While the broader market digests a variety of economic numbers this morning – including the latest jobs data, the minutes from the last Fed meeting and the services sector survey from the Institute for Supply Management – we continue to direct our attention on microcaps that are largely immune from macroeconomic forces and the latest slings and arrows from Washington.
We focus today on Caladrius Biosciences (NASDAQ: CLBS), which will be represented at three conferences this week – two related events in Boston on Thursday and one event in New York on Friday. We’ve been following this company for some time, and we note that it has been making progress on both clinical and financial fronts.
Some of you may remember Caladrius when it was called NeoStem until changing its name two years ago. In Roman mythology, the Caladrius was a bird that visited the ill, absorbed their illnesses and flew away. The bird dispersed the illness and healed both itself and the patients. (You may also find a game by the same name in your children’s stack of Xbox 360 or PlayStation games.) The company is developing a proprietary platform technology to treat recent onset Type 1 diabetes based on T regulatory cells, which are the part of the body’s immune system that serves to suppress immune responses in other cells.
The lead product candidate, CLBS03, is the subject of an ongoing Phase 2 clinical trial in collaboration with Sanford Research, a subsidiary of Sanford Health, and has been granted Orphan Drug and Fast Track designation by the FDA and Advanced Therapeutic Medicinal Product classification by the European Medicines Agency.
Calabrius has had several recent positive developments, including:
- In February 2017, the California Institute for Regenerative Medicine (CIRM) awarded a grant to Caladrius, providing up to $12.2 million for the development of CLBS03.
- In March 2017, Hitachi Chemical (Tokyo: 4217; OTC: HCHMY) of America agreed to acquire Caladrius’ 80.1% share of PCT in a $75 million cash transaction (plus an additional $5 million if PCT hits a revenue milestone) that is expected to close next month. PCT is a well-known development and manufacturing company exclusively focused on the cell therapy industry that has served over 100 clients since 1999. The deal positions Caladrius as a cell therapeutics-only development company
with multiple proprietary technology platforms and significant capital resources to fund
future programs. - Two days ago, Caladrius announced that four additional clinical sites have opened to enroll subjects for the Phase 2 clinical trial of CLBS03, including Joslin Diabetes Center, the world’s largest diabetes research center, Children’s Mercy Hospital in Kansas City, the University of Miami Diabetes Research Institute and Vanderbilt University Hospital. These sites will join the existing seven clinical sites and contribute to the continued enrollment of subjects in the trial to meet the total of 111.
Source: Caladrius Biosciences Corporate Overview, March 2017
Three key members of the Caladrius management team will be at scientific and financial conferences this week:
Thursday, April 6th at 9:20am ET at the Hyatt Regency in Boston
- Dr. Douglas Losordo, Senior Vice President, Clinical, Medical and Regulatory Affairs and Chief Medical Officer, will be presenting at the GTCbio Diabetes Drug Discover & Development Conference to discuss the science behind the current Phase 2 clinical trial.
Thursday, April 6th at 1:50pm ET at the Hyatt Regency in Boston
- Dr. William Sietsema, Executive Director, Global Regulatory Affairs, will be presenting at the GTCbio Stem Cell Product Development & Commercialization Conference as part of a roundtable discussion on global regulation of cell therapies.
Friday, April 7th at 9:00am ET at the Millennium Broadway in New York
- Mr. Joseph Talamo, Chief Financial Officer, will be attending the Biocentury Future Leaders Conference and will be available for one-on-one meetings.
Please email us at [email protected] if you are a Public Company and would like to see our Testimonials.
Please click here if you would like information on our new trading platform.
Please click here if you’re an investor and would like to see our weekly newsletter.
Read Next
