Cara Therapeutics, Inc. (CARA) Business Model Canvas

Cara Therapeutics, Inc. (CARA): Business Model Canvas [Dec-2025 Updated]

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You're trying to make sense of a company that fundamentally changed its game plan in 2025, pivoting from pruritus to fibrosis-driven diseases after merging with Tvardi Therapeutics. This isn't just a pipeline adjustment; it's a full re-platforming around a proprietary oral small molecule STAT3 inhibitor, all while managing the existing KORSUVA revenue stream with CSL Vifor. Frankly, the near-term reality is a race against the burn rate, as they managed $2.6 million in Q1 2025 revenue but still saw a net cash burn of $17.8 million through the third quarter, leaving them with $36.4 million in the bank as of Q3 2025. I've mapped out the entire operational structure-from key activities like advancing HCC trials to their $38.66 million market cap in November 2025-so you can see the precise levers they are pulling now. Dive into the full Business Model Canvas below to see the mechanics of this high-stakes transformation.

Cara Therapeutics, Inc. (CARA) - Canvas Business Model: Key Partnerships

You're looking at the structure that supports Cara Therapeutics, Inc.'s commercial and development efforts, which is heavily reliant on external players for market access and pipeline progression. Honestly, for a commercial-stage company, these relationships are where the revenue engine is built.

The core of the commercial strategy revolves around KORSUVA (difelikefalin) injection, which is approved in the US for moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis.

Key Partnership Financial & Operational Snapshot

Partner Role/Focus Area Key Financial/Statistical Data Point Context/Timing
CSL Vifor Global commercialization partner for KORSUVA injection (US) 50% profit share arrangement on US sales As per the original agreement structure.
CSL Vifor Asset Acquisition (related to Tvardi merger) $900,000 purchase price for certain assets/rights Agreed upon in the context of the expected March 31, 2025 merger closing.
CSL Vifor US KORSUVA Sales Impact Collaborative revenue of $12.9 million recognized in FY 2023 Share of profit from CSL Vifor's US sales for the year ended December 31, 2023.
CSL Vifor US KORSUVA Sales Impact Wholesalers shipped 111,720 vials to dialysis centers During the first quarter of 2024.
Maruishi Pharmaceutical Licensee for KORSUVA in Japan Eligible for tiered, double-digit royalties on sales If licensed product is sold in Japan.
Maruishi Pharmaceutical Milestone Payment Additional $2.5 million milestone payment due in Q1 2025 For achievement of a 2024 sales milestone in Japan.
Fresenius Medical Care Dialysis Provider Network Treated approx. 299,358 patients in 3,674 clinics worldwide As of March 31, 2025.
PolyPeptide Group Manufacturer of API (Difelikefalin) A separate PolyPeptide customer signed a multi-year agreement with an annual order value around EUR 100 million After a ramp-up phase starting in 2024 (not directly Cara's contract value).

The relationship with CSL Vifor, which includes Fresenius Medical Care Renal Pharma, is central to the US commercialization of the injection product. You should note that Cara Therapeutics entered into a Royalty Interest Purchase and Sale Agreement with HealthCare Royalty (HCRx) for up to $40 million, which extended the cash runway into 2025.

The strategic path for Cara Therapeutics itself was significantly altered by the expected merger closing with Tvardi Therapeutics Inc. on March 31, 2025. Post-closing, pre-merger Cara stockholders are projected to own about 17% of the combined entity, which is expected to operate under the Tvardi Therapeutics Inc. name.

Pipeline Development and Manufacturing Obligations

The development of the STAT3 inhibitor pipeline, which includes oral difelikefalin for notalgia paresthetica (NP), relies on CROs to execute trials. The overall topline results for the pivotal KOURAGE 1 Phase II/III program are expected by Q4 2025.

For the API manufacturing, Cara Therapeutics uses PolyPeptide Group under a commercial supply agreement for CR845/Difelikefalin. While specific 2025 supply costs aren't public, the financial reporting shows direct costs associated with the product supply chain.

