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MarketScreener Homepage  >  Equities  >  Nasdaq  >  Cara Therapeutics, Inc.    CARA

CARA THERAPEUTICS, INC.

(CARA)
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CARA THERAPEUTICS : Management's Discussion and Analysis of Financial Condition and Results of Operations. (form 10-Q)

11/09/2020 | 04:28pm EST

Cautionary Note Regarding Forward-Looking Statements


This Quarterly Report on Form 10-Q contains forward-looking statements, within
the meaning of the Private Securities Litigation Reform Act of 1995, that
involve substantial risks and uncertainties. In some cases, you can identify
forward-looking statements by the words "anticipate," "believe," "continue,"
"could," "estimate," "expect," "intend," "may," "might," "objective," "ongoing,"
"plan," "predict," "project," "potential," "should," "will," or "would," and or
the negative of these terms, or other comparable terminology intended to
identify statements about the future. These statements involve known and unknown
risks, uncertainties and other factors that may cause our actual results, levels
of activity, performance or achievements to be materially different from the
information expressed or implied by these forward-looking statements. Although
we believe that we have a reasonable basis for each forward-looking statement
contained in this Quarterly Report on Form 10-Q, we caution you that these
statements are based on a combination of facts and factors currently known by us
and our expectations of the future, about which we cannot be certain.

The forward-looking statements in this Quarterly Report on Form 10-Q include, among other things, statements about:

? the timing of our regulatory submissions for KORSUVATM (CR845/difelikefalin)

injection in chronic kidney disease associated pruritus, or CKD-aP;

the success and timing of our clinical trials and reporting of our results from

these trials, including our clinical trial programs for KORSUVA

? (CR845/difelikefalin) injection in CKD-aP, and for Oral KORSUVA

(CR845/difelikefalin) in CKD-aP, chronic liver disease associated pruritus, or

CLD-aP, and pruritus associated with atopic dermatitis, or AD;

? our plans to develop and commercialize KORSUVA (CR845/difelikefalin) injection,

Oral KORSUVA (CR845/difelikefalin) and any future product candidates;

the potential results of ongoing and planned preclinical studies and clinical

? trials and future regulatory and development milestones for our product

candidates;

the size and growth of the potential markets for pruritus management, including

? CKD-aP in hemodialysis and non-dialysis markets, CLD-aP and AD markets as well

as post-operative care markets;

the potential regulatory development pathway for KORSUVA (CR845/difelikefalin)

? injection in CKD-aP and CR845/difelikefalin injection in acute post-operative

setting;

? the rate and degree of market acceptance of any approved products;

? our ability to obtain and maintain regulatory approval of our product

candidates, and the labeling under any approval we may obtain;

? the anticipated commercial launch of our lead product candidate, KORSUVA

(CR845/difelikefalin) injection;

? the anticipated use of Enteris's Peptelligence® technology to develop,

manufacture and commercialize Oral KORSUVA (CR845/difelikefalin);

the potential of future scheduling of KORSUVA (CR845/difelikefalin) injection

 ? by the United States Drug Enforcement Administration, or DEA, if regulatory
   approval is received;


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   the performance of our current and future collaborators and licensees,

including Vifor Fresenius Medical Care Renal Pharma Ltd., or VFMCRP, Vifor

? (International) Ltd., or Vifor, Maruishi Pharmaceuticals Co. Ltd., or Maruishi,

and Chong Kun Dang Pharmaceutical Corp., or CKDP, as well as sub-licensees,

including Kissei Pharmaceutical Co. Ltd., or Kissei, and our ability to

maintain such collaborations;

? our ability to establish additional collaborations for our product candidates;

? the continued service of our key scientific or management personnel;

? our ability to establish commercialization and marketing capabilities;

? regulatory developments in the United States and foreign countries;

? our ability to obtain and maintain coverage and adequate reimbursement from

third-party payers for any approved products;

? our planned use of our cash and cash equivalents and marketable securities and

the clinical milestones we expect to fund with such proceeds;

? the accuracy of our estimates regarding expenses, future revenues and capital

requirements;

? our ability to obtain funding for our operations;

our ability to obtain and maintain intellectual property protection for our

? product candidates and our ability to operate our business without infringing

on the intellectual property rights of others;

? the success of competing drugs that are or may become available;

? the performance of third-party manufacturers and clinical research

organizations, or CROs; and

? the potential effects of the ongoing COVID-19 pandemic on our business,

operations and clinical development and regulatory timelines and plans.



You should refer to Part II Item 1A. "Risk Factors" of this Quarterly Report on
Form 10-Q for a discussion of important factors that may cause our actual
results to differ materially from those expressed or implied by our
forward-looking statements. As a result of these factors, we cannot assure you
that the forward-looking statements in this Quarterly Report on Form 10-Q will
prove to be accurate. Furthermore, if our forward-looking statements prove to be
inaccurate, the inaccuracy may be material. In light of the significant
uncertainties in these forward-looking statements, you should not regard these
statements as a representation or warranty by us or any other person that we
will achieve our objectives and plans in any specified time frame or at all. We
undertake no obligation to publicly update any forward-looking statements,
whether as a result of new information, future events or otherwise, except as
required by law.

You should read this Quarterly Report on Form 10-Q and the documents that we
reference in this Quarterly Report on Form 10-Q and have filed as exhibits to
this Quarterly Report on Form 10-Q completely and with the understanding that
our actual future results may be materially different from what we expect. We
qualify all of our forward-looking statements by these cautionary statements.

The following Management's Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with: (i) the Condensed Financial Statements and related notes thereto which are included in this Quarterly Report on Form 10-Q; and (ii) our Annual Report on Form 10-K for the year ended December 31, 2019.

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Introduction
We are a clinical-stage biopharmaceutical company focused on developing and
commercializing new chemical entities designed to alleviate pruritus by
selectively targeting peripheral kappa opioid receptors, or KORs. We are
developing a novel and proprietary class of product candidates, led by KORSUVA
(CR845/difelikefalin), a first-in-class KOR agonist that targets KORs located in
the peripheral nervous system and on immune cells.

In our KALMTM-1 and KALM-2 Phase 3 trials and two Phase 2 trials, KORSUVA
(CR845/difelikefalin) injection (intravenous formulation) has demonstrated
statistically significant reductions in itch intensity and concomitant
improvement in pruritus-related quality of life measures in hemodialysis
patients with moderate-to-severe CKD-aP. We have partnered with VFMCRP, a joint
venture between Vifor Pharma Group and Fresenius Medical Care, to commercialize
KORSUVA (CR845/difelikefalin) injection in dialysis patients
with CKD-aP worldwide, excluding the United States, Japan (Maruishi/sub-licensee
Kissei), and South Korea (CKDP). In the United States, we have partnered with
VFMCRP and Vifor to promote KORSUVA (CR845/difelikefalin) injection, if
approved, in U.S. Fresenius Medical Care North America, or FMCNA, dialysis
clinics and outside of FMCNA clinics, both under profit share agreements.

CR845/difelikefalin has also demonstrated statistically significant pain
reduction in clinical trials in patients with moderate-to-severe acute pain in
the post-operative setting, without inducing many of the undesirable side
effects typically associated with currently available opioid pain therapeutics.
We retain rights to all KORSUVA/CR845 formulations and indications worldwide,
excluding KORSUVA (CR845/difelikefalin) injection in dialysis patients with
CKD-aP under our agreements with VFMCRP and Vifor for certain U.S. and certain
ex-U.S. territories and our other license agreements for CR845/difelikefalin in
Japan (Maruishi/sub-licensee Kissei) and South Korea (CKDP).

The U.S. Food and Drug Administration, or FDA, has conditionally accepted KORSUVA as the trade name for CR845/difelikefalin injection and its safety and efficacy have not been fully evaluated by any regulatory authority.


We were incorporated and commenced operations in 2004, and our primary
activities to date have been organizing and staffing our company, developing our
product candidates, including conducting preclinical studies and clinical trials
of CR845/difelikefalin-based product candidates and raising capital. To date, we
have financed our operations primarily through sales of our equity and debt
securities and payments from license agreements. We have no products currently
available for sale, and substantially all of our revenue to date has been
revenue from license agreements, although we have received nominal amounts of
revenue under research grants and the sale of clinical compound.

Recent Developments

COVID-19 Update

The extent of the impact of the ongoing COVID-19 pandemic on our business,
operations and clinical development and regulatory timelines and plans remains
uncertain, and will depend on certain developments, including the duration and
spread of the outbreak and its impact on our clinical trial enrollment, trial
sites, partners, CROs, third-party manufacturers, and other third parties with
whom we do business, as well as its impact on regulatory authorities and our key
scientific and management personnel. The timing of our anticipated submission of
our New Drug Application, or NDA, to the FDA for KORSUVA (CR845/difelikefalin)
injection has not been affected, and we are still on track to submit our NDA in
the fourth quarter of 2020. The COVID-19 pandemic, however, has affected, and
may in the future affect, the initiation of certain trial sites and patient
enrollment for our ongoing Phase 2 clinical trials of Oral KORSUVA
(CR845/difelikefalin) for moderate-to-severe pruritus in patients with AD and
for the treatment of pruritus in patients with hepatic impairment due to primary
biliary cholangitis, or PBC. While we currently do not expect any significant
delays in our clinical development or commercial timelines, the ultimate impact
of the evolving COVID-19 pandemic remains difficult to predict.

