Kalytera Therapeutics, Inc. (TSXV:KALY and OTCQB:KALTF) (the “Company” or “Kalytera”) today announced positive interim data from its ongoing Phase 2 clinical study evaluating cannabidiol (“CBD”) for the prevention of acute graft versus host disease (“GVHD”) following bone marrow transplant.
GVHD is a life-threatening complication commonly occurring after bone marrow transplant procedures. GVHD occurs when the transplanted donor cells attack the patient’s organs, including the skin, GI tract, liver, lungs, and eyes. GVHD is associated with acute and chronic illness, infections, disability, reduced quality of life, and death. There are currently no FDA approved therapies for either the prevention or treatment of acute GVHD.
It is estimated that up to 50% of patients who undergo a bone marrow transplant from a sibling donor, and up to 70% of patients who undergo a bone marrow transplant from an unrelated donor, will develop some level of GVHD.
Key Findings to Date:
Interim data from the initial 12-patient cohort support the following key findings to date:
- No patients receiving oral CBD at the lowest study dose of 75 mg twice daily (“BID”) have developed grades 3 or 4 acute GVHD, the most serious forms of the disease.
- One patient developed grade 2 acute GVHD, the least serious form of the disease.
- CBD has demonstrated a good safety and tolerability profile, with no significant adverse events relating to its use.
Kalytera’s ongoing Phase 2 clinical study is an open label, multicenter study to evaluate multiple doses of CBD for the prevention of acute GVHD following allogeneic hematopoietic cell transplantation, commonly referred to as bone marrow transplantation. The study will evaluate the PK profile, safety, and efficacy of CBD at doses of 75, 150, and 300 mg BID. All patients in the study receive CBD treatment for 7-days prior to their bone marrow transplant procedure, and for 98-days following the procedure.
The study will enroll a total of 36 patients in three 12-patient cohorts. The first cohort is the low dose cohort, with patients in this cohort receiving the 75 mg BID dose. Enrollment of the first cohort is complete, although all 12 patients in this cohort have not yet completed the entire 105-day course of treatment with CBD. It is anticipated that all of the patients in the first cohort will have completed the entire 105-day course of treatment with CBD by February 28, 2019.
To date, two patients in the first cohort have died. Significantly, however, these patients died from causes unrelated to GVHD, and neither of these patients developed GVHD while in the study. One of the patients in the first cohort did develop stage 2 acute GVHD, which is the least serious form of the disease, after 91 days on study.
CBD is a non-psychotropic ingredient of cannabis that does not cause euphoria or cognitive effects. The formulation of CBD that Kalytera is evaluating for the prevention of acute GVHD is a proprietary formulation that is designed to improve product stability and absorption after oral dosing.
“We are very pleased with these interim results to date, which show compelling safety, tolerability and PK data, as well as evidence of potential efficacy. The fact that these positive results were seen in patients in the lowest dose cohort is particularly encouraging,” said Robert Farrell, President and CEO of Kalytera. “These clinical data confirm our expectation that CBD has potential to become the first pharmaceutical approved for prevention of acute GVHD following bone marrow transplantation.”
Mr. Farrell further stated that, “With no FDA approved therapy for the prevention of acute GVHD, there exists an important unmet medical need that we believe we can address. We are optimistic that our CBD product will address this unmet need, and will be demonstrated to be a safe and effective means to prevent the onset of acute GVHD. The complete Phase 2 data set should provide strong support for our planned Phase 3 study, which we expect to initiate in 2019.”
The Potential Commercial Opportunity is Large
The commercial opportunity for Kalytera’s CBD product for prevention of acute GVHD is large. Because acute GVHD is a serious and life threatening orphan disease, Kalytera believes that it will be able to obtain premium pricing for a course of treatment. The incidence of acute GVHD following bone marrow transplantation in the six major markets of the U.S., Germany, the U.K., France, Spain and Japan is above 20,000 patients per year. Given this addressable market, and the expected premium pricing that Kalytera believes it will obtain, the commercial opportunity for the Company’s CBD product in prevention of acute GVHD is potentially more than USD $1 billion annually.
