Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company
focused on developing and commercializing new chemical entities
designed to alleviate pruritus by selectively targeting peripheral
kappa opioid receptors (KORs), today announced financial results
and operational highlights for the fourth quarter and full year
ended December 31, 2020.
“During 2020, we made significant advances in
our late-stage clinical pruritus programs, culminating in the
acceptance by the U.S. Food and Drug Administration (FDA) of our
first New Drug Application (NDA) filing for our lead product
candidate, KORSUVA™ (CR845/difelikefalin) Injection for the
treatment of moderate-to-severe pruritus in hemodialysis patients,”
said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive
Officer of Cara Therapeutics. “In addition, we executed a strategic
commercial licensing agreement with Vifor (International) Ltd.
(Vifor) that we believe will provide significant momentum for the
launch and adoption of KORSUVA Injection in the United States, if
approved. Looking forward, we also expect 2021 to be a very
exciting year for our Oral KORSUVA pruritus programs as we report
top-line data for the KARE Phase 2 dose-ranging trial in atopic
dermatitis in the first half of 2021 and initiate our Phase 3
registration trials in stage III-V CKD patients in the second half
of the year.”
Fourth Quarter and Recent
Developments:
KORSUVA Injection: Chronic Kidney
Disease-Associated Pruritus (CKD-aP): Hemodialysis
In February 2021, the FDA accepted the filing of
the NDA for KORSUVA Injection for the treatment of
moderate-to-severe pruritus in hemodialysis patients. If approved,
KORSUVA Injection would be the first treatment for CKD-aP in
dialysis patients. If granted priority review, potential approval
and commercial launch of KORSUVA Injection could take place in the
second half of 2021.
In October 2020, the Company entered into a
license agreement with Vifor under which it granted Vifor an
exclusive license to commercialize KORSUVA Injection for the
treatment of pruritus in hemodialysis patients in the United
States under a Cara 60%, Vifor 40% profit-sharing arrangement.
Under the terms of the agreement, the Company received an upfront
payment of $100.0 million from Vifor and an additional
payment of $50.0 million for the purchase of the
Company’s common stock at a price of $17.0094 per
share.
Upon U.S. regulatory approval of
KORSUVA Injection, the Company 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 the Company’s
common stock as of such date. In addition, the Company is eligible
to receive payments of up to $240.0 million upon the
achievement of certain sales-based milestones.
Oral KORSUVA: CKD-aP:
Non-Hemodialysis
In December 2019, the Company announced positive
top-line results from its Phase 2 dose-ranging trial of Oral
KORSUVA for the treatment of pruritus in patients with stage III-V
(moderate-to-severe) CKD. The Company expects to conduct an End of
Phase 2 Meeting with the FDA regarding this indication in the
second quarter of 2021. Following the meeting, the Company intends
to initiate the Phase 3 program in patients with stage III-V CKD in
the second half of 2021.
Oral KORSUVA: Atopic Dermatitis
(AD)
In December 2020, the Company announced that it
has completed full enrollment in the ongoing KARE Phase 2
dose-ranging trial of Oral KORSUVA for the treatment of
moderate-to-severe pruritus in approximately 400 adult AD patients.
The study is evaluating the safety and efficacy of three tablet
strengths (0.25 mg, 0.5 mg and 1.0 mg, twice daily) of Oral KORSUVA
versus placebo for 12 weeks, followed by a four-week active
extension phase.
KARE’s primary efficacy endpoint is change from
baseline in the weekly mean of the daily 24-hour Worst Itch –
Numeric Rating Scale (WI-NRS) score at week 12 of the treatment
period. The key secondary endpoint for KARE is the assessment of
the proportion of patients achieving an improvement from baseline
of ≥4 points with respect to the weekly mean of the daily 24-hour
WI-NRS score at week 12. Itch-related quality of life scores at the
end of week 12 are assessed by the total Skindex-10 and 5-D itch
scales.
The Company aims to report top-line results from
this trial in the first half of 2021, subject to any delays related
to the ongoing COVID-19 pandemic.
Oral KORSUVA: Chronic Liver
Disease-Associated Pruritus (CLD-aP): Primary Biliary Cholangitis
(PBC)
The Company is currently conducting a Phase 2
trial of Oral KORSUVA for the treatment of pruritus in patients
with hepatic impairment due to PBC. The trial is evaluating the
safety and efficacy of Oral KORSUVA (1.0 mg tablet, twice daily)
versus placebo for 16 weeks. The Company aims to have top-line data
in the second half of 2021, due in part to delays related to the
ongoing COVID-19 pandemic.
