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Cara Therapeutics, Inc. (CARA)

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Company Description: Cara Therapeutics is an emerging biotechnology company focused on developing novel therapeutics to treat human diseases associated with pain and inflammation. Cara possesses both near-term clinical development opportunities combined with proprietary approaches to developing first-in-class novel therapeutics. Cara's most advanced patented compound, CR845, is currently undergoing clinical testing for acute pain. This compound possesses analgesic and anti-inflammatory activities appropriate for multiple therapeutic applications. In addition, Cara aims to develop a future pipeline of first-in-class molecules at novel analgesic and anti-inflammatory targets using its proprietary drug screening technology.

Intellectual property: CR845 was discovered by CARA's scientists. CARA owns six U.S. patents pertaining to CR845  with claims covering compositions of matter and methods of use for CR845. The earliest U.S. patent claiming CR845 compositions will expire no earlier than November 12, 2027. To date CARA has built an extensive patent portfolio with 58 patents issued and 72 pending.

Pipeline and Technologies: CR845 has completed three Phase 2 clinical trials in acute post-operative pain. Cara's most advanced CB compound, CR701, is in preclinical development.





CB Antagonists: Studies on the effects of cannabis have led to the discovery of an endogenous system of ligands involved in pain and inflammation. The main naturally occurring ligands for this system, anandamide and 2-arachidonoylglycerol (2-AG), activate a number of cannabinoid receptors, including CB1 and CB2 receptors. Like opioid receptors, CB1 and CB2 receptors are members of the G protein-coupled receptor superfamily. CB1 receptors and associated ligands are mainly localized in the brain whereas CB2 receptors are found mainly in peripheral tissues, particularly immune cells such as leukocytes and mast cells, which have been shown to be involved in pain and inflammatory responses. Cara is developing lead molecules that selectively modulate peripheral CB receptors without targeting CNS cannabinoid receptors. Peripheral CB receptor modulators will be initially developed as a novel therapeutic approach for neuropathic pain, a condition currently without consistently effective therapies.

Revenue from License Agreements: All of CARA's revenue to date has been from license agreements. They have received aggregate payments of $28.8 million pursuant to license agreements related to CR845. In April 2013, CARA entered into a license agreement with Maruishi under which CARA granted Maruishi an exclusive license to develop, manufacture and commercialize drug products containing CR845 in Japan in the acute pain and uremic pruritus fields.

Under the terms of the agreement, CARA received a non-refundable and non-creditable upfront license fee of $15.0 million and is eligible to receive an aggregate of $6 million in clinical development milestones and $4.5 million in regulatory milestones. CARA is also eligible to receive tiered royalties, with percentages ranging from the low double-digits to the low twenties, based on net sales of products containing CR845 in Japan, if any, and share in any sub-license fees.

Use of Proceeds: CARA expects to net $52.9 million from its IPO. Proceeds are allocated as follows: $44 million to conduct its planned Phase 3 clinical trials and other development activities for I.V. CR845 $2.1 million to conduct its planned Phase 1 clinical trial for Oral CR845 $4.6 million to conduct its planned Phase 2a clinical trials and other development activities for Oral CR845; and the remainder for working capital and other general corporate purposes.
 
 

PIPELINE & TECHNOLOGIES






ClinicalTrials.gov
A service of the U.S. National Institutes of Health

 
Find Studies:

https://clinicaltrials.gov/ct2/results?term=CR845&Search=Search


 


KAPPA RECEPTOR AGONISTS

Opiate analgesics can act through three different types of opioid receptors, called mu, delta, and kappa. Morphine, the most widely used opiate analgesic, acts primarily via activation of the mu opioid receptor located in the central nervous system (CNS).

This CNS action induces pain relief but is also associated with a wide array of CNS-mediated side effects including sedation, respiratory depression, and abuse liability. As a way to avoid these undesirable CNS effects, there has been an effort to develop opioids which activate peripheral opioid receptors present on sensory nerves, but are also largely excluded from the brain. Such compounds are thought to have the potential to provide pain relief (peripheral opioid analgesia) without producing significant CNS side effects. CR845 belongs to this pharmacological class of compounds; it is a potent peripheral kappa opioid receptor agonist with high selectivity over other opioid receptors.

