Search Results for: Tilray

Tilray Releases 11 Million Shares From Lock-Up Agreement

CANADA: Tilray, a global pioneer in cannabis production, research, cultivation and distribution, announced that the Board of Directors of Tilray unanimously approved the pro rata release of 11 million shares of Class 2 common stock held by the former equity holders of Privateer Holdings, Inc.

The shares are being released from lock-up agreements entered into in under the Agreement and Plan of Merger and Reorganization, dated September 9, 2019, by and among Tilray, Privateer, Down River Merger Sub, LLC, a Delaware limited liability company and wholly owned subsidiary of Tilray, and Michael Blue, as the Stockholder Representative. The waiver and release will take effect on April 3, 2020, and the released shares may be sold on or after that date, subject to applicable securities law or contractual limitations.

A previously announced agreement between Tilray and Privateer required that each Privateer equity holder who received the shares of Tilray stock or options to purchase Tilray stock in the merger were subject to a lock-up allowing for the sale of such shares only under certain circumstances over a two-year period beginning December 12, 2020. During the first year following the closing of the merger, shares will be released only pursuant to certain offerings or sales arranged by and at the discretion of Tilray. The pro rata release will be treated as a “permitted sale” under the lock-up agreements, waiving the release requirements with respect to such shares included in the lock-up agreement.

“The shares to be released on April 3, 2020 are part of the previously announced release of Tilray stock over a two-year period,” said Michael Kruteck, Tilray’s Chief Financial Officer. “We believe the staggered release of locked-up shares, as well as strategic and marketed offerings, will manage our public float in an orderly fashion.”

The waiver and release announced today will apply on a pro rata basis to each former Privateer equity holder who received shares of or options to purchase Tilray Class 2 common stock in the merger, including certain Tilray officers and directors.

The waiver and release of the 11 million shares represents approximately 14.5% of the locked-up shares (including for purposes of this percentage calculation shares that remain subject to escrow and/or subject to outstanding assumed stock options).

Tilray Expands Global Leadership Team With New COO And CFO

CANADA: Tilray, a global pioneer in cannabis production, research, cultivation, and distribution, announces the expansion of its global senior leadership team with two strategic hires: Jon Levin as Chief Operating Officer, who was formerly with Revlon, and Michael Kruteck as Chief Financial Officer, who was formerly with Molson Coors and Pharmaca. Mr. Kruteck’s appointment will be effective immediately after filing the Annual Report on Form 10-K for the year ended December 31, 2019. Mark Castaneda, Tilray’s current CFO, will take on the role of Strategic Business Development and continue to advise the company and assist in Kruteck’s transition.
 
“We are thrilled to have these experienced leaders join our team as we continue to disrupt the global pharmaceutical, alcohol, CPG and functional food and beverage industries,” said Brendan Kennedy, Tilray CEO. “Jon and Michael come to Tilray with extensive expertise in their respective fields and we look forward to their contributions as we pioneer the future of cannabis and hemp around the world.  As CFO, Mark has led the company through its IPO and substantial growth in the past couple years and we thank him as he transitions to a new strategic role with the company.”
 
Levin, COO, joins Tilray from Revlon where he most recently was General Manager, U.S. Mass Markets, responsible for the consumer products sold through major retailers in the United States. With 25 years of experience, Levin has general management knowledge in diverse industries including beauty and health, CPG and sporting goods. Prior to Revlon, he was the Executive Vice President, Sales, for Ferrara Candy Company, and had senior sales leadership positions with Nautilus, Wrigley and Acosta. Levin has a B.S. in Economics from Portland State University and a degree in Executive Management from Cornell University.
 
Kruteck, CFO, served multiple senior financial roles at Molson Coors Beverage Company and most recently as CFO for Pharmaca Integrative Pharmacy. With over 30 years of experience, Kruteck possesses a broad finance background with specific experience in financial and operational transformations, supply chain, corporate finance, and financial planning and analysis. Michael received his MBA from the Garvin School of International Management (Thunderbird) and his B.A. from the University of Colorado at Boulder.
 
Tilray’s current CFO, Mark Castaneda, who joined the company in March 2018, will take on the role of Strategic Business Development focusing on strategic initiatives for Tilray while also supporting Kruteck through the transition.

Tilray Exports First-Ever Shipment Of Medical Cannabis Allowed Into Israel

CANADA: Tilray, a global pioneer in cannabis research, cultivation, production and distribution, today announced it has entered into an agreement with Canndoc Ltd., a wholly-owned subsidiary of InterCure Ltd., through its wholly-owned subsidiary Tilray Portugal Unipessoal Lda., to export a wholesale shipment of up to 2.5 tonnes of medical cannabis from Portugal to Israel. The shipment, which will arrive early this month, is the first medical cannabis import allowed into Israel.
  
“We at Canndoc are driven by the mission of meeting patients’ needs and improving their quality of life,” says Ehud Barak, former Israeli Prime Minister and Chairman of the Canndoc Board of Directors. “With a supply shortage of medical cannabis in Israel, it’s incredibly important to partner with a trusted company like Tilray to import and distribute GMP-certified medical cannabis to physicians, pharmacies and patients across the country.”
 
Brendan Kennedy, Tilray’s Chief Executive Officer, said, “To be able to import medical cannabis into Israel for patients in need is truly a historic moment not only for Tilray, but the whole industry.” He continued,  “We’re incredibly honored to help increase patient access in Israel while becoming the first to ship medical cannabis into the country. Israel represents our fifteenth export country and the second shipment from our EU Campus in Cantanhede, Portugal.”
 
Founded in 2008 in Herzliya, Israel, Canndoc is an IMCA (Israeli Medical Cannabis Agency) permit holder for the manufacturing of medical cannabis in Israel and is the country’s first public company in the field. Canndoc has been active for more than 10 years in researching, developing, cultivating and marketing medical cannabis to thousands of patients under a wide range of medical indications approved by Israel’s Ministry of Health.
 
Tilray has a pioneering track record as a company committed to making pharmaceutical-grade medical cannabis products available to patients in need around the world. Tilray was the first licensed medical cannabis producer to successfully export medical cannabis from North America and import medical cannabis products into the EU in 2016.
 
In addition to the Tilray-Canndoc Israel supply agreement and to further support the Israeli medical cannabis market expansion, Tilray has also agreed to purchase up to 5 tonnes of GMP-certified whole flower from Canndoc beginning in mid-2020. If future Israeli regulations allow, the whole flower will be shipped to Tilray’s Portugal facility and turned into GMP-certified finished product to distribute across Europe.  Otherwise, the whole flower will be developed into finished medical cannabis and distributed as a Tilray-Canndoc branded GMP-certified finished product in Israel to further support local supply needs.

Tilray Completes Merger With Privateer Holdings

TilrayPrivateerCANADA: Tilray, Inc., a global pioneer in cannabis research, cultivation, production and distribution, today announced that the merger with Privateer Holdings, Inc. closed on December 12, 2019.
 
Mark Castaneda, Chief Financial Officer of Tilray, said: “We appreciate the long-term confidence that Privateer has in the Tilray business and we look forward to having their investors as part of our stockholder base. We believe this transaction will give Tilray greater control and operating flexibility, while allowing us to effectively manage our public float.”
 
Pursuant to the merger, all of Privateer’s capital stock outstanding immediately prior to the effective time of the merger (excluding certain shares) were cancelled and automatically converted solely into the right to receive the applicable portion of an aggregate shares of Tilray Class 2 common stock and shares of Tilray Class 1 common stock (inclusive of shares of Tilray Class 2 common stock held in escrow for contingent release to Privateer’s stockholders) issuable as consideration in merger.  Tilray did not pay any cash consideration in connection with the merger.

