–
– Conference call today at
“During 2020, we made significant advances in our late-stage clinical pruritus programs, culminating in the acceptance by the
Fourth Quarter and Recent Developments:
KORSUVA Injection: Chronic Kidney Disease-Associated Pruritus (CKD-aP): Hemodialysis
In
In October 2020, the Company entered into a license agreement with Vifor under which it granted Vifor an exclusive license to commercialize KORSUVA Injection for the treatment of pruritus in hemodialysis patients in the United States under a Cara 60%, Vifor 40% profit-sharing arrangement. Under the terms of the agreement, the Company received an upfront payment of $100.0 million from Vifor and an additional payment of $50.0 million for the purchase of the Company’s common stock at a price of $17.0094 per share.
Upon U.S. regulatory approval of KORSUVA Injection, the Company will also be eligible to receive an additional $50.0 million common stock investment at a 20% premium to the 30-day trailing average price of the Company’s common stock as of such date. In addition, the Company is eligible to receive payments of up to $240.0 million upon the achievement of certain sales-based milestones.
Oral KORSUVA: CKD-aP: Non-Hemodialysis
In
Oral KORSUVA: Atopic Dermatitis (AD)
In
KARE’s primary efficacy endpoint is change from baseline in the weekly mean of the daily 24-hour Worst Itch – Numeric Rating Scale (WI-NRS) score at week 12 of the treatment period. The key secondary endpoint for KARE is the assessment of the proportion of patients achieving an improvement from baseline of ≥4 points with respect to the weekly mean of the daily 24-hour WI-NRS score at week 12. Itch-related quality of life scores at the end of week 12 are assessed by the total
The Company aims to report top-line results from this trial 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 currently 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 aims to have top-line data in the second half of 2021, due in part to delays related to the ongoing COVID-19 pandemic.
Oral KORSUVA: Notalgia Paresthetica (NP)
In
The Phase 2 multicenter, randomized, double-blind, placebo-controlled 8-week study is designed to evaluate the efficacy and safety of Oral KORSUVA for moderate-to-severe pruritus in approximately 120 subjects with NP. Subjects will be randomized to receive Oral KORSUVA 2.0 mg twice daily versus placebo for 8 weeks, followed by a four-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 change from baseline in itch-related quality of life scores and a change from baseline in itch-related sleep disturbance subscale at the end of Week 8.
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 ongoing and planned clinical trials.
Based on guidelines from the Centers for Disease Control and Prevention and the State of
Expected 2021 Milestones
- Top-line data from the KARE Phase 2 dose-ranging trial of Oral KORSUVA in AD patients in the first half of 2021.
- End of Phase 2 Meeting with the FDA in the second quarter of 2021 to enable initiation of a Phase 3 program of Oral KORSUVA in non-hemodialysis CKD-aP patients in the second half of 2021.
- Potential FDA approval of NDA for KORSUVA Injection in the second half of 2021.
- Top-line data from the Phase 2 trial of Oral KORSUVA in CLD-aP in the second half of 2021.
- Initiate Phase 3 trial of Oral KORSUVA for CKD-aP patients in the second half of 2021.
Upcoming Meeting Activities
The Company expects to make presentations at the following upcoming conferences:
National Kidney Foundation Spring Clinical Meeting,April 6-10, 2021 Needham & Co. Annual Healthcare Conference,April 12-15, 2021 - American Nephrology Nurses Association National Symposium,
May 2-5, 2021 Bank of America Merrill Lynch Healthcare Conference ,May 10-13, 2021
Fourth Quarter and Full Year 2020 Financial Results
Cash, cash equivalents and marketable securities at
For the fourth quarter of 2020, net income was
Revenues: Total revenue was
$112.1 million of license and milestone fees revenue during the fourth quarter of 2020, of which$111.6 million related to the license agreement with Vifor and$0.5 million related to the license agreement withVifor Fresenius Medical Care Renal Pharma Ltd. (VFMCRP). The Company recognized$4.5 million of license and milestone fees revenue during the fourth quarter of 2019, which related to the license agreement with VFMCRP.
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
For the full year ended
Revenues: Total revenue was
$134.4 million of license and milestone fees revenue for the year endedDecember 31, 2020 , of which$111.6 million related to the license agreement with Vifor,$22.3 million related to the license agreement with VFMCRP, and$0.6 million related to the achievement of a milestone related to its license agreement with Chong Kun Dang Pharmaceutical Corp. The Company also recognized$19.7 million of license and milestone fees revenue for the year endedDecember 31, 2019 , which related to the license agreement with VFMCRP.- Approximately
$643,000 and$140,000 of revenue from the sales of clinical compound during the years endedDecember 31, 2020 and 2019, respectively, in connection with the sale of clinical compound toVFMCRP and Maruishi Pharmaceutical Co. Ltd.
