“We are very excited by the recent success of our KALM™-2 pivotal Phase 3 trial of KORSUVA™ Injection in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus. With no approved therapies in the
First Quarter and Recent Developments
KORSUVA Injection: Chronic Kidney Disease-Associated Pruritus (CKD-aP): Hemodialysis
More than 1,500 total patient exposures have now 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.
The Company remains on track to submit an NDA to the
Oral KORSUVA: CKD-aP: Non-Hemodialysis
Oral KORSUVA: Atopic Dermatitis (AD)
The Company remains on track to complete an interim statistical analysis in the second quarter of 2020, after approximately 50% of the targeted number of patients complete the designated 12-week treatment period. The Company expects to report top-line results from this trial in 2020, subject to any delays related to the COVID-19 pandemic.
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 KORSUVA (1.0 mg tablet, twice daily) versus placebo for 16 weeks. The Company expects top-line results from this trial in 2020, subject to any delays related to the COVID-19 pandemic.
COVID-19 Impacts and Business Operations
Due to the 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 ensure sufficient supply of KORSUVA and the Company currently believes future supply will be uninterrupted.
Based on guidelines from the
The Company expects to make presentations at the following upcoming virtual conferences:
BofA Securities2020 Health Care Conference, May 12-14, 2020 Jefferies Global Healthcare Conference, June 2-4, 2020
First Quarter 2020 Financial Results
Net Loss: Net loss was
Revenues: Total revenue was
- The Company recognized
$8.0 millionand $4.2 millionof license and milestone fees revenue for the three months ended March 31, 2020and 2019, respectively, related to its license agreement with Vifor Fresenius Medical Care Renal Pharma Ltd.
- The Company recognized
$72,000and $140,000of revenue from the sales of clinical compound for the three months ended March 31, 2020and 2019, respectively, in connection with 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, net: Other income, net 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 3875739. 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.
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, 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 STATEMENTS OF OPERATIONS
|(amounts in thousands, except share and per share data)|
|Three Months Ended
|License and milestone fees||$||8,021||$||4,242|
|Clinical compound revenue||72||140|
|Research and development||33,536||23,608|
|General and administrative||4,558||3,908|
|Total operating expenses||38,094||27,516|
|Other income, net||957||1,089|
|Loss before benefit from income taxes||(29,044||)||(22,045||)|
|Benefit from income taxes||122||85|
|Net loss per share :|
|Basic and Diluted||$||(0.62||)||$||(0.56||)|
|Weighted average shares:|
|Basic and Diluted||46,724,951||39,552,277|
|CONDENSED BALANCE SHEETS|
|Cash and cash equivalents||$||17,036||$||18,305|
|Income tax receivable||938||816|
|Total current assets||132,669||165,656|
|Operating lease right-of-use asset||2,876||3,036|
|Marketable securities, non-current||59,568||63,159|
|Property and equipment, net||652||700|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||17,371||$||19,665|
|Operating lease liability, current||991||967|
|Current portion of deferred revenue||14,241||22,262|
|Total current liabilities||32,603||42,894|
|Operating lease liability, non-current||3,096||3,352|
|Commitments and contingencies||-||-|
|Additional paid-in capital||590,144||$||587,223|
|Accumulated other comprehensive income (loss)||(68||)||170|
|Total stockholders’ equity||160,474||186,713|
|Total liabilities and stockholders’ equity||$||196,173||$||232,959|
Stern Investor Relations, Inc.
Source: Cara Therapeutics, Inc.