Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE) has started its ZYN001 Phase I clinical program to evaluate the firm’s patent-protected, pro-drug of THC delivered through a transdermal patch. This trial will assess multiple and single rising doses of numerous formulations of ZYN001 to ascertain the optimal dose to move into Phase II trials.
Armando Anido, the CEO and Chairman of Zynerba, reported that the commencement of the ZYN001 clinical plan is a major milestone for the firm, as they now have two clinical phase resources which upon approval may resolve grave unmet medical needs in many disease settings. They consider that ZYN001 will be vital in numerous pain indications, provided THC’s identified impact on analgesic and pain transmission effect in people suffering from chronic pain.
The advanced transdermal patch delivery provides innovative benefits to people, including the prospect for more sustained, consistent delivery and better THC tolerability. This first in man trial is a randomized, placebo-controlled, double-blind Phase I study. First, the tolerability, pharmacokinetic and safety profile of a single dose of ‘ZYN001’ against placebo will be assessed.
Numerous formulations and patch wear times moving from 24 hours to 7 days will be evaluated in up to 48 healthy people. Based on report from the single dose part of this study, two formulations will be assessed in numerous patch applications for 14 days in as many as 32 healthy people who will be randomized 3:1 to placebo or ZYN001.
The objective is to offer constant levels of THC to increase efficacy while reducing CNS side effects. With the strong completion of this multiple and single dose trial, a Phase II plan for ZYN001 in neuropathic pain and fibromyalgia is intended to commence in 2H2017.
Zynerba reported that ZYN001 is being advanced for patients with peripheral neuropathic pain and fibromyalgia. THC is a CB1 agonist which works at numerous places along pain transmission pathways. It has been demonstrated to have an analgesic impact in chronic pain models.
Why CV Sciences Inc (OTCMKTS:CVSI) Shares are Surging Again
Even though it is under fire from law firms and battling poor sentiment, CV Sciences Inc (OTCMKTS:CVSI) shares have started to surge back to the upside in recent action, crossing back above the stock’s 50-day moving average to close out last week. To help drive the story, the company recently announced that it has introduced PlusCBD Oil Gummies at the Natural Product Expo East 2018.
A look at the company’s press release from late September reveals additional details: “A new category of PlusCBD Oil products, PlusCBD Oil Gummies are offered in two tasty flavors, Cherry Mango and Citrus Punch. A line extension of our Gold Formula line with no artificial ingredients, each gummy contains 5 mg of CBD and a mere 1.5 g of sugar. Gluten free, vegan friendly, and non-GMO, these new products support healthy balance of the body and mind.”
CV Sciences Inc (OTCMKTS:CVSI) bills itself as a company that operates two distinct business segments: a drug development division focused on developing and commercializing novel therapeutics utilizing synthetic CBD; and, a consumer product division focused on manufacturing, marketing and selling plant-based CBD products to a range of market sectors.
CV Sciences, Inc. has primary offices and facilities in San Diego, California and Las Vegas, Nevada.
Moreover, CV Sciences, Inc. operates as a life science company. It operates through two segments, Specialty Pharmaceuticals and Consumer Products. The company focuses on developing and commercializing prescription drugs utilizing synthetic cannabidiol (CBD) as the active pharmaceutical ingredient. Its initial drug candidate is CVSI-007 that combines CBD and nicotine for the treatment of smokeless tobacco use and addiction.
The company also engages in the development, manufacture, marketing, and sale of consumer products containing plant-based CBD under the PlusCBD Oil name in various market sectors, including nutraceutical, beauty care, specialty foods, and vape.
CV Sciences, Inc. was founded in 2010 and is based in Las Vegas, Nevada.
CV Sciences Inc (OTCMKTS:CVSI) pulled in sales of $12.3M in its last reported quarterly financials, representing top line growth of 202.5%. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($7.2M against $3M).
Shares of CVSI have powered higher over the past month, rallying roughly 52% in that time on strong overall action. Moreover, the listing has registered increased average transaction volume recently, with the past month seeing 15% beyond what we have been seeing over the larger time frame.
The action has taken the stock back above its critical 50-day moving average. The most recent press from the company, as discussed above, is its announcement that it has introduced PlusCBD Oil Gummies at the Natural Product Expo East 2018.
“We are pleased to introduce PlusCBD Oil Gummies to our existing line of industry leading hemp extract products that include balms, sprays, drops, capsules, and softgels,” stated Joseph Dowling, Chief Executive Officer of CV Sciences. “We are committed to innovation of our PlusCBD Oil products, and as the demand for CBD infused products continues to grow, it is important to expand our wide variety of products to suit all customer preferences. We foresee PlusCBD Oil Gummies being a solid revenue driving category for our Company.”
Phoenix Life Sciences International Limited (OTCMKTS:PLSI): The New Kid on the Cannabis Block
Phoenix Life Sciences International Limited (OTCMKTS:PLSI) shares continue to look ripe for some potential action as the stock holds key support at the 200-day moving average in recent sessions. The company is a relatively new player on the cannabis playing field, but one with obviously very big plans. That is further supported by its news out on Wednesday.
Specifically, the company just announced its new Board of Directors and executive team, which includes some pretty impressive characters. “We have strategically selected these dedicated professionals based upon their ability to deliver and find creative solutions to help the company grow,” said Chief Executive Officer of Phoenix Life Martin Tindall. “I look forward to working with this talented team and know that we will continue to be successful in our commitment to the vision of life-enhancement through better healthcare.”
