I have received enough questions from followers about Nemus Bioscience (OTCQB:NMUS) that my curiosity was finally piqued to the point of action. While Seeking Alpha has certainly presented a fair share of information and analysis about NMUS, the time is probably ripe for management to provide a detailed update as to the current state of NMUS, as well as to provide guidance on its near term ambitions.
Being that as it may, I went straight to the source, and NMUS management was more than receptive to providing some current data and to provide investors with a fresh take on what NMUS is working to accomplish.
From my point of view, NMUS is growing and is charting a course for growth in the near term. From managements perspective, they are already well on their way.
Q. In looking at NEMUS' portfolio of cannabinoid product candidates and the unique relationship with The University of Mississippi, can you provide us with an overview of the pipeline and patent portfolio?
The University of Mississippi has held the only contract to cultivate cannabis for research purposes on behalf of the Federal Government since 1968. By virtue of the University's 49-year experience with the Cannabis plant, Nemus benefits tremendously from the University's knowledge. Nemus is the sole developmental and commercialization partner with the University and has exclusive, global licenses to intellectual property related to these molecules.
Those licenses include access to intellectual property for both a prodrug of tetrahydrocannabinol (THC) and an analogue of cannabidiol (CBD). The THC-prodrug is being developed as a therapeutic agent for glaucoma and chemotherapy-induced nausea and vomiting (CINV). The analogue of CBD is being explored as a possible therapeutic for chemotherapy-induced peripheral neuropathy (CIPN) and other pain syndromes. Lastly, Nemus is developing cannabinoid-based platforms for use as anti-infectives, especially for use against bacteria and viruses that have developed resistance to established therapies.
Q. Often times investors confuse pharmaceutical-based cannabinoids with plant derived products. Can you give a layman's overview of the difference and significance from a regulatory standpoint?
The Cannabis plant is known to have more than 100 different cannabinoid molecules. These molecules can possess diverse activity at the cellular level in multiple organs in the body. Plant-derived molecules are very hydrophobic or not that soluble in water. The lack of significant water solubility makes these molecules difficult to administer into the body, especially by oral ingestion. Nemus' cannabinoid molecules have been re-engineered to make them chemically more hydrophilic or water soluble, so they can traverse cellular membranes easier with the goal that they can be absorbed in a more predictable and safer way. Patents have been issued for compounds licensed by Nemus that have intellectual property claims related to composition of matter, methods of synthesis, and methods of use.
Nemus cannabinoid molecules are being chemically synthesized to meet purity and scale-up criteria for eventual commercialization. The synthetic manufacturing process must meet DEA and FDA specifications for cannabinoid-based drug product. Furthermore, Nemus plans to conduct the necessary pre-clinical and clinical studies so these molecules meet the specifications to be an approvable drug product.
Q. In terms of competition in the space with GW Pharma, Zynerba, and Insys, how do you feel NEMUS should be compared?
Nemus is an early-stage developmental company compared to the listed cannabinoid-market incumbents. We aspire to be a second-generation market disruptor.
a) Nemus does not rely on plant extraction for its drug product candidates and in fact, by virtue of biosynthetic manufacturing, can potentially develop high-purity active pharmaceutical ingredients (APIs) with associated shorter manufacturing times.
b) Nemus's portfolio consists of re-engineered cannabinoids, a prodrug of THC and an analogue of CBD. These drug product candidates are designed to have multiple routes of administration specific to the disease indication that could potentially give Nemus a competitive advantage on issues of bio-distribution, bioavailability, and pharmacokinetics.
c) Unlike companies that use traditional plant cannabinoids, Nemus' licensed bio-engineered molecules have been issued patents for composition of matter as well as methods of use. Consequently, Nemus may not have to rely on orphan indications for market exclusivity but could approach entire therapeutic areas globally. These markets, namely glaucoma, pain, methicillin-resistant Staphylococcus aureus (MRSA) and CINV, are all multi-billion dollar global opportunities with an urgent medical need for newer, safe and effective therapies.
d) Nemus currently holds some market distinctions, including, to our knowledge, being the only cannabinoid company developing a portfolio of drug candidates for use in ophthalmology, with a leading indication being glaucoma; the only cannabinoid company developing an anti-infective platform against multiple infectious agents; the only cannabinoid company utilizing biosynthetic manufacturing; and the only cannabinoid company with prodrug and analogue capability with multiple potential routes of administration including ocular, trans-mucosal/buccal, transdermal, and transmembranous delivery that avoids first-pass metabolism by the liver.
