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 third quarter ended September
30, 2020.
“In the third quarter, we built on the progress
of the first half of the year and have made significant
advancements in our clinical development programs for both KORSUVA™
(CR845/difelikefalin) Injection and Oral KORSUVA. With our pivotal
Phase 3 program for KORSUVA Injection for chronic kidney
disease-associated pruritus (CKD-aP) in hemodialysis patients
complete, we remain on track to submit a New Drug Application (NDA)
to the U.S. Food and Drug Administration (FDA) in the fourth
quarter,” said Derek Chalmers, Ph.D., D.Sc., President and Chief
Executive Officer of Cara Therapeutics. “Furthermore, we were very
pleased to recently enter into a commercial license agreement with
Vifor (International) Ltd. (Vifor) which we believe will provide
significant momentum for the launch and adoption of KORSUVA
Injection in the U.S. dialysis market, if approved. Looking ahead,
we anticipate significant progress for our Oral KORSUVA programs in
the coming quarters, including the completion of an End of Phase 2
Meeting with the FDA for CKD-aP non-hemodialysis patients in early
2021 and top-line data readout for our KARE Phase 2 dose-ranging
trial in atopic dermatitis patients, anticipated in the first half
of 2021.”
Third Quarter and
Recent Developments:
KORSUVA Injection: Chronic Kidney
Disease-Associated Pruritus (CKD-aP): Hemodialysis
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.
The Company remains on track to submit an NDA
for KORSUVA Injection to the FDA in the fourth quarter of 2020.
Oral KORSUVA: CKD-aP:
Non-Hemodialysis
Following the announcement of 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 in December 2019, the Company plans to
conduct an End of Phase 2 Meeting with the FDA in the first quarter
of 2021. Additionally, the Company intends to initiate the safety
portion of the Phase 3 program in the fourth quarter of 2020 prior
to the meeting.
Oral KORSUVA: Atopic Dermatitis
(AD)
The Company is currently conducting the ongoing KARE Phase 2
dose-ranging trial of Oral KORSUVA for the treatment of
moderate-to-severe pruritus in 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 4-week active extension phase.
The Company continues to expect that the trial will be fully
enrolled in the fourth quarter of 2020 and anticipates reporting
top-line results in the first half of 2021, subject to any delays
related to the effects of 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
first half of 2021, due in part to delays related to the ongoing
COVID-19 pandemic.
Appointments
In October 2020, the Company appointed Thomas Reilly, M.B.A., as
Chief Financial Officer of Cara Therapeutics. Mr. Reilly is
responsible for overseeing the Company’s financial strategy and
activities related to accounting, capital markets, and business
operations. Mr. Reilly previously served as the Finance Head for
the U.S. General Medicine Commercial Business at Allergan, now part
of AbbVie.
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 primarily work remotely and business travel
has been restricted.
Upcoming Activities
The Company expects to make presentations at the
following upcoming conferences:
-
Stifel Healthcare Conference, November 16-18, 2020
-
Jefferies Global Healthcare Conference, November 17-19, 2020
-
Piper Sandler Healthcare Conference, December 1-3, 2020
-
J.P. Morgan Healthcare Conference, January 11-14, 2021
Third Quarter
2020 Financial
Results
Net Loss: Net loss was $16.5 million, or $0.35
per basic and diluted share, for the three months ended September
30, 2020, compared to a net loss of $32.8 million, or $0.74 per
basic and diluted share, for the same period of 2019.
Revenues: Total revenue was $9.3 million for the
three months ended September 30, 2020, compared to $5.8 million
during the same period of 2019. Total revenue primarily consisted
of:
- The Company recognized $9.3 million
and $5.8 million of license and milestone fees revenue for the
three months ended September 30, 2020 and 2019, respectively,
related to license fees earned in connection with its license
agreement with Vifor Fresenius Medical Care Renal Pharma Ltd.
(VFMCRP).
Research and Development (R&D) Expenses:
R&D expenses were $21.1 million for the three months ended
September 30, 2020 compared to $36.0 million for the three months
ended September 30, 2019. The lower R&D expenses in 2020 were
primarily due to a net decrease in clinical trial costs, an $8.0
million upfront payment made upon entering the license agreement
with Enteris BioPharma, Inc. (Enteris) in 2019, and a decrease in
travel and related costs, partially offset by increases in
stock-based compensation expense, payroll and related costs, and a
$2.5 million milestone earned by Enteris in 2020.
General and Administrative (G&A) Expenses:
G&A expenses were $5.2 million for the three months ended
September 30, 2020 compared to $4.2 million for the three months
ended September 30, 2019. The increase in 2020 was primarily
due to increases in insurance costs, franchise taxes, payroll and
related costs, and commercial costs, partially offset by decreases
in consultants’ costs.
Other Income, Net: Other income, net was
$379,000 for the three months ended September 30, 2020 compared to
$1.3 million for the three months ended September 30, 2019. The
decrease in 2020 was due to a decrease in net accretion income and
a decrease in interest income resulting from a lower yield on the
Company’s lower average balance of its portfolio of investments in
the 2020 period.
