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Medical Marijuana Sector – The Green Rush is back
Marijuana stocks have been making a major comeback in 2016. Many are comparing it to the boom we saw in 2014. With the presidential elections approaching and new legislations, the cannabis debate is attracting mainstream media exposure similar to 2014, the year of the “Green Rush”. According to multiple reports, the legalized marijuana industry may potentially be prime to quadruple by the year 2020. Companies that were once at the forefront of the marijuana industry are starting to re-ignite the rapidly growing sector back to life.
Cara Therapeutics Inc. (NASDAQ:CARA)
Cara Therapeutics, Inc., incorporated on July 2, 2004, is a clinical-stage biopharmaceutical company. The Company is focused on developing and commercializing chemical entities designed to alleviate pain and pruritus by focusing on kappa opioid receptors. The Company is engaged in developing product candidates that focus on the body’s peripheral nervous system. Its product candidate pipeline includes I.V. CR845 for acute pain; I.V. CR845 for uremic pruritus; Oral CR845 for acute and chronic pain, and CR701 for neuropathic and inflammatory pain. CR845 is a peripherally-acting kappa opioid receptor agonist for the treatment of both acute and chronic pain. Due to its selectivity for the kappa opioid receptor and ability to decrease mu opioid use, CR845 has demonstrated an ability to decrease the acute opioid-related adverse events (AEs) of nausea and vomiting with no evidence of drug-related respiratory depression. CR845 has been administered to over 400 human subjects in Phase I and Phase II clinical trials as an intravenous infusion, rapid intravenous injection or oral capsule or tablet and was considered to be safe and well tolerated in these clinical trials. It has completed a Phase Ia/Ib clinical trial of a tablet formulation of Oral CR845.
The Company’s advanced product candidate, I.V. CR845, is an injectable version of its peripheral kappa opioid receptor agonist, which is designed to provide pain relief without stimulating mu opioid receptors and therefore without mu opioid-related side effects, such as nausea, vomiting, respiratory depression and euphoria. I.V. CR845 has demonstrated efficacy and tolerability in three randomized, double-blind, placebo-controlled Phase II clinical trials in patients undergoing soft tissue (laparoscopic hysterectomy) and hard tissue (bunionectomy) surgery. In both the laparoscopic hysterectomy and bunionectomy clinical trials, CR845 administration resulted in reductions in pain intensity. The Company is also developing an oral version of CR845. The Company, using a third-party formulation technology, is developing a tablet formulation with improved pharmaceutical properties in order to conduct proof-of-concept clinical safety and efficacy trials. It completed a single United States center, randomized, placebo-controlled, escalating single oral dose, sequential group Phase I clinical trial of Oral CR845 (Study 1002-PO).
In addition to the Company’s CR845 family of peripheral kappa agonists, it is developing lead molecules that modulate peripheral cannabinoid receptors. The Company’s CR701 is a peripherally-restricted, mixed-CB1/CB2 receptor agonist that interacts with these cannabinoid receptor subtypes, with no off-target activities. The compound is orally bioavailable, active in preclinical models of inflammatory and neuropathic pain, and does not produce the side effects characteristic of centrally-active cannabinoids, such as sedation and hypothermia.
Recent News and Analysis:
The company recently reported financial results for the fourth quarter and full year ended December 31, 2015. “2015 was full of important development milestones, as we initiated an adaptive pivotal trial of I.V. CR845 in acute postoperative pain following abdominal surgery, met the primary endpoint in our Phase 2 study of I.V. CR845 in uremic pruritus, and demonstrated positive Phase 2a data on Oral CR845 in osteoarthritis patients,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “We look forward to promptly resolving the IND clinical hold on our CLIN3001 trial in postoperative pain. Furthermore, we believe our strong balance sheet enables us to continue to execute on all of our planned clinical development activities for I.V. and Oral CR845.”
The Company reported a net loss of $9.5 million, or $0.35 per basic and diluted share, for the fourth quarter of 2015 compared to a net loss of $4.2 million, or $0.18 per basic and diluted share, for the same period of 2014. The Company did not recognize any revenues during the fourth quarter of 2015. For the fourth quarter of 2014, collaborative revenue was $399,000, comprising revenue that had been deferred upon entry into the license agreement with Maruishi Pharmaceutical Company Ltd. and clinical compound revenue was $515,000 from the sale of clinical compound to Maruishi.
