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, 2021.
“I am excited to be joining Cara at a
transformational point for the Company as it prepares for the
commercial launch of KORSUVA injection for the treatment of
moderate-to-severe pruritus associated with chronic kidney disease
in hemodialysis patients in the first half of 2022,” said
Christopher Posner, Cara’s newly appointed President and Chief
Executive Officer. “As Cara continues to develop Oral KORSUVA
across multiple patient populations, I believe the Company is
well-positioned to become the leader in the treatment of
itch-dominant medical conditions such as atopic dermatitis.”
“In the third quarter of 2021, Cara made
significant progress across our development programs, culminating
with the FDA approval of KORSUVA injection for moderate-to-severe
pruritus associated with chronic kidney disease in hemodialysis
patients,” said Derek Chalmers, Ph.D., D.Sc., President and Chief
Executive Officer of Cara Therapeutics. “We are also making
important clinical and regulatory progress with our Oral KORSUVA
programs. Following recent guidance from the FDA, we aim to
initiate Phase 3 programs with Oral Korsuva for the treatment of
moderate to severe pruritus in both atopic dermatitis and
non-dialysis dependent chronic kidney disease patients in the first
quarter of 2022. Finally, I would like to welcome Chris as Cara’s
new President and CEO. Having worked closely with Chris as a Cara
board member, I am confident in his ability to lead the Company
through its next phase of development as an early commercial-stage
biopharmaceutical company.”
Third Quarter and Recent
Developments:
Leadership Appointments
In November 2021, the Company announced the
appointment of Christopher Posner as President and Chief Executive
Officer of Cara Therapeutics, effective November 9, 2021. Mr.
Posner joins the Company from LEO Pharma, Inc., the US affiliate of
LEO Pharma A/S, a global leader in medical dermatology, where he
was President and Chief Executive Officer. Mr. Posner succeeds Dr.
Derek Chalmers, who will transition to a Senior Advisor Role to the
Company.
KORSUVA Injection: Chronic Kidney
Disease-Associated Pruritus (CKD-aP): Hemodialysis
In August 2021, the FDA approved KORSUVA
injection for the treatment of moderate-to-severe pruritus
associated with chronic kidney disease in adults undergoing
hemodialysis, making it the first and only therapy currently
approved by the FDA for treatment of this indication. The New Drug
Application for KORSUVA injection received Priority Review by the
FDA, granted to therapies that, if approved, would offer
significant improvements in the safety or effectiveness of the
treatment, diagnosis, or prevention of serious conditions when
compared to standard applications, and was supported by positive
data from two pivotal Phase 3 trials and supportive data from an
additional 32 clinical studies.
Following the FDA approval of KORSUVA injection,
the Company has been collaborating with its commercial partner,
Vifor Pharma, on the promotional launch of KORSUVA injection in the
United States. In September 2021, Vifor Pharma and Cara submitted
the required documentation to the U.S. Centers for Medicare and
Medicaid Services (CMS) to secure reimbursement for KORSUVA
injection. Vifor Pharma expects to initiate the commercial launch
of KORSUVA injection in the first half of 2022, subject to CMS
timelines.
In October 2020, Vifor Pharma and Cara agreed to
an exclusive license to commercialize KORSUVA in the United States.
That agreement features a Cara 60%, Vifor Pharma 40% profit-sharing
arrangement in non-Fresenius Medical Care clinics in the U.S. Under
the terms of this agreement, the Company received a $50.0 million
common stock investment from Vifor in October 2021 at a 20% premium
to the 30-day trailing average price of the Company’s common stock
for achievement of U.S. regulatory approval of KORSUVA injection.
In addition, the Company is eligible to receive up to $240.0
million upon the achievement of certain sales-based milestones.
Under another existing agreement, Vifor Fresenius Medical Care
Renal Pharma Ltd. (VFMCRP) and the Company agreed to market KORSUVA
injection to Fresenius Medical Care North America dialysis clinics
in the U.S. under a Cara 50%, Vifor Pharma 50% profit-sharing
arrangement. In October 2021, the Company received a $15.0 million
cash payment based on the achievement of U.S. regulatory approval
of KORSUVA injection.
