Financial Data and Key Metrics Changes - Research and development expenses for Q1 2021 were $5.1 million, up from $1.5 million in Q1 2020, reflecting a focus on advancing the ischemic repair platform and related clinical trials [11] - General and administrative expenses increased to $3 million in Q1 2021 from $2.6 million in Q1 2020, representing an 18% increase due to stock awards and rising insurance premiums [12] - Net losses for Q1 2021 were $8.1 million compared to $4 million in Q1 2020 [12] - As of March 31, 2021, the company had cash, cash equivalents, and marketable securities of approximately $111.5 million, expected to fund operations for several years [16] Business Line Data and Key Metrics Changes - The company is advancing multiple clinical programs, including CLBS16 for coronary microvascular dysfunction, HONEDRA for critical limb ischemia and Buerger's disease, and CLBS201 for diabetic kidney disease [8][19] - The FREEDOM trial for CLBS16 is currently recruiting patients, with top-line data anticipated in Q3 2022 [29] - The HONEDRA study in Japan has shown positive results, particularly in the Buerger's disease cohort, with four out of seven subjects meeting the primary endpoint [39][40] Market Data and Key Metrics Changes - The company has successfully raised $90 million in new capital in 2021, providing financial security amidst a challenging market for small biopharma companies [15] - The ongoing COVID-19 pandemic has impacted patient enrollment in the HONEDRA trial in Japan, while the FREEDOM trial has experienced minimal impact [54][56] Company Strategy and Development Direction - The company focuses on developing autologous cellular therapies aimed at reversing diseases, with a commitment to personalized curative cell therapy products [19][20] - The strategy includes exploring additional pipeline expansion opportunities, particularly in areas related to ischemic conditions and renal diseases [72] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial position and ability to fund operations for the next several years based on current development plans [8][16] - The company remains optimistic about the progress of its clinical trials and the potential for successful outcomes despite the challenges posed by the pandemic [50] Other Important Information - The FDA granted orphan designation to CLBS12 for the treatment of Buerger's disease in the U.S., enhancing its development prospects [40] - The company is actively seeking partnerships for the commercialization of HONEDRA in Japan [42] Q&A Session Summary Question: Impact of COVID-19 on the FREEDOM trial - Management indicated minimal impact on the FREEDOM trial due to COVID-19, with site openings on track and patient recruitment not significantly affected [54] Question: Patient recruitment considerations for the FREEDOM trial - Management confirmed that they are accounting for gender and age in patient enrollment, targeting a population primarily consisting of younger females [60] Question: Financial burn rate and future spending - Management clarified that while the current burn rate is around $8 million per quarter, future spending will depend on the outcomes of ongoing trials and potential new studies [66][69] Question: Pipeline expansion opportunities - Management stated that pipeline expansion explorations are opportunistic, focusing on affordable projects with a high probability of clinical success [72] Question: Discussions with the FDA regarding NORDA - Management expressed frustration with the FDA's requirements for a large clinical trial for NORDA, emphasizing the need for a more practical study design to facilitate patient enrollment [79]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from __________________ to _________________________ Commission File Number 001-33650 CALADRIUS BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) Delaw ...

caladrius Developing Regenerative Therapies that Reverse Chronic Disease David J. Mazzo, PhD President & Chief Executive Officer February 25, 2021 | Nasdaq: CLBS Forward-looking statement 2 This Investor Presentation 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 presentation, and involve certain risks and uncertainties. All statements other than state ...

Caladrius Biosciences, Inc. (CLBS) Q4 2020 Earnings Conference Call February 25, 2021 4:30 PM ET Company Participants John Menditto - Vice President, Investor Relations and Corporate Communications David Mazzo - President and Chief Executive Officer Conference Call Participants Emanuela Branchetti - H.C. Wainwright Pete Enderlin - MAZ Partners Operator Welcome to the Caladrius Biosciences Fourth Quarter and Year End 2020 Financial Results and Business Update Conference Call. [Operator Instructions] As a rem ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from __________________ to _________________________ Commission File Number 001-33650 CALADRIUS BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) ...

caladrius Developing Regenerative Therapies that Reverse Chronic Disease David J. Mazzo, PhD President & Chief Executive Officer January 19, 2021 | Nasdaq: CLBS Forward-looking statement 2 This Investor Presentation 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 presentation, and involve certain risks and uncertainties. All statements other than statem ...

Caladrius Biosciences, Inc. (CLBS) Q3 2020 Earnings Conference Call November 5, 2020 4:30 PM ET Company Participants John Menditto - VP of IR & Corporate Communications David Mazzo - President & CEO Conference Call Participants Emanuela Branchetti - H.C. Wainwright & Co. Kumar Raja - Brookline Capital Markets Peter Enderlin - MAZ Capital Advisors Operator Welcome to the Caladrius Biosciences' Third Quarter 2020 Financial Results and Business Update Conference Call. Currently, all participants are in listen- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 For the Transition Period from __________________ to _________________________ Commission File Number 001-33650 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED September 30, 2020 CALADRIUS BIOSCIENCES, INC. OR (Exact name of registrant as specified in its charter) Delaware 22-2343568 (State or other jurisdiction of incorporation or organization) (I.R.S. E ...

| --- | --- | --- | --- | |-------|-------|---------------------|-----------------------------------------------------------------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Developing Regenerative Therapies that Reverse Chronic Disease | | | | David J. Mazzo, PhD | | | | | | President and Chief Executive Officer | September 15, 2020 | Nasdaq: CLBS Forward-looking statement 2 This Investor Presentation contains forward-looking statements within the meaning of th ...

Caladrius Biosciences, Inc. (CLBS) Q2 2020 Earnings Conference Call August 13, 2020 4:30 PM ET Company Participants John Menditto – Vice President, Investor Relations and Corporate Communications David Mazzo – President and Chief Executive Officer Conference Call Participants Kumar Raja – Brookline Capital Management Joe Pantginis – H.C. Wainwright Operator Welcome to the Caladrius Bioscience Second Quarter 2020 Financial Results and Business Update Conference Call. [Operator Instructions] As a reminder, th ...