Based on timing expectations and projected costs for current clinical development plans, Cara expects that its existing cash and cash equivalents and available-for-sale marketable securities as of December 31, 2015 will be sufficient for the Company to fund its operating expenses and capital expenditure requirements through the end of the first quarter of 2018, without giving effect to any potential milestone payments under existing collaborations.
Cara Therapeutics has a market cap of $163 million and an enterprise value of $66 million. This stock trades at a premium valuation, with a price-to-sales of 37.64 and a price-to-book of 1.56. Its estimated growth rate for this year is -63%, and for next year it’s pegged at -19%. This is a cash-rich company, since the total cash position on its balance sheet is $111.12 million and its total debt is zero. From a technical perspective, Cara Therapeutics is currently trending below both its 50-day and 200-day moving averages, which is bearish. This stock has been uptrending over the last few weeks, with shares moving higher off its low of $4.5 to its intraday high on Wednesday of $6.75 a share. During that uptrend, shares of Cara Therapeutics have been consistently making higher lows and higher highs, which is bullish technical price action. If you’re bullish on Cara Therapeutics then I would look for long-biased trades as long as this stock is trending above its 20-day moving average of $5.40 a share and then once it breaks out above Wednesday’s intraday high of $6.75 a share with high volume. Look for a sustained move or close above that level with volume that hits near or above its three-month average action of 566,092 shares. If that breakout triggers soon, then this stock will set up to re-test or possibly take out its next major overhead resistance levels at its 50-day moving average of $7.64 to $7.84, or even $8.30 to around $9 a share.
CannaGrow Holdings, Inc. (OTCMKTS: CGRW)
CannaGrow Holdings, Inc. provides solutions to the cannabis industry in the State of Colorado. It operates as a lessor, liaison, and consultant to licensed growers in the medical/recreational cannabis industry, as well as provides them with growing facilities. The company was formerly known as BizAuctions, Inc. and changed its name to CannaGrow Holdings, Inc. in November 2014. CannaGrow Holdings, Inc. is based in Las Vegas, Nevada.
Recent News and Analysis:
The company recently announced a key update on the Buffalo Ranch Project located in Huerfano County, Colorado. As confirmed by the CEO of CannaGrow Holdings, Delmar Janovec, NuGro Industries, Inc., the landowner and developer for the Colorado Buffalo Ranch Project, carried through with the first of several purchase orders for major equipment and supplies required for the initiation of Cannabis production at the Colorado Buffalo Ranch Facilities. An order was placed for 70 grow lights through Growers House (www.growershouse.com), followed by the purchase of 80 cubic yards of organic seasoned compost from Innovative Organics (www.innovativeorganics.com). A number of additional purchase orders are being negotiated for immediate execution, including hundreds of grow containers, drip irrigation system components, environmental control systems, and all natural amendments for a soil-based growing medium. The Colorado Buffalo Ranch Marijuana Cultivation Facility represents an innovative transformation from the traditional “indoor” grow room or warehouse environment to a largely greenhouse-based sunshine-driven high-throughput production system. Janovec confirmed that the 3200-ft2 Head House building provides a state-of-the-art nursery environment for the massive propagation of seeds and vegetative cuttings, as well as a genetic vault where mother and father plants of numerous Cannabis strains will be grown in vegetative state for the perpetual production of vegetative cuttings; additional rooms provide ideal climates for drying and curing harvested product, as well as for staging controlled Cannabis breeding trials. The fully automated 3000-ft2 Nexus Greenhouse provides an optimal light deprivation environment for producing full crops of harvestable product, as well as a staging area for the massive production of hundreds of young plants required to fill the seasonal greenhouses in the early spring months of each year.
CannaGrow CEO stated, “We intend to have the greenhouses erected and fully functional for seasonal production starting this spring, with first harvest in the autumn,” explained Dr. Janovec. “In addition, the installation of Modine BTU gas heater units in each of the three (3) greenhouses will enable extension of the growing season and harvest potential into the early winter months.” Over the last 30 days CGRW has rallied 43.17% from lows of $0.39 in Mid-February to highs of $0.650 on Wednesday. More in store for CGRW as the greenhouse are built and fully operational.
