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, today announced financial results and
operational highlights for the third quarter ended September 30,
2019.
“During the quarter, we completed several key
clinical, financing and licensing objectives that position the
Company well to continue to achieve our clinical, regulatory and
commercial goals for later this year and next year,” said Derek
Chalmers, Ph.D., DSc., President and Chief Executive Officer of
Cara Therapeutics. “Based on the recent interim statistical
analysis of our KALM-2 Phase 3 global trial and the continued
progress with our two open-label safety trials, we continue to
maintain our projected timeline for the submission of our first New
Drug Application, or NDA, for KORSUVA Injection in dialysis
patients with chronic kidney disease-associated pruritus, or
CKD-aP, in the second half of 2020. In addition, our Phase 2 trial
of Oral KORSUVA in non-hemodialysis patients with CKD-aP remains on
track to read out top-line data before year-end.”
Third Quarter and Recent
Developments:
KORSUVA™ (CR845/difelikefalin) Injection
Phase 3 Program: Chronic Kidney Disease-Associated Pruritus
(CKD-aP): Hemodialysis
In October 2019, the Company announced the completion of an
interim statistical assessment and a small increase in target
enrollment for its pivotal KALM-2 Phase 3 global trial of KORSUVA
Injection. Based on the recommendation of the Independent Data
Monitoring Committee, or IDMC, the size of the trial will be
increased from an original enrollment target of 350 patients to 430
patients. The prespecified interim conditional power assessment was
conducted after approximately 50% of the targeted 350 patients
completed the designated 12-week treatment period. The Company
expects the trial to be fully enrolled in the fourth quarter of
2019 and remains on track to file the NDA for KORSUVA Injection in
the second half of 2020.
Additionally, the Company continues to enroll two open-label
safety trials, both of which are expected to support worldwide
registration filings of KORSUVA Injection. The Company’s long-term,
52-week open-label Phase 3 safety trial continues to progress, with
approximately 185 patients having completed at least 6 months of
treatment and over 100 of these patients having completed 1 year of
treatment. The Company’s 12-week open-label safety trial, launched
in the second quarter of 2019, is expected to enroll up to 250
patients.
Oral KORSUVA: CKD-aP: Non-Hemodialysis
In July 2019, based on the recommendation of the IDMC, the
Company announced that the Phase 2 trial of Oral KORSUVA will
continue as planned with no changes to the original enrollment
target of 240 stage III-V CKD patients with moderate-to-severe
pruritus. The prespecified interim conditional power assessment was
conducted after approximately 50% of the 240 patients had completed
the designated 12-week treatment period. The Company also announced
the completion of enrollment in the Phase 2 trial and expects
top-line data from this trial in the fourth quarter of 2019.
Oral KORSUVA: Atopic Dermatitis (AD)
In July 2019, the Company initiated a Phase 2 trial of Oral
KORSUVA for the treatment of pruritus in patients with AD,
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. Top-line
data from this trial are expected in 2020.
Oral KORSUVA: Chronic Liver Disease-Associated Pruritus
(CLD-aP): Primary Biliary Cholangitis (PBC)
The Company continues to screen patients in the ongoing 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 KOSRUVA (1.0 mg tablet, twice daily)
versus placebo for 16 weeks. We aim to have top-line data from this
trial in 2020.
Enteris BioPharma, Inc. License
Agreement
In August 2019, the Company entered into a non-exclusive
commercial license agreement with Enteris BioPharma, Inc., or
Enteris, for oral formulation rights to Enteris’ Peptelligence®
Technology to develop and commercialize Oral KORSUVA in any
indication worldwide, excluding South Korea and Japan. Under the
terms of the agreement, the Company paid an upfront fee equal to
$8.0 million, consisting of $4.0 million in cash and $4.0 million
in shares of the Company’s common stock. The Company is also
obligated to pay Enteris certain development, regulatory and tiered
commercial milestone payments, as well as low, single-digit
royalties based on net sales in the licensed territory. Until the
second anniversary of the entry into the License Agreement, the
Company has the right, but not the obligation, to terminate its
obligation to pay any royalties under the License Agreement in
exchange for a lump sum payment.
Follow-on Public Offering
In July 2019, the Company issued and sold 6,325,000 shares of
its common stock in a follow-on public offering at $23.00 per
share, including the full exercise of the underwriters’ option to
purchase 825,000 additional shares of common stock. The Company
received net proceeds of approximately $136.5 million after
deducting underwriting discounts and commissions and estimated
offering expenses payable by the Company.
