“During 2019, we reported significant advancements in both our KORSUVA™ Injection and Oral KORSUVA late-stage clinical pruritus programs, including positive results from our first pivotal Phase 3 efficacy trial (KALM™‑1) of KORSUVA Injection for the treatment of chronic kidney disease-associated pruritus in patients undergoing hemodialysis and our Phase 2 trial of Oral KORSUVA in pre-dialysis patients. Additionally, we broadened our clinical pruritus program for Oral KORSUVA with the initiation of Phase 2 trials in both atopic dermatitis and liver disease patients,” said
Fourth Quarter and Recent Developments:
KORSUVA Injection: Chronic Kidney Disease-Associated Pruritus (CKD-aP): Hemodialysis
The Company expects top-line data for its pivotal KALM-2 Phase 3 global trial of KORSUVA Injection in the second quarter of 2020 and remains on track to file a New Drug Application, or NDA, to the
Currently, more than 1,500 total patient exposures have been achieved, including all ongoing safety trials, with more than 600 patients completing at least six months of treatment and more than 300 patients completing one year of treatment.
Oral KORSUVA: CKD-aP: Non-Hemodialysis
Oral KORSUVA: Atopic Dermatitis (AD)
Oral KORSUVA: Chronic Liver Disease-Associated Pruritus (CLD-aP): Primary Biliary Cholangitis (PBC)
The Company continues to enroll patients in the ongoing 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 KOSRUVA (1.0 mg tablet, twice daily) versus placebo for 16 weeks. The Company aims to report top-line data from this trial in 2020.
Expected 2020 Milestones
- Top-line efficacy and safety data from the KALM-2 Phase 3 trial of KORSUVA Injection in hemodialysis patients with moderate-to-severe CKD-aP in the second quarter of 2020.
- Interim statistical analysis on the Phase 2 trial of Oral KORSUVA in AD in the second quarter of 2020.
- Submission of an NDA to the FDA for KORSUVA Injection in hemodialysis patients with moderate-to-severe CKD-aP in the second half of 2020.
- Top-line data from the Phase 2 trial of Oral KORSUVA in AD in 2020.
- Top-line data from the Phase 2 trial of Oral KORSUVA in CLD-aP in 2020.
- Completion of End of Phase 2 Meeting with the FDA to enable initiation of a Phase 3 program of Oral KORSUVA in non-hemodialysis CKD-aP patients in the second half of 2020.
Upcoming Meeting Activities
The Company expects to make presentations at the following upcoming conferences:
American Academy of DermatologyAnnual Meeting, March 20-24, 2020 Needham & Co.Annual Healthcare Conference, April 14-15, 2020 H.C. Wainwright Global Life Sciences Conference, April 19-21, 2020 Bank of America Merrill Lynch Health Care Conference, May 12-14, 2020
Fourth Quarter and Full Year 2019 Financial Results
Cash, cash equivalents and marketable securities at
For the fourth quarter of 2019, net loss was
- Revenues: The Company recognized
$4.5 millionand $5.5 millionof license and milestone fees revenue during the fourth quarter of 2019 and 2018, respectively, related to its collaboration agreement with Vifor Fresenius Medical Care Renal Pharma Ltd., or VFMCRP.
- Research and Development (R&D) Expenses: R&D expenses were
$29.9 millionin the fourth quarter of 2019 compared to $22.8 millionin the same period of 2018. The higher R&D expenses in 2019 were principally due to a net increase in costs associated with clinical trials, as well as increases in payroll and related costs.
- General and Administrative (G&A) Expenses: G&A expenses were relatively consistent at
$4.6 millionduring the fourth quarter of 2019 compared to $4.7 millionin the same period of 2018.
- Other Income: Other income was
$1.2 millionin the fourth quarter of both 2019 and 2018.
For the full year ended
- Revenues: Total revenue was
$19.9 millionfor the full year ended December 31, 2019as compared to $13.5 millionfor the full year ended December 31, 2018. Total revenue consisted of:
(1) License and milestone fees revenue of
$19.7 millionand $13.4 millionfor the full year ended December 31, 2019and 2018, respectively, was recognized by the Company related to its license agreement with VFMCRP.
(2) There was no collaborative revenue recognized for the full year ended
December 31, 2019or 2018.
(3) The Company recognized
$140,000and $33,000of revenue from the sales of clinical compound during the full year ended December 31, 2019and 2018, respectively, in connection with the sale of clinical compound to Maruishi Pharmaceuticals Co. Ltd.
- Research and Development (R&D) Expenses: R&D expenses were
$113.8 millionfor the full year ended December 31, 2019compared to $75.5 millionfor the full year ended December 31, 2018. The higher R&D expenses in 2019 were principally due to a net increase in clinical trial costs, increases in stock compensation expense, payroll and related costs as well as an expense in connection with the license agreement with Enteris Biopharma, Inc.in 2019.
- General and Administrative (G&A) Expenses: G&A expenses were
$17.7 millionfor the full year ended December 31, 2019compared to $15.3 millionfor the full year ended December 31, 2018. The increase in 2019 was primarily due to increases in stock compensation expense, payroll and related costs, consultants’ costs, legal and accounting fees, insurance costs and franchise taxes. Those increases were partially offset by decreased rent, utilities and related costs.
- Other Income: Other income was
$4.5 millionfor the full year ended December 31, 2019compared to $3.0 millionfor the year ended 2018. The increase in 2019 was primarily due to a higher average balance of the Company’s portfolio of investments in 2019.
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
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 9907568. 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.
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.
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 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 first NDA, 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
Financial tables follow
|STATEMENTS OF OPERATIONS|
|(amounts in thousands, except share and per share data)|
|Three Months Ended
|License and milestone fees||$||4,511||$||5,533||$||19,746||$||13,436|
|Clinical compound revenue||-||-||140||33|
|Research and development||29,864||22,799||113,820||75,531|
|General and administrative||4,617||4,711||17,745||15,320|
|Total operating expenses||34,481||27,510||131,565||90,851|
|Loss before benefit from income taxes||(28,777||)||(20,777||)||(107,189||)||(74,402||)|
|Benefit from income taxes||166||125||816||389|
|Net loss per share:|
|Basic and Diluted||$||(0.61||)||$||(0.52||)||$||(2.49||)||$||(2.06||)|
|Weighted average shares:|
|Basic and Diluted||46,691,009||39,441,640||42,669,333||35,892,786|
|Cash and cash equivalents||$||18,305||$||15,081|
|Income tax receivable||816||664|
|Restricted cash, current||-||361|
|Total current assets||165,656||168,139|
|Operating lease right-of-use asset||3,036||-|
|Marketable securities, noncurrent||63,159||21,396|
|Property and equipment, net||700||880|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||19,665||$||13,622|
|Operating lease liability, current||967||-|
|Current portion of deferred revenue||22,262||26,825|
|Total current liabilities||42,894||40,447|
|Operating lease liability, non-current||3,352||-|
|Deferred revenue, non-current||-||15,184|
|Deferred lease obligation||-||1,562|
|Commitments and contingencies||-||-|
|Additional paid-in capital||587,223||428,059|
|Accumulated other comprehensive income (loss)||170||(114||)|
|Total stockholders’ equity||186,713||133,630|
|Total liabilities and stockholders’ equity||$||232,959||$||190,823|
Stern Investor Relations, Inc.
Source: Cara Therapeutics, Inc.