Cara Therapeutics, Inc. (Nasdaq: CARA), a commercial-stage
biopharmaceutical company leading a new treatment paradigm to
improve the lives of patients suffering from pruritus, today
announced financial results and operational highlights for the
second quarter ended June 30, 2022.
“During the second quarter of 2022, we made
great strides toward establishing Cara Therapeutics as the leader
in the treatment of chronic pruritus,” said Christopher Posner,
President and Chief Executive Officer of Cara Therapeutics. “The
early U.S. launch of KORSUVA™ (difelikefalin) injection with our
commercial partner Vifor has been progressing as expected, with
independent and midsize dialysis organizations driving initial
product uptake. We anticipate demand to accelerate in the coming
months, driven by large dialysis organizations that started
purchasing early in the third quarter.”
Mr. Posner continued, “In June 2022, we were
pleased to announce positive topline results from our KOMFORT Phase
2 proof-of-concept trial of oral difelikefalin for the treatment of
pruritus in patients with notalgia paresthetica. We continue to
deliver against our commitments associated with our three strategic
priorities both on the commercial and development side of the
business thereby driving long-term growth and value creation.”
Second Quarter and Recent
Developments:
KORSUVA Injection: Chronic Kidney
Disease-Associated Pruritus: Hemodialysis
In April 2022, the Company and its commercial
partner, Vifor, launched KORSUVA (difelikefalin) injection in the
U.S. for the treatment of moderate-to-severe pruritus associated
with chronic kidney disease (CKD) in adults undergoing
hemodialysis. KORSUVA injection generated net sales of $16.8
million in the second quarter of 2022, translating into $8 million
in profit-sharing revenue for Cara. Wholesalers shipped 1,812 vials
driven by independent and midsize dialysis organizations.
In the second quarter, the Company received the
$15 million regulatory milestone payment triggered by the April
2022 European Commission approval of Kapruvia® (difelikefalin) for
the treatment of moderate-to-severe pruritus associated with CKD in
adult hemodialysis patients. Also in April 2022, Kapruvia was
approved in the UK. The Company expects the commercial launches of
Kapruvia to commence in certain European markets in the second half
of 2022.
Oral Difelikefalin: Notalgia
Paresthetica
In June 2022, the Company announced positive
topline results from the KOMFORT Phase 2 multicenter, randomized,
double-blind, placebo-controlled, 8-week study evaluating the
efficacy and safety of oral difelikefalin for moderate-to-severe
pruritus in patients with notalgia paresthetica (NP). The Company
has submitted the data for presentation at an upcoming medical
meeting and plans to host an R&D Day focused on NP in the third
quarter of 2022. In addition, the Company anticipates having a
meeting with the U.S. Food and Drug Administration in the second
half of 2022 to discuss next steps in the development of oral
difelikefalin for the treatment of pruritus in patients with
NP.
Oral Difelikefalin: Pruritus Associated
with Non-Dialysis Dependent Advanced Chronic Kidney
Disease
The Phase 3 program of oral difelikefalin in
patients with advanced CKD stages 4 or 5 with moderate-to-severe
pruritus who are not on dialysis is ongoing. The Phase 3 program is
comprised of two identical 12-week, double-blind,
placebo-controlled studies, known as KICK 1 and KICK 2. The Company
expects to report topline results in the second half of 2024.
Oral Difelikefalin: Atopic
Dermatitis
The Phase 3 program for oral difelikefalin as an
adjunctive therapy to topical corticosteroids in atopic dermatitis
(AD) patients with moderate-to-severe pruritus is ongoing. The
program is comprised of two studies, known as KIND 1 and KIND 2.
Both studies are double-blind, controlled, 12-week studies with
patients allowed to roll over to 52-week open-label safety
extensions. At the end of the 12-week treatment period in Part A of
KIND 1, the Company expects to have an internal data readout to
inform the dose and sample size to initiate Part B and KIND 2. The
internal readout is expected for the second half of 2023.
Oral Difelikefalin: Chronic Liver
Disease-Associated Pruritus: Primary Biliary
Cholangitis
The Company is currently conducting a
proof-of-concept Phase 2 clinical trial of oral difelikefalin for
the treatment of pruritus in patients with hepatic impairment due
to primary biliary cholangitis (PBC). The trial is evaluating the
safety and efficacy of oral difelikefalin versus placebo for 16
weeks. The Company expects to report topline data in the second
half of 2022.
Upcoming Meeting
Activities:
The Company expects to present at the following
upcoming investment conferences:
- Canaccord Genuity 42nd Annual
Growth Conference, August 8-11
- H.C. Wainwright 24th Annual Global
Investment Conference, September 12-14
Second Quarter 2022 Financial
Results
Cash, cash equivalents and marketable securities
at June 30, 2022 totaled $204.7 million compared to $236.8 million
at December 31, 2021. The decrease in the balance primarily
resulted from $30.0 million of cash used in operating
activities.
For the second quarter of 2022, net loss was
$4.2 million, or $(0.08) per basic and diluted share, compared to
net loss of $30.7 million, or ($0.61) per basic and diluted share,
for the same period in 2021.
Revenues: Total revenue was $23.0 million for
the three months ended June 30, 2022. There was no revenue during
the same period of 2021. Revenue consisted of:
- $15.0 million of license and milestone fees revenue, related to
the regulatory milestone payment for the approval of Kapruvia by
the European Commission in April 2022 during the three months ended
June 30, 2022; and
- $8.0 million of collaborative
revenue, related to the profit-sharing revenue from Vifor’s sales
of KORSUVA injection to third parties during the three months ended
June 30, 2022.
Cost of Goods Sold (COGS): There was no COGS
during the three months ended June 30, 2022 or June 30, 2021, as
there was no commercial supply revenue recognized for the
period.
Research and Development (R&D) Expenses:
R&D expenses were $19.9 million for the three months ended June
30, 2022 compared to $25.2 million in the same period of 2021. The
lower R&D expenses in 2022 were principally due to a $10.0
million milestone earned by Enteris during the three months ended
June 30, 2021, partially offset by increases in direct clinical
trial costs and related consultant costs during the three months
ended June 30, 2022.
General and Administrative (G&A) Expenses:
G&A expenses were $7.6 million for the three months ended June
30, 2022 compared to $5.7 million in the same period of 2021. The
higher G&A expenses for the three months ended June 30, 2022
were principally due to increases in stock-based compensation
expense, which included additional compensation expense relating to
the modification of the Company’s former Chief Executive Officer’s
equity awards in November 2021, as well as increases in accounting
and auditing fees and payroll related costs.
Other Income, net: Other income, net was $0.3
million for the three months ended June 30, 2022 compared to $0.1
million in the same period of 2021. The increase in other income,
net was primarily due to an increase in interest income resulting
from a higher yield on the Company’s portfolio of investments
during the three months ended June 30, 2022, partially offset by an
increase in net amortization expense of available-for-sale
securities during the three months ended June 30, 2022.
Financial Guidance
Based on timing expectations and projected costs
for current clinical development plans, which include conducting
supportive Phase 1 trials, Phase 2 trials in PBC and NP, and Phase
3 trials in CKD and AD, Cara expects that its current unrestricted
cash and cash equivalents and available-for-sale marketable
securities will be sufficient to fund its currently anticipated
operating expenses and capital requirements into the first half of
2024, without giving effect to product revenue the Company receives
from the commercialization of KORSUVA injection or Kapruvia or any
potential milestone payments or potential additional product
revenue the Company may receive under collaboration agreements.
About Cara Therapeutics
Cara Therapeutics is a commercial-stage biopharmaceutical
company leading a new treatment paradigm to improve the lives of
patients suffering from pruritus. The Company’s novel KORSUVA™
(difelikefalin) injection is the first and only FDA-approved
treatment for moderate-to-severe pruritus associated with chronic
kidney disease in adults undergoing hemodialysis. The Company is
developing an oral formulation of difelikefalin and has initiated
Phase 3 programs for the treatment of pruritus in patients with
non-dialysis dependent advanced chronic kidney disease and atopic
dermatitis. The Company has completed the placebo-controlled phase
of a Phase 2 proof-of-concept trial of oral difelikefalin for the
treatment of moderate-to-severe pruritus in patients with notalgia
paresthetica. A Phase 2 proof-of-concept trial in primary biliary
cholangitis patients with moderate-to-severe pruritus is ongoing.
For more information, visit www.CaraTherapeutics.com and follow the
company on Twitter, LinkedIn and Instagram.
Forward-looking Statements
Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Examples of these forward-looking statements include
statements concerning the Company’s ability to successfully
commercialize KORSUVA injection and Kapruvia, risks that KORSUVA
injection and Kapruvia revenue, expenses and costs may not be as
expected, planned future regulatory meetings and/or submissions and
potential future regulatory approvals, the performance of the
Company’s commercial partners, including Vifor, expected timing of
the initiation, enrollment and data readouts from the Company’s
planned and ongoing clinical trials, the potential results of
ongoing clinical trials, timing of future regulatory and
development milestones for the Company’s product candidates, the
potential for the Company’s product candidates to be alternatives
in the therapeutic areas investigated, including NP, and the
potential for oral difelikefalin to address additional pruritic
indications, the size and growth of the potential markets for
pruritus management, the Company’s expected cash reach, and the
potential impact of COVID-19, geopolitical tensions and
macroeconomic conditions on the Company’s clinical development and
regulatory timelines and plans. Because such statements are subject
to risks and uncertainties, actual results may differ materially
from those expressed or implied by such forward-looking statements.
Risks are described more fully in Cara Therapeutics’ filings with
the Securities and Exchange Commission, including the “Risk
Factors” section of the Company’s Annual Report on Form 10-K for
the year ending December 31, 2021 and its other documents
subsequently filed with or furnished to the Securities and Exchange
Commission, including its Form 10-Q for the quarter ended June 30,
2022. All forward-looking statements contained in this press
release speak only as of the date on which they were made. Cara
Therapeutics undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the
date on which they were made, except as required by law.
Financial tables follow
|
CARA THERAPEUTICS, INC. |
CONDENSED BALANCE SHEETS |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
46,718 |
|
|
$ |
13,453 |
|
|
Marketable securities |
|
|
110,794 |
|
|
|
153,582 |
|
|
Accounts receivable - related party |
|
|
8,003 |
|
|
|
- |
|
|
Inventory, net |
|
|
3,460 |
|
|
|
2,584 |
|
|
Income tax receivable |
|
|
697 |
|
|
|
697 |
|
|
Other receivables |
|
|
468 |
|
|
|
455 |
|
|
Prepaid expenses |
|
|
6,026 |
|
|
|
2,519 |
|
Total current assets |
|
|
176,166 |
|
|
|
173,290 |
|
|
Operating lease right-of-use assets |
|
|
2,278 |
|
|
|
2,973 |
|
|
Marketable securities, non-current |
|
|
47,171 |
|
|
|
69,754 |
|
|
Property and equipment, net |
|
|
549 |
|
|
|
631 |
|
|
Restricted cash |
|
|
408 |
|
|
|
408 |
|
Total assets |
|
$ |
226,572 |
|
|
$ |
247,056 |
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
19,332 |
|
|
$ |
15,861 |
|
|
Operating lease liabilities, current |
|
|
1,835 |
|
|
|
1,755 |
|
Total current liabilities |
|
|
21,167 |
|
|
|
17,616 |
|
|
|
|
|
|
|
|
Operating lease liabilities, non-current |
|
|
983 |
|
|
|
1,918 |
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
Preferred stock |
|
|
- |
|
|
|
- |
|
|
Common stock |
|
|
53 |
|
|
|
53 |
|
|
Additional paid-in capital |
|
|
719,129 |
|
|
|
708,585 |
|
|
Accumulated deficit |
|
|
(512,713 |
) |
|
|
(480,758 |
) |
|
Accumulated other comprehensive loss |
|
|
(2,047 |
) |
|
|
(358 |
) |
Total stockholders’ equity |
|
|
204,422 |
|
|
|
227,522 |
|
Total liabilities and stockholders’ equity |
|
$ |
226,572 |
|
|
$ |
247,056 |
|
|
|
|
|
|
|
|
CARA THERAPEUTICS, INC. CONDENSED
STATEMENTS OF OPERATIONS (amounts in thousands, except
share and per share data) (unaudited) |
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License and milestone fees |
|
$ |
15,000 |
|
|
|
$ |
- |
|
|
|
$ |
15,000 |
|
|
|
$ |
1,192 |
|
|
Collaborative revenue |
|
8,003 |
|
|
|
- |
|
|
|
8,003 |
|
|
|
706 |
|
|
Commercial supply revenue |
|
- |
|
|
|
- |
|
|
|
4,790 |
|
|
|
- |
|
|
Clinical compound revenue |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
37 |
|
Total revenue |
|
23,003 |
|
|
|
- |
|
|
|
27,793 |
|
|
|
1,935 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
- |
|
|
|
- |
|
|
|
2,081 |
|
|
|
- |
|
|
Research and development |
|
19,905 |
|
|
|
25,225 |
|
|
|
41,178 |
|
|
|
44,356 |
|
|
General and administrative |
|
7,570 |
|
|
|
5,651 |
|
|
|
16,917 |
|
|
|
12,016 |
|
Total operating expenses |
|
27,475 |
|
|
|
30,876 |
|
|
|
60,176 |
|
|
|
56,372 |
|
Operating loss |
|
|
(4,472 |
) |
|
|
|
(30,876 |
) |
|
|
|
(32,383 |
) |
|
|
|
(54,437 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
266 |
|
|
|
131 |
|
|
|
428 |
|
|
|
391 |
|
Net loss |
|
|
(4,206 |
) |
|
|
|
(30,745 |
) |
|
|
|
(31,955 |
) |
|
|
|
(54,046 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted |
|
$ |
(0.08 |
) |
|
|
$ |
(0.61 |
) |
|
|
$ |
(0.60 |
) |
|
|
$ |
(1.08 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted |
|
53,614,668 |
|
|
|
50,059,984 |
|
|
|
53,561,161 |
|
|
|
49,989,379 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MEDIA CONTACT:Annie Spinetta6
Degrees973-768-2170aspinetta@6degreespr.com
INVESTOR CONTACT:Iris Francesconi, Ph.D.Cara
Therapeutics203-406-3700investor@caratherapeutics.com
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