– Conference call today at
“In the second quarter, we continued to advance our clinical development programs for both KORSUVA™ Injection and Oral KORSUVA. Following positive top-line data from our KALM™-2 pivotal Phase 3 trial of KORSUVA Injection for chronic kidney disease-associated pruritus (CKD-aP) in hemodialysis patients, we remain on track to submit our first New Drug Application (NDA) to the
Second Quarter and Recent Developments:
KORSUVA Injection: Chronic Kidney Disease-Associated Pruritus (CKD-aP): Hemodialysis
All safety databases are now closed with more than 1,500 total patient exposures achieved, including more than 700 patients completing at least six months of treatment and more than 400 patients completing one year of treatment.
The Company remains on track to submit an NDA for KORSUVA Injection to the FDA in the fourth quarter of 2020.
Oral KORSUVA: CKD-aP: Non-Hemodialysis
Oral KORSUVA: Atopic Dermatitis (AD)
Based on the recommendation of the Independent Data Monitoring Committee, the size of the trial was increased from an original enrollment target of 320 patients to 410 patients, to maintain the prespecified statistical power of 80% or greater on the trial’s primary endpoint of change from baseline in the weekly mean of the daily 24-hour Worst Itching Intensity NRS and key secondary endpoint of the proportion of patients achieving a four point or greater improvement in Worst Itching Intensity NRS score at week 12. The prespecified interim conditional power assessment was conducted after approximately 50% of the originally targeted patient number had completed the designated 12-week treatment period. The Company expects the trial to be fully enrolled in the fourth quarter of 2020 and aims to report top-line results 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 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 continues to screen patients and aims to have top-line data in the first half of 2021, due in part to delays related to the ongoing COVID-19 pandemic.
Board of Directors Expansion and Appointment
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 clinical trials.
Based on guidelines from the
The Company expects to make presentations at the following upcoming conferences:
- 40th Annual
Canaccord Genuity Growth Conference, August 11-13, 2020 Cantor Fitzgerald Global Healthcare Conference, September 15-17, 2020 American Society of Nephrology Kidney Week, October 19-25, 2020 Stifel Healthcare Conference, November 17-18, 2020 Jefferies Global Healthcare Conference, November 17-19, 2020 Piper Sandler Health Care Conference, December 1-3, 2020
Second Quarter 2020 Financial Results
Net Loss: Net loss was
Revenues: Total revenue was
- The Company recognized
$4.5 millionand $5.2 millionof license and milestone fees revenue for the three months ended June 30, 2020and 2019, respectively, related to its license agreement with Vifor Fresenius Medical Care Renal Pharma Ltd.(VFMCRP).
- The Company recognized
$0.6 millionof license and milestone fees revenue for the three months ended June 30, 2020related to the achievement of a milestone related to its license agreement with Chong Kun Dang Pharmaceutical Corp.
- The Company recognized
$0.5 millionof clinical compound revenue from the sales of clinical compound for the three months ended June 30, 2020to Maruishi Pharmaceutical Company Ltd.and VFMCRP. There were no sales of clinical compound for the three months ended June 30, 2019.
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 7669087. 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 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, including the Company’s projected timeline for the submission of its NDA for 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
CONDENSED STATEMENTS OF OPERATIONS
(amounts in thousands, except share and per share data)
|Three Months Ended
||Six Months Ended
|License and milestone fees||$||5,099||$||5,208||$||13,120||$||9,450|
|Clinical compound revenue||535||-||607||140|
|Research and development||26,108||24,356||59,644||47,964|
|General and administrative||5,410||4,994||9,968||8,902|
|Total operating expenses||31,518||29,350||69,612||56,866|
|Other income, net||634||947||1,591||2,036|
|Loss before benefit from income taxes||(25,250||)||(23,195||)||(54,294||)||(45,240||)|
|Benefit from income taxes||182||235||304||320|
|Net loss per share:|
|Basic and Diluted||$||(0.54||)||$||(0.58||)||$||(1.15||)||$||(1.13||)|
|Weighted average shares:|
|Basic and Diluted||46,799,703||39,818,162||46,762,327||39,685,954|
|CONDENSED BALANCE SHEETS|
|Cash and cash equivalents||$||56,967||$||18,305|
|Income tax receivable||1,120||816|
|Total current assets||141,915||165,656|
|Operating lease right-of-use asset||2,825||3,036|
|Marketable securities, non-current||22,861||63,159|
|Property and equipment, net||604||700|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||13,952||$||19,665|
|Operating lease liability, current||1,006||967|
|Current portion of deferred revenue||9,768||22,262|
|Total current liabilities||24,726||42,894|
|Operating lease liability, non-current||2,959||3,352|
|Commitments and contingencies||-||-|
|Additional paid-in capital||594,963||587,223|
|Accumulated other comprehensive income||635||170|
|Total stockholders’ equity||140,928||186,713|
|Total liabilities and stockholders’ equity||$||168,613||$||232,959|
Stern Investor Relations, Inc.
Source: Cara Therapeutics, Inc.