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what's going on with VRX???
Valeant Has More Time, And Flexibility, Than You Might Think
Summary
The big debt maturity hurdle won't arrive until 2022.
The drug company is producing adequate, even if not impressive, free cash flow.
Most experts think the equity-for-debt swap isn't likely to happen.
https://seekingalpha.com/article/4085432-valeant-time-flexibility-might-think
New York DOJ Attorney Announces Charges Against Two Former Valeant Pharma (VRX) Execs
http://www.streetinsider.com/Corporate+News/New+York+AG+Announces+Charges+Against+Two+Former+Valeant+Pharma+%28VRX%29+Execs/12261501.html
There are two Events & Presentations next Week
Nov 15, 2016 at 1:30 PM ET
Stifel 2016 Healthcare Conference
Nov 17, 2016 at 11:00 AM ET
Kidney Week 2016
Nasdaq Cannabis Stocks Rally After Recreational and Medical Use Passes
Cannabis stocks listed on the Nasdaq continued to rally after voters ended prohibition and approved the recreational use of marijuana in California, Massachusetts, Maine and Nevada.
Cannabis stocks listed on the Nasdaq continued to rally on Wednesday after voters ended prohibition and approved the recreational use of marijuana in California, Massachusetts, Maine and Nevada while Arkansas, Florida and North Dakota adopted medical marijuana laws.
Arizona rejected its measure for recreational use while Montana voters approved a measure to improve access to medical marijuana providers.
"Whether they live in blue or red states, voters have spoken in an overwhelming majority that they want media and recreational marijuana," said Jason Spatafora, co-founder of Marijuanastocks.com and a Miami-based trader and investor known as @WolfofWeedST on Twitter. "One election night we witnessed not just a political shift, but a paradigm shift for cannabis where prohibition has become untenable."
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Interest in cannabis-related stocks continues to increase from micro cap to Nasdaq-listed equities and will only continue its upward trend as investors should be poised for several decades of additional expansion as more states legalize either recreational or medical use and could emerge as acquisition targets.
"The legal cannabis movement scored its most significant victory yet," said Michael Berger, a former Raymond James energy analyst and founder of Technical420, a Miami-based company that conducts research on cannabis stocks. "Although the results of the election will be a turning point for the legal cannabis industry, we are only in the first inning of what will be a multi-decade growth cycle. As legalization measures continue to go into effect, market sentiment will improve for cannabis stocks and this should serve as a catalyst for many companies."
The economic impact for these states is immense - California is estimated to increase to $10 billion market by 2020, while Florida's medical market should be a $1 billion industry by 2020, he said.
"I expect the cannabis industry to be a $75 billion dollar industry by 2020," Berger said. "Although many people's estimates are below this, I take into account more than just the sale legal cannabis because the ancillary business will benefit significantly."
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Several stocks have been undervalued as investors were skittish and the use of drugs produced by major cannabis-focused biopharmaceutical companies have not been widely adopted. The current options for mainstream investors in this budding sector are limited to a handful of companies listed on the Nasdaq, including GW Pharmaceuticals (GWPH) , a U.K.-based biotech company with a cannabis-based epilepsy drug; Insys Therapeutics (INSY) , a Phoenix company known for its cancer pain management drug but is developing a cannabis-based drug for the treatment of epilepsy; Cara Therapeutics (CARA) , a Shelton, Conn.-based clinical state biopharmaceutical company that develops and commercializes pain relief drugs and Zynerba Pharmaceuticals (ZYNE) , a Devon, Pa.-based company focused on developing and commercializing synthetic cannabinoid therapeutics.
Being undervalued means many of these companies such as Cara, Zynerba and GW Pharmaceuticals are also attractive acquisition targets, said Spatafora. All three companies are appealing candidates because of their intellectual property and their pipeline of current and upcoming drugs.
"The intellectual property for GW Pharmaceuticals is based on having cannabis plant-based drugs rather than synthetic alternatives and in my estimate is worth $6 billion or roughly $190 per share if bought out," he said.
Since GW Pharmaceuticals is the bellwether company of the cannabis industry and tends to benefit from positive developments in the sector, the stock could be poised for headwinds as a result from the increased market volatility.
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"We continue to view GW Pharmaceutical as the best long-term cannabis investment due to its deep pipeline of products, its successful FDA testing results, its Wall Street coverage and its valuation as its shares are trading well below the average Wall Street price target," said Berger. "We continue to view GWPH as a buy opportunity on weakness from today."
While there is less research available from analysts, some cannabis stocks listed on the OTC are also worth consideration, because they will benefit from the laws that passed in Florida, Nevada and California, Spatafora said.
Florida's adoption of medical marijuana use could be advantageous for Arcturus Growthstar Technologies (AGSTF) , which entered into a letter of intent to purchase a Florida farm that is zoned for cannabis. The state currently has six licensed producers and expansion will be needed to meet "massive demand," he said.
"They hedged on the LOI to wait and see if the law passed," Spatafora said. "The company was pretty wise in this potential acquisition because the farm already produces $2.6 million in revenue annually."
With Nevada voters approving adult use of cannabis, mCig Inc. (MCIG) , which used to specialize in lifestyle brands in the vaping and cannabinoid markets, could benefit. The company founded a construction division called Scalable Solutions geared toward the Nevada cannabis cultivation market.
"We are about to see an explosion of new money come into the state in order to support the licensed holders and see capitalized holders of licenses ramp up construction operations to expedite production as the cannabis supply has already been running at a deficit," he said. "Supply and demand issues will be an absolute windfall for mCig and this division."
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Other stocks which are expected to rise higher include Medicine Man Technologies (MDCL) , which provides cultivation consulting services and the company has clients in Arizona, California, Florida, Maryland, Nevada, Oregon, Ohio, Oklahoma, Ohio, Pennsylvania, Texas and Puerto Rico.
"We are favorable on MDCL's leverage to the cannabis industry and the company stands to benefit from ballot initiatives passed in California, Florida and Nevada," said Berger.
American Cannabis Company (AMMJ) provides advisory and consulting services for cannabis businesses in the U.S. and Canada and generates revenue from the sales of products used in the cultivation, processing and sale of cannabis.
"Although AMMJ is poised to benefit from the election results, the shares are up more than 1,600% since September 1, and we are watching how AMMJ trades to see if there are legs left in this run," he said.
MassRoots (MSRT) has been called the Yelp of the cannabis industry and its mobile app can be downloaded only in states where medical cannabis is legal.
"The election will be a catalyst for MSRT because its user base and businesses network will benefit from ballot initiatives passing in California, Florida, Massachusetts, Nevada, North Dakota and Arkansas," Berger said.
Three other stocks to keep an eye on include Kush Bottles (KSHB) , which is focused on providing exit bag products that are in compliance with regulations; Finore Mining Inc. (FIN: CSE) (FNREF: OTC); and Terra Tech ( (TRTC) ).
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"We see a lot of opportunity for growth now that new state markets will open and existing markets will expand and develop," he said. "We are favorable on Kush Bottles due to the product it provides, its geographic diversity and its continued execution and shares should continue to move higher off this news."
Finore Mining is likely to benefit from the passage of Proposition 64 following its acquisition of KushTown USA, a California-based cannabis infused products company whose products are sold in more than 500 dispensaries across the state. The company is focused on penetrating new markets within California as demand for cannabis infused products continues to grow, Berger said.
Terra Tech is levered to the results in California and Nevada through its multiple subsidiaries. The company's Blum medical cannabis collective has one location in California and four locations in Nevada with two that are already operational.
"TRTC will also benefit as we expect to see its IVXX subsidiary sell more cannabis products out of its California and Nevada dispensary locations," Berger said.
