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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
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Bid Ask Day's Range
CARA News: Cannabis-Based Therapies with Potential to Dull the Pain of Opioid Abuse 05/17/2017 08:45:00 AM
CARA News: Cara Therapeutics to Present at the 17th Annual Conference on Pain Therapeutics 05/17/2017 08:00:00 AM
CARA News: Cara Therapeutics to Host KOL Meeting on Chronic Kidney Disease-Associated Pruritus on May 16, 2017 05/12/2017 04:01:00 PM
CARA News: Initial Statement of Beneficial Ownership (3) 05/11/2017 04:48:17 PM
CARA News: Additional Proxy Soliciting Materials (definitive) (defa14a) 05/10/2017 04:10:38 PM
PostSubject
#1319   I don't want to talk too fast especially CoachMarc 05/25/17 03:49:48 PM
#1318   Looks like many of us on this board CoachMarc 05/24/17 06:45:23 PM
#1317   Buy low and sell high. pennystockaholic 05/24/17 06:25:07 PM
#1316   I've been in and out of both CARA CoachMarc 05/23/17 04:46:35 PM
#1315   I think many here are in as well. a surfer 05/23/17 02:23:00 PM
#1314   Not to pump another ticker but has anyone Loosingstocks 05/23/17 01:55:11 PM
#1313   I picked 1500 @ $17.50 but get harder now Loosingstocks 05/23/17 11:51:42 AM
#1312   May get harder to buy down low. CARA acrazjo 05/23/17 11:46:57 AM
#1311   I completely agree! I set my sell price CoachMarc 05/23/17 10:03:14 AM
#1310   Could have a 10% plus day at any a surfer 05/22/17 11:23:18 PM
#1309   Yes, trading in and out is making me acrazjo 05/22/17 05:46:42 PM
#1308   It's a great stock. I'm doing Loosingstocks 05/22/17 11:32:06 AM
#1307   About to sell CARA once again. This swings acrazjo 05/22/17 11:30:45 AM
#1306   Bought back in at 15.90. been in and acrazjo 05/18/17 09:12:18 PM
#1305   Nice HOD close!! djmurdock 05/18/17 06:45:41 PM
#1304   Yea it's all just to shake out the JohnBlaze 05/18/17 05:47:14 PM
#1303   Nice recovery though. Loosingstocks 05/18/17 05:32:53 PM
#1302   If it wasn't for the Trump/media circus, we'd CoachMarc 05/18/17 05:22:25 PM
#1301   Whats your goal entry ? And do you pennystockaholic 05/18/17 04:24:11 PM
#1300   Up almost 7% percent today. This is a pennystockaholic 05/18/17 04:15:52 PM
#1299   And the futures are way down again today. king oil 05/18/17 08:07:44 AM
#1298   Today sucked donkey for me all around. Sick djmurdock 05/17/17 11:08:16 PM
#1296   Another company applying the medical properties of cannabis Cbdpotential 05/17/17 04:33:10 PM
#1295   It'll pan out...Many want trump out and will a surfer 05/17/17 12:33:50 PM
#1289   yup. a surfer 05/17/17 11:07:56 AM
#1288   Market is way down and folks are taking CoachMarc 05/17/17 11:07:46 AM
#1287   the overall market is tanking with talk of impeachment. king oil 05/17/17 11:06:25 AM
#1286   It's going to bounce back as hard. Loosingstocks 05/17/17 11:01:12 AM
#1285   Big hit today. Lets see if she a surfer 05/17/17 10:41:47 AM
#1284   Cara Therapeutics to Present at the 17th Annual a surfer 05/17/17 08:38:13 AM
#1283   Great presentation! http://wsw.com/webcast/cc/cara/index.aspx a surfer 05/17/17 12:30:41 AM
#1282   Just got prescribed Hydrocodone for a car accident, snickerPP 05/16/17 04:45:52 PM
#1281   Agreed, I hold a core account just in acrazjo 05/16/17 04:45:06 PM
#1280   Yes, I really like the quiet time between acrazjo 05/16/17 04:44:06 PM
#1279   Just saw Gov. Sununu on fox biz talking djmurdock 05/16/17 02:59:10 PM
#1278   Cara Therapeutics: A Tool To Fight The Opioid Epidemic? king oil 05/16/17 09:27:15 AM
#1277   Waiting... name of the game, tomorrow's event should snickerPP 05/15/17 04:54:37 PM
#1276   Can't wait for the good news. pennystockaholic 05/15/17 04:52:04 PM
#1275   Whose ready for some more gains this week snickerPP 05/15/17 04:51:34 AM
#1274   I'm glad to see you here again. This pennystockaholic 05/12/17 10:19:44 PM
#1273   The real action is holding long. I could djmurdock 05/12/17 09:25:40 PM
#1272   Yep, 4th time I bought low sold high. acrazjo 05/12/17 08:41:31 PM
#1271   Yup buy on lows and sell at highs. pennystockaholic 05/12/17 04:31:53 PM
#1270   Like we said, CARA doesn't stay down for CoachMarc 05/12/17 12:44:49 PM
#1269   It's nice to see this back on the king oil 05/12/17 12:20:03 PM
#1268   Great opportunity for those who picked up the Loosingstocks 05/12/17 12:07:20 PM
#1267   Back over 17! Great action! a surfer 05/12/17 12:00:09 PM
#1266   I like waves. :) a surfer 05/11/17 10:27:36 PM
#1265   7's in waves here 21-14-21-28 on a 1 edge 05/11/17 09:37:35 PM
#1264   They are going to learn a hard lesson CoachMarc 05/11/17 03:18:36 PM
PostSubject