Cara Therapeutics Continues to Climb (NASDAQ:CARA)

We think Cara Therapeutics (NASDAQ: CARA), a boutique “clinical stage” biotech/biopharma firm which develops novel compounds (including cannabis derived chemicals) for neuropathic pain is worthy of a close look. Cannabis regulation has been relaxing both globally and in the United States and this influences our stance on CARA stock. But there has also been positive recent product news. Furthermore, current trend analysis indicates that CARA could be on the cusp of becoming a real steady performer on the market.

Good news: The U.S. Food and Drug Administration (FDA) just granted “breakthrough therapy status” to Cara’s CR845, a unique therapeutic compound which has provided significant clinical benefits to some patients with chronic kidney disease and osteoarthritis (more on that in a bit) and trading has picked up significantly in recent days likely as a result.

Cara is based in Stamford, CT and was founded by Derek T. Chalmers, Michael E. Lewis, and Frédérique Menzaghi in 2004 (initial IPO on January 30 of that year) with the following mission:

… to fundamentally change the way acute pain, chronic pain and pruritus are managed.  We aim to achieve this by developing new products that selectively target the body’s peripheral kappa opioid receptors. Cara is developing a novel and proprietary class of product candidates that target the body’s peripheral nervous system and have demonstrated initial efficacy in patients with moderate-to-severe pain and pruritus (itch) without inducing many of the undesirable side effects typically associated with currently available pain and itch therapeutics.

Recent News & Developments:

The FDA granted breakthrough therapy status for CR845, a drug for treating itching (uremic pruritis), which is an intractable and common (affecting up to 50% of patients) presenting symptom with chronic kidney disease patients undergoing hemodialysis. Currently CR845 is an intravenous drug, but an oral version is in late stage development. This is significant because of the lack of available effective systemic treatments that is compounded by a dearth of new product development by other pharmaceutical companies. Available treatment regimens span the gamut from oral antihistamines to topical creams, standard analgesics (NSAIDs) to risky ultraviolet light treatments which can cause skin cancers in individuals with fair complexions. CR845 showed a 68% reduction in worse itching scores and a 100% improvement to quality of life.

A quick note on the meaning of breakthrough therapy status: According to Wikipedia, breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the July 9, 2012 Food and Drug Administration Safety and Innovation Act. It allows the FDA to grant priority review to drug candidates if preliminary clinical trials indicate that the therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases. The FDA will work with the sponsor of the drug application to expedite the approval process. This can include rolling reviews, smaller clinical trials, and alternative trial designs. In short, it simply means that 3-9 months are potentially shaved off of the standard review and approval cycle time.

Cara’s pipeline consists of CR845, variants upon CR845 and CR701, a chronic pain treatment which operates on peripheral cannabinoid receptors, particularly in immune cells such as leukocytes and mast cells, which have been shown to be involved in pain and inflammatory responses but do not affect cannabinoid receptors of the Central Nervous System (CNS). CR701 is an advanced compound presently in preclinical development for hyperalgesia (extreme sensitivity to pain) and allodynia (perception of harmless stimuli as pain) where it has been proven significantly effective in laboratory trials involving rodents.

Looking to extend their coverage abroad,Cara has in place licensing agreements with Chong Kun Dang Pharmaceutical Corporation to develop, manufacture, and commercialize products containing CR845 in South Korea; and Maruishi Pharmaceutical Co., Ltd to develop, manufacture, and commercialize drug products containing CR845 in Japan.

Market Data & Performance:

In 2017, Cara shares have risen a phenomenal 134+%, with stocks going for about $4.50 in July of 2016 trending all the way up to where they sat at $22.87 on Friday June 23, 2017. There was a slight dip in afterhours trading ending at $22.59 – but overall performance for CARA definitely defied the general biotech sector’s slide for the past month or so. Market Cap is $736.28M. Financials appear to be up-to-date and are listed at www.sec.gov or at their investor relations webpage. An EPS of $-2.52 might usually raise red flags, but given that we’re talking about a biotech – a sector in which firms lose money for years during the development of patient-ready products – CARA’s negative earnings per share is probably not a big deal.

Conclusion & Looking Ahead:

With the recent good news from the FDA and resulting trading performance, you can probably assume that EPS and share prices will improve in the near- to mid-term, but it will be important to keep an eye on how CARA manages its revenues and expenses moving forward.

