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 second quarter ended June 30,
2020.
“In the second quarter, we continued to advance
our clinical development programs for both KORSUVA™ Injection and
Oral KORSUVA. Following positive top-line data from our KALM™-2
pivotal Phase 3 trial of KORSUVA Injection for chronic kidney
disease-associated pruritus (CKD-aP) in hemodialysis patients, we
remain on track to submit our first 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. “We also successfully completed a
planned interim statistical analysis of our KARE Phase 2
dose-ranging trial of Oral KORSUVA for moderate-to-severe pruritus
in atopic dermatitis (AD) patients and expect the trial to be fully
enrolled by the fourth quarter.”
Second Quarter and Recent
Developments:
KORSUVA Injection: Chronic Kidney
Disease-Associated Pruritus (CKD-aP): Hemodialysis
In April 2020, the Company announced positive
top-line results from its KALM-2 global 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 proportion of patients on KORSUVA Injection achieving a
three-point or greater improvement from baseline in the weekly mean
Worst Itching Intensity Numeric Rating Scale (NRS) versus placebo
(p=0.02) at week 12. The trial also met the key secondary endpoint,
with a statistically significant proportion of patients on KORSUVA
Injection achieving a four-point or greater improvement from
baseline in the weekly mean Worst Itching Intensity NRS versus
placebo (p=0.01) at week 12. KORSUVA Injection was generally
well-tolerated through 12 weeks of treatment with a safety profile
consistent with prior clinical trials.
All safety databases are now closed with more
than 1,500 total patient exposures achieved, including more than
700 patients completing at least six months of treatment and more
than 400 patients completing one year of treatment.
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
In December 2019, the Company announced 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. The Company plans to conduct an End of
Phase 2 Meeting with the FDA in the first quarter of 2021. In
advance of that meeting, the Company intends to initiate the safety
portion of the Phase 3 program in the fourth quarter of 2020.
Oral KORSUVA: Atopic Dermatitis
(AD)
In June 2020, the Company announced the
completion of an interim conditional power assessment of its
ongoing KARE Phase 2 dose-ranging trial of Oral KORSUVA for the
treatment of moderate-to-severe pruritus in AD patients. The trial
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.
Based on the recommendation of the Independent
Data Monitoring Committee, the size of the trial was increased from
an original enrollment target of 320 patients to 410 patients, to
maintain the prespecified statistical power of 80% or greater on
the trial’s primary endpoint of change from baseline in the weekly
mean of the daily 24-hour Worst Itching Intensity NRS and key
secondary endpoint of the proportion of patients achieving a four
point or greater improvement in Worst Itching Intensity NRS score
at week 12. The prespecified interim conditional power assessment
was conducted after approximately 50% of the originally targeted
patient number had completed the designated 12-week treatment
period. The Company expects the trial to be fully enrolled in the
fourth quarter of 2020 and aims to report top-line results in the
first half of 2021, subject to any delays related to the ongoing
COVID-19 pandemic.
Oral KORSUVA: Chronic Liver
Disease-Associated Pruritus (CLD-aP): Primary Biliary Cholangitis
(PBC)
The Company is 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 and
aims to have top-line data in the first half of 2021, due in part
to delays related to the ongoing COVID-19 pandemic.
Board of Directors Expansion and
Appointment
In June 2020, the Company expanded its Board of
Directors by appointing Susan Shiff, Ph.D., M.B.A., as a new
Director. Dr. Shiff currently serves as Senior Vice President and
Head of the Center for Observational and Real-World Evidence at
Merck, known as MSD outside the United States and Canada.
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 clinical trials.
Based on guidelines from the Centers for Disease
Control and Prevention and the State of Connecticut, all Cara
employees continue to work remotely and business travel has been
restricted.
Upcoming Activities
The Company expects to make presentations at the
following upcoming conferences:
- 40th Annual Canaccord Genuity Growth Conference, August 11-13,
2020
- Cantor Fitzgerald Global Healthcare Conference, September
15-17, 2020
- American Society of Nephrology Kidney Week, October 19-25,
2020
- Stifel Healthcare Conference, November 17-18, 2020
- Jefferies Global Healthcare Conference, November 17-19,
2020
- Piper Sandler Health Care Conference, December 1-3, 2020
Second Quarter 2020 Financial Results
Net Loss: Net loss was $25.1 million, or $0.54
per basic and diluted share, for the three months ended June 30,
2020, compared to a net loss of $23.0 million, or $0.58 per basic
and diluted share, for the same period of 2019.
Revenues: Total revenue was $5.6 million for the
three months ended June 30, 2020, compared to $5.2 million during
the same period of 2019. Total revenue consisted of:
- The Company recognized $4.5 million and $5.2 million of license
and milestone fees revenue for the three months ended June 30, 2020
and 2019, respectively, related to its license agreement with Vifor
Fresenius Medical Care Renal Pharma Ltd. (VFMCRP).
- The Company recognized $0.6 million of license and milestone
fees revenue for the three months ended June 30, 2020 related to
the achievement of a milestone related to its license agreement
with Chong Kun Dang Pharmaceutical Corp.