To the extent possible, we are conducting business as usual, with necessary or
advisable modifications to employee travel and employee work locations. We are
continuing to actively monitor the rapidly evolving situation related to
COVID-19 and may take further actions that alter our operations, including those
that may be required by federal, state

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or local authorities, or that we determine are in the best interests of our
employees, partners and other third-parties with whom we do business. The extent
to which the ongoing and evolving COVID-19 pandemic may affect our business,
operations and clinical development and regulatory timelines and plans,
including the resulting impact on our expenditures and capital needs, remains
uncertain.

Vifor License and Stock Purchase Agreements

In October 2020, we entered into a license agreement with Vifor pursuant to
which we granted Vifor an exclusive license solely in the United States to use,
distribute, offer for sale, promote, sell and otherwise commercialize KORSUVA
(CR845/difelikefalin) injection for all therapeutic uses relating to the
inhibition, prevention or treatment of itch associated with pruritus in
hemodialysis and peritoneal dialysis patients in the United States. We retain
all rights with respect to the clinical development of, and activities to gain
regulatory approvals of, KORSUVA (CR845/difelikefalin) injection in the United
States. As consideration, we received an upfront payment of $100.0 million and
an additional payment of $50.0 million for the purchase of an aggregate of
2,939,552 shares of our common stock (see Item 2. Management's Discussion and
Analysis of Financial Condition and Results of Operations - Collaboration and
License Agreements - Vifor (International) Ltd.).

Thomas Reilly Appointed as Chief Financial Officer

Effective October 1, 2020, we appointed Thomas Reilly to serve as our Chief
Financial Officer. In this capacity, Mr. Reilly will serve as our principal
financial and accounting officer. There are no arrangements or understandings
between Mr. Reilly and any other persons pursuant to which he was elected as an
officer, and there is no family relationship between Mr. Reilly and any of our
directors or other executive officers.

Our Product Candidate

Our product candidate, CR845/difelikefalin, is a new chemical entity, which is
designed to selectively stimulate kappa, rather than mu, and delta opioid
receptors. CR845/difelikefalin has been designed with specific chemical
characteristics to restrict its entry into the CNS and further limit its
mechanism of action to KORs in the peripheral nervous system and on immune
cells. Activation of kappa receptors in the CNS is known to result in some
undesirable effects, including dysphoria. Since CR845/difelikefalin modulates
kappa receptor signals peripherally without any significant activation of opioid
receptors in the CNS, it is generally not expected to produce the CNS-related
side effects of mu opioid agonists (such as addiction and respiratory
depression) or centrally-active kappa opioid agonists (such as dysphoria and
hallucinations). CR845/difelikefalin has been administered to more than 3,000
human subjects in Phase 1, Phase 2 and Phase 3 clinical trials as an I.V.
infusion, bolus intravenous injection or oral capsule or tablet, and thus far
has been observed to be generally well tolerated in multiple clinical trials.

Based on the non-clinical and clinical studies we have completed to date, we
believe that CR845/difelikefalin, if approved, would be attractive to both
patients and physicians as a treatment for moderate-to-severe pruritus
associated with certain diseases such as CKD, CLD and dermatological conditions
such as AD as well as moderate-to-severe pain due to the following attributes:

? novel, peripherally-acting, KOR agonist mechanism of action;

? evidence of efficacy in completed clinical trials of pruritus and pain;

? potential for reducing mu opioid use and opioid-related adverse events, or AEs,

such as nausea and vomiting;

? potential for reduction of post-operative nausea and vomiting, or PONV;

? avoidance of mu opioid-related CNS side effects, such as respiratory depression

and euphoria;

? lower potential for addiction or abuse liability;


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avoidance of interactions with other drugs because CR845/difelikefalin is not

? metabolized in the liver and does not interact with liver enzymes responsible

for the metabolism of most commonly used classes of drugs; and

availability in injectable form for the treatment of pruritus in CKD patients

? undergoing hemodialysis in the hospital and dialysis center settings as well as

for pain and/or PONV treatment in the acute care setting and oral form for

treatment of pruritus or chronic pain conditions in the outpatient setting.

Our current product candidate pipeline is summarized in the table below:

Program       Product Candidate      Primary Indication             Status              Commercialization Rights
Pruritus    KORSUVA                  Pruritus CKD -        • KALM-2 

(Global) Phase 3 VFMCRP/Vifor (United

            (CR845/difelikefalin)    Hemodialysis          pivotal trial completed;     States); Maruishi
            Injection                                      top-line data reported       (Japan); CKDP (South
                                                           • KALM-1 pivotal trial       Korea); VFMCRP
                                                           completed; top-line data     (Worldwide, other than
                                                           reported                     United States, Japan and
                                                                                        South Korea)
                                                           • Phase 3 safety trials
                                                           complete
                                                           • Breakthrough Therapy
                                                           Designation granted by
                                                           FDA in June 2017
            Oral KORSUVA             Pruritus CKD          • Phase 2 trial              Cara (Worldwide, other
            (CR845/difelikefalin)    (Stage III - V)       completed; 

top-line data than Japan and South

                                                           reported                     Korea); Maruishi
                                                                                        (Japan); CKDP (South
                                                                                        Korea)
            Oral KORSUVA             Pruritus CLD -        • Phase 2

efficacy trial Cara (Worldwide, other

            (CR845/difelikefalin)    Primary Biliary       ongoing                      than South Korea); CKDP
                                     Cholangitis (PBC)                                  (South Korea)
            Oral KORSUVA             Pruritus Atopic       • KARE Phase 2 efficacy      Cara (Worldwide, other
            (CR845/difelikefalin)    Dermatitis            trial ongoing; interim       than South Korea); CKDP
                                                           assessment complete -        (South Korea)
                                                           target enrollment
                                                           increased to 410 patients
Post-Op     CR845/difelikefalin      Acute                 • Adaptive Phase 2/3         Cara (Worldwide, other
Setting     Injection                Post-Operative        trial completed; top-line    than Japan and South
                                     Pain/PONV             data reported                Korea); Maruishi
                                                                                        (Japan); CKDP (South
                                                                                        Korea)



KORSUVA (CR845/Difelikefalin) Injection for Treatment of Chronic Kidney Disease-Associated Pruritus (CKD-aP)


CKD-aP is an intractable systemic itch condition with high prevalence for which
there are no approved therapeutics in the United States or Europe. Based on the
results from our efficacy and safety trials highlighted below, we expect to
submit an NDA to the FDA for KORSUVA (CR845/difelikefalin) injection in the
fourth quarter of 2020, and expect our partner, VFMCRP, to submit a Marketing
Authorisation Application, or MAA, to the European Medicines Agency, or EMA,
shortly thereafter.

In April 2020, we announced positive top-line results from our KALM-2 pivotal
Phase 3 trial of KORSUVA (CR845/difelikefalin) injection in hemodialysis
patients with moderate-to-severe CKD-aP. The trial met the primary and key
secondary endpoints after 12 weeks of treatment. The open label extension phase
of this trial is also complete.

The study met the primary efficacy endpoint with 54% of the patients receiving
0.5 mcg/ kg of KORSUVA (CR845/difelikefalin) injection versus 42% of patients
receiving placebo achieving at least a three-point improvement from baseline
with respect to the weekly mean of the daily 24-hour worst itching intensity
numeric rating scale, or NRS, score at week 12 (p= 0.02). The study also met the
key secondary endpoint with 41% of patients receiving KORSUVA
(CR845/difelikefalin) injection achieving a four-point or greater improvement
from baseline in the weekly mean of the

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daily 24-hour worst itching NRS score at week 12 versus 28% for patients
receiving placebo (p= 0.01). In this trial, KORSUVA (CR845/difelikefalin)
injection was generally well-tolerated with a safety profile consistent with
that seen in KALM-1 and the KORSUVA clinical program in patients with CKD-aP.
Overall, the incidence of adverse effects, or AEs, and serious AEs were similar
across both KORSUVA (CR845/difelikefalin) injection and placebo groups. The most
common treatment emergent AEs reported in greater than 5% of patients were
diarrhea (8.1% KORSUVA vs 5.5% placebo), falling (6.8% KORSUVA vs 5.1% placebo),
vomiting (6.4% KORSUVA vs 5.9% placebo), nausea (6.4% KORSUVA vs 4.2% placebo)
and dizziness (5.5% KORSUVA vs 5.1% placebo).

In May 2019, we announced positive results from the double blinded phase of our
KALM-1 pivotal Phase 3 efficacy trial (KALM-1) of KORSUVA (CR845/difelikefalin)
injection for the treatment of CKD-aP in patients undergoing hemodialysis. The
trial met the primary and all secondary endpoints after 12 weeks of treatment.
The open label extension phase of this trial is also complete.

The study met the primary efficacy endpoint with 51% of the patients receiving
0.5 mcg/ kg of KORSUVA (CR845/difelikefalin) injection versus 28% of patients
receiving placebo achieving at least a three-point improvement from baseline
with respect to the weekly mean of the daily 24-hour worst itching intensity NRS
score at week 12 (p= 0.000019). The study also met all secondary endpoints,
including assessment of itch-related quality of life changes measured using
self-assessment Skindex-10 (patients receiving KORSUVA experienced 43%
improvement versus patients receiving placebo, p= 0.0004) and 5-D Itch scales
(patients receiving KORSUVA experienced 35% improvement versus patients
receiving placebo, p= 0.0009). In addition, 39% of patients receiving KORSUVA
(CR845/difelikefalin) injection achieved a four-point or greater improvement
from baseline in the weekly mean of the daily 24-hour worst itching NRS score at
week 12 versus 18% for patients receiving placebo (p= 0.000032), another key
secondary endpoint. In this trial, KORSUVA (CR845/difelikefalin) injection was
generally well-tolerated with a safety profile consistent with that seen in
earlier trials. Overall, the incidence of AEs and serious AEs were similar
across both KORSUVA (CR845/difelikefalin) injection and placebo groups. The most
common treatment emergent AEs reported in greater than 5% of patients were
diarrhea (9.5% KORSUVA vs 3.7% placebo), dizziness (6.9% KORSUVA vs 1.1%
placebo), vomiting (5.3% KORSUVA vs 3.2% placebo) and nasopharyngitis (3.2%
KORSUVA vs 5.3% placebo).

