I have read and understood Mountain Valley MD's Forward Looking Statement.
Patented Quicksome™ liposome technology utilizes an advanced 2-step encapsulation and desiccation process to formulate normally highly un-bioavailable active ingredients into highly effective rapid oral dissolving product formats.
Patented Quicksol™ technology for macrocyclic lactones, including Ivermectin and Selamectin, to enable enhanced injection or other liquid application of poorly soluble drugs to enhance bioavailability with new delivery options.
Patent-Pending Porous Aluminum Nanostructure Adjuvant has high surface area for vaccine-antigen binding to provide dose sparing advantages with long-term stability in aqueous media, and greater stability in harsh environments.
We take existing approved vaccines, drugs and nutraceuticals and increase delivery effectiveness into the body.
Patented Quicksome™ liposome technology utilizes an advanced 2-step encapsulation and desiccation process to formulate normally highly un-bioavailable active ingredients into highly effective oral product formats.
Easy oral dissolve formats
Increased bioavailability
Minimizes variability
Precise dosing
Needleless format
Eliminates Cold Chain
Simplifies administration
We take approved macrocyclic lactone drugs and enhance their solubility (potent broad-spectrum anti-parasitic drugs with significant anti-viral properties).
Patented Quicksol™ technology utilizes an advanced solubilization technique to create injectable and liquid formulations.
Application across oral and injectable methods
Increased bioavailability
Eliminates variability
Precise dosing
Simplifies administration
Solubility is one of the most important parameters to achieve desired concentration of drug in systemic circulation to achieve the desired pharmacological response. Any drug to be absorbed must be present in the form of solution at the site of absorption. One of the major problems associated with poorly soluble drugs is very low bioavailability. Low solubility and absorption often decrease a drug’s efficacy. A drug with low absorption is generally not a good fit for providing an efficacious product solution.
With increased solubility, a drug can more easily reach the maximum plasma level. Poorly solubilized drugs require higher doses in order to reach therapeutic plasma concentrations.
MVMD’s solubility technology delivered 800% increase in bio availability through intramuscular (IM)injection and 500% increase in bio availability through sublingual compared tooral tablets.
MVMD’s IM injection reaches TMAX (the time to reach the maximum concentration of Ivermectin in the body) at 15 minutes compared to current commercial oral and subcutaneous forms which take between 6 and 36 hours and is well documented. The Company’s sublingual strips had a TMAX of 1 hour, a 600% increase over oral tablets.
Both MVMD applications showed zero decline in CMAX (peak serum concentration that a drug achieves) over an extended timeframe of 12 hours, with gradual decline over 96 hours (vs 36 hours for oral tablet) almost 3x extended clearance - a very significant indication over oral and subcutaneous forms.
Both MVMD applications show minimal pharmacokinetic variability, with IM injection at zero percent variability and sublingual strips at 5% variability compared to 40% variability for oral tablets. Variability contributes to the potential for adverse effects or not achieving the required therapeutic index.
MVMD has developed porous aluminum nano structures for use as adjuvants in vaccines against various infectious diseases, including polio. These porous aluminum nano structures have a high surface area for vaccine-antigen binding, provide long-term stability in aqueous media, and promote greater stability in harsh environments.
“If we achieve our scientific objective to deliver Inactivated polioVaccine with the same effect but use at least 20 times less of the vaccine with our dose sparing adjuvant while creating mucosal immunity, the scourge of polio can finally be eradicated from earth.” Mike Farber, Director of Life Sciences at Mountain Valley MD.
Adjuvant work is critical to achieving MVMD’s objective to completely eradicate polio, and additionally this program will inform significant dose sparing applications across hundreds of vaccines.
We are working against leading consumer propositions that offer increased bioavailability with rapid onset across the $2 trillion USD nutraceutical, vaccine and pharmaceutical industries.
MVMD’s advanced desiccated liposome formulations provide transmucosal delivery benefits across leading drug and vaccine application categories, including nutraceutical applications such as pain management, energy, focus, weight management, sleep, anxiety, and more.
Our Quicksome™ technology is available to leading nutraceutical, vaccine and pharmaceutical companies for license across a broad spectrum of molecules that provide unprecedented value propositions across their businesses.
