler U.S. operator with a disciplined approach to capital allocation, we’ve sized this offering to balance our near-term objectives with the best long-term interests of shareholders and we believe we’re in an excellent position to deliver stronger financial performance as a result of this transaction,” said Founder & Chief Executive Officer, Kyle Kingsley , M.D. “Our recent focus on building production capacity to meet increasing demand positions us to drive stronger sell through of higher margin retail sales, which will remain a key area of focus for our team in 2020 in addition to advancing scientific innovation.”

Each Unit is comprised of one subordinate voting share in the capital of Vireo (a “Share”) and one subordinate voting share purchase warrant of Vireo (a “Warrant”). Each Warrant entitles the holder to purchase one Share (a “Warrant Share”) for a period of three years from the date of issuance at an exercise price of CAD $0.96 per Warrant Share, subject to adjustment in certain events. Vireo has the right to force the holders of the Warrants to exercise the Warrants into Shares if, prior to the maturity date, the five-trading-day volume weighted-average price of the Shares equals or exceeds CAD $1.44 , subject to adjustment in certain events.

The Company intends to use the proceeds from the Offering to fund various growth initiatives, as well as for working capital and general corporate purposes. Additional tranches of the Offering may be closed on or before April 17, 2020 , subject to the satisfaction of customary closing conditions. All of the securities issuable in connection with the Offering will be subject to a statutory hold period of four months plus a day from the date of issuance in accordance with applicable securities legislation. The Company does not expect the Warrants to be listed on any securities exchange.

Corporate Update Regarding Recent Strategic Initiatives

The Company also disclosed that it has implemented several strategic initiatives over the course of the last 90 days in order to optimize its cost structure and operating model. The objectives of these initiatives are to build sustainable value with changing market conditions and to improve the Company’s operating performance. Since December 2, 2019 , these actions have reduced corporate overhead and SG&A expenses by approximately 25 percent on an annualized basis.

Chief Financial Officer, Shaun Nugent , commented, “Our management team and Board of Directors is committed to significantly improving financial performance and generating positive free cash flow, and these actions were important steps we had to take in order to improve unit economics across our business so that we may achieve those goals. We expect to utilize a portion of the proceeds from the private placement transaction to expand our retail dispensary footprint in several key markets, which will be a critical component in driving stronger revenue growth, operating margins, and ultimately cash flow.”

The Company will provide additional updates regarding its strategic priorities and financial performance during its upcoming fourth-quarter and full-year 2019 earnings conference call, which is scheduled for April 30, 2020 .

Additional Disclosures Surrounding Related Party Transaction

Bruce Linton , a director, officer and insider of Vireo indirectly subscribed for 1,736,715 Units in the Offering. Mr. Linton’s participation in the Offering and amendments to his employment agreement with the Company (the “Amended Employment Agreement”) constitute a “related party transaction” within the meaning of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions (“MI 61-101”). The Company has relied on exemptions from the valuation and minority shareholder approval requirements of MI 61-101 contained in sections 5.5(a) and 5.7(1)(a) of MI 61-101 in respect of the Mr. Linton’s participation in the Offering and the Amended Employment Agreement as neither transaction exceed 25% of the Company’s market capitalization. Under the terms of the Amended Employment Agreement, the Company expects to advance Mr. Linton the aggregate exercise price of the first tranche of incentive warrants issued to Mr. Linton and disclosed by the Company on November 7, 2019 , in accordance with the terms of such warrants. The warrants become effectively cashless if the market capitalization of the company reaches U.S. $275 million . The terms of the Offering and the Amended Employment Agreement were reviewed and unanimously approved by the disinterested members of the Company’s board of directors.

Other Information

All currency figures referenced in this release reflect Canadian dollar amounts, unless otherwise noted. The securities to be issued pursuant to the Offering have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “1933 Act”), or under any state securities laws, and may not be offered or sold, directly or indirectly, or delivered within the United States absent registration or an applicable exemption from the registration requirements. This news release does not constitute an offer to sell or a solicitation to buy such securities in the United States . The Canadian Securities Exchange (“CSE”) has neither approved nor disapproved the contents of this news release. Neither the CSE nor its Market Regulator (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.