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https://www.thestreet.com/story/13887089/2/nasdaq-cannabis-stocks-rally-after-recreational-and-medical-use-passes.html
Election Results by State
http://www.politico.com/2016-election/results/map/ballot-measures
Cara Therapeutics: A Run-Up Interrupted
Nov. 7, 2016 9:27 AM ET|
About: Cara Therapeutics Inc. (CARA)
Summary
Cara Therapeutics has several material catalysts coming in the first half of 2017.
By targeting kappa opioid receptors the company believes its drug candidate CR845 has several advantages over traditional opioid treatments.
Prior phase 2 trials showed statistically significant reductions in post-op pain and nausea/vomiting, while a liability trial showed CR845 was much less likely to be abused by patients.
There are several risks here, including concentration risk, drug development risk, near- to medium-term dilution, market weakness, and the current headwinds the biotech space is experiencing as a whole.
Shares of Cara Therapeutics (NASDAQ:CARA) have pulled back in the past month after hitting a $10 ceiling, reaching $6 recently. In reality, I see it as an ongoing run-up to important data readouts in 2017 that was interrupted by the current rout in biotech.
Figure 1: Cara Therapeutics stock chart (source: stockcharts.com)
Let's take a further look at the company to see why investors might be well-served to establish their positions, even in the middle of weakness in the markets and upcoming elections likely to cause a flight to safety.
Company Overview
Cara Therapeutics is developing treatments for pain and pruritus through targeting kappa opioid receptors.
Figure 2: Cara Therapeutics pipeline (source: corporate presentation)
Currently utilized opioids can result in undesired side effects, such as respiratory depression, vomiting, nausea, sedation, and addiction. Management believes that Cara's drug candidates could achieve the desired results without patients experiencing similar effects.
As the pipeline is heavily focused on drug candidate CR845, I consider risk to be heightened, as any hiccups in the drug's development leave the company without other late stage assets to fall back on.
In liability trials patients were shown to like and prefer pentazocine instead of Cara's CR845, showing the latter drug is less likely to be abused by patients.
Figure 3: Drug Liking over 8-hour test session (source: company presentation)
In prior phase 2 trials, CR845 was shown to significantly reduce post-op pain in hysterectomy and bunionectomy trials. Additionally, the drug reduced post-op nausea and vomiting with high statistical significance.
In a prior phase 2 study with uremic pruritus patients, CR845 significantly lowered itch intensity over 2 weeks of treatment, as well as itch related quality of life. According to the company there are 9.3 million patients diagnosed with pruritus in the United States, 32% of which are treated for pruritus. It's also estimated that there are 456,000 chronic kidney disease patients in the United States undergoing dialysis, with between 60%-70% being treated for pruritus.
The company reported cash and equivalents of $71.4 million, estimating that it can continue operations through early 2018 without needing additional funds. With a net loss of $11.5 million for the third quarter, I believe they will raise funds in the first quarter of 2017 in order to extend their cash runway and take one more concern off the table prior to data readout.
As for catalysts, in the first quarter of 2017 investors can expect to see data for the phase 2/3 trial of I.V. CR845 in patients suffering from moderate to severe uremic pruritus, as well as results for a safety trial involving oral CR845 in hemodialysis patients to check out the viability an oral formulation in the same patient population.
In the first half of the year we should see data from the phase 2b trial of oral CR845 for the treatment of pain associated with osteoarthritis. Also in the first half of the year an interim analysis will be conducted of the phase 3 trial in postoperative pain utilizing I.V. CR845.
Conclusion
At the current price level investors might do well to establish a starter position in the company, awaiting further weakness to add to their position. For more conservative investors, waiting a few days for political uncertainty to unnerve markets might provide a lower entry point into the stock.
I fully expect a 50% + runup in share price in the next three or so months, in which investors could take some risk off the table prior to data readout.
Risks include overall market weakness muting or negating the runup, as well as drug development risk inherent to most small biotech companies. Additionally, investors can expect dilution in the near to medium term in the form of a secondary offering, while other non dilutive alternatives would be welcome but are unexpected. Pipeline concentration risk is a big one here too, as CR845 is the company's only late stage drug candidate.
The average price target for the company is $21.50, representing over 150% upside from current levels.
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.
http://seekingalpha.com/article/4020483-cara-therapeutics-run-just-getting-started?auth_param=1dbdf8:1c213rn:e168c0e63f6ab7b16d4f0622470c2c5e&dr=1#alt2
Cara Therapeutics' (CARA) CEO Derek Chalmers on Q3 2016 Results - Earnings Call Transcript
Nov. 3, 2016 11:23 PM ET|
About: Cara Therapeutics Inc. (CARA)
Q3 2016 Earnings Summary
Press Release
News
EPS of $-0.42 beats by $0.05 | Revenue of $ (- 100.0% Y/Y) misses by $-0.34M
Cara Therapeutics Inc. (NASDAQ:CARA)
Q3 2016 Earnings Conference Call
November 3, 2016 4:30 PM ET
Executives
Michael Schaffzin – Stern Investor Relations
Derek Chalmers – Chief Executive Officer, President, and Director
Joe Stauffer – Chief Medical Officer
Joe Schoell – Chief Financial Officer
Analysts
Esther – Stifel Financial Corp
Charles Duncan – Analyst
Alan Carr – Analyst
Chiara Russo – H.C. Wainwright
Ken Trbovich – Laidlaw & Co. (NASDAQ:UK) Ltd
Charles Duncan – Piper Jaffray
Operator
Good afternoon, ladies and gentlemen, and welcome to the Q3 2016 Cara Therapeutics Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference is being recorded.
I would now like to turn the conference over to your host Mr. Michael Schaffzin.
Michael Schaffzin
Good afternoon. This is Michael Schaffzin with Stern Investor Relations. And welcome to Cara Therapeutics third quarter 2016 earnings conference call. The news release with our third quarter financial results and corporate update became available at 4:01 PM today and can be found on our website at www.caratherapeutics.com. You may also listen to live webcast and replay of today’s call on the Investors section of the website.
Before we begin, let me remind you that statements made on today’s call regarding matters that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, examples of these forward-looking statements including statements concerning the expected rate of patient enrollment in our ongoing and planned clinical trials, the expected timing for the company’s clinical trials and the reporting of clinical trial results, the potential results of ongoing and planned clinical trials and future regulatory and development milestones for the company’s product candidates, and the company’s expected cash reach.
Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in the Cara Therapeutics filings with the Securities and Exchange Commission, including the Risk Factor section of the company’s annual report on Form 10-K for the year ended December 31, 2015 and its other documents subsequently filled with or furnished to the Securities and Exchange Commission.
All forward-looking statements made on today’s call speak only as of the date on which they are made. Cara Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Now, let me turn the call over to Cara President and CEO, Dr. Derek Chalmers.
Derek Chalmers
Thanks, Michael. Good afternoon everybody and thanks for being with us on the call. I’m joined today by our Chief Medical Officer, Joe Stauffer; and our Chief Financial Officer, Joe Schoell. So, today, we like to highlight our recent progress in the clinic and walk you through all of our expected upcoming milestones for the rest of 2016 and into the first half of next year.
So during the third quarter of 2016, we’ve made significant progress and we do expect the coming quarters to be an important time for data-readouts across all of our clinical programs. So starting with our Oral CR845 program for chronic pain, in September we announced that we initiated our Phase 2b trial of Oral CR845 for the treatment of chronic pain in patients with osteoarthritis of the knee or head. Building off our Phase 2a data on osteoarthritis patients where we saw both pain and rescue medication reduction over a two week treatment period.