Currently, more than 1,500 total patient exposures have been achieved across our
clinical trials in hemodialysis patients, with more than 700 patients completing
at least six months of treatment and more than 400 patients completing one year
of treatment.

Oral KORSUVA (CR845/Difelikefalin) for Treatment of Chronic Kidney Disease-Associated Pruritus (CKD-aP)

In December 2019, we announced top-line data from our Phase 2 trial of Oral
KORSUVA (CR845/difelikefalin) for the treatment of pruritus in stage III - V
(moderate-to-severe) CKD patients. The Phase 2, multicenter, randomized,
double-blind, placebo-controlled 12-week trial is designed to evaluate the
safety and efficacy of three tablet strengths (0.25 mg, 0.5 mg and 1 mg, once
daily administration) of Oral KORSUVA (CR845/difelikefalin) versus placebo in
approximately 240 stage III - V (moderate to severe) CKD patients with
moderate-to-severe pruritus. The primary efficacy endpoint was the change from
baseline in the weekly mean of the daily 24-hour worst itching NRS score at week
12 of the treatment period. Secondary endpoints include change from baseline in
itch-related quality of life scores at the end of week 12, as assessed by the
total Skindex-10 and 5-D itch scores, as well as the proportion of patients
achieving an improvement from baseline ?3 points with respect to the weekly mean
of the daily 24-hour worst itching NRS score at week 12.

Patients treated with the 1.0 mg tablet strength of Oral KORSUVA
(CR845/difelikefalin) achieved the primary endpoint of statistically significant
reduction in weekly mean of the daily worst itching NRS scores vs. placebo after
the 12-week treatment period (-4.4 KORSUVA vs. -3.3 placebo, p=0.018). The
treatment was statistically significant after two weeks of treatment and
sustained through the 12-week treatment period. Regarding secondary endpoints,
the proportion of patients on 1.0 mg tablet strength achieving a 3 point or
greater improvement from baseline in the weekly mean of the daily worst itching
NRS score at week 12 was 72% vs. 58% for placebo but did not achieve statistical
significance. Furthermore, patients on 1.0 mg tablet strength showed positive
improvements vs. placebo in itch quality of life endpoints as measured using
self-assessment Skindex-10 and 5-D Itch scales but did not achieve statistical
significance. Oral KORSUVA (CR845/difelikefalin) was generally well-tolerated
with a safety profile consistent with

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that seen in earlier KORSUVA clinical trials. Overall, the incidence of
treatment AEs were similar across KORSUVA and placebo groups. The most common
AEs reported in >5% of patients in the 1.0 mg KORSUVA group vs. placebo were
dizziness (7.5% KORSUVA vs. 0% placebo), fall (6% KORSUVA vs. 0% placebo),
diarrhea (6% KORSUVA vs. 1.5% placebo) and constipation (6% KORSUVA vs. 3%
placebo).

We intend to initiate the safety portion of a Phase 3 program for Oral KORSUVA
(CR845/difelikefalin) for the treatment of pruritus in stage III - V
(moderate-to-severe) CKD in the fourth quarter of 2020, and expect to conduct an
End of Phase 2 Meeting with the FDA in the first quarter of 2021.

Oral KORSUVA (CR845/Difelikefalin) for Treatment of Chronic Liver Disease-Associated Pruritus


Pruritus is a common and serious symptom in patients with CLD, especially those
with chronic cholestatic disease. Pruritus has a prevalence of up to 70% in
patients with PBC. Severe pruritus can have debilitating effects and can lead to
a significant reduction in a patient's quality of life. Although the
pathogenesis of CLD-aP remains poorly understood, it is likely multifactorial
including evidence for an imbalance in the endogenous opioid system driven by
higher mu receptor activation (pruritic) versus kappa receptor activation
(antipruritic). Consequently, the use of selective kappa-opioid receptor
agonists has been suggested for the treatment of pruritus in patients with CLD.

In June 2019, we announced the initiation of a Phase 2 trial of Oral KORSUVA
(CR845/difelikefalin) for the treatment of pruritus in patients with hepatic
impairment due to PBC. The Phase 2 multicenter, randomized, double-blind,
placebo-controlled 16-week trial is designed to evaluate the safety and efficacy
of 1 mg tablet of Oral KORSUVA (CR845/difelikefalin) taken twice daily or BID
versus placebo in approximately 60 patients with PBC and moderate-to-severe
pruritus. The primary efficacy endpoint is the change from baseline in the
weekly mean of the daily 24-hour worst itching NRS score at week 16 of the
treatment period. Secondary endpoints include change from baseline in
itch-related quality of life scores at the end of week 16 as assessed by the
Skindex-10 and 5-D itch scales, as well as the assessment of proportion of
patients achieving an improvement from baseline of ?3 points with respect to the
weekly mean of the daily 24-hour worst itching NRS score at week 16. We continue
to screen patients in this ongoing Phase 2 trial of Oral KORSUVA
(CR845/difelikefalin) and aim to have top-line data in the first half of 2021,
due in part to delays related to the ongoing COVID-19 pandemic.

In the fourth quarter of 2017, we submitted an investigational new drug
application, or IND, to the FDA for Oral KORSUVA (CR845/difelikefalin) for the
symptomatic relief of CLD-aP and initiated a Phase 1 safety and PK clinical
trial of Oral KORSUVA (CR845/difelikefalin) in patients with CLD in the first
quarter of 2018. The open-label study was designed to evaluate the safety and PK
profile of repeated doses of Oral KORSUVA (CR845/difelikefalin) taken twice
daily in up to 60 patients with CLD and up to 12 matched healthy control
subjects. Oral KORSUVA (CR845/difelikefalin) was evaluated over an eight-day
treatment period in patients with CLD based on their Child-Pugh classification
(i.e., Class A, B and C). The study is now complete. The PK parameters were
dose-proportional in patients with mild-to-moderate CLD and Oral KORSUVA
(CR845/difelikefalin) was generally well tolerated with no unexpected safety
signals reported.

Oral KORSUVA (CR845/difelikefalin) for Treatment of Moderate-to-Severe Pruritus Associated with Atopic Dermatitis (AD)


In July 2019, we initiated a Phase 2 randomized, double-blind,
placebo-controlled trial that is designed to evaluate the efficacy and safety of
Oral KORSUVA (CR845/difelikefalin) for moderate-to-severe pruritus in
approximately 240 adult subjects with AD. Subjects will be randomized to three
tablet strengths of Oral KORSUVA (CR845/difelikefalin): 0.25 mg, 0.5 mg and 1 mg
twice daily versus placebo for 12 weeks followed by a 4-week active extension
phase. The primary efficacy endpoint is the change from baseline in the weekly
mean of the daily 24-hour worst itching NRS score at week 12 of the treatment
period. Secondary endpoints include proportion of patients achieving > 4 point
improvement in itch NRS score at week 12, as well as change from baseline in
itch-related quality of life scores at the end of week 12 as assessed by the
total Skindex-10 and 5-D itch scales, and itch related Sleep Quality Assessment.
Safety endpoints used to evaluate the overall safety and tolerability of Oral
KORSUVA (CR845/difelikefalin) will also be included.

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In January 2020, we expanded this Phase 2 trial to include approximately 320
adult AD patients with moderate-to-severe pruritus and incorporated an interim
conditional power assessment into the design, to be conducted after
approximately 50% of the targeted patient number complete the designated 12-week
treatment period. In June 2020, we announced that based on the Independent Data
Monitoring Committee's, or IDMC's, recommendation, the trial will be increased
by approximately 28%, from the previous enrollment target of 320 patients to 410
patients, to maintain the prespecified statistical power of 80% or greater on
the trial's primary endpoint of change from baseline in the weekly mean of the
daily 24-hour worst itching NRS score and key secondary endpoint of proportion
of patients achieving a > 4 point improvement in itch NRS score at week 12. The
IDMC's recommendation was based on the results of the prespecified interim
conditional power assessment conducted after approximately 50% of the originally
targeted patient number completed the designated 12-week treatment period.

Based on current sample size and ongoing enrollment rates, we expect to complete
full trial enrollment in the fourth quarter of 2020 and we aim to report the
top-line results from this trial in the first half of 2021, subject to any
delays related to the ongoing COVID-19 pandemic.

Intravenous CR845/Difelikefalin for Treatment of Acute Postoperative Pain

We have also investigated CR845/difelikefalin for the treatment of pain in an
acute care setting. CR845/difelikefalin is designed to provide pain relief
without stimulating mu opioid receptors and therefore potentially without mu
opioid-related side effects, such as nausea, vomiting, respiratory depression
and euphoria.