In March 2021, the Company and VFMCRP announced
that the European Medicines Agency (EMA) accepted to review the
Marketing Authorization Application (MAA) for difelikefalin
injection for the treatment of pruritus associated with chronic
kidney disease in hemodialysis patients. The EMA will review the
application under the centralized marketing authorization
procedure. If approved, difelikefalin would receive marketing
authorization in all member states of the European Union (EU), as
well as in Iceland, Liechtenstein, and Norway. The EMA is expected
to render a decision on the EU MAA in the second quarter of
2022.
Oral KORSUVA: Atopic Dermatitis
(AD)
In April 2021, the Company announced top-line
results from its Phase 2 KARE dose-ranging clinical trial of Oral
KORSUVA for the treatment of moderate-to-severe pruritus in
mild-to-severe atopic dermatitis patients. While the study did not
meet its primary endpoint, in a pre-specified analysis of
mild-to-moderate (BSA <10%) AD patients (64% of ITT patient
population), the study met its primary endpoint of WI-NRS change
and secondary endpoint of 4-point responder analysis in this
patient population. Additionally, a statistically significant
improvement was demonstrated in the 4-point responder analysis,
which we expect will be the Phase 3 registrational endpoint, in
mild-to-moderate AD patients, with 32% of KORSUVA-treated patients
achieving a greater than 4-point reduction vs. 19% in placebo group
(p=0.03). Oral KORSUVA was generally well-tolerated across all
doses.
In the third quarter, the Company held an
End-of-Phase 2 Meeting with the FDA to discuss the results from its
Phase 2 KARE dose-ranging clinical trial of Oral KORSUVA for the
treatment of moderate-to-severe pruritus in atopic dermatitis
patients. Based on meeting guidance, the Company plans to initiate
a Phase 3 program in AD patients in the first quarter of 2022.
Oral KORSUVA: Non-Dialysis Dependent
(NDD) CKD-aP
In April 2021, the Company held an End-of-Phase
2 Meeting with the FDA to discuss the results of the Phase 2 trial
of Oral KORSUVA in NDD CKD-aP and the potential Phase 3 program.
Based on meeting guidance, the FDA indicated the acceptability of
Stage 5 pre-dialysis CKD patients as a viable patient population
for a Phase 3 trial.
In November 2021, the FDA provided written
guidance indicating the patient population can be expanded to
include the group of Stage 4 pre-dialysis patients with advanced
CKD in a registration program consisting of two pivotal Phase 3
clinical trials. The Company expects to initiate this registration
program in the first quarter of 2022.
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 continues to screen
patients in this ongoing Phase 2 trial and, primarily due to the
ongoing effects of the COVID-19 pandemic on patient enrollment,
currently expects to report top-line data in the first half of
2022.
Oral KORSUVA: Notalgia Paresthetica
(NP)
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 back, in early 2021. The Phase 2
trial remains on track to be fully enrolled by year-end.
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 4-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. The Company is working
closely with its clinical and commercial manufacturing partners to
continue to ensure sufficient supply of KORSUVA is available for
the commercial launch of KORSUVA injection and its ongoing and
planned clinical trials.
Upcoming Meeting Activities
The Company expects to make presentations at the
following upcoming conferences:
- Stifel Healthcare Conference,
November 15-17, 2021
- Jefferies Global Healthcare
Conference, November 16-18, 2021
- Piper Sandler Health Care
Conference, November 30-December 2, 2021
- J.P. Morgan Healthcare Conference,
January 10-13, 2022
- 2022 Winter Clinical Dermatology
Conference – Hawaii, January 14-19, 2022
Third Quarter 2021 Financial
Results
Cash, cash equivalents and marketable securities
at September 30, 2021 totaled $193.4 million compared to $251.5
million at December 31, 2020. The decrease in the balance primarily
resulted from cash used in operating activities of $58.8 million,
partially offset by proceeds of $1.3 million from the exercise of
stock options.