The ongoing Phase 2b trail is a larger approximately 330 patients study, testing three tablet strengths of CR845 over an eight-week treatment period to inform a potential registration trial design for this indication. We’ve been very happy to see exceptional enrollment rates in that trial across now 36 active sites and we are anticipating data-readout during the first half of next year.
Again to remind you, we see this trial as an important POC and step forward in establishing the potential clinical utility of Oral CR845 to provide a safer, nonabusable alternative for osteoarthritis patients and potentially chronic pain patients in general. And Joe is going to provide more color on the design and the endpoints for that trial in just a moment.
Moving onto our adaptive Phase 2/3 trial of I.V. CR845 in dialysis patients suffering from moderate-to-severe uremic pruritus. Part A of this trial is a randomized double-blind placebo controlled study to examine the efficacy of three does levels of I.V. CR845 administered after each dialysis session that is three-times in a week or t.i.w. over an eight-week treatment period to reduce itch intensity in HD patients experiencing moderate-to-severe uremic pruritus. Thus trial has also enrolled very well across 33 active sites and I’m very happy to report today that we’re currently expecting the full enrollment in this quarter with top-line data-readout in Q1 of 2017.
Data from this Part A will inform dose selection for Part B, which will be a pivotal double-blind placebo-controlled trial of one optimized dose of I.V. CR845, administered again three-times a week after dialysis sessions over a 12-week treatment period and up to 240 dialysis patients. In the UP program, we also expect top-line data in Q1 2017 from our pharmacokinetic safety bioequivalent study of Oral CR845 in hemodialysis patients. Aim to define bioequivalent tablets strengths to enable the development of the tablet formulation of CR845 suitable for chronic kidney disease associated pruritus. And Joe again will talk a little more and details related to that trial.
Finally, we are also expecting to conduct our pre-planned conditional power analysis in the first half of 2017 from our adaptive pivotal Phase 3 trail of I.V. CR845 for postoperative pain. We are currently recruiting across 22 active sites. The data will help guide those on any potential adjustments needed prior to competing enrollment at around 450 total patients.
Overall, we continue to operate in a capital efficient manner. And in Q3 with approximately $71 million in cash and we’re encouraged that our strong trial enrollment rates in each of these late-stage programs will afford top-line data-readouts within a relatively short timeframe.
And with that, I’ll turn the call over to Joe Stauffer, who will provide some additional color from our ongoing clinical trials.
Joe Stauffer
Thanks, Derek. As he just walked through we are very pleased to report progress and increased rates of enrollment across our late-stage clinical programs that will allow us to readout top-line data during the first half of next year, and I’d like to give you a more detailed look at the enrollment trends we have seen and why we are confident on hitting these timelines.
Starting with our recently initiated Phase 2b trial with Oral CR845 in OA patients, principal investigator interest in this trial has been overwhelming and this has translated to a rapid uptake in site activations in patient screening activity. Since trial screening initiation in September of this year, we have screened over 500 patients for this trial. And in a similar fashion to our Phase 2a trial in OA patients, we expect this study to enroll quickly to allow top-line data-readout in the first half of 2017.
As a reminder, this is a double-blind placebo-controlled multiple dose Phase 2b design testing three tablet strength of CR845 dose twice-daily over an eight-week treatment period in osteoarthritis patients with moderate-to-severe pain. The trial design incorporates a four-week titration period for response followed by a four-week maintenance period. The primary endpoint will be difference from baseline and pain scores in CR845 treated patients versus placebo at the end of the eight-week treatment period.
Secondary endpoints include the change from baseline in the Western Ontario and McMaster Osteoarthritis Index amount of rescue medication use and the Patient Global Assessment, PGA of osteoarthritis. We would expect the data for this trial to from the basis for an end of Phase 2 discussion with the FDA as the dose selection for a standard 12-week registration trial in the same patient population.
Now moving onto our Phase 2/3 program in uremic pruritus. As we talked about last quarter, Part A is a randomized double-blind placebo-controlled study of three doses of intravenous CR845 administered three times a week after dialysis over an eight-week period in 160 patients, which will inform our optimized dose for Part B. As discussed, this trial has enrolled very efficiently and we expect top-line data-readout in the first quarter of 2017. The primary endpoint will be reduction in worst itching scores from baseline values measured on a standard Numeric Rating Scale alongside secondary quantitative quality of life endpoints measured on the validated Skindex-10 scale and complementary quality of life measurements.
Then as Derek mentioned, we have also initiated a pharmacokinetic safety trial of multiple doses of Oral CR845 in haemodialysis patients to define bioequivalent tablet strengths to confirm our ability to develop an oral tablet formulation for this indication in both HD patients and also potentially expanding to pruritus in non-haemodialysis CKD patients. And last but very importantly, our adaptive pivotal clinical CLIN-3001 trial in post-operative pain is expected to reach its interim assessment during the first half of next year as well.
As we walk through last quarter and earlier this year, we have moved forward with this study as a three-arm trial, testing one microgram per kilogram and 0.5 micrograms per kilogram of CR845 versus placebo and up to 450 patients undergoing various abdominal surgeries. The trial accommodates an interim assessment for conditional power across doses at approximately 65% enrollment with an adaptation to optimum dose and subsequent progression to complete enrollment. This trial is enrolling very well across 22 active sites, but we expect to report on our interim assessment and full data-readout in the first half of 2017.
As a side note, we were very happy to receive enthusiastic interest in this program in response to our recent symposium at the annual meeting of the American Society of Anesthesiologists. Principal investigators and other physicians clearly see the role for CR845 in the evolving pre-operative treatment paradigm of ERAS otherwise known as enhanced recovery after surgery and the importance of reducing or eliminating the use of Opioid drugs as part of a multimodal approach to post-operative pain.
In summary, we’re very encouraged by our progress across our three late-stage programs where we expect to report top-line data on the total of some 900 patients in the next two quarters.
And with that, I’ll turn it over to Joe Schoell for the financials.
Joe Schoell
Thanks, Joe. As a reminder the full financial results for the third quarter and nine months ended September 30, 2016 can be found in our press release issued today after the market closed. We reported a net loss of $11.5 million or $0.42 per basic and diluted share for the third quarter of 2016 compared to a net loss of $4.8 million or $0.19 per share basic and diluted for the same period 2015.
We did not have any revenue during the third quarter of 2016. For the third quarter of 2015 total revenue recognized was $2.4 million including $1.7 million of license and milestone fees and $730,000 of collaborative revenue comprising revenue which was earned upon the achievement of defined milestones under the license agreements with Maruishi and CKD. As well as revenue that had been deferred upon entry into the license agreement with Maruishi.
R&D expenses were $9.7 million in the third quarter of 2016 compared to $5.6 million in the same period of 2015. The higher R&D expenses in the third quarter of 2016 were principally due to the net increase in direct clinical trial costs, consultant services in support of the clinical trials and an increase in payroll and related costs for R&D personnel.
General and administrative expenses were $2.1 million in the third quarter of 2016 compared to $1.9 million in the same period of 2015. The increase in the third quarter of 2016 was primarily due to increases in payroll and related costs and in franchise taxes. Other income was $176,000 during the third quarter of 2016, which included interest income and dividends earned on cash, cash equivalents and marketable securities and realized gains on the sale of marketable securities compared to $22,000 of interest income during the same period of 2015.
The increase in the third quarter ended September 30, 2016 was primarily due to investments and marketable securities in the 2016 period but not in the 2015 period as well as higher interest rates in 2016 on the company’s money market account balances compared with interest rates in 2015. As of September 30, 2016 cash, cash equivalents and marketable securities totaled $71.4 million compared to $106.7 million at December 31, 2015. The decrease in the balance of cash, cash equivalents and marketable securities primarily resulted from $34.2 million of cash used in operating activities.
