Cara Therapeutics and Tvardi Therapeutics Announce Entry into Merger Agreement Proposed Merger to create a Nasdaq-listed, clinical-stage biopharmaceutical company developing novel treatments targeting STAT3 to treat fibr

Cara Therapeutics and Tvardi Therapeutics Announce

Entry into Merger Agreement

Proposed Merger to create a Nasdaq-listed,

clinical-stage biopharmaceutical company developing novel treatments targeting STAT3 to treat fibrosis-driven diseases

completed an approximately $28 million private financing, which, together with Tvardi's existing cash and Cara's anticipated

cash balance, is expected to fund the combined company into the second half of 2026

Tvardi anticipates reporting topline data in

the second half of 2025 from two Phase 2 clinical programs utilizing its STAT3 inhibitor, TTI-101, including its lead program in idiopathic

pulmonary fibrosis and its program in hepatocellular carcinoma

Companies to host investor conference call and webcast today, December

CT and HOUSTON, TX - December 18, 2024 - Cara Therapeutics, Inc. (Nasdaq: CARA) and Tvardi Therapeutics, Inc.

("Tvardi"), a privately held, clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule

therapies targeting STAT3 to treat fibrosis-driven diseases, today announced that the companies have entered into a definitive merger

agreement to combine in an all-stock transaction (the "Merger").

Under the terms of the agreement, Tvardi will merge with a wholly owned

subsidiary of Cara. Upon completion of the Merger, pre-Merger Cara Therapeutics stockholders are expected to own approximately 17.0% of

the combined company and pre-Merger Tvardi Therapeutics investors are expected to own approximately 83.0% of the combined company, in

each case, prior to adjustment from the issuance of the shares in the recently completed Tvardi financing and assuming Cara has net cash

at closing of between $22.875 million and $23.125 million. The percentage of the combined company that pre-merger Cara stockholders and

pre-merger Tvardi stockholders will own upon the closing of the merger is subject to further adjustment if Cara's net cash balance

falls outside of the range. Upon completion of the Merger, the combined company is expected to operate under the name Tvardi Therapeutics, Inc.

and trade on Nasdaq under the ticker symbol "TVRD".

Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi Therapeutics,

stated, "As we approach meaningful value inflection points next year, including two Phase 2 readouts of our lead program in idiopathic

pulmonary fibrosis, followed by the readout in our hepatocellular carcinoma program, this merger, the recently completed financing, and

becoming a publicly traded company give us access to the critical funding required to further advance our promising pipeline programs

that address significant unmet needs. I am grateful to the Cara Board, leadership team, and shareholders who share our vision of Tvardi

that is well-positioned to introduce effective, new treatment options to patients suffering from serious, chronic, fibrosis-driven diseases."

"We are very excited to enter into this merger agreement with

Tvardi and combine our financial resources with their expertise in STAT3 inhibition," added Christopher Posner, President and Chief

Executive Officer of Cara Therapeutics. "Our management and our Board of Directors thoroughly explored numerous strategic alternatives

and believe that this merger with Tvardi is in the best interests of our stockholders and provides them with the opportunity to meaningfully

participate in a company treating fibrosis-driven diseases in an innovative way."

Tvardi has recently completed an approximately $28 million private

financing from a syndicate of new and existing institutional investors. With the cash from both companies at closing and the proceeds

of this financing, the combined company is expected to have sufficient cash to fund its operating expenses and capital expenditure requirements

into the second half of 2026, past the anticipated Phase 2 readouts in the second half of 2025.

KORSUVA/KAPRUVIA Asset Sale

Concurrent with the entry into the merger agreement with Tvardi, Cara

also entered into an asset purchase agreement with Vifor Fresenius Medical Care Renal Pharma, Ltd. ("CSL Vifor"), a company

jointly owned by Fresenius Medical Care and by the CSL Vifor business unit of the CSL Group. Pursuant to such asset purchase agreement,

at the consummation of the transaction, Cara will sell to CSL Vifor and CSL Vifor will acquire from Cara certain assets and rights to

the development, manufacture and commercialization of Korsuva /Kapruvia (difelikefalin) as well as certain associated liabilities

(the "Asset Disposition") for a purchase price of $900,000 (subject to certain adjustments with respect to inventory). Additionally,

pursuant to the Asset Purchase Agreement, at the consummation of the Asset Disposition, Cara has agreed to pay CSL Vifor $3,000,000 to

compensate CSL Vifor for the estimated incremental future expenses to be incurred by CSL Vifor as a result of the transfer of the assets

to be acquired and the liabilities to be assumed by it in connection with the Asset Disposition.