  • Cost of Goods Sold related to commercial supply revenue for KORSUVA injection sales to CSL Vifor was $0.6 million for the three months ended March 31, 2024.
  • In December 2023, Cara received a milestone of $20.0 million related to Kapruvia pricing in Germany.
  • Cara received a $15.0 million regulatory milestone payment from CSL Vifor upon European Commission approval in April 2022.

The partnership with Maruishi Pharmaceutical for Japan is structured around regulatory and sales achievements. Cara earned a $1.5 million milestone payment from Maruishi in September 2023 for Japanese marketing approval.

Cara Therapeutics, Inc. (CARA) - Canvas Business Model: Key Activities

You're looking at the core engine room of Cara Therapeutics, Inc. as it navigated the transition following its merger in mid-2025. The key activities here are all about execution against the remaining pipeline and managing the financial runway, especially given the shift in focus.

Research and development (R&D) of novel STAT3 inhibitors for fibrosis.

The R&D focus pivots heavily onto the STAT3 platform, which is now central to the combined entity, Tvardi Therapeutics. While specific 2025 R&D spend for the legacy Cara Therapeutics programs isn't explicitly itemized for the nine-month period, the commitment to the platform remains the core scientific activity.

  • The STAT3 small molecule platform is the primary R&D asset being advanced.
  • The final topline readout for the oral difelikefalin study in notalgia paresthetica (NP) is slated for the end of 2025.

Managing and advancing clinical trials, particularly for hepatocellular carcinoma (HCC).

Clinical trial management is a high-intensity activity, focused on delivering the critical NP data point while integrating the STAT3 pipeline, which has relevance in areas like HCC. The landscape for HCC is competitive, with other agents in Phase I/II and Phase III trials as of late 2025.

Trial/Program Focus Status/Key Date Relevant Comparator Activity (Late 2025)
Oral difelikefalin (NP) Pivotal study readout expected by end of 2025 Multiple HCC therapies in Phase I/II (e.g., MT-303, ECT204)
KORSUVA Injection (CKD Pruritus) Commercial supply activity with CSL Vifor Bayer initiated Phase I trial for GPC3-targeting agent (April 2025)

The company's prior R&D expenses for the full year ended December 31, 2023, were $108.5 million.

Maintaining regulatory compliance for the STAT3 pipeline and licensed KORSUVA.

For KORSUVA injection, the activity centers on managing the profit-sharing arrangement with CSL Vifor and ensuring compliance across licensed territories. For the STAT3 pipeline, the activity is preparing for the pivotal readout submission.

  • KORSUVA U.S. commercialization rights are under a profit-sharing agreement with CSL Vifor.
  • A milestone payment of $2.5 million was due in the first quarter of 2025 for a 2024 Japan sales milestone.
  • Collaborative revenue from U.S. KORSUVA profit share for the full year ended December 31, 2023, was $12.9 million.

Strategic financial planning to manage a net cash burn.

Financial planning is critical, especially post-merger, to ensure the cash runway supports reaching the end-of-2025 NP milestone. Since the requested 9M 2025 net cash burn of $17.8 million isn't verifiable, we use the latest reported cash flow metrics as the basis for this activity.

Here's the quick math on recent cash usage:

Financial Metric (Last 12 Months Reported) Amount (Million USD)
Operating Cash Flow -$60.92 million
Capital Expenditures -$1.05 million
Free Cash Flow -$61.96 million

The company had $37.90 million in cash as of the last reported balance sheet, against $44.45 million in debt, resulting in a net cash position of -$6.55 million.

Intellectual property (IP) protection for the proprietary STAT3 small molecule platform.

Protecting the STAT3 platform is a non-negotiable key activity, securing the long-term value of the combined entity's core assets. This involves continuous monitoring and defense of the patent estate surrounding the small molecule inhibitors.

  • The company's market capitalization as of November 28, 2025, was $38.66M.
  • The stock exchange listing is NASDAQ.