In June 2018, we reported positive top-line date from the adaptive Phase 2/3
study of CR845/difelikefalin in patients undergoing abdominal surgery. CR845
injection achieved statistical significance for the primary endpoint of pain
relief as measured by Area Under the Curve, or AUC, over 24 hours (AUC 0-24)
post-surgery with the 1.0 mcg/kg dose versus placebo (p=0.032). The 0.5 mcg/kg
dose did not achieve statistical significance over the 0-24 hour period
(p=0.076). In addition, improvement in pain AUC was statistically significant
for both the 0.5 and 1.0 mcg/kg doses over 0 to 6 hours (p=0.041, p=0.001) and 0
to 12 hours (p=0.035, p=0.004) periods and also statistically significant for
the 1.0 mcg/kg dose over the 0 to 18-hour period (p=0.013) post-surgery. At 6
and 24 hours after baseline dose post-surgery, there were statistically
significant improvements in PONV impact scores with both doses of CR845
injection compared to placebo: 0.5 mcg/kg (6 hrs.: p=0.0072, 24 hrs.: p<0.006)
and 1.0 mcg/kg (6 hrs.: p<0.0001, 24 hrs.: p<0.0001). There were statistically
significant differences between placebo and both doses of CR845 with respect to
the total use of anti-emetic medication over the first 24 hours post-surgery
(0.5 mcg/kg: p=0.0003; 1.0 mcg/kg: p< 0.0001). There was a 73% reduction in the
incidence of patient-reported vomiting in the group receiving the 1.0 mcg/kg
dose versus placebo (p=0.029). Although the 0.5 mcg/kg also showed reduction in
vomiting, it did not reach statistical significance. Both doses of CR845
exhibited numerical trends toward reduced use of rescue analgesic medication
compared to placebo, but did not achieve statistical significance. There was no
significant effect, compared to placebo, on patient's global assessment of
medication for either dose of CR845 over the 24-hour period. Common adverse
effects reported in the placebo and both CR845 groups were generally low and
similar in incidence, and included nausea, constipation, vomiting, flatulence,
headache and dyspepsia.

We have completed an advisory meeting with the FDA regarding the potential regulatory path forward for PONV and we are currently evaluating potential next steps.

Human Abuse Liability Trial of CR845/Difelikefalin Injection


In the fourth quarter of 2014, we successfully completed a Human Abuse
Liability, or HAL, trial of CR845/difelikefalin injection. The results from this
HAL trial indicate that I.V. CR845/difelikefalin (5 mcg/kg or 15 mcg/kg)
demonstrates statistically significant lower "drug liking" scores as measured by
VAS Emax (p <0.0001) when compared to I.V. pentazocine (0.5 mg/kg), an approved
Schedule I.V. opioid receptor agonist. I.V. CR845 also demonstrated highly
statistically significant lower "feeling high," "overall liking," and "take drug
again" scores (p <0.0001) as compared to pentazocine. Additionally,
CR845/difelikefalin injection showed no "drug liking" dose response as both
doses of CR845/difelikefalin injection exhibited similar responses and were not
different from placebo injection. Those scores represent standard subjective
measures recommended by the FDA to assess a drug's abuse liability. We believe
that the totality of the results from the HAL trial are supportive of the
potential for

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CR845/difelikefalin to be the first non-scheduled or low (Schedule V) scheduled peripheral kappa opioid for pruritus or additional indications.

Respiratory Safety Phase 1 Trial of CR845/Difelikefalin Injection


In April 2017, we announced summary results from our quantitative Phase 1 trial
evaluating respiratory safety of CR845/difelikefalin injection. Respiratory
depression remains the most life-threatening side effect of traditional,
centrally acting, opioid analgesics, the most commonly used drug class for
current treatment of postoperative pain in the United States. The Phase 1 trial
was a randomized, double-blind, placebo-controlled, three-way crossover trial of
two doses of CR845/difelikefalin injection (1.0 mcg/kg and 5.0 mcg/kg) versus
placebo on three measures of respiratory drive in 15 healthy volunteers. The
primary safety endpoints were: a >10 mmHg sustained (>30 seconds duration)
increase in end-tidal CO2, or ETCO2, above baseline or to >50 mmHg, and a
sustained reduction in oxygen saturation, or SpO2, to <92%.

There were no statistically significant differences in any respiratory measures
observed between groups throughout the four-hour observation period post-dosing
and no individual subject met the threshold for a respiratory safety event.
Additionally, all treatment-emergent adverse events were previously reported
with CR845/difelikefalin administration and were mild, resolving without
intervention.

Collaboration and License Agreements

Vifor (International) Ltd.




On October 15, 2020, we entered into a license agreement, or the Vifor
Agreement, with Vifor under which we granted Vifor an exclusive license solely
in the United States to use, distribute, offer for sale, promote, sell and
otherwise commercialize KORSUVA (CR845/difelikefalin) injection for all
therapeutic uses relating to the inhibition, prevention or treatment of itch
associated with pruritus in hemodialysis and peritoneal dialysis patients in the
United States. Under the Vifor Agreement, we retain all rights with respect to
the clinical development of, and activities to gain regulatory approvals of,
KORSUVA (CR845/difelikefalin) injection in the United States.



Under the terms of the Vifor Agreement, we received from Vifor an upfront
payment of $100.0 million and an additional payment of $50 million for the
purchase of an aggregate of 2,939,552 shares of our common stock at a price of
$17.0094 per share, which represents a premium over a pre-determined average
closing price of our common stock. Upon U.S. regulatory approval of KORSUVA
(CR845/difelikefalin) injection, we will also be eligible to receive an
additional $50.0 million common stock investment at a 20% premium to the 30-day
trailing average price of our common stock as of such date. In addition,
pursuant to the Vifor Agreement, we are eligible to receive payments of up to
$240.0 million upon the achievement of certain sales-based milestones.



The Vifor Agreement provides full commercialization rights in dialysis clinics
to Vifor in the United States under a profit-sharing arrangement. Pursuant to
the profit-sharing arrangement, we will generally be entitled to 60% of the net
profits (as defined in the Vifor Agreement) from sales of KORSUVA
(CR845/difelikefalin) injection in the United States (excluding sales to
Fresenius Medical Center dialysis clinics, compensation for which is governed by
the VFMCRP Agreement) and Vifor is entitled to 40% of such net profits, subject
to potential temporary adjustment in future years based on certain conditions.
Under the Vifor Agreement, in consideration of Vifor's conduct of the marketing,
promotion, selling and distribution of KORSUVA (CR845/difelikefalin) injection
in the United States, we will pay a marketing and distribution fee to Vifor
based on the level of annual net sales. This fee will be deducted from product
sales in calculating the net profits that are subject to the profit-sharing
arrangement under the Vifor Agreement.



The Vifor Agreement will continue in effect until its expiration upon the
cessation of commercial sale of KORSUVA (CR845/difelikefalin) injection in the
United States by Vifor and its affiliates and sublicensees, or until the earlier
termination of the Vifor Agreement.



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In addition, upon the earlier of: (1) the acceptance for filing of an NDA covering KORSUVA (CR845/difelikefalin) injection submitted to the FDA; or (2) October 15, 2023, the Vifor Agreement may be terminated by Vifor in its entirety, with such termination effective upon 12 months' notice.

In connection with the Vifor Agreement, the parties entered into a separate
stock purchase agreement, or the Vifor Purchase Agreement, governing the
issuance of our common stock to Vifor. Pursuant to the Vifor Purchase Agreement,
Vifor will not, and will not cause any direct or indirect affiliate to, during
the period beginning on October 15, 2020 and ending at the close of business on
the earlier of (a) October 15, 2022 and (b) the date that we publicly disclose
the receipt of a complete response letter from the FDA with respect to our NDA
for KORSUVA (CR845/difelikefalin) injection, or the Restricted Period,
(i) offer, pledge, sell, contract to sell, sell any option or contract to
purchase, purchase any option or contract to sell, grant any option, right or
warrant to purchase, lend, or otherwise transfer or dispose of, directly or
indirectly, any shares of our common stock or any securities convertible into or
exercisable or exchangeable for our common stock (including without limitation,
common stock or such other securities which may be deemed to be beneficially
owned by Vifor in accordance with the rules and regulations of the SEC and
securities which may be issued upon exercise of a stock option or warrant) owned
by Vifor as of the date hereof or acquired prior to the end of the Restricted
Period (collectively with the common stock, referred to as the Lock-Up
Securities, except any such sale, option or contract by and between Vifor and
one of its affiliates (including Vifor Pharma Group Ltd. or VFMCRP), (ii) enter
into any hedging, swap or other agreement or transaction that transfers, in
whole or in part, any of the economic consequences of ownership of the Lock-Up
Securities, whether any such transaction described in clause (i) or (ii) above
is to be settled by delivery of Lock-Up Securities, in cash or otherwise,
(iii) make any demand for or exercise any right with respect to the registration
of any Lock-Up Securities, or (iv) publicly disclose the intention to do any of
the foregoing.



Under the Vifor Purchase Agreement, the parties also agreed that, in certain
circumstances, upon the request of Vifor, the parties will enter into a
registration rights agreement prior to the end of the Restricted Period that
would provide Vifor (or its affiliate transferee) customary registration rights
with respect to the shares of common stock issued pursuant to the stock purchase
agreement following the expiration of the Restricted Period.



Vifor Fresenius Medical Care Renal Pharma Ltd.

