Mr. Dennis Hancock reports

MOUNTAIN VALLEY MD PROCEEDING WITH PRE-CLINICAL CANCER TRIALS, FILES RELATED CANCER PATENT

Mountain Valley MD Holdings Inc. has filed a novel cancer adjuvant patent and is proceeding with preclinical trials with third party cancer contract research organizations (CROs) in triple-negative breast cancer, metastatic melanoma and lung carcinoma.

Summary

• Mountain Valley files cancer patent for direct intratumoural injection, intravenously, infusions or instillations as adjuvants for broad chemotherapeutic to immunotherapeutic cancer regimens.
• The company is proceeding with three separate preclinical trials with specialized third party cancer CROs: (1) triple-negative breast cancer; (2) metastatic melanoma; and (3) Lewis lung carcinoma as a proxy for non-small cell lung carcinoma.
• The company believes the research will have near-immediate application to direct human trials based on safety and efficacy of ivermectin.

"The extensive research supporting the drug ivermectin as effective in the inhibition of proliferation, metastasis and angiogenic activity in a variety of cancers, and as an initiator of immunogenic cell death, is overwhelming," stated Mike Farber, director of life sciences at Mountain Valley MD. "Imagine what is possible when you have the world's only human injectable form of ivermectin that can be directly injected into a tumour or provided through more bio-available forms such as intravenously. We believe this will be groundbreaking research with near-immediate application to be able to proceed directly to human trials based on the safety and efficacy of ivermectin."

Leading up to the implementation of preclinical trial cancer research, Mountain Valley has been extensively researching the drug ivermectin, including its impact on cancer.

As cited by Pharmacological Research in January, 2021, Ivermectin has powerful anti-tumour effects in a variety of cancer cells and promotes programmed cancer cell death, including apoptosis, autophagy and necrosis. The research also identifies how ivermectin has been shown to inhibit tumour stem cells and reverse multidrug resistance.

Mountain Valley filed its cancer adjuvant patent, Novel Injectable, Infusable, Instillable Ivermectin Adjuvant for Cancer Therapies for its solubilized ivermectin (Ivectosol). The patent-pending adjuvant utilizes the company's advances in macrocyclic lactone solubility to consider Ivectosol as a viable adjuvant for numerous cancer therapies. Mountain Valley'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 U.S. Food and Drug Administration, making it a leading candidate for human injection or intravenous infusion.

The preclinical trials that are being conducted are designed to prove the utility of Ivectosol to synergize and improve various cancer regimens currently in use and as a potent enhancer of current immunotherapies and chemotherapies for difficult-to-treat cancers.

Study 1: triple-negative breast cancer

• Study will test the effectiveness of Ivectosol combined with checkpoint inhibitor that would be equivalent to either OPDIVO or Keytruda for disease progression and complete response rate;
• Arms in the study will look at single checkpoint inhibitor, oral IVM plus checkpoint inhibitor and intratumoural IVM plus checkpoint inhibitor;
• Estimated initial readouts/analysis -- second week of June, 2021;
• Complete readout with flow cytometry and statistical evaluation estimated mid-July, 2021, with possible abstract submission in August, 2021.

Study 2: metastatic melanoma

• Study will test the effectiveness of Ivectosol intratumoural combined with checkpoint inhibitor for disease progression and complete response rate;
• Arms in the study will look at single checkpoint inhibitor, oral IVM plus checkpoint inhibitor and intratumoural IVM plus checkpoint inhibitor;
• Estimated initial readouts by end of June, 2021;
• Complete readout with flow cytometry and statistical evaluations estimated end of July, 2021, with possible abstract submission in August, 2021.

Study 3: Lewis lung carcinoma as a proxy for non-small cell lung carcinoma

• Study will test the effectiveness of Ivectosol intratumourally combined with checkpoint inhibitor for disease progression and complete response rate;
• Arms in the study will look at single checkpoint inhibitor, oral IVM plus checkpoint inhibitor, intratumoural IVM plus checkpoint inhibitor and navalbine plus intratumoural IVM;
• Estimated initial readouts by end of June, 2021;
• Complete readouts with flow cytometry and statistical evaluation estimated by end of July, 2021, with possible abstract submission in August, 2021.

All three studies will assess tumour growth and metastases through bioluminescence imaging, a non-invasive optical imaging modality designed to visualize and quantify bioluminescent signal in tissues. The company is also actively pursuing a preclinical trial for bladder cancer and is currently assessing the best option to proceed through the evaluation of CRO proposals.

"Ivermectin is a Nobel-prize-winning global blockbuster drug with unprecedented potential. Overcoming its No. 1 limitation of solubility using FDA-approved excipients has opened up significant applications across multiple human and animal health lanes for Mountain Valley MD and our partners," stated Dennis Hancock, president and chief executive officer of Mountain Valley MD. "Driving innovation in cancer research to support positive outcomes for increased survival rates, productivity and improved quality of life for the global population is directly aligned with our mission of more life, less death. We couldn't be more honoured to drive forward this important work."

According to the World Health Organization, cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020. The World Cancer Day foundation estimates the total annual economic cost of cancer at approximately$1.16-trillion (U.S.).

About Mountain Valley MD Holdings Inc.

Mountain Valley MD is building a world-class biotech and life sciences company organization centred around the implementation of its patented Quicksome oral drug formulation and delivery technologies and its Quicksol solubilization technology for macrocyclic lactones, to innovate industry leading products that are sought out globally.

Mountain Valley's proposition for delivering Quicksome formulations that have rapid onset, high-bioavailability, low-variability and precision dosing is core to the company's success across key health and wellness categories. Consistent with its vision toward "helping people live their best life," Mountain Valley applies its Quicksome and Quicksol technologies to its groundbreaking work for advanced delivery of vaccines and pharmaceutical drugs as well as the development of products for pain management, weight loss, energy, focus, sleep, anxiety and more.

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

The company's patented Quicksol solubilization technology covers all highly solubilized macrocyclic lactones (including the drugs Ivermectin and Selamectin). Mountain Valley's solubility technology applied to the Ivermectin drug is the only form in the world that only uses excipients that are currently approved by the U.S. Food and Drug Administration, 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.

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