Full Press Release Details
Cara Therapeutics Reports Third Quarter 2023
- Non-dilutive financing agreement with
HealthCare Royalty for up to $40 million expected to extend cash runway into 2025 -
- Key data readouts for all three late-stage
oral difelikefalin clinical programs anticipated within current financial runway -
- Topline results from Part A of
KIND 1 Phase 3 atopic dermatitis trial expected in December 2023 -
- 3Q23 total revenue of $4.9M including
collaborative revenue of $1.9M from the Company's share of profit of KORSUVA (difelikefalin) injection -
- Conference call today at 4:30 p.m. EST
STAMFORD, Conn., November 13, 2023
- Cara Therapeutics, Inc. (Nasdaq: CARA), a commercial-stage biopharmaceutical company leading a new treatment paradigm
to improve the lives of patients suffering from pruritus, today announced financial results and operational highlights for the third
quarter ended September 30, 2023.
"We are pleased to have closed our non-dilutive
financing transaction with HealthCare Royalty, which extends our cash runway into 2025," said Christopher Posner, President and
Chief Executive Officer of Cara Therapeutics. "This financing will help us reach key clinical catalysts which we believe will validate
the potential of our oral difelikefalin pipeline."
Mr. Posner continued, "We look forward
to releasing topline efficacy and safety data from Part A of our KIND 1 atopic dermatitis (AD) trial in December. Our other two
late-stage clinical programs for the treatment of pruritus associated with advanced chronic kidney disease (CKD) and notalgia paresthetica
(NP) are on track for key data readouts in 2024. We will continue to focus on maintaining a strong balance sheet and delivering on our
commitments across our wholly owned pipeline."
3Q23 and Recent Highlights
| Entered into Royalty Interest Purchase and Sale Agreement with HealthCare Royalty (HCRx) for up to $40 million, extending Cara's cash runway into 2025 | ||
| Topline efficacy and safety data from Part A of the KIND 1 Phase 3 program in pruritus associated with AD expected in December 2023 | ||
| Enrollment on track in the KICK Phase 3 program in pruritus associated with advanced CKD, with topline results expected in 2H24 |
| Enrollment also on track in the KOURAGE Phase 2/3 program in NP, with readout from Part A targeted in 2H24 and final topline results for the program in 1H26 | ||
| Findings from the Neuropathic Itch Patient Survey (NIRVE) were reported in an oral presentation at the EADV Congress 2023 | ||
| Centers for Medicare & Medicaid Services issued the CY 2024 End Stage Renal Disease Prospective Payment System final rule | ||
| Helen M. Boudreau was appointed to the Company's Board of Directors and will serve as Chair of the Audit Committee | ||
| Harrison M. Bains retired from the Company's Board of Directors |
KORSUVA Injection U.S. Update: 3Q23
In the third quarter of 2023, KORSUVA injection
generated net sales of $4.4 million and the Company recorded collaborative revenue of $1.9 million, which represented the Company's
share of the profit from sales of KORSUVA injection.
Wholesalers shipped 90,828 vials to dialysis
centers during the third quarter of 2023. Vial orders increased 36% quarter to quarter.
In October 2023, the Centers for Medicare &
Medicaid Services (CMS) issued a final rule for the End Stage Renal Disease Prospective Payment System (ESRD PPS) for calendar year
2024, which confirmed the TDAPA period for KORSUVA injection until March 31, 2024, and maintained the reimbursement methodology
from the June 2023 proposed rule.
Upcoming Meeting Activities
The Company expects to present at the following
upcoming investor conferences:
| Stifel Healthcare Conference, November 15, 2023, at 10:55 a.m. EST | ||
| Jefferies London Healthcare Conference, November 16, 2023, at 8:00 a.m. GMT | ||
| Piper Sandler Healthcare Conference, November 29, 2023, at 4:30 p.m. EST |
Third Quarter 2023 Financial Results
Cash, cash equivalents and marketable securities
at September 30, 2023 totaled $83.3 million compared to $156.7 million at December 31, 2022. The decrease in the balance primarily
resulted from $74.7 million of cash used in operating activities.
For the third quarter of 2023, net loss was $28.0
million, or $(0.52) per basic and diluted share, compared to net loss of $23.2 million, or $(0.43) per basic and diluted share, for the
same period in 2022.
Revenues: Total revenue was $4.9 million
and $10.8 million for the three months ended September 30, 2023 and 2022, respectively. Revenue consisted of:
Cost of Goods Sold: Cost of goods sold
was $1.6 million and $3.1 million during the three months ended September 30, 2023 and 2022, respectively, related to commercial
supply revenue for KORSUVA injection sales to CSL Vifor.
Research and Development (R&D) Expenses:
R&D expenses were $25.5 million for the three months ended September 30, 2023 compared to $24.7 million in the same period
of 2022. The slightly higher R&D expenses in 2023 were primarily due to increases in clinical trial costs related to our three late-stage
development programs, partially offset by a decrease in stock-based compensation expense. R&D expenses for the three months ended
September 30, 2022 included $5.0 million related to a milestone payment due to Enteris Biopharma, Inc.
General and Administrative (G&A) Expenses:
G&A expenses were essentially flat at $6.8 million for the three months ended September 30, 2023 compared to $6.9 million
in the same period of 2022.
Other Income, net: Other income, net was
approximately $866,000 for the three months ended September 30, 2023 compared to approximately $665,000 in the same period of 2022.
The increase in other income, net was primarily due to an increase in interest income resulting from a higher yield on our portfolio
of investments during the three months ended September 30, 2023.
Cara expects that our current unrestricted cash
and cash equivalents and available-for-sale marketable securities, including the proceeds from our recently announced royalty financing
and the collaborative revenue from our share of the profit from KORSUVA injection, will be sufficient to fund our currently anticipated
operating plan into 2025.
About Cara Therapeutics
Cara Therapeutics is
a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus.
The Company's KORSUVA (difelikefalin) injection is the first and only FDA-approved treatment for moderate-to-severe pruritus
associated with chronic kidney disease in adults undergoing hemodialysis. The Company is developing an oral formulation of difelikefalin
and has Phase 3 programs ongoing for the treatment of pruritus in patients with advanced chronic kidney disease and atopic dermatitis.
In addition, the Company has an ongoing Phase 2/3 program of oral difelikefalin for the treatment of moderate-to-severe pruritus in patients
with notalgia paresthetica. For more information, visit www.CaraTherapeutics.com and follow the company on X (Twitter),
LinkedIn and Instagram.
Forward-looking Statements
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 and its partners ongoing
commercialization of and ability to successfully commercialize KORSUVA injection and Kapruvia, future revenue and profit share from sales
of KORSUVA and Kapruvia, planned future regulatory submissions and potential future regulatory approvals, future product launches, the
performance of the Company's commercial partners, including CSL Vifor, 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 and the potential for oral difelikefalin to address additional pruritic indications,
the size and growth of the potential markets for pruritus management, the receipt of potential milestone payments pursuant to the Purchase
and Sale Agreement with HealthCare Royalty 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. These risks
and uncertainties include the risks inherent in the launch of new products, including that our commercial partners, including CSL Vifor,
may not perform as expected, risks inherent in the clinical and regulatory development of pharmaceutical products, and the risks described
more fully in Cara Therapeutics' filings with the Securities and Exchange Commission, including the "Risk Factors"
section of the Company's Annual Report on Form 10-K for the year ending December 31, 2022 and its other documents subsequently
filed with or furnished to the Securities and Exchange Commission, including its Form 10-Q for the quarter ended September 30,
2023. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cara Therapeutics
undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they
were made, except as required by law.
Financial tables follow
| CARA THERAPEUTICS, INC. |
| CONDENSED BALANCE SHEETS |
| (in thousands) |
| (unaudited) |