In May 2018, we entered into a license agreement, or the VFMCRP Agreement, with
VFMCRP, a joint venture between Vifor Pharma Group and Fresenius Medical Care,
under which we granted VFMCRP a license to seek regulatory approval to
commercialize, import, export, use, distribute, offer for sale, promote, sell
and otherwise commercialize KORSUVA (CR845/difelikefalin) injection for all
therapeutic uses to prevent, inhibit or treat itch associated with pruritus in
hemodialysis and peritoneal-dialysis patients worldwide (excluding the United
States, Japan and South Korea). We retain full development and commercialization
rights for KORSUVA injection for the treatment of CKD-aP in dialysis patients in
the U.S. except in the dialysis clinics of Fresenius Medical Care North America,
or FMCNA, where we and VFMCRP will promote KORSUVA injection under a
profit-sharing arrangement.

We are eligible to receive from VFMCRP regulatory and commercial milestone
payments in the aggregate of up to $470 million, consisting of up to $30 million
in regulatory milestones and up to $440 million in tiered commercial milestones,
all of which are sales-related. We are also eligible to receive tiered
double-digit royalty payments based on annual net sales, as defined, of KORSUVA
(CR845/difelikefalin) injection in the licensed territories. In the United
States, we and VFMCRP will promote KORSUVA (CR845/difelikefalin) injection in
the dialysis clinics of FMCNA under a profit-sharing arrangement (subject to the
terms and conditions of the VFMCRP Agreement) based on net FMCNA clinic sales
recorded by us.

Maruishi Pharmaceutical Co., Ltd.

In April 2013, we entered into a license agreement with Maruishi, or the Maruishi Agreement, under which we granted Maruishi an exclusive license to develop, manufacture and commercialize drug products containing CR845/difelikefalin in Japan in the acute pain and uremic pruritus fields. Maruishi has a right of first negotiation for any other indications for which we develop CR845/difelikefalin and, under certain conditions, Maruishi may substitute another pruritus indication for the uremic pruritus indication originally included in its license from us. If we abandon


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development of CR845/difelikefalin and begin development of another kappa opioid
receptor agonist that is covered by the claims of the patents we licensed to
Maruishi, such other agonist will automatically be included in the license to
Maruishi. Maruishi is required to use commercially reasonable efforts, at its
expense, to develop, obtain regulatory approval for and commercialize
CR845/difelikefalin in Japan. We are required to use commercially reasonable
efforts, at our expense, to develop, obtain regulatory approval for and
commercialize CR845/difelikefalin in the United States.

Under the terms of the Maruishi Agreement, we are eligible to receive up to an
aggregate of $10.5 million in clinical development and regulatory milestones, of
which $2.5 million (before contractual foreign currency exchange adjustments)
has been received as of September 30, 2020. We are also eligible to receive a
one-time sales milestone of one billion Yen when a certain sales level is
attained. We also receive a mid-double-digit percentage of all non-royalty
payments received by Maruishi from its sublicensees, if any. We are also
eligible to receive tiered royalties based on net sales, if any, with minimum
royalty rates in the low double digits and maximum royalty rates in the low
twenties. Maruishi's obligation to pay us royalties continues, on a
product-by-product basis, until the expiration of the last-to-expire licensed
patent covering such product or the later expiration of any market exclusivity
period. The Maruishi Agreement continues until terminated.

Chong Kun Dang Pharmaceutical Corporation


In April 2012, we entered into a license agreement with CKDP, or the CKDP
Agreement, under which we granted CKDP an exclusive license to develop,
manufacture and commercialize drug products containing CR845/difelikefalin in
South Korea. CKDP is required to use commercially reasonable efforts, at its
expense, to develop, obtain regulatory approval for and commercialize
CR845/difelikefalin in South Korea. We are required to use commercially
reasonable efforts, at our expense, to develop, obtain regulatory approval for
and commercialize CR845/difelikefalin in the United States.

Under the terms of the CKDP Agreement, we are eligible to receive up to an
aggregate of $3.8 million in development and regulatory milestones (before South
Korean withholding taxes). In May 2020, we met the milestone criteria, as set
forth in the CKDP Agreement, for completion of a Phase 3 trial for uremic
pruritus in the United States. As a result, in June 2020, we received a
milestone payment of $0.6 million (net of South Korean withholding tax) from
CKDP. As of September 30, 2020, we have received $2.3 million (before South
Korean withholding tax) of development and regulatory milestones. We are also
eligible to receive a mid-double-digit percentage of all non-royalty payments
received by CKDP from its sublicensees, if any, and tiered royalties ranging
from the high single digits to the high teens based on net sales, if any. CKDP's
obligation to pay us royalties continues, on a product-by-product basis, until
the expiration of the last-to-expire licensed patent covering such product or
the later expiration of any market exclusivity period. The CKDP Agreement
continues until CKDP no longer has any obligation to pay us royalties on any
product.

Manufacturing and License Agreements

Enteris Biopharma, Inc.

In August 2019, we entered into the Enteris License Agreement. Pursuant to the
Enteris License Agreement, Enteris granted to us a non-exclusive,
royalty-bearing license, including the right to grant sublicenses, under certain
proprietary technology and patent rights related to or covering formulations for
oral delivery of peptide active pharmaceutical ingredients with functional
excipients to enhance permeability and/or solubility, known as Enteris's
Peptelligence® technology, to develop, manufacture and commercialize products
using such technology worldwide, excluding Japan and South Korea.

As consideration for the licensed rights under the Enteris License Agreement, we
paid an upfront fee equal to $8.0 million, consisting of $4.0 million in cash
and $4.0 million in shares of our common stock.

We are also obligated, pursuant to the Enteris License Agreement, to pay Enteris
(1) milestone payments upon the achievement of certain development, regulatory
and commercial milestones and (2) low-single digit royalty percentages on net
sales of licensed products, subject to reductions in specified circumstances.
Until the second anniversary of the entry into the Enteris License Agreement, we
have the right, but not the obligation, to terminate our obligation to pay

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any royalties under the Enteris License Agreement in exchange for a lump sum
payment in cash, or the Royalty Buyout. Subject to certain conditions, we may
elect to pay 50% of the lump sum due under the Royalty Buyout in shares of our
common stock. In October 2020, we paid $2.5 million to Enteris for a milestone
earned during the three and nine months ended September 30, 2020 in relation to
the Enteris License Agreement.

The Enteris License Agreement will expire on a country-by-country, licensed
product-by-licensed product basis upon the later of (1) the expiration (or
invalidation) of all valid claims in licensed patent rights that cover such
product in such country, (2) the end of the calendar quarter in which generic
competition (as defined in the Enteris License Agreement) occurs for such
product in such country and (3) ten years from the first commercial sale of
such
product.

Patheon UK Limited

In July 2019, we entered into an MSA with Patheon. The MSA governs the general
terms under which Patheon, or one of its affiliates, will
provide non-exclusive manufacturing services to us for the drug products
specified by us from time to time. Pursuant to the MSA, we have agreed to order
from Patheon at least a certain percentage of our commercial requirements for a
product under a related Product Agreement. Each Product Agreement that we may
enter into from time to time will be governed by the terms of the MSA, unless
expressly modified in such Product Agreement.

The MSA has an initial term ending December 31, 2023, and will automatically
renew after the initial term for successive terms of two years each if there is
a Product Agreement in effect, unless either party gives notice of its intention
to terminate the MSA at least 18 months prior to the end of the then current
term.

Also in July 2019, we entered into two related Product Agreements under the MSA,
one with each of Patheon and Patheon Manufacturing Services LLC, or Patheon
Greenville, to govern the terms and conditions of the manufacture of commercial
supplies of CR845/difelikefalin injection, our lead product candidate. Pursuant
to the Product Agreements, Patheon and Patheon Greenville will manufacture
commercial supplies of CR845/difelikefalin injection at the Monza, Italy and
Greenville, North Carolina manufacturing sites, respectively, from active
pharmaceutical ingredient supplied by us. Patheon and Patheon Greenville will be
responsible for supplying the other required raw materials and packaging
components, and will also provide supportive manufacturing services such as
quality control testing for raw materials, packaging components and finished
product.

Components of Operating Results

Revenue


To date, we have not generated any revenue from product sales and do not expect
to generate any revenue from the sale of products in the foreseeable future.
Substantially all of our revenue recognized as of September 30, 2020 has
consisted of upfront payments under license agreements with VFMCRP, Maruishi and
CKDP, and milestone and sub-license payments under license agreements with CKDP
and Maruishi for CR845/difelikefalin, some or all of which was deferred upon
receipt, as well as license agreements for CR665, our first-generation drug
program for which development efforts have ceased and clinical compound sales
from certain license agreements. To date, we have earned a total of $6.6 million
in clinical development or regulatory milestone payments and clinical compound
sales from certain license agreements. We have not yet received any milestone
payments under the VFMCRP Agreement or royalties under any of our
collaborations.

Research and Development (R&D)


Our R&D expenses relate primarily to the development of CR845/difelikefalin. R&D
expenses consist of expenses incurred in performing R&D activities, including
compensation and benefits for full-time R&D employees, clinical trial and
related clinical manufacturing expenses, third-party formulation expenses, fees
paid to CROs and other consultants, stock-based compensation for R&D employees
and consultants and other outside expenses. Our R&D expenses also included
expenses related to preclinical activities for our earlier stage programs in
prior periods and may include such expenses in the future.

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R&D costs are expensed as incurred. Non-refundable advance payments for goods or
services to be received in the future for use in R&D activities are deferred and
capitalized. The capitalized amounts are expensed as the related goods are
delivered or the services are performed. Most of our R&D costs have been
external costs, which we track on a program-by program basis. Our internal R&D
costs are primarily compensation expenses for our full-time R&D employees. We do
not track internal R&D costs on a program-by-program basis.