Turning to financial guidance based on timing expectations and projected costs for current clinical development plans Cara continues to expect that its existing cash, cash equivalents and available for sale and marketable securities as of September 30, 2016 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.
Now we will open it up to Q&A, operator?
Question-and-Answer Session
Operator
[Operator Instructions] Your first question comes from Annabel Samimy [Stifel Financial Corp]. Your line is open.
Esther
Hi. This is Esther in for Annabel. I have a question and then a follow-up. So the first question is, it seems like we’re in an increasingly pressing environment in pain with an exceedingly great need for non-narcotic options. So is there anything that can be done to streamline your program just a little bit more as the rate of speed up enrollment open more sites et cetera anything else?
Joe Stauffer
This is Joe, I’ll take that question. I think we’re pretty streamlined as we are going right now, it’s not just as simple as opening up more sites. When you open up more sites you also open up more variability a potential for the data and that’s not a good thing. And so I think you got to keep in mind that it’s not about how many sites you have open, it’s about how many efficient sites you have working for you enrolling patients that’s the real key here.
And so I think that we’ve got that optimized at this point. So for both the I.V. pain trail as well as the osteoarthritis trial. I would say we’re moving about as fast as we can without add in anymore sloppiness for efficiency.
Esther
Okay. And on the oral program, so from the Phase 2b are you going to be doing an adaptive trial design again. And then move to a Phase 3 or can we expect to see something more typical?
Joe Stauffer
Right. So this is a typical Phase 2b trial, it’s a large trial and what we'll do here is – we’ll see it if we have a signal between any of these doses versus placebo and when we do. Then we’ll go to the FDA have a discussion about what that signal looks like and then plan for the Phase 3 pivotals. The difference between those trials would obviously be there will be 12-week trials not an 8-week trial like this one.
Esther
Okay, great and then just a quick question. So on October 28 CMS issued its final rule on payment policies that ESRD perspective payments for 2017, what are your general thoughts on the policy and how do you the think environment will be around the time I.V. CR845 is potentially approved for UP. Thanks.
Derek Chalmers
Yes. Thanks for asking that’s a great question. Obviously there’s a little bit of a gray area based on the current legislation there in terms of the functional groups that are defined in that legislation. And we have began talks with CMS in relation to this. So clearly the antipyretic group that is designed in that legislation is fundamentally no antipyretic in this patient population and I think they're becoming increasingly better educated in that regard. So that's an ongoing conversation we have with them.
We were encouraged to see the ability of Amgen to develop a novel intravenous formulation for another categorized functional group and oral comes from [indiscernible] and actually receive an agreement from the CMS that that would be with the bundle for at least 24 months, to access usage. And we think that's a precedent that we could follow with a novel I.V. with no equivalent essential oral medications. So it's something we are looking at we plan to develop the I.V. and we plan to continue communication with CMS in that regard.
Esther
Great. Thank you.
Derek Chalmers
Thanks Esther.
Operator
Your next question comes from the line of Charles Duncan. Your line is open.
Charles Duncan
Thanks. Hi Derek, Joe and Joe. Thanks for taking my questions and congrats on a good quarter progress. So my first question is on the oral OA study First of all good enrollment progress there. Do you think that speaks to the unmet need the differentiated mechanism or both. And also are you screening for previous opioid experience in those OA patients.
Joe Stauffer
Sure, so three is parts to your question, I think one of the reasons one of the biggest reasons why people are interested in this trial is the mere fact that it's mu opioid. They know it's a newer novel mechanism. So that's interesting to the patients and to the physicians. I think they like this side effect profile or lack of a side effect profile that's very interesting.
I also believe we call it big tailwind quite honestly from the NGX going on clinical hold. Some of those patients – I think that was a little back pain trial but there are a lot of patients that are that are tied up in many of these trials that are osteoarthritis so we're getting some of them as well. And I think the other part of your question had to do, what was the third-party of your question. Charles I thought I had all three of them.
Charles Duncan
Yes. Are you screening for previous opiates?
Joe Stauffer
Previous opiates. Right, good question. So we do allow people coming into the trial who were on previous opiates most of them have not been we only allow certain amount of opioid exposure over a certain period of time before they can come into the trial what we don't want is people who are failing opioids. And then coming into this trial right because they're going to have to get them tapered off of their opioids and go through all the potential side effects that you go through and when you do that. So by in large most of these patients have not been mu opioid exposed although some of them have.
Charles Duncan
And they are other…
Joe Stauffer
I’m sorry to interrupt you. We have a washout period – all patients have to wash out of all their analgesic drug before they're actually randomized.
Charles Duncan
Well and the other reason I ask is because the previous opiate experience may impact the binding, I guess because if you don't have that opiate side effect profile. People may decide that they're on the drug or not.
Joe Stauffer
Yes, the nice part about this drug is that you don't go through opioid withdrawal when you stop our drug.
Charles Duncan
Yes.
Joe Stauffer
And that’s another nice part about being on this drug and in this clinical trial. So I think for those reasons we’re getting the right kind of patients. And as I said before, it's been rolling quite fast actually a lot faster than I've seen in osteoarthritis trials and my previous experience.
Joe Schoell
Charles, it’s possible we're getting a little bit of tailwind from the lack of NGF antibody activity in recent weeks with the hold on that molecule. But the recruitment rate has certainly been outstanding for that particular trial.
Charles Duncan
Yes, that's a positive. I also though wanted to ask you about the IV program in pain, the CLIN3001 study. I'm kind of wondering the timing estimate seems broad sometime in first half of 2017. Is there any way that you can take that up, or is that only a function of enrollment rate or is there something else going on, that is having you call in the first half.
Joe Stauffer
So it's two parts. It’s enrollment rate, but we also remember we have to take a pause, while we do the interim assessment. And the interim assessment, depending upon what it is, will help guide us. So for instance if the interim assessment tells us that we have conditional power, such that we don't need to increase the sample size, that's a good thing. Perhaps we can decrease the sample size that could help us grow faster. If the interim assessment tells us that one of the doses, let's say the lower dose has really no chance of ever reaching any type of efficacy, we could drop that dose. That would cut the sample size down by a third from that point on, which would be nice. That would make things go faster.
So that’s the beauty, and the essence and the whole spirit of the Phase 2/3 adaptive design, is that you get to do these things because you pre-specify them. You don't take a p-value hit as we call in the business.
Charles Duncan
Yes.
Joe Stauffer
And you can kind of fix the plane while you're flying it, not that there's anything to fix, it’s that you can make choices in a smarter way to help reduce your risk of failure.
Charles Duncan
And Joe have you ever talked about the effect size or response rates that you are assuming in terms of taking a look at that interim and deciding whether or not to power out?
Joe Stauffer
No it's not really an effect size story, I mean clearly the standard deviation affects the effect size. But what we're really looking for is just trends toward conditional power to make sure that we get a POS in 0.05. That’s the goal. As you guys have heard me say before, effect size is meaningful only in the context of whether or not the drug is safe. And the FDA has to calculate that in its assessment and we do the same thing as well.
So for me and for us, it's more about do we do we have power to be placebo. The effect size is something that we will not necessarily pre-specify as part of a Phase 3 pivotal trial, going forward.
Charles Duncan
And you're tracking safety in at least the blinded way how do you feel about things?
Joe Stauffer
It's looking good. I mean I look at these numbers every week, in all the trials actually. And it's going quite well. And so I'm very confident there that our safety profile is right where we want it to be.
