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Item 9A. Controls and Procedures

2023-03-30 compared with 2022-03-22 · 244 added, 34 removed, 91 unchanged (75% of the section changed)

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Disclosure Controls and Procedures

Disclosure controls and procedures are the Company’s controls and other procedures that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Securities Exchange Act of 1934 (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934), as amended (the “Exchange Act”) is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms.

Disclosure controls and procedures are our controls and other procedures that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Securities Exchange Act of 1934 (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934), as amended (the “Exchange Act”) is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms.

Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in the reports that we file under the Exchange Act is accumulated and communicated to management, including the Chief Executive Officer/Principal Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

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Controls and procedures can only provide reasonable, not absolute, assurance that the above objectives have been met.

On March 7, 2022, the Company evaluated, with the participation of its management, including our Chief Executive Officer and Chief Legal Officer, the effectiveness of the Company’s disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934.

Based on that evaluation, our Chief Executive Officer/Principal Financial Officer concluded that the Company’s disclosure controls and procedures were effective, at the reasonable assurance level, in ensuring that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms and is accumulated and communicated to management, including the Chief Executive Officer and Chief Legal Officer, as appropriate to allow timely decisions regarding required disclosure.

As of December 31, 2022, we evaluated, with the participation of our management, including our Chief Executive Officer (who serves as both Principal Executive Officer and Principal Financial Officer), the effectiveness our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act.

Based on that evaluation, our Chief Executive Officer concluded that our disclosure controls and procedures were effective, at the reasonable assurance level, in ensuring that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms and is accumulated and communicated to management, including the Chief Executive Officer, as appropriate to allow timely decisions regarding required disclosure.

Internal Control Over Financial Reporting

Management’s Annual Report on Internal Control Over Financial Reporting

The Company's management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934.

The Company's internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:

• Pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the Company;

• Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and the board of directors of the Company;

• Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements.

Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act.

Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:

• Pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets;

• Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of management and our board of directors;

• Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.

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In making this assessment, they used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) in Internal Control-Integrated Framework (2013) .

As of December 31, 2021, based on management’s assessment, the Company’s internal control over financial reporting was effective.

As of December 31, 2022, based on management’s assessment, our internal control over financial reporting was effective.

Changes in Internal Control over Financial Reporting

There have been no changes in the Company’s internal control over financial reporting that occurred during the quarter ended December 31, 2021 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

There have been no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

OTHER INFORMATION.

Item 5.02 Departure of Directors or Certain Officers;

Election of Directors;

Appointment of Certain Officers;

Compensatory Arrangements of Certain Officers.

On March 28, 2023, our board of directors, in accordance with the recommendation of our Compensation Committee, adopted the Lisata Therapeutics, Inc.

Clawback Policy (the “Clawback Policy”).

The Clawback Policy requires the Company to seek recoupment of certain incentive-based compensation received by (i) the Company’s current and former executive officers, as determined by the board of directors in accordance with the requirements of Section 10D of the Exchange Act and any applicable rules or standards adopted by the SEC and any national securities exchange on which the Company’s securities are listed, and (ii) such other employees who may from time to time be deemed subject to the Clawback Policy by the board of directors, in the event that the Company is required to prepare an accounting restatement that corrects an error in previously issued financial statements that is material to the previously issued financial statements, or that would result in a material misstatement if the error were corrected in the current period or left uncorrected in the current period.

The foregoing description of the terms of the Clawback Policy does not purport to be complete and is qualified in its entirety by reference to the full text of the Clawback Policy, which is filed as Exhibit 10.24 to this Annual Report on Form 10-K.

DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.

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DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

The response to this item is incorporated by reference from the discussion responsive thereto under the captions “Management and Corporate and Governance Matters,” “Section 16(a) Beneficial Ownership Reporting Compliance,” and “Code of Conduct and Ethics” in the Company's Proxy Statement for the 2022 Annual Meeting of Stockholders.

The response to this item is incorporated by reference from the discussion responsive thereto under the captions “Management and Corporate Governance Matters,” “Section 16(a) Beneficial Ownership Reporting Compliance,” and “Code of Ethics” in the our Proxy Statement for the 2023 Annual Meeting of Stockholders.