The Company believes that it will be able to successfully overcome the threat of competition from non-prescription generic CBD for the following reasons:
- Kalytera’s CBD product is covered by two issued U.S. patents, which provide market exclusivity through approximately 2034. Kalytera has also applied for patents in the EU and other jurisdictions.
- Kalytera has been granted orphan drug designation (“ODD Designation”) for its CBD product for the prevention of acute GVHD in both the U.S. and the EU. These ODD Designations will provide another form of market exclusivity: 7-years in the U.S. and 10-years in the EU.
- Most importantly, patients who have undergone a bone marrow transplantation procedure are at high risk of developing acute GVHD, which is a serious and life threatening disorder. These patients are often in isolation in the intensive care unit, and it is highly unlikely that a treating physician would prescribe any form of CBD other than an approved formulation. Of secondary importance is the fact that in all jurisdictions where the Company intends to market its CBD product, neither private insurance nor government provided healthcare reimbursement would be available for non-prescription generic CBD.
New Results Consistent with Previously Announced Positive Data from Earlier Studies in Prevention of Acute GVHD
Prior to the ongoing Phase 2 clinical study in prevention of acute GVHD, two Phase 2a clinical studies were completed evaluating CBD in the prevention of GVHD. Kalytera has previously announced the results from these two studies. Data from both of these clinical studies were positive and highly encouraging. Dr. Moshe Yeshurun, Kalytera’s Chief Medical Officer, was the Principal Investigator for both of these studies, which were conducted at the Institute of Hematology, Davidoff Center, Rabin Medical Center, Petah Tikva, Israel. These studies were carried out by Dr. Yeshurun prior to the date he joined the Company, and the Company subsequently acquired the relevant technology through its acquisition of Talent Biotechs Ltd. in February 2017.
“I am very enthusiastic about the results to date from our ongoing Phase 2 study,” commented Dr. Moshe Yeshurun. “These data are consistent with our two previous Phase 2a clinical studies evaluating CBD in the prevention of acute GVHD. Data from both of those clinical studies were positive and highly encouraging.”
The results from the first of these previous clinical studies were published in May 2015 in Biology of Blood and Marrow Transplantation (Cannabidiol for the Prevention of Graft-versus-Host-Disease after Allogeneic Hematopoietic Cell Transplantation: Results of a Phase II Study, M. Yeshurun et al. / Biology Blood Marrow Transplant 21 (2015) 1770 – 1775).
As previously announced, the data from this study, in which 48 patients received daily doses of 150 mg of CBD administered twice daily for 7 days prior to the bone marrow transplant procedure and for 30 days after, demonstrated the following results:
- No patients developed acute GVHD while being treated with CBD;
- The rates of grades 2-4 acute GVHD by day 100 were 12.1%, compared with 46% in a group of all 101 hematopoietic stem cell transplant recipients who received standard GVHD prophylaxis at the same institution in Israel (the Institute of Hematology, Davidoff Center, Rabin Medical Center at Beilinson Hospital) directly prior to the onset of this study; and
- CBD was found to be safe and well tolerated
Kalytera also previously announced the results from the second of the two previous clinical studies, in which 12 patients were administered CBD at a dose of 150 mg administered twice daily from 7 days prior to the bone marrow transplant procedure until up to 100-days post transplantation. In that study, no safety issues were observed, and only 15% of patients in the CBD treatment group developed grades 2-4 acute GVHD, compared to a 46% incidence at the same institution in the historical group of 101 patients described above.
Kalytera is the exclusive licensee of two issued U.S. patents covering the use of CBD in the prevention and treatment of GVHD, and is also the exclusive licensee of pending patent applications in other jurisdictions for the use of CBD in the prevention and treatment of GVHD.