Charles Duncan
Last question, which I've gotten from in past years is, if you could remind us or help us better understand the evidence that you have for the dose response, particularly given that this trial is studying a lower dose, than was used in Phase 2? Can you provide us any more information at this point or should just wait and see the results of the study?
Derek Chalmers
Yes. Let me start on the [indiscernible] and then Joe can add some more details. So I think you and I have had this conversation on a few occasions. So pharmacologically a microgram per kilo in fact less dosage on a microgram per kilo provides pharmacological power for this drug. As you know we have a very high affinity for the human capital receptor in the region of 300 thinking more of which essentially translates the activity in the picogram per mill level from a plasma concentration wise.
So we know from our PK–PD relationship with the drug that at one microgram per kilo, we have a pharmacologically active dose. We’ve also looked as you know the 90 patients we took an interim work for safety, we’ve also looked to transfer that data. Those patients are quarantined out of the trial. And we've reported that we've seen trends in all three of the parameters we’re interested in those patients, so that obviously helps in terms of confidence.
And finally, as we've discussed, microgram per kilo, is an extremely active dose we've used in the Uremic Pruritus trials and continue to use in the Uremic Pruritus trials. We’re essentially looking at the same mechanism and ambition of the CV preferably and diminishment and the inflammatory response. So we are fairly confident that pharmacologically that should be an active dose.
Charles Duncan
That's helpful, Derek. So you believe there may be some read through if we see some activity in the Uremic Pruritus trial in the first quarter to possibly in – okay.
Derek Chalmers
Absolutely, and again we have seen activity in UP microgram per kilo, you’ll recall our Phase 2a study was microgram per kilo for two weeks and they're getting back to effect size since you brought up that was a 0.7 approximate effect size in those patients. So that was a very robust response.
Charles Duncan
Yes. Okay. Perfect. Thanks for taking my question.
Derek Chalmers
Thanks Charles.
Operator
Your next question comes from the line of Alan Carr. Your line is open.
Alan Carr
Hi. Thanks for taking my questions. Maybe to follow-up on the last one, how much are you going to disclose publicly around your interim analysis in terms of the changes that you make to the I.V. trial while it's ongoing. And then, so far you characterize safety profile is fine so far, but I wonder if you comment whether not there were any – have been any cases of hypernatremia?
Joe Stauffer
No cases of hypernatremia, no patients that we had to drop due to that. So on answer to the last part of your questions first there Alan. Second part is it's an interim assessment not interim analysis. And so we're not as I said taking the p-value hit to do this it's pre-specified between us, the FDA and our outside independent group. And we will have to let everybody know what's happening in terms of what changes we're making to the protocol for instance increase in the sample size or if we're dropping the treatment arm that all has to be laid out for everybody because we have to make those changes in the protocol, let the FDA know that and then put that in clinicaltrials.gov. So that becomes known.
What we won't do is we won't necessarily tell the world what the conditional power is, those exact numbers that those are pieces that we keep close to the investors I said this is a new and adaptive way of looking to clinical trials in pain.
But we've pre-specified what that is and the FDA has agreed to that. {***Spart-000***} {***Epart-000***}
{***Part – 30 to 32***}
new and adaptive way of looking at clinical trials in pain. But we pre-specified of what that is and the FDA has agreed to that. And so, if we're within those parameters then we move forward by either, again, increasing sample size, decreasing sample size, dropping a treatment arm or in the worst case scenario you have to talk about this right maybe there's just nothing there. That's also something that we would do too, but we don't expect that. And as Derek said before, the trends that we saw early on weren't just in pain score reduction, was also nausea, vomiting reduction as well.
Alan Carr
Okay, thanks. And then with respect to the OA trial, the Phase 2 OA trial, you’ve mentioned that maybe assuming positive results takes down to an end of Phase 2 meeting with the FDA to discuss Phase 3 design. So maybe you can comment on strategy here in terms of whether or not you keep something that late stage in-house would you run a Phase 3 yourselves would the cost of that be and or would you partner at that point? Thanks.
Derek Chalmers
Yes, I think we said in the past Alan that we’d most likely look for the suitable partner for the chronic pain trial due to the size of the commercial effort required there. And that’s still our position on that. The other two programs we feel fairly confident. We can push forward ourselves other way to commercial, but at that point we most likely will put partner on the chronic pain.
Alan Carr
Okay. And then last one any expectations for milestone payments from partners? Are there any big events coming from them that might trigger some revenues there? Thanks.
Joe Stauffer
Alan, it’s Joe. We’re usually disclosing the 10-Q that will be filed later tonight. Yes, there will be milestones as we progress on the I.V. trial and complete a Phase 3, we will be getting milestones from Maruishi and CKD.
Alan Carr
Great, thanks very much.
Derek Chalmers
Okay.
Operator
Your next question comes from the line of Jim Molloy [Needham & Company]. Your line is open.
Unidentified Analyst
Hi, this is actually Frank on for Jim. Thanks for taking the question. So for IV CR845 for post-op pain after this interim not analysis but assessment in terms of part three, obviously it depends if you have to add or take out a number of patients but do we expect Phase 3 the last part of this after the interim work. The data to read out before the end of 2017.
Derek Chalmers
Yes. For sure.
Unidentified Analyst
Okay, okay. Great. And then I guess is UP unit pricing and kidney dialysis likely, I guess think there's a chance it sees broad off label usage. If approved or?
Derek Chalmers
Frank. I don't think we'd see off-label usage with the IV formulation but I think with an oral formulation and we do see a fairly high percentage incidence in CKD patients that are non-hemodialysis for pruritus. And there as we talked about the four we think the mechanism for our molecule is probably broadly applicable even beyond the CKD population into pruritus associated with dermatological conditions and also in the endocrinological conditions whatever disease et cetera. So those are areas we plan to investigate starting with CKD patients non-hemodialysis. And then expanding dovetailing into other pruritic populations beyond that.
Unidentified Analyst
Got you. And then for IV CR845 for UP, so you got the Part A I’m expecting the first quarter here. But you guys mentioned a Part B also for that are we expecting is that the last part, is there Part C and should that data read out by end of 2017 as well?
Derek Chalmers
No. Part B is a registration. Part A is three doses, dosed over 8 weeks. We look at that data in Q1 we select the optimum dose for that and the registration trial will be 12 week, registration trial at one optimized dose.
Unidentified Analyst
Okay, great. Now for the Oral CR845 for UP after the PK safety here to figure out tablet strength and such, what should we be expecting after this low kg, This is 1Q 2017 after that what can you guys says about the strategy for oral.
Derek Chalmers
Yes. So Frank, that Joe can comment on this, but that really provides us with optionality as to whether we develop an IV, or we develop an IV and an oral and to the HD population and then we’ve discussed this before there are advantages there from a reimbursement standpoint not really depends on the conversation and where we are with the CMS and their views on the IV, in terms of exception to the bundle. So that’s the main reason to make sure we can define tablet strengths or bioequivalence there to what we know is already active in that population is also providing valuable information for our PK modeling to walk that back, and to CKD patients that are not end stage, but Stage 4 or Stage 5 non-HD and gives as an ability to model what tablets strengths would be – would be suitable to use in that population.
Unidentified Analyst
Great. And then this is probably more for Joe. You’d mentioned just the enrollments going very well and adding sites is not necessary, it adds very variability to the trial. Other than adding sites for more efficacy and just to find efficient centers what else is there that could be done.