CR845 has completed three Phase 2 clinical trials in acute post-operative pain.
 


 

CR845

Cara possesses peripherally-selective molecules that interact with kappa opioid receptors present on peripheral, pain-sensing nerves.

These compounds exhibit potent analgesic and anti-inflammatory properties in animals. Unlike currently marketed opioids, these new compounds do not produce inhibition of intestinal transit (ileus), do not induce life-threatening respiratory depression, nor do they elicit signs of addiction or euphoria in animal models.

The degree of kappa receptor selectivity displayed by CR845 ranks as best-in-class compared to all other previously developed compounds for this therapeutic target. Moreover, CR845 displayed no significant affinity for any other non-opioid known receptors.
 


 

CR845 & OTHER KAPPA AGONISTS

Cara has developed two peripheral kappa agonists, CR845 and CR665, which display unmatched peripheral selectivity in animal models when compared to first generation kappa compounds.

Both compounds are intrinsically poor at penetrating the blood-brain barrier which decreases the likelihood of CNS-mediated side effects. The peripheral selectivity of CR665 was evaluated in rodents by comparing the 50% effective dose (i.e., A 50 value) to reduce viscero-somatic pain versus the 50% effective dose to induce a CNS-mediated effect. Pain was measured by the number of writhing movements after administration of an irritant into the abdomen, while the CNS effects were determined by impairment of motor coordination (inability to balance on a rotating horizontal rod). As shown (figure), previously developed kappa agonists such as enadoline, asimadoline, and TRK-820 inhibited the pain response at doses only 2- to 8-fold less than those producing an impairment of motor coordination in rodents. CR665, in contrast, showed a much larger safety margin with greater than 500-fold separation of doses required to produce analgesia versus CNS side effect.

Kappa Agonists                                                                                                         Preipheral Selectivity of CR665

 


CB AGONISTS

Studies on the effects of cannabis (marijuana) have led to the recent discovery of an endogenous system of ligands in humans involved in a number of physiological processes including pain and inflammation.

The main naturally occurring ligands for this system, anandamide and 2-arachidonoylglycerol (2-AG), activate a number of cannabinoid receptors, including CB1 and CB2 receptors. Like opioid receptors, CB1 and CB2 receptors are members of the G protein-coupled receptor superfamily. CB1 receptors and associated ligands are mainly localized in the brain whereas CB2 receptors are found mainly in peripheral tissues, particularly immune cells such as leukocytes and mast cells, which have been shown to be involved in pain and inflammatory responses. Cara is developing lead molecules that selectively modulate peripheral CB receptors without targeting CNS cannabinoid receptors. Peripheral CB receptor modulators will be initially developed as a novel therapeutic approach for neuropathic pain, a condition currently without consistently effective therapies.

Cara's most advanced CB compound, CR701, is in preclinical development.

 
 

CR701

CR701 has been evaluated in a rodent model of neuropathic pain that produces both hyperalgesia (sensitization of nerve endings to painful stimuli) and allodynia (painful perception of innocuous stimuli) comparable to human conditions. As shown in the figure below, administration of CR701 to animals with neuropathy resulted in significant reversal of both hyperalgesia and allodynia, as measured by responses to thermal and tactile stimuli, respectively.

CB701                                                                                                                                                                  Reversal of Neurpathic Pain Symptoms by CR701

 


DimerScreen Technology

The most successful and therapeutically useful drug targets in modern medicine are a superfamily of membrane proteins, the G protein-coupled receptors (GPCRs).

This is particularly evident within the pain markets where all of today's clinically effective opioid analgesics and a number of anti-inflammatory agents, such as the leukotriene antagonists, act through this class of receptor protein.

In recent years, studies have demonstrated that GPCRs can form paired protein complexes - dimers - with other GPCRs on the cell surface. Two of the same GPCRs can pair up to form a homodimer , or two different GPCRs can pair up to form a heterodimer. Compared to the GPCR monomers, some of these receptor dimers display new, unexpected drug recognition and response properties, which means that there exists a broad, new array of unexplored drug targets within the GPCR superfamily.