For the three months ended September 30, 2021,
net loss was $1.0 million, or $0.02 per basic and diluted share,
compared to a net loss of $16.5 million, or $0.35 per basic and
diluted share, for the same period in 2020.
Revenues: Revenue for the three months ended
September 30, 2021 and 2020 was $20.3 million and $9.3 million,
respectively. License and milestone fees revenue of $20.0 million
for the three months ended September 30, 2021 was related to the
milestone payments the Company earned from Vifor (International)
Ltd. (Vifor) and VFMCRP that was allocated to the license fee
performance obligation under the Vifor and VFMCRP agreements, as
the variable consideration was deemed probable upon the regulatory
approval of KORSUVA injection in August 2021. This included $5.0
million of the $50.0 million equity milestone investment under the
agreement with Vifor. License and milestone fees revenue of $9.3
million for the three months ended September 30, 2020 was related
to license fees earned by us in connection with the VFMCRP
Agreement.
Research and Development (R&D) Expenses:
R&D expenses were $15.5 million for the three months ended
September 30, 2021 compared to $21.1 million in the same period of
2020. The lower R&D expenses in 2021 were principally due to a
net decrease in costs associated with clinical trials and a $2.5
million milestone earned by Enteris Biopharma, Inc. during the
three months ended September 30, 2020, partially offset by
increases in stock compensation expense, payroll and related costs,
and cost of compound sales.
General and Administrative (G&A) Expenses:
G&A expenses were $5.9 million for the three months ended
September 30, 2021 compared to $5.2 million in the same period of
2020. The higher G&A expenses in 2021 were principally due
to an increase in stock compensation expense, consultants’ costs,
legal fees, and insurance costs, partially offset by decreases in
commercial costs.
Other Income, net: Other income, net was $0.1
million for the three months ended September 30, 2021 compared to
$0.4 million in the same period of 2020. The decrease in other
income, net was primarily due to a decrease in interest income and
an increase in net amortization expense of available-for-sale
marketable securities resulting from a lower yield on the Company’s
portfolio of investments in the 2021 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 September 30, 2021,
including the milestone payments received in October 2021 of $65.0
million from Vifor and VFMCRP, will be sufficient to fund its
currently anticipated operating expenses and capital expenditures
through 2023, without giving effect to any additional 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 third quarter 2021 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 1480703. 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 an early commercial-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
the body’s peripheral nervous system, as well as certain immune
cells. KORSUVA injection was approved by the FDA for the
treatment of moderate-to-severe CKD-aP in adults undergoing
hemodialysis on August 23, 2021. Oral KORSUVA has completed
Phase 2 trials for the treatment of pruritus in patients with CKD
and AD and is currently in Phase 2 trials in PBC and NP patients
with moderate-to-severe pruritus.