The following table sets forth the name and position of each of our executive officers and directors as of March 30, 2023.

Name Position(s)

Chief Executive Officer and Class II Director

David Slack President and Chief Business Officer and Class I Director

Executive Vice President R&D and Chief Medical Officer

Class II Director;

Chairman of Board of Directors

Klosk Class III Director

Flowers Class I Director

Heidi Henson Class II Director

Erkki Ruoslahti, M.D., Ph.D.

Class I Director

Mohammad Azab, MD, MBA Class III Director

was appointed as our President and Chief Executive Officer on March 28, 2017.

Mazzo was previously appointed as our Chief Executive Officer and as a member of our board of directors on January 5, 2015.

Mazzo brings to Lisata over 38 years of experience in the pharmaceutical industry.

Prior to joining Lisata, Dr.

Mazzo served from August 2008 to October 2014 as Chief Executive Officer and as a member of the board of directors of Regado Biosciences, Inc.

RGDO), a biopharmaceutical company focused on the development of novel antithrombotic drug systems for acute and sub-acute cardiovascular indications.

Prior to his leading Regado, from March 2007 to April 2008, Dr.

Mazzo was President, Chief Executive Officer and a director of Æterna Zentaris, Inc.

AEZS), a publicly held international biopharmaceutical company.

From 2003 until 2007 Dr.

Mazzo served as President, Chief Executive Officer and director of Chugai Pharma USA, LLC, a biopharmaceutical company and U.S.

subsidiary of Chugai Pharmaceutical Co., Ltd.

of Japan and a member of the Roche Group.

Mazzo has also held senior management and executive positions in research and development and was a director of the Essex Chimie European subsidiary at Schering-Plough Corporation, a publicly held pharmaceutical company that was subsequently acquired by Merck & Co., Inc.;

Hoechst Marion Roussel, Inc., the U.S.

subsidiary of Hoechst AG, that was subsequently acquired by Sanofi, a multinational pharmaceuticals company;

and Rhone-Poulenc Rorer, Inc., a subsidiary of Rhone-Poulenc SA, a French pharmaceuticals company, that was subsequently acquired by Hoechst AG.

He previously served on the board of directors of publicly held EyePoint Pharmaceuticals, Inc.

(formerly known as pSivida Corp.), a biopharmaceutical company, from October 2005 to June 2020, Seneca Biopharmaceuticals, Inc.

SNCA), a therapeutics development company focused on CNS applications that merged with Palisade BIO, from April 2019 to April 2021 and Avanir Pharmaceuticals, Inc., from October 2005 through January 2015, a pharmaceutical company that was sold to Otsuka Holdings in 2015.

He currently serves on the board of directors of VTI, Inc.

VTI), a developer and seller of therapeutic contact lenses, where he has served as Chairman of the board since February 2020 and Feldan Therapeutics, a private company developing technology for the intracellular delivery of therapeutic agents, where he has served on the board since January 2021.

Mazzo earned a B.A.

in the Honors Program (Interdisciplinary Humanities) and a B.S.

in Chemistry from Villanova University.

In addition, Dr.

Mazzo received his M.S.

in chemistry and his Ph.D.

degree in Analytical Chemistry from the University of Massachusetts, Amherst.

He was also a research fellow at the Ecole Polytechnique Federale de Lausanne, Switzerland.

Slack was appointed as President and Chief Business Officer and as a member of our board of directors in September 2022, and prior to that served as a member of the Cend board of directors since December 3, 2019 and as its President and Chief Executive Officer since March 29, 2021.

He is responsible for overseeing all Research and Development and operational activities, as well as overseeing fundraising, business development and M&A activity.

Slack also currently serves as an Industry Advisor for non-profit pancreatic cancer patient advocacy organization, Trovanow, where he advises the organization with respect to prospective industry partnership and philanthropic fundraising.

From March 2020 to March 2021, Mr.

Slack was a Consultant for Cend.

From January 2004 to March 2021, Mr.

Slack served as a Principal of DS Lifescience Consulting.

Also, from August 2016 to July 2020 he was the Chief Business Officer of Viracta Therapeutics, a publicly traded company, listed on Nasdaq.

From 2000 to 2004, Mr.