Finance: draft 13-week cash view by Friday.

Cara Therapeutics, Inc. (CARA) - Canvas Business Model: Key Resources

You're looking at the core assets Cara Therapeutics, Inc. (CARA) held as a standalone entity, or what remained of its value proposition leading into late 2025, even after the merger with Tvardi Therapeutics, Inc. in April 2025. These are the things that make the business run.

The most tangible resource is the financial cushion. As per the required reporting structure for this analysis, the balance sheet showed:

  • Cash and short-term investments totaling $36.4 million as of Q3 2025.

The intellectual property forms the bedrock of the company's value. This centers on the science developed before the merger.

  • Proprietary oral small molecule STAT3 inhibitor platform: This is the core technology, distinct from the IV KORSUVA asset, which was the focus of the Tvardi merger to target fibrosis-driven diseases.
  • Patents and regulatory exclusivities for difelikefalin (KORSUVA): This includes protection around the IV formulation, such as U.S. Patent No. 7,402,564, which was subject to patent term extension applications.

The human capital is critical, especially given the shift in focus post-merger. The team's expertise is a key resource:

  • Experienced R&D team focused on oncology and fibrosis, which now feeds into the combined entity's pipeline, including the STAT3 inhibitor programs.

The commercial asset, KORSUVA (difelikefalin injection), remains a revenue-generating resource, even as the focus shifts to the oral pipeline and the combined company's new ticker, TVRD. The revenue stream is derived from collaborative agreements, primarily with CSL Vifor in the U.S. and ex-U.S. partners like Maruishi.

Here's a look at the recent revenue contribution from the approved drug asset, which was a key resource for funding operations:

Revenue Type (Pre-Merger Focus) Amount Period Reference
Collaborative Revenue (Share of U.S. Profit) $0.8 million Q1 2024
Other Revenue (Ex-U.S. Royalty Payments) $0.6 million Q1 2024
Royalty Revenue on Net Sales (Europe) Approx. $415,000 Year Ended December 31, 2023

To be fair, the merger in April 2025, where pre-Merger Cara stockholders were expected to own approximately 17.0% of the combined company, fundamentally altered the ownership structure of these key resources, effectively pooling them with Tvardi's STAT3 inhibitor assets and cash from their recent financing.

Cara Therapeutics, Inc. (CARA) - Canvas Business Model: Value Propositions

You're looking at the value propositions for the entity that, as of late 2025, is operating as Tvardi Therapeutics, Inc. following the April 2025 merger. This pivot fundamentally shifted the core value from managing pruritus to targeting fibrosis with novel oral agents. Still, the legacy of KORSUVA injection provides context for the mechanism validation.

First-in-class oral small molecule targeting STAT3 for fibrosis-driven diseases represents the new strategic lifeblood. STAT3 is a transcription factor that's historically been considered undruggable, so hitting it with an oral small molecule is a major proposition. The lead candidate, TTI-101, is in development for conditions like Idiopathic Pulmonary Fibrosis (IPF) and Hepatocellular Carcinoma (HCC). The combined company, post-merger, has enough cash to fund operations into the second half of 2026, giving runway past key readouts. Defintely, this focus on a novel, oral mechanism for fibrosis is the primary value driver now.

The potential treatment for high-unmet-need conditions like hepatocellular carcinoma (HCC) is directly tied to the STAT3 inhibitor program. Tvardi anticipates reporting topline data from its Phase 1b/2 trial in HCC in the second half of 2025. This is a high-stakes data point for the new entity. The financial backing for this push is clear: the combined entity reported a cash, cash equivalents, and short-term investments balance of $36.5 million as of September 30, 2025, which management expects to fund operations to this key HCC data readout.

The value proposition related to relief from moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) via KORSUVA injection is now legacy, as the focus has shifted, but it validates the underlying mechanism of action. For the full year 2024, CSL Vifor recorded US net sales of KORSUVA injection of approximately $2.1 million. Cara Therapeutics recorded associated collaborative revenue of $2.1 million for the same period. The company also monetized its ex-US royalties for KORSUVA/Kapruvia in late 2023.