The U.S. FDA has recommended that Kalytera apply for both Breakthrough Therapy and Fast Track Designations for its CBD products for prevention and treatment of acute GVHD, each of which could accelerate the approval process for these products.
About Kalytera Therapeutics
Kalytera Therapeutics, Inc. is pioneering the development of CBD therapeutics. Through its proven leadership, drug development expertise, and intellectual property portfolio, Kalytera seeks to establish a leading position in the development of CBD medicines for a range of important unmet medical needs, with an initial focus on GVHD and treatment of acute and chronic pain.
- Website Home: https://kalytera.co/
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Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
This press release may contain certain forward-looking information and statements (“forward-looking information”) within the meaning of applicable Canadian securities legislation, that are not based on historical fact, including without limitation in respect of its product candidate pipeline, planned clinical trials, regulatory approval prospects, intellectual property objectives and other statements containing the words “believes”, “anticipates”, “plans”, “intends”, “will”, “should”, “expects”, “continue”, “estimate”, “forecasts” and other similar expressions. Readers are cautioned to not place undue reliance on forward-looking information. Actual results and developments may differ materially from those contemplated by these statements depending on, among other things, the risk that future clinical studies may not proceed as expected or may produce unfavourable results. Kalytera undertakes no obligation to comment on analyses, expectations or statements made by third parties, its securities, or financial or operating results (as applicable). Although Kalytera believes that the expectations reflected in forward-looking information in this press release are reasonable, such forward-looking information has been based on expectations, factors and assumptions concerning future events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond Kalytera’s control. The forward-looking information contained in this press release is expressly qualified by this cautionary statement and is made as of the date hereof. Kalytera disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking information, whether as a result of new information, future events or otherwise.
A report just released in early April confirms that the cannabis beverage sector is thriving. According to this report from industry stalwart, Marijuana Business Daily while sales for vapes, pre-rolls and flower were lackluster, cannabis beverages shined:
“The beverage category continued to shine in the first quarter, leading all categories with sales growing 68.4% over the same period last year and 14.2% versus the fourth quarter of 2020. Most beverage categories experienced double-digit growth going into 2021.”
That’s a staggering increase. And from the looks of the numbers, it’s a trend, not a fad. Cannabis beverages are becoming an option for consumers as more and more hit shelves and brands get smarter about dosing, flavors, and what customers want. With the summer months fast approaching, sales have been picking up in key markets.
It’s a good time to be a health and wellness company, and the cannabis beverage space as the category leads the industry in growth. There are only a few companies leading the industry, including HEXO Cannabis Canopy Growth Corp, Keef Beverages (Private). BevCanna Enterprises Inc. (CSE:BEV, Q:BVNNF, FSE:7BC) has been making significant progress recently, and is now run by former Pepsi Co. executive, Melise Panetta, a veteran CPG and Cannabis executive with years of expertise selling and marketing some of the world’s most recognized beverage brands. It also added two veteran CPG (Consumer Packaged Goods) senior sales leaders to the organization.
BevCanna not only owns their own water source, a pristine alkaline spring water aquifer in British Columbia, but a world–class 40,000–square–foot, HACCP certified manufacturing facility which has a bottling capacity to produce up to 200M bottles annually. BevCanna’s extensive distribution network includes more than 3,000 points of retail distribution through its market-leading TRACE brand in Canada, a growing natural health and wellness e-commerce platform, Pure Therapy , its fully licensed Canadian cannabis manufacturing plant and distribution network, and a partnership with #1 U.S. cannabis beverage company Keef Brands .
Growing product line, world class leadership, and a growing sales team with experience, BevCanna is positioned to capitalize on the growing demand of Cannabis 3.0 beverages, and it’s looking to capture a piece of the market, which appears to be one of the hottest right now in the ever expanding cannabis industry.
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BevCanna Enterprises (CSE:BEV,OTCQQ:BVNNF,FWB:7BC) CEO Marcello Leone shared how the company is scaling up its products to forge partnerships and explore opportunities across Canada, the US and Western Europe.