Our focus on strategic distribution and licensing partnerships in key markets will enable us to leverage our intellectual property, establish licensing agreements and monetize our IP rapidly.
Across our delivery sciences IP portfolio and R&D work, MVMD prioritizes investment opportunities on disruptive technologies for health and wellness applications.
Our management team brings together world-class leadership across mucosal delivery sciences, molecular research, IP and legal management, marketing, distribution and financial services.
Formulas
Advancing Liposome Technology
Molecules & Conditions
Technology application
Prototypes
Internaltesting
Technical proof of concept
Pharmacokinetics
Safety
Efficacy
Animals
Bio-equivalency
Human Safety
Effectiveness
Scientific Data
Government Approvals
Ethical Standards
Quality Standards
Legal Standards
Manufacturing (MVMD or Partner)
Distribution
Marketing
After Market
Patented Quicksol™ technology for macrocyclic lactones, including Ivermectin and Selamectin, to enable enhanced injection or other liquid application of poorly soluble drugs to enhance bioavailability with new delivery options.
Development of Quicksol™, involves a patented process to improve solubility of traditionally insoluble molecules such as drugs in the macrocyclic lactone class. With Quicksol™, we are able to form macrocyclic cyclodextrin inclusion complexes that when combined with a surfactant and dissolved in water, can form aqueous solutions. The process includes the use of FDA approved non-ionic solvents to increase solubility and bioavailability of the molecule, opening possibilities for parenteral administration of drugs that have poor oral absorption
Patented Quicksol™ technology for macrocyclic lactones, including Ivermectin and Selamectin, to enable enhanced injection or other liquid application of poorly soluble drugs to enhance bioavailability with new delivery options.
Development of Quicksol™, involves a patented process to improve solubility of traditionally insoluble molecules such as drugs in the macrocyclic lactone class. With Quicksol™, we are able to form macrocyclic cyclodextrin inclusion complexes that when combined with a surfactant and dissolved in water, can form aqueous solutions. The process includes the use of FDA approved non-ionic solvents to increase solubility and bioavailability of the molecule, opening possibilities for parenteral administration of drugs that have poor oral absorption
Patented Quicksol™ technology for macrocyclic lactones, including Ivermectin and Selamectin, to enable enhanced injection or other liquid application of poorly soluble drugs to enhance bioavailability with new delivery options.
Challenges with livestock infections and administration of medication to cure animal infectious disease has caused significant reductions in yield across a variety of animal species, leading to pressure on agriculture economics, livestock management, and the overall production of food for the globally growing human population. We have applied our patented solubility technology to the drug Ivermectin and have developed the only form in the world that uses excipients that are currently approved by the US Food and Drug Administration, making it a leading candidate for broad husbandry animal treatments.
Patented Quicksome™ liposome technology utilizes an advanced 2-step encapsulation and desiccation process to formulate normally highly un-bioavailable active ingredients into highly effective rapid oral dissolving product formats.
Cold chain is a temperature-controlled supply chain that prescribes necessary conditions during the transport, storage, and handling of vaccines and drugs administered. With Quicksome™ technology we are working to enable vaccine distribution outside of cold chain, which will potentially support the use of less vaccine per dose, cost reduction, increase vaccine output, and be key for global disease eradication.
Based on the cold chain technology achievements announced in July of 2021, the Company has commenced additional characterization studies with its proprietary Quicksome™ technology to optimize application in the current Trivalent Inactivated Poliovirus Vaccine (tIPV) work and additional vaccines and proteins. The Company believes the technology would allow for long term stability and ease of global distribution, appropriate for pandemic preparedness, and other administration and distribution advantages, including potential sublingual applications that would eliminate the use of needles where desired.
Patented Quicksol™ technology for macrocyclic lactones, including Ivermectin and Selamectin, to enable enhanced injection or other liquid application of poorly soluble drugs to enhance bioavailability with new delivery options.
In oncology our work is currently focussed on applying our our Quicksol™ technology to reformulate existing molecules with anti-cancer effects as potential oncology treatments. Published literature has shown very interesting in vitro results for the potential effect of the macrocyclic lactone class on a wide variety of tumor types. Applying our technology to this class, and to other insoluble molecules, allows the investigation of these potential anti-cancer therapies as new options for oncology treatment.