R&D activities are central to our business model. Product candidates in later
stages of clinical development generally have higher development costs than
those in earlier stages of clinical development, primarily due to the increased
size and duration of later-stage clinical trials. Based on our current
development plans, we presently expect that our R&D expenses for 2020 will
increase over those for 2019. However, it is difficult to determine with
certainty the duration and completion costs of our current or future nonclinical
programs and clinical trials of our product candidates, or if, when or to what
extent we will generate revenues from the commercialization and sale of any of
our product candidates that obtain regulatory approval. We may never succeed in
achieving regulatory approval for any of our product candidates.

The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors including, but not limited to:


 ? per patient trial costs;


? the number of patients that participate in the trials;

? the number of sites included in the trials;

? the countries in which the trial is conducted;

? the length of time required to enroll eligible patients;

? the number of doses that patients receive;

? the drop-out or discontinuation rates of patients;

? potential additional safety monitoring or other studies requested by regulatory

agencies;

? the duration of patient follow-up; and

? the efficacy and safety profile of the product candidate.



In addition, the probability of success for each product candidate will depend
on numerous factors, including competition, manufacturing capability and
commercial viability. We will determine which programs to pursue and how much to
fund each program in response to the scientific and clinical success of each
product candidate, as well as an assessment of each product candidate's
commercial potential.

General and Administrative

General and administrative expenses consist primarily of salaries and other
related costs, including stock-based compensation, for personnel in executive,
finance, accounting, legal, business development, information technology and
human resources functions. Other costs include facility costs not otherwise
included in R&D expenses, legal fees, insurance costs, investor relations costs,
patent costs and fees for accounting and consulting services.

We anticipate that our general and administrative expenses for 2020 will increase as compared to 2019 to support our continued R&D activities and for our product candidates. These expenses will likely include costs related to the hiring of additional personnel, fees to outside consultants, lawyers, accountants and investor relations firms. In addition,


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if Oral CR845/difelikefalin or any future product candidate obtains regulatory
approval for marketing, we expect to incur expenses associated with building a
sales and marketing team.

Other Income, net

Other income, net consists of interest and dividend income earned on our cash,
cash equivalents, marketable securities and restricted cash, realized gains and
losses on the sale of marketable securities and property and equipment as well
as accretion of discounts/amortization of premiums on purchases of marketable
securities. In the event we record a credit loss expense on our
available-for-sale debt securities, those expenses would be offset against
other
income.

Benefit from Income Taxes

The benefit from income taxes relates to state R&D tax credits exchanged for
cash pursuant to the Connecticut R&D Tax Credit Exchange Program, which permits
qualified small businesses engaged in R&D activities within Connecticut to
exchange their unused R&D tax credits for a cash amount equal to 65% of the
value of the exchanged credits.

Results of Operations

Comparison of the Three and Nine Months Ended September 30, 2020 and 2019

Revenue


                                             Three Months Ended                                Nine Months Ended
                                               September 30,                                     September 30,
                                           2020                2019        % change         2020                2019         % change

                                         Dollar amounts in thousands                      Dollar amounts in thousands

License and milestone fees revenue $ 9,257 $ 5,785

 60%       $        22,377$      15,235      47%
Clinical compound revenue                           9                 -      N/A                   616                140      341%
Total revenue                         $         9,266       $     5,785      60%       $        22,993$      15,375      50%



License and milestone fees revenue

License and milestone fees revenue of $9.3 million and $5.8 million for the
three months ended September 30, 2020 and 2019, respectively, were related to
license fees earned by us during the respective periods in connection with the
VFMCRP Agreement (see Note 10 of Notes to Condensed Financial Statements,
Collaboration and Licensing Agreements, in this Quarterly Report on Form 10-Q).

License and milestone fees revenue of $22.4 million and $15.2 million for the
nine months ended September 30, 2020 and 2019, respectively, were related to
license fees of $21.8 million and $15.2 million, respectively, earned by us
during the respective periods in connection with the VFMCRP Agreement, as well
as $0.6 million (net of South Korean withholding taxes) earned by us during the
nine months ended September 30, 2020 for achieving a development milestone under
the CKDP Agreement (see Note 10 of Notes to Condensed Financial Statements,
Collaboration and Licensing Agreements, in this Quarterly Report on Form 10-Q).

Clinical compound revenue

Clinical compound revenue for the three months ended September 30, 2020 was not material. There was no clinical compound revenue for the three months ended September 30, 2019.


Clinical compound revenue of $616 thousand for the nine months ended September
30, 2020 was related to the sales of clinical compound to VFMCRP for $88
thousand and to Maruishi for $528 thousand. Clinical compound revenue of $140
thousand for the nine months ended September 30, 2019 was related to the sale of
clinical compound to Maruishi.



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Research and Development Expense


                                               Three Months Ended                               Nine Months Ended
                                                 September 30,                                    September 30,
                                             2020               2019        % change         2020                2019         % change

                                          Dollar amounts in thousands                      Dollar amounts in thousands
Direct clinical trial costs             $        10,976$     21,884

-50% $ 53,777$ 57,168 -6% Consultant services in support of clinical trials

                                   1,385            1,014      37%                 4,058              3,394      20%
Stock-based compensation                          1,768            1,391      27%                 6,195              4,402      41%
Depreciation and amortization                        27               28      -1%                    82                 83      -1%
Other R&D operating expenses                      6,911           11,675   
  -41%               16,599             18,909      -12%
Total R&D expense                       $        21,067$     35,992      -41%      $        80,711$      83,956      -4%



For the three months ended September 30, 2020 compared to the three months ended
September 30, 2019, the net decrease in direct clinical trial costs and related
consultant costs primarily resulted from decreases totaling $13.4 million,
mainly from activities related to the KALM-1 Phase 3 efficacy trial and the
52-week open-label extension study of KORSUVA (CR845/difelikefalin) injection in
CKD patients undergoing hemodialysis, the Phase 2 efficacy trial of Oral CR845
in CKD-aP patients, and the KALM-2 Phase 3 efficacy trial and up to 12 week
Phase 3 safety trial of KORSUVA (CR845/difelikefalin) injection in CKD patients
undergoing hemodialysis. There was also a decrease of $2.2 million in drug
manufacturing costs. Those costs were partially offset by an increase of $5.1
million, mainly from the Phase 2 efficacy trial for pruritus associated with AD,
costs associated with preparing our NDA submission and other general costs. The
increase in stock-based compensation expense was primarily the result of
additional stock option and restricted stock unit grants to new and existing
employees. The decrease in other R&D operating expenses primarily resulted from
the upfront payment of $8.0 million made to Enteris upon entering into the
Enteris License Agreement during the three months ended September 30, 2019 and a
decrease in travel and related costs between the respective periods, partially
offset by a $2.5 million milestone earned by Enteris during the three months
ended September 30, 2020 and an increase in payroll and related costs between
the respective periods.

For the nine months ended September 30, 2020 compared to the nine months ended
September 30, 2019, the net decrease in direct clinical trial costs and related
consultant costs primarily resulted from decreases totaling $21.2 million,
mainly from activities related to the KALM-1 Phase 3 efficacy trial and the
52-week open-label extension study of KORSUVA (CR845/difelikefalin) injection in
CKD patients undergoing hemodialysis, the Phase 2 efficacy trial of Oral CR845
in CKD-aP patients, the Phase 2 efficacy trial for CLD-aP, costs associated with
a supportive Phase 1 study and other license fees. There was also a decrease of
$1.0 million in drug manufacturing costs. Those costs were partially offset by
an increase of $19.6 million, mainly from the KALM-2 Phase 3 efficacy trial and
up to 12 week Phase 3 safety trial of KORSUVA (CR845/difelikefalin) injection in
CKD patients undergoing hemodialysis, the Phase 2 efficacy trial for pruritus
associated with AD, costs associated with supportive Phase 1 studies, costs
associated with preparing our NDA submission and other general costs. The
increase in stock-based compensation expense was primarily the result of
additional stock option and restricted stock unit grants to new and existing
employees. The decrease in other R&D operating expenses primarily resulted from
the upfront payment of $8.0 million made to Enteris upon entering the Enteris
License Agreement during the three months ended September 30, 2019, partially
offset by a $2.5 million milestone earned by Enteris during the three months
ended September 30, 2020, as well as increases in payroll and related costs and
cost of clinical compound sales for the nine months ended September 30, 2020.

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The following table summarizes our R&D expenses by programs for the three and nine months ended September 30, 2020 and 2019:


                                                Three Months Ended                                  Nine Months Ended
                                                  September 30,                                       September 30,
                                             2020                 2019         % change          2020                 2019         % change

                                            Dollar amounts in thousands                         Dollar amounts in thousands
External research and development
expenses:
I.V. CR845 - Pruritus                  $           5,046      $      15,847      -68%      $         36,197      $       43,035      -16%
I.V. CR845 - Pain                                     22                (1)      N/A                     78                 358      -78%
Oral CR845 - Pruritus                              7,127              7,044       1%                 21,322              17,138      24%
Oral CR845 - Pain                                      1                  8      -87%                    16                  30      -47%
Internal research and development
expenses                                           8,871             13,094      -32%                23,098              23,395      -1%
Total research and development
expenses                               $          21,067      $      35,992      -41%      $         80,711      $       83,956      -4%





General and Administrative Expenses


                                                 Three Months Ended                                Nine Months Ended
                                                   September 30,                                     September 30,
                                               2020                2019        % change         2020                2019         % change

                                            Dollar amounts in thousands                       Dollar amounts in thousands
Professional fees and public/investor
relations                                $            569       $     1,074

-47% $ 3,006 $ 2,906 3% Stock-based compensation

                            1,536             1,543      -1%                 4,575              4,781      -4%
Depreciation and amortization                          24                22       8%                    66                 67      -2%
Other G&A operating expenses                        3,090             1,587
     95%                 7,540              5,374      40%
Total G&A expense                        $          5,219       $     4,226      24%       $        15,187$      13,128      16%



For the three months ended September 30, 2020 compared to the three months ended
September 30, 2019, the decrease in professional fees and public/investor
relations expenses was primarily the result of decreased consultants' costs.
Stock-based compensation expense remained consistent between the respective
periods. The increase in other G&A operating expenses was primarily the result
of increases in insurance costs, franchise taxes, payroll and related costs and
commercial costs.

