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Lesser-known U.S. Cell Therapy Companies with Phase 3 or Approved Asset

We searched our online BiopharmIQ platform, for cell therapy companies that have a Phase 3 or later (including approved) asset. We found 48 public cell therapy companies that met this criteria, 35 of which have a location in the U.S. (data not shown). We were surprised to find 13 companies with a U.S. location that are not listed on a major U.S. stock exchange that meets this profile of having a Phase 3 or later asset (FIG. 1). We believe 11 of 13 of these companies are private companies. The majority of these companies (9 of 13) have their primary U.S. location in California (FIG. 1). Two of these lesser-known cell therapy companies have approved therapeutics (Ossium Health (San Francisco) and Stermline Therapeutics (New York, NY).

FIG. 1. Privately held U.S. cell-therapy companies with a Ph3 or later asset

(See * and ** for 2 public companies not on major U.S. markets)

These cell therapy companies that are not well known to U.S. investors are developing an interesting assortment of cell therapies to treat a variety of diseases. Phase 3 privately-held cell therapy assets include for example, Bimini’s KERASTEM, which are purified fat and adipose-derived regenerative cells (ADRC) that when injected into the scalp have been found to reawaken declining and dormant hair follicles (FIG. 2).

FIG. 2. KERASTEM process.

FIG. 3 SanBio’s Pipeline

Therapeutic Solutions International (TSI). TSI is traded on the over-the-counter (OTC) market. They are another example of a small cell therapy company that is not well known to U.S. investors, with a lot of indications being considered for its cell therapy assets. TSI has cell therapy products in development for many indications in regenerative medicine (FIG. 4A) and as immunotherapies (FIG. 4B). Its lead asset is ARDScells, which are in a Phase 3 trial to treat acute respiratory distress syndrome (ARDS). ARDScells are umbilical cord-derived mesenchymal stem cells.

FIG. 4A. TSI’s Regenerative Medicine Pipeline

FIG. 4B TSI’s Immunotherapy Pipeline

Article History:

1/26/24 - EJV

This article is not legal, regulatory, or financial advice.

1 Comment

Emanuel Vacchiano
Emanuel Vacchiano
Feb 01


Please note that it has come to our attention that Stemline Therapeutics is not a cell therapy company. We have updated our database accordingly.

BiopharmIQ Team

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