Slack served as Vice President of Business Development for Ionis Pharmaceuticals, Inc.

a publicly traded company, listed on Nasdaq.

From 1998-2000, Mr.

Slack served as Director of Technology Alliances and Licensing at Rhone-Poulenc Rorer Pharmaceuticals and Aventis Pharmaceuticals, a publicly listed pharmaceutical company He received his Bachelor of Arts in Psychology and his Bachelor of Science in Molecular Biology from California State University Sacramento.

Slack received his Masters of Business Administration in Business and Strategic Marketing from Monterey Institute of International Studies (now Middlebury Institute of International Studies).

Buck joined Lisata in September 2021 as Executive Vice President of R&D and Chief Medical Officer (“CMO”) of the Company.

Prior to joining Lisata, Dr.

Buck worked at ICON plc from March 2020 to July 2021, where she served as its CMO and 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, Dr.

Buck was Senior Vice President & Chief of Clinical Development at Optum Insights (part of the United Healthcare Group) from August 2018 to March 2020, where she led the clinical operations and regulatory groups within the Digital Research Network (DRN) clinical trial business.

From January 2014 to July 2018, Dr.

Buck held a position at Quintiles/IQVIA as Vice President of Global Strategic Drug Development designing clinical development plans and protocols across all therapeutic areas for emerging biotech and large pharma.

Earlier in her career, Dr.

Buck worked as a primary care physician and then later served as a medical officer in the FDA’s Office of New Drugs Division of Gastrointestinal and Hematology Drug Products where she was responsible for reviewing efficacy and safety data for new drug indications, as well as post-marketing safety data for over 40 drugs.

Buck worked at AstraZeneca where she served as a Global Safety Physician and Global Study Physician.

Her experience ranges over multiple therapeutic indications including cardiovascular/metabolic, rare diseases, gastrointestinal, neuroscience, oncology, immunology, and women’s health.

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 a private practice as a primary care physician.

was appointed to our board of directors in October 2016 and was elected Chairman by our board of directors on February 16, 2017.

Brown is currently Chief Executive Officer of Memgen, Inc., a development-stage biotechnology company.

Brown co-founded HealthCare Royalty Partners (“HCR Partners”), a healthcare-focused private asset management firm investing in biopharmaceutical and medical products, and developing and deploying innovative risk-mitigated investment strategies to deliver non-correlated cash flow.

Brown served as Vice Chairman of HCR Partners until December 2022 and remains a member of the firm’s SAB.

Brown was educated as a transplantation immunologist and trained as a thoracic and vascular surgeon.

He practiced thoracic and vascular surgery in a community setting where he also founded and led a health maintenance organization.

He brings particular expertise in the scientific, technical, clinical and medical evaluation of products as well as in healthcare systems and payor/reimbursement dynamics.

He has been involved in sourcing, performing due diligence on and closing more than $1 billion of royalty financings.

Before co-founding HCR Partners, Dr.

Brown was a partner at Paul Capital Partners where he co-managed that firm’s royalty investments as a member of the royalty management committee.

Prior to beginning his principal investment career in 2003, Dr.

Brown was co-head of investment banking and head of healthcare at Adams, Harkness & Hill (now Canaccord Genuity) and a ranked biotechnology research analyst at Vector Securities International.

Brown holds a B.A.

from Yale, an M.D.

from SUNY Upstate Medical Center and an M.B.A.

from Harvard Business School.

He currently serves on the boards of FAST Biomedical since January 2020, Memgen, Inc.

since October 2018, and Aquestive Therapeutics, Inc.

He previously served on the boards of Cambrex Corporation, Faron Pharmaceuticals, Oy, Invuity, Inc.

and Vanderbilt Clinical, S.a.r.l.

Klosk joined our board of directors in 2014.

He is a senior executive with extensive management experience in the life sciences industry.

He served as a Director at Cambrex Corporation (NYSE:CBM) from May 2008 through December 2019, until it was acquired by Permira and then as Director from December 2019 until June 2020.

Cambrex is one of the leading providers of active pharmaceutical ingredients, advanced intermediates and finished dosage form products to the branded and generic pharmaceutical markets, where he served as President and Chief Executive Officer from May 2008 through June 2020.

