BiQ: 11/25/25 Additional Thoughts on Capricor (CAPR)

After I published my article on Deramiocel this morning, I received a few emails from members asking whether the situation with Capricor (CAPR) could be considered analogous to that faced by Urogen (URGN) earlier this year.

As members may recall, earlier this year, URGN's stock price cratered after an unfavorable outcome from the ADCOM. I added shares at the time because I still believed that Zusduri, then known as UGN-102, had a good chance of approval based on the clinical data. However, I also moved URGN to the Probation List due to the increased risk to the thesis. Fortunately, Zusduri was subsequently approved.

However, the situation with CAPR is not parallel to the situation with URGN. There are several significant differences:

• Unlike URGN, which was included in the BiQ Active Portfolio, CAPR is not included in the BiQAP due to its highly speculative nature.
• UGN-102 had a much larger set of data than Deramiocel does, which helped us to have a higher level of confidence in the outcome.
• URGN was already a commercial-stage company and had achieved prior proof of concept with JELMYTO, making the R/R more favorable.
• Deramiocel involves an entirely novel MOA, which merits extra caution based on the limited data set.

While I hold a speculative position in CAPR in my personal portfolio, CAPR is too speculative to be included in the BiQAP. Also, to date, and until we see the results from HOPE-3, Capricor has only produced meaningful clinical data in 10 patients who received Deramiocel during the HOPE-2 trial.

I remain cautiously optimistic about the outcome of HOPE-3; however, at this stage, I still consider CAPR highly speculative, and it may not be appropriate for risk-averse investors. For members who are comfortable with the binary risk, position sizing and risk management remain critical in the case of an unfavorable outcome in HOPE-3.

We should see HOPE-3 results any day now. Until then, I recommend remaining cautious and cognizant of the potential risks.

CAPR share price at time of publication: $4.60

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