DimerScreen™, is designed to specifically and selectively identify molecules interacting with GPCR dimers and thus allows for the discovery of compounds with new pharmacological properties at identified dimeric drug targets.

 

Upcoming Projected Clinical Milestones 2016

Reinitiate CLIN3001 Abdominal Pain Trial Q2, 2016

Initiation Uremic Pruritus Phase 2/3 Program Q2, 2016

Initiation 2nd Phase 3 Acute Pain Trial 2H, 2016

Initiation Phase 2b Oral OA Trial 2H, 2016

 
 

Novel Peripheral Kappa Opioid Product Candidates: Efficacy Without Opioid Side Effects
 
http://files.shareholder.com/downloads/AMDA-2C4IM7/1922207038x0x885511/AB0DDDC1-F921-49C7-9D9C-5665E055FAE5/Needham_2016_CARA.pdf

 

Consensus Ratings for Cara Therapeutics (NASDAQ:CARA)
 
Ratings Breakdown: 6 Buy Rating(s)
Consensus Rating: Buy (Score: 3.00)
Consensus Price Target: $23.83 (265.54% upside)


Analysts' Ratings History for Cara Therapeutics (NASDAQ:CARA)
 
 
Date Firm Action Rating Price Target  
4/23/2016 Piper Jaffray Reiterated Rating Overweight $23.00  
4/21/2016 Needham & Company LLC Reiterated Rating Buy    
4/20/2016 Cantor Fitzgerald Reiterated Rating Buy    
3/12/2016 Janney Montgomery Scott Reiterated Rating Buy $23.00 -> $18.00  
2/29/2016 Laidlaw Lower Price Target Buy $30.00 -> $17.00  
11/11/2015 Canaccord Genuity Reiterated Rating Buy $30.00  
3/3/2015 MLV & Co. Initiated Coverage Buy $26.00  
12/9/2014 Summer Street Initiated Coverage Buy $20.00  
(Data available from 4/29/2014 forward)

 
   
http://www.caratherapeutics.com/
Start with investors link.





 


Cara Therapeutics Inc. (NASDAQ:CARA)

Q1 2016 Results Earnings Conference Call

May 5, 2016 04:30 PM ET


seekingalpha.com/article/...rnings-call-transcript?part=single

 

Cara Therapeutics Is Feeling The Pain; But Not For Long

Jun. 2, 2016 3:15 AM ET

http://seekingalpha.com/article/3979324-cara-therapeutics-feeling-pain-long
 



Post-op pain treatment is ~$9B market; if CR845 pulls even 5% that's approx $450M rev.


http://seekingalpha.com/article/3977994-biotech-2-attractive-buyout-targets-7-share