Regarding the negative EPS, in Q1 2017 CARA managed to expend $22M, but the prospect of having its first product reach the market many months ahead of schedule means they have a good shot of reversing cashflow into the black sooner rather than later – and making a serious run at $30/share in the next six months. Of course there are well documented risks for retail investors in small cap biotech so it’s not wise to make such a stock the centerpiece of your portfolio or go in too heavy before the medical sector starts buying CARA’s products in quantity. We think this is a cannabis related stock to watch closely through the end of Q2 and into Q3, 2017.

(OTCMKTS:ADRNY) ADRNY Ahold NV Goes Green

(OTCMKTS:ADRNY) Ahold NV Goes Green on Massive Volume

Shares of (OTCMKTS:ADRNY) Ahold NV traded green with massive volume brought on by possible Kroger speculation ( Amazon just purchased Whole Foods). ADRNY shares have been on a downward ride for almost a month but today that changed. With over 7,000,000 shares trading, and a close of $18.37

As traders talk of possible take over by Kroger (NYSE:KR) things look promising considering the Amazon purchase of Whole Foods. A large acquisition from Kroger could make stealthy traders very happy. Of course this is all speculation, but speculation may not be the only driving force. With share price at a one year low the bottom of ADRNY was bound to be found, Is this it?

Could this be the bottom of ADRNY? Could we see a share price of $22 or $23 again?

Company Profile 

Ahold Delhaize is one of the world’s largest food retail groups, a leader in supermarkets and e-commerce, and a company at the forefront of sustainable retailing. Our family of 21 great local brands serves more than 50 million shoppers each week in 11 countries. Each brand shares a passion for delivering great food, value and innovations, and for creating inclusive workplaces that provide rewarding professional opportunities. Our brands have also established meaningful, lasting commitments to strengthen local communities, source responsibly and help customers make healthier choices. Ahold Delhaize was formed in July 2016 from the merger of Ahold and Delhaize Group, retail innovators for almost 150 years. Our local brands employ more than 375,000 associates in 6,500 local grocery, small format and specialty stores.

Ahold owns US brands such as Food Lion, Stop & Shop New York, Hannaford, and Martin’s Food Markets among other large retail stores.

https://www.aholddelhaize.com/en/home/

Todays volume was nothing short of crazy for ADRNY with a few trades exceding 1.9million shares. Another day like today could be what ADRNY needs to change from red to green.  I will be watching this one close over the next few weeks.

We will continue to follow (OTCMKTS:ADRNY) Ahold NV with any updates.

Blue Apron APRN vs Amazon (NASDAQ:AMZN)

Blue Apron (NYSE:APRN) offers customers a simple cook at home meal delivery service in a growing market where consumers demand home delivery options.

Founded in 2012, the New York based company has shown impressive growth through aggressive marketing and strategic partnerships with its vendors and consumers. Recently the company has show interest in the public markets and is currently poised to sell 30,000,000 shares around $15 – $17 per share.

Investors are having mixed emotions after Amazon (NASDAQ:AMZN) announced a bid to purchase Whole Foods (NASDAQ:WFM) Friday. Investors are worried that Amazons take over of Whole Foods could send he majority of  food delivery service market share into the hands of the retail giant. With Amazons growing delivery service and delivery speeds along with the the brick and mortar Whole Foods locations a simpler & faster service is the obvious goal.  Having a wide and cost-efficient distribution network for fresh food.

Blue Apron’s market is also faced with strong competition from HelloFresh, Purple Carrot, Sun Basket, and Green Chef to name a few.

As Blue Apron argues that its business model is different than Amazon’s service “Prime Fresh”, investors may be hard to convince , we will see…

DELIVERED DAILY, COOK AT HOME MEALS, FROM AMAZON, Prime Fresh by Amazon

Blue Apron’s offering is being led by Goldman Sachs, Morgan Stanley, Citigroup and Barclays. The company plans to list on the New York Stock Exchange under the ticker symbol APRN.

As of 6/20/17 Blue Apron plans to sell 30,000,000 shares around $15-$17 each

Blue Apron, which was founded five years ago by Matt Salzberg, Ilia Papas and Matt Wadiak, believes its rapid growth will be sufficient to entice investors, despite having never turned a profit.  Blue Apron has fulfillment centers in Richmond, California, Jersey City, New Jersey, and Arlington, Texas and has also worked to increased its automation.