Patented Quicksome™ liposome technology utilizes an advanced 2-step encapsulation and desiccation process to formulate normally highly un-bioavailable active ingredients into highly effective rapid oral dissolving product formats.
Production of a stable, quick onset, oral dissolve formulation to provide potential benefits of precise dosing, reduced variability, and dose sparing.
Red White & Bloom is a publicly traded multi-state cannabis operator and house of premium brands that are available across the cannabis market in the United States. MVMD’s agreement with RWB establishes the terms upon which the Company will develop and license formulas using the Company’s Quicksome™ technology and novel cannabinoid solubilization techniques to be applied by RWB to various cannabis product applications. The Agreement grants RWB an exclusive 5-year license in Florida, Michigan and California to manufacture and distribute its cannabis products in exchange for the payment of product fees and ongoing sales royalties. MVMD has no immediate control of the final in-market product timing or production scale as that is the responsibility of RWB. MVMD is working closely with RWB to apply proprietary formulations across a number of branded medical and recreational product lines. The MVMD Quicksome™ sublingual applications, include a proprietary THC-based sleep formulation created for RWB, which is planned to be the initial product that RWB will introduce in the medical sleep market in the United States. The product packaging, approvals and go-to-market timing, including providing market updates, are the sole responsibility of RWB.
MVMD has been working closely with Circadian Wellness on proprietary formulations for mushroom-infused products that achieve an increase in overall molecule efficacy with the Company’s Quicksome™ desiccated liposome technology applied across a variety of rapid dissolve sublingual and dermal products. Circadian is finalizing its product plans and go-to-market strategy for a broad line of naturally derived mushroom products that MVMD has been advised will be distributed initially in North America and expanded globally in future phases. The initial work includes mushroom infused sublingual sleep and energy products and a hemp-based mushroom pain management cream. Although outside of MVMD’s control, it is anticipated that Circadian will be introducing its first consumer products for sale in the United States in the first half of 2022 under its EONS brand.
Patent-Pending Porous Aluminum Nanostructure Adjuvant has high surface area for vaccine-antigen binding to provide dose sparing advantages with long-term stability in aqueous media, and greater stability in harsh environments.
The purpose of the Company’s PANA process is to produce stable nano-particulate adjuvant with the intention of overcoming certain limitations of traditional aluminum-based adjuvants. The potential to use less vaccine per dose with a dose sparing adjuvant could lead to a number of potential benefits including: cost reduction, increased vaccine output, facilitation of mucosal and herd immunity, long-term stability in aqueous media, applications across hundreds of vaccines, and a key to global disease eradication.
Patented Quicksome™ liposome technology utilizes an advanced 2-step encapsulation and desiccation process to formulate normally highly un-bioavailable active ingredients into highly effective rapid oral dissolving product formats.
Although there has been significant innovation in recent years in relation to diabetes, insulin remains a cornerstone of treatment and that there is an unmet need in the insulin space, resulting from challenges such as costs, the use of needles, hypoglycaemia, and fear of injection. The company is currently exploring the application of QuicksomeTM technology to the needle-less administration of insulin through formulation experiments, to optimize the potential delivery of rapid-acting human insulin in a sublingual format.
Patented Quicksol™ technology for macrocyclic lactones, including Ivermectin and Selamectin, to enable enhanced injection or other liquid application of poorly soluble drugs to enhance bioavailability with new delivery options.
Application of patented Quicksol™ technology to the macrocyclic class of drugs to assess anti-infective properties across a wide range of diseases.
