"This has been a significant year for MVMD, and I am pleased with how our team and partners have executed on our strategic objectives," stated Dennis Hancock, President & CEO of Mountain Valley MD. "We have significantly advanced the commercialization of our technologies, strengthened our manufacturing and distribution relationships, and expanded our geographic footprint. Our efforts are now translating into marketable products and early initial revenues, and we believe 2025 will be a year of continued growth and meaningful results for our shareholders."
MVMD's patented liposomal Quicksome™ technology uses proprietary formulations and stabilizing agents to encapsulate active ingredients with the goal of optimizing molecule delivery in sublingual nutraceutical applications. The Company’s Quicksome™ technology is currently focused on delivering molecules where enhanced efficacy, precise dosing, reduced variability, and dose sparing are valued.
"As our formulators continue to work across different product value propositions, the benefits of the Quicksome™ technology for dose sparing is particularly evident in the reduction of manufacturing costs, often using up to one-seventh of a target molecule versus what might be used in more traditional orally consumed products," stated Mr. Hancock. "We believe Quicksome’s™ dose sparing benefits are becoming increasingly relevant as consumers are more aware and careful about what they put in their bodies."
In line with MVMD’s nutraceutical GMP manufacturing product strategy, the Company had entered into a license agreement with its selected third-party lead production partner in the United States (the "Lead Manufacturer"), as previously disclosed. Under this approach, the Lead Manufacturer produces nutraceutical products based on or embodying MVMD’s proprietary technologies for MVMD’s current and future licensees, and for MVMD’s own "Mountains Of…" brand as needed.
The Company is actively working with the Lead Manufacturer on multiple proprietary formulation projects. Notable among these are:
-
Opioid Use Disorder (OUD) Adjunct Therapy: MVMD, working with its Lead Manufacturer, has developed a proprietary OUD formulation using MVMD’s technology. Sublingual tablet samples were formulated for a U.S. biotech client and are currently ready for manufacturing to support anticipated human trials in 2025. The client is coordinating the design and implementation of OUD clinical trials, focusing on adjunct therapy to reduce opioid cravings and relapses.
-
Fenugreek Glycosides Testosterone Product: MVMD has formulated a novel sublingual fenugreek glycosides testosterone product with the Quicksome™ technology to promote increased testosterone levels in users, potentially supporting muscle mass, strength, energy, vitality, libido, and sperm production. The testosterone product was developed based on business development discussions with a U.S. client in collaboration with the Company’s Lead Manufacturer. The testosterone product that embodies MVMD’s Quicksome™ technology is currently being tested in male human subjects, where timed blood tests clinically measure the production of free testosterone and testosterone in participants.
Circadian Wellness License Agreement and Product Expansion
Under the Company’s license agreement with Circadian Wellness Corp. ("Circadian"), the Company’s Quicksome™ technology is being applied to functional mushroom-based products. Initial product formulation work and dissolution testing have been completed and accepted by Circadian for its Eons branded product line, including formulations for sleep, energy, immunity, and anxiety-reducing products.
Circadian has launched two mushroom-infused sublingual products under their Eons brand that embody MVMD’s Quicksome™ technology, Eons Deeper Sleep and Eons Dialed. The Eons Dialed product, a novel anxiety-reducing, calming product, was recently introduced to the U.S. market in the fourth quarter of 2024. Circadian expects to continue creating and introducing new product SKUs that embody MVMD’s technology under its Eons brand on an ongoing basis in the U.S. marketplace. MVMD had previously received formulation and royalty advances from Circadian and anticipates that Circadian will begin reporting and making royalty payments starting in the first quarter of the 2025 calendar year.
"Mountains Of…" Proprietary Brand
MVMD’s "Mountains Of…" product line has received trademark protection in the United States for multiple product categories (Sleep, Energy, Relief, Libido, Lean), as well as for the overarching "MOUNTAINS OF…" brand. This positioning allows the Company to pursue additional nutraceutical distribution partnerships. The Lead Manufacturer is prepared to support "Mountains Of…" product manufacturing for partners who wish to leverage these formulations or co-develop new solutions.