Oral KORSUVA: Notalgia Paresthetica
(NP)
In January 2021, the Company initiated a Phase 2
trial of Oral KORSUVA for the treatment of moderate-to-severe
pruritus in patients suffering from NP, a nerve disorder
characterized by chronic pruritus of the upper to middle back.
The Phase 2 multicenter, randomized,
double-blind, placebo-controlled 8-week study is designed to
evaluate the efficacy and safety of Oral KORSUVA for
moderate-to-severe pruritus in approximately 120 subjects with NP.
Subjects will be randomized to receive Oral KORSUVA 2.0 mg twice
daily versus placebo for 8 weeks, followed by a four-week active
extension period. The primary efficacy endpoint is the change from
baseline in the weekly mean of the daily 24-hour WI-NRS score at
Week 8 of the treatment period. Secondary endpoints include change
from baseline in itch-related quality of life scores and a change
from baseline in itch-related sleep disturbance subscale at the end
of Week 8.
COVID-19 Impacts and Business
Operations
Due to the ongoing COVID-19 pandemic and in
accordance with the FDA’s updated guidance for conducting clinical
trials, the Company has implemented numerous clinical and
operational measures to prioritize the health and safety of
patients, employees and study investigators and minimize potential
disruptions to its ongoing clinical studies. Cara is working
closely with its clinical and commercial manufacturing partners to
continue to ensure sufficient supply of KORSUVA is available for
its ongoing and planned clinical trials.
Based on guidelines from the Centers for
Disease Control and Prevention and the State of
Connecticut, all Cara employees continue to work remotely, and
business travel has been restricted.
Expected 2021 Milestones
- Top-line data from the KARE Phase 2
dose-ranging trial of Oral KORSUVA in AD patients in the first half
of 2021.
- End of Phase 2 Meeting with the FDA
in the second quarter of 2021 to enable initiation of a Phase 3
program of Oral KORSUVA in non-hemodialysis CKD-aP patients in the
second half of 2021.
- Potential FDA approval of NDA for
KORSUVA Injection in the second half of 2021.
- Top-line data from the Phase 2
trial of Oral KORSUVA in CLD-aP in the second half of 2021.
- Initiate Phase 3 trial of Oral
KORSUVA for CKD-aP patients in the second half of 2021.
Upcoming Meeting Activities
The Company expects to make presentations at the
following upcoming conferences:
- National Kidney Foundation Spring
Clinical Meeting, April 6-10, 2021
- Needham & Co. Annual Healthcare
Conference, April 12-15, 2021
- American Nephrology Nurses
Association National Symposium, May 2-5, 2021
- Bank of America Merrill Lynch
Healthcare Conference, May 10-13, 2021
Fourth Quarter and Full Year 2020
Financial Results
Cash, cash equivalents and marketable securities
at December 31, 2020 totaled $251.5 million compared to $218.2
million at December 31, 2019. The increase in the balance primarily
resulted from $38.4 million from the sale of common stock in a
license agreement with Vifor, partially offset by $5.5 million of
cash used in operating activities, which includes $111.6 million of
cash received from the Vifor Agreement which was included as
license and milestone fees revenue.
For the fourth quarter of 2020, net income was
$78.9 million, or $1.60 per basic share and $1.59 per diluted
share, compared to a net loss of $28.6 million, or $0.61 per basic
and diluted share, for the same period in 2019.
Revenues: Total revenue was $112.1 million for
the fourth quarter of 2020, compared to $4.5 million during the
same period of 2019. Total revenue primarily consisted of:
-
$112.1 million of license and milestone fees revenue during the
fourth quarter of 2020, of which $111.6 million related to the
license agreement with Vifor and $0.5 million related to the
license agreement with Vifor Fresenius Medical Care Renal Pharma
Ltd. (VFMCRP). The Company recognized $4.5 million of license and
milestone fees revenue during the fourth quarter of 2019, which
related to the license agreement with VFMCRP.
Research and Development (R&D) Expenses:
R&D expenses were $27.1 million in the fourth quarter of 2020
compared to $29.9 million in the same period of 2019. The lower
R&D expenses in 2020 were principally due to a net decrease in
costs associated with clinical trials and travel and related costs,
partially offset by a $2.5 million milestone payment made in
connection with the license agreement with Enteris Biopharma, Inc.
(Enteris), increases in payroll and related costs, and increases in
stock compensation expense.
General and Administrative (G&A) Expenses:
G&A expenses were $6.7 million in the fourth quarter of 2020
compared to $4.6 million in the same period of 2019. The
higher G&A expenses in 2020 were principally due to increases
in payroll and related costs, commercial costs, and insurance
costs.
Other Income, net: Other income, net was $0.4
million in the fourth quarter of 2020 compared to $1.2 million in
the same period of 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 portfolio of
investments in the 2020 period.