As previously disclosed, each Privateer equity holder who received the shares of Tilray stock in the merger is subject to a lock-up allowing for the sale of such shares only under certain circumstances over a two-year period. During the first year following the closing of the merger, shares will be released only pursuant to certain offerings or sales arranged by and at the discretion of Tilray. At the end of the first year, to the extent not already released at Tilray’s discretion as a result of the aforementioned offerings or sales, 50 percent of the total shares subject to the lock-up will be released. Over the course of the second year following closing, the remaining shares will be subject to a staggered release in four equal quarterly increments.

Tilray And Privateer Sign Definitive Agreement To Extend Lock-up And Provide For Orderly Distribution Of 75 Million Tilray Shares Held By Privateer

CANADA: Tilray, a global leader in cannabis research, cultivation, production, and distribution, today announced that it has signed a definitive merger agreement with its largest stockholder Privateer Holdings, Inc. for a transaction that will extend the lock-up on and provide for the issuance of up to 75 million Tilray shares to Privateer’s equity holders (and the cancellation of the 75 million shares currently owned by Privateer). These shares currently represent 77 percent of Tilray’s total shares outstanding. Tilray and Privateer previously announced the signing of a non-binding Letter of Intent for this transaction on June 10, 2019.
 
Under the terms of the definitive agreement, the parties will effect a downstream merger of Privateer with and into a wholly-owned subsidiary of Tilray, with the Tilray subsidiary surviving the merger, and the issuance by Tilray to Privateer equity holders of newly issued and registered shares of Tilray common stock and options to purchase shares of Tilray common stock in an aggregate amount equal to the number of Tilray common shares currently held by Privateer. As set forth in the definitive agreement, at its sole election (to be made prior to closing), Tilray may pay a portion of the merger consideration in cash in lieu of issuing an equivalent number of shares of Tilray.  All Tilray shares held by Privateer and all outstanding Privateer stock will be cancelled upon consummation of the merger.
 
Tilray was originally incubated and financed by Privateer as one of its wholly-owned operating subsidiaries before closing a Series A round of capital in February 2018 and then becoming the first cannabis producer to complete an Initial Public Offering (IPO) on a major U.S. stock exchange in July 2018. Earlier this year, Privateer distributed its ownership of its three other operating subsidiaries unrelated to Tilray directly to Privateer stockholders, leaving no material assets in Privateer other than the 75 million shares it currently holds in Tilray.
 
Pursuant to the terms of the definitive merger agreement, each Privateer equity holder who receives the shares of Tilray stock in the merger will be subject to a lock-up allowing for the sale of such shares only under certain circumstances over a two-year period. During the first year following the closing of the merger, shares will be released only pursuant to certain offerings or sales arranged by and at the discretion of Tilray. At the end of the first year, to the extent not already released as a result of any cash paid at closing and/or the aforementioned offerings or sales, 50 percent of the total shares subject to the lock-up will be released. Over the course of the second year following closing, the remaining shares will be subject to a staggered release in equal quarterly increments. 
 
Mark Castaneda, Chief Financial Officer of Tilray, said: “We appreciate the long-term confidence that Privateer has in the Tilray business and we look forward to having their investors as part of our stockholder base. We believe this transaction will give Tilray greater control and operating flexibility, while allowing us to effectively manage our public float.”
 
Michael Blue, Managing Partner of Privateer, said: “We are pleased to sign this agreement with Tilray, which we believe will maximize overall returns for our visionary investors in a tax-efficient manner while giving Tilray the operating flexibility it needs to continue to be a leader in the rapidly emerging global cannabis industry.”
 
In accordance with the terms of the transaction, the 16.7 million shares of Tilray Class 1 Common Stock (which have ten (10) votes per share) will be issued to Brendan Kennedy, Christian Groh and Michael Blue, the cofounders of Privateer, as part of their proportionate share of the merger consideration, with the remainder of the stock merger consideration being Tilray Class 2 Common Stock (which have one (1) vote per share). The merger agreement provides that $125 million worth of Tilray Class 2 Common Stock will be held in escrow for 18 months following the closing of the transaction to secure any potential indemnification claims, with the initial 50 percent of such escrow being withheld from all Privateer stockholders on a pro rata basis, and the remaining 50 percent coming solely from the Privateer cofounders.
 