GW Pharmaceuticals plc. (NASDAQ: GWPH)
GW Pharmaceuticals plc. is involved in the development of cannabinoid prescription medicines using botanical extracts derived from the Cannabis Sativa plant. The Company develops a portfolio of cannabinoid medicines, including Epidiolex, which is an oral medicine for the treatment of refractory childhood epilepsies. The Company operates through three segments: Commercial, Sativex Research and Development (Sativex R&D), and Pipeline Research and Development. The Commercial segment distributes and sells the Company’s commercial products. The Sativex R&D segment seeks to maximize the potential of Sativex through the development of indications. The Sativex R&D segment focuses on the Phase III clinical development program of Sativex for use in the treatment of cancer pain. The Pipeline Research and Development segment seeks to develop cannabinoid medications other than Sativex across a range of therapeutic areas using the Company’s cannabinoid technology platform.
Recent News and Analysis:
The company recently announced positive results of the first pivotal Phase 3 study of its investigational medicine Epidiolex® (cannabidiol or CBD) for the treatment of Dravet syndrome. In this study, Epidiolex achieved the primary endpoint of a significant reduction in convulsive seizures assessed over the entire treatment period compared with placebo (p=0.01). Epidiolex has both Orphan Drug Designation and Fast Track Designation from the U.S. Food and Drug Administration (FDA) in the treatment of Dravet syndrome, a rare and debilitating type of epilepsy for which there are currently no treatments approved in the U.S. “The results of this Epidiolex pivotal trial are important and exciting as they represent the first placebo-controlled evidence to support the safety and efficacy of pharmaceutical cannabidiol in children with Dravet syndrome, one of the most severe and difficult-to-treat types of epilepsy,” said Orrin Devinsky, M.D., of New York University Langone Medical Center’s Comprehensive Epilepsy Center. “These data demonstrate that Epidiolex delivers clinically important reductions in seizure frequency together with an acceptable safety and tolerability profile, providing the epilepsy community with the prospect of an appropriately standardized and tested pharmaceutical formulation of cannabidiol being made available by prescription in the future.” “The positive outcome of this Phase 3 trial is a significant milestone in the development of Epidiolex as a potential new treatment for patients suffering from Dravet syndrome. We are excited about the potential for Epidiolex to become the first FDA approved treatment option specifically for Dravet syndrome patients and their families,” stated Justin Gover, GW’s Chief Executive Officer. “In light of this positive data, we will now request a pre-NDA meeting with the FDA to discuss our proposed regulatory submission. We also look forward with excitement to the upcoming results from the two Phase 3 trials in Lennox-Gastaut syndrome and the second pivotal trial in Dravet syndrome.”
“Dravet syndrome is one of the most catastrophic types of epilepsy in children and safe and effective treatments are desperately needed. We are thrilled to learn of these positive results, which bring much needed hope to the children and families who have been living with these debilitating seizures,” said Mary Anne Meskis, Executive Director of the Dravet Syndrome Foundation.
GW Pharma was reiterated as Buy by Merrill Lynch’s Tazeen Ahmad. The firm’s prior $150.00 price objective was already north of 100% upside, given the $80.74 close from Wednesday. But now the price objective was raised to $172.00, at the top of all analyst call targets, for implied upside of some 136% if Merrill Lynch’s price objective comes to fruition. Ahmad believes that the positive Dravet’s trial validates GW Pharma’s cannabis-based platform. Epidiolex achieved its primary endpoint of median reduction in seizure frequency in patients with Dravet Syndrome, and the higher rating is based on a higher chance of approval for Epidiolex in Dravet Syndrome. While $172 is at the highest rung of analyst price targets, the Merrill Lynch report suggests that upside to its price objective may be drawn from positive data in another form of epilepsy, which may be seen in the second quarter of 2016.
INSYS Therapeutics, Inc. (NASDAQ: INSY)
Insys Therapeutics, Inc., incorporated on June 15, 1990, is a commercial-stage specialty pharmaceutical company. The Company develops and commercializes supportive care products. The Company has two marketed products: Subsys, a sublingual fentanyl spray for breakthrough cancer pain (BTCP) in opioid-tolerant patients and Dronabinol SG Capsule, a generic equivalent to Marinol (dronabinol), an approved second-line treatment of chemotherapy-induced nausea and vomiting (CINV), and anorexia associated with weight loss in patients with AIDS. The Company’s lead product candidate is Dronabinol oral solution, an orally administered liquid formulation of dronabinol. Dronabinol Oral Solution has demonstrated more rapidly detectable blood levels and a more reliable absorption profile than Marinol in its clinical studies. Subsys is a single-use product that delivers fentanyl, an opioid analgesic, for transmucosal absorption underneath the tongue. The Company received marketing approval for Subsys from the United States Food and Drug Administration (FDA) for the treatment of BTCP. Subsys is developed to treat BTCP through the delivery of a liquid fentanyl formulation in 100, 200, 400, 600, 800, 1,200 and 1,600 micrograms (mcg) dosages. The 1,200 and 1,600 mcg doses of Subsys are achieved by administering two 600 and 800 mcg doses, respectively. The mechanism by which the liquid is delivered is a one-step process in which a plume of fentanyl is generated by the actuation of the device. The plume disperses a small volume of liquid across the surface area of the sublingual mucosa and facilitates rapid absorption by the body.