“Getting your standard processing license and being fully compliant at a federal level is critical in Canada, and we were successful in getting that done. Now we’re getting ready to launch our Keef line of beverages within the next 45 days,” Leone said.
As a young company, Leone said BevCanna has only started, but it took a four-pronged approach to make sure that it is a revenue-generating company prepared for the opening of many jurisdictions for CBD-based products.
“We are blessed that we have a beautiful infrastructure of our own, a state-of-the-art bottling facility with a capacity of almost 200 million bottles per annum and a strong balance sheet of $55 million. We are in a strong position to scale and grow this company.”
BevCanna has received a Standard Processing License from Health Canada and is now fully authorized to begin production at its full-service, high-capacity beverage manufacturing facility. The company will begin production of its white-label products, number one US cannabis beverage brand Keef and its in-house beverages through licensed Canadian retailers, positioning the company to fully capitalize on the burgeoning Canadian cannabis-infused beverage sector.
Watch the full interview with CEO Marcello Leone above.
This interview is sponsored by BevCanna Enterprises (CSE:BEV,OTCQB:BVNNF,FWB:7BC). This interview provides information which was sourced by the Investing News Network (INN) and approved by BevCanna Enterprises in order to help investors learn more about the company. BevCanna Enterprises is a client of INN. The company’s campaign fees pay for INN to create and update this interview.
INN does not provide investment advice and the information on this profile should not be considered a recommendation to buy or sell any security. INN does not endorse or recommend the business, products, services or securities of any company profiled.
The information contained here is for information purposes only and is not to be construed as an offer or solicitation for the sale or purchase of securities. Readers should conduct their own research for all information publicly available concerning the company. Prior to making any investment decision, it is recommended that readers consult directly with BevCanna Enterprises and seek advice from a qualified investment advisor.
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Positive distributor feedback and strong consumer interest accelerating launch with distributors
Emerging leader in innovative health and wellness beverages and products, BevCanna Enterprises Inc. ( CSE:BEV , Q:BVNNF , FSE:7BC ) (“ BevCanna ” or the “ Company ”) announces today that its wholly-owned subsidiary Naturo Group has successfully completed its initial shipment of TRACE plant-based products to one of Japan’s largest beverage distributors.
Following up on its recently announced Japanese distribution agreement with Mirai Marketing Inc., the Company is now in active discussions with established beverage distributors to leverage their robust distribution networks and integrate TRACE’s proprietary plant-based mineral formulation into their distribution pipeline, targeting the growing health-conscious consumer segment in Japan.
“BevCanna’s market research on Japanese purchaser preferences confirms that these consumers are very responsive to natural, health-conscious products, and that TRACE’s proprietary plant-based mineralized beverages and nutraceuticals will be well received,” said Melise Panetta, President of BevCanna. “Our first product shipment to Japan will build our distribution network within this burgeoning market and solidify Japan as a primary market within our international expansion strategy.”
About BevCanna Enterprises Inc.
BevCanna Enterprises Inc. ( CSE:BEV , Q:BVNNF , FSE:7BC ) is a diversified health & wellness beverage and natural products company. BevCanna develops and manufactures a range of plant-based and cannabinoid beverages and supplements for both in-house brands and white-label clients.
With decades of experience creating, manufacturing and distributing iconic brands that resonate with consumers on a global scale, the team demonstrates an expertise unmatched in the nutraceutical and cannabis-infused beverage categories. Based in British Columbia, Canada, BevCanna owns a pristine alkaline spring water aquifer and a world–class 40,000–square–foot, HACCP certified manufacturing facility, with a bottling capacity of up to 210M bottles annually. BevCanna’s extensive distribution network includes more than 3,000 points of retail distribution through its market-leading TRACE brand, its Pure Therapy natural health and wellness e-commerce platform, its fully licensed Canadian cannabis manufacturing and distribution network, and a partnership with #1 U.S. cannabis beverage company Keef Brands .