The transaction has been unanimously approved by each of the Special Committee of Tilray’s Board of Directors (comprised of independent directors) and Privateer’s Board of Directors. The merger and the transactions contemplated in connection therewith will be consummated only if all conditions to closing set forth in the merger agreement are satisfied, including the requisite approval of the merger by the stockholders of Privateer and Tilray. Both parties intend to complete the transaction as expeditiously as possible.
 

Tilray Announces Agreement To Export First Shipment Of Medical Cannabis From Portugal To Germany

CANADA: Tilray, a global pioneer in cannabis research, cultivation, production and distribution, today announced it has entered into an agreement with Cannamedical Pharma GmbH (“Cannamedical”) through its wholly-owned subsidiary Tilray Portugal Unipessoal Lda. (“Tilray Portugal”), to export a wholesale shipment of $3.3 (€3) million worth of medical cannabis from Portugal to Germany. The shipment, which is expected to be completed in fall 2019, will be Tilray’s first from its state-of-the-art EU campus in Portugal to supply patients in Germany.

 tilray

“This is a significant milestone for Tilray as we ramp up our capacity to serve international markets and generate revenue from our EU campus through the end of 2019,” says Tilray CEO Brendan Kennedy. “We believe our 2.5 million square feet of cultivation and state-of-the-art processing space in Europe is an important differentiator, which will enable us to reduce costs and improve margins while hedging against regulatory risk.”

Founded in 2016 in Cologne, Germany, Cannamedical is fully licensed and GDP-certified (Good Distribution Practice) to import and distribute high quality medical cannabis products. The privately owned company is a leading independent supplier of medical cannabis products to 2,500 pharmacies and clinical facilities across Germany.

 “We at Cannamedical Pharma are committed to helping doctors, medical specialists and pharmacists improve their patients’ quality of life,” says Cannamedical CEO David Henn. “Tilray’s product has passed our strict quality control standards, and we’re excited to have found a partner able to deliver medical cannabis products for use in Cannamedical’s own brands. We look forward to increasing access for patients in need across the country.”

Tilray has a pioneering track record as a company committed to making pharmaceutical-grade medical cannabis products available to patients in need around the world. Tilray was the first licensed medical cannabis producer to successfully export medical cannabis from North America and import medical cannabis products into the EU in 2016 and the first company to import cannabis oils into the German market in 2017.

“We are pleased to enter into an agreement with a partner who shares Tilray’s commitment to product quality and safety and patient access,” says Sascha Mielcarek, Tilray’s Managing Director, Europe. “This initial shipment will be the first of many from

Tilray Reports Second Quarter 2019 Financial Results

 

CANADA: Tilray, a global pioneer in cannabis research, cultivation, production and distribution, today reported financial results for the second quarter ended June 30, 2019. All financial information in this press release is reported in U.S. dollars, unless otherwise indicated.

“We are pleased with our second quarter results and strong business momentum,” said Brendan Kennedy, Tilray President and Chief Executive Officer. “Our team has executed against our plan, with adult-use revenue nearly doubling in the second quarter compared to the first quarter and gross margin increasing sequentially for the second quarter in a row. As we continue to grow, we remain focused on our long-term strategic objectives and deploying capital to maximize stockholder value.”

