Cara Therapeutics Reports Second Quarter 2023 Financial Results - 2Q23 total revenue of $6.9M including collaborative revenue of $5.4M from the Company's share of profit of KORSUVA (difelikefalin) injection - - Demand fo

Cara Therapeutics Reports Second Quarter 2023

- 2Q23 total revenue of $6.9M including

collaborative revenue of $5.4M from the Company's share of profit of KORSUVA (difelikefalin) injection -

- Demand for KORSUVA injection accelerating

with 46% increase in vial orders quarter to quarter -

- 2024 ESRD PPS proposed rule suggests

additional funding for TDAPA-designated products in existing functional category; final rule expected in 4Q23 -

- Three late-stage oral difelikefalin

clinical programs tracking to plan; Internal readout of Part A of KIND 1 atopic dermatitis trial expected in 4Q23 -

- Conference call today at 4:30 p.m. EDT

STAMFORD, Conn., August 7, 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 second quarter ended

"In the second quarter of 2023, the commercialization

of KORSUVA (difelikefalin) injection in the U.S. and Kapruvia in countries around the world continued

to make meaningful progress. We believe the increased vial shipments and reorder rates in the U.S., as well as the positive feedback from

providers and patients globally, confirm the significant need for an anti-pruritic treatment for chronic kidney disease (CKD) patients,"

said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. "In June, CMS issued the CY2024 ESRD PPS proposed

rule, providing clarity around the reimbursement of KORSUVA injection post its TDAPA period. While we were pleased that CMS included additional

funding outside the bundle rate in the proposed rule, we will continue to work with CMS on refining the reimbursement methodology ahead

of the release of the final rule, which is expected in the fourth quarter of 2023."

Mr. Posner continued, "On the development

front, we are pleased with the progress of our late-stage oral difelikefalin programs for pruritus associated with atopic dermatitis (AD),

advanced CKD and notalgia paresthetica (NP). All three trials are enrolling patients and the internal readout from Part A of our

KIND Phase 3 program in AD is expected in the fourth quarter of 2023. As the key driver of our long-term value, we are focused on advancing

the development of oral difelikefalin in our nephrology and medical dermatology franchises and remain steadfast in our commitment to establishing

Cara Therapeutics as the leader in the treatment of chronic pruritus."

2Q23 and Recent Highlights

KORSUVA Injection Launch Update: 2Q23

In the second quarter of 2023, KORSUVA injection

generated net sales of $11.4 million and the Company recorded collaborative revenue of $5.4 million, which represented the Company's

share of the profit from sales of KORSUVA injection.

Wholesalers shipped 66,852 vials to dialysis centers,

the majority of which were Fresenius clinics, during the second quarter of 2023. Vial orders increased 46% quarter to quarter, indicating

an acceleration in patient demand.

In June 2023, the Centers for Medicare &

Medicaid Services (CMS) issued a proposed rule for the End Stage Renal Disease Prospective Payment System (ESRD PPS) for calendar

year 2024, which addresses the reimbursement of KORSUVA injection after its Transitional Drug Add-On Payment Adjustment (TDAPA) period.

The final rule is expected in the fourth quarter of 2023.

In the second quarter of 2023, Kapruvia generated

$1.2 million in net sales and the Company recorded $123,000 in royalty revenue associated with Kapruvia sales in Europe.

Seven EU countries have launched Kapruvia to date,

and the Company expects additional launches to commence over the coming months. In May 2023, England's NICE recommended Kapruvia

for the treatment of moderate-to-severe CKD-aP in adult patients on hemodialysis.

The Company continues to expect its licensing

partner Maruishi Pharmaceutical Co., Ltd. to receive a regulatory decision from the Pharmaceuticals and Medical Devices Agency (PMDA)

in Japan in the second half of 2023.

Upcoming Meeting Activities

The Company expects to present at the following

upcoming investor conferences:

Second Quarter 2023 Financial Results

Cash, cash equivalents and marketable securities

at June 30, 2023 totaled $101.7 million compared to $156.7 million at December 31, 2022. The decrease in the balance primarily

resulted from $55.1 million of cash used in operating activities.

For the second quarter of 2023, net loss was $31.5

million, or $(0.58) per basic and diluted share, compared to net loss of $4.2 million, or $(0.08) per basic and diluted share, for the

same period in 2022.

Revenues: Total revenue was $6.9 million

and $23.0 million for the three months ended June 30, 2023 and 2022, respectively. Revenue primarily consisted of:

Cost of Goods Sold: Cost of goods

sold was $1.4 million during the three months ended June 30, 2023, related to commercial supply revenue for KORSUVA injection

sales to CSL Vifor. There was no associated cost of goods sold during the three months ended June 30, 2022 as there was no

commercial supply revenue from CSL Vifor.

Research and Development (R&D) Expenses:

R&D expenses were $30.3 million for the three months ended June 30, 2023 compared to $19.9 million in the same period of

2022. The 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.

General and Administrative (G&A) Expenses:

G&A expenses were essentially flat at $7.5 million for the three months ended June 30, 2023 compared to $7.6 million in the same

Other Income, net: Other income, net was

approximately $861,000 for the three months ended June 30, 2023 compared to approximately $266,000 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 June 30, 2023.

We expect that our current unrestricted cash and

cash equivalents and available-for-sale marketable securities, including collaborative revenue from our share of the profit from KORSUVA

injection, will be sufficient to fund our currently anticipated operating plan for at least the next 12 months.

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 initiated a 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 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, potential for post-TDAPA reimbursement of KORSUVA

and timing of final rules related thereto, 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 Company's participation in certain conferences 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.