About Vireo Health International, Inc.

Vireo Health International, Inc. is a physician-led cannabis company focused on building long-term, sustainable value by bringing the best of medicine, science, and engineering to the cannabis industry. With operations strategically located in early-stage, limited-license medical markets, Vireo manufactures pharmaceutical-grade cannabis products in environmentally-friendly greenhouses and distributes its products through its growing network of Green Goods™ retail dispensaries and hundreds of third-party locations. Its current core medical markets of New York , Minnesota , Pennsylvania , Arizona , New Mexico , Maryland , Ohio and Rhode Island all have the potential to enact adult-use legalization in the next three to 24 months, and three additional markets in Puerto Rico , Massachusetts and Nevada also have potential for commercialization. Combined with its teams’ focus on driving scientific innovation within the industry and securing meaningful intellectual property, Vireo believes it is well positioned to become a global market leader in the cannabis industry. In aggregate, Vireo’s total license portfolio spans 11 state markets with a total addressable population of over 80 million patients. Today, eight of its 11 state markets are operational with 13 of its 32 total retail dispensary licenses open for business. For more information about the company, please visit www.vireohealth.com .

Caution Regarding Cannabis Operations in the United States

Investors should note that there are significant legal restrictions and regulations that govern the cannabis industry in the United States . Cannabis remains a Schedule I drug under the US Controlled Substances Act, making it illegal under federal law in the United States to, among other things, cultivate, distribute or possess cannabis in the United States . Financial transactions involving proceeds generated by, or intended to promote, cannabis-related business activities in the United States may form the basis for prosecution under applicable US federal money laundering legislation.

While the approach to enforcement of such laws by the federal government in the United States has trended toward non-enforcement against individuals and businesses that comply with medical or adult-use cannabis programs in states where such programs are legal, strict compliance with state laws with respect to cannabis will neither absolve Vireo of liability under U.S. federal law, nor will it provide a defense to any federal proceeding which may be brought against Vireo. The enforcement of federal laws in the United States is a significant risk to the business of Vireo and any proceedings brought against Vireo thereunder may adversely affect Vireo’s operations and financial performance.

Forward-Looking Statement Disclosure

This news release contains “forward-looking information” within the meaning of applicable Canadian securities legislation. To the extent any forward-looking information in this news release constitutes “financial outlooks” within the meaning of applicable Canadian securities laws, such information is being provided as preliminary financial results and the reader is cautioned that this information may not be appropriate for any other purpose and the reader should not place undue reliance on such financial outlooks. Forward-looking information contained in this press release may be identified by the use of words such as, “may”, “would”, “could”, “will”, “likely”, “expect”, “anticipate”, “believe, “intend”, “plan”, “forecast”, “project”, “estimate”, “outlook” and other similar expressions, and include statements with respect to the opportunities for the Company to leverage increasing scale to improve sales growth and operating performance; the anticipation that seven medical-only state markets could enact recreational-use legislation over the near-to mid-term future; future tranches of the Offerings, including the expected timing for closing subsequent tranches of the Offering; the use of proceeds from the Offering; the anticipated benefits of the strategic initiatives implemented over the last 90 days; the annualized reduction of corporate overhead and SG&A expenses; the improvement to unit economics; expansion of retail dispensaries in key markets; and the expectation that such expansion will drive stronger revenue growth, operating margins and free cash flow. Forward-looking information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company or its subsidiaries to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this news release. Financial outlooks, as with forward-looking information generally, are, without limitation, based on the assumptions and subject to various risks as set out herein. Our actual financial position and results of operations may differ materially from management’s current expectations and, as a result, our revenue and cash on hand may differ materially from the revenue and cash values provided in this news release. Forward-looking information is based upon a number of estimates and assumptions of management in light of management’s experience and perception of trends, current conditions and expected developments, as well as other factors relevant in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment; and the availability of licenses, approvals and permits.