In that role he was responsible for all aspects of Cambrex’s global business with manufacturing and R&D facilities in the United States, Sweden, Italy, Estonia and Germany.

In addition, he has served on the board of directors of Recipharm, a leading pharmaceutical contract development & manufacturing organization since March 2021 and Golden Arrow Merger Corp.

since March 2021.

In addition, since 2021 he has served on the board of directors of Formulated Solutions, a topicalsCDMO where he is the chairman of the board;

BioIVT, a leading supplier of biologics specimens for biotech research;

BIOVECTRA, a leading small molecule and biologics CDMO;

and NJ Bio, a leading antibody drug conjugate contract research organization.

Klosk held other executive positions at Cambrex Corporation, including President, Executive Vice President & COO as well as President, Pharma Business Unit (2007-2008) where he had full P&L and balance sheet responsibility for four operating units in North America and Europe.

Prior to this he was Executive Vice President & COO Cambrex Pharma & Biopharmaceuticals Business Unit (2003-2007) where he was responsible for managing a highly profitable global business with six operating units in North America and Europe.

Earlier in his career Mr.

Klosk served as Vice President, Administration for The Genlyte Group, Inc., a publicly traded producer of lighting fixtures.

Klosk earned a B.S.

from Cornell University and a J.D.

from New York Law School.

Flowers was appointed to our board of directors in November 2018.

She is the owner of EIR Advisory LLC, a life sciences advisory and strategic investment firm.

From February 2014 through November 2017, Ms.

Flowers was President and Chief Executive Officer of Ipsen North America, where she led the transformation of the company as it became the highest-growth subsidiary worldwide.

Prior to joining Ipsen, she served as President of Eisai Pharmaceuticals, where she oversaw commercial operations, medical affairs and services, manufacturing, alliance management and other functions.

She has also held general management roles, both domestically and internationally, at Amgen Inc.

and Johnson & Johnson.

Flowers began her career as an oncology/critical care nurse.

Flowers currently serves on the board of Hikma Pharmaceuticals PLC, a multigenerational generics company and G1 Therapeutics Inc., a biotechnology clinical development company.

She has held positions on numerous corporate and non-profit boards, including Nanoform Finland OYi, a nanoparticle manufacturing company, Kadmon Group, Inc., a clinical stage biopharmaceutical company, the Women’s Leadership Advisory Board for the John F.

Kennedy School of Government at Harvard University and the board of directors for the Sarah Cannon Oncology Research Institute.

She currently serves as a Wharton Business School Leadership Advisor.

Flowers holds an M.B.A.

from the Wharton School of the University of Pennsylvania and a B.S.N.

from the University of Delaware.

Henson was appointed to our board of directors in September 2022 and before that served as a member of the Cend board of directors since 2019.

Since 2021, she has served as the Chief Financial Officers of Pardes Biosciences, Inc., a publicly traded company listed on Nasdaq under the symbol “PRDS”, where she is responsible for building out the company’s infrastructure and implementing processes and procedures relating to being a public company.

She also concurrently serves on the board of directors of PepGen, Inc.

From 2012-2012 she served on the board as Chief Financial Officer of the San Diego Children’s Choir, and from 2010 to 2013 she served as the board as Treasurer of the San Diego Children’s Choir Parent Association.

From 2020 to 2021 she was a consultant for Pardes.

From 2019-2020 Ms.

Henson served as the Chief Financial Officer of Imbria Pharmaceuticals, Inc.

and from 2018 to 2019 she was the Chief Financial Officer and Chief Compliance Officers of Respivant Sciences, Inc.

where she was responsible for the implementation and monitoring of the compliance program.

From 2014 to 2018, she served as the Chief Financial Officers of Kura Oncology, Inc, a publicly traded company listed on Nasdaq under the symbol “KURA”, where she led the private placement, reverse merger, and up-listing of the company to Nasdaq.

From 2012 to 2018, she was the Chief Financial Officer for Wellspring Biosciences, LLC and its parent company Araxes Pharma, LLC.

From 2007 to 2012, Ms.

Henson was the Vice President of Finance for Intellikine, Inc.

From 2005 to 2011, she worked as a consultant for various pharmaceutical industry clients, and she would assist with SEC reporting, implementation of financial processes and controls and implementation of SOX 404 compliance plans and documentation.

