– Conference call today at 4:30 p.m. ET
–
Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company
focused on developing and commercializing new chemical entities
designed to alleviate pruritus and pain by selectively targeting
peripheral kappa opioid receptors, today announced financial
results and operational highlights for the third quarter ended
September 30, 2018.
“In the past few months, we made significant
clinical and corporate advancements, including the expanded pivotal
Phase 3 development of KORSUVA™ Injection for chronic kidney
disease-associated pruritus, or CKD-aP. We also strengthened our
balance sheet with the successful completion of our follow-on
offering and made key additions to our executive management team
and board,” said Derek Chalmers, Ph.D., D.Sc., President and Chief
Executive Officer of Cara Therapeutics. “We expect 2019 to be a
significant year for Cara, with anticipated readouts from both of
our pivotal Phase 3 trials of KORSUVA™ Injection in dialysis
patients with CKD-aP, and data from our ongoing Phase 2 trial of
Oral KORSUVA™ in non-dialysis patients with CKD-aP. We also expect
to initiate our clinical development program of Oral KORSUVA™ in
dermatological conditions.”
Third Quarter and Recent
Developments
Appointments:
- Chief Medical Officer - In October 2018, the
Company announced the appointment of Joana Goncalves, M.D., as
Chief Medical Officer (CMO). The Company’s former CMO, Dr. Joseph
Stauffer, has transitioned to a consulting role for the
Company.
- Member, Board of Directors - In August 2018,
the Company announced the appointment of Christopher A. Posner to
its Board of Directors. Mr. Posner currently serves as President
and CEO of LEO Pharma, Inc., the U.S. subsidiary of LEO Pharma A/S,
a global healthcare company specializing in dermatology and
critical care.
Offering of Common Stock
In July 2018, the Company completed a public
offering of 5,175,000 shares of its common stock, including the
full exercise of the underwriters’ option to purchase additional
shares at $19.00 per share, raising approximately $92.1 million in
net proceeds after deducting underwriting discounts and commissions
and offering expenses.
KORSUVA Injection: Chronic Kidney Disease-Associated
Pruritus (CKD-aP): Hemodialysis
In August 2018, the Company announced the dosing
of the first patient in the global pivotal Phase 3 efficacy trial
(KALM™-2) of KORSUVA (CR845/difelikefalin) Injection for the
treatment of CKD-aP in patients undergoing hemodialysis. Cara
continues to enroll patients in the U.S. Phase 3 trial (KALM-1)
and, based on current projections, anticipates completing the
planned interim assessment by year-end or early 2019 and completing
the trial’s 12-week treatment period by the first half of 2019.
Oral KORSUVA: Chronic Kidney Disease-Associated Pruritus
(CKD-aP): Non-Hemodialysis
In July 2018, the Company announced the dosing
of patients in a Phase 2 trial of Oral KORSUVA
(CR845/difelikefalin) for the treatment of pruritus in stage III-V
(moderate-to-severe) CKD patients, evaluating the safety and
efficacy of three dose levels (0.25 mg, 0.5 mg and 1.0 mg, once
daily) of Oral KORSUVA versus placebo.
Oral KORSUVA: Chronic Liver
Disease-Associated Pruritus (CLD-aP)
The Phase 1 pharmacokinetic and safety trial of
Oral KORSUVA in patients with CLD is fully enrolled and the Company
plans to announce top-line data within the fourth quarter of 2018.
Additionally, the Company expects to initiate a Phase 2 trial in
patients with moderate-to-severe CLD-associated pruritus (CLD-aP)
by year-end or early 2019.
Upcoming Meeting Activities
The Company expects to make presentations at the
following upcoming conferences:
- Stifel 2018 Healthcare Conference, November 13-14
- Jefferies 2018 London Healthcare Conference, November
14-15
- Piper Jaffray 30th Annual Healthcare Conference, November
27-28
- Dermatology Drug Development Summit 2018, November 27-28
Third Quarter 2018 Financial Results
Net Loss: The Company reported a net loss of
$19.4 million, or $0.51 per basic and diluted share, for the third
quarter of 2018 compared to a net loss of $12.4 million, or $0.38
per basic and diluted share, for the same quarter of 2017.
Revenues: The Company recognized $5.0 million of
license and milestone fee revenue during the third quarter of 2018
related to its license agreement with Vifor Fresenius Medical Care
Renal Pharma (VFMCRP), a joint company of Vifor Pharma Group and
Fresenius Medical Care. There was no license and milestone fee
revenue recognized during the third quarter of 2017.
The Company recognized $33,000 of clinical
compound revenue during the third quarter of 2018 in connection
with the sale of clinical compound to Maruishi Pharmaceutical Co.,
Ltd. There was no clinical compound revenue recognized during the
third quarter of 2017.
Research and Development (R&D) Expenses:
R&D expenses were $22.3 million in the third quarter of 2018
compared to $9.2 million in the same period of 2017. The higher
R&D expenses in 2018 were principally due to a net increase in
costs associated with clinical trials, as well as increases in
stock compensation expense and payroll and related costs for
R&D personnel. Those increases were partially offset by lower
costs associated with conferences.
General and Administrative (G&A) Expenses:
G&A expenses were $3.2 million during the third quarter of 2018
compared to $3.8 million in the same period of 2017. The
decrease in 2018 was primarily due to decreases in stock
compensation expense, rent, utilities and related costs. Those
decreases were partially offset by increased consultants’ costs and
legal fees.
Other Income: Other income was $1.0 million in
the third quarter of 2018 compared to $367,000 in the same period
of 2017. The increase in 2018 was primarily due to a higher average
balance of the Company’s portfolio of investments in the 2018
period.
Cash and Cash Equivalents and Marketable
Securities Position: At September 30, 2018, cash and cash
equivalents and marketable securities totaled $206.1 million
compared to $92.6 million at December 31, 2017. The increase in the
balance of cash and cash equivalents and marketable securities
primarily resulted from $92.1 million of net proceeds raised in a
follow-on offering of 5,175,000 shares of the Company’s common
stock in July 2018, proceeds of $70.0 million related to the
license agreement with VFMCRP (including upfront payment of $50.0
million in cash and $20.0 million of equity investment at premium),
and $3.6 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 cash and cash equivalents and available-for-sale
marketable securities as of September 30, 2018 will be sufficient
to fund its currently anticipated operating expenses and capital
expenditures into 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 2018 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 8739658. 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 and pain by
selectively targeting peripheral kappa opioid receptors (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. In Phase 2 trials,
KORSUVA Injection has demonstrated statistically significant
reductions in itch intensity and concomitant improvement in quality
of life measures in hemodialysis patients with moderate-to-severe
chronic kidney disease-associated pruritus (CKD-aP) and is
currently being investigated in Phase 3 trials in hemodialysis
patients with CKD-aP. Additionally, in a recently completed Phase
2/3 trial in post-operative patients, I.V. CR845/difelikefalin has
demonstrated reduction in moderate-to-severe pain, while also
reducing the incidence and intensity of nausea and vomiting
throughout the post-operative period.
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 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, 2017 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 EndedSeptember 30, |
|
Nine Months EndedSeptember 30, |
|
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
License and milestone
fees revenue |
|
$ |
5,029 |
|
|
$ |
- |
|
|
$ |
7,903 |
|
|
$ |
530 |
|
|
Collaborative
revenue |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
313 |
|
|
Clinical compound
revenue |
|
|
33 |
|
|
|
- |
|
|
|
33 |
|
|
|
68 |
|
Total
revenue |
|
|
5,062 |
|
|
|
- |
|
|
|
7,936 |
|
|
|
911 |
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research and
development |
|
|
22,303 |
|
|
|
9,151 |
|
|
|
52,732 |
|
|
|
36,948 |
|
|
General and
administrative |
|
|
3,227 |
|
|
|
3,805 |
|
|
|
10,609 |
|
|
|
8,877 |
|
Total
operating expenses |
|
|
25,530 |
|
|
|
12,956 |
|
|
|
63,341 |
|
|
|
45,825 |
|
Operating
loss |
|
|
(20,468 |
) |
|
|
(12,956 |
) |
|
|
(55,405 |
) |
|
|
(44,914 |
) |
|
|
|
|
|
|
|
|
|
|
Other
income |
|
|
1,002 |
|
|
|
367 |
|
|
|
1,780 |
|
|
|
788 |
|
Loss before
benefit from income taxes |
|
|
(19,466 |
) |
|
|
(12,589 |
) |
|
|
(53,625 |
) |
|
|
(44,126 |
) |
|
|
|
|
|
|
|
|
|
|
Benefit
from income taxes |
|
|
66 |
|
|
|
145 |
|
|
|
264 |
|
|
|
178 |
|
Net
loss |
|
$ |
(19,400 |
) |
|
$ |
(12,444 |
) |
|
$ |
(53,361 |
) |
|
$ |
(43,948 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss
per share: |
|
|
|
|
|
|
|
|
Basic and Diluted |
|
$ |
(0.51 |
) |
|
$ |
(0.38 |
) |
|
$ |
(1.54 |
) |
|
$ |
(1.43 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted
average shares: |
|
|
|
|
|
|
|
|
Basic and Diluted |
|
|
38,034,216 |
|
|
|
32,591,550 |
|
|
|
34,696,835 |
|
|
|
30,729,752 |
|
|
|
|
|
|
|
|
|
|
|
CARA THERAPEUTICS, INC. |
CONDENSED BALANCE SHEETS |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and cash
equivalents |
|
$ |
96,729 |
|
|
$ |
9,388 |
|
|
Marketable
securities |
|
|
109,348 |
|
|
|
83,181 |
|
|
Income tax
receivable |
|
|
539 |
|
|
|
731 |
|
|
Other receivables |
|
|
193 |
|
|
|
123 |
|
|
Prepaid
expenses |
|
|
4,218 |
|
|
|
1,635 |
|
|
Restricted cash,
current |
|
|
361 |
|
|
|
- |
|
Total
current assets |
|
|
211,388 |
|
|
|
95,058 |
|
Property
and equipment, net |
|
|
908 |
|
|
|
1,177 |
|
Restricted
cash |
|
|
408 |
|
|
|
769 |
|
Total
assets |
|
$ |
212,704 |
|
|
$ |
97,004 |
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable and
accrued expenses |
|
$ |
14,003 |
|
|
$ |
8,506 |
|
|
Current portion of
deferred revenue |
|
|
29,242 |
|
|
|
- |
|
Total
current liabilities |
|
|
43,245 |
|
|
|
8,506 |
|
|
|
|
|
|
|
Deferred
revenue, non-current |
|
|
18,300 |
|
|
|
- |
|
Deferred
lease obligation |
|
|
1,629 |
|
|
|
1,718 |
|
|
|
|
|
|
|
Commitments
and contingencies |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
Preferred stock |
|
|
- |
|
|
|
- |
|
|
Common stock |
|
|
39 |
|
|
|
33 |
|
|
Additional paid-in
capital |
|
|
423,180 |
|
|
|
307,158 |
|
|
Accumulated
deficit |
|
|
(273,702 |
) |
|
|
(220,341 |
) |
|
Accumulated
other comprehensive income (loss) |
|
13 |
|
|
|
(70 |
) |
Total
stockholders’ equity |
|
|
149,530 |
|
|
|
86,780 |
|
Total
liabilities and stockholders’ equity |
|
$ |
212,704 |
|
|
$ |
97,004 |
|
INVESTOR CONTACT:Michael SchaffzinStern
Investor Relations, Inc. 212-362-1200 michael@sternir.com
MEDIA CONTACT:Annie Starr6 Degrees973-415-8838
astarr@6degreespr.com
Cara Therapeutics (NASDAQ:CARA)
Historical Stock Chart
From Apr 2024 to May 2024
Cara Therapeutics (NASDAQ:CARA)
Historical Stock Chart
From May 2023 to May 2024