The Asset Disposition is subject to certain conditions to closing,

including the consummation of the merger with Tvardi substantially contemporaneously with the Asset Disposition.

Tvardi's Pipeline of STAT3 Inhibitors

The combined company will focus on advancing Tvardi's pipeline

of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases with significant unmet need, including its

lead candidate, TTI-101, which is in a Phase 2 trial for idiopathic pulmonary fibrosis (IPF) and a Phase 1b/2 trial for hepatocellular

carcinoma (HCC). STAT3 is a highly validated, yet historically undruggable, transcription factor, which is a central catalyst in fibrosis-driven

TTI-101 is an orally bioavailable, small-molecule inhibitor of signal

transducer and activator of transcription 3 (STAT3), a transcription factor whose upregulation and activation acts as a catalyst across

critical pathways associated with fibrosis-driven diseases. TTI-101's differentiated mechanism of action is designed to inhibit

STAT3 to address the unmet need in fibrosis-driven diseases, without interfering with its other essential biological functions. TTI-101

has shown a robust pharmacokinetic profile, potency in inhibiting STAT3 activation and efficacy in animal models of fibrosis-driven diseases.

In addition, in clinical trials performed to date, oral dosing with TTI-101 lowered levels of activated STAT3 in tumor tissue, was generally

well-tolerated, and led to clinical responses in HCC and other tumor types.

ongoing clinical trial is evaluating the safety and efficacy of TTI-101 alone or in addition to nintedanib (OFEV ) in patients

suffering from IPF. The clinical trial is testing two different doses of TTI-101 compared to placebo using a Phase 2, randomized, double-blind,

placebo-controlled design and is being conducted in the United States. Unblinded data from the REVERTIPF study is anticipated

to be reported in the second half of 2025. ClinicalTrials.gov ID: NCT05671835

CANCER ongoing clinical trial is evaluating the safety and efficacy of TTI-101 across three cohorts of patients with HCC:

alone or in combination with standard of care treatments pembrolizumab (Keytruda ) or atezolizumab (Tecentriq ) and bevacizumab

(Avastin or biosimilars Vegzelma , Alymsys , Zirabev , and Mvasi ). The clinical trial is a Phase 1b/2 open-label

study design being conducted in the United States. Preliminary topline data from the REVERTLIVER CANCER study is anticipated in

the second half of 2025. ClinicalTrials.gov ID: NCT05440708

TTI-109, Tvardi's second product candidate, is an oral, small-molecule,

which is structurally related to, yet chemically distinct from, TTI-101 and is designed to enhance the ability to target STAT3. An IND

application for TTI-109's first human study is expected in the first half of 2025.

Management and Organization

Following the Merger, the combined company will be headquartered in

Houston, Texas and will be led by Tvardi's CEO, Imran Alibhai, Ph.D., and other members of the Tvardi management team. The

combined company's board of directors will be comprised of six directors from Tvardi's Board of Directors and one director from

Cara's Board of Directors.

About the Proposed Merger

The transaction has been approved by the Boards of Directors of both

companies and is expected to close in the first half of 2025, subject to certain closing conditions, including, among other things, approval

by the stockholders of each company, the effectiveness of a registration statement to be filed with the SEC to register the shares of

Tvardi common stock to be issued in connection with the Merger, Cara having a minimum amount of net cash as of the closing, and other

customary closing conditions. In connection with the Merger, directors and officers of Cara and directors, officers and certain stockholders

of Tvardi have executed support agreements, pursuant to which they have agreed to vote all their shares of capital stock in favor of the

Piper Sandler & Co. is serving as

exclusive financial advisor to Cara Therapeutics. Mintz, Levin, Cohn, Ferris, Glovsky, and Popeo, P.C. is serving as legal counsel to

Cara Therapeutics. Cooley LLP and Goodwin Procter LLP are serving as legal counsel to Tvardi.

Conference Call and Webcast

The management teams of both companies will

host an investor conference call and webcast today, December 18th, at 8:30am ET, to discuss the proposed Merger.

Investors dial-in: 1-844-826-3035 (domestic)

Investors dial-in: 1-412-317-5195 (International)

Conference ID: 10194904

To utilize the Call me feature, which

provides instant telephone access to the event without assistance from an operator:

Call me Passcode: 8242749

webcast can be accessed here: