Capricor Huge Possibilities

Capricor Huge Possibilities

March 8, 2021 0 By Mark Man
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Capricor (NASDAQ:CAPR) Earnings call on March 11th 2021

Capricor Therapeutics (CAPR) announced their earnings call last week and scheduled it for March 11th 2021 which is about one week ahead of the expected date. If you’ve been following CAPR, they usually make some major announcement before the earnings calls and this time, investors should be on the lookout for the following updates.

mRNA Exosomes Vaccine

Given how the milestones are laid out in their investor presentation (see below), investors should at the outset be focused on the updates from the “pre-IND meeting” with the FDA. The expected outcome of this meeting is that CAPR will file an IND for a Phase-I study on the next-generation COVID vaccine using the exosomes platform shortly thereafter. Exosomes offer an intriguing alternative to the currently approved vaccines in the sense that CAPR’s vaccine has been touted as being significantly more robust since it contains all four viral proteins (S, E, M, N) as opposed to just the single  ‘S’- SPIKE protein contained in current vaccines. This could offer a crucial alternative as being the vaccine that can successfully address both current and future mutations of the virus.

INSPIRE Trial Enrollment update

The second major update expected is around the enrollment for the INSPIRE clinical trial. From what we understand, the trial is expected to enroll 60 patients in a double-blind, placebo -controlled setting with registrational status which allows for immediate approval under EUA guidelines for COVID. This trial is being monitored by the independent Data and Safety Monitoring Board (DSMB), that conducted a review in December last year and recommended that the study continue as designed with Capricor’s cardiac cell therapy, CAP-1002, for treating patients with severe COVID-19. In addition, an independent prespecified review of the safety data was conducted on an initial group of INSPIRE patients and the study is continuing according to the study protocol. Based on our information, the pace of enrollment has picked up in recent weeks with multiple enrollment centers now actively recruiting patients for this study. We expect that there will be an announcement on the enrollment completion this month with results very likely in the first half of 2021.

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Updates on Accelerated Approval dialog with FDA

Even though we are not expecting an update in this earnings call, we believe that there has been continuous dialog with the FDA regarding path forward for DMD AA. From what we understand, they’re waiting to see the results of an ongoing Open Label Expansion (OLE) study before this dialog can come to any logical conclusion. This is the wild-card for CAPR investors, because any positive update on this front has the potential to significantly update the valuation on CAPR multiple-fold. In recent times, the FDA just approved Bristol Myers’ Breyanzi – the first of about 50 drugs with the rate RMAT designation – so we’re definitely starting to see movement on this front.

Read our previous article on DMD market and players

Hiring, Cash burn, etc.

Lastly, we will likely look some updates around the hiring front and on the cash position. As of this publication, Capricor has the following open positions listed on their website which seem more consistent with readiness for a commercial launch as opposed to clinical development. We will look for updates and clues on this front during the earnings call.

  • Research Associate
  • Human Resources Manager
  • Senior Clinical Trials Associate
  • Scientist, Mammalian Cell Culture Process Development
  • Scientist, Downstream Process Development
  • Quality Associate/Quality Specialist
  • Senior Scientist
  • Senior Technical Writer
  • Small Animal Surgeon
  • Manufacturing Manager
  • Manufacturing Associate I
  • Manufacturing Associate II

 

Capricor Exosomes


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