Dennis Hancock is a senior sales and marketing executive with over 25 years of experience spanning automotive, pharmaceutical, tech, telco, retail and financial services sectors. Initially providing consulting services to Mountain Valley MD in 2018, Dennis transitioned to assume the President & CEO position in early 2019 to lead the Company’s go-public strategy and develop the business strategy to pursue broad health and wellness opportunities approach across human, animal and plant health applications. Dennis spent more than 12 years in a leadership role at one of North America’s leading performance improvement and Loyalty providers, Maritz, who works with 70% of the world’s Super 50 companies. Previously, Dennis led publicly traded ZENN Motor Company as the Vice President of Sales and Marketing. As a senior officer at ZMC, Dennis drove the establishment of ZENN – (Zero Emission, No Noise) as one of the most recognized “green tech” brands in North America. Dennis has several start-ups established, including PerformanceSPARK, an agency that works with leading organizations to identify and deliver on the key elements necessary to drive measurable performance growth, and co-founder of CrowdSeating Inc., an innovative social concert platform.
Kevin is an entrepreneur and visionary. With over 26 years of executive experience, he has developed an astute ability to identify global market trends and partners with key people and organizations to ensure success in all his endeavors. Kevin currently has agricultural and pharmaceutical projects for genetic development as well as strategic land acquisitions in India and Uganda. He also maintains his position as president and CEO of Pund-IT; an IT business technology firm that is focused on helping to bring technology solutions to a wide variety of industries. Kevin’s love of collaboration and networking has led him to hold board positions in not-for-profit, financial, healthcare, manufacturing, and digital media organizations. He is a founding member of the Entrepreneurs Organization (EO) of South Western Ontario and continues to play an active role in the chapter.
Nancy Richardson is a veteran of the pharmaceutical and agency world, developed continuing medical education for physicians, pharmacists and nurses for over two decades. Together with her business partner, Nancy ran a successful multi-million-dollar medical communications agency for twelve years, bringing numerous drugs to market, overseeing accounts, generating sales and managing daily operations. She is an experienced pharmaceutical marketing strategist, facilitator and project manager, who conducted countless advisory boards across the globe. Nancy successfully sold her business in 2017, and is now acting as VP of Client Service for LWT Communications, a localization agency with offices in North America and Europe. Nancy currently serves on the Board of Directors of the Institute of Cultural Affairs Canada, an organization that brings leadership and facilitation expertise to communities in need all over the world. Nancy is also the Local Chapter Leader for the Monroe Institute in Toronto - an organization that delivers workshops and seminars on human consciousness.
Paul Lockhard is an experienced business leader, entrepreneur and digital marketer. Over 35 years Paul has built a strong foundation in consumer goods and digital marketing for such brands as Trident Gum, Energizer Batteries, Ford, Lenscrafters, Labatt Breweries and Guardian Capital. He has founded 4 successful businesses, and helped 200+ startups over the past 19 years. He is a co-founder of Virtacore, a values-based organization of entrepreneurs and intrapreneurs, dedicated to helping other entrepreneurs launch and grow successful enterprises. Paul is currently Chief Client Officer at William Thomas Digital, a CRM agency in Toronto serving major Canadian and global companies in retail, loyalty and consumer goods.
Dennis Hancock is a senior sales and marketing executive with over 25 years of experience spanning automotive, pharmaceutical, tech, telco, retail and financial services sectors. Initially providing consulting services to Mountain Valley MD in 2018, Dennis transitioned to assume the President & CEO position in early 2019 to lead the Company’s go-public strategy and develop the business strategy to pursue broad health and wellness opportunities approach across human, animal and plant health applications. Dennis spent more than 12 years in a leadership role at one of North America’s leading performance improvement and Loyalty providers, Maritz, who works with 70% of the world’s Super 50 companies. Previously, Dennis led publicly traded ZENN Motor Company as the Vice President of Sales and Marketing. As a senior officer at ZMC, Dennis drove the establishment of ZENN – (Zero Emission, No Noise) as one of the most recognized “green tech” brands in North America. Dennis has several start-ups established, including PerformanceSPARK, an agency that works with leading organizations to identify and deliver on the key elements necessary to drive measurable performance growth, and co-founder of CrowdSeating Inc., an innovative social concert platform.
