Cara Therapeutics Reports Third Quarter 2021 Financial Results
– KORSUVA™ (CR845/difelikefalin) injection Approved as First and Only Treatment for Chronic Kidney Disease-associated Pruritus (CKD-aP) in Adult Hemodialysis Patients by
– Christopher Posner Appointed President and Chief Executive Officer Effective
– Conference call today at
“I am excited to be joining Cara at a transformational point for the Company as it prepares for the commercial launch of KORSUVA injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in hemodialysis patients in the first half of 2022,” said
“In the third quarter of 2021, Cara made significant progress across our development programs, culminating with the FDA approval of KORSUVA injection for moderate-to-severe pruritus associated with chronic kidney disease in hemodialysis patients,” said
Third Quarter and Recent Developments:
KORSUVA Injection: Chronic Kidney Disease-Associated Pruritus (CKD-aP): Hemodialysis
Following the FDA approval of KORSUVA injection, the Company has been collaborating with its commercial partner, Vifor Pharma, on the promotional launch of KORSUVA injection in
Oral KORSUVA: Atopic Dermatitis (AD)
In the third quarter, the Company held an End-of-Phase 2 Meeting with the FDA to discuss the results from its Phase 2 KARE dose-ranging clinical trial of Oral KORSUVA for the treatment of moderate-to-severe pruritus in atopic dermatitis patients. Based on meeting guidance, the Company plans to initiate a Phase 3 program in AD patients in the first quarter of 2022.
Oral KORSUVA: Non-Dialysis Dependent (NDD) CKD-aP
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 continues to screen patients in this ongoing Phase 2 trial and, primarily due to the ongoing effects of the COVID-19 pandemic on patient enrollment, currently expects to report top-line data in the first half of 2022.
Oral KORSUVA: Notalgia Paresthetica (NP)
The Company initiated a Phase 2 trial of Oral KORSUVA for the treatment of moderate-to-severe pruritus in patients suffering from NP, a nerve disorder characterized by chronic pruritus of the upper back, in early 2021. The Phase 2 trial remains on track to be fully enrolled by year-end.
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 4-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. The Company is working closely with its clinical and commercial manufacturing partners to continue to ensure sufficient supply of KORSUVA is available for the commercial launch of KORSUVA injection and its ongoing and planned clinical trials.
Upcoming Meeting Activities
The Company expects to make presentations at the following upcoming conferences:
Stifel Healthcare Conference, November 15-17, 2021 Jefferies Global Healthcare Conference, November 16-18, 2021 Piper Sandler Health Care Conference, November 30-December 2, 2021 J.P. Morgan Healthcare Conference, January 10-13, 2022
Winter Clinical Dermatology Conference– Hawaii, January 14-19, 2022
Third Quarter 2021 Financial Results
Cash, cash equivalents and marketable securities at
For the three months ended
Revenues: Revenue for the three months ended
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
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
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 1480703. 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.
Cara Therapeutics is an early commercial-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral KORs. Cara is developing a novel and proprietary class of product candidates, led by KORSUVA™ (CR845/difelikefalin), a first-in-class KOR agonist that targets the body’s peripheral nervous system, as well as certain immune cells. KORSUVA injection was approved by the FDA for the treatment of moderate-to-severe CKD-aP in adults undergoing hemodialysis on August 23, 2021. Oral KORSUVA has completed Phase 2 trials for the treatment of pruritus in patients with CKD and AD and is currently in Phase 2 trials in PBC and NP patients with moderate-to-severe pruritus.
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 Company’s ability to commercialize KORSUVA injection, including the timing of additional regulatory submissions and approvals, the Company’s ability to obtain and maintain coverage and adequate reimbursement for KORSUVA injection, the performance of our commercial partners, including Vifor Pharma, expected timing of the initiation, enrollment and data readouts from the Company’s planned and ongoing clinical trials, the potential results of ongoing clinical trials, timing of 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, the Company’s expected cash reach, and the potential impact of COVID-19 on the Company’s commercial launch, 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
|| Nine Months Ended
|License and milestone fees||$||20,031||$||9,257||$||21,223||$||22,377|
|Clinical compound revenue||241||9||278||616|
|Research and development||15,514||21,067||59,870||80,711|
|General and administrative||5,882||5,219||17,898||15,187|
|Total operating expenses||21,396||26,286||77,768||95,898|
|Other income, net||111||379||502||1,970|
|Loss before benefit from income taxes||(1,013)||(16,641)||(55,059)||(70,935)|
|Benefit from income taxes||-||132||-||436|
|Net loss per share:|
|Basic and Diluted||$||(0.02)||$||(0.35)||$||(1.10)||$||(1.51)|
|Weighted average shares:|
|Basic and Diluted||50,114,710||46,885,424||$||50,031,615||46,803,659|
|CONDENSED BALANCE SHEETS|
|Cash and cash equivalents||$||22,991||$||31,683|
|Income tax receivable||697||1,507|
|Total current assets||171,499||195,065|
|Operating lease right-of-use assets||3,310||4,279|
|Marketable securities, non-current||49,221||70,565|
|Property and equipment, net||654||840|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||13,812||$||16,881|
|Operating lease liabilities, current||1,716||1,602|
|Total current liabilities||15,528||18,483|
|Operating lease liabilities, non-current||2,373||3,673|
|Commitments and contingencies||-||-|
|Common stock subscribed in Vifor stock purchase||3||-|
|Additional paid-in capital||699,482||641,195|
|Stock subscription receivable||(44,969||)||-|
|Accumulated other comprehensive income||1||73|
|Total stockholders’ equity||207,191||249,001|
|Total liabilities and stockholders’ equity||$||225,092||$||271,157|
Source: Cara Therapeutics, Inc.