– Conference call today at
“We are pleased with the progress made across our clinical pruritus programs in chronic kidney disease in the first quarter and remain on track to release top-line data from KALM-1, the first of our pivotal Phase 3 trials of KORSUVA Injection for chronic kidney disease-associated pruritus in hemodialysis patients, in the second quarter,” said
First Quarter and Recent Developments:
KORSUVA™ (CR845/difelikefalin) Injection Phase 3 Program: Chronic Kidney Disease-Associated Pruritus (CKD-aP): Hemodialysis
The Company continues to enroll patients in
The Company’s long term, 52-week open-label Phase 3 safety trial continues to progress. Approximately 150 patients have completed at least 6 months of treatment and approximately 40% of these patients have completed 1 year of treatment.
In the second quarter of 2019, the Company initiated an additional open-label safety trial of KORSUVA Injection that is expected to enroll up to 400 hemodialysis patients with CKD-aP for up to 12 weeks of treatment. Both of the safety trials are expected to support worldwide registration filings of KORSUVA Injection.
Oral KORSUVA: CKD-aP: Non-Hemodialysis
The Company continues to enroll patients in the Phase 2 trial of Oral KORSUVA for the treatment of pruritus in stage III - V (moderate-to-severe) chronic kidney disease, or CKD, patients. Based on current enrollment projections, the Company anticipates top-line data from this trial in the second half of 2019.
Oral KORSUVA: Chronic Liver Disease-Associated Pruritus (CLD-aP)
The Company recently completed a Phase 1 trial of Oral KORSUVA at multiple tablet strengths in patients with chronic liver disease, or CLD. The pharmacokinetic parameters were dose proportional and Oral KORSUVA was generally well tolerated with no unexpected safety signals reported. The Company expects to initiate a Phase 2 trial in CLD patients with moderate-to-severe pruritus in the second quarter of 2019.
Oral KORSUVA: Atopic Dermatitis
The Company plans to initiate a multi-dose, proof-of-concept Phase 2 trial of Oral KORSUVA in atopic dermatitis patients with moderate-to-severe pruritus around mid-year 2019.
The Company expects to make presentations at the following conferences:
Bank of America Merrill Lynch Health Care Conference2019, May 14-16, 2019
- Jefferies 2019 Healthcare Conference,
June 4-7, 2019 European Academy of Dermatology and Venereology, October 9–13, 2019
First Quarter 2019 Financial Results
Net Loss: The Company reported a net loss of
Revenues: Total revenue was
- License and milestone fees revenue of
$4.2 millionthat was recognized by the Company related to its license agreement with Vifor Fresenius Medical Care Renal Pharma Ltd.
- Clinical compound revenue of
$140,000that was earned by the Company from the sale of clinical compound to 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: Other income was
Cash and Cash Equivalents and Marketable Securities Position: At
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 3027399. 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.
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 expected timing for initiation of the Company’s planned clinical trials, the potential results of ongoing and planned clinical trials, 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, 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
|CARA THERAPEUTICS, INC.|
|CONDENSED STATEMENTS OF OPERATIONS|
|(amounts in thousands, except share and per share data)|
|Three Months Ended March 31,|
|License and milestone fees||$||4,242||$||-|
|Clinical compound revenue||140||-|
|Research and development||23,608||13,427|
|General and administrative||3,908||3,697|
|Total operating expenses||27,516||17,124|
|Loss before benefit from income taxes||(22,045||)||(16,813||)|
|Benefit from income taxes||85||46|
|Net loss per share :|
|Basic and Diluted||$||(0.56||)||$||(0.51||)|
|Weighted average shares:|
|Basic and Diluted||39,552,277||32,681,661|
|CARA THERAPEUTICS, INC.|
|CONDENSED BALANCE SHEETS|
|March 31,||December 31,|
|Cash and cash equivalents||$||14,188||$||15,081|
|Income tax receivable||749||664|
|Restricted cash, current||361||361|
|Total current assets||144,159||168,139|
|Operating lease right-of-use asset||3,492||-|
|Marketable securities, non-current||21,687||21,396|
|Property and equipment, net||841||880|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||13,310||$||13,622|
|Operating lease liability, current||901||-|
|Current portion of deferred revenue||28,194||26,825|
|Total current liabilities||42,405||40,447|
|Operating lease liability, non-current||4,087||-|
|Deferred revenue, non-current||9,573||15,184|
|Deferred lease obligation||-||1,562|
|Commitments and contingencies||-||-|
|Additional paid-in capital||430,724||428,059|
|Accumulated other comprehensive income (loss)||73||(114||)|
|Total stockholders’ equity||114,522||133,630|
|Total liabilities and stockholders’ equity||$||170,587||$||190,823|
Stern Investor Relations, Inc.
Source: Cara Therapeutics, Inc.