Although the Company believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because the Company can give no assurance that they will prove to be correct, including preliminary financial expectations regarding the annualized reduction of corporate overhead and SG&A expenses. Actual results and developments may differ materially from those contemplated by these statements. Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information. Such risks and uncertainties include, but are not limited to, risks related to preliminary financial results being subject to the completion of the Company’s financial closing procedures and not being audited or reviewed by the Company’s independent registered public accounting firm; the timing of recreational-use legislation in markets where the Company currently operates; closing subsequent tranches of the Offerings; the expected timing for completion of subsequent tranches of the Offerings, including the satisfaction of customary closing conditions; current and future market conditions, including the market price of the subordinate voting shares of the Company; federal, state, local and foreign government laws, rules and regulations, including federal and state laws in the United States relating to cannabis operations in the United States ; limited operating history; changes in laws, regulations and guidelines; operational, regulatory and other risks; execution of business strategy; management of growth; difficulty to forecast; conflicts of interest; risks inherent in an agricultural business; liquidity and additional financing; foreign private issuer status and the risk factors set out in the Company’s listing statement dated March 19, 2019 , filed with the Canadian securities regulators and available under the Company’s profile on SEDAR at www.sedar.com .

The statements in this press release are made as of the date of this release. The Company disclaims any intent or obligation to update any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws. 

 

SOURCE Vireo Health International, Inc.

TORONTO, Feb. 10, 2020 – Revive Therapeutics Ltd. (“Revive”), a cannabis life sciences company focused on novel cannabinoid-based treatments for rare inflammatory diseases, is pleased to announce that it has entered into a supply and collaboration agreement (the “Agreement”) with Red Light Holland Financing Inc. (“Red Light”), an arm’s length party.

Pursuant to the Agreement Red Light will sell to Revive a consistent strain of truffles for the sole purpose of Revive undertaking research and development on the suitability and implementation of its novel cannabinoid delivery technology with respect to the truffles and its extracts. Red Light has also agreed to, upon request, provide Revive with any information, studies, papers and other information it may have pertaining to the truffles which may be deemed to be beneficial to Revive for undertaking the research and development.

“Revive is excited to be working with Red Light to explore the use of its delivery technology with unique products such as truffles,” stated Michael Frank, the President of Revive. “We are confident that the results of Revive’s research will highlight the versatility of its cannabinoid delivery platform.”

“As Red Light Holland heads down the road of securing its facility in the Netherlands and commencing our cultivation of Premium Red Light Truffles, we are elated to be partnering and eventually aiming to supply companies with our truffles, such as Revive, who will perform true clinical testing in hopes of publishing ground-breaking and progressive medical results,” said Todd Shapiro, CEO of Red Light Holland.

In addition, as a condition of the Agreement, Revive has agreed to subscribe for 2,500,000 subscription receipts (the “Subscription Receipts”) of Red Light at a price of $0.06 per Subscription Receipt for an aggregate consideration of $150,000. Each Subscription Receipt shall entitle Revive, upon conversion and with any additional consideration, to acquire one common share in the capital of Red Light. In consideration for the Subscription Receipts, Revive will issue to Red Light an aggregate of 3,000,000 common shares in the capital of Revive at a price of $0.05 per share for aggregate consideration of $150,000.

About Red Light Holland Financing Inc.

Red Light’s core business is expected to revolve around the production, growth and sale of truffles’ products in compliance with all applicable laws and is a company registering, strategically, to be based in the Netherlands, an area that currently sells truffles. Red Light has collected a core group of highly skilled individuals who bring a wealth of knowledge and experience relating to growing, mass-producing, compliance, distributing, marketing and managing – which the company believes is necessary to assist in establishing itself as a leader in this emerging field. Red Light intends to fill this gap by providing a product that is grown under the strictest health and safety guidelines, and intends to market and sell its products pursuant to an EU-GMP certification, which it does not currently possess. Red Light plans to generate revenues by providing recreational grade truffles and potentially EU-GMP medical grade truffles to the current adult use market in the Netherlands.

About Revive Therapeutics Ltd.

Revive is a cannabis life sciences company focused on the research, development and commercialization of novel cannabinoid-based products. Revive’s novel cannabinoid delivery technology is being advanced to fill the medical needs for diseases and disorders such as pain, inflammation, and wound care. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory and liver diseases. For more information, visit www.ReviveThera.com.