Disclaimer for Forward-Looking Information
This news release contains forward-looking statements. All statements, other than statements of historical fact that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future are forward-looking statements. Forward-looking statements in this news release include statements regarding: that the Company is now in active discussions with established beverage distributors to leverage their robust distribution networks and integrate TRACE’s proprietary plant-based mineral formulation into their distribution pipeline, targeting the growing health-conscious consumer segment in Japan; the Company’s first product shipment to Japan will build its distribution network within this burgeoning market and solidify Japan as a primary market within its international expansion strategy; and other statements regarding the business plans of the Company. The forward-looking statements reflect management’s current expectations based on information currently available and are subject to a number of risks and uncertainties that may cause outcomes to differ materially from those discussed in the forward-looking statements.
Although the Company believes that the assumptions inherent in the forward-looking statements are reasonable, forward-looking statements are not guarantees of future performance and, accordingly, undue reliance should not be put on such statements due to their inherent uncertainty. Factors that could cause actual results or events to differ materially from current expectations include, among other things: general market conditions; changes to consumer preferences; volatility of commodity prices; future legislative, tax and regulatory developments; inability to access sufficient capital from internal and external sources, and/or inability to access sufficient capital on favourable terms; the inability to implement business strategies; competition; currency and interest rate fluctuations; inability to successfully negotiate and enter into commercial arrangements with other parties; and other factors beyond the control of the Company and its commercial partners. The Company disclaims any intention or 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, and the Company does not assume any liability for disclosure relating to any other company mentioned herein.
On behalf of the Board of Directors:
John Campbell, Chief Financial Officer and Chief Strategy Officer
Director, BevCanna Enterprises Inc.
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Cresco Labs Announces the Appointment of Tarik Brooks to Its Board of Directors and the Retirement of Dominic Sergi
Cresco Labs (CSE:CL) (OTCQX:CRLBF) (“Cresco Labs” or the “Company”), a vertically integrated multistate operator and the number one U.S. wholesaler of branded cannabis products, today announced an additional refreshment of its board of directors to further strengthen its leadership in the cannabis industry.
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Cresco Labs appoints Tarik Brooks, President of Combs Enterprises, to its Board of Directors (Photo: Business Wire)
Appointment of Tarik Brooks
Cresco Labs has appointed Tarik Brooks to its board of directors, effective immediately. Mr. Brooks is a seasoned executive with more than 22 years of experience driving large scale business transformations across several industries including spirits, hospitality and media.
Currently, as President of Combs Enterprises, Mr. Brooks oversees all business operations and investments owned by Sean “Diddy” Combs. This diverse portfolio includes ventures in spirits (Ciroc Vodka and DeLeon Tequila), media (Revolt TV), music (Bad Boy Records), consumer packaged goods (AquaHydrate), and education (Capital Preparatory Schools). Mr. Brooks also leads all new business development activity, including the launch of “Our Fair Share”, a platform to help minority owned businesses access capital through the Paycheck Protection Program (PPP).
Prior to his current role, Mr. Brooks was the Chief Operating Officer of Account Management and Trading at Bridgewater Associates, the world’s largest hedge fund. Earlier in his career, Mr. Brooks served as Executive Vice President at RLJ Companies, a portfolio of companies owned by investor Robert L. Johnson, where Mr. Brooks led the development of gaming/nightlife ventures in the Caribbean and the completion of RLJ Kendeja, a resort hotel in Liberia.
Throughout his career, Brooks has negotiated transactions, including acquisitions and capital raises, led major strategic initiatives, and oversaw compliance in highly regulated industries. Mr. Brooks is a graduate of Howard University and Harvard Business School.
“I’m thrilled to welcome Tarik Brooks to our board of directors. He has remarkable experience building and managing consumer brands and will be an invaluable member of our organization as cannabis continues to evolve as a consumer packaged good,” said Tom Manning, Cresco Labs Executive Chairman. “We’ve taken a measured approach to building our board, periodically making refreshments that add new skills and experience to the group. Tarik represents another key appointment for Cresco Labs at a critical time of growth and expansion for the company.”