Second Quarter 2019 Financial Highlights

  • Revenue increased 371.1% to $45.9 (C$60.9) million, compared to the second quarter of last year, driven by the Manitoba Harvest acquisition, the legalization of the Canadian adult-use market, and growth in international medical markets, particularly in Europe. Excluding excise tax, revenue was $42.0 (C$55.8) million.
  • Total kilogram equivalents sold more than tripled to 5,588 kilograms from 1,514 kilograms in the prior year period.
  • Average net selling price per gram decreased to $4.61 (C$6.12) compared to $6.38 (C$8.36) in the prior year period. The average net selling price excluding excise taxes was $3.92 (C$5.20) per gram for the second quarter of 2019. The decrease was due to a reduced mix of higher priced extract products and a greater mix of adult-use revenue, which are at lower prices per gram compared to other channels.
  • Gross margin increased sequentially to 27% from 23% in the prior quarter. Gross margin in the second quarter of 2018 was 43%. Gross margin continues to be impacted by increased costs incurred with the ramping up of cultivation facilities in Canada and Portugal and acquiring third party supply. Food product margins were also impacted by a $1.4 million non-cash charge related to purchase accounting for the fair value of inventory.  Excluding this purchase accounting charge, gross margin was 30% for the quarter.
  • Net loss for the quarter was $35.1 million or $0.36 per share compared to a loss of $12.8 million or $0.17 per share for the prior year period. The adjusted net loss for the quarter was $31.2 million or $0.32 per share for the second quarter of 2019. The adjustments to the net loss are non-recurring acquisition related charges and a non-recurring non-cash charge related to purchase accounting for the fair value of inventory. Adjusted EBITDA was a loss of $17.9 million compared to a loss of $4.7 million the prior year period. The increased net loss and Adjusted EBITDA declines were primarily due to the increase in operating expenses related to growth initiatives, interest expense from our convertible notes, the addition of Manitoba Harvest and Natura businesses, and the expansion of international operations.

Business Highlights   

  • Signed Letter of Intent (LOI) with Privateer Holdings, Inc. to extend lock-up for up to two years and provide for orderly release of the 75 million Tilray shares held by Privateer.
  • Significant capacity expansion:
    • Expanded international export capacity with standard manufacturing license and Good Manufacturing Practices (GMP) certification for EU Campus that allows Tilray Portugal to manufacture and export GMP-certified dried cannabis as an active substance for medicinal products.
    • Increased international export capacity with an additional 20 hectares (50 acres) of outdoor cultivation space in Portugal through a Definitive Agreement with Esporão, one of the largest and most sophisticated agricultural businesses in Portugal. This agreement will expand Tilray’s total production and manufacturing footprint to 3.4 million square feet worldwide.
    • Announced an investment of $32.6 million to increase our Canadian production and manufacturing footprint by 203,000 square feet across three facilities in Nanaimo, British Columbia, Leamington, Ontario, and London, Ontario.
  • Key international market developments:
    • Imported GMP-certified finished medical cannabis oil solutions into Ireland for nationwide distribution under the Medical Cannabis Access Programme.
    • Manitoba Harvest launched a Broad Spectrum Hemp Extract line that is Generally Recognized as Safe (GRAS) in the United States, marking Tilray’s first entry into the U.S. CBD market under this brand.
  • Expanding our brand portfolio: 
    • Acquired Smith & Sinclair, an innovative U.K.-based confectionary company that will introduce CBD-infused consumer products where regulations permit.
  • Clinical research developments: 
    • Announced support of two new clinical studies: a pilot study led by Murdoch Children’s Research Institute (MCRI) in Melbourne, Australia, to evaluate the feasibility and acceptability of a larger randomized placebo-controlled trial of cannabis extract as a form of treatment for reducing Severe Behavioral Problems (SBP) in pediatric patients with Intellectual Disabilities (ID); and a study with McGill University Health Centre’s Division of Infectious Diseases and Chronic Viral Illness in Quebec, Canada to examine the effectiveness of medical cannabis on immune activation in People Living with HIV.
    • Imported an initial shipment of medical cannabinoids into the United States, with approval from the U.S. government, to support two clinical trials led by NYU School of Medicine for patients with Alcohol Use Disorder and Post-Traumatic Stress Disorder with Alcohol Use Disorder.
  • Expanded global senior leadership team:
    • Appointed Kristina Adamski as Executive Vice President of Corporate Affairs, globally overseeing communications, government affairs and corporate social responsibility.
    • Strengthened European leadership team with the appointment of Arne Wilkens as Vice President, Business Expansion, Europe; José Tempero as Medical Affairs Director, Europe; Maike Gerlach as Vice President, Marketing, Europe; Nadja Frenzel as Vice President, Commercial Development, Europe; and Natalie Bucceri as Director, Global Portfolio Expansion.