From 2004 to 2005, she was the Controller for La Jolla Pharmaceutical Company, listed on Nasdaq under “LJPC”.

Prior to 2005 she was a Director, Finance at Anadys Pharmaceutical, Inc.

ANDS), held several positions at Fair Isaac & Co, Inc (Nasdaq:

FICO), and was a financial analyst at Alaris Medical Systems, Inc.

and senior auditor from

PricewaterhouseCoopers, LLP.

Henson received her Bachelors of Accountancy from the University of San Diego and is a member of the Association of Bioscience Financial Officers.

Erkki Ruoslahti, M.D., Ph.D.

Ruoslahti was appointed to our board of directors in September 2022, and prior to that he served as a member of the Cend board of directors since 2015 and as its Founder, President and Chief Executive Officer from 2015 to 2020.

Ruoslahti became a Consultant for Cend.

He has over 30 years of experience in biotech that includes founding Impilo Therapeutics, Inc.

where he served as a Director until about September 2020 when it was acquired by Cend.

Most significantly, from January 1976 to September 2020 Dr.

Ruoslahti has served as Researcher, Scientific Director, President, Chief Executive Officer of Sanford Burnham Prebys Medical Discovery Institute where he took the once fledgling 50-person research organization to a world-renowned research institution.

When he stepped down as Chief Executive Officer, the institute had 500 employees and was ranked number one among all research organizations in world in the number of citations its publications received in the cell/molecular biology literature.

The core technology from Cend originates from his laboratory.

Currently, Dr.

Ruoslahti has an informal emeritus relationship with the institute.

From 2005 to 2008 he served as a Director for Advances Technologies, Inc, a publicly traded company listed on Nasdaq.

From 2000 to 2002, he co-founded was a Director of Targeted Molecules, Inc.

and from 1993 to 1996 he served as a Director of Canji and from 1987 to 1995, he co-founded and served as a director of Telios Pharmaceuticals, Inc.

a publicly traded company on Nasdaq.

Ruoslahti received his M.D., and Ph.D.

from the University of Helsinki, Helsinki Finland.

From 1968 to 1970 he was a Postdoctoral fellow at CalTech.

Ruoslahti is a member of the U.S.

National Academy of Sciences.

Mohammad Azab, MD, MBA

Mohammad Azab, M.D., MSc, MBA was appointed to our board of directors in September 2022.

Azab is a leader in clinical and regulatory development of biopharmaceutical drugs with particular expertise in oncology drug development.

In July 2009, Dr.

Azab joined Astex Pharmaceuticals, Inc.

(“Astex”), a pharmaceutical company focused on the discovery and development of drugs in oncology and other areas, as its Chief Medical Officer.

Azab served as President and Chief Medical Officer of Astex from January 2014 to November 2020, and has served as the chair of its board of directors from November 2020 to May 1, 2022.

Since January 2021, Dr.

Azab has served on the board of directors of DURECT Corporation (Nasdaq:

DRRX), a biopharmaceutical company committed to transforming the treatment of acute organ injury and chronic liver diseases.

Additionally, Dr.

Azab has served on the board of directors of Xenon Pharmaceuticals Inc.

XENE), a biopharmaceutical company delivering innovative medicines to patients with neurological disorders, since January 2003.

Previously, Dr.

Azab served as President and Chief Executive Officer of Intradigm Corporation, a developer of siRNA cancer therapeutics.

Prior to this, Dr.

Azab served as Executive Vice President of Research and Development and Chief Medical Officer of QLT Inc.

and in several leadership positions at AstraZeneca plc in the United Kingdom and Sanofi in France.

Azab holds an MBA from the Richard Ivey School of Business, University of Western Ontario, and an MB ChB from Cairo University.

He received post-graduate training and degrees in oncology research from the University of Paris-Sud and in biostatistics from the University of Pierre et Marie Curie in Paris, France.

EXECUTIVE COMPENSATION

The response to this item is incorporated by reference from the discussion responsive thereto under the captions “Executive Compensation” and “Caladrius Director Compensation,” in the Company’s Proxy Statement for the 2022 Annual Meeting of Stockholders.