Phoenix Life Sciences International Limited (OTCMKTS:PLSI) is an adaptive healthcare solutions company. PLSI is in business to advance research and integrate programs and manufacturing of products that target and treat diabetes, pain, cancer, and address psychological, gastrointestinal, autoimmune, neurological and sleep disorders.
The company strives to create partnerships and integrate these programs for human health into communities worldwide as part of its Global Health Initiative.
According to company materials, “Phoenix Life Sciences International Limited is headquartered in Denver, Colorado. Over the past four years, many of our partner organizations have worked hard to develop and access a broad range of industry and pharmacology specialists. The partnership includes botanists, biologists, industrial and organic chemists, medical doctors, researchers, packagers and distributors. We are delighted to announce that in September 2018 we merged many of these partnerships and affiliations together under the name Phoenix Life Sciences International Limited. Without the support and collaboration of many individuals, this vision wouldn’t have been realized and we thank them for their global vision.”
A Solid Foundation
“It was important for Phoenix Life Sciences International to select individuals that believe in our mission to create a global platform for the reintroduction of plant-based pharmaceuticals, including medical cannabis products, into mainstream healthcare,” continued Tindall. “This new team is comprised of key leaders with decades of cumulative years of experience and I feel confident that we will make great strides together.”
Most centrally, Martin Tindall has been appointed as the company’s Chief Executive Officer.
According to the release, “He has held various roles including Chief Information Officer at Bartercard and Executive Director of Kronos International Investments, working with clients in a wide range of industries. Tindall founded Phoenix Life and its related companies after losing his father to chemotherapy in treating pancreatic cancer. Today, driving the vision for a better future for healthcare, Tindall leads the Phoenix Team.”
At this time, carrying a capital value in the market of $523.28k, PLSI has virtually no cash on the books, which compares with about $2.1M in total current liabilities. One should also note that debt has been growing over recent quarters.
However, the growth that is starting to heat up the top line grants speculators some interesting fuel to see the potential upside ahead: y/y quarterly revenues are growing at 541.4%.
We will update the story again soon as developments transpire.
What May Spur the Next Breakout in Aphria Inc (OTCMKTS:APHQF)?
Aphria Inc (OTCMKTS:APHQF) shares have been tracing out an interesting sideways trading range over the past month. That range is starting to come to a head in recent trade. The trend is clearly to the upside on almost every timeframe, and trend traders should be on the lookout for catalysts that can serve to push that extension.
Further pushing the story forward, the company just announced that it has closed the acquisition of LATAM Holdings Inc. from Scythian Biosciences. According to the release, “The Transaction was funded by the assumption of US$1 million of existing LATAM Holdings debt with the remaining consideration funded by the issuance of 15,678,310 common shares of Aphria. The closing was pursuant to the terms of the definitive share purchase agreement previously announced by the Company on July 17, 2018.”
Aphria Inc (OTCMKTS:APHQF) commands a market cap of $3.22B as a leading global cannabis company driven by “an unrelenting commitment to our people, product quality and innovation.”
Headquartered in Leamington, Ontario – the greenhouse capital of Canada – Aphria has been setting the standard for the low-cost production of safe, clean and pure pharmaceutical-grade cannabis at scale, grown in the most natural conditions possible. Focusing on untapped opportunities and backed by the latest technologies, Aphria is committed to bringing breakthrough innovation to the global cannabis market.
The Company’s portfolio of brands is grounded in expertly-researched consumer insights designed to meet the needs of every consumer segment. “Rooted in our founders’ multi-generational expertise in commercial agriculture, Aphria drives sustainable long-term shareholder value through a diversified approach to innovation, strategic partnerships and global expansion, with a presence in more than 10 countries across 5 continents.”
The company touts itself as one of Canada’s lowest cost producers, produces, supplies and sells medical cannabis. The company is truly powered by sunlight, allowing for the most natural growing conditions available. “We are committed to providing pharma-grade medical cannabis, superior patient care while balancing patient economics and returns to shareholders. We are the first public licensed producer to report positive cash flow from operations and the first to report positive earnings in consecutive quarters.”
Aphria Inc (OTCMKTS:APHQF) has been raking in the cash, with $9.4 million coming in its quarter-ended May 31. Revenues are growing at a robust 110%. The company is also sitting on a strong balance sheet, with total assets now above $1 billion against total debt at just above $115 million.
New Catalysts in Technical Context
As discussed above, APHQF just announced that it has closed the acquisition of LATAM Holdings Inc. from Scythian Biosciences.
“Aphria continues to execute on its plans for strategic international expansion, including in Latin America and the Caribbean,” said Vic Neufeld, Chief Executive Officer of Aphria. “With a combined population of nearly 640 million, and with significant momentum from numerous countries introducing new or modernizing existing medical cannabis legislation, the region represents a significant opportunity for long-term growth. It also hosts some of the most favourable conditions for cultivating high-quality medical cannabis at substantial efficiencies – ideal for both regional supply and export opportunities. This acquisition firmly cements Aphria’s leadership in the region and on the global cannabis stage.”
Shares continue to hold up in a range over the past 3 weeks, with a possible breakout lined up if and when we see the stock push back above resistance in the $16/share area.
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