Cara Therapeutics Reports Second Quarter 2022 Financial Results
– Net revenue was
– KOMFORT Phase 2 trial met primary endpoint in notalgia paresthetica, validating potential broad utility of oral difelikefalin across multiple disease categories; FDA meeting expected in 2H 2022 –
– Conference call today at
“During the second quarter of 2022, we made great strides toward establishing
Second Quarter and Recent Developments:
KORSUVA Injection: Chronic Kidney Disease-Associated Pruritus: Hemodialysis
In
In the second quarter, the Company received the
Oral Difelikefalin: Notalgia Paresthetica
In
Oral Difelikefalin: Pruritus Associated with Non-Dialysis Dependent Advanced Chronic Kidney Disease
The Phase 3 program of oral difelikefalin in patients with advanced CKD stages 4 or 5 with moderate-to-severe pruritus who are not on dialysis is ongoing. The Phase 3 program is comprised of two identical 12-week, double-blind, placebo-controlled studies, known as KICK 1 and KICK 2. The Company expects to report topline results in the second half of 2024.
Oral Difelikefalin: Atopic Dermatitis
The Phase 3 program for oral difelikefalin as an adjunctive therapy to topical corticosteroids in atopic dermatitis (AD) patients with moderate-to-severe pruritus is ongoing. 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. At the end of the 12-week treatment period in Part A of KIND 1, the Company expects to have an internal data readout to inform the dose and sample size to initiate Part B and KIND 2. The internal readout is expected for the second half of 2023.
Oral Difelikefalin: Chronic Liver Disease-Associated Pruritus: Primary Biliary Cholangitis
The Company is currently conducting a proof-of-concept Phase 2 clinical trial of oral 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 difelikefalin versus placebo for 16 weeks. The Company expects to report topline data in the second half of 2022.
Upcoming Meeting Activities:
The Company expects to present at the following upcoming investment conferences:
- Canaccord Genuity 42nd Annual Growth Conference,
August 8-11 H.C. Wainwright 24th AnnualGlobal Investment Conference ,September 12-14
Second Quarter 2022 Financial Results
Cash, cash equivalents and marketable securities at
For the second quarter of 2022, net loss was
Revenues: Total revenue was
$15.0 million of license and milestone fees revenue, related to the regulatory milestone payment for the approval of Kapruvia by theEuropean Commission inApril 2022 during the three months endedJune 30, 2022 ; and$8.0 million of collaborative revenue, related to the profit-sharing revenue from Vifor’s sales of KORSUVA injection to third parties during the three months endedJune 30, 2022 .
Cost of Goods Sold (COGS): There was no COGS during the three months ended
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, which include conducting supportive Phase 1 trials, Phase 2 trials in PBC and NP, and Phase 3 trials in CKD and AD, Cara expects that its current unrestricted cash and cash equivalents and available-for-sale marketable securities will be sufficient to fund its currently anticipated operating expenses and capital requirements into the first half of 2024, without giving effect to product revenue the Company receives from the commercialization of KORSUVA injection or Kapruvia or any potential milestone payments or potential additional product revenue the Company may receive under collaboration agreements.
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, risks that KORSUVA injection and Kapruvia revenue, expenses and costs may not be as expected, planned future regulatory meetings and/or submissions and potential future regulatory approvals, the performance of the Company’s commercial partners, including Vifor, 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, including NP, and the potential for oral difelikefalin to address additional pruritic indications, the size and growth of the potential markets for pruritus management, the Company’s expected cash reach, and the potential impact of COVID-19, geopolitical tensions and macroeconomic conditions 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 | $ | 46,718 | $ | 13,453 | |||||
Marketable securities | 110,794 | 153,582 | |||||||
Accounts receivable - related party | 8,003 | - | |||||||
Inventory, net | 3,460 | 2,584 | |||||||
Income tax receivable | 697 | 697 | |||||||
Other receivables | 468 | 455 | |||||||
Prepaid expenses | 6,026 | 2,519 | |||||||
Total current assets | 176,166 | 173,290 | |||||||
Operating lease right-of-use assets | 2,278 | 2,973 | |||||||
Marketable securities, non-current | 47,171 | 69,754 | |||||||
Property and equipment, net | 549 | 631 | |||||||
Restricted cash | 408 | 408 | |||||||
Total assets | $ | 226,572 | $ | 247,056 | |||||
Liabilities and stockholders’ equity | |||||||||
Current liabilities: | |||||||||
Accounts payable and accrued expenses | $ | 19,332 | $ | 15,861 | |||||
Operating lease liabilities, current | 1,835 | 1,755 | |||||||
Total current liabilities | 21,167 | 17,616 | |||||||
Operating lease liabilities, non-current | 983 | 1,918 | |||||||
Commitments and contingencies | - | - | |||||||
Stockholders’ equity: | |||||||||
Preferred stock | - | - | |||||||
Common stock | 53 | 53 | |||||||
Additional paid-in capital | 719,129 | 708,585 | |||||||
Accumulated deficit | (512,713 | ) | (480,758 | ) | |||||
Accumulated other comprehensive loss | (2,047 | ) | (358 | ) | |||||
Total stockholders’ equity | 204,422 | 227,522 | |||||||
Total liabilities and stockholders’ equity | $ | 226,572 | $ | 247,056 | |||||
CONDENSED STATEMENTS OF OPERATIONS (amounts in thousands, except share and per share data) (unaudited) |
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Three Months Ended |
Six Months Ended |
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2022 |
2021 |
2022 |
2021 |
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Revenue: | ||||||||||||||||||||
License and milestone fees | $ | 15,000 | $ | - | $ | 15,000 | $ | 1,192 | ||||||||||||
Collaborative revenue | 8,003 | - | 8,003 | 706 | ||||||||||||||||
Commercial supply revenue | - | - | 4,790 | - | ||||||||||||||||
Clinical compound revenue | - | - | - | 37 | ||||||||||||||||
Total revenue | 23,003 | - | 27,793 | 1,935 | ||||||||||||||||
Operating expenses: | ||||||||||||||||||||
Cost of goods sold | - | - | 2,081 | - | ||||||||||||||||
Research and development | 19,905 | 25,225 | 41,178 | 44,356 | ||||||||||||||||
General and administrative | 7,570 | 5,651 | 16,917 | 12,016 | ||||||||||||||||
Total operating expenses | 27,475 | 30,876 | 60,176 | 56,372 | ||||||||||||||||
Operating loss | (4,472 | ) | (30,876 | ) | (32,383 | ) | (54,437 | ) | ||||||||||||
Other income, net | 266 | 131 | 428 | 391 | ||||||||||||||||
Net loss | (4,206 | ) | (30,745 | ) | (31,955 | ) | (54,046 | ) | ||||||||||||
Net loss per share: | ||||||||||||||||||||
Basic and Diluted | $ | (0.08 | ) | $ | (0.61 | ) | $ | (0.60 | ) | $ | (1.08 | ) | ||||||||
Weighted average shares: | ||||||||||||||||||||
Basic and Diluted | 53,614,668 | 50,059,984 | 53,561,161 | 49,989,379 | ||||||||||||||||
MEDIA CONTACT:
6 Degrees
973-768-2170
aspinetta@6degreespr.com
INVESTOR CONTACT:
203-406-3700
investor@caratherapeutics.com

Source: Cara Therapeutics, Inc.