Joe Stauffer
In fact we’ve actually gotten rid of some sites which is actually one of the ways you can help to improve your efficacy and efficiencies. So I said before it’s not the number of sites you have, it’s the number of sites that are enrolling well and following the protocol and not giving us any types of headaches during the trial, the sites that we’ve got right now are doing a very good job of doing that and that’s the most important thing. I think the big misunderstanding about clinical trials and operationalization of trials people get hung up on number of sites. I really caution everybody to think about that right. Its good sites, that’s what’s key. And so good sites, good patient screening, good evaluations of selecting the right patients that switch what’s key to the kingdom in terms of making things go fast and this was going faster than we thought which is quite nice.
Unidentified Analyst
Okay. So quality over quantity. And then one last question in terms of safety you said that – you’ve taken a lot of looks at it. Do you guys have DSMB looks in any –its like how frequently do safety looks have when you said every week…
Joe Stauffer
Every week. Right, every week and that’s for all the trials.
Unidentified Analyst
Okay. All right, great. That’s it from me. Thank you.
Joe Stauffer
Thanks, Frank.
Operator
Your next question comes from the line of Chiara Russo [H.C. Wainwright]. Your line is open.
Chiara Russo
Hey, guys. Thank you for taking the question I think I will be pretty quick. Just to take you back off of I think what Ong kind of asking about it, about the hypernatremia, you just saying that you’re not seeing it at all in the side effect profile.
Derek Chalmers
Correct.
Chiara Russo
All right. Okay.
Derek Chalmers
So we have stopping rules in this trial and we have not had anybody that would put into a trial stopping rule the hypernatremia business. So what we – what we’ve done is modifications in the trial that the way that we’re being aggressive with how we handle the patients post-operatively particularly in terms of getting to drink water early, which is fully in the spirit of ERAS which I mentioned earlier in the call. I think that’s helped tremendously and just better education of the monitors the nurses at the sites and the doctors. It’s made a big difference, so I’m feeling pretty good about that.
Chiara Russo
[Indiscernible] (0:38:55) it’s also probably worth mentioning, we monitor our oral trial every week as well and there we don’t have any issue.
Derek Chalmers
Same thing there, so.
Chiara Russo
Same thing there. Okay. Thank you professor, you basically being much more active with the management of the water and take up the patients.
Derek Chalmers
Correct.
Chiara Russo
Okay, okay. And then obviously you’ve got some interesting data coming out. Are you going to be publishing any of that, do we get to look at the posters with the stuff on it?
Derek Chalmers
Well, as soon as we would do that kind of stuff as soon as we get the clinical study reports written but that’s going to be next year, the next year thing at best. A lot of those deadlines for a lot of the posters depending upon the Congress will happen right when we’re unblinding data. So we’ll probably miss some of those deadlines. But as soon as we can get it out there, we will and get it out to as many anesthesia, pain medicine, Congresses, same thing for kidney and renal congresses as well.
Chiara Russo
All right. Awesome. And then you obviously are experiencing some nice enrollment rates generally higher enrollment rate equals higher expenses. Any the color on what we should be expecting for the last quarter of the year for R& D expense heading into first quarter 2017?
Derek Chalmers
Yes. We’ve no get it, third quarter, Chiara but everything…
Joe Stauffer
Your estimates are correct. They are going to go up in the fourth quarter, and throughout the first quarter.
Chiara Russo
Okay, okay. That will work. All right, awesome. Great, great call guys thank you for giving us some nice deadlines so look forward to next year.
Joe Stauffer
Nice, Chiara.
Operator
Your next question comes from the line of Ken Trbovich [Laidlaw & Co. (UK) Ltd]. Your line is open.
Ken Trbovich
Thanks for taking the question, couple quick ones. First on the oral OA study, when the patients wash out of their analgesics, what’s the – what’s a pain score they have to reach in order to qualify for the study?
Joe Stauffer
Right. So they have to have a five or greater.
Ken Trbovich
Got it. And that’s after washing out.
Joe Stauffer
That’s correct. So it’s a classic flare design.
Ken Trbovich
Sure. So can you give us a sense as a five of sleepless night and pain or what’s a five sort of anecdotally relate to in terms of how we might categorize it in other symptomatic versions?
Joe Stauffer
Sure. That’s a good question. So a five on a zero to 10 scale is obviously right in the middle and we consider that moderate pain. So most of – all these patients have to have at least moderate to severe pain, and during that washout period we are obviously don’t force patients to stay in pain. They’re actually allowed to take some amount of acetaminophen rescue during that timeframe. But once they get their threshold then they come in and they start dosing. So it’s moderate to severe pain.
Ken Trbovich
Got it. And then I was looking and I noticed that as it related to Maruishi and the license agreement, you guys have been pretty specific in the fact that on the oral side, you’ve only got rights for acute pain indications and yet obviously you’re doing an oral study in something that is chronic. Can you help us to reconcile, I mean, obviously it means you wouldn’t get milestones associated with this trial, but would Maruishi be a natural partner to look at this just on a credibility basis, because they’ve been an early partner often that you would give them some sort of first right of refusal on the chronic side, or is this open for business, you’ll consider all comers because there’s a separate story out today talking about Shionogi looking at pain and having an interest in meeting with pain companies specifically for licensing and M&A?
Joe Stauffer
Yes. So, Ken, just to clarify the agreement with Maruishi, the field of use there is for strictly for post-operative pain, so obviously that’s intravenous formulation. And also for uremic pruritus using whichever formulation is available for them and it’s really within their territory for them to decide. They are – as you know moving forward with an intravenous formulation, they think that provides significant advantage for them over the marketed kappa agonist there which is [indiscernible] and they can administer that as we do three times a week at the dialysis center and they’re going to get 100% compliance. So they’re happy to move forward due to right, they don’t have rights in terms of chronic pain at this point in Japan.
Ken Trbovich
Okay. But they don’t also have some sort of right of first refusal.
Joe Stauffer
They don’t have a right of first refusal, they have a right to look at our data and we have – in constant communication with my Maruishi and if the conditions were right for us to deal with Maruishi for that territory that would certainly be something we look at.
Ken Trbovich
Okay. And I guess maybe that turnabout on this would be the point at which you enter into discussions with potential partners whether it’s Maruishi or others internationally or even here in the U.S. its sounds like, it’s a second half of them before you can even begin those discussions and earnest with data enhanced.
Joe Stauffer
Yes, that’s going to be related to when the data is available. Ken, you’re correct.
Ken Trbovich
Okay. And then I guess sort of – sorry, catch off.
Joe Stauffer
No, that’s all right. As you say, we’re pretty confident, we’ve guided, we expect data in the first half of 2017.
Ken Trbovich
Sure. And then on you uremic pruritus, Joe I get your point about it’s not about percenters, but if we just talk about months you guys are enrolling 27 patients a month roughly, if we just sort of back into what you guys just told us it would suggest that Part B could be enrolled in about nine months. What sort of a gap should we expect in time between Part A and Part B?
Joe Stauffer
Well, I mean, there’s definitely going to be somewhat of a gap there and now we have to make sure we pick the right dose and make sure that that right dose is also balanced with the right safety profile that’s before expectations. So there won’t be a big gap, there will definitely be some type of gap. I wouldn’t anticipate that it would be longer than, maybe a month or two.
Ken Trbovich
Right. So it doesn’t require going back to the agency and getting feedback from the agency. This trail design is already set. Part B is a matter of you guys meeting with your consultants and deciding which notes.
Joe Stauffer
Yes, and no, I mean we want to make sure that we’re comfortable with the dose and we also want to make sure that the agencies comfortable with the dose, and also that they haven’t changed anything in terms of what their expectations are as well.
Ken Trbovich
So does that mean you could put the median request in before you have the data that you’ve got a placeholder?