 
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CARA News: Cara Therapeutics Announces Participation in 2018 Spring Clinical Meetings of the National Kidney Foundation 04/10/2018 07:00:00 AM
CARA News: Securities Registration: Employee Benefit Plan (s-8) 03/16/2018 04:19:23 PM
CARA News: Annual Report (10-k) 03/15/2018 05:21:24 PM
CARA News: Current Report Filing (8-k) 03/15/2018 04:13:33 PM
CARA News: Cara Therapeutics Reports Fourth Quarter and Full Year 2017 Financial Results 03/15/2018 04:01:00 PM
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PostSubject
#1809   Nice to see a little green this morning. JFBroderick 03/21/18 10:29:35 AM
#1808   Didn't expect this morning's sell-off. JFBroderick 03/19/18 10:32:39 AM
#1807   I figured we might test the 52-week low. king oil 03/16/18 01:09:12 PM
#1806   Wow, total overreaction to yesterday's news. Would JFBroderick 03/16/18 10:47:04 AM
#1805   a good number of potentially major milestones in king oil 03/15/18 07:42:53 PM
#1804   Expected 2018 Milestones JFBroderick 03/15/18 04:58:14 PM
#1803   Aftermarket sells JFBroderick 03/15/18 04:50:40 PM
#1802   Options being received. Does not look like a sale. hogar 03/14/18 07:16:36 PM
#1801   are they options/warrants being exercised? They're not sales. king oil 03/14/18 02:49:33 PM
#1800   Don't look like purchases to me. hogar 03/14/18 01:32:59 PM
#1799   A bunch of directors have purchased shares recently. king oil 03/14/18 11:44:04 AM
#1798   For sure she’ll be at 22-25 by eoy 52172 03/14/18 07:22:29 AM
#1797   Cara Therapeutics Doses First Patient in Phase 1 a surfer 02/28/18 08:59:35 AM
#1796   Bought at 4.92 sold at 18. I oldmusky 02/21/18 03:34:45 PM
#1795   15's.. a surfer 02/16/18 11:11:59 AM
#1794   65k premarket buy @ 14.15 JFBroderick 02/13/18 08:52:34 AM
#1793   Nice bump up from the Analyst upgrade today Winsor1 02/12/18 01:45:29 PM
#1792   well so much for that , time to Derek261 02/09/18 12:46:54 PM
#1791   well at least CARA seems to refuse going Derek261 02/09/18 12:04:27 PM
#1790   Looks like she regained her footing ;) JFBroderick 02/06/18 04:00:31 PM
#1789   WTF cara apparently I should have sold some Derek261 02/05/18 01:08:00 PM
#1788   Yea, I have no idea how the news JFBroderick 01/31/18 02:14:45 PM
#1787   Think we close green. $CARA jjh573 01/31/18 12:42:08 PM
#1786   yet the stock price falls. bizarre king oil 01/31/18 12:27:19 PM
#1785   Agreed, positive news $CARA! jjh573 01/31/18 09:12:30 AM
#1784   Based on the news, it should be a JFBroderick 01/31/18 08:56:29 AM
#1783   Consolidated nicely on high volume, agree very odd, jjh573 01/25/18 05:40:21 PM
#1782   Odd after hours JFBroderick 01/25/18 05:07:58 PM
#1781   Largest long-term MJ long-term position in mi portfolio pj McMulligan 01/25/18 11:13:48 AM
#1780   :) $CARA jjh573 01/25/18 11:11:48 AM
#1779   I see green and I'm not looking down JFBroderick 01/25/18 10:55:04 AM
#1778   Healthy consolidation here, agreed! $CARA jjh573 01/25/18 10:20:49 AM
#1777   Hold tight. IMO, we will be green EOD JFBroderick 01/25/18 10:13:05 AM
#1776   Some pm interest, open should be interesting. GLTA $CARA jjh573 01/25/18 09:11:25 AM
#1775   The amount of after hours is insane. JFBroderick 01/24/18 09:40:34 PM
#1774   Agreed, this was making its run just before jjh573 01/24/18 08:01:11 PM
#1773   Apparently there was an alert on heavy call king oil 01/24/18 07:59:32 PM
#1772   We are up this high on no news JFBroderick 01/24/18 07:08:48 PM
#1771   Very nice piece! Strong day here with the jjh573 01/24/18 04:01:49 PM
#1770   Also https://www.morningstar.com/news/market-watch/TDJNMW_20180124260/update-5-b protagonist12 01/24/18 12:29:32 PM
#1769   Of course! Right when I am about to djmurdock 01/24/18 11:13:56 AM
#1768   Here comes the coverage! Perfect timing.. GLTA!! $CARA https://www.google.com/ jjh573 01/24/18 09:07:28 AM
#1767   Holy premarket Batman!! JFBroderick 01/24/18 08:10:13 AM
#1766   What the next catalyst? trial result coming up? Thanks djmurdock 01/23/18 01:53:52 PM
#1765   $CARA the shows about to start here. jjh573 01/22/18 10:51:27 AM
#1764   here we go king oil 01/22/18 10:05:57 AM
#1763   DJ Cara Therapeutics Price Target Announced at $27.00/Share JFBroderick 01/22/18 08:13:18 AM
#1762   Now this. My List Of The Best Early JFBroderick 01/19/18 12:28:15 PM
#1761   Possible explanation (although you probably already saw): Premarket analyst Noahfrigault 01/19/18 12:12:56 PM
#1760   Around $200k in premarket this morning. Interesting JFBroderick 01/19/18 09:23:00 AM
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