Aaron Triplett is a Chartered Professional Accountant (CPA, CA), and has accumulated over 15 years experience in the field of financial management and accounting, specializing in forecasting, compliance and risk management, and the development and monitoring of control systems. Most recently, Mr. Triplett served as CFO of Grande West Transportation Group Inc. (TSXV: BUS), a Canadian manufacturer of mid-sized multi-purpose transit vehicles for sale in Canada and the United States. Aaron was instrumental in the Company’s financial growth initiatives, securing a $20 million and $5 million revolving credit facility with major Canadian banks. Prior to that, Mr. Triplett served as the CFO of Angkor Resources Corp. (TSXV: ANK), a mineral exploration company with operations in Cambodia. Mr. Triplett’s work experience also includes audit and assurance manager for a mid size public accounting firm.
Azhar Rana is a Canadian-born Doctor of Medicine and innovator with more than 10 years of leadership experience across the pharmaceutical industry. Having worked with leading companies like Bristol Myers-Squibb, Novo Nordisk and AstraZeneca, Dr. Rana’s perspectives and practices are informed by a wide variety of science innovation across global markets. During his extensive pharmaceutical career, he gained invaluable experience in the development, launch, and life cycle management of novel therapeutics, while leading and collaborating with teams in clinical operations and development, medical affairs, regulatory affairs, quality, and pharmacovigilance. Dr. Rana established the North American organization for integrated medhealth communications (imc Group), a globally-recognized medical communications agency supporting pharmaceutical, biotech and medical device companies. As President & Managing Director, Dr. Rana led an extensive cross-functional medical marketing team, working with global companies and healthcare professionals at different stages of drug and device development. He brings a wealth of experience in a number of disease areas, including virology, oncology, dermatology and metabolic disease. Dr. Rana completed his medical degree at the Aga Khan University and subsequently trained in internal medicine in the United Kingdom.
Richa Mandalay is the Director of Analytical Sciences at Mountain Valley MD (MVMD). As a first generation American in the biotechnology space, she is focused on contributing important and unique perspectives that are helping to reshape the future of health and wellness. Currently, Richa supports the development of innovative technologies including Quicksome™ and Quicksol™, a stream of technologies designed to maximize the efficacy of existing pharmaceuticals and vaccines while lowering side effects to help those suffering from aggressive cancers such as metastatic melanoma, triple negative breast cancer and lung cancer. Prior to her position at MVMD, Richa spent over five years in labs and medical rotations. She held the position of Lead for the Cord Blood Bank at the prestigious MD Anderson Cancer Center, the largest Cancer Centre in the United States, where she facilitated donations from pregnant mothers providing the stem cells needed to help increase the lifespan of children suffering from blood disorders and cancers. Her impressive tenure involved leading a team of cord blood collectors and implementing protocols for quality assurance of cord blood collection and storage. Mandalay’s educational training is in health sciences. She holds a Master’s degree in Biomedical Sciences from Rutgers University, and a Bachelor’s degree in Biochemistry and Molecular Biology from Stockton University. At a young age, she explored her curiosities in health and wellness by volunteering at a nursing home, which eventually led to a career in medicine where she could continue her mission of enhancing quality of life for all humans.
Dr. Norton is an immunologist with 20 years of experience in evaluating immunity, vaccines, and microbial infections. She has a public health and research background with a current faculty appointment in the Department of Microbiology & Immunology at Tulane University in Louisiana, U.S., as Associate Professor with tenure. Dr. Norton began her training at the Centers for Disease Control (CDC) and received an MPH (Master of Public Health) in international health. In her doctoral and post-doctoral programs at Tulane University she evaluated innate immunomodulation and mucosal delivery techniques, with a main focus of her lab to evaluate strategies to improve memory responses to vaccines through mucosal adjuvants. Her work has involved management of large, collaborative projects for adjuvanted polio and tuberculosis vaccines, and has also pioneered a derivative adjuvant for intranasal use in pneumonia, opioid, and influenza vaccines. Since the SARS-CoV-2 pandemic, Dr. Norton also runs a project for the Tulane University Convalescent Antibody and Immunity Network (TUCAIN) NIH/NCI U54 evaluating cellular and memory responses to SARS-CoV-2 infection or vaccine responses in adults, children, and cancer subjects and oversees blood and tissue collections. Dr. Norton has been consistently NIH (National Institutes of Health) funded since 2013, authored over 30 peer-reviewed publications, received 3 patents, served on numerous NIH and other study sections and is a national and international speaker in her field.