The Company has an approved dronabinol product and is developing several dronabinol product candidates for the treatment of CINV and anorexia associated with weight loss in patients with AIDS. The Company has received an approval from the United States Food and Drug Administration (FDA) for Dronabinol SG Capsule and is commercializing this product in the United States through its exclusive distribution agreement with Mylan. Dronabinol, the active ingredient in Marinol, is a synthetic form of an orally active cannabinoid, delta-9-tetrahydrocannabinol (THC). Marinol is formulated in sesame oil and encapsulated in soft gelatin capsules and must be stored in cool storage conditions or in a refrigerator. Its portfolio consists of its Dronabinol SG Capsule product, Dronabinol Oral Solution and other product candidate, such as cannabinoid line extensions and sublingual spray product candidates. Dronabinol SG Capsule is a simple solution of dronabinol in sesame oil that is encapsulated in soft gelatin. Dronabinol SG Capsule is supplied in 2.5, 5.0 and 10.0 milligrams dosage strengths. Dronabinol Oral Solution is a synthetic THC in an oral liquid formulation, which contains ingredients to enhance absorption. The Company has completed a pivotal bioequivalence study for Dronabinol Oral Solution. The pivotal bioequivalence study was a 52-patient crossover bioavailability and Pharmacokinetic (PK) clinical trial comparing Dronabinol Oral Solution with Marinol. In the study, 100% of subjects receiving Dronabinol Oral Solution achieved detectable plasma levels at 15 minutes compared to less than 25% of the subjects receiving Marinol, and Dronabinol Oral Solution demonstrated a more than 60% decrease in dose-to-dose drug exposure variability as measured by patient coefficient of variation for AUC.
The Company’s other product candidates include other dronabinol line extensions and sublingual spray product candidates. Additional dronabinol delivery systems, including sublingual spray, inhalation and intravenous dronabinol formulations are in preclinical development. The Company has submitted a supplemental abbreviated new drug application (ANDA) for a room temperature stable version of its dronabinol soft gel capsule, which is referred to as Dronabinol RT Capsule. The Company is conducting preclinical development for multiple, approved molecules for delivery through its sublingual drug delivery technology.
Recent News and Analysis:
The company recently announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for Syndros (dronabinol oral solution) from April 1, 2016 until July 1, 2016. Insys voluntarily submitted information, which did not involve any clinical data, related to the scheduling of Syndros under the Controlled Substances Act. The FDA determined that this information constituted a major amendment to this New Drug Application and exercised its option to extend the PDUFA date to provide the FDA time to complete its review. “Insys is in negotiations concerning the scheduling of Syndros and is working closely with the Agency,” stated Steve Sherman, Sr. Vice President of Regulatory Affairs, Insys Therapeutics. “We hope to resolve this issue shortly and this extension demonstrates the Agency’s willingness to review our new data and work with us going forward.”
Investors and analysts will be looking ahead to Insys Therapeutics, Inc. (NASDAQ:INSY)’s next earnings report which is slated to be released sometime on or around 2016-05-05 for the period ending on 2016-03-31. Street analysts have a consensus EPS projection of $0.27 for the current quarter. The company posted EPS of $0.26 for the same quarter last year. Whether a company misses or beats analyst estimates, the earnings report may guide short-term stock price movements. Investors may also take note of the directional trend of estimates before a company’s earnings report. The company most recently posted actual quarterly EPS of $0.22 compared to the Zacks Research consensus estimate of $0.25. The resulting difference was $-0.03 creating a surprise factor of -12%. 2 brokerage firms are currently covering Insys Therapeutics, Inc. These analysts polled by Zacks Research currently have a mean target price of $34.5 on the stock. The highest target is currently $46 and the most conservative target sees the stock hitting $23 within the year.