For the full year ended December 31, 2020, net
income was $8.4 million, or $0.18 per basic and diluted share
compared to a net loss of $106.4 million, or $2.49 per basic and
diluted share, for the full year ended December 31, 2019.
Revenues: Total revenue was $135.1 million for
the full year ended December 31, 2020 compared to $19.9 million for
the full year ended December 31, 2019. Total revenue primarily
consisted of:
- $134.4 million of license and
milestone fees revenue for the year ended December 31, 2020, of
which $111.6 million related to the license agreement with Vifor,
$22.3 million related to the license agreement with VFMCRP, and
$0.6 million related to the achievement of a milestone related to
its license agreement with Chong Kun Dang Pharmaceutical Corp. The
Company also recognized $19.7 million of license and milestone fees
revenue for the year ended December 31, 2019, which related to the
license agreement with VFMCRP.
- Approximately $643,000 and $140,000
of revenue from the sales of clinical compound during the years
ended December 31, 2020 and 2019, respectively, in connection with
the sale of clinical compound to VFMCRP and Maruishi Pharmaceutical
Co. Ltd.
Research and Development (R&D) Expenses:
R&D expenses were $107.9 million for the full year ended
December 31, 2020 compared to $113.8 million for the full year
ended December 31, 2019. The lower R&D expenses in 2020 were
principally due to a net decrease in clinical trial costs and
related consultant costs, lower payments made to Enteris during the
year ended December 2020, and a decrease in travel and related
costs, partially offset by increases in stock compensation expense,
payroll and related costs, and cost of clinical compound sales.
General and Administrative (G&A) Expenses:
G&A expenses were $21.8 million for the full year ended
December 31, 2020 compared to $17.7 million for the full year ended
December 31, 2019. The increase in 2020 was primarily due to
increases in commercial costs, insurance costs, payroll and related
costs, and accounting fees, partially offset by decreases in
consultants’ costs and stock compensation expense.
Other Income, net: Other income, net was $2.3
million for the full year ended December 31, 2020 compared to $4.5
million for the full year ended December 31, 2019. The decrease in
2020 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, partially offset by a realized gain of approximately $0.3
million from the sale of our available-for-sale marketable
securities in the 2020 period.
Financial Guidance
Based on timing expectations and projected costs
for current clinical development plans, Cara expects that its
existing unrestricted cash and cash equivalents and
available-for-sale marketable securities as of December 31, 2020
will be sufficient to fund its currently anticipated operating
expenses and capital expenditures into 2023, without giving effect
to any potential milestone payments or potential product revenue
under existing collaborations.
Conference Call
Cara management will host a conference call
today at 4:30 p.m. ET to discuss fourth quarter and full year 2020
financial results and provide a business update.
To participate in the conference call, please
dial (855) 445-2816 (domestic) or (484) 756-4300 (international)
and refer to conference ID 6676157. A live webcast of the call can
be accessed under "Events and Presentations" in the News &
Investors section of the Company's website at
www.CaraTherapeutics.com.
An archived webcast recording will be available
on the Cara website beginning approximately two hours after the
call.
About Cara Therapeutics
Cara Therapeutics is a clinical-stage biopharmaceutical company
focused on developing and commercializing new chemical entities
designed to alleviate pruritus by selectively targeting peripheral
KORs. Cara is 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 the Company’s KALMTM-1 and KALM-2
Phase 3 trials and two Phase 2 trials, KORSUVA Injection 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.
Cara has successfully completed its Phase 2 trial of Oral KORSUVA
for the treatment of pruritus in patients with CKD and is currently
conducting Phase 2 trials of Oral KORSUVA in AD, PBC and NP
patients with moderate-to-severe pruritus.
The FDA has accepted the NDA filing for KORSUVA Injection for
the treatment of moderate-to-severe pruritus in hemodialysis
patients and conditionally accepted KORSUVA as the trade name for
difelikefalin injection. CR845/difelikefalin is an investigational
drug product and its safety and efficacy have not been fully
evaluated by any regulatory authority.
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
expected timing of the enrollment and data readouts from the
Company’s ongoing clinical trials, the potential results of ongoing
clinical trials, timing of future regulatory and development
milestones for the Company’s product candidates and potential
commercialization of KORSUVA Injection for CKD-aP, the expected
timeline for conducting meetings with the FDA concerning the
Company’s product candidates, the potential for the Company’s
product candidates to be alternatives in the therapeutic areas
investigated, the Company’s expected cash reach, and the potential
impact of COVID-19 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 most recent
Annual Report on Form 10-K and its other documents subsequently
filed with or furnished to the Securities and Exchange
Commission. 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.