Q. With GW Pharma being the most advanced in the clinic with a market cap of almost $3 Billion, how do you see NEMUS moving forward with GW having the first mover advantage?
With a pipeline bio-engineered with the goal of better target-organ access, we believe Nemus can be a classical second-mover to capitalize on unmet medical needs of first-in-class drugs. Those needs include: more rapid onset of action, predictable bioavailability and pharmacokinetics, routes of administration that avoid first-pass liver metabolism, versatility in dosing mechanisms, and efficient API manufacturing. We believe Nemus will be able to enter large therapeutic areas versus having to focus on orphan indications.
Q. From a regulatory standpoint at the federal level and some of the laws that have been passed, do you believe the current administration will loosen plant-based cannabinoids versus pharmaceutical, and how would that impact your business model?
Time will tell what the new administration's position will be. For pharmaceutical developers, the pathway to drug approval is carefully delineated and all drugs must meet the criteria set by the regulatory agencies. If marijuana is re-scheduled as a Schedule II drug, pharmaceutical developers will be required to conduct clinical trials and have scientifically rigorous data to make claims about and promote the medicinal benefits of the Cannibas plant as was done with other Schedule II medications like oxycontin. Nemus plans to conduct research and development in accordance with FDA standards so the proper regulatory filings can be made to reach drug approval.
Q. Looking forward at how you advance your portfolio, should investors be looking at structures such as co-development or licensing agreements, and are there examples of such in the cannabinoid industry?
It will come as no surprise to anyone that drug development is time consuming and expensive, especially on a global scale. Nemus has access to patents and compounds that have shown activity in both in vitro and animal testing. To maximize shareholder value, Nemus is open to explore strategic collaborations with partners that can help expedite our goals to commercialize our pipeline. That collaboration could possibly take the form of a co-development deal, an in-licensing of our products, or an outright acquisition of a promising platform, especially one that requires resources that an early-stage biotechnology company may not have.
Mature companies in the cannabinoid sector like GW Pharma have also partnered with larger firms, especially those that can provide development capital and provide sales capabilities in overseas territories. We anticipate that this will be more the rule than the exception as breakthrough companies in the pharmaceuticalized cannabinoid space expand their capabilities.
Q. In closing, given all of the developments that have occurred both in NEMUS and the cannabinoid sector over the past year, what should investors focus on in 2017?
I believe investors will see strides in the cannabinoid sector beyond pain and epilepsy as companies like Nemus advance other cannabinoid molecules for newer indications. I feel the cannabinoid sector is a hyper-competitive space and there will be greater emphasis to expand treatment options utilizing different routes of administration to enhance safety and the clinical response. Nemus has licenses from the University of Mississippi that allow the company to develop unique methods to administer our novel forms of cannabinoids and we look forward to introducing these approaches into the development pipeline in 2017.
While technically not a marijuana stock, NMUS will most likely rise and fall with the sector, at least until the market fully understands the differentiating features of the company. NMUS is certainly a stock to keep an eye on in the near term, as cannabinoids are becoming increasingly popular in clinical trials and are demonstrating significant therapeutic benefit for a host of disease and illness.
Thanks to Brian Murphy and the rest of the management team at NMUS for taking the time to update shareholders. While all small caps have risk, the ones that have a clear plan of action hold the most promise of making it out of penny land alive. For NMUS, as long as management can stay focused to their tasks at hand and remain steadfast to their corporate responsibilities, they may fare well in the next 12-24 months.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
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