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Mountain Valley MD looking to eradicate needles with its patented Quicksome oral drug delivery technology

Snapshot

Quicksome enables unprecedented delivery impact through sublingual and buccal formats that provide direct absorption into the bloodstream, dramatically improving drug efficacy, dosing and end-user experience

Mountain Valley MD Holdings Inc - Mountain Valley MD looking to eradicate needles with its patented Quicksome oral drug delivery technology

Quick facts: Mountain Valley MD Holdings Inc

Price: 0.51 CAD

CSE:MVMD
Market: CSE
Market Cap: $127.28 m
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  • Quicksome utilizes advanced liposomes and other stabilizing molecules to encapsulate and formulate active ingredients into highly efficient product formats
  • Developing products for pain management, weight loss, energy, focus, sleep and anxiety
  • Looking at the fight against the coronavirus (COVID-19)

What Mountain Valley MD does:

Mountain Valley MD Holdings Inc (CSE:MVMD) (OTCMKTS:MVMD) is building a world-class biotech and life sciences company centered around the implementation of its patented Quicksome oral drug formulation and delivery technologies.

The Vancouver, British Columbia-based company applies its Quicksome desiccation technology towards the oral delivery of vaccines and pharmaceutical drugs as well as the development of products for pain management, weight loss, energy, focus, sleep and anxiety. It is also looking at the fight against the coronavirus (COVID-19).

The patented Quicksome technology utilizes advanced liposomes and other stabilizing molecules to encapsulate and formulate active ingredients into highly efficient product formats that are consumed orally.

Quicksome enables unprecedented delivery impact through sublingual and buccal formats that provide direct absorption into the bloodstream, dramatically improving drug efficacy, dosing and end-user experience.

The result is a new generation of product formulations that are capable of delivering vaccines, drugs and nutraceuticals into the body faster, with greater impact, efficiency and accuracy.

Activating molecules and formulas with Quicksome also vastly improves their economic viability, opening up markets and applications that were previously not feasible for our partners. By way of example, the group is working on applications where it can eliminate the need for subcutaneous injection with needles. Such applications can vastly improve access and the economics for life-saving drugs globally.

The Quicksome technology has been in development since 2010, and initially incorporated into several commercial dietary supplement products. To date, the company has 14 patents in its portfolio, 12 extensions and has filed over a dozen provisional patents with respect to its Quicksome technology.

Led by president and CEO, Dennis Hancock, the group’s management team brings together world-class leadership across mucosal delivery sciences, molecular research, IP and legal management, marketing, distribution and financial services

How is it doing:

On December 29, 2020, Mountain Valley MD announced that its operating business had completed the first portion of a multiprong strategic agreement with Circadian Wellness Corp., a privately-held Ontario corporation that is focused on the rapidly emerging global mushroom space.

The company said it has completed the previously announced transaction under a share purchase and exchange agreement to sell its wholly-owned subsidiary, Mountain Valley Medicinals Inc. (MVM) and its related assets, including the company’s property on Vancouver Island in British Columbia - which to date has not been built on, advanced or utilized for any current operations - for the amount of C$1,000,000, made up of a combination of cash and a 9% equity stake in Circadian.

The company said this is part of its ongoing strategy to shift away from ownership of physical property and idle assets, towards focusing on monetizing licenses against its more lucrative technology patent portfolio.

Mountain Valley MD has been working closely with Circadian on proprietary formulations for mushroom-infused products that achieved a significant increase in overall molecule efficacy with the company’s Quicksome desiccated liposome technology applied across a variety of rapid dissolve oral products. Circadian plans on bringing a broad line of naturally derived mushroom products to the global marketplace, with many of the extracts coming from the old-growth forests found on the MVM property being sold.

The group noted that internal formulation and testing work the company has completed for Circadian across a variety of mushroom molecules has reached desired efficacy targets while using up to 1/50th of the raw mushroom extracts versus comparable tincture dosing.

The company said it believes the dramatic increase in bioavailability across convenient and easy-to-use rapid dissolve Quicksome oral delivery formats will position Circadian Wellness products as a leading contender in the rapidly growing mushroom marketplace.

Mountain Valley MD and Circadian are now working to finalize the commercial licence agreement as contemplated in an executed binding letter of intent based on applying the group's Quicksome technology to mushroom nutraceutical products, with the anticipation of completion in January 2021.

Circadian is a privately held Ontario corporation in the business of mushroom cultivation, extraction, clinical research and development, and end-user consumer health and wellness products and retreats.