AGRICULTURE
Agrarius Business Development and Market Expansion
"We continue to work hand-in-hand with some of the largest agricultural brands in the world who are effectively working with our agronomists to evaluate the Agrarius product performance across a variety of key crops," continued Hancock. "The implications of our business development pipeline and partnership approach are key contributors towards our goal of creating long-term shareholder value."
Since executing an Amended and Restated Supply and License Agreement (the "Agreement") with Agrarius Corp. ("AC") in April 2024, MVMD has made significant strides in commercializing Agrarius. The updated Agreement with AC was primarily for the Company to acquire an exclusive license to sell AC’s agricultural plant signaling technology in North America, Mexico, South America, Central America, and the Caribbean (the "Exclusive Territory"), while retaining its global non-exclusive rights outside of the Exclusive Territory.
The product, designed to naturally increase crop yields, reduce fertilizer and pesticide requirements where desired, and bolster plant resilience, is now officially saleable in the European Union, Canada, Colombia, Brazil, Panama, Peru, and in 44 U.S. states. Additional state approvals in the U.S. and product registrations in Costa Rica, Uruguay, Chile, Mexico, and South Africa are pending.
In line with Panamanian Agrarius product registration obtained in early December, 2024, the Company is negotiating a supply agreement with a distributor who currently provides agricultural products nationally in Panama.
"Obtaining the Agrarius registration for Panama in early December, 2024 was timely as we look to scale our commercialization success in 2025," continued Mr. Hancock. "Our Agrarius inventory is managed with our Panamanian distribution partner, so this registration was important on many fronts as we facilitate product logistics and shipments throughout Latin America."
The Company has also recently completed its first product import trial process run from its Panama distribution facility into Brazil, where extensive coordination was required to facilitate the necessary inspection and customs clearance. Finalizing the trial import process for the Agrarius product into Brazil was a key requirement to allow larger scale shipments of Agrarius that are anticipated in 2025.
MVMD had previously announced as part of the updated Agreement with AC, that the Company has implemented a performance guarantee program (the "Performance Guarantee Program") initially targeting farm operations in Canada and the United States. Under this program, contracted clients only pay for Agrarius product if a minimum agreed performance threshold is met after application to their crops. A goal of the program is to minimize trialing hesitation that is common with farmers with regard to the application of new agricultural products to their crops. The Company has contracted with farming clients under the Performance Guarantee Program in the states of Montana and Illinois, U.S. and in the province of Alberta, Canada to conduct a trial application of Agrarius during the 2024 season.
To support the global monitoring and management of Agrarius applications as the business scales, the Company has contracted with a global satellite management company who provides visual references via GPS coordinates such as normalized difference vegetation index ("NDVI") that allows visual comparison from Agrarius treated areas versus untreated control areas.
The data collected under the Performance Guarantee Program confirmed the benefits of Agrarius in contributing to increased crop yields and/or overall plant health and reducing trialing hesitation for key farming partners. As a result of the trial program in North America, the Company has agreed to expand the markets for the Performance Guarantee Program with AC to now include key markets in Latin America. The Company is in the process of invoicing contracted farms for the Agrarius product used and this revenue is anticipated in the first quarter of the 2025 calendar year.
HUSBANDRY ANIMALS / AQUATIC SPECIES
Soluvec™ 1% Product Progress in Bangladesh and Beyond
MVMD’s Quicksol™ technology has been successfully applied to the drug Ivermectin to create its Soluvec™ 1% product formulation. In Bangladesh, MVMD’s licensee has completed initial sales and distribution of approximately 100 tonnes of Soluvec™ 1% coated fish feed, despite progress being slowed by disruptions following Cyclone Remal in May 2024. With the market stabilizing, manufacturing of Soluvec™ 1% coated feed recommenced in November 2024, and the licensee anticipates ongoing manufacturing and sales activity through 2025. The licensee is also exploring broader husbandry applications to diversify beyond aquatic species.
Global interest in Soluvec™ remains positive in management’s view. MVMD continues to explore licensing opportunities in other key markets and has filed for patent protection in 12 additional markets outside of the United States, including Canada, China, India, Mexico, Sri Lanka, Thailand, Philippines, Malaysia, Brazil, Peru, Argentina, and Chile. The Company’s published peer-reviewed study data in the journal Therapeutic Delivery supports the improved bioavailability, efficacy, and potential cost savings of Soluvec™ for both animals and potentially human health applications.
ABOUT MOUNTAIN VALLEY MD HOLDINGS INC.
Mountain Valley MD is building a world-class organization centered around the implementation, licensing and reselling of key technologies and formulations:
-
patented Quicksome™ oral formulation and delivery technologies,
-
patented Quicksol™ solubility formulation technology
-
licensed product reseller of Agrarius™, a novel agricultural plant signaling technology
Consistent with its vision towards "More Life", MVMD applies its owned and licensed technologies to its work for advanced delivery of molecules for human and husbandry animal applications, including the development of products for pain management, weight loss, energy, focus, sleep, anxiety, and more. Additionally, MVMD’s work with Agrarius is focused on generating a positive impact on crop yields and reducing fertilizer usage.
MVMD’s patented Quicksome™ technology utilizes proprietary formulations and stabilizing molecules to encapsulate and formulate active ingredients into highly efficient product formats. The result is a new generation of product formulations that could be capable of delivering nutraceutical and drug molecules into the body faster, with greater impact, efficiency and accuracy.
MVMD’s patented Quicksol™ technology covers all highly solubilized macrocyclic lactones that could be effectively applied in multiple viral applications that could positively impact human and animal health globally.
MVMD’s licensed Agrarius™ agricultural plant signalling technology is designed to be applied to crops to naturally increase yields, reduce fertilizer usage, and increase general resilience to pests and climate change.
For more Company information and contact details, visit www.MVMD.com.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION
Certain statements contained in this news release may constitute forward-looking information. Forward-looking information is often, but not always, identified by the use of words such as "anticipate", "plan", "estimate", "expect", "may", "will", "intend", "should", and similar expressions. Forward-looking information involves known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those anticipated in such forward-looking information.
The Company's actual results could differ materially from those anticipated in this forward-looking information as a result of regulatory decisions, competitive factors in the industries in which the Company operates, prevailing economic conditions, and other factors, many of which are beyond the control of the Company.
The Company is making forward-looking statements, including but not limited to: the Company’s outlook, strategy, intended growth and results in 2025; business development efforts in relation to each line of business and new licensees and the timing thereof; Circadian’s anticipated product roll-out plans and the timing thereof; OUD clinical trials and the timing thereof; the continued development of new products embodying MVMD’s technology and the anticipated receipt of reporting and royalty payments; the proposed impact of Agrarius on the Company and its growth objectives; anticipated registration and sales territories for Agrarius product; the expansion of the Performance Guarantee Program and the anticipating invoicing of contracted farms; and the continued manufacturing and sales activity of Soluvec™ 1% inside Bangladesh.
The Company believes that the expectations reflected in the forward-looking information are reasonable, but no assurance can be given that these expectations will prove to be correct and such forward-looking information should not be unduly relied upon. Any forward-looking information contained in this news release represents the Company's expectations as of the date hereof and is subject to change after such date. The Company disclaims any intention or obligation 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 legislation.
Neither the CSE nor OTC has reviewed or approved the contents of this press release.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241231264555/en/
Contacts
Dennis Hancock
President and Chief Executive Officer
Mountain Valley MD Holdings Inc.
Investor Relations @ 647-725-9755
Email: info@mvmd.com
www.MVMD.com