Upcoming Activities
The Company expects to make presentations at the following
conferences:
- Kidney Week 2019, November 5-10, 2019 (late breaking oral
presentation of pivotal Phase 3 KALM-1 trial results)
- World Congress of Itch, November 17-19, 2019
- Stifel Healthcare Conference, November 19-20, 2019
- Jefferies Global Healthcare Conference, November 20-21,
2019
- Piper Jaffray Healthcare Conference, December 3-5, 2019
Third Quarter 2019 Financial Results
Net Loss: The Company reported a net loss of
$32.8 million, or $0.74 per basic and diluted share, for the third
quarter of 2019 compared to a net loss of $19.4 million, or $0.51
per basic and diluted share, for the third quarter of 2018.
Revenues: Total revenue of $5.8 million for the
three months ended September 30, 2019 consisted of license and
milestone fees revenue that was recognized by the Company related
to its license agreement with Vifor Fresenius Medical Care Renal
Pharma Ltd, or Vifor.
Total revenue of $5.1 million for the three
months ended September 30, 2018 consisted of license and milestone
fees revenue of $5.0 million that was recognized by the Company
related to its license agreement with Vifor as well as clinical
compound revenue of $33,000, which was related to the sale of
clinical compound to Maruishi Pharmaceutical Co., Ltd.
Research and Development (R&D) Expenses:
R&D expenses were $36.0 million for the three months ended
September 30, 2019 compared to $22.3 million for the three months
ended September 30, 2018. The higher R&D expenses in 2019 were
primarily due to the $8.0 million upfront payment made upon
entering into the license agreement with Enteris, a net increase in
clinical trial costs, as well as increases in stock-based
compensation expense and payroll and related costs.
General and Administrative (G&A) Expenses:
G&A expenses were $4.2 million for the three months ended
September 30, 2019 compared to $3.2 million for the three months
ended September 30, 2018. The increase in 2019 was primarily
due to increased consultants’ costs and accounting fees, as well as
increases in stock-based compensation expense.
Other Income: Other income was $1.3 million for
the three months ended September 30, 2019 compared to $1.0 million
for the three months ended September 30, 2018. The increase in 2019
was due to an increase in interest and accretion income resulting
from a higher average balance of the Company’s portfolio of
investments in the 2019 period.
Cash and Cash Equivalents and Marketable
Securities Position: At September 30, 2019, cash and cash
equivalents and marketable securities totaled $249.1 million
compared to $182.8 million at December 31, 2018. The increase in
the balance of cash and cash equivalents and marketable securities
primarily resulted from net proceeds of $136.5 million from the
sale of the Company’s common stock in a follow-on public offering
in July 2019 and proceeds of $6.1 million from the exercise of
stock options, partially offset by cash used in operations of $78.1
million.
Financial Guidance
Based on timing expectations and projected costs
for current clinical development plans, Cara expects that its
existing cash and cash equivalents and available-for-sale
marketable securities as of September 30, 2019 will be sufficient
to fund its currently anticipated operating expenses and capital
expenditures into the second half of 2021, 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 2019 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 9284479. 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 kappa opioid receptors, or 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 a Phase 3 and two Phase 2 trials, KORSUVA
(CR845/difelikefalin) 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 and is
currently being investigated in Phase 3 trials in hemodialysis
patients with CKD-aP. Oral KORSUVA is in Phase 2 trials for the
treatment of pruritus in patients with CKD, AD and primary biliary
cholangitis.
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 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 first NDA, the potential for the
Company’s product candidates to be alternatives in the therapeutic
areas investigated, and the Company’s expected cash reach. 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 ended December
31, 2018 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, |
|
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
License and milestone fees
revenue |
|
$ |
5,785 |
|
|
$ |
5,029 |
|
|
$ |
15,235 |
|
|
$ |
7,903 |
|
|
|
Clinical compound revenue |
|
|
- |
|
|
|
33 |
|
|
|
140 |
|
|
|
33 |
|
|
Total revenue |
|
|
5,785 |
|
|
|
5,062 |
|
|
|
15,375 |
|
|
|
7,936 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
35,992 |
|
|
|
22,303 |
|
|
|
83,956 |
|
|
|
52,732 |
|
|
|
General and
administrative |
|
|
4,226 |
|
|
|
3,227 |
|
|
|
13,128 |
|
|
|
10,609 |
|
|
Total operating
expenses |
|
|
40,218 |
|
|
|
25,530 |
|
|
|
97,084 |
|
|
|
63,341 |
|
|
Operating
loss |
|
|
(34,433 |
) |
|
|
(20,468 |
) |
|
|
(81,709 |
) |
|
|
(55,405 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other income |
|
|
1,261 |
|
|
|
1,002 |
|
|
|
3,297 |
|
|
|
1,780 |
|
|
Loss before
benefit from income taxes |
|
|
(33,172 |
) |
|
|
(19,466 |
) |
|
|
(78,412 |
) |
|
|
(53,625 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Benefit from
income taxes |
|
|
330 |
|
|
|
66 |
|
|
|
650 |
|
|
|
264 |
|
|
Net loss |
|
$ |
(32,842 |
) |
|
$ |
(19,400 |
) |
|
$ |
(77,762 |
) |
|
$ |
(53,361 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share: |
|
|
|
|
|
|
|
|
|
Basic and
Diluted |
|
$ |
(0.74 |
) |
|
$ |
(0.51 |
) |
|
$ |
(1.88 |
) |
|
$ |
(1.54 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares: |
|
|
|
|
|
|
|
|
|
Basic and
Diluted |
|
|
44,517,134 |
|
|
|
38,034,216 |
|
|
|
41,314,044 |
|
|
|
34,696,835 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CARA THERAPEUTICS, INC. |
|
CONDENSED BALANCE SHEETS |
|
(in thousands) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
34,705 |
|
|
$ |
15,081 |
|
|
|
Marketable securities |
|
|
158,384 |
|
|
|
146,302 |
|
|
|
Income tax receivable |
|
|
1,033 |
|
|
|
664 |
|
|
|
Other receivables |
|
|
784 |
|
|
|
926 |
|
|
|
Prepaid expenses |
|
|
8,556 |
|
|
|
4,805 |
|
|
|
Restricted cash, current |
|
|
- |
|
|
|
361 |
|
|
Total current
assets |
|
|
203,462 |
|
|
|
168,139 |
|
|
|
Operating lease right-of-use asset |
|
|
3,192 |
|
|
|
- |
|
|
|
Marketable securities, non-current |
|
|
55,985 |
|
|
|
21,396 |
|
|
|
Property and equipment,
net |
|
|
748 |
|
|
|
880 |
|
|
|
Restricted cash |
|
|
408 |
|
|
|
408 |
|
|
Total assets |
|
$ |
263,795 |
|
|
$ |
190,823 |
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable and accrued
expenses |
|
$ |
20,581 |
|
|
$ |
13,622 |
|
|
|
Operating lease liability, current |
|
|
945 |
|
|
|
- |
|
|
|
Current portion of deferred
revenue |
|
|
26,773 |
|
|
|
26,825 |
|
|
Total current
liabilities |
|
|
48,299 |
|
|
|
40,447 |
|
|
|
|
|
|
|
|
|
|
Operating lease liability, non-current |
|
|
3,602 |
|
|
|
- |
|
|
|
Deferred revenue,
non-current |
|
|
- |
|
|
|
15,184 |
|
|
|
Deferred lease obligation |
|
|
- |
|
|
|
1,562 |
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
|
|
Preferred stock |
|
|
- |
|
|
|
- |
|
|
|
Common stock |
|
|
46 |
|
|
|
39 |
|
|
|
Additional paid-in
capital |
|
|
583,811 |
|
|
|
428,059 |
|
|
|
Accumulated deficit |
|
|
(372,116 |
) |
|
|
(294,354 |
) |
|
|
Accumulated other
comprehensive income (loss) |
|
153 |
|
|
|
(114 |
) |
|
Total
stockholders’ equity |
|
|
211,894 |
|
|
|
133,630 |
|
|
Total liabilities
and stockholders’ equity |
|
$ |
263,795 |
|
|
$ |
190,823 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INVESTOR CONTACT:Jane UrheimStern Investor
Relations, Inc. 212-362-1200 Jane.Urheim@SternIR.com
MEDIA CONTACT:Annie Starr6 Degrees973-415-8838
astarr@6degreespr.com
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