Joe Stauffer
Yes. Exactly, I mean, we always try to do things as fast as you can, that’s one of the techniques you do is to have that request in for sure. We would obviously do that.
Ken Trbovich
Okay. And then just with regard to the difference between Part A and Part B as it relates to site selection. You mentioned obviously that that’s key. But certainly it seems that your experience thus far in both studies have been rapid enrollment. We’ve seen that with the studies you’ve done thus far. Is there anything about the pivotal nature of the trial that makes you perhaps reconsider some of those 33 sites and consider different ones or should we just assume that this is truly same sites rolling into the second part of the study?
Joe Stauffer
It’s definitely the same sites that are performing well, but we’re always open to look at new sites. We have people approaching us, that don’t want to get into the trial, they hear about us, they read about us, they see us a congresses, I mentioned that before earlier at ASA for the I.V. post-operative pain trial. So we’re always open to looking at new sites, if not just for these trials but also for trials going forward.
Ken Trbovich
Got it. And in terms of looking at the oral and any sort of special conditions around the oral, I know obviously you haven’t identified a dose from a further testing standpoint. But is there anything about going with the oral route that would cause there to be any additional safety studies or things of that nature that we should be thinking of as it expand to the oral development?
Joe Stauffer
No, not at all. The oral profile, as we said, I look at it every week with the rest of the team, and these patients are taking this drug twice a day. They’re also taking many of their other medications as well, right; so blood pressure meds and diabetes drugs, the drugs for depression. So you think about all the different drugs that an osteoarthritis patient would take and they’re taking our drug on top of that. We have not seen any safety profile that’s getting my tension in a bad way.
Ken Trbovich
Got it. And I met more around the UP side in terms of CKD on the oral side. Is there anything about that patient population whether its drug interaction? I mean obviously on the I.V. side you’ve got the opportunity to look at drug interaction, but is there anything about those CKD patients are on and all dosing that we should be thinking about?
Joe Stauffer
No, same thing, my apologies; I thought your first part was going to be osteoarthritis patients. No, same thing here, right; this drug is really nice. Whether it’s I.V. or whether it’s oral it’s excrete a hole through the kidney and it’s emphatic. So the potential for drug-drug interaction, no matter who you are is very close to zero; whether you’re on dialysis, whether you have pain post-op, whether you have osteoarthritis or whether you have CKD non-hemodialysis.
Ken Trbovich
Got it. Perfect . Thanks again and congratulations on the progress, obviously a rapid development. Looks like it be exciting times when data commence in.
Joe Stauffer
Yes. We’re excited. Thank you.
Joe Schoell
Thanks, Ken.
Operator
[Operator Instructions] Your next question comes from the line of Charles Duncan [Piper Jaffray]. Your line is open.
Charles Duncan
Hi, guys, thanks for taking the follow-up. Lots of questions, so I’m just going to ask really – just one, and that is regarding the oral form of 845. It seems like when we read through the press release there is a lot of talk about hemodialysis and kind of seems like it might be the same mechanism behind kidney dialysis, but really what’s the strategy behind that, what’s what are your basic observations? Suggest if there is a good clinical rationale and commercial opportunity.
Joe Stauffer
Yes, it’s really two fold, Charles. And I think we touched on this slightly earlier. One is we’re looking for an alternative formulation that is automatically with the bundling payment system for assay renal disease patients and that would be oral.
Charles Duncan
Yes.
Joe Stauffer
And so we want to make sure that we can define bioequivalence in HD patients. And also that data as you’re well aware is going to enable us to walk back into CKD patients that are non-HD, that are late stage predominately four and five that have some kidney function, but limited, and because as we said a couple of times here we have a drug that’s excrete hole via the kidney then the PK effects we have to take into account when we administer that to patients with diminished kidney function. So this data is going to help us model which tablets strengths would be effective and appropriate to use in those CKD end-stage patients that are not on HD, not on hemodialysis yet.
Charles Duncan
Not on dialysis yet.
Joe Stauffer
Yes.
Charles Duncan
So perhaps broader market opportunity? Okay, that’s helpful. Appreciate the clarification.
Joe Stauffer
Thanks, Charles.
Operator
I’m showing no further questions at this time. I’d now like to turn the conference call back to Derek Chalmers.
Derek Chalmers
Great. Thank you everybody. Thanks for participating in today’s call. And we certainly look forward to updating you again very soon in the coming two quarter. Thank you, have a good day.
Operator
Ladies and gentlemen, this concludes today’s conference. Thank you for your participation and have a wonderful day. You may all disconnect.
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Healthcare ratings roundup - new coverage
Oct 14 2016, 06:44 ET | By: Douglas W. House, SA News Editor
Cara Therapeutics (NASDAQ:CARA) initiated with Buy rating and $20 (147% upside) price target by H.C. Wainwright.
http://seekingalpha.com/news/3213862-healthcare-ratings-roundup-new-coverage?source=email_rt_mc_readmore&dr=1#email_link
Only Idiots are Scared...........
Why are people idiots on the market?
Who is selling at this low Price?
Shake it hard Baby ; )
There's no stopping this stock. Congrats to all you longs.
added more today ; )
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Cara Therapeutics Inc (NASDAQ:CARA): What We’re Looking For From The OA Trial
http://streetregister.com/2016/09/17/cara-therapeutics-inc-nasdaqcara-what-were-looking-for-from-the-oa-trial/
Cara Therapeutics Initiates Enrollment in Phase 2b Trial of Peripherally Acting Kappa Opioid Agonist, Oral CR845, in Chronic
Cara Therapeutics: Major Upside Potential
Sep. 12, 2016 7:30 AM ET|
Summary
Today we do a deep dive on Cara Therapeutics, a rare small-cap that is part of both the Biotech Forum and Insiders Forum portfolios.
The company has many positive traits, including upcoming milestones, insider buying, a solid balance sheet, downside technical support and an attractive risk/reward profile.
The stock could double just by getting to half some of the analyst price targets proferred on the stock recently.
In today's deep analysis, we look at a rare small-cap name that I hold both within my Biotech Forum and Insiders Forum portfolio, as this small biopharma focusing on pain management has a very attractive risk/reward profile at its current trading levels as well as heavy insider buying in 2016. It also has myriad traits I look for before adding a small stake in a developmental concern, including a solid drug candidate(s), upcoming milestones, good balance, strong analyst support, and the stock appears significantly undervalued with a positive risk/reward profile. If the stock can get to just halfway to recent analyst price targets, substantial gains lie ahead.
Company Overview
Cara Therapeutics (NASDAQ:CARA) is a Connecticut-based emerging biotechnology company with just over a $150 million market capitalization. The company came public two and a half years ago and is currently priced just below $6 a share. Shares have sold for north of $20.00 within the past year. They have also developed a hard downside technical support around $5, making this an asymmetrical upside play.
Cara is focused on developing novel therapeutics to treat human diseases associated with pain, inflammation and pruritus. The company possesses near-term clinical development opportunities combined with proprietary approaches to developing first-in-class novel therapeutics.
Cara's most advanced compound, CR845, is currently undergoing clinical testing for acute pain and pruritus. This patented compound possesses analgesic, anti-inflammatory and anti-pruritic activities appropriate for multiple therapeutic applications. In addition, the company aims to develop a future pipeline of first-in-class molecules at novel analgesic and anti-inflammatory targets using its proprietary drug screening technology.
Pipeline
As stated above, Cara's primary drug candidate is CR845, which is in mid- to late-stage trials for treatments in three distinct areas. Numerous milestones should be hit in 2016, which will be discussed in a section below. CR845's primary benefit is that unlike currently marketed opioids, this new compound does not produce inhibition of intestinal transit (ileus), does not induce life-threatening respiratory depression, nor does it elicit signs of addiction or euphoria.
