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 second quarter ended June 30, 2019.
“We were very pleased with the progress made
across our late stage clinical pipeline this quarter, including
positive top-line data from our KALM-1 pivotal Phase 3 trial of
KORSUVA Injection for chronic kidney disease-associated pruritus
(CKD-aP) in hemodialysis patients, as well as the successful
completion of the Interim Statistical Assessment of our Phase 2
trial of Oral KORSUVA™ for CKD-aP in non-hemodialysis patients,”
said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive
Officer of Cara Therapeutics. “With a strengthened balance sheet
from our recently completed follow-on offering, the Company is well
positioned to deliver on a number of significant clinical
milestones by year end, including top-line data from both our
KALM-2 pivotal Phase 3 trial and Oral KORSUVA™ Phase 2 CKD-aP
trial.”
Second Quarter and Recent
Developments:
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, which includes the full exercise of the underwriters’
option to purchase 825,000 additional shares of common stock at
$23.00 per share. The Company received net proceeds of
approximately $136.4 million after deducting underwriting discounts
and commissions and estimated offering expenses payable by the
Company.
KORSUVA™ (CR845/difelikefalin) Injection
Phase 3 Program: Chronic Kidney Disease-Associated Pruritus
(CKD-aP): Hemodialysis
In May 2019, the Company announced positive
top-line data from the KALM-1 pivotal Phase 3 trial of KORSUVA
Injection in hemodialysis patients with moderate-to-severe CKD-aP.
The trial met the primary endpoint, with a statistically
significant improvement in the proportion of patients on KORSUVA
Injection achieving a three-point or greater improvement in the
mean Worst Itching Intensity Numeric Rating Scale versus placebo
(p=0.000019). In addition, the trial also met all secondary
endpoints and was generally well-tolerated through 12 weeks of
treatment with a safety profile consistent with prior clinical
trials.
The Company continues to enroll patients in the
United States, Europe and Asia Pacific in KALM-2, the global Phase
3 efficacy trial of KORSUVA Injection. Based on current patient
enrollment projections, the Company expects top-line data from this
trial in the fourth quarter of 2019.
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 165 patients having completed at least
6 months of treatment and over 50% of these patients having
completed 1 year of treatment. The Company’s 12-week open-label
safety trial, launched this quarter, is expected to enroll up to
400 patients.
Oral KORSUVA: CKD-aP: Non-Hemodialysis
In July 2019, based on the recommendation of the
Independent Data Monitoring Committee, 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 CKD-aP. 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 announced the
initiation of 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.
Oral KORSUVA: Chronic Liver Disease-Associated Pruritus
(CLD-aP): Primary Biliary Cholangitis (PBC)
In June 2019, the Company announced the
initiation of 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 KOSRUVA (1 mg tablet,
twice daily) versus placebo for 16 weeks.
Upcoming Activities
The Company expects to make presentations at the following
conferences:
- Cantor Fitzgerald Global Healthcare Conference, October 2-4,
2019
- European Academy of Dermatology and Venereology, October 9-13,
2019
- Stifel Healthcare Conference, November 19-20, 2019
- Jefferies Global Healthcare Conference, November 20-21,
2019
- Piper Jaffray Health Care Conference, December 3-5, 2019
Second Quarter 2019 Financial Results
Net Loss: The Company reported a net loss of
$23.0 million, or $0.58 per basic and diluted share, for the second
quarter of 2019 compared to a net loss of $17.2 million, or $0.52
per basic and diluted share, for the second quarter of 2018.
Revenues: Total revenue of $5.2 million and $2.9
million for the three months ended June 30, 2019 and 2018,
respectively, 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.
Research and Development (R&D) Expenses:
R&D expenses were $24.4 million for the three months ended June
30, 2019 compared to $17.0 million for the three months ended June
30, 2018. The higher R&D expenses in 2019 were primarily due to
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 $5.0 million for the three months ended June
30, 2019 compared to $3.7 million for the three months ended June
30, 2018. The increase in 2019 was primarily due to increases
in stock-based compensation expense, payroll and related costs, and
franchise taxes.
Other Income: Other income was $947,000 for the
three months ended June 30, 2019 compared to $467,000 for the three
months ended June 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 June 30, 2019, cash and cash equivalents
and marketable securities totaled $135.6 million compared to $182.8
million at December 31, 2018. The decrease in the balance of cash
and cash equivalents and marketable securities primarily resulted
from cash used in operations of $52.4 million, partially offset by
proceeds of $4.2 million from the exercise of stock options.
Additionally, in July 2019, the Company raised
approximately $136.4 million in net proceeds from a public offering
of 6,325,000 shares of its common stock.
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 June 30, 2019, as well as approximately
$136.4 million of net proceeds from the Company’s public offering
in July 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 second 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 6576266. 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 PBC.
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 expected timing for initiation of the
Company’s planned clinical trials, the potential results of ongoing
and planned clinical trials, 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, 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 June 30, |
|
Six Months Ended June 30, |
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
License and milestone fees
revenue |
|
$ |
5,208 |
|
|
$ |
2,874 |
|
|
$ |
9,450 |
|
|
$ |
2,874 |
|
|
Clinical compound revenue |
|
|
- |
|
|
|
- |
|
|
|
140 |
|
|
|
- |
|
Total revenue |
|
|
5,208 |
|
|
|
2,874 |
|
|
|
9,590 |
|
|
|
2,874 |
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
24,356 |
|
|
|
17,002 |
|
|
|
47,964 |
|
|
|
30,429 |
|
|
General and
administrative |
|
|
4,994 |
|
|
|
3,685 |
|
|
|
8,902 |
|
|
|
7,382 |
|
Total operating
expenses |
|
|
29,350 |
|
|
|
20,687 |
|
|
|
56,866 |
|
|
|
37,811 |
|
Operating
loss |
|
|
(24,142 |
) |
|
|
(17,813 |
) |
|
|
(47,276 |
) |
|
|
(34,937 |
) |
|
|
|
|
|
|
|
|
|
|
Other
income |
|
|
947 |
|
|
|
467 |
|
|
|
2,036 |
|
|
|
778 |
|
Loss before
benefit from income taxes |
|
|
(23,195 |
) |
|
|
(17,346 |
) |
|
|
(45,240 |
) |
|
|
(34,159 |
) |
|
|
|
|
|
|
|
|
|
|
Benefit from
income taxes |
|
|
235 |
|
|
|
152 |
|
|
|
320 |
|
|
|
198 |
|
Net loss |
|
$ |
(22,960 |
) |
|
$ |
(17,194 |
) |
|
$ |
(44,920 |
) |
|
$ |
(33,961 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss per
share: |
|
|
|
|
|
|
|
|
Basic and Diluted |
|
$ |
(0.58 |
) |
|
$ |
(0.52 |
) |
|
$ |
(1.13 |
) |
|
$ |
(1.03 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average
shares: |
|
|
|
|
|
|
|
|
Basic and Diluted |
|
|
39,818,162 |
|
|
|
33,315,809 |
|
|
|
39,685,954 |
|
|
|
33,000,487 |
|
|
|
|
|
|
|
|
|
|
|
|
CARA THERAPEUTICS, INC. |
CONDENSED BALANCE SHEETS |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
December 31, |
|
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
Current
assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
18,494 |
|
|
$ |
15,081 |
|
|
Marketable securities |
|
|
96,815 |
|
|
|
146,302 |
|
|
Income tax receivable |
|
|
984 |
|
|
|
664 |
|
|
Other receivables |
|
|
605 |
|
|
|
926 |
|
|
Prepaid expenses |
|
|
7,512 |
|
|
|
4,805 |
|
|
Restricted cash, current |
|
|
361 |
|
|
|
361 |
|
Total current
assets |
|
|
124,771 |
|
|
|
168,139 |
|
|
Operating lease right-of-use asset |
|
|
3,344 |
|
|
|
- |
|
|
Marketable securities, non-current |
|
|
20,320 |
|
|
|
21,396 |
|
|
Property and equipment,
net |
|
|
798 |
|
|
|
880 |
|
|
Restricted cash |
|
|
408 |
|
|
|
408 |
|
Total assets |
|
$ |
149,641 |
|
|
$ |
190,823 |
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
Current
liabilities: |
|
|
|
|
Accounts payable and accrued
expenses |
|
$ |
12,766 |
|
|
$ |
13,622 |
|
|
Operating lease liability, current |
|
|
923 |
|
|
|
- |
|
|
Current portion of deferred
revenue |
|
|
26,473 |
|
|
|
26,825 |
|
Total current
liabilities |
|
|
40,162 |
|
|
|
40,447 |
|
|
|
|
|
|
|
Operating lease liability, non-current |
|
|
3,849 |
|
|
|
- |
|
|
Deferred revenue,
non-current |
|
|
6,085 |
|
|
|
15,184 |
|
|
Deferred lease obligation |
|
|
- |
|
|
|
1,562 |
|
|
|
|
|
|
Commitments and
contingencies |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
Preferred stock |
|
|
- |
|
|
|
- |
|
|
Common stock |
|
|
40 |
|
|
|
39 |
|
|
Additional paid-in
capital |
|
|
438,614 |
|
|
|
428,059 |
|
|
Accumulated deficit |
|
|
(339,274 |
) |
|
|
(294,354 |
) |
|
Accumulated other
comprehensive income (loss) |
|
165 |
|
|
|
(114 |
) |
Total
stockholders’ equity |
|
|
99,545 |
|
|
|
133,630 |
|
Total liabilities
and stockholders’ equity |
|
$ |
149,641 |
|
|
$ |
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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