The response to this item is incorporated by reference from the discussion responsive thereto under the captions “Executive Compensation” and “Lisata Director Compensation” in our Proxy Statement for the 2023 Annual Meeting of Stockholders.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

The response to this item is incorporated by reference from the discussion responsive thereto under the caption “Security Ownership of Management and Certain Beneficial Owners and Management” and “Equity Compensation Plan Information” in the Company’s Proxy Statement for the 2022 Annual Meeting of Stockholders.

The response to this item is incorporated by reference from the discussion responsive thereto under the caption “Security Ownership of Management and Certain Beneficial Owners” and “Equity Compensation Plan Information” in our Proxy Statement for the 2023 Annual Meeting of Stockholders.

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

The response to this item is incorporated by reference from the discussion responsive thereto under the captions “Certain Relationships and Related Party Transactions” and “Management and Corporate Governance Matters” in the Company’s Proxy Statement for the 2022 Annual Meeting of Stockholders.

The response to this item is incorporated by reference from the discussion responsive thereto under the captions “Certain Relationships and Related Party Transactions” and “Management and Corporate Governance Matters” in our Proxy Statement for the 2023 Annual Meeting of Stockholders.

PRINCIPAL ACCOUNTANT FEES AND SERVICES

The response to this item is incorporated by reference from the discussion responsive thereto under the caption “Accounting Fees and Other Accounting Matters” in the Company’s Proxy Statement for the 2022 Annual Meeting of Stockholders.

The response to this item is incorporated by reference from the discussion responsive thereto under the caption “Accounting Fees and Other Accounting Matters” in our Proxy Statement for the 2023 Annual Meeting of Stockholders.

EXHIBITS, FINANCIAL STATEMENT SCHEDULES.

The following documents are being filed as part of this Report:

The following documents are being filed as part of this Annual Report:

(a)(1) FINANCIAL STATEMENTS:

Reference is made to the Index to Financial Statements on Page 48 of this Annual Report on Form 10-K.

Reference is made to the Index to Financial Statements on Page 70 of this Annual Report.

All other schedules have been omitted because the required information is not present or is not present in amounts sufficient to require submission of the schedule, or because the information required is included in the Financial Statements or Notes thereto.

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Exhibit Description

Amended and Restated Certificate of Incorporation of Caladrius Biosciences, Inc., as amended, effective July 27, 2016 (filed as Exhibit 3.1 to the Company’s on Form 10-Q for the quarter ended June 30, 2016, filed with the SEC on August 9, 2016).

Amended and Restated By-Laws of the Caladrius Biosciences, Inc.

Certificate of Amendment (Reverse Stock Split) to the Amended and Restated Certificate of Incorporation, dated September 14, 2022 (filed as Exhibit 3.1 to the Company's Current Report on 8-K, filed with the SEC on September 15, 2022).

Certificate of Amendment (Name Change) to the Amended and Restated Certificate of Incorporation, dated September 15, 2022 (filed as Exhibit 3.2 to the Company's Current Report on Form 8-K, filed with the SEC on September 15, 2022).

Amended and Restated Certificate of Incorporation of Lisata Therapeutics, Inc., as amended, effective July 27, 2016 (filed as Exhibit 3.1 to the Company’s on Form 10-Q for the quarter ended June 30, 2016, filed with the SEC on August 9, 2016).

Amended and Restated By-Laws of the Lisata Therapeutics, Inc.

as amended, effective as of July 27, 2016 (filed as Exhibit 3.2 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, filed with the SEC on August 9, 2016).

Amendments to Amended and Restated Bylaws of Caladrius Biosciences, Inc., effective as of September 18, 2017 (filed as Exhibit 3.1 to the Company's Current Report on Form 8-K, filed with the SEC on September 21, 2017).

Amendments to Amended and Restated Bylaws of Lisata Therapeutics, Inc., effective as of September 18, 2017 (filed as Exhibit 3.1 to the Company's Current Report on Form 8-K, filed with the SEC on September 21, 2017).

Description of Capital Stock.

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Form of Warrant (filed as Exhibit 4.1 to the Company's Current Report on Form 8-K, filed with the SEC on January 25, 2021).

Director Compensation Policy (filed as Exhibit 10.1 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2018, filed with the SEC on March 22, 2018 and amended on April 2, 2018).