- The Company recognized $0.5 million of clinical compound
revenue from the sales of clinical compound for the three months
ended June 30, 2020 to Maruishi Pharmaceutical Company Ltd. and
VFMCRP. There were no sales of clinical compound for the three
months ended June 30, 2019.
Research and Development (R&D) Expenses:
R&D expenses were $26.1 million for the three months ended June
30, 2020 compared to $24.4 million for the three months ended June
30, 2019. The higher R&D expenses in 2020 were primarily due to
increases in stock-based compensation expense, payroll and related
costs and cost of clinical compound sales, partially offset by a
net decrease in clinical trial costs, conferences, and travel and
related costs.
General and Administrative (G&A) Expenses:
G&A expenses were $5.4 million for the three months ended June
30, 2020 compared to $5.0 million for the three months ended June
30, 2019. The increase in 2020 was primarily due to increases
in consultants’ costs, legal fees, and insurance costs, partially
offset by decreases in stock-based compensation expense.
Other Income, Net: Other income, net was
$634,000 for the three months ended June 30, 2020 compared to
$947,000 for the three months ended June 30, 2019. The decrease in
2020 was due to a decrease in accretion and interest income
resulting from a lower yield on our portfolio of investments in the
2020 period.
Cash and Cash Equivalents and Marketable
Securities Position: At June 30, 2020, cash and cash equivalents
and marketable securities totaled $153.0 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 $66.0 million, partially offset by
proceeds of $0.3 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 June 30, 2020 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 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 7669087. 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 KALM-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 for
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 June 30, |
|
|
Six Months Ended June 30, |
|
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
License and milestone
fees |
|
$ |
5,099 |
|
|
$ |
5,208 |
|
|
$ |
13,120 |
|
|
$ |
9,450 |
|
|
Clinical compound revenue |
|
535 |
|
|
- |
|
|
607 |
|
|
140 |
|
Total revenue |
|
5,634 |
|
|
5,208 |
|
|
13,727 |
|
|
9,590 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
26,108 |
|
|
24,356 |
|
|
59,644 |
|
|
47,964 |
|
|
General and
administrative |
|
5,410 |
|
|
4,994 |
|
|
9,968 |
|
|
8,902 |
|
Total operating
expenses |
|
31,518 |
|
|
29,350 |
|
|
69,612 |
|
|
56,866 |
|
Operating
loss |
|
(25,884 |
) |
|
(24,142 |
) |
|
(55,885 |
) |
|
(47,276 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income,
net |
|
634 |
|
|
947 |
|
|
1,591 |
|
|
2,036 |
|
Loss before
benefit from income taxes |
|
(25,250 |
) |
|
(23,195 |
) |
|
(54,294 |
) |
|
(45,240 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Benefit from
income taxes |
|
182 |
|
|
235 |
|
|
304 |
|
|
320 |
|
Net loss |
|
$ |
(25,068 |
) |
|
$ |
(22,960 |
) |
|
$ |
(53,990 |
) |
|
$ |
(44,920 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted |
|
$ |
(0.54 |
) |
|
$ |
(0.58 |
) |
|
$ |
(1.15 |
) |
|
$ |
(1.13 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted |
|
46,799,703 |
|
|
39,818,162 |
|
|
46,762,327 |
|
|
39,685,954 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CARA THERAPEUTICS, INC. |
CONDENSED BALANCE SHEETS |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
56,967 |
|
|
$ |
18,305 |
|
|
Marketable securities |
73,218 |
|
|
136,701 |
|
|
Income tax receivable |
1,120 |
|
|
816 |
|
|
Other receivables |
486 |
|
|
971 |
|
|
Prepaid expenses |
10,124 |
|
|
8,863 |
|
Total current
assets |
141,915 |
|
|
165,656 |
|
|
Operating lease right-of-use asset |
2,825 |
|
|
3,036 |
|
|
Marketable securities, non-current |
22,861 |
|
|
63,159 |
|
|
Property and equipment,
net |
604 |
|
|
700 |
|
|
Restricted cash |
408 |
|
|
408 |
|
Total assets |
$ |
168,613 |
|
|
$ |
232,959 |
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable and accrued
expenses |
$ |
13,952 |
|
|
$ |
19,665 |
|
|
Operating lease liability, current |
1,006 |
|
|
967 |
|
|
Current portion of deferred
revenue |
9,768 |
|
|
22,262 |
|
Total current
liabilities |
24,726 |
|
|
42,894 |
|
|
|
|
|
|
|
|
|
Operating lease liability, non-current |
2,959 |
|
|
3,352 |
|
|
|
|
|
|
|
|
Commitments and
contingencies |
- |
|
|
- |
|
|
|
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
|
|
Preferred stock |
- |
|
|
- |
|
|
Common stock |
47 |
|
|
47 |
|
|
Additional paid-in
capital |
594,963 |
|
|
587,223 |
|
|
Accumulated deficit |
(454,717 |
) |
|
(400,727 |
) |
|
Accumulated other
comprehensive income |
635 |
|
|
170 |
|
Total
stockholders’ equity |
140,928 |
|
|
186,713 |
|
Total liabilities
and stockholders’ equity |
$ |
168,613 |
|
|
$ |
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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