A week earlier, Mountain Valley MD revealed it had filed for an accelerated review of its macrocyclic lactone solubilization patent with the United States Patent and Trademark Office (USPTO).

To support the accelerated patent examination request, the company said it has provided the USPTO with new formulation analyses of different diluted concentrations of its Quicksol Ivermectin in solution, data that the company had fast-tracked for completion and validation by a third-party contract research organization (CRO).

Mountain Valley MD previously confirmed its ability to make the anti-parasitic drug Ivermectin highly water-soluble without the use of organic solvents, improving its water solubility by nearly 5,000 times and that it had completed its initial safety and improved efficacy in pre-clinical validation with the leading third-party preclinical CRO. 

The pre-clinical trials confirmed a significant improvement in the Ivermectin pharmacokinetics and efficacy when applied through the group's Quicksome and Quicksol technologies versus existing oral and subcutaneous forms.

Mountain Valley MD's solubility technology applied to the Ivermectin drug is the only form in the world that uses strictly excipients that are currently approved by the US Food and Drug Administration (FDA), making it a leading candidate for human injection and sublingual applications as well as significantly broader husbandry and companion animal treatments based on its low viscosity.

The company said it has been closely monitoring the global studies and reports that demonstrate the efficacy of the drug Ivermectin as a therapeutic for coronavirus (COVID-19), including the ongoing work from the Front Line COVID-19 Critical Care Alliance (FLCCC Alliance) and its recent publication outlining the evidence base supporting the efficacy of Ivermectin as a therapeutic to fight COVID-19, including data from 7,825 patients across 24 trials. 

Additionally, according to a meta-analysis recently performed by an independent research consortium, it was calculated that the chances that Ivermectin is ineffective in COVID-19 to be 1 in 67 million.

Mountain Valley MD said its patent application covers all highly solubilized macrocyclic lactones, including Ivermectin and Selamectin, which have also been shown to be effective in the treatment of tuberculosis even with limited solubility. The company believes its solubility technology can dramatically enhance the efficacy of both inhaled and injected Selamectin or Ivermectin providing a novel effective therapeutic for tuberculosis.

On the financing front, on December 22, 2020, Mountain Valley MD closed an oversubscribed non-brokered private placement that raised gross proceeds of over $4.3 million. The private placement saw the issue of 19,650,908 units which each comprised one share and one half of one share purchase warrant, with each warrant exercisable for 24 months at an exercise price of $0.45 per share.

The company said the funds will be used for the advancement of “formulation research and development, pre-clinical trials, patent management and general working capital purposes.”

Launching the placement on December 14, Mountain Valley MD also unveiled plans to settle its aggregate indebtedness of approximately $400,00 with arm’s length third parties. The company said it intends to issue units to such third parties at $0.071 each - which had been reserved by the company in early November 2020 based on the market price at that time – with each settlement unit comprised of one common share and one half of one share purchase warrant which as a whole has an exercise price of $0.13 and an expiration date of 24 months from the date of issuance.

At the same time, Mountain MD announced the appointment of seasoned pharmaceutical executive, Sid Senroy as an advisor to the company. In this capacity, the group said, Senroy will work with its leadership team on pharmaceutical licensing strategy, facilitate strategic introductions to key pharmaceutical partners and support the development of the company’s overall business development

It noted that Senroy has expertise in helping companies pass compliance assessments, develop robust quality systems and prepare for US Food and Drug Administration reviews and inspections. Over the past two decades, he 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.

Inflection points:

  • Further moves in multiprong strategic agreement with Circadian Wellness
  • Advancement of formulation research and development, pre-clinical trials
  • Patent management moves

What the boss says:

"The timing of our strategic investment capitalization and zero debt position places Mountain Valley MD in a tremendous position to advance our business and realize our impact on global human and animal health," said Mountain Valley MD CEO Dennis Hancock in a statement accompanying December’s private placement.

"Presenting over the past week to numerous identified strategic biotech and pharmaceutical investors has brought some significant partners into the fold who want to support our success. We believe this oversubscription represents the significant interest in our business by this industry," he added.

Contact the author at [email protected]

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Mountain Valley MD makes history receiving patent for their proprietary...

Mountain Valley MD (CSE: MVMD) Director of Life Sciences Mike Farber joined Steve Darling from Proactive with news the company has received a patent for their Quicksome Technology. This patent approval is the first for MVMD in the Canadian marketplace to pass the formal allowance...

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