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 commercialize KORSUVA injection, including the
timing of additional regulatory submissions and approvals, the
Company’s ability to obtain and maintain coverage and adequate
reimbursement for KORSUVA injection, the performance of our
commercial partners, including Vifor Pharma, 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, the Company’s expected cash reach,
and the potential impact of COVID-19 on the Company’s commercial
launch, 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
|
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, |
|
|
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
License and milestone fees |
|
$ |
20,031 |
|
$ |
9,257 |
|
$ |
21,223 |
|
$ |
22,377 |
|
|
Collaborative revenue |
|
- |
|
- |
|
706 |
|
- |
|
|
Clinical
compound revenue |
|
241 |
|
9 |
|
278 |
|
616 |
|
Total revenue |
|
20,272 |
|
9,266 |
|
22,207 |
|
22,993 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
15,514 |
|
21,067 |
|
59,870 |
|
80,711 |
|
|
General and
administrative |
|
5,882 |
|
5,219 |
|
17,898 |
|
15,187 |
|
Total operating expenses |
|
21,396 |
|
26,286 |
|
77,768 |
|
95,898 |
|
Operating loss |
|
(1,124) |
|
(17,020) |
|
(55,561) |
|
(72,905) |
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
111 |
|
379 |
|
502 |
|
1,970 |
|
Loss before benefit from income taxes |
|
(1,013) |
|
(16,641) |
|
(55,059) |
|
(70,935) |
|
|
|
|
|
|
|
|
|
|
|
|
Benefit from income taxes |
|
- |
|
132 |
|
- |
|
436 |
|
Net loss |
|
$ |
(1,013) |
|
$ |
(16,509) |
|
$ |
(55,059) |
|
$ |
(70,499) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
|
|
Basic and Diluted |
|
$ |
(0.02) |
|
$ |
(0.35) |
|
$ |
(1.10) |
|
$ |
(1.51) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
|
|
Basic and Diluted |
|
50,114,710 |
|
46,885,424 |
|
$ |
50,031,615 |
|
46,803,659 |
|
|
|
|
|
|
|
|
|
|
|
|
CARA
THERAPEUTICS, INC. |
|
CONDENSED
BALANCE SHEETS |
|
(in thousands) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
September
30, |
December 31, |
|
|
|
|
2021 |
|
2020 |
|
|
|
|
|
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
22,991 |
|
|
$ |
31,683 |
|
|
|
Marketable
securities |
|
|
121,203 |
|
|
|
149,242 |
|
|
|
Income tax
receivable |
|
|
697 |
|
|
|
1,507 |
|
|
|
Other
receivables |
|
|
20,350 |
|
|
|
557 |
|
|
|
Prepaid
expenses |
|
|
6,258 |
|
|
|
12,076 |
|
|
Total current assets |
|
|
171,499 |
|
|
|
195,065 |
|
|
|
Operating
lease right-of-use assets |
|
|
3,310 |
|
|
|
4,279 |
|
|
|
Marketable
securities, non-current |
|
|
49,221 |
|
|
|
70,565 |
|
|
|
Property and
equipment, net |
|
|
654 |
|
|
|
840 |
|
|
|
Restricted
cash |
|
|
408 |
|
|
|
408 |
|
|
Total assets |
|
$ |
225,092 |
|
|
$ |
271,157 |
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts
payable and accrued expenses |
|
$ |
13,812 |
|
|
$ |
16,881 |
|
|
|
Operating
lease liabilities, current |
|
|
1,716 |
|
|
|
1,602 |
|
|
Total current liabilities |
|
|
15,528 |
|
|
|
18,483 |
|
|
|
|
|
|
|
|
|
|
Operating
lease liabilities, non-current |
|
|
2,373 |
|
|
|
3,673 |
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred
stock |
|
|
- |
|
|
|
- |
|
|
|
Common
stock |
|
|
50 |
|
|
|
50 |
|
|
|
Common stock
subscribed in Vifor stock purchase |
|
|
3 |
|
|
|
- |
|
|
|
Additional
paid-in capital |
|
|
699,482 |
|
|
|
641,195 |
|
|
|
Stock
subscription receivable |
|
|
(44,969 |
) |
|
|
- |
|
|
|
Accumulated
deficit |
|
|
(447,376 |
) |
|
|
(392,317 |
) |
|
|
Accumulated
other comprehensive income |
|
|
1 |
|
|
|
73 |
|
|
Total stockholders’ equity |
|
|
207,191 |
|
|
|
249,001 |
|
|
Total liabilities and stockholders’ equity |
|
$ |
225,092 |
|
|
$ |
271,157 |
|
|
|
|
|
|
|
|
|
MEDIA CONTACT:Annie Spinetta6
Degrees973-768-2170 aspinetta@6degreespr.com
INVESTOR CONTACT:Janhavi MohiteStern IR,
Inc.212-362-1200 janhavi.mohite@SternIR.com
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