2015 Equity Compensation Plan (filed as Annex A to the Company’s Definitive Proxy Statement filed on Schedule 14A, filed with the SEC on June 8, 2015).

2017 Employee Stock Purchase Plan (filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 10, 2017).

Form of Indemnification Agreement for executive officers (filed as Exhibit 10.44 to the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2014 as filed with the SEC on March 2, 2015).

Director Compensation Policy, dated April 21, 2021.

Lisata Therapeutics, Inc.

2018 Equity Incentive Compensation Plan, as amended, effective as of September 15, 2022.

2018 Equity Incentive Compensation Plan, effective June 20, 2018, as amended on June 18, 2020 and further amended on June 16, 2021.

2015 Equity Incentive Compensation Plan, effective July 15, 2015.

Amended & Restated 2009 Equity Compensation Plan, effective October 4, 2012.

2017 Employee Stock Purchase Plan, as amended (incorporated by reference to Appendix B of the Company's definitive proxy statement on Schedule 14A, filed with the Securities and Exchange Commission on April 24, 2018).

Form of Indemnification Agreement between the Company and each of its directors and officers (filed as Exhibit 10.2 to the Company's Current Report on Form 8-K filed with the SEC on September 15, 2022).

Employment Agreement, dated as of January 5, 2015 and effective on January 5, 2015, by and between the Company and David J.

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Mazzo, dated December 6, 2018 (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on December 7, 2018).

Amended and Restated Employment Agreement with David J.

Mazzo, dated March 19, 2021 (filed as Exhibit 10.1 to the Company's Current Report on Form 8-K, filed with the SEC on March 19, 2021).

Employment Agreement dated as of September 15, 2022 by and between Lisata Therapeutics, Inc.

and David Slack, filed as Exhibit 10.1 to the Company's Current Report on Form 8-K, filed with the SEC on September 15, 2022).

Form of Purchase Agreement, dated April 23, 2020, by and between Caladrius Biosciences, Inc.

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and each purchaser identified on the signature pages thereto (incorporated by reference to Exhibit 10.2 of the Registrant’s Form 8-K filed on February 16, 2021).

Code of Ethics for Senior Financial Officers (filed as Exhibit 14.1 to the Company's Annual Report on Form 10-K for the year ended December 31, 2018 filed with the SEC on March 14, 2019).

Subsidiaries of Caladrius Biosciences, Inc.

Placement Agent Agreement, dated February 11, 2021, by and between Caladrius Biosciences, Inc.

Wainwright & Co., LLC (filed as Exhibit 10.3 to the Company's Current Report on Form 8-K, filed with the SEC on February 16, 2021).

Lisata Therapeutics, Inc.

Clawback Policy, effective as of March 28, 2023.

Code of Ethics for Senior Financial Officers, effective as of November 7, 2022.

Subsidiaries of Lisata Therapeutics, Inc.

Consent of Grant Thornton LLP.

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Furnished herewith.

Certain portions of this exhibit were omitted based upon a request for confidential treatment, and the omitted portions were filed separately with the SEC on a confidential basis.

FORM 10-K SUMMARY

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, in Basking Ridge (Bernards Township), State of New Jersey, on March 30, 2023.

CALADRIUS BIOSCIENCES, INC.

President and Chief Executive Officer (Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer)

LISATA THERAPEUTICS, INC.

Chief Executive Officer

(Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer)

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

Signature Title Date

Director, and President and Chief Executive Officer (Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer) March 22, 2022

Director and Chief Executive Officer (Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer) March 30, 2023

/s/ David Slack

David Slack, MDA

Director and Chief Business Officer March 30, 2023

/s/ Gregory B.

Chairman of the Board of Directors March 30, 2023

/s/ Michael H.

/s/ Mohammad Azab

Mohamad Azab, MD, MBA

Director March 30, 2023

1 unchanged sentence

Director March 30, 2023

/s/ Steven M.

Director March 22, 2022

/s/ Steven S.

/s/ Heidi Henson

Director March 30, 2023

/s/ Steven M.

Director March 30, 2023

/s/ Erkki Ruoslahti

Erkki Ruoslahti, MD, PhD

Director March 30, 2023

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures