Cara Therapeutics Reports First Quarter 2022 Financial Results
KORSUVA™ (difelikefalin) injection
Kapruvia® (difelikefalin) approved by
Top-line data from Phase 2 proof-of-concept trial of Oral KORSUVA (difelikefalin) in notalgia paresthetica expected in 2Q 2022
Oral KORSUVA (difelikefalin) Phase 3 pruritus programs in non-dialysis dependent advanced chronic kidney disease and atopic dermatitis underway
Conference call today at
“We kicked off 2022 with substantial progress and execution of our mission to establish
First Quarter and Recent Developments:
KORSUVA Injection: Chronic Kidney Disease-Associated Pruritus: Hemodialysis
In
In
Oral KORSUVA (difelikefalin): Pruritus Associated with Non-Dialysis Dependent Advanced Chronic Kidney Disease
The Company initiated a Phase 3 program of Oral KORSUVA (difelikefalin) in patients with advanced CKD stages 4 or 5 with moderate-to-severe pruritus who are not on dialysis. The Phase 3 program is comprised of two identical 12-week, double-blind, placebo-controlled studies, known as KICK 1 and KICK 2. Each study is expected to enroll approximately 400 patients who will be randomized 1:1 to either Oral KORSUVA (difelikefalin) 1 mg once daily or placebo. The primary endpoint is the proportion of patients with ≥4-point improvement at Week 12 from baseline in the Worst Itch Numeric Rating Scale (WI-NRS) score. The Company expects to report top-line results in the second half of 2024.
After the initial 12-week treatment period, patients are allowed to enter the safety extension. Patients will be re-randomized to either Oral KORSUVA (difelikefalin) or placebo for up to 52 weeks.
Oral KORSUVA (difelikefalin): Atopic Dermatitis
The Company initiated a Phase 3 program for Oral KORSUVA (difelikefalin) as an adjunctive therapy to topical corticosteroids (TCS) in atopic dermatitis patients with moderate-to-severe pruritus. The program is comprised of two studies, known as KIND 1 and KIND 2. Both studies are double-blind, controlled, 12-week studies with patients allowed to roll over to 52-week open-label safety extensions. KIND 1 is composed of two parts, Part A and Part B. Part A is expected to include 280 patients who will be randomized equally to four arms – Oral KORSUVA (difelikefalin) 0.25 mg twice daily + TCS, Oral KORSUVA (difelikefalin) 0.5 mg twice daily + TCS, placebo twice daily + TCS, and placebo twice daily + vehicle. At the end of the 12-week treatment period in Part A, the Company expects to have an internal data readout in the second half of 2023, to inform the dose and sample size to initiate Part B and KIND 2.
Oral KORSUVA (difelikefalin): Notalgia Paresthetica
The Company is evaluating the efficacy and safety of Oral KORSUVA (difelikefalin) for moderate-to-severe pruritus in approximately 120 patients with notalgia paresthetica (NP) in a Phase 2 proof-of-concept trial. In this multicenter, randomized, double-blind, placebo-controlled 8-week trial, patients are randomized to receive Oral KORSUVA (difelikefalin) 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 itch-related quality of life scores and sleep assessments. The Company expects to report top-line results from this trial in the second quarter of 2022.
Oral KORSUVA (difelikefalin): Chronic Liver Disease-Associated Pruritus: Primary Biliary Cholangitis
The Company is currently conducting a proof-of-concept Phase 2 clinical trial of Oral KORSUVA (difelikefalin) for the treatment of pruritus in patients with hepatic impairment due to primary biliary cholangitis (PBC). The trial is evaluating the safety and efficacy of Oral KORSUVA (difelikefalin) (1.0 mg tablet, twice daily) versus placebo for 16 weeks. The Company expects to report top-line data in the second half of 2022.
Upcoming Meeting Activities:
The Company expects to make presentations at the following upcoming conferences:
BofA Securities 2022 Healthcare Conference,May 10-12 H.C. Wainwright Global Investment Conference ,May 23-26 Jefferies Healthcare Conference ,June 8-10
First Quarter 2022 Financial Results
Cash, cash equivalents and marketable securities at
For the first quarter of 2022, net loss was
Revenues: Total revenue was
$4.8 million of commercial supply revenue related to sales of KORSUVA injection to Vifor Pharma for the three months endedMarch 31, 2022 . There was no commercial supply revenue for the same period in 2021.- There was no license and milestone fees revenue or collaborative revenue for the three months ended
March 31, 2022 .$1.9 million of license and milestone fees revenue and collaborative revenue for the three months endedMarch 31, 2021 related to the milestone payment the Company earned from Maruishi Pharmaceutical Co. Ltd.’s (Maruishi) first initiation of a Phase 3 trial for uremic pruritus inJapan under the agreement with Maruishi.
Cost of Goods Sold (COGS): Through
Research and Development (R&D) Expenses: R&D expenses were
General and Administrative (G&A) Expenses: G&A expenses were
Other Income, net: Other income, net was
Financial Guidance
Based on timing expectations and projected costs for current clinical development plans, Cara expects that its current unrestricted cash and cash equivalents and available-for-sale marketable securities, including the
About
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 successfully commercialize KORSUVA injection and Kapruvia, planned future regulatory submissions and potential future regulatory approvals, the Company’s ability to obtain and maintain coverage and adequate reimbursement for KORSUVA injection, the performance of the Company’s 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 size and growth of the potential markets for pruritus management, 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
Financial tables follow
CONDENSED BALANCE SHEETS | |||||||
(in thousands) | |||||||
(unaudited) | |||||||
2022 | 2021 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 21,362 | $ | 13,453 | |||
Marketable securities | 119,749 | 153,582 | |||||
Accounts receivable - related party | 2,496 | - | |||||
Inventory, net | 1,907 | 2,584 | |||||
Income tax receivable | 697 | 697 | |||||
Other receivables | 438 | 455 | |||||
Prepaid expenses | 5,113 | 2,519 | |||||
Total current assets | 151,762 | 173,290 | |||||
Operating lease right-of-use assets | 2,629 | 2,973 | |||||
Marketable securities, non-current | 68,456 | 69,754 | |||||
Property and equipment, net | 611 | 631 | |||||
Restricted cash | 408 | 408 | |||||
Total assets | $ | 223,866 | 247,056 | ||||
Liabilities and stockholders’ equity | |||||||
Current liabilities: | |||||||
Accounts payable and accrued expenses | $ | 16,501 | $ | 15,861 | |||
Operating lease liabilities, current | 1,795 | 1,755 | |||||
Total current liabilities | 18,296 | 17,616 | |||||
Operating lease liabilities, non-current | 1,455 | 1,918 | |||||
Commitments and contingencies | - | - | |||||
Stockholders' equity: | |||||||
Preferred stock | - | - | |||||
Common stock | 53 | 53 | |||||
Additional paid-in capital | 714,292 | 708,585 | |||||
Accumulated deficit | (508,507 | ) | (480,758 | ) | |||
Accumulated other comprehensive loss | (1,723 | ) | (358 | ) | |||
Total stockholders’ equity | 204,115 | 227,522 | |||||
Total liabilities and stockholders’ equity | $ | 223,866 | $ | 247,056 | |||
CONDENSED STATEMENTS OF OPERATIONS (amounts in thousands, except share and per share data) (unaudited) |
||||||||
Three Months Ended |
||||||||
2022 | 2021 | |||||||
Revenue: | ||||||||
Commercial supply revenue | $ | 4,790 | $ | - | ||||
License and milestone fees | - | 1,192 | ||||||
Collaborative revenue | - | 706 | ||||||
Clinical compound revenue | - | 37 | ||||||
Total revenue | 4,790 | 1,935 | ||||||
Operating expenses: | ||||||||
Cost of goods sold | 2,081 | - | ||||||
Research and development | 21,273 | 19,131 | ||||||
General and administrative | 9,347 | 6,365 | ||||||
Total operating expenses | 32,701 | 25,496 | ||||||
Operating loss | (27,911 | ) | (23,561 | ) | ||||
Other income, net | 162 | 260 | ||||||
Net loss | $ | (27,749 | ) | $ | (23,301 | ) | ||
Net loss per share: | ||||||||
Basic and diluted | $ | (0.52 | ) | $ | (0.47 | ) | ||
Weighted average shares: | ||||||||
Basic and diluted | 53,507,060 | 49,917,990 | ||||||
MEDIA CONTACT:
6 Degrees
973-768-2170
aspinetta@6degreespr.com
INVESTOR CONTACT:
203-406-3700
investor@caratherapeutics.com

Source: Cara Therapeutics, Inc.