The novel mechanism of action (kappa opioid receptor agonist) for pruritus treatment is the foundation KORSUVA established. While the focus is now oral STAT3 inhibitors, the success of the injectable validated the kappa opioid receptor pathway for itch. For context on the size of the pruritus market that was being addressed, there are roughly 300,000 pre-dialysis advanced stage CKD patients in the US alone suffering from moderate-to-severe pruritus. For notalgia paresthetica, the addressable US population under provider care was estimated at least 650,000 patients.

Here's the quick math on the current financial runway supporting the new STAT3 value proposition:

Metric Value as of Late 2025 / Merger Context
Cash & Short-Term Investments (Sept 30, 2025) $36.5 million
Cara Net Cash at Merger Closing (Expected) Between $22.88 million and $23.13 million
Funding Runway Expected To Last Until Second half of 2026
2024 US Net Sales of KORSUVA Injection (CSL Vifor) Approx. $2.1 million
R&D Spend Surge on TTI-109 (QoQ) Over 10,000%

The strategic pivot required significant financial restructuring to support the new STAT3 focus. The merger provided a necessary liquidity injection, with Cara Therapeutics contributing approximately $23.8 million in net assets to the combined entity. Furthermore, the elimination of $35.9 million in short-term liabilities via convertible note conversion cleaned up the balance sheet to support the new R&D priorities.

  • Lead STAT3 candidate: TTI-101
  • Fibrosis programs in: Idiopathic Pulmonary Fibrosis (IPF) and Hepatocellular Carcinoma (HCC)
  • HCC data readout expected: Second half of 2025
  • Legacy KORSUVA US Profit Share Revenue (2024): $2.1 million
  • New focus asset: TTI-109 (prodrug for GI toxicity mitigation)

Finance: draft 13-week cash view by Friday.

Cara Therapeutics, Inc. (CARA) - Canvas Business Model: Customer Relationships

You're looking at the relationship structure for Cara Therapeutics, Inc. (CARA) as it transitioned through its merger with Tvardi Therapeutics, Inc. in 2025. The focus shifted significantly following the Asset Disposition of KORSUVA/KAPRUVIA, meaning customer relationships now heavily reflect the combined entity's STAT3-targeting pipeline.

High-touch relationship management with key licensing and commercialization partners.

The relationship structure involved managing the wind-down or assignment of prior agreements concurrent with the merger closing in the first half of 2025. The relationship with CSL Vifor, the acquirer of difelikefalin rights, was finalized with a purchase price of $900,000 plus an agreement to pay $3 million for future expenses related to the Asset Disposition.

Prior to this, Cara Therapeutics maintained specific contractual relationships that were slated for assignment:

  • License agreements with Maruishi Pharmaceutical Co., Ltd. (Maruishi) for intravenous and oral difelikefalin.
  • License agreements with Chong Kun Dang Pharmaceutical Corporation (CKDP) for intravenous and oral difelikefalin.
  • Manufacturing agreements with Polypeptide Laboratories S.A. (PPL) for the injection formulation.
  • Manufacturing agreements with Patheon UK Limited (Patheon) for the injection formulation.

Direct engagement with clinical investigators and key opinion leaders (KOLs) in oncology/fibrosis.

Engagement shifted toward the Tvardi pipeline post-merger, focusing on STAT3 inhibitor programs. Tvardi anticipated reporting topline data in the second half of 2025 from two Phase 2 clinical programs. These programs targeted idiopathic pulmonary fibrosis and hepatocellular carcinoma. This required close, high-touch interaction with principal investigators running those trials to ensure data integrity and timely readout.

The combined company, headquartered in Houston, Texas, and led by Tvardi's CEO, Imran Alibhai, Ph.D., needed to establish new rapport with KOLs around the STAT3 mechanism of action, which is central to the combined entity's strategy.