Cash and Cash Equivalents and Marketable
Securities Position: At September 30, 2020, cash and cash
equivalents and marketable securities totaled $131.4 million
compared to $218.2 million at December 31, 2019. The decrease in
the balance of cash and cash equivalents and marketable securities
primarily resulted from cash used in operations of $87.6 million,
partially offset by proceeds of $0.7 million from the exercise of
stock options.
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 September 30, 2020,
with the additional funding of $150.0 million from the license
agreement with Vifor in October 2020, will be sufficient to fund
its currently anticipated operating expenses and capital
expenditures into 2023, without giving effect to any potential
milestone payments under existing collaborations.
Conference Call
Cara management will host a conference call
today at 4:30 p.m. ET to discuss third quarter 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 2192536. A live webcast of the call can
be accessed under "Events & 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 and PBC patients
with moderate-to-severe pruritus.
The FDA has 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, including the Company’s projected timeline for the
submission of its NDA 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 Quarterly Report on Form 10-Q 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
|
|
CARA THERAPEUTICS, INC. |
CONDENSED STATEMENTS OF OPERATIONS |
(amounts in thousands, except share and per share data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
License and milestone fees |
|
$ 9,257 |
|
$ 5,785 |
|
$ 22,377 |
|
$ 15,235 |
|
Clinical compound revenue |
|
9 |
|
- |
|
616 |
|
140 |
Total revenue |
|
9,266 |
|
5,785 |
|
22,993 |
|
15,375 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
21,067 |
|
35,992 |
|
80,711 |
|
83,956 |
|
General and administrative |
|
5,219 |
|
4,226 |
|
15,187 |
|
13,128 |
Total operating expenses |
|
26,286 |
|
40,218 |
|
95,898 |
|
97,084 |
Operating loss |
|
(17,020) |
|
(34,433) |
|
(72,905) |
|
(81,709) |
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
379 |
|
1,261 |
|
1,970 |
|
3,297 |
Loss before benefit from income taxes |
|
(16,641) |
|
(33,172) |
|
(70,935) |
|
(78,412) |
|
|
|
|
|
|
|
|
|
|
Benefit from income taxes |
|
132 |
|
330 |
|
436 |
|
650 |
Net loss |
|
$ (16,509) |
|
$ (32,842) |
|
$ (70,499) |
|
$ (77,762) |
|
|
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
|
Basic and Diluted |
|
$ (0.35) |
|
$ (0.74) |
|
$ (1.51) |
|
$ (1.88) |
|
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
|
Basic and Diluted |
|
46,885,424 |
|
44,517,134 |
|
46,803,659 |
|
41,314,044 |
|
|
|
|
|
|
|
|
|
|
CARA
THERAPEUTICS, INC. |
CONDENSED
BALANCE SHEETS |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
|
|
September
30, |
|
December 31, |
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
75,281 |
|
|
$ |
18,305 |
|
|
Marketable
securities |
|
|
45,588 |
|
|
|
136,701 |
|
|
Income tax
receivable |
|
|
1,252 |
|
|
|
816 |
|
|
Other
receivables |
|
|
462 |
|
|
|
971 |
|
|
Prepaid
expenses |
|
|
10,254 |
|
|
|
8,863 |
|
Total current assets |
|
|
132,837 |
|
|
|
165,656 |
|
|
Operating
lease right-of-use asset |
|
|
2,654 |
|
|
|
3,036 |
|
|
Marketable
securities, non-current |
|
|
10,506 |
|
|
|
63,159 |
|
|
Property and
equipment, net |
|
|
731 |
|
|
|
700 |
|
|
Restricted
cash |
|
|
408 |
|
|
|
408 |
|
Total assets |
|
$ |
147,136 |
|
|
$ |
232,959 |
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
Accounts
payable and accrued expenses |
|
$ |
15,057 |
|
|
$ |
19,665 |
|
|
Operating
lease liability, current |
|
|
1,030 |
|
|
|
967 |
|
|
Current
portion of deferred revenue |
|
|
511 |
|
|
|
22,262 |
|
Total current liabilities |
|
|
16,598 |
|
|
|
42,894 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating
lease liability, non-current |
|
|
2,691 |
|
|
|
3,352 |
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
|
Preferred
stock |
|
|
- |
|
|
|
- |
|
|
Common
stock |
|
|
47 |
|
|
|
47 |
|
|
Additional
paid-in capital |
|
|
598,663 |
|
|
|
587,223 |
|
|
Accumulated
deficit |
|
|
(471,226 |
) |
|
|
(400,727 |
) |
|
Accumulated
other comprehensive income |
|
|
363 |
|
|
|
170 |
|
Total stockholders’ equity |
|
|
127,847 |
|
|
|
186,713 |
|
Total liabilities and stockholders’ equity |
|
$ |
147,136 |
|
|
$ |
232,959 |
|
|
|
|
|
|
|
|
|
|
|
INVESTOR CONTACT:Janhavi
MohiteStern Investor Relations,
Inc.212-362-1200 Janhavi.Mohite@sternir.com
MEDIA CONTACT:Annie Starr6 Degrees973-415-8838
astarr@6degreespr.com
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