For more information please contact:

Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.

Tel: Email: Website:

905.605.5535 mfrank@fbn.436.myftpupload.com www.revivethera.com

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BERLIN and MIAMI, Jan. 24, 2020 /PRNewswire/ — ATAI Life Sciences AG (“ATAI” or the “Company”), a global biotech platform that envisions an end to mental illnesses, today announced an investment in two separate joint ventures (JV) with DemeRx, a clinical stage pharmaceutical company focused on developing ibogaine and noribogaine for the treatment of opioid use disorder (OUD).

OUD represents a significant unmet medical need, particularly in the United States. In 2018 alone, 2.1 million Americans met the diagnostic criteria for OUD, while 47,600 people died from opioid overdoses. Current treatment options for OUD are limited and carry risk of significant side effects and abuse potential. Overall, relapse rates across substance use disorders are estimated to be between 40 and 60%, due in part to the lack of effective therapeutics and low patient compliance.

Ibogaine is a natural indole alkaloid derived from the West African iboga plant and has previously been marketed as a stimulant and antidepressant in France under the brand name Lambarène. Known for its oneirophrenic and hallucinogenic properties, uncontrolled data from hundreds of patients suggest that ibogaine is effective as both an acute detoxifier and treatment for opioid addiction.

The largest study of ibogaine to date, an open-label case series of 102 opioid dependent and 89 cocaine dependent subjects in St. Kitts, West Indies, found that a single low, orally administered dose of ibogaine significantly reduced opioid withdrawal scores 36-hours post treatment, while also reducing the severity of cravings and depression in both cohorts. Importantly, these positive effects persisted at a one-month follow up.

“Not only were patients able to safely and successfully transition into sobriety, we found no evidence of additional abuse potential,” said Dr. Deborah Mash, CEO of DemeRx and principal investigator on the St. Kitts study. “Given the limitation in currently available treatments, ibogaine represents an enormous leap forward for OUD sufferers.”

While complications related to ibogaine have been documented, most such cases appear to be due to prior medical conditions or drug interaction. Of 19 recorded fatalities between 1990 and 2008, none were found to be the result of ibogaine’s toxicity. Nevertheless, ibogaine therapy is contraindicated for those with cardiovascular issues, particularly in cases of prolonged QTc Interval or hypertrophic cardiomyopathy. The ibogaine JV will involve developing a treatment protocol that includes proper screening procedures, dosing guidelines, and administration best practices to ensure patient safety.

Ibogaine affects a variety of neurotransmitter systems, including serotonin, opioid, and NMDA receptors. In humans, ibogaine is metabolized into noribogaine, which may itself have applications as a follow-up or maintenance therapy; its potential as a separate treatment will be evaluated in the noribogaine JV. Although the exact mechanisms behind ibogaine’s dissociative psychedelic effects are unclear, it has been speculated that the dream-like state induced in patients leads to a kind of “brain reset” that is important for the therapeutic effects observed.

Due to the extensive database for ibogaine, including a substantial amount of human data, ATAI and DemeRx plan to submit Clinical Trial Applications for a Phase II study in opioid-dependent patients.

“We are very concerned about the opioid epidemic in the United States and around the world,” said Florian Brand, CEO of ATAI. “Together with DemeRx, we are committed to developing novel approaches to both treat and prevent opioid addiction.”

“This addition to our platform is particularly meaningful for us because it rounds out our focus on the essentials of mental healthcare, namely depression, anxiety – and now – addiction,” added ATAI founder Christian Angermayer. “Our values are aligned with the needs of underserved patients, so we see it as our responsibility to tackle the opioid crisis head on.”

About ATAI Life Sciences
ATAI Life Sciences AG is a global biotech platform and company builder founded by Christian Angermayer. Based in Berlin, London and New York, its vision is to cure mental health disorders, enabling people to live healthier and happier lives. www.atai.life

Company Contact:
Allan Malievsky
ATAI Life Sciences
Phone: +1 (917) 974-1371
Email: Allan@ATAI.life

Investor Contact:
Allison Soss
KCSA Strategic Communications
Phone: +1 (212) 896-1267
Email: ATAI@KCSA.com

SOURCE ATAI Life Sciences

Related Links

http://www.atai.life

BERLIN and MIAMI, Jan. 24, 2020 /PRNewswire/ — ATAI Life Sciences AG (“ATAI” or the “Company”), a global biotech platform that envisions an end to mental illnesses, today announced an investment in two separate joint ventures (JV) with DemeRx, a clinical stage pharmaceutical company focused on developing ibogaine and noribogaine for the treatment of opioid use disorder (OUD).

OUD represents a significant unmet medical need, particularly in the United States. In 2018 alone, 2.1 million Americans met the diagnostic criteria for OUD, while 47,600 people died from opioid overdoses. Current treatment options for OUD are limited and carry risk of significant side effects and abuse potential. Overall, relapse rates across substance use disorders are estimated to be between 40 and 60%, due in part to the lack of effective therapeutics and low patient compliance.

Ibogaine is a natural indole alkaloid derived from the West African iboga plant and has previously been marketed as a stimulant and antidepressant in France under the brand name Lambarène. Known for its oneirophrenic and hallucinogenic properties, uncontrolled data from hundreds of patients suggest that ibogaine is effective as both an acute detoxifier and treatment for opioid addiction.

The largest study of ibogaine to date, an open-label case series of 102 opioid dependent and 89 cocaine dependent subjects in St. Kitts, West Indies, found that a single low, orally administered dose of ibogaine significantly reduced opioid withdrawal scores 36-hours post treatment, while also reducing the severity of cravings and depression in both cohorts. Importantly, these positive effects persisted at a one-month follow up.

“Not only were patients able to safely and successfully transition into sobriety, we found no evidence of additional abuse potential,” said Dr. Deborah Mash, CEO of DemeRx and principal investigator on the St. Kitts study. “Given the limitation in currently available treatments, ibogaine represents an enormous leap forward for OUD sufferers.”

While complications related to ibogaine have been documented, most such cases appear to be due to prior medical conditions or drug interaction. Of 19 recorded fatalities between 1990 and 2008, none were found to be the result of ibogaine’s toxicity. Nevertheless, ibogaine therapy is contraindicated for those with cardiovascular issues, particularly in cases of prolonged QTc Interval or hypertrophic cardiomyopathy. The ibogaine JV will involve developing a treatment protocol that includes proper screening procedures, dosing guidelines, and administration best practices to ensure patient safety.

Ibogaine affects a variety of neurotransmitter systems, including serotonin, opioid, and NMDA receptors. In humans, ibogaine is metabolized into noribogaine, which may itself have applications as a follow-up or maintenance therapy; its potential as a separate treatment will be evaluated in the noribogaine JV. Although the exact mechanisms behind ibogaine’s dissociative psychedelic effects are unclear, it has been speculated that the dream-like state induced in patients leads to a kind of “brain reset” that is important for the therapeutic effects observed.

Due to the extensive database for ibogaine, including a substantial amount of human data, ATAI and DemeRx plan to submit Clinical Trial Applications for a Phase II study in opioid-dependent patients.

“We are very concerned about the opioid epidemic in the United States and around the world,” said Florian Brand, CEO of ATAI. “Together with DemeRx, we are committed to developing novel approaches to both treat and prevent opioid addiction.”

“This addition to our platform is particularly meaningful for us because it rounds out our focus on the essentials of mental healthcare, namely depression, anxiety – and now – addiction,” added ATAI founder Christian Angermayer. “Our values are aligned with the needs of underserved patients, so we see it as our responsibility to tackle the opioid crisis head on.”

About ATAI Life Sciences
ATAI Life Sciences AG is a global biotech platform and company builder founded by Christian Angermayer. Based in Berlin, London and New York, its vision is to cure mental health disorders, enabling people to live healthier and happier lives. www.atai.life

Company Contact:
Allan Malievsky
ATAI Life Sciences
Phone: +1 (917) 974-1371
Email: Allan@ATAI.life

Investor Contact:
Allison Soss
KCSA Strategic Communications
Phone: +1 (212) 896-1267
Email: ATAI@KCSA.com

SOURCE ATAI Life Sciences

Related Links

http://www.atai.life