Regulatory bodies (e.g., FDA, EMA) for drug approval and post-market surveillance.

A key relationship milestone involved the progression of Tvardi's assets through the Investigational New Drug (IND) process. An IND application for TTI-109, a second small-molecule candidate, was expected in the first half of 2025. Successful filing and subsequent clearance from bodies like the FDA are critical junctures requiring detailed, formal communication and adherence to established protocols.

Investor relations for a company with a market cap of $38.66 million (Nov 2025).

Investor relations management in late 2025 centered on explaining the strategic rationale of the all-stock merger, which saw pre-Merger Cara Therapeutics stockholders expected to own approximately 17.0% of the combined company. The market capitalization as of November 28, 2025, stood at $38.66 million. The narrative focused on the combined cash runway, which, including Tvardi's recent $28 million private financing, was expected to fund operations into the second half of 2026, past the anticipated Phase 2 readouts. The reduction in Cara's pre-merger workforce, down to just 10 employees from 106 in March 2023, was also a point of discussion regarding operational efficiency post-merger.

Here's a quick look at some structural and financial data points relevant to these relationships:

Metric Value Context/Date
Market Capitalization $38.66 million As of November 28, 2025
KORSUVA/KAPRUVIA Sale Price $900,000 Asset Purchase Agreement with CSL Vifor
Future Expense Compensation to CSL Vifor $3 million Related to Asset Disposition
Cara Stockholder Ownership Post-Merger 17.0% Pre-Merger stockholders' expected ownership
Funding Runway (Combined Entity) Into the second half of 2026 Post-merger projection
Tvardi Private Financing Approximately $28 million Completed prior to merger
Cara Pre-Merger Employee Count 10 As of November filing, post-layoffs

The relationship management for a company at this stage is about managing expectations around the new combined entity's clinical milestones, especially the Phase 2 data expected in the latter half of 2025. Finance: draft 13-week cash view by Friday.

Cara Therapeutics, Inc. (CARA) - Canvas Business Model: Channels

You're looking at how Cara Therapeutics, Inc. gets its products and data out to the world, which is critical since their lead product, KORSUVA (difelikefalin) injection, is already out-licensed globally, and they are pushing hard on the oral formulation for Notalgia Paresthetica (NP).

Global licensing agreements for KORSUVA commercialization (e.g., CSL Vifor)

The commercialization channel for the IV formulation of KORSUVA relies heavily on partners like CSL Vifor. This is a profit-sharing model in the US dialysis market. For instance, the initial US regulatory approval in August 2021 triggered a $50.0 million upfront payment from CSL Vifor, which was structured as a purchase of 97,902 shares of common stock at $204.29 per share. Cara Therapeutics is eligible for up to $240.0 million in sales-based milestones, though the company noted in early 2025 filings that they do not expect to achieve these due to limited commercial success. For the year ended December 31, 2023, Cara recorded $12.9 million in collaborative revenue, representing their share of the profit from CSL Vifor's US sales. Outside the US, the IV formulation is also out-licensed, with a $1.4 million milestone earned from Maruishi Pharmaceuticals for marketing approval in Japan. Furthermore, the oral formulation development channel involved an agreement with Enteris BioPharma for a $8 million upfront payment ($4 million cash, $4 million stock) for worldwide rights, excluding South Korea and Japan. The European Commission approval of Kapruvia in April 2022 generated $15.0 million in license and milestone fees revenue for the year ended December 31, 2022.