Conference Call
The Company will host a conference call to discuss these results today at 5:00 p.m. ET. Investors interested in participating in the live call can dial 877-489-6528 from the U.S. and 629-228-0736 internationally. A telephone replay will be available approximately two hours after the call concludes through Tuesday, August 27, 2019, by dialing 855-859-2056 from the U.S., or 404-537-3406 from international locations, and entering confirmation code 1489081.

There will also be a simultaneous, live webcast available on the Investors section of the Company’s website at www.tilray.com. The webcast will be archived for 30 days.

Tilray Imports Bulk Supply of Medical Cannabis Oil Into The United Kingdom

CANADA: Tilray, a global pioneer in cannabis research, cultivation, production and distribution, today announced it has imported medical cannabis oral solutions in bulk into the United Kingdom from its Good Manufacturing Practices (GMP)-certified facility in Canada. This export allows Tilray to provide authorized U.K. patients in need with a locally maintained supply of medical cannabis oral solutions.
 
In September 2018, Tilray announced the successful import of Tilray 2:100 medical cannabis oil for a pediatric patient in need in the United Kingdom. Tilray’s 2:100 cannabis oil was supplied via a government-approved special access program following the U.K. Home Secretary’s historic announcement that declared prescriptions of cannabis-derived medicines legal for patients with an exceptional clinical need.
 
“As demand ramps up in the U.K., Tilray is well positioned to be a leading supplier of medical cannabis products,” says Sascha Mielcarek, Managing Director of Tilray Europe. “Regulations are progressing as more and more countries across Europe are recognizing the benefits of medical cannabis and its potential to improve patients’ quality of life. We’re pleased to reaffirm our commitment to delivering medical cannabis to patients in the U.K. and look forward to offering a variety of GMP-certified, pharmaceutical-grade products in the coming months.”
 
Tilray has six medical cannabis products approved for medical use in the U.K. that can be made available to patients with medical cannabis prescriptions obtained through private practice or the National Health Service. Tilray anticipates supplying a variety of cannabidiol (CBD)-dominant, tetrahydrocannabinol (THC)-dominant and balanced oral solutions for patients looking to use medicines derived from cannabis.
 
“This bulk import of Tilray medical cannabis oral solutions provides patients in need access to a sustained supply of GMP-certified, high quality medical cannabis,” says Catherine Jacobson, Tilray’s Vice President of Medical and Regulatory Affairs. “This is an important step in improving access in the U.K. Tilray will continue to advocate for reasonable patient access to medical cannabis in the U.K. and countries around the world.”

Tilray Hosts Official Ribbon-Cutting Ceremony At European Union Campus For Medical Cannabis Production and Distribution

The 250,000 square-foot facility located in Cantanhede, Portugal serves as the hub for Tilray’s cultivation, processing, distribution and research of medical cannabis products in Europe

CANADA: Tilray, a global pioneer in the research, cultivation, production and distribution of cannabis today celebrated the official opening of its European Union (EU) Campus located in Cantanhede, Portugal. Tilray CEO Brendan Kennedy, global senior leaders and the EU Campus Team welcomed guests from all over the world including international healthcare professionals, government officials and local dignitaries to celebrate the inauguration of the company’s European production and distribution centre.   
 
For the event, which followed Tilray’s successful outdoor harvest last year and greenhouse harvest earlier this year, guests were invited to attend a ribbon-cutting ceremony and tour Tilray’s state-of-the-art facility. 

Tilray’s EU Campus in Portugal is a multi-faceted production facility that includes indoor, outdoor and greenhouse cultivation sites, as well as research labs, processing, packaging and distribution sites for medical cannabis and cannabinoid-derived medical products. To date, Tilray has invested approximately €20 million in the facility, which totals approximately 250,000 square-feet with additional room to expand. Tilray’s EU Campus also serves as a hub supporting Tilray’s clinical research and product development efforts across Europe. Tilray’s EU Campus currently employs more than 100 professionals, and that number is expected to double by the end of 2019, with production ramping up and multiple harvests anticipated in the coming months. 
 