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 existing unrestricted cash and cash equivalents and available-for-sale marketable securities as of
Conference Call
Cara management will host a conference call today at
To participate in the conference call, please dial (855) 445-2816 (domestic) or (484) 756-4300 (international) and refer to conference ID 6676157. 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
The FDA has accepted the NDA filing for KORSUVA Injection for the treatment of moderate-to-severe pruritus in hemodialysis patients and 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 and potential commercialization of 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
Financial tables follow
STATEMENTS OF OPERATIONS | |||||||||||||||||
(amounts in thousands, except share and per share data) | |||||||||||||||||
(unaudited) | |||||||||||||||||
Three Months Ended | Year Ended | ||||||||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||||||||
Revenue: | |||||||||||||||||
License and milestone fees | $ | 112,062 | $ | 4,511 | $ | 134,439 | $ | 19,746 | |||||||||
Clinical compound revenue | 27 | - | 643 | 140 | |||||||||||||
Total revenue | 112,089 | 4,511 | 135,082 | 19,886 | |||||||||||||
Operating expenses: | |||||||||||||||||
Research and development | 27,140 | 29,864 | 107,851 | 113,820 | |||||||||||||
General and administrative | 6,659 | 4,617 | 21,846 | 17,745 | |||||||||||||
Total operating expenses | 33,799 | 34,481 | 129,697 | 131,565 | |||||||||||||
Operating income (loss) | 78,290 | (29,970 | ) | 5,385 | (111,679 | ) | |||||||||||
Other income, net | 364 | 1,193 | 2,334 | 4,490 | |||||||||||||
Income (loss) before benefit from income taxes | 78,654 | (28,777 | ) | 7,719 | (107,189 | ) | |||||||||||
Benefit from income taxes | 255 | 166 | 691 | 816 | |||||||||||||
Net income (loss) | $ | 78,909 | $ | (28,611 | ) | $ | 8,410 | $ | (106,373 | ) | |||||||
Net income (loss) per share: | |||||||||||||||||
Basic | $ | 1.60 | $ | (0.61 | ) | $ | 0.18 | $ | (2.49 | ) | |||||||
Diluted | $ | 1.59 | $ | (0.61 | ) | $ | 0.18 | $ | (2.49 | ) | |||||||
Weighted average shares: | |||||||||||||||||
Basic | 49,228,774 | 46,691,009 | 47,413,250 | 42,669,333 | |||||||||||||
Diluted | 49,701,864 | 46,691,009 | 47,915,030 | 42,669,333 | |||||||||||||
BALANCE SHEETS | |||||||
(in thousands) | |||||||
(unaudited) | |||||||
2020 | 2019 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 31,683 | $ | 18,305 | |||
Marketable securities | 149,242 | 136,701 | |||||
Income tax receivable | 1,507 | 816 | |||||
Other receivables | 557 | 971 | |||||
Prepaid expenses | 12,076 | 8,863 | |||||
Total current assets | 195,065 | 165,656 | |||||
Operating lease right-of-use assets | 4,279 | 3,036 | |||||
Marketable securities, non-current | 70,565 | 63,159 | |||||
Property and equipment, net | 840 | 700 | |||||
Restricted cash | 408 | 408 | |||||
Total assets | $ | 271,157 | $ | 232,959 | |||
Liabilities and stockholders’ equity | |||||||
Current liabilities: | |||||||
Accounts payable and accrued expenses | $ | 16,881 | $ | 19,665 | |||
Operating lease liabilities, current | 1,602 | 967 | |||||
Current portion of deferred revenue | - | 22,262 | |||||
Total current liabilities | 18,483 | 42,894 | |||||
Operating lease liabilities, non-current | 3,673 | 3,352 | |||||
Commitments and contingencies | - | - | |||||
Stockholders' equity: | |||||||
Preferred stock | - | - | |||||
Common stock | 50 | 47 | |||||
Additional paid-in capital | 641,195 | 587,223 | |||||
Accumulated deficit | (392,317 | ) | (400,727 | ) | |||
Accumulated other comprehensive income | 73 | 170 | |||||
Total stockholders’ equity | 249,001 | 186,713 | |||||
Total liabilities and stockholders’ equity | $ | 271,157 | $ | 232,959 | |||
INVESTOR CONTACT:
Stern Investor Relations, Inc.
212-362-1200
Janhavi.Mohite@sternir.com
MEDIA CONTACT:
6 Degrees
315-765-1462
clacagnina@6degreespr.com
Source:
2021 GlobeNewswire, Inc., source