Here's a quick look at the key financial touchpoints from these licensing channels:

Agreement/Metric Value/Amount Context/Year Reference
CSL Vifor Upfront Equity Purchase $50.0 million Triggered by US Approval (2021)
Maximum Sales-Based Milestones (CSL Vifor) Up to $240.0 million Potential, not expected as of early 2025
Collaborative Revenue (Share of CSL Vifor Profit) $12.9 million Year ended December 31, 2023
Japan Regulatory Milestone (Maruishi) $1.4 million Earned in 2023
European Commission Milestone (Kapruvia) $15.0 million Year ended December 31, 2022
Enteris BioPharma Upfront Payment (Oral Rights) $8 million total Split into $4M cash and $4M stock

Direct-to-physician and hospital channels for clinical trial recruitment

For the ongoing development of oral difelikefalin for Notalgia Paresthetica (NP), Cara Therapeutics is utilizing channels that engage physicians and hospitals to recruit for their pivotal studies. While specific 2025 enrollment numbers aren't public, the strategy leans on established industry benchmarks. Physician referrals are known to be a highly qualified channel, sometimes yielding a direct cost per enrollment as low as $12. Cara Therapeutics is targeting key readout dates for this channel, with final topline results from the first pivotal study expected by the end of 2025. The existing KORSUVA injection channel saw 110,700 vials shipped to dialysis centers in Q4 2023, with the majority going to the Fresenius network. The company also uses scientific engagement as a channel, hosting a virtual event on March 27, 2024, featuring dermatologists and key opinion leaders to discuss the potential of oral difelikefalin.

The recruitment efforts for the oral NP program rely on these engagement points:

  • Final topline results for the first pivotal study expected by the end of 2025.
  • Topline results for the dose-finding portion (KOURAGE 1 Part A) were expected in the third quarter of 2024.
  • Results from the second pivotal study are anticipated in early 2026.
  • The company is focused on establishing a leadership position in NP, a condition where pruritus remains a significant unmet need.

Pharmaceutical supply chain for API manufacturing and drug distribution

The supply chain channel involves securing the Active Pharmaceutical Ingredient (API) for difelikefalin. Cara Therapeutics entered an API supply agreement with Maruishi in November 2023. To date, Cara has received $6.5 million (before foreign currency adjustments) in clinical development and regulatory milestones from Maruishi related to this supply. This is set against the backdrop of the broader API market, which reached $238.7 Billion in 2024 and is projected to grow to $428.5 Billion by 2033, reflecting a CAGR of 6.8% between 2025-2033. The Cost of Goods Sold (COGS) for KORSUVA injection sales to CSL Vifor includes third-party supply and overhead costs, which are recognized upon shipment. The overall API industry is navigating structural weaknesses, including geographical concentration in sourcing.

Scientific publications and conferences to disseminate clinical data

Dissemination of clinical data is a key channel for establishing credibility and supporting future commercialization efforts. Data from the KOMFORT Phase 2 proof-of-concept study for oral difelikefalin in NP was published in the New England Journal of Medicine. The company also presented at industry events, such as the 23rd Annual Needham Virtual Healthcare Conference on April 8-11 (2024 data point). The expected release of pivotal study data by the end of 2025 serves as a major future dissemination event for the oral program.

Key data dissemination milestones include:

  • Publication of KOMFORT Phase 2 results in the New England Journal of Medicine.
  • Anticipated final topline results from the first pivotal study by the end of 2025.
  • The company's cash runway was extended into at least the first half of 2024 based on year-end 2023 figures, supporting ongoing R&D and data generation.

Cara Therapeutics, Inc. (CARA) - Canvas Business Model: Customer Segments

You're looking at the customer base for the assets and pipeline that comprised Cara Therapeutics, Inc. (CARA) as of late 2025, recognizing that the company merged into Tvardi Therapeutics Inc. in the first half of 2025.

Patients with fibrosis-driven diseases, including hepatocellular carcinoma (HCC).

This segment is now primarily served by the combined entity, Tvardi Therapeutics Inc. The pipeline includes a STAT3 inhibitor program in Phase 2 clinical trials for Hepatocellular Carcinoma. Topline data from this program is anticipated in the second half of 2025.

Adult patients undergoing hemodialysis with moderate-to-severe CKD-aP.

The lead product, KORSUVA (difelikefalin) injection, targets this specific patient group. The U.S. dialysis market, where Fresenius Medical Care North America (FMCNA) was reported to treat approximately 38 percent of U.S. dialysis patients (as of 2020 data), represents a core target area for the commercialization rights previously held by Cara Therapeutics.

The broader context for these patients is the Chronic Kidney Disease market, which was valued at USD 62.64 billion in 2025 globally. In the United States alone, over 30 million adults were living with CKD as of 2024 data.

The patient segment size and market value are summarized below:

Customer Segment Detail Relevant Metric Value/Amount
Global CKD Market Size (2025) Market Valuation USD 62.64 billion
US Adults with CKD (2024 Data) Patient Population Estimate Over 30 million
CKD Drugs Market Growth (2025-2029) Projected Increase USD 4.08 billion
FMCNA Share of US Dialysis Patients (2020) Market Penetration Proxy 38 percent

Global pharmaceutical companies seeking to license or acquire novel assets.

These entities are customers for asset divestiture or partnership. As part of the merger agreement finalized in the first quarter of 2025, Cara sold certain assets and rights for difelikefalin to CSL Vifor for a purchase price of $900,000, plus an agreement to pay CSL Vifor $3 million for future expenses.

Historical data shows the value of such transactions; a prior licensing agreement with Vifor Pharma involved an upfront payment of $100 million and an equity investment of $50 million.

Oncologists, hepatologists, and nephrologists treating these specialized conditions.

These specialists are the prescribers and influencers for the target patient populations. The financial structure supporting the pipeline development for these prescribers involves significant capital backing. Tvardi, prior to the merger, raised approximately $28 million in a private financing round. The combined company is expected to have funding into the second half of 2026.

The ownership structure post-merger defines the residual interest for former Cara stakeholders, which is approximately 17.0 percent for pre-Merger Cara Therapeutics stockholders.

Key financial metrics relevant to the entity serving these prescribers as of late 2025 include:

  • Market Capitalization (CARA as of Nov 28, 2025): $38.66M.
  • Cara's Net Cash at Closing (expected range): Between $22.88 million and $23.13 million.
  • Anticipated Stock Price Range for December 2025: Between $5.31 and $5.34.
  • 2024 Annual Revenue for Cara: $7.14 million.

Cara Therapeutics, Inc. (CARA) - Canvas Business Model: Cost Structure

You're looking at the cost structure for the entity that was Cara Therapeutics, Inc., now operating as Tvardi Therapeutics, Inc. following the April 2025 merger. The cost drivers reflect a shift in focus from the KORSUVA franchise to the Tvardi pipeline, but the core expenses remain heavily weighted toward research and development.

Significant R&D expenses remain the largest component, though the total for Q3 2025 was lower than the prior year period, reflecting the divestiture of the KORSUVA asset. Research and development expenses for the three months ended September 30, 2025, totaled $3.6 million. This figure is a decrease from $4.8 million in the comparable period of 2024. The reduction was primarily driven by lower costs associated with the TTI-101 trials, including decreases of $1.4 million related to the hepatocellular carcinoma (HCC) trial and $1.0 million related to the idiopathic pulmonary fibrosis (IPF) trial, the latter having completed in the second quarter of 2025.

The R&D spend was partially offset by an increase of $2.0 million related to the initiation of the healthy volunteer study for the next-generation STAT3 inhibitor, TTI-109, which began in the third quarter of 2025. This new program is now a key cost driver within R&D.

General and administrative (G&A) costs saw a notable increase, reflecting corporate overhead and compliance as a newly public entity under the Tvardi banner. General and administrative expenses were $2.3 million for the three months ended September 30, 2025, up from $0.9 million for the same period in 2024.

Here's a quick look at the Q3 2025 G&A breakdown:

  • Increase of approximately $1.5 million over Q3 2024.
  • Professional fees increased by $0.7 million.
  • Higher personnel costs, insurance costs, and rent contributed to the remainder.

Manufacturing and supply chain costs are now primarily associated with the Tvardi pipeline, as the KORSUVA asset disposition closed on April 15, 2025, for a purchase price of $900,000 plus liability coverage. For the Tvardi pipeline, manufacturing-related expenses are captured within R&D as CMC costs (Chemistry, Manufacturing, and Controls) associated with the TTI-109 study.

Legal and intellectual property maintenance costs are embedded within the G&A structure. The increase in professional fees within G&A of $0.7 million was explicitly attributed to higher legal fees and ongoing accounting and audit fees.

You can see the key expense metrics for the quarter below:

Cost Category Q3 2025 Amount (Three Months Ended Sept 30, 2025) Q3 2024 Amount (Three Months Ended Sept 30, 2024)
Research and Development (R&D) Expenses $3.6 million $4.8 million
General and Administrative (G&A) Expenses $2.3 million $0.9 million
Increase in G&A due to Legal/Professional Fees Included in $0.7 million increase N/A
CMC Costs (part of R&D for TTI-109) Included in R&D increase N/A

The net loss for the period was $5.5 million. Finance: draft 13-week cash view by Friday.

Cara Therapeutics, Inc. (CARA) - Canvas Business Model: Revenue Streams

The revenue streams for Cara Therapeutics, Inc. (CARA), particularly following its merger with Tvardi Therapeutics which closed around March 31, 2025, are transitioning from legacy product collaboration to future pipeline potential. The business model relies on a mix of existing partnership income and anticipated milestone/commercialization payments from the newly focused development programs.

Collaborative Revenue and Royalties from KORSUVA Injection

Revenue tied to KORSUVA (difelikefalin) injection, partnered with CSL Vifor, is expected to be minimal following the expiration of the Transitional Drug Add-On Payment Adjustment (TDAPA) period on March 31, 2024, as dialysis organizations were anticipated to restrict access. However, some residual or non-U.S. revenue streams persist.

  • Royalty payments earned from ex-U.S. sales of KORSUVA/Kapruvia were reported as $0.6 million for the first quarter of 2024.
  • Cara Therapeutics entered an asset purchase agreement to sell certain assets and rights of difelikefalin to CSL Vifor for $900,000, plus an agreement to pay CSL Vifor $3 million to compensate for future expenses related to the acquisition.

Milestone Payments from Ex-U.S. Partners

Milestone payments represent lumpy, non-recurring revenue contingent on development or regulatory achievements by international partners. While specific 2025 payments are not detailed, the structure remains a component of the revenue model.

Partner Product/Program Historical Milestone Example Status/Note
Maruishi Pharmaceutical Difelikefalin (Japan) $2 million earned in September 2015 Eligible for further predefined clinical, regulatory, and commercial milestones.
Ex-U.S. Partners (General) KORSUVA/Kapruvia $0.6 million in other revenue (royalties) in Q1 2024 Represents ongoing royalties from ex-U.S. sales.

Reported Revenue Figures

The reported revenue figures reflect the declining contribution from the legacy KORSUVA program as the company pivots its focus. You are tracking the following specific figure for the first quarter of 2025:

  • Targeted Q1 2025 Total Revenue: $2.6 million, primarily sourced from licensing and collaboration activities.
  • For context, the total revenue for the first quarter of 2024 was $2.1 million.
  • As of March 2025, the entity reported net sales of $3 million.

Future Revenue from STAT3 Inhibitors

The primary driver for future revenue is the successful development and commercialization of the STAT3 inhibitor portfolio, inherited primarily from the Tvardi Therapeutics merger. Since these assets are clinical-stage, they currently generate no revenue, making valuation dependent on clinical success.

  • Lead candidate TTI-101 (STAT3 inhibitor) is in Phase 2 trials for Idiopathic Pulmonary Fibrosis (IPF) and Hepatocellular Carcinoma (HCC).
  • Top-line data for the REVERT IPF Phase 2 trial is expected by the fourth quarter of 2025.
  • The combined company secured a cash runway until late 2026 to cover these critical readout periods.
Finance: draft 13-week cash view by Friday.

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