BUSINESS DETAILS

(NASDAQ: CARA)

Address: 4 Stamford Plaza 107 Elm Street, 9th Floor
Stamford, CT 06902
Website: www.caratherapeutics.com
Phone: (203) 406-3700
Email: [email protected]
CEO: Derek Chalmers
Employees: 37
Auditor: Ernst & Young LLP

Company Overview

Cara Therapeutics is a clinical-stage biotechnical company that focused on developing and commercializing chemical entities designed to change pain management by selectively targeting the body’s peripheral kappa opioid receptors.

Cara is developing a completely new class of medicine called Kappa Opioid Receptor Agonists (KORAs) that targets the body’s peripheral nervous system and treat moderate-to-severe pain and pruritus (itch) without opioid-related adverse events or abuse and addiction issues

The company started its operations in 2004. Currently, they have no products available for sale. To date, the company financed their operations primarily through sales of equity and debt securities and payments from license agreements. Nominal amounts of revenue under research grants are received.

The product candidate CR845/difelikefalin is a new chemical entity, designed to selectively stimulate kappa and with specific chemical characteristics to restrict its entry into the central nervous system (CNS) and limit its mechanism of action to kappa opioid receptors in the peripheral nervous system, or nerves outside of the brain and spinal cord.

If approved by the FDA, Cara will build a speciality sales and marketing organization to commercialize KORSUVA (CR845/difelikefalin) injection and establish a sales force to market to nephrologists in dialysis centers across the United States.

The company also plans to establish a hospital-based sales force to market I.V. CR845/difelikefalin to physicians in the United States, if approved.

The Oral CR845/difelikefalin, which did not meet significant statistical reduction in pain scores across all osteoarthritis (OA) patients, is subjected to further development and commercialization through partnerships and collaborations with companies that have development and commercialization expertise in chronic pain.

Cara’s product candidate pipeline is summarized below:

The synthetic peptide amide kappa opioid agonist patent portfolio receives thirteen issued US patents with claims to wide range of composition, including the CR845/difelikefalin and related molecules, as well as methods of using these compounds.

The imidazoheterocycle cannabinoid compound patent portfolio includes three U.S. Patent numbers.

Cara also owns several other US Patents for cannabinoid compounds and regulation of prolactin in mammals including humans.

The company’s partnership with Maruishi Pharmaceutical Co., Ltd. provides license to develop, manufacture and commercialize drug products containing CR845/difelikefalin in Japan in the acute pain and uremic pruritus fields.

Through its partnership with Chong Kun Dang Pharmaceutical Corporation (CKDP), drug products containing CR845/difelikefalin are developed, manufactured and commercialized in South Korea.

To date, the company earned a total of $5.2 million in clinical development or regulatory milestone payments and sub-license fees, net of contractual foreign currency adjustments and South Korean withholding taxes, but have not received any royalties, under these collaborations.

Financial and Operating Highlights (First Quarter of 2018)

In January 2018, the Company initiated the first pivotal Phase 3 efficacy trial (KALM-1) of KORSUVA (CR845/difelikefalin) injection in the United States for the treatment of CKD-aP in patients undergoing hemodialysis.
The open label, dose-escalating Phase 1 pharmacokinetic (PK), safety and tolerability trial continues to enroll moderate and severe CKD patients in escalating dose cohorts.
In February 2018, the Company announced dosing of the first patient in a Phase 1 PK and safety trial of Oral KORSUVA in patients with CLD.
Enrollment for I.V. CR845/Difelikefalin for Acute Post-Operative Pain is complete in the adaptive Phase 3 trial
The Company reported a net loss of $16.8 million, or $0.51 per basic and diluted share, for the compared to a net loss of $22.2 million, or $0.81 per basic and diluted share, for the same quarter of 2017.
The Company did not recognize any revenue during the first quarter of 2018. Total revenue in the first quarter of 2017 was $911,000
R&D expenses were $13.4 million compared to $20.8 million in the same period of 2017.
General and Administrative (G&A) Expenses were $3.7 million compared to $2.4 million in the same period of 2017
Other income was $311,000 in the first quarter of 2018 compared to $90,000 in the same period of 2017.
Cash and Cash Equivalents and Marketable Securities Position on March 31, 2018 totaled $74.5 million compared to $92.6 million on December 31, 2017.

History

Cara Therapeutics was incorporated in the state of Delaware in July 2004.

In April 2013, Cara entered into a license agreement with Maruishi Pharmaceutical Co., Ltd., which granted exclusive license to develop, manufacture and commercialize drug products containing CR845/difelikefalin in Japan in the acute pain and uremic pruritus fields. Cara received an upfront license fee of $15.0 million plus an aggregate of $10.5 million in clinical development and regulatory milestones.

In April 2012, the company entered into a license agreement with Chong Kun Dang Pharmaceutical Corporation (CKDP) that granted an exclusive license to develop, manufacture and commercialize drug products containing CR845/difelikefalin in South Korea. Cara received a non-refundable and non-creditable $0.6 million upfront payment and is eligible to earn up to an aggregate of $3.8 million in development and regulatory milestones.