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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: Confidential Treatment Order (ct Order) 09/11/2018 11:27:39 AM
CARA News: Statement of Changes in Beneficial Ownership (4) 09/06/2018 05:36:08 PM
CARA News: Statement of Changes in Beneficial Ownership (4) 09/06/2018 05:35:42 PM
CARA News: Cara Therapeutics to Present at the 27th European Academy of Dermatology & Venereology Congress 09/05/2018 04:01:00 PM
CARA News: Statement of Changes in Beneficial Ownership (4) 08/22/2018 05:28:22 PM
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#1868   The chart is looking lovely to say the least! JFBroderick 09/18/18 03:38:25 PM
#1867   Loving this! a surfer 09/13/18 12:14:31 PM
#1866   NEWS COMING!! Stockbroker upgrades to $30 per share Confidential treatment Chas42va 09/13/18 10:12:29 AM
#1865   News must be on the horizon here...quite the JFBroderick 08/28/18 12:26:49 PM
#1864   Well received 10Q. a surfer 08/08/18 01:48:15 PM
#1863   Update please. Help me understand why here weee Bella33 08/06/18 03:03:12 AM
#1862   I sold my $7s at $12 and am Jaymeinnyc 07/28/18 12:26:01 PM
#1861   I'm not sure. Maybe over concerns of king oil 07/28/18 11:38:59 AM
#1860   Great question. Can’t seem to find anything. zerowinner 07/26/18 02:49:09 PM
#1859   Why in the world is this tanking? JFBroderick 07/26/18 01:53:11 PM
#1858   They just did. It's at $19, which is djmurdock 07/18/18 09:15:36 PM
#1857   No. Usually just means more shares will be king oil 07/18/18 11:37:09 AM
#1856   Does this offering mean our shares are worth less? oldmusky 07/18/18 09:57:46 AM
#1855   Why would they announce an offering and not JFBroderick 07/18/18 09:09:27 AM
#1854   Yup...another offering. We'll see where it leads us. a surfer 07/17/18 06:27:01 PM
#1853   Ugliest after-hours JFBroderick 07/17/18 06:24:11 PM
#1852   Looking solid on decent volume! a surfer 07/11/18 05:30:27 PM
#1851   Very possible! http://stockcharts.com/c-sc/sc?s=CARA&p=W&b=5&g=1&i=p737683 a surfer 07/03/18 04:38:36 PM
#1850   Anyone think we’ll see new highs fairly soon? Vinnyd321 06/28/18 08:49:21 AM
#1849   Premarket coming in already JFBroderick 06/28/18 05:14:16 AM
#1848   Everyone scared from last years retrace I assume a surfer 06/27/18 04:51:36 PM
#1847   CARA leading indicators predicted the positive cycle at joanne4trade 06/27/18 12:29:45 PM
#1846   Healthy consolidation. Next leg up this afternoon. JFBroderick 06/27/18 11:21:18 AM
#1845   Profit taking has dropped it back to the Walt123 06/27/18 11:04:45 AM
#1844   Excuse my French but holy s**t we are JFBroderick 06/27/18 08:05:36 AM
#1843   Jun 27, 2018 Cara Therapeutics Reports Positive a surfer 06/27/18 07:07:03 AM
#1842   $CARA vs. $INSY Better Marijuana Stock: Insys Pharmaceuticals MazelTov 06/26/18 06:53:27 PM
#1841   June 8th Found this on Flipboard , from Politico  ben177b 06/17/18 11:09:54 AM
#1838   That gut feeling... Good luck luck everyone $CARA Much love Cbdpotential 06/10/18 01:07:19 AM
#1837   I have two months left until I have JFBroderick 06/07/18 09:35:23 AM
#1836   Yep, I am glad I sold half my acrazjo 05/29/18 11:00:40 AM
#1835   Shorts are loving the down market this morning. JFBroderick 05/29/18 10:56:40 AM
#1834   Upgrades coming next week 52172 05/25/18 01:12:40 PM
#1833   Not selling any until 25 52172 05/25/18 01:12:16 PM
#1832   Good bounce today! I held 1/2 my position. acrazjo 05/25/18 11:33:17 AM
#1831   Also, MarketEdge, The Street, etc. will change their JFBroderick 05/25/18 10:25:49 AM
#1830   Amazing rebound here. JFBroderick 05/24/18 11:32:26 AM
#1829   I sold @ 16.61 > You be crudeoil24 05/24/18 10:50:39 AM
#1828   Be careful suggesting something of that nature when acrazjo 05/24/18 10:46:39 AM
#1827   Remember they have trial results coming in June. Walt123 05/23/18 10:13:21 PM
#1826   Better Marijuana Stock Insys Pharmaceuticals vs. Cara Therapeutics MazelTov 05/23/18 09:13:08 PM
#1825   https://www.gurufocus.com/news/660223/leading-stock-website-the-motley-fool-feat MazelTov 05/23/18 09:11:58 PM
#1824   Likely up some come tomorrow with some selling acrazjo 05/23/18 08:52:20 PM
#1823   Hope your right! Just bought yesterday on fraz123 05/23/18 08:25:12 PM
#1822   Above $20+ by Friday close $. crudeoil24 05/23/18 04:15:29 PM
#1821   Solid. Looks poised to reach new highs a surfer 05/23/18 03:28:09 PM
#1820   We were trading sideways for a while around JFBroderick 05/23/18 02:44:07 PM
#1819   CARA > very solid bull running on huge news. crudeoil24 05/23/18 02:42:26 PM
#1818   Will it pull back or keep going????? Punkertone40 05/23/18 02:41:58 PM
#1817   Ready for some serious short covering. ++40% JFBroderick 05/23/18 02:37:34 PM
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