PR Newswire
•
Valens to serve as exclusive supplier of CBD for PMI’s clinical trial, which will measure
anti-inflammatory applications of medical-grade, nano-water emulsified CBD oil
•
Valens will manufacture and distribute CBD infused and uninfused Predilife
Ⓡ
prebiotic products for
PMI throughout the country
KELOWNA, BC
,
Dec. 21, 2021
/PRNewswire/ –
The Valens Company Inc.
(TSX: VLNS) (NASDAQ: VLNS) (the
“Company,”
“The Valens Company”
or
“Valens”
), a leading manufacturer of cannabis products, announced today two agreements with
PM
I
Mexico
, a subsidiary of Merger Group, one of the main drug suppliers of the Mexican government. Under the first agreement, Valens will supply CBD for PMI’s ongoing pharmacokinetic (PK) stage medical trials, which are focused on anti-inflammatory applications of medical-grade, nano-water emulsified CBD oil. The clinical trial has already been approved by The Medical Ethics Board of Mexico. The clinical trial, which is set to begin once Valens shipments arrive in Q1 of 2022, will be conducted across private hospitals in
Mexico
. At the conclusion of the trial, Valens will be the sole manufacturer and global distributor in collaboration with PMI.
Under the second agreement, Valens will manufacture and distribute CBD-infused and uninfused Predilife
Ⓡ
products globally while PMI will be responsible for distribution of the Predilife
Ⓡ
products in
Mexico
. Predilife is an agave-based prebiotic powder that has been submitted as a drug master file” (DMF) to the FDA. Valens will manufacture the products at its Green Roads facility in
Florida
, where it will be infused with CBD as required and then packaged and distributed through Valens’ third-party supplier channels across
Asia
, U.S.,
Latin America
and
Mexico
. The formulation will be offered in both powder and liquid sachets, initially for human consumption, with animal variations planned for the second half of 2022.
“The relationship we have built with PMI Mexico marks an important milestone for Valens’ international expansion and the beginning of our Central and
Latin America
strategy,” said
Tyler Robson
, CEO, Chair & Co-founder of The Valens Company. “Predilife has significant and unique versatility in terms of reach and market potential given it can be consumed infused or uninfused with CBD. This enables unimpeded distribution of the product regardless of local cannabis regulations, providing Valens access to several international markets. This agreement diversifies our global strategy and increases our revenue streams through creative, non-traditional strategies that separate us from our peers.”
Gustavo Bustillo PhD, Scientific Director of PMI said, “In Valens we found a technological partner that was capable of providing us not only the required quality but also the technical support and necessary documents needed to comply with pharmaceutical regulations. We look forward to initiating our commercial relationship and watching it expand globally over the coming years.”
At Valens, it’s Personal.
About The Valens Company
The Valens Company is a global leader in the end-to-end development and manufacturing of innovative, cannabinoid based products. The Valens Company is focused on being the partner of choice for leading Canadian and international cannabis brands by providing best-in-class, proprietary services including CO2, ethanol, hydrocarbon, solvent-less and terpene extraction, analytical testing, formulation and product development and custom manufacturing. Valens is the largest third-party extraction company in
Canada
with an annual capacity of 425,000 kg of dried cannabis and hemp biomass at our purpose-built facility in
Kelowna, British Columbia
which is in the process of becoming European Union (EU) Good Manufacturing Practices (GMP) compliant. The Valens Company currently offers a wide range of product formats, including tinctures, two-piece caps, soft gels, oral sprays and vape pens as well as beverages, concentrates, topicals, edibles, injectables, natural health products and has a strong pipeline of next-generation products in development for future release. Finally, The Valens Company’s wholly-owned subsidiary
Valens Labs
is a Health Canada licensed ISO 17025 accredited cannabis testing lab providing sector-leading analytical services and has partnered with Thermo Fisher Scientific to develop a Centre of Excellence in Plant-Based Science. For more information, please visit
. The Valens Company’s investor deck can be found specifically at
.
About Merger Group
Merger Group, based in
Newark, Delaware
is a pioneer in developing drugs and supplements with over 20 years of experience across the pharmaceutical industry. Merger Group is dedicated to the research, innovation and development of both medicine and natural and herbal products which can help progress the lifestyles of its users by improving their health and well-being. PMI Mexico, a division of Merger Group, is a subsidiary dedicated to the research, clinical studies, review and integration of technical documentation to obtain health records, coordination of logistics and import permits.
Notice regarding Forward Looking Statements
All information included in this press release, including any information as to the future financial or operating performance and other statements of The Valens Company that express management’s expectations or estimates of future performance, other than statements of historical fact, constitute forward-looking information or forward-looking statements within the meaning of applicable securities laws and are based on expectations, estimates and projections as of the date hereof. Forward-looking statements are included for the purpose of providing information about management’s current expectations and plans relating to the future. Wherever possible, words such as “plans”, “expects”, “scheduled”, “trends”, “forecasts”, “future”, “indications”, “potential”, “estimates”, “predicts”, “anticipate”, “to establish”, “believe”, “intend”, “ability to”, or statements that certain actions, events or results “may”, “should”, “could”, “would”, “might”, “will”, or are “likely” to be taken, occur or be achieved, or the negative of these words or other variations thereof, have been used to identify such forward-looking information. Specific forward-looking statements include, without limitation, all disclosure regarding future results of operations, future outcomes of transactions, economic conditions, and anticipated courses of action. Investors and other parties are advised that there is not necessarily any correlation between the number of SKUs manufactured and shipped and revenue and profit, and undue reliance should not be placed on such information.
The risks and uncertainties that may affect forward-looking statements include, among others, whether the Company will be able to fulfill all of listing requirements of the Nasdaq, Canadian regulatory risk, Australian regulatory risk, U.S. regulatory risk, U.S. border crossing and travel bans, the uncertainties, effects of and responses to the COVID-19 pandemic, reliance on licenses, expansion of facilities, competition, dependence on supply of cannabis and reliance on other key inputs, dependence on senior management and key personnel, general business risk and liability, regulation of the cannabis industry, change in laws, regulations and guidelines, compliance with laws, limited operating history, vulnerability to rising energy costs, unfavorable publicity or consumer perception, product liability, risks related to intellectual property, product recalls, difficulties with forecasts, management of growth and litigation, many of which are beyond the control of The Valens Company. For a more comprehensive discussion of the risks faced by The Valens Company, and which may cause the actual financial results, performance or achievements of The Valens Company to be materially different from estimated future results, performance or achievements expressed or implied by forward-looking information or forward-looking statements, please refer to The Valens Company’s latest Annual Information Form filed with Canadian securities regulatory authorities at
www.sedar.com
or on The Valens Company’s website at
www.thevalenscompany.com
. The risks described in such Annual Information Form are hereby incorporated by reference herein. Although the forward-looking statements contained herein reflect management’s current beliefs and reasonable assumptions based upon information available to management as of the date hereof, The Valens Company cannot be certain that actual results will be consistent with such forward-looking information. The Valens Company cautions you not to place undue reliance upon any such forward-looking statements. The Valens 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 applicable law. Nothing herein should be construed as either an offer to sell or a solicitation to buy or sell securities of The Valens Company.
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SOURCE The Valens Company Inc.