Insys Therapeutics is facing a probe for suspected off-label sales concerning its lead drug Subsys, an advanced pain therapy for cancer patients. Due to the ongoing problem, in a worst case development, depending on what the market have historically witnessed when a firm’s marketing practices are probed, Insys could be smashed with a financial penalty. Despite the ongoing problems, Subsys fourth quarter sales surged 38% to $91.1 million, and Insys Therapeutics ended the fiscal with $202.3 million in cash, investments, and cash equivalents. Though not a definite case for optimism, the company hardly resembles another firm that should swallow as elevated short share percentage as it shows currently.
Terra Tech Corp. (OTCMKTS: TRTC)
Terra Tech Corp., incorporated on July 22, 2008, is a holding company. The Company has three wholly owned subsidiaries, GrowOp Technology Ltd., Edible Garden Corp. and IVXX, LLC. The Company also has ownership interests in MediFarm, MediFarm I and MediFarm II.
The Company, through its wholly owned subsidiary, GrowOp Technology Ltd. is engaged in the design, marketing and sale of hydroponic equipment with a technology to create solutions for the cultivation of indoor agriculture. GrowOp Technology Ltd.’s principal products include environmental controllers and timers, tents and film, ducting and filtration, fans, ballasts, bulbs, reflectors, nutrients and portable hydroponic trailers. The portable hydroponic trailers, The Big Bud and Little Bud, are custom fabricated cultivation systems.
The Company through its wholly owned subsidiary, Edible Garden Corp., acts as a retail seller of locally grown hydroponic produce. Edible Garden Corp. distributes hydroponic produce across the Northeast, Midwest and Florida.
Recent News and Analysis:
The company recently announced that the Grand Opening of its medical cannabis dispensary located at 1921 Western Avenue in Las Vegas, Nevada will be held on April 20, 2016. Located adjacent to the Las Vegas Strip, the Western Avenue dispensary will offer patients the Company’s proprietary IVXX™ brand of premium medical cannabis, including flowers, shatters, waxes and oils, among other high-quality cannabis products from a range of reputable providers of superior grade medical cannabis. The 3,900 square foot facility is located adjacent to the Las Vegas Strip at 1921 Western Avenue and is expected to benefit from the heavy traffic in Las Vegas. The dispensary, which will be operated through the Company’s subsidiary, MediFarm, LLC, is due to complete its final inspections by the State of Nevada and the City of Las Vegas in late March, 2016. The Company expects to receive its business license from the City of Las Vegas on April 6, 2016, contingent upon it passing all inspections, which will be followed by a soft launch of the site. The Grand Opening, on April 20, 2016, will mark the official launch of the dispensary and is intended to showcase the Company’s portfolio of medical cannabis products to the community. Western Las Vegas is the first of four retail medical cannabis dispensaries slated to open in Nevada in 2016. Three of those, operating under the store name Blüm, will be in Southern Nevada, on Western Avenue, Desert Inn Road near the Las Vegas Convention Center, and Decatur Boulevard. The fourth is to be located in Reno, in Northwest Nevada. All locations are expected to open in time to take advantage of the very active summer tourism season in Nevada.
Terra Tech CEO Derek Peterson noted, “We are excited to launch of our first medical cannabis dispensary in Las Vegas. This is an extremely important market for us as Nevada formally recognizes the patient status of non-residents, opening up our addressable market significantly. Our dispensary will offer the highest quality medical cannabis products which, coupled with our staff’s extensive knowledge of how different strains and products can treat various ailments, will enable our patients to choose the right medicine for them. We encourage members of the local community that have an interest in the health benefits of cannabis to stop by our retail dispensary on April 20th to hear more about our offering.” In the last month TRTC has seen increases of 49.38% hitting lows of $0.125 to highs on Wednesday March 23th of $0.242. More ups for this small cap medical marijuana company.
There is no doubt that Cannabis stocks took its fair share of beatings in 2015. But it looks to be that the Cannabis sector has found its second wind in 2016 and former industry leaders such as Cara Therapeutics Inc. (CARA), CannaGrow Holdings Inc. (CGRW), INSYS Therapeutics, Inc. (INSY), GW Pharmaceuticals plc. (GWPH), and Terra Tech Corp. (TRTC) are starting to emerge back at the forefront in the month of March.
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