Ivermectin

TORONTO--( BUSINESS WIRE )-- Mountain Valley MD Holdings Inc. (the “ Company ” or “ MVMD ”) (CSE: MVMD) (OTCQB: MVMDF) (FRA: 20MP) is pleased to provide a general business update on its progress across its three core lines of business: Nutraceuticals - novel innovations through the Company’s Quicksome™ technology that are designed to improve the administration and efficacy of nutraceutical health and wellness products; Agriculture – the Company’s licensed Agrarius agricultural plant signaling technology that is designed to organically drive increases in crop yields and overall plant health, while offering the potential to reduce fertilizer and pesticide use where desired; and Husbandry Animals/Aquatic Species - the application of solubilized drugs through the Company’s Quicksol™ technology that is designed to positively impact the health of husbandry animals and aquatic species. " This past six months has been a truly transformative window for MVMD and our extensive partner network as we see the differentiation and positive reception of our technologies in the marketplace,” stated Dennis Hancock, President & CEO of Mountain Valley MD. “ I am very proud of our team who is working tirelessly during this pivotal phase in our journey, delivering innovative products with unique value propositions, all while supporting the scaling of our operations and expansion of our strategic partnerships across a broad distribution territory.” BUSINESS UPDATES NUTRACEUTICALS Quicksome ™ Powered Products and Business Development Progress MVMD’s contracted manufacturing partner in the U.S. (“Lead Manufacturer”) has completed the set-up and testing of equipment to enable the proprietary production of nutraceutical applications for MVMD’s Quicksome™ technology, including sublingual rapid dissolve tablets and powders. The GMP manufacturing facility is now fully operational and supporting Quicksome™ related business development and manufacturing requirements. The Lead Manufacturer has worked closely with the Company to complete the initial product and production elements necessary to support the MVMD’s current license agreement with Circadian Wellness (“Circadian”) for mushroom-based nutraceutical products embodying the Company’s proprietary Quicksome™ technology, as well as for MVMD’s proprietary product line, “Mountains Of…”, and additional business development projects with potential new licensees. The Company has completed product formulation work for Circadian for its Eons branded product line-up, including sleep, energy, immunity and most recently, an amanita mushroom product. Circadian commenced sales of its mushroom-infused sublingual sleep product, Eons Deeper Sleep, embodying MVMD’s technology in February 2024 on its website eons.com , with the additional products deemed “manufacturing ready” for Circadian to direct the Lead Manufacturer in line with its anticipated product roll-out plans through the remainder of the 2024 calendar year. The Eons Deeper Sleep product is a rapid dissolve format that a user places under their tongue sublingually. The Company’s Quicksome™ technology enables the use of a fraction of the active ingredients of competitive products in the nutraceutical space with great effect, including rapid onset and reduced variability due to substances diffusing directly into the bloodstream through tissues under the tongue, bypassing the gastrointestinal tract where substances absorbed in the intestines are subject to first-pass metabolism in the liver before entering the general circulation. The efficacy of Eons Deeper Sleep product was tested internally with oversight by the Company’s Director of Research and Development, Richa Mandalay, to gauge the impact of a variety of sleep measurements. The testing involved the use of a well-known wearable device that tracks over 20 biometrics related to well-being. Participants tracked their sleep biometrics for up to 45 days through the wearable technology, and documented instances where the Deeper Sleep product was consumed prior to bedtime. One hundred percent of participants experienced improved sleep scores with the following key outcomes documented: Total Sleep Average : Increased from 387.98 minutes to 450.17 minutes. REM Sleep Average : Increased from 76.50 minutes to 97.22 minutes. Deep Sleep Average : Increased from 73.81 minutes to 100.96 minutes. Time Awake Average : Decreased from 74.77 minutes to 62.12 minutes. “ Seeing the results of the Deeper Sleep study was a validation of the impact Quicksome™ can have in using high-quality ingredients in a smaller dose than typical competitors are using,” continued Hancock. “ As we believe consumers are becoming more aware than ever in what they are putting into their bodies, using less of an ingredient to greater effect is a key part of the Quicksome™ value proposition.” MVMD has commenced its business