The compound was in a Phase 3 trial for a treatment for acute post-op pain before a recent clinical hold was placed on the trial earlier this year. This caused the stock to crater, which continues to have created an advantageous entry point (more on that in a separate section below). The hold was lifted in late April, with two of the three dosage levels remaining in the trial. The highest dose was discarded for now due to some very mild side effects. The company is currently in the middle of recruiting patients to restart this trial. Post-op pain treatments is roughly a $9 billion annual market in the United States. Obviously, just a small percentage of that market would be a significant potential revenue and earnings stream for Cara.
To add some color to the opportunity, management has stated in a recent conference call: "With the recent increased regulatory focus from CDC, the FDA itself and NIH to kappa prescription opioid abuse and associated deaths and the increasing physician and media focused to the novel approach is to chronic pain, we believe CR845 has a significant potential to provide an alternative approach to traditional new opioids and deliver effective pain relief in the absence of abuse, misuse and addiction, as already indicated by our established human abuse liability data."
The company is also testing an oral version of CR845 for acute and chronic pain. It plans a multiple-dose Phase 2b study in OA patients in the second half of this year, which will be an upcoming milestone when it commences. The study will include 330 patients randomized across three CR845 tablet strengths and a placebo arm at 15 sites across United States. An oral CR845 Phase 2a study in osteoarthritis patients ("OA") showed in December of last year that CR845 exhibited a dose-related reduction in main baseline pain score to the end of the two-week treatment period, with up to an approximate 34% reduction for the highest dose group.
Finally, in the third quarter of last year, Cara provided data from its Phase 2 trial, where CR845 treatment resulted in statistically significant reductions in both the primary endpoint of worse itching or pruritus in uraemic pruritus ("UP") and dialysis patients as well as secondary endpoints assessing quality of life measurements in these patients. This is an unmet need in the market, with no approved treatments either in the United States or Europe for UP. The next step is a two-part Phase 2/3 adaptive design in haemodialysis patients exhibiting moderate-to-severe uremic pruritus which just commenced in late June.
Clinical Hold
The stock started the year at around $15.00 a share, then tanked soon into 2016. The primary cause driving it down is that the company, in February, announced a critical Phase 3 trial has been placed on clinical hold following a limited number of patients reaching a pre-specified stopping rule related to increases in serum sodium concentrations to the mild to moderate hyponatremia level that is greater than or equal to 150 Millimoles Per Litre. To put in perspective, the normal range expected in this population without treatment is 135-145 Millimoles Per Litre. The trial will continue at the lower dosage levels that have shown to be effective, and is in recruitment stage. If results of this trial are eventually successful, as expected, this should be a substantial positive catalyst for the company and the stock.
Balance Sheet
Cara ended the second quarter with $84 million in cash, cash equivalents and marketable securities. Management continues to expect that its existing cash and cash equivalents and available-for-sale marketable securities as of June 30, 2016 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. In addition, the fact that Cara's market capitalization outside its cash position is under $70 million means it is potential cheap acquisition even with a substantial premium.
Analyst Commentary and Insider Buying
When the stock fell apart thanks to the clinical hold in mid-March, a director bought almost $2 million in new shares. A beneficial owner did the same. This is nearly three percent of the outstanding float and a big vote of confidence. This confidence will be rewarded in a big way if analysts are anywhere close to correct on their recent views on the company. Recently, Cantor Fitzgerald, Needham and Canaccord Genuity have all reiterated Buy ratings on the stock, with price targets ranging from $18 to $30 a share. I take particular comfort in the Buy rating and $23 price target from Needham, since it comes from a five-star ranked analyst (TipRanks)
Outlook
Cara Therapeutics looks clearly oversold based on its past share price, analyst price targets and the size of addressable markets for the company's primary drug candidate. It also has funding in place for all key trials, upcoming milestones and a strong belief in its future by management, based on insider buying. The stock seems to offer a very positive risk/reward profile at current trading levels.
Note: To celebrate my 50th birthday and the kickoff of the NFL Season, The Biotech Forum will be giving away free two-week trials to the second-most-subscribed-to service of over 60 in the Marketplace throughout the weekend and through the final gun of Monday Night Football.
Thank You & Happy Hunting
Bret Jensen
Founder, Biotech Forum
Disclosure: I am/we are long CARA.
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.
http://seekingalpha.com/article/4005559-cara-therapeutics-major-upside-potential?auth_param=1dbdf8:1btd4gv:ccddf7ea29a2010fa99169d35787f294&dr=1&utoken=fde862ed26167c3db5259c54d35b862b
Biotech Industry Conference 2016 Presentation is now available
https://app.scoutfin.com/document.html?id=57d663117edda6e85ee8c374&_branch_match_id=303814899813973767
Cara Therapeutics Inc (NASDAQ:CARA) Watching for $6.17 breakout. All indicators are in favor of an upward price movement. The daily MACD is about to flash a bullish crossover while the RSI has regained the 50 level for the first time this month. This momentum could push this stock much higher from here, so keep the stock on your radar for Thurday’s trading day, as there is good upside potential in this move.
http://ac-investor.blogspot.de/2016/09/my-watchlist-for-thursday-september-08.html?m=1
Here's Why Investors Should Steer Clear of Opioids
Sep 6, 2016 12:37 PM EDT
https://www.thestreet.com/story/13693642/1/here-s-why-investors-should-steer-clear-of-opioids.html
4 Undervalued Growth Stocks Deserving Your Interest
Bret Jensen August 20, 2016
http://www.investorsalley.com/let-me-ease-your-pain/
Cara Therapeutics Inc (NASDAQ:CARA)’s CR845 Could Be A Game Changer In Pain Management
http://streetregister.com/2016/08/17/cara-therapeutics-inc-nasdaqcaras-cr845-could-be-a-game-changer-in-pain-management/
Canaccord Genuity 36th Annual Growth Conference
https://app.scoutfin.com/document.html?id=57acc0db783cf4b56b40b38d&&_branch_match_id=289857999597931710
Cara Therapeutics to Webcast Presentation at Canaccord Genuity 36th Annual Growth Conference
Cara Therapeutics' (CARA) CEO Derek Chalmers on Q2 2016 Results - Earnings Call Transcript
Aug. 4, 2016 10:28 PM ET|
About: Cara Therapeutics Inc. (CARA)
http://seekingalpha.com/article/3996120-cara-therapeutics-cara-ceo-derek-chalmers-q2-2016-results-earnings-call-transcript?page=8
JPMorgan Chase & Co. Has $3,194,000 Position in Cara Therapeutics Inc. (CARA)
Posted by Tony Sherman on Jul 27th, 2016 // No Comments
http://www.webbreakingnews.com/2016/07/27/jpmorgan-chase-co-has-3194000-position-in-cara-therapeutics-inc-cara/
hugh volume today in the first 30 min. 1.5 Mio. Share's traded
today's high was 7 at the moment..
loook great about CARA ; )
time to 2.nd leg up ; )
go baby goooo
High Tension
here we go above 7 ....
High 6,88
here weeeee gooo 6,75
BREAKING NEWS. U.S. GOV’T WILL LEGALIZE MARIJUANA ON AUGUST 1
The U.S. Drug Enforcement Administration will reclassify marijuana as a “Schedule Two” drug on August 1, 2016, essentially legalizing medicinal cannabis in all 50 states with a doctor’s prescription, said a DEA lawyer with knowledge of the matter.
http://healthynutrition.co/breaking-news-u-s-govt-will-legalize-marijuana-on-august-1/