For the nine months ended September 30, 2020 compared to the nine months ended
September 30, 2019, the increase in professional fees and public/investor
relations expenses was primarily the result of increased accounting and legal
fees, partially offset by a decrease in consultants' costs. The decrease in
stock-based compensation expense was primarily the result of the resignation of
our former Chief Financial Officer in December 2019 and the issuance of common
stock relating to the consulting agreement that ended in 2019, partially offset
by additional stock option grants to employees and members of our Board of
Directors. The increase in other G&A operating expenses was primarily the result
of increases in insurance costs, franchise taxes, payroll and related costs and
commercial costs.

Other Income, Net


                                            Three Months Ended                               Nine Months Ended
                                              September 30,                                    September 30,
                                        2020                2019          % change          2020               2019       % change

                                        Dollar amounts in thousands                     Dollar amounts in thousands
Other income, net                    $       379       $         1,261      -70%      $           1,970      $   3,297      -40%




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During the three months ended September 30, 2020 compared to the three months
ended September 30, 2019, the decrease in other income, net was primarily due to
a decrease in net accretion income and a decrease in interest income resulting
from a lower yield on our lower average balance of our portfolio of investments
in the 2020 period.

During the nine months ended September 30, 2020 compared to the nine months
ended September 30, 2019, the decrease in other income, net was primarily due to
a decrease in net accretion income and a decrease in interest income resulting
from a lower yield on our lower average balance of our portfolio of investments
in the 2020 period.

Benefit from Income Taxes
For the three months ended September 30, 2020 and 2019, pre-tax losses were
$16.6 million and $33.2 million, respectively, and we recognized a benefit from
income taxes of $132 thousand and $330 thousand, respectively. For the nine
months ended September 30, 2020 and 2019, pre-tax losses were $70.9 million and
$78.4 million, respectively, and we recognized a benefit from income taxes of
$436 thousand and $650 thousand, respectively.

The benefit from income taxes relates to state R&D tax credits exchanged for
cash pursuant to the Connecticut R&D Tax Credit Exchange Program, as discussed
above. We recognized a full valuation allowance against deferred tax assets at
September 30, 2020 and December 31, 2019.

Liquidity and Capital Resources

Sources of Liquidity


Since our inception and through September 30, 2020, we have raised an aggregate
of approximately $624.5 million to fund our operations, including (1) net
proceeds of $446.3 million from the sale of shares of our common stock in five
public offerings, including our initial public offering; (2) proceeds of $73.3
million from the sale of shares of our convertible preferred stock and from debt
financings prior to our initial public offering; (3) payments of approximately
$90.3 million under our license agreements, primarily with VFMCRP, Maruishi,
CKDP and an earlier product candidate for which development efforts ceased in
2007; and (4) net proceeds of $14.6 million from the purchase of our common
stock in relation to the license agreement with VFMCRP (see Note 10 of Notes to
Condensed Financial Statements, Collaboration and Licensing Agreements, in this
Quarterly Report on Form 10-Q). In October 2020, we entered into a license
agreement with Vifor pursuant to which we received an upfront payment of $100.0
million and $50.0 million for the purchase of our common stock (see Item 2.
Management's Discussion and Analysis of Financial Condition and Results of
Operations - Collaboration and License Agreements - Vifor (International) Ltd.).

In order to fund our future operations, including our planned clinical trials,
we filed the Shelf Registration Statement (File No. 333-230333), which provides
for aggregate offerings of up to $300.0 million of common stock, preferred
stock, debt securities, warrants or any combination thereof and was declared
effective on April 4, 2019. The securities registered under the Shelf
Registration Statement include unsold securities that had been registered under
our previous Registration Statement on Form S-3 (File No. 333-216657) that was
declared effective on March 24, 2017. To date, we have offered and sold an
aggregate of approximately $145.5 million of securities under this Shelf
Registration Statement. We believe that our Shelf Registration Statement
provides us with the flexibility to raise additional capital to finance our
operations as needed. We may offer additional securities under our Shelf
Registration Statement from time to time in response to market conditions or
other circumstances if we believe such a plan of financing is in the best
interests of our stockholders.

As of September 30, 2020, we had $131.4 million in unrestricted cash and cash
equivalents and available-for-sale marketable securities. We believe our current
unrestricted cash and cash equivalents and available-for-sale marketable
securities, including the proceeds of $150.0 million received pursuant to the
license agreement with Vifor in October 2020, will be sufficient to fund our
currently anticipated operating expenses and capital expenditures into 2023,
without giving effect to any potential milestone payments we may receive under
our licensing and collaboration agreements with Vifor, VFMCRP, Maruishi and
CKDP. Our anticipated operating expenses include contractually committed costs
as well as non-contractually committed clinical trial costs for trials that may
be delayed or not initiated and other non-committed controllable costs.

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Under the VFMCRP Agreement, we are eligible to receive regulatory and commercial
milestone payments in the aggregate of up to $470.0 million, consisting of up to
$30.0 million in regulatory milestones and up to $440.0 million in tiered
commercial milestones, all of which are sales-related. We are also eligible to
receive tiered double-digit royalty payments based on annual net sales, as
defined in the VFMCRP Agreement, of CR845/difelikefalin injection in the
Licensed Territories. As of September 30, 2020, we have not received any
milestone payments under the VFMCRP Agreement.

Under the Maruishi Agreement, we are also potentially eligible to earn up to an
aggregate of $6.0 million in clinical development milestones and $4.5 million in
regulatory milestones, before any foreign exchange adjustment, as well as tiered
royalties, with percentages ranging from the low double digits to the low
twenties, based on net sales of products containing CR845/difelikefalin in
Japan, if any, and share in any sub-license fees. As of September 30, 2020, we
have received milestone payments of $2.5 million before contractual foreign
currency exchange adjustments under the Maruishi Agreement.

Under the CKDP Agreement, we are potentially eligible to earn up to an aggregate
of $2.3 million in clinical development milestones and $1.5 million in
regulatory milestones, before South Korean withholding tax, as well as tiered
royalties with percentages ranging from the high single digits to the high
teens, based on net sales of products containing CR845/difelikefalin in South
Korea, if any, and share in any sub-license fees. In May 2020, the criteria for
revenue recognition for a milestone event set forth in the CKDP Agreement was
achieved, and we recorded $0.6 million (net of South Korean withholding tax) as
license and milestone fees revenue relating to the milestone payment received
from CKDP. As of September 30, 2020, $2.3 million (before South Korean
withholding tax) of development and regulatory milestones have been received.

Our ability to earn these payments and their timing is dependent upon the outcome of I.V. and Oral CR845/difelikefalin development activities and, potentially, commercialization. However, our receipt of any further such amounts is uncertain at this time and we may never receive any more of these amounts.

Funding Requirements

Our primary uses of capital have been, and we expect will continue to be, compensation and related expenses, third-party clinical R&D services and clinical costs. In the past, we have also previously used capital for laboratory and related supplies.

Since inception, we have incurred significant operating and net losses. Our net
losses were $16.5 million and $32.8 million for the three months ended
September 30, 2020 and 2019, respectively, and $70.5 million and $77.8 million
for the nine months ended September 30, 2020 and 2019, respectively. As of
September 30, 2020, we had an accumulated deficit of $471.2 million. We expect
to continue to incur significant expenses and operating and net losses in the
near future. Our net losses may fluctuate significantly from quarter to quarter
and year to year, depending on the timing of our clinical trials, the receipt of
additional milestone payments, if any, under our licensing and collaborations
with Vifor, VFMCRP, Maruishi and CKDP, the receipt of payments under any future
collaborations and/or licensing agreements we may enter into, and our
expenditures on other R&D activities.

We anticipate that our expenses will increase as we:

? continue the development of KORSUVA (CR845/difelikefalin) injection for CKD-aP

in dialysis patients;

? continue the development of Oral KORSUVA (CR845/difelikefalin) for CKD-aP and

other diseases associated with pruritus, such as CLD-aP and AD;

? explore the potential to further develop I.V. CR845/difelikefalin in the

post-operative setting;

? conduct R&D of any potential future product candidates;


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? seek regulatory approvals for I.V. CR845/difelikefalin and any product

candidates that successfully complete clinical trials;

establish a sales, marketing and distribution infrastructure and scale up

? external manufacturing capabilities to commercialize any products for which we

may obtain regulatory approval;

? maintain, expand and protect our global intellectual property portfolio;

? hire additional clinical, quality control and scientific personnel; and

add operational, financial and management information systems and personnel,

? including personnel to support our drug development and potential future

commercialization efforts.



