Caladrius Biosciences: Matters Of The Heart...

(RTTNews) - Shares of Caladrius Biosciences Inc. (CLBS) are down 25 percent year-to-date while the iShares Nasdaq Biotechnology ETF (IBB), a bellwether of investor sentiment, is up nearly 15 percent for the same period.

Caladrius Biosciences is a late-stage biopharmaceutical company developing cell therapies for cardiovascular and autoimmune diseases.

The most advanced product candidate in the pipeline is CLBS14, CD34+ cell therapy, for the treatment of no-option refractory disabling angina.

Angina, caused by reduced blood flow to the heart, is characterized by pain, heaviness or discomfort in the chest. Refractory angina patients are defined as being "no option" since they are deemed not amenable for conventional revascularization treatment for reasons related to diffuse coronary lesions, unsuitability to chronic total occlusion mechanical revascularization, or frailty from the presence of severe comorbidities. (Source: NCBI).

All preparatory work for the initiation of a confirmatory phase III trial of CLBS14 in no-option refractory disabling angina has been completed. However, enrollment in this study will not commence until the Company identifies sufficient capital resources to fund the study.

Up next in the pipeline is CLBS12, which is under a pivotal phase II trial for the treatment of no-option critical limb ischemia in Japan.

Critical Limb Ischemia, or CLI, is a result of severe obstruction of the arteries that markedly reduces blood flow to the extremities, principally the feet and legs. CLI can lead to pain, skin ulcers, and dermal sores, and, if not successfully addressed, amputation. No-option CLI means that pharmacotherapy has been ineffective and options for bypass or angioplasty have been exhausted.

The phase II trial of CLBS12 in Japan is enrolling patients. The enrollment is expected to be completed in the first half of 2020, with top-line data targeted for late 2020 or early in 2021.

Another ongoing phase II trial is that of CLBS16 for the treatment of coronary microvascular dysfunction, dubbed ESCaPE-CMD. This study, being conducted in the U.S., is fully enrolled, with updated data scheduled for presentation at the upcoming American Heart Association Scientific Sessions 2019 on November 16, 2019. Full results from the trial are expected in the first quarter of 2020.

Balance sheet:

The Company ended September 30, 2019, with $29.2 million in cash and zero debt, with cash runway projected into 2021.

Given the fact that potential value-creating events are expected to occur in the next 12 months based on development milestones across the pipeline, Caladrius Biosciences is a stock to keep an eye on.

CLBS has traded in a range of $2.00 to $5.44 in the last 1 year. The stock closed Wednesday's trading at $2.61, up 15.49%.