Mr. Senroy is a seasoned pharmaceutical executive with an MBA from Pepperdine University with expertise in helping companies pass compliance assessments, develop robust quality systems and prepare for U.S. Food and Drug Administration reviews and inspections. Over the past two decades, Mr. Senroy has successfully led several global Quality and Compliance business units as an executive or senior consultant, leading to the approval of key blockbuster drugs with cumulative sales exceeding $30 billion annually over the last 10 years. Mr. Senroy’s ability to form cross-functional alliances for improvement and growth, in addition to a sensitivity to cultural nuances, has helped him succeed on a global scale. He has worked extensively throughout North America, Europe, Asia and South America. Mr. Senroy works with the leadership team on pharmaceutical licensing strategy, facilitation of strategic introductions to key pharmaceutical partners and supports the development of the Company’s overall business development plan.
Mr. Kannan is a partner at Zephyr Venture Partners and a rising star in bioengineering & chemical engineering research. He earned a Batchelor of Science from the University of California, Berkeley in Chemical Engineering with a minor in Bioengineering. He has had 7 years of research experience at UC Berkeley, Johns Hopkins, and Gilead, working with doctors Sanjay Kumar, Richard Saykally, Takanori Takebe, and Sapna Kudchadkar, among others. Mr. Kannan’s research thus far has focused on drug delivery, biomaterials, tissue engineering & regenerative medicine, and physical & medicinal chemistry/chemical engineering. Recently, his work has focused on studying using biomaterials and computational biology to study microglia, glioblastoma & cancer biology, and tissue engineering, with 8 publications in press or under review and multiple cover articles in prominent journals. Mr. Kannan is an inventor on four pending patents including both therapeutic and device patents. His work has been featured in the New York Times, Science Magazine, The Economist, and more than 15 other major science news outlets. Mr. Kannan, at the young age of 21, has already received a number of major research awards from prominent societies including the American Academy of Neurology, and the Society for Biomaterials.
Mr. Gelnaw is an esteemed financial executive whose career spans more than 35 years in financial management, business leadership, and corporate strategy, including acting as CEO and CFO for Cynvec LLC, a research-based cancer entity that partnered with NYU in the development of a Sindbis virus for the treatment of ovarian and colon cancer. Mr. Gelnaw’s past executive roles include Chief Operating Officer of Deutsche Bank, Chief Operating and Financial Officer at Lehman Brothers, senior roles at Salomon Brothers and Arthur Andersen, and founder of Breakwater Ventures which manages a diverse array of investments and strategies across many industry platforms, including Medical Devices, FinTech, Cancer Research and Development, Health and Wellness, Covid 19 Testing and Collection, Real Estate, and financial enterprises.
Michel Rondeau, Doctor of Veterinary Medicine, oversees MVMD’s husbandry and companion animal studies, while driving global pharmaceutical animal applications as part of the ongoing business commercialization of MVMD’s technology. Dr. Rondeau has extensive experience in veterinary research having worked with numerous pharmaceutical companies in animal drug field trials and is credited with co-inventing a global award winning sprayable vaccination device that was acquired by Rhone Poulenc. Dr. Rondeau has completed an extensive range of research and development projects across a diverse range of husbandry animals including porcine industrial medicine across preventative and curative medicine, nutrition and animal health products and automated feed systems.
Jeff has served as a strategic advisor in the development of the medicinal cannabis market for over 12 years and is recognized globally as a leading financial and cultivation expert across the industry. A seasoned entrepreneur, Jeff’s knowledge and expertise is steeped in 20 years of hands-on executive experience in diverse and dynamic markets including the restaurant and entertainment industries, advertising, global sales and financial investment profiles. A big-picture thinker, Jeff leverages his global connections to rapidly identify and advance business opportunities. His keen sense of vision are anchored in practical strategies focused on execution and financial success.
Mr. Hughes brings over fifteen years of professional experience in integrated corporate and marketing communications and extensive experience in venture capital services and commercialization of private and public companies across the globe: North America, Australia, and the Asia Pacific Region. Mr. Hughes supports the Company’s work in the areas of mergers and acquisitions, corporate finance and pharmaceutical licensing.