UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 28, 2020
CALADRIUS BIOSCIENCES, INC.
(Exact Name of Registrant as Specified in Charter)
Delaware (State or Other Jurisdiction of Incorporation) | 001-33650 (Commission File Number) | 22-2343568 (IRS Employer Identification No.) |
110 Allen Road, Second Floor, Basking Ridge, NJ 07920
(Address of Principal Executive Offices)(Zip Code)
(908) 842-0100
Registrant's Telephone Number
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Common Stock, par value $0.001 per share | CLBS | The Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
o Emerging growth company
o If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 5.02 Departure of Directors or Principal Officers; Election of Officers; Appointment of Principal Officers; Compensatory Arrangements of Certain Officers
(d) On July 28, 2020, the Board of Directors (the “Board”) of Caladrius Biosciences, Inc. (the “Company”) appointed Dr. Michael H. Davidson as a Class III member of the Company’s Board effective immediately. Dr. Davidson will serve as a member of the Science & Technology Committee and the Nominating & Governance Committee of the Board.
Dr. Davidson is a nationally recognized expert in lipidology and has been named one of "The Best Doctors in America" by Best Doctors Inc. for the past 10 years. Dr. Davidson was the co-founding Chief Medical Officer of Omthera Pharmaceuticals in 2008, which was later acquired by Astra Zeneca Pharmaceutical in 2013. He also founded the Chicago Center for Clinical Research, which became the largest investigator site in the United States and was acquired by Pharmaceutical Product Development in 1996. His research and clinical development background encompass both pharmaceutical and nutritional clinical trials, including extensive research on statins, novel lipid-lowering drugs, and omega-3 fatty acids. Michael is board-certified in internal medicine, cardiology and clinical lipidology and served as President of the National Lipid Association from 2010 to 2011. He received his BA and MS from Northwestern University and an MD from The Ohio State University School of Medicine.
As a non-employee director, Dr. Davidson is entitled to receive cash compensation and grants of stock options or other equity awards in accordance with the arrangements in effect for non-employee directors of the Company and its committees. In connection with his appointment to the Company’s Board, Dr. Davidson will receive a grant of restricted stock units of the Company’s common stock, with a value of $120,000, with one-third of the shares vesting annually on each of the first, second and third anniversaries of the grant date.
There are no arrangements or understandings between Dr. Davidson and any other person pursuant to which he was selected as a member of the Board. The Company is not aware of any transaction in which Dr. Davidson has an interest requiring disclosure under Item 404(a) of Regulation S-K. On July 28, 2020, the Company issued a press release announcing the appointment of Dr. Davidson to the Board. A copy of this press release is filed as Exhibit 99.1 to this current report.
Item 9.01. Financial Statement and Exhibits.
Exhibit No. | Description |
Press release, dated July 28, 2020 | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
CALADRIUS BIOSCIENCES, INC.
By: /s/ David J. Mazzo
Name: David J. Mazzo, PhD
Title: President and Chief Executive Officer
Dated: July 28, 2020
Exhibit 99.1
Caladrius Biosciences Appoints Dr. Michael H. Davidson
to Board of Directors
BASKING RIDGE, N.J. (July 28, 2020) - Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse, not simply manage, disease, today announced the appointment of Michael H. Davidson, MD to its Board of Directors. Dr. Davidson, an industry leader and expert in preventative cardiology and lipidology, is the Founder and Chief Scientific Officer of Corvidia Therapeutics, which recently announced its sale to Novo-Nordisk for $2.1 billion. Dr. Davidson also serves as Clinical Professor and Director of the Lipid Clinic at the University of Chicago Pritzker School of Medicine.
“We are very pleased to welcome Dr. Davidson to the Caladrius Board of Directors. Dr. Davidson’s extensive clinical research background, combined with his senior executive experience, will make him a valuable advisor as we seek to advance Caladrius’ clinical programs through late-stage development and commercialization,” said Gregory B. Brown, MD, Caladrius’ Board Chairman.
“We are honored to welcome Dr. Davidson as a member of the Board of Directors. His appointment further strengthens our esteemed board through his invaluable experience in all elements of leadership, from research and clinical development to regulatory approval, partnering and M&A,” said David J. Mazzo, PhD, President and Chief Executive Officer of Caladrius.
In addition to his current roles, Dr. Davidson is a nationally recognized expert in lipidology and has been named one of "The Best Doctors in America" by Best Doctors Inc. for the past 10 years. Dr. Davidson was the co-founding Chief Medical Officer of Omthera Pharmaceuticals in 2008, which was later acquired by Astra Zeneca Pharmaceutical in 2013 for $443 million. He also founded the Chicago Center for Clinical Research, which became the largest investigator site in the United States and was acquired by Pharmaceutical Product Development in 1996. His research and clinical development background encompass both pharmaceutical and nutritional clinical trials, including extensive research on statins, novel lipid-lowering drugs, and omega-3 fatty acids. Michael is board-certified in internal medicine, cardiology and clinical lipidology and served as President of the National Lipid Association from 2010 to 2011. He received his BA and MS from Northwestern University and an MD from The Ohio State University School of Medicine.
"I am delighted to join the Caladrius Board of Directors during such an important time for the Company. I look forward to contributing guidance to the Company as a Board member as the Company’s pipeline of innovative products continues to develop. Caladrius’ CD34+ cell therapy technology could be a revolutionary advance for cardiovascular medicine, and I look forward to working with my fellow Board members and the Caladrius management team to create value for patients and shareholders,” said Dr. Davidson.
About Caladrius Biosciences
Caladrius Biosciences, Inc. is a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse, not manage, disease. We are developing a first- in-class cell therapy product that is based on the notion that our body contains finely tuned mechanisms for self-repair. 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 CLBS119, a CD34+ cell therapy product candidate for the repair of lung damage found in patients with severe COVID-19 infection who experienced respiratory failure, for which the Company plans to initiate a clinical trial in the coming months, as well as three developmental treatments for ischemic diseases based on its CD34+ cell therapy platform: CLBS12, recipient of SAKIGAKE designation and
eligible for early conditional approval in Japan for the treatment of critical limb ischemia ("CLI") based on the results of an ongoing clinical trial; CLBS16, the subject of a recently completed positive Phase 2 clinical trial in the U.S. for the treatment of coronary microvascular dysfunction ("CMD"); and CLBS14, a Regenerative Medicine Advanced Therapy ("RMAT") designated therapy for which the Company has finalized with the U.S. Food and Drug Administration (the "FDA") a protocol for a Phase 3 confirmatory trial in subjects with no-option refractory disabling angina ("NORDA"). For more information on the company, please visit www.caladrius.com.
Contact:
Investors:
Caladrius Biosciences, Inc.
John Menditto
Vice President, Investor Relations and Corporate Communications
Phone: +1-908-842-0084
Email: jmenditto@caladrius.com
Media:
W2O Group
Christiana Pascale
Phone: +1-212-257-6722
Email: cpascale@w2ogroup.com
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