“We’re thrilled to celebrate another milestone as we continue to expand our global presence and pioneer the future of the cannabis industry. We are grateful for the warm welcome we’ve received from Portugal and the city of Cantanhede,” says Brendan Kennedy, Tilray CEO. “We’re looking forward to utilizing Tilray’s EU Campus to serve the European Union medical cannabis markets with high-quality, pharmaceutical-grade medical cannabis products.”
 
Tilray announced a successful harvest from its EU Campus in February 2019 with multiple harvests expected in the coming months. Tilray looks forward to supplying patients in Europe from its EU Campus when it receives GMP certification.
 

 

 

Tilray Announces Support Of Two New Clinical Research Studies In Australia And Canada

CANADA: Tilray, Inc., a global leader in cannabis research and production, today announced its support of two new clinical studies: a pilot study led by Murdoch Children’s Research Institute (MCRI) in Melbourne, to evaluate the feasibility and acceptability of a larger randomized placebo-controlled trial of cannabis extract as a form of treatment for reducing Severe Behavioral Problems (SBP) in pediatric patients with Intellectual Disabilities (ID); and a study with McGill University Health Centre’s Division of Infectious Diseases and Chronic Viral Illness, to examine the effectiveness of medical cannabis on immune activation in People Living with HIV.
 
Tilray_Logo“Tilray is at the forefront of clinical research in the medical cannabis field and we’re very proud to support two groundbreaking studies that have potential to identify more indications in which medical cannabis can benefit patients in-need,” says Philippe Lucas, VP of Global Patient Research and Access, Tilray. “We are committed to advancing cannabinoid-based science to further understand the potential benefits of medical cannabis as a treatment option among these critical patient populations. There is a serious need for more clinical data in our field, and we are proud to support research like this around the world.”
 
Murdoch Children’s Research Institute in Australia:  

Over 50,000 youth in Australia today have Intellectual Disability with Severe Behavioral Problems such as irritability, aggression, and self-injury. Anti-psychotic and other psychotropic medications are prescribed for half of these patients in Australia, despite limited evidence for their efficacy and a high risk of serious side-effects, including weight gain, metabolic syndrome and extrapyramidal movement disorders. Polypharmacy and off-label prescribing are common in these patients, and drugs are sometimes added to treat side effects. Novel interventions are urgently needed for this highly vulnerable patient group.
 
The American Academy of Pediatrics and the Royal Australasian College of Physicians have highlighted the need for further research into the therapeutic uses of cannabinoids in youth. There is intense interest from parents and physicians in medical cannabis as a treatment for SBP in youth with ID. Research to date suggests that CBD and other cannabis extracts, have had fewer reported side-effects than anti-psychotic medications; however, there is currently insufficient evidence to inform its use in treating SBP. MCRI is among the first institutions to conduct research specifically testing the effectiveness of CBD on patients with intellectual disabilities to reduce severe behavioral problems.  
 
“We are committed to increasing the scientific understanding of cannabinoid-based medicine as treatment for pediatric patients with intellectual disability and associated severe behavioral problems through this study.” says Associate Professor Daryl Efron, senior researcher at MCRI and pediatrician.
 
The single site, double-blind, parallel group, randomized, placebo-controlled pilot study of 10 participants, compares CBD with a placebo in reducing Severe Behavioral Problems in pediatric patients aged eight to 16 years of age with Intellectual Disability. Participants are randomized 1:1 to receive either Tilray C100 oral solution or the placebo.
 
Tilray supplied the medical cannabis products used for this trial, which were successfully exported from Tilray’s Good Manufacturing Practices (GMP) certified facility in Nanaimo, British, Columbia, Canada to Australia in early 2019, with the trial commencing shortly thereafter.
 
The results from this trial are expected to be published by 2020.