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iwfal

01/23/24 10:15 AM

#250384 RE: iwfal #250135

CARA just discontinued their almost completed ph3s in non-dialysis CKD. To provide runway to the indication that had the strongest ph2 results (Notalgia Parathetica (sp?)). Note further they were very clear they did not terminate the CKD trials because they had indication they would fail - but clearly they have immense money problems and can’t pursue both CKD and NP.

They were pretty clear that their goal was biggest possible indication - hence ignoring the indication with much stronger ph2 results. (At least one of the conf calls was pretty interesting because the analysts were clearly probing with the message 'what in the world are you doing?')



Very clearly the analysts were completely correct above. Prioritize the indication with the strongest results, NOT the biggest indications.

Comments:

A) they’ve finally admitted in this conference call that bundling for dialysis essentially means QoL drugs cannot possibly win space in the dialysis market (my comments: this is particularly true of subjective QoL endpoints. And there are probably exceptions if they are displacing an existing QoL drug or have immense efficacy. But the default should be ‘it’s pointless’). This is hardly new news, but they were immensely naive about it for years. But they now, finally, acknowledge they can never make any appreciable $ in dialysis with their approved IV version of the drug.

B) there is still a reasonable chance they screw up the dose ranging portion of the trial and pick a dose too low. (Better to get approved, even with more side effects than optimal, than tank the company trying to thread a dimly seen needle.). Of companies with a moderately well proven drug in current trials, they have about the worst decision making I’ve seen.
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DewDiligence

12/18/24 11:31 AM

#253936 RE: iwfal #250135

CARA reverse-merges with (private) Tvardi Therapeutics:

https://www.globenewswire.com/news-release/2024/12/18/2998930/0/en/Cara-Therapeutics-and-Tvardi-Therapeutics-Announce-Entry-into-Merger-Agreement.html

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…

…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”.

… Tvardi is a privately held, clinical-stage, biopharmaceutical company focused on the development of novel, oral small molecule therapies targeting STAT3 to treat fibrosis-driven diseases with significant unmet need. …The company is conducting Phase 2 clinical trials in fibrosis-driven diseases with high unmet need: idiopathic pulmonary fibrosis (NCT05671835) and hepatocellular carcinoma (NCT05440708).