Financial tables follow
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CARA
THERAPEUTICS, INC. |
|
|
STATEMENTS
OF OPERATIONS |
|
|
(amounts in
thousands, except share and per share data) |
|
|
(unaudited) |
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Three Months Ended December 31, |
|
Year Ended December 31, |
|
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
License and
milestone fees |
|
$ |
112,062 |
|
|
$ |
4,511 |
|
|
$ |
134,439 |
|
|
$ |
19,746 |
|
|
Clinical
compound revenue |
|
|
27 |
|
|
- |
|
|
|
643 |
|
|
140 |
|
Total revenue |
|
|
112,089 |
|
|
4,511 |
|
|
|
135,082 |
|
|
19,886 |
|
|
|
|
|
|
|
|
|
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|
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Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Research and
development |
|
|
27,140 |
|
|
29,864 |
|
|
|
107,851 |
|
|
113,820 |
|
|
General and
administrative |
|
|
6,659 |
|
|
4,617 |
|
|
|
21,846 |
|
|
17,745 |
|
Total operating expenses |
|
|
33,799 |
|
|
34,481 |
|
|
|
129,697 |
|
|
131,565 |
|
Operating income (loss) |
|
|
78,290 |
|
|
(29,970 |
) |
|
|
5,385 |
|
|
(111,679 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
|
364 |
|
|
1,193 |
|
|
|
2,334 |
|
|
4,490 |
|
Income (loss) before benefit from income taxes |
|
78,654 |
|
|
(28,777 |
) |
|
|
7,719 |
|
|
(107,189 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Benefit from income taxes |
|
|
255 |
|
|
166 |
|
|
|
691 |
|
|
816 |
|
Net income (loss) |
|
$ |
78,909 |
|
|
$ |
(28,611 |
) |
|
$ |
8,410 |
|
|
$ |
(106,373 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
1.60 |
|
|
$ |
(0.61 |
) |
|
$ |
0.18 |
|
|
$ |
(2.49 |
) |
Diluted |
|
$ |
1.59 |
|
|
$ |
(0.61 |
) |
|
$ |
0.18 |
|
|
$ |
(2.49 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
49,228,774 |
|
|
46,691,009 |
|
|
|
47,413,250 |
|
|
42,669,333 |
|
Diluted |
|
|
49,701,864 |
|
|
46,691,009 |
|
|
|
47,915,030 |
|
|
42,669,333 |
|
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CARA
THERAPEUTICS, INC. |
BALANCE
SHEETS |
(in thousands) |
(unaudited) |
|
|
|
|
|
December 31, |
|
2020 |
|
2019 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
31,683 |
|
|
$ |
18,305 |
|
Marketable securities |
|
149,242 |
|
|
|
136,701 |
|
Income tax receivable |
|
1,507 |
|
|
|
816 |
|
Other receivables |
|
557 |
|
|
|
971 |
|
Prepaid expenses |
|
12,076 |
|
|
|
8,863 |
|
Total current assets |
|
195,065 |
|
|
|
165,656 |
|
Operating lease right-of-use assets |
|
4,279 |
|
|
|
3,036 |
|
Marketable securities, non-current |
|
70,565 |
|
|
|
63,159 |
|
Property and equipment, net |
|
840 |
|
|
|
700 |
|
Restricted cash |
|
408 |
|
|
|
408 |
|
Total assets |
$ |
271,157 |
|
|
$ |
232,959 |
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable and accrued expenses |
$ |
16,881 |
|
|
$ |
19,665 |
|
Operating lease liabilities, current |
|
1,602 |
|
|
|
967 |
|
Current portion of deferred revenue |
|
- |
|
|
|
22,262 |
|
Total current liabilities |
|
18,483 |
|
|
|
42,894 |
|
|
|
|
|
Operating lease liabilities, non-current |
|
3,673 |
|
|
|
3,352 |
|
|
|
|
|
Commitments and contingencies |
|
- |
|
|
|
- |
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
Preferred
stock |
|
- |
|
|
|
- |
|
Common
stock |
|
50 |
|
|
|
47 |
|
Additional
paid-in capital |
|
641,195 |
|
|
|
587,223 |
|
Accumulated
deficit |
|
(392,317 |
) |
|
|
(400,727 |
) |
Accumulated
other comprehensive income |
|
73 |
|
|
|
170 |
|
Total
stockholders’ equity |
|
249,001 |
|
|
|
186,713 |
|
Total
liabilities and stockholders’ equity |
$ |
271,157 |
|
|
$ |
232,959 |
|
|
|
|
|
INVESTOR CONTACT:Janhavi MohiteStern Investor
Relations, Inc.212-362-1200 Janhavi.Mohite@sternir.com
MEDIA CONTACT:Claire LaCagnina6
Degrees315-765-1462 clacagnina@6degreespr.com
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