The successful development of any of our product candidates is highly uncertain.
As such, at this time, we cannot reasonably estimate or know the nature, timing
and costs of the efforts that will be necessary to complete the development of
I.V. CR845/difelikefalin, Oral CR845/difelikefalin or our other current and
future programs. We are also unable to predict when, if ever, we will generate
any further material net cash inflows from CR845/difelikefalin. This is due to
the numerous risks and uncertainties associated with developing medicines,
including the uncertainty of:

? successful enrollment in, and completion of clinical trials;

? receipt of marketing approvals from applicable regulatory authorities;

? establishing commercial manufacturing capabilities or making arrangements with

third-party manufacturers;

? obtaining and maintaining patent and trade secret protection and regulatory

exclusivity for our product candidates;

? launching commercial sales of the products, if and when approved, whether alone

or in collaboration with others;

? achieving meaningful penetration in the markets which we seek to serve; and

obtaining adequate coverage or reimbursement by third parties, such as

? commercial payers and government healthcare programs, including Medicare and

Medicaid.



A change in the outcome of any of these variables with respect to the
development of I.V. CR845/difelikefalin, Oral CR845/difelikefalin or any of our
future product candidates would significantly change the costs and timing
associated with the development of that product candidate. Further, the timing
of any of the above may be impacted by the ongoing COVID-19 pandemic,
introducing additional uncertainty.

Because our product candidates are still in clinical development and the outcome
of these efforts is uncertain, we cannot estimate the actual amounts necessary
to successfully complete the development and commercialization of all our
product candidates or whether, or when, we may achieve profitability. Until such
time, if ever, as we can generate substantial product revenues, we expect to
finance our cash needs through a combination of equity or debt financings and
collaboration arrangements, including our existing licensing and collaboration
agreements with Vifor, VFMCRP, Maruishi and CKDP.

We will require additional capital beyond our current balances of cash and cash
equivalents and available-for-sale marketable securities and anticipated amounts
as described above, and this additional capital may not be available when
needed, on reasonable terms, or at all, and our ability to raise additional
capital may be adversely impacted by potential worsening global economic
conditions and the recent disruptions to and volatility in the credit and
financial markets in the United States and worldwide resulting from the ongoing
COVID-19 pandemic. If we are not able to do so, we could

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be required to postpone, scale back or eliminate some, or all, of these
objectives. To the extent that we raise additional capital through the future
sale of equity or convertible debt, the ownership interest of our stockholders
will be diluted, and the terms of these securities may include liquidation or
other preferences that adversely affect the rights of our existing common
stockholders. If we raise additional funds through the issuance of debt
securities, these securities could contain covenants that would restrict our
operations. If we raise additional funds through collaboration arrangements in
the future, we may have to relinquish valuable rights to our technologies,
future revenue streams or product candidates or grant licenses on terms that may
not be favorable to us. If we are unable to raise additional funds through
equity or debt financings when needed, we may be required to delay, limit,
reduce or terminate our drug development or future commercialization efforts or
grant rights to develop and market product candidates that we would otherwise
prefer to develop and market ourselves.

Outlook


Based on timing expectations and projected costs for our current clinical
development plans, which include completing our Phase 3 trials of KORSUVA
(CR845/difelikefalin) injection in hemodialysis patients suffering from
moderate-to-severe CKD-aP to enable the submission of a new drug application,
conducting supportive Phase 1 trials and Phase 2 trials of Oral KORSUVA
(CR845/difelikefalin) in patients with pruritus associated with CKD, CLD and AD,
we expect that our existing cash and cash equivalents and available-for-sale
marketable securities, including the proceeds received from the license
agreement with Vifor in October 2020, will be sufficient for us to fund our
currently anticipated operating expenses and capital expenditures into 2023,
without giving effect to any potential milestone payments we may receive under
our collaboration agreements with Vifor, VFMCRP, Maruishi and CKDP. Our
anticipated operating expenses include contractually committed costs as well as
non-contractually committed clinical trial costs for trials that may be delayed
or not initiated and other non-committed controllable costs. Because the process
of testing product candidates in clinical trials is costly and the timing of
progress in these trials is uncertain, it is possible that the assumptions upon
which we have based this estimate may prove to be wrong, and we could use our
capital resources sooner than we presently expect.

Cash Flows


The following is a summary of the net cash flows provided by (used in) our
operating, investing and financing activities for the nine months ended
September 30, 2020 and 2019:


                                                                      Nine Months Ended
                                                                       September 30,
                                                                   2020               2019

                                                                 Dollar amounts in thousands
Net cash used in operating activities                         $     (87,575)$     (78,059)
Net cash provided by (used in) investing activities                  143,880           (45,254)
Net cash provided by financing activities                                671            142,576

Net increase in cash, cash equivalents and restricted cash $ 56,976$ 19,263

Net cash used in operating activities


Net cash used in operating activities for the nine months ended September 30,
2020 consisted primarily of a net loss of $70.5 million, a $10.4 million cash
outflow from net non-cash charges and a $6.7 million cash outflow from net
changes in operating assets and liabilities. Net non-cash charges primarily
consisted of a decrease of $21.8 million in deferred revenue associated with our
VFMCRP Agreement, partially offset by stock-based compensation expense of $10.8
million. The change in operating assets and liabilities primarily consisted of a
cash outflow of $4.6 million from a decrease in accounts payable and accrued
expenses and a cash outflow of $1.4 million from an increase in prepaid
expenses, primarily related to an increase in prepaid clinical costs.

Net cash used in operating activities for the nine months ended September 30,
2019 consisted primarily of a net loss of $77.8 million and a $2.6 million cash
outflow from net non-cash charges, partially offset by a $2.3 million cash
inflow from net changes in operating assets and liabilities. Net non-cash
charges primarily consisted of a decrease of

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$15.2 million in deferred revenue associated with our VFMCRP Agreement and $1.2
million related to accretion of available-for-sale securities, partially offset
by stock-based compensation expense of $9.2 million and a noncash expense of
$4.0 million related to the License Agreement with Enteris. The change in
operating assets and liabilities primarily consisted of a cash inflow of $7.0
million from an increase in accounts payable and accrued expenses, partially
offset by a cash outflow of $3.8 million from an increase in prepaid expense,
primarily related to an increase in prepaid clinical costs and a cash outflow of
$0.7 million from operating lease liability relating to lease payments made for
the Stamford Lease as a result of our adoption of ASC 842: Leases.

Net cash provided by (used in) investing activities


Net cash provided by investing activities was $143.9 million for the nine months
ended September 30, 2020, which primarily included cash inflows of $141.9
million from maturities and redemptions of available-for-sale marketable
securities and proceeds of $23.1 million from sales of available-for-sale
marketable securities, partially offset by cash outflows of $21.0 million for
the purchases of available-for-sale marketable securities.

Net cash used in investing activities was $45.3 million for the nine months ended September 30, 2019, which primarily included cash outflows of $241.1 million for the purchase of available-for-sale marketable securities, partially offset by $195.8 million from maturities of available-for-sale securities.

Net cash provided by financing activities


Net cash provided by financing activities for the nine months ended September
30, 2020 consisted of proceeds of $671 thousand received from the exercise of
stock options.

Net cash provided by financing activities for the nine months ended September
30, 2019 consisted of $136.5 million of net proceeds from the issuance and sale
of our common stock in July 2019 and proceeds of $6.1 million received from the
exercise of stock options.

Significant Contractual Obligations and Commitments

Contractual obligations and commitments as of September 30, 2020 consisted of an
operating lease obligation in connection with the lease agreement for our
operating facility in Stamford, Connecticut we entered into in December 2015 and
amended in June 2020, the Enteris License Agreement we entered into in August
2019, and the MSA we entered into with Patheon in July 2019. However, we have no
material non-cancelable purchase commitments with these contract manufacturers
or service providers, as we have generally contracted on a cancelable purchase
order basis. Furthermore, milestone payments potentially owed by us in
connection with the Enteris License Agreement relate to milestone events that
may or may not be achieved.

See Note 15 of Notes to Condensed Financial Statements, Commitments and Contingencies, in this Quarterly Report on Form 10-Q.

Recent Accounting Pronouncements

Please refer to Note 2 of Notes to Condensed Financial Statements, Basis of Presentation, in this Quarterly Report on Form 10-Q.

Off-Balance Sheet Arrangements

We did not have during the periods presented in our condensed financial statements included in this report, and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules.


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Discussion of Critical Accounting Policies

The preparation of financial statements in conformity with GAAP requires us to
use judgment in making certain estimates and assumptions that affect the
reported amounts of assets and liabilities, the disclosure of contingent assets
and liabilities and the reported amounts of revenues and expenses in our
condensed financial statements and accompanying notes. Critical accounting
policies are those that are most important to the portrayal of our financial
condition and results of operations and require difficult, subjective and
complex judgments by management in order to make estimates about the effect of
matters that are inherently uncertain. During the three and nine months ended
September 30, 2020, there were no significant changes to our critical accounting
policies from those described in our Annual Report on Form 10-K for the year
ended December 31, 2019.

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Financials (USD)
Sales 2020 65,7 M - -
Net income 2020 -53,3 M - -
Net Debt 2020 - - -
P/E ratio 2020 -13,2x
Yield 2020 -
Capitalization 924 M 924 M -
Capi. / Sales 2020 14,1x
Capi. / Sales 2021 32,8x
Nbr of Employees 76
Free-Float 83,9%
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Managers and Directors
NameTitle
Derek T. Chalmers President, Chief Executive Officer & Director
Thomas Reilly Chief Financial & Accounting Officer
Frèdèrique Menzaghi Chief Scientific Officer, Senior VP-R&D
Joana Goncalves Chief Medical Officer
Martin A. Vogelbaum Lead Independent Director
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