development work with its Lead Manufacturer, who has a broad list of clientele who currently purchase “white label” and proprietary products from the Lead Manufacturer. The Company has several proprietary formulation projects with multiple business prospects, including, by way of example, work with a biotech company in the USA that is working on an opioid use disorder (OUD) solution. To date, the Company has worked with its Lead Manufacturer on a proprietary OUD formulation using the Company’s technology and samples have been created and provided to the client for initial feedback, with the objective to support their planned OUD clinical trials in the third calendar quarter of 2024. The OUD clinical trials are being designed to focus on helping patients with an adjunct therapy that helps to reduce opioid cravings and increasing the instances of relapse prevention. To support anticipated business development initiatives planned for the latter half of the 2024 calendar year, the Company has completed Quicksome™ formulations for a broad product line, including sleep, energy, appetite suppressant, pain relief, focus, stress and anxiety relief. AGRICULTURE Agrarius Business Development and Product Registration/Salability Advancements including Brazil, Colombia and Canada Following its year end, MVMD closed a transaction with Agrarius Corp. (“AC”), whereby the Company executed an Amended and Restated Supply and License Agreement with AC to acquire an exclusive license to AC’s agricultural plant signaling technology in North America, Mexico, South America, Central America, and the Caribbean (the “Exclusive Territory”). The Agrarius product is certified organic through the Organic Materials Review Institute (OMRI) in the USA and is designed to be applied to agricultural crops to naturally increase yields, reduce fertilizer usage, and increase general resilience to pests and climate change. The Agrarius product is mixed either with water or with other agricultural products, such as fertilizers, pesticides, or herbicides, at the point of application and then applied via sprayer to agricultural crops at ideal times during a plant’s lifecycle. Agrarius has been tested across numerous major agricultural crops and has demonstrated its ability to naturally increase crop yields from approximately ten to fifty percent or more depending on crop type, reduce fertilizer usage where used by more than thirty percent, and increase general resilience to pests and climate change forces such as drought. MVMD believes Agrarius presents a significant opportunity to support its growth objectives given the rapidly changing global agricultural landscape due to mass fertilizer shortages, population growth, and urban sprawl limiting available farmlands and has focused significant resources on the development of this line of business. The Company’s agronomists have been working with certified third-party agricultural testing partners and academic institutions to conduct extensive metabolic and physiological analysis studies for Agrarius-treated crops to more closely evaluate the different metabolic routes involved in plant stress responses, which include enzyme regulation, chlorophyll production, and overall crop health and yields compared to control plants, when fertilizers and pesticides are systematically reduced and when other environmental factors are involved, in numerous crop trials. The Company believes the third-party reports received for the initial analysis, using molecular biology techniques and chemical reduction studies for fertilizer and pesticide usage, are very positive in support of the numerous benefits to crops from Agrarius applications, including enhancing overall plant health, increasing yields, and the potential to actively reduce fertilizer and pesticide usage where desired, while using the Agrarius product. The Company plans on publishing this data in greater detail once a full analysis is received and reviewed across various crop types. MVMD is currently conducting business development activity in Mexico, Central America, South America, Canada, and the United States of America, within the Exclusive Territory. The Company has been working with AC on the product registrations in key focus markets in line with its business development activities and the product is now officially saleable in all of the European Union, 44 states in the USA (with additional state approvals anticipated through the 2024 calendar year), Canada, and Brazil. Additionally, the Company received import approval for Colombia on July 19, 2024, and anticipates the final government approval for Agrarius sales inside Colombia by early August 2024. The Company anticipates additional registration approvals through the remainder of the 2024 calendar year in Panama, Costa Rica, Peru, Uruguay, and Mexico, and is working through a broader registration strategy to address Agrarius salability through all of Central and South America in line with anticipated demand. “ We believe the recent attainment of registration in Brazil is significant to support our commercialization plans and long-term shareholder value creation,” continued Hancock. “ Brazil is one of the largest agricultural markets in the world and we have a very strong business development pipeline in this market that includes directly working with some of the top agricultural organizations in the world who have been introduced to Agrarius and are actively trialing or planning trials with the Agrarius product.” To support the positive registration developments and its broader business development objectives, the Company has been working to secure trademark protection for the Agrarius brand and has filed initially for Agrarius trademark protection for Brazil, Mexico, Chile, Colombia, Uruguay, Panama, Costa Rica, Peru, Ecuador, Argentina, Paraguay, and Bolivia. As part of the execution of the Amended and Restated Supply and License Agreement with AC, the Company has launched a performance guarantee program (the “Performance Guarantee Program”), initially targeting farm operations in Canada and the United States, whereby the Company’s prospective client is required to pay for the Agrarius product only after it has achieved a minimum agreed performance enhancement on the targeted crop. The Performance Guarantee Program is designed to demonstrate the believed disruptive nature of the Agrarius product, while limiting the risk of any financial investment by the prospective client and ensuring the desired outcome of yield improvement and increased plant health are achieved in line with compensation. Given the seasonality of the North American agricultural industry and crop planting and harvest cycles, the allocated Performance Guarantee Program inventory is being marketed to potential clients for immediate application to eligible crops or by way of purchase order commitments for early spring 2025 crop applications. A goal of the program is to minimize trialing cautiousness that the Company believes to be common with farmers who may otherwise be hesitant to apply new agricultural products to their crops without first trialing on smaller areas of their crops. The Company has contracted with farming clients who have applied Agrarius under the Performance Guarantee Program on crops that include: corn, russet potatoes, faba beans, wheat, barley, and canola. Given the first application of Agrarius is typically applied early to crops when there are three to four leaves in the growth cycle, there is very little time or target crops available in North America for the current 2024 calendar year, resulting in the Company anticipating the majority of the inventory that is allocated to the Performance Guarantee Program to be secured against purchase order commitments for applications in early spring of the 2025 calendar year. To support the Company’s business development objectives and implementation of the Performance Guarantee Program, MVMD has recently employed a global Agrarius brand update, including a focus on developing internationalization into the website's strategy and present market-specific content in the user’s native/preferred language based on identifying IP address locale. This includes the development of a primary Agrarius brand positioning video asset to support business development in English, Spanish and Portuguese languages. Given the recent confirmation of Agrarius registration and salability in Brazil, Canada, expanded USA states and the near-term approval anticipated in Colombia, management believes that initial Agrarius-related revenues can be expected in the fourth quarter of the 2024 calendar year. HUSBANDRY ANIMALS / AQUATIC SPECIES Soluvec™ 1% Product Developments, First Product Shipments Planned in Q3, 2024 The Company has applied its Quicksol™ solubilization technology to the drug Ivermectin to create its Soluvec™ 1% product formulation, which was designed to provide a safer and more effective solution that can be administered broadly across the husbandry animal and aquatic species marketplace. The Company has demonstrated through a third-party Contract Research Organization (CRO) that its Soluvec™ 1% is 2,500 times more soluble than standard Ivermectin, enhancing its potential efficacy and its ability to be absorbed across multiple applications. The Company previously disclosed positive outcomes of multiple pharmacokinetic trials that were conducted under the supervision of The People's Republic of Bangladesh’s Ministry of Fisheries & Livestock for an injectable Soluvec™ 1% solubilized Ivermectin technology, and Soluvec™ 1% coated standard fish feed across farmed fish species. In aquaculture, Soluvec™ 1% treated feed led to enhanced growth and survivability outcomes in species like Indian Catfish and Tilapia, indicating potentially substantial benefits for biomass production. Farmed fish trials were conducted on Indian Catfish, Pangas, Common Carp, Tilapia, and Rui (Ruho) fish species. One group received Soluvec™ 1% coated standard fish feed, while the control group was given non-Soluvec™ 1% standard fish feed. The results showed an increase in average daily growth and a reduction in mortality, leading to an overall net average increase in net production of 145%. The feed conversion ratio also improved by an average of 16% for all fish species treated with Soluvec™ 1% coated fish feed compared to those receiving non-Soluvec™ 1% coated fish feed, indicating that the former group required less feed to produce higher units of biomass. The Company executed a license agreement with a privately held Ontario corporation (the “Licensee”) for its Soluvec™ 1% animal husbandry applications for the territory of the People's Republic of Bangladesh. In exchange for a royalty percentage against net sales, the agreement provides the Licensee with the exclusive rights, within Bangladesh, to work through its partners inside the territory to coordinate Soluvec™ 1% manufacturing and distribution of related Soluvec™ 1% products, both in injectable and food coating applications. The Licensee has confirmed to management that it has received necessary government approvals and completed the manufacturing agreements that have enabled the Licensee to commence manufacturing of the Soluvec™ 1% coated standard fish feed for farmed fish species within Bangladesh. The Licensee had communicated to the Company that it anticipated the salability of its Soluvec™ 1% coated standard fish feed in Bangladesh in the second quarter of the 2024 calendar year but is currently navigating start-up delays from challenges sourcing initial raw material inventory needed for manufacturing by approximately 60 days, and that have been compounded by the recent cyclone Remal in May 2024 that affected Bangladesh. The Company was made aware by its Licensee that the recent cyclone Remal that affected West Bengal and Bangladesh in May 2024 was devastating for the coastal fish farming sector. Floods triggered by the storm have created severe damage to fish enclosures, ponds, and related infrastructure, resulting in substantial financial losses for Bangladesh fish farmers 1 . Despite the delays communicated by the Licensee to the Company, the Licensee has shared with management that the Licensee has contracted with five distributors in Bangladesh and plans to formally ship Soluvec™ 1% coated standard fish feed for farmed fish species within Bangladesh in the third quarter to the 2024 calendar year. The Licensee has also communicated to the Company that the Licensee is working on expanding production and sales focus to broader husbandry applications across Bangladesh to support expanded sales opportunities beyond the current aquatic species focus. The Company continues to evaluate the opportunity to license its Soluvec™ 1% product in territories outside of Bangladesh. The government product approval from Bangladesh granted to the Licensee for farmed fisheries enables the Company to look at strategic business development initiatives in line with the product production capability in Bangladesh. The Company believes that sending commercially manufactured samples of the Soluvec™ 1% product will reduce costs and enable several independent evaluation trials to happen simultaneously with potential key partners in a variety of territories. The Licensee has communicated to the Company that it has no restrictions on its export capacity from the government of Bangladesh under its current sales and manufacturing license. To safeguard its intellectual property and the Company’s licensing royalty model, the Company has initially filed for Quicksol™ patent protection in key markets it has deemed strategically important at this time for expansion outside of Bangladesh. MVMD has filed for Soluvec™ 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. 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: 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 proposed impact of Agrarius on the Company and its growth objectives; Agrarius analysis studies and the anticipated final results, release and timing thereof; the attaining of additional registrations for Agrarius, and the locations and timing thereof; the Performance Guarantee Program, anticipated results thereof, and anticipated timing related to additional trials and purchases; anticipated timing for initial revenues from Agrarius; the timing of commercialization of Soluvec™ 1% inside Bangladesh and matters related thereto; and future opportunities for Soluvec™ 1% outside of 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. 1 https://seafoodnetworkbd.com/cyclone-remal-devastates-coastal-fish-farming-in-bangladesh