Retirement of Dominic Sergi
The Company announced today that Dominic Sergi, an original founder of Cresco Labs, has retired from the Company’s board of directors as part of the planned board refreshment process. Mr. Sergi currently serves as CEO of Clear Height Properties and spends his free time supporting the Nicholas D. Sergi Foundation. Mr. Sergi has been a foundational part of Cresco Labs since the company’s inception and his experience in real estate development has played an instrumental part in the construction of Cresco Labs’ asset base.
“I want to sincerely thank Dominic for his many years of service and for helping to guide this organization toward the top of the cannabis industry. Dominic is one of the most considerate and giving people I know and it has been a pleasure building this Company together,” said Charlie Bachtell, CEO of Cresco Labs.
About Cresco Labs Inc.
Cresco Labs is one of the largest vertically integrated multistate cannabis operators in the United States, with a mission to normalize and professionalize the cannabis industry. Employing a consumer-packaged goods (“CPG”) approach, Cresco Labs is the largest wholesaler of branded cannabis products in the U.S. Its brands are designed to meet the needs of all consumer segments and comprised of some of the most recognized and trusted national brands including Cresco, High Supply, Mindy’s Edibles, Good News, Remedi, Wonder Wellness Co. and FloraCal Farms. Sunnyside, Cresco Labs’ national dispensary brand, is a wellness-focused retailer created to build trust, education and convenience for both existing and new cannabis consumers. Recognizing that the cannabis industry is poised to become one of the leading job creators in the country, Cresco Labs operates the industry’s largest Social Equity and Educational Development initiative, SEED, which was established to ensure that all members of society have the skills, knowledge and opportunity to work and own businesses in the cannabis industry. Learn more about Cresco Labs at www.crescolabs.com .
Forward Looking Statements
This press release contains “forward-looking information” within the meaning of applicable Canadian securities legislation and may also contain statements that may constitute “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such forward-looking information and forward-looking statements are not representative of historical facts or information or current condition, but instead represent only the Company’s beliefs regarding future events, plans or objectives, many of which, by their nature, are inherently uncertain and outside of the Company’s control. Generally, such forward-looking information or forward-looking statements can be identified by the use of forward-looking terminology such as, ‘may,’ ‘will,’ ‘should,’ ‘could,’ ‘would,’ ‘expects,’ ‘plans,’ ‘anticipates,’ ‘believes,’ ‘estimates,’ ‘projects,’ ‘predicts,’ ‘potential’ or ‘continue’ or the negative of those forms or other comparable terms and includes, but is not limited to, statements relating to the expected timing by which Bluma Wellness will be de-listed from the CSE and the intention to apply to have Bluma Wellness cease to be a reporting issuer and terminate its public reporting obligations. The Company’s forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including but not limited to those risks discussed under “Risk Factors” in the Company’s Annual Information Form for the year ended December 31, 2020 dated March 26, 2021, and other documents filed by the Company with Canadian securities regulatory authorities; and other factors, many of which are beyond the control of the Company. Readers are cautioned that the foregoing list of factors is not exhaustive. Because of these uncertainties, you should not place undue reliance on the Company’s forward-looking statements. No assurances are given as to the future trading price or trading volumes of Cresco Labs’ shares, nor as to the Company’s financial performance in future financial periods. The Company does not intend to update any of these factors or to publicly announce the result of any revisions to any of the Company’s forward-looking statements contained herein, whether as a result of new information, any future event or otherwise. Except as otherwise indicated, this press release speaks as of the date hereof. The distribution of this press release does not imply that there has been no change in the affairs of the Company after the date hereof or create any duty or commitment to update or supplement any information provided in this press release or otherwise.
Jason Erkes, Cresco Labs
Chief Communications Officer
Jake Graves, Cresco Labs
Manager, Investor Relations
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