BASKING RIDGE, N.J., Sept. 01, 2021 (GLOBE NEWSWIRE) — Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease, today announced the appointment of Dr. Kristen K. Buck as the Company’s Chief Medical Officer (“CMO”).
Dr. Buck joins Caladrius from ICON plc (“ICON”), a global provider of drug and device development and commercialization services to the pharmaceutical, biotechnology and medical device industries. During her time at ICON, Dr. Buck served as its CMO, where she represented the company’s position on key scientific, ethical, and medical governance matters, provided guidance and oversight to the medical and scientific groups, and led the Drug Development Services group. Prior to that, she was Senior Vice President & Chief of Clinical Development at Optum Insights (part of the United Healthcare Group) where she led the clinical operations and regulatory groups within the Digital Research Network (DRN) clinical trial business. Dr. Buck brings extensive drug development experience in multiple therapeutic indications including cardiovascular/metabolic, rare diseases, gastrointestinal, neuroscience, oncology, immunology, and women’s health.
“We are delighted to welcome Dr. Buck to Caladrius,” said David J. Mazzo, PhD, President and Chief Executive Officer of Caladrius. “Kristen’s wealth of knowledge and extensive medical, drug/device, regulatory, and safety expertise across many therapeutic areas will prove instrumental during the Company’s evolution as we continue to advance and expand our clinical development programs and execute upon our vision.”
Dr. Buck is a board certified and licensed physician who received her medical degree from the Pennsylvania State University School of Medicine and completed her internship and residency in Internal Medicine at Abington Memorial Hospital before working in private practice as a primary care physician. Subsequently, she moved to the U.S. Food and Drug Administration’s Office of New Drugs Division of Gastrointestinal and Hematology Drug Products where she was responsible for reviewing efficacy and safety data for all new indications, as well as post-marketing safety data for over 40 drugs. Earlier in her career Dr. Buck worked at AstraZeneca where she served as a Global Safety Physician and Global Study Physician. Dr. Buck also held a position at Quintiles/IQVIA as VP Global Strategic Drug Development designing clinical development plans and protocols across all therapeutic areas for emerging biotech and large pharma.
“Caladrius is in a unique position. I believe this is an exciting time to join the Company with several key milestones on its horizon. As Chief Medical Officer, my primary objective will be to lead the Company’s clinical development in a scientifically rigorous manner that will result in clinical, regulatory and commercial success,” said Dr. Buck. “Caladrius’ CD34+ cell therapy technology has the potential to revolutionize the treatment of ischemic diseases, and I am pleased to be joining such a talented and dedicated team to create value for shareholders while bringing innovative treatments to patients in need.”
About Caladrius Biosciences
Caladrius Biosciences, Inc. is a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease. We are developing first-in-class cell therapy products based on the finely tuned mechanisms for self-repair that exist in the human body. Our technology leverages and enables these mechanisms in the form of specific cells, using formulations and modes of delivery unique to each medical indication.
The Company’s current product candidates include: CLBS16, the subject of both a recently completed positive Phase 2a study and a newly initiated Phase 2b study (www.freedom-trial.com) in the U.S. for the treatment of coronary microvascular dysfunction (“CMD”); CLBS12 (HONEDRA® in Japan), recipient of orphan designation for Buerger’s Disease in the U.S. and, in Japan, recipient of a SAKIGAKE designation and eligible for early conditional approval for the treatment of critical limb ischemia (“CLI”) and Buerger’s Disease based on the results of an ongoing clinical trial; and CLBS201, designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for diabetic kidney disease (“DKD). For more information on the Company, please visit www.caladrius.com.
Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. All statements other than statements of historical fact contained in this press release are forward-looking statements including, without limitation, any expectations of revenues, expenses, cash flows, earnings or losses from operations, cash required to maintain current and planned operations, capital or other financial items; any statements of the plans, strategies and objectives of management for future operations; market and other conditions; any plans or expectations with respect to product research, development and commercialization, including regulatory approvals; any other statements of expectations, plans, intentions or beliefs; and any statements of assumptions underlying any of the foregoing. Without limiting the foregoing, the words “plan,” “project,” “forecast,” “outlook,” “intend,” “may,” “will,” “expect,” “likely,” “believe,” “could,” “anticipate,” “estimate,” “continue” or similar expressions or other variations or comparable terminology are intended to identify such forward-looking statements, although some forward-looking statements are expressed differently. Factors that could cause future results to differ materially from the recent results or those projected in forward-looking statements include the “Risk Factors” described in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on February 25, 2021 and in the Company’s other periodic filings with the SEC. The Company’s further development is highly dependent on, among other things, future medical and research developments and market acceptance, which are outside of its control. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this Press Release. Caladrius does not intend, and disclaims any obligation, to update or revise any forward-looking information contained in this Press Release or with respect to the matters described herein, except as required by law.
Contact:
Investors:
Caladrius Biosciences, Inc.
John Menditto
Vice President, Investor Relations and Corporate Communications
Phone: 908-842-0084
Email: jmenditto@caladrius.com
Media:
Real Chemistry
Rachel Girard
Real Chemistry
Phone: 401-477-4030
Email: rgirard@realchemistry.com
