Our Company

Caladrius is a clinical-stage biopharmaceutical company committed to the development of innovative products in cardiovascular and autoimmune disease that have the potential to restore the health of people with chronic illnesses. Our leadership team collectively has decades of drug development experience and globally-recognized scientific achievement. Our goal is to build a broad portfolio of novel and versatile products that address important unmet medical needs.

 

Caladrius currently has four programs in the mid to late stages of clinical development. Our product candidates include three cell therapies for cardiovascular diseases that are based on our autologous CD34+ cell therapy platform: CLBS12, in Phase 2 testing in Japan, recipient of SAKIGAKE designation (similar to breakthrough designation in the USA), and eligible for early conditional approval for the treatment of critical limb ischemia; CLBS14-CMD, in Phase 2 testing for the treatment of coronary microvascular dysfunction; and CLBS14-RfA, in late-stage development for refractory angina and a recipient of Regenerative Medicine Advanced Therapy designation (essentially, breakthrough designation for cell and gene therapies) from the FDA. In addition, Caladrius has an autoimmune product candidate, CLBS03, in Phase 2 testing. CLBS03 is an autologous ex vivo expanded and activated polyclonal T regulatory cell therapy for the treatment of recent-onset type 1 diabetes. CLBS03 has been awarded Fast Track and Orphan designations by the FDA and Advanced Therapeutic Medicine Product classification by the EMA.

 

We are developing new products to treat those in need and are dedicated to enabling people to enjoy healthier, longer, and more productive lives. Our vision includes commitment to the following goals:

  • To be recognized for our culture of communication, transparency, respect, teamwork and patient-centric mindset.
  • To generate industry-leading growth through innovation and executional excellence.
  • To set ourselves apart in the industry, creating value by allowing our people, shareholders and company to prosper.
  • To bring significant life-improving medical treatments to patients.

Mission

At Caladrius Biosciences, our mission is to bring new, innovative and treatment paradigm-changing medical therapies to market based on our unique expertise and experience, and in so doing, to improve patients’ lives and create value for our shareholders.

Research and Discovery

To accomplish our mission and see our vision through to the end we are combining state-of-the-art science with the body’s intricate biologic systems, and are working to leverage our bodies’ development of cell capabilities with complex and specific functions. We believe that each study we perform expands the foundations of cell therapy and biologic science and believe that our research and discovery will have meaningful and lasting influence. We pledge to use our experience and knowledge to advance science, research and development.

Patients

We conduct all of our work in order to ultimately benefit the patients who put their trust and hope in our hands. We will continue to pursue therapies in areas of significant unmet medical need so that we can have the greatest impact on them. We know it won’t be easy, but we are committed to striving to successfully guide our product candidates through the development process in order that they may ultimately reach and serve the patients.

Education

The cell therapy industry needs credible sources disseminating information. We pledge to be that credible source, promoting ethical science and ethical business, and playing an educational role in bringing cell therapy to the public which includes dispelling controversy, decreasing confusion and increasing awareness of cellular therapies and their potential to heal the body and fight disease.