Cara Therapeutics Reports First Quarter 2024 Financial Results - Topline efficacy and safety results from KOURAGE 1 Part A portion of notalgia paresthetica (NP) pivotal program now expected by the end of 2Q24

Reports First Quarter 2024 Financial Results

efficacy and safety results from KOURAGE 1 Part A portion of notalgia paresthetica (NP) pivotal program now expected by the end

STAMFORD, Conn., May 13, 2024

- Cara Therapeutics, Inc. (Nasdaq: CARA), a development-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 first

quarter ended March 31, 2024.

"Our notalgia paresthetica (NP)

pivotal clinical program is progressing ahead of schedule and we now expect to report topline efficacy and safety results from KOURAGE

1 Part A by the end of the second quarter of 2024," said Christopher Posner, President and Chief Executive Officer of Cara

Therapeutics. "We believe the medical dermatology community's interest in our clinical program underscores the significant

unmet need for an effective and safe anti-pruritic treatment for the sizeable NP patient population. We look forward to rapidly advancing

the ongoing Phase 2/3 program of our differentiated asset, oral difelikefalin, in this common but under-explored sensory neuropathy."

KOURAGE 1 Part A is the dose-finding

portion of the Phase 2/3 clinical program evaluating oral difelikefalin for the treatment of moderate-to-severe pruritus in patients

with NP. The Company enrolled 214 patients and expects topline efficacy and safety results from KOURAGE 1 Part A by the end of the

second quarter of 2024. Part A is not powered for statistical significance. This readout will provide key information, specifically

the dose and sample size to initiate the Phase 3 pivotal portion of the program - Part B of KOURAGE 1 and the second study

KOURAGE 2. Final topline results from the first pivotal study are expected by the end of 2025 with the second pivotal study results in

In March 2024, the Company hosted

a virtual event, Meet the NP Experts, featuring a panel of leading dermatologists and key opinion leaders to discuss the unmet need in

NP and the potential of oral difelikefalin. A replay of the webcast is available under "Events & Presentations"

in the Investors section of the Company's website, www.CaraTherapeutics.com.

Injection U.S. Update

In the first quarter

of 2024, KORSUVA (difelikefalin) injection generated net sales of approximately $1.8 million and the Company recorded

collaborative revenue of approximately $800,000, which represented the Company's share of the profit from sales of KORSUVA injection.

111,720 vials to dialysis centers during the first quarter of 2024.

2024, the Transitional Drug Add-On Payment Adjustment (TDAPA) period for KORSUVA injection expired. After the TDAPA period, KORSUVA injection

is reimbursed through the ESRD PPS bundle.

2024 Financial Results

Cash, cash equivalents

and marketable securities at March 31, 2024 totaled $69.8 million compared to $100.8 million at December 31, 2023. The decrease

in the balance primarily resulted from $30.5 million of cash used in operating activities.

For the first quarter

of 2024, net loss was $30.7 million, or $(0.56) per basic and diluted share, compared to net loss of $26.7 million, or ($0.49) per basic

and diluted share, for the same period in 2023.

Total revenue was $2.1 million and $6.2 million for the three months ended March 31, 2024 and 2023, respectively. Revenue primarily

Sold: Cost of goods sold was $0.6 million and $2.6 million for the three months ended March 31, 2024 and 2023, respectively,

related to commercial supply revenue for KORSUVA injection sales to CSL Vifor.

Development (R&D) Expenses: R&D expenses were $22.0 million for the three months ended March 31, 2024 compared to $24.3

million in the same period of 2023. The lower R&D expenses in 2024 were primarily due to decreases in stock-based compensation expense,

payroll and related costs, travel costs and other related conference costs as well as lower costs associated with the discontinuation

of our atopic dermatitis and advanced chronic kidney disease programs, partially offset by increases related to the oral difelikefalin

Administrative (G&A) Expenses: G&A expenses were essentially flat at $6.8 million for the three months ended March 31,

2024 compared to $6.9 million in the same period of 2023.

Expenses: Restructuring expenses were $2.4 million for the three months ended March 31, 2024 which were related to our strategic

prioritization of NP and the associated workforce reduction in the 2024 period. There were no restructuring expenses recorded during

the three months ended March 31, 2023.

net: Other income, net was approximately $1.0 million for each of the three months ended March 31, 2024 and 2023.

expense on liability related to sales of future royalties and milestones: Non-cash interest expense was $2.0 million which represented

imputed interest on the carrying value of the liability associated with the HCR Agreement and the amortization of the related issuance

costs associated with the HCR Agreement for the three months ended March 31, 2024. There was no non-cash interest expense for the

three months ended March 31, 2023.

our current unrestricted cash and cash equivalents and available-for-sale marketable securities will be sufficient to fund our currently

anticipated operating plan into 2026. Our current operating plan assumes certain costs related to our planned pivotal trials in NP.

Phase 2/3 Clinical Program in Notalgia Paresthetica

2/3 clinical program evaluating oral difelikefalin for the treatment of moderate-to-severe pruritus in patients with notalgia paresthetica

(NP). The program is comprised of two studies - KOURAGE 1 and KOURAGE 2 - which will likely be double-blind, placebo-controlled,

8-week studies with patients allowed to roll-over into open-label 52-week extensions.

KOURAGE 1 is composed

of two parts. The dose-finding portion of KOURAGE 1 (Part A) includes 214 patients who are randomized equally to four arms (0.25

mg BID, 1.0 mg BID, 2.0 mg BID, placebo BID). Part A is not powered for statistical significance.

KOURAGE 2 will likely be double-blind, placebo-controlled, 8-week studies with patients randomized 1:1 to either difelikefalin or matching

placebo. The primary endpoint for both the dose-finding portion of KOURAGE 1 (Part A) and the two pivotal studies Part B and

KOURAGE 2 will likely be the proportion of patients with a 4-point improvement at Week 8 from baseline in the worst itch numeric

About Cara Therapeutics

Cara Therapeutics is

a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus.

The Company is developing an oral formulation of difelikefalin, a selective, peripherally acting, non-scheduled kappa opioid receptor

agonist, for the treatment of chronic pruritus associated with notalgia paresthetica (NP), a common, underdiagnosed neuropathy affecting

the upper back for which there are no FDA-approved therapies. The Company is conducting a Phase 2/3 clinical program in NP with topline

results of the dose-finding portion expected by the end of the second quarter of 2024. Cara Therapeutics also developed an IV formulation

of difelikefalin, which is approved in the United States, EU, and multiple other countries for the treatment of moderate-to-severe pruritus

associated with advanced chronic kidney disease in adults undergoing hemodialysis. The IV formulation is out-licensed worldwide. For

more information, visit www.CaraTherapeutics.com and follow the company on X (Twitter), LinkedIn and Instagram.

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 planned future regulatory submissions and potential future regulatory approvals, future product launches, 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 candidate, the potential

for the Company's product candidate to be an alternative in the therapeutic areas investigated, including notalgia paresthetica,

the size and growth of the potential markets for pruritus management such as notalgia paresthetica, the commercial potential of the Company's

product candidate, and the Company's cash runway. Because such statements are subject to risks and uncertainties, actual results

may differ materially from those expressed or implied by such forward-looking statements. The risks are 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, 2023 and its other documents subsequently filed with or furnished

to the Securities and Exchange Commission, including its Form 10-Q for the quarter ended March 31, 2024. 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

CARA THERAPEUTICS, INC.

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Iris Francesconi, Ph.D.