LISTHER ATAPEUTICS A Targeted Therapy Delivered David J. Mazzo, Ph.D. Chief Executive Officer LD Micro Main Event XV| October 2022 Nasdaq: LSTA www.lisata.com Copyright ©2022 Lisata Therapeutics, Inc. All rights reserved. Forward-looking Statements This presentation contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, i ...

Caladrius Biosciences, Inc. (CLBS) Q2 2022 Results Conference Call August 4, 2022 4:30 PM ET Company Participants John Menditto - VP, IR & Corporate Communications David Mazzo - President, CEO Kristen Buck - EVP, Research and Development & CMO James Nisco - VP, Finance & Treasury Conference Call Participants Kumar Raja - Brookline Capital Pete Enderlin - MAZ Partners Operator Welcome to the Caladrius Biosciences' Second Quarter 2022 Financial Results and Business Update Conference Call. Currently all partic ...

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 June 30, 2022 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) | Dela ...

caladrius Developing Innovative Therapies that Treat or Reverse Disease David J. Mazzo, PhD President & Chief Executive Officer M ay 5 , 2 0 22| N a s d a q : C L B S 2 Information regarding disclosures Forward-Looking Statements This presentation contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this com ...

Financial Data and Key Metrics Changes - Research and development expenses for Q1 2022 were $3.3 million, down from $5.1 million in Q1 2021, reflecting a focus on advancing the ischemic repair platform and related trials [11] - General and administrative expenses increased to $3.3 million in Q1 2022 from $3 million in Q1 2021, primarily due to higher fees related to potential strategic transactions [12] - Net losses decreased to $4.2 million in Q1 2022 from $8.1 million in Q1 2021 [12] - As of March 31, 2022, the company had cash, cash equivalents, and marketable securities of approximately $88.5 million, positioning it well for projected capital obligations [13] Business Line Data and Key Metrics Changes - The company advanced its CD34-positive cell therapy development pipeline, initiating a proof-of-concept study for CLBS201 in diabetic kidney disease [6] - The merger with Cend Therapeutics is expected to create a financially sound NASDAQ-listed company with a diverse product development pipeline [7] Market Data and Key Metrics Changes - The biotech sector, as measured by the XBI, is down approximately 35% year-to-date, with the aggregate enterprise value of the biotech sector down about 70% since February 2021 [29] - IPO and follow-on offerings are down nearly 100% year-over-year, indicating a challenging fundraising environment for life science companies [30] Company Strategy and Development Direction - The merger with Cend Therapeutics aims to diversify and derisk the development pipeline, focusing on oncology and solid tumor indications [31][32] - The company is excited about the potential of CEND-1, which could enhance the efficacy of existing cancer therapies [56] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenging financial environment characterized by high inflation and tightening capital availability, emphasizing the need for proactive strategies [29][31] - The merger is seen as a critical step to control the company's destiny and address current headwinds [31] Other Important Information - The SAKIGAKE designation for HONEDRA in Japan allows for prioritized regulatory consultation and potentially expedited approval processes [18] - The company is focusing on securing a partner in Japan for HONEDRA, with several companies expressing interest pending regulatory guidance [37] Q&A Session Summary Question: Will the PMDA guidance be based on the pre-consultation meeting? - Management confirmed that the pre-consultation meeting will provide clear guidance on how to proceed with the regulatory process [35] Question: What is the status of finding a partner in Japan for HONEDRA? - Management indicated that there are more than six companies in diligence expressing serious interest, with expectations of closing a transaction increasing after receiving guidance from the PMDA [37] Question: What is happening with CLBS201 in diabetic kidney disease? - Management confirmed that the first patient has been treated, and the second patient was dosed recently, with plans to proceed based on the data safety monitoring board's review [39] Question: What is the strategy for data release regarding HONEDRA? - Management stated that full data sets will be released after discussions with regulatory authorities to avoid jeopardizing the review process [44] Question: What are the challenges faced in the XOWNA trial? - Management highlighted obstacles related to COVID-19, supply chain issues, and the need to amend protocols, but confirmed that additional sites have been added [46] Question: When will the proxy statement for the merger be filed? - Management aims to file the proxy statement by the end of May or early June, pending completion of financial audits [50] Question: Can you provide details on Cend stockholders? - Management noted that Cend is a closely held private company with less than 10 major shareholders [51] Question: What parameters determine the ownership ratio in the merger? - Management explained that the ratio will be based on valuations considering market potential, existing deals, and liabilities [53] Question: Is there high IP protection for Cend's technology? - Management confirmed that there is a high level of IP protection for the technology [58] Question: Will pricing affect partnerships for CD34 programs? - Management acknowledged that perceptions of high costs for autologous therapies may hinder partnerships, but emphasized the cost-effectiveness of their processes [60]

PART I - FINANCIAL INFORMATION [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) Caladrius Biosciences reported a net loss of **$4.2 million** for Q1 2022, an improvement from **$8.1 million** in Q1 2021, with a definitive merger agreement with Cend Therapeutics announced Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2022 (Unaudited) | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $12,747 | $24,647 | | Marketable securities | $75,772 | $70,323 | | Total current assets | $90,700 | $96,182 | | Total assets | $91,463 | $97,008 | | **Liabilities & Equity** | | | | Total current liabilities | $2,801 | $4,523 | | Total liabilities | $3,222 | $5,008 | | Total stockholders' equity | $88,241 | $92,000 | Consolidated Statement of Operations Highlights (in thousands, except per share data) | Account | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Research and development | $3,278 | $5,076 | | General and administrative | $3,342 | $3,010 | | Total operating expenses | $6,620 | $8,086 | | Operating loss | $(6,620) | $(8,086) | | Benefit from income taxes | $(2,479) | $— | | Net loss | $(4,226) | $(8,063) | | Basic and diluted loss per share | $(0.07) | $(0.19) | Consolidated Statement of Cash Flows Highlights (in thousands) | Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,642) | $(7,975) | | Net cash used in investing activities | $(6,090) | $(65,090) | | Net cash (used in) provided by financing activities | $(168) | $85,297 | | Net (decrease) increase in cash and cash equivalents | $(11,900) | $12,232 | - On April 26, 2022, the company entered into a merger agreement with Cend Therapeutics, Inc. Upon completion, former Cend stockholders and existing Caladrius stockholders are each expected to own approximately **50%** of the combined company[32](index=32&type=chunk)[82](index=82&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical-stage biopharmaceutical operations, the proposed Cend Therapeutics merger, Q1 2022 financial performance, and liquidity, noting a Nasdaq listing deficiency [Business Overview and Cend Merger](index=24&type=section&id=Business%20Overview%20and%20Cend%20Merger) Caladrius, a clinical-stage biopharmaceutical company, entered a merger agreement with Cend Therapeutics to diversify its pipeline, with Caladrius investing **$10 million** in Cend's Series D Preferred Stock - The company's current product candidates are XOWNA® (CLBS16) for coronary microvascular dysfunction (CMD), HONEDRA® (CLBS12) for critical limb ischemia (CLI), and CLBS201 for diabetic kidney disease (DKD)[91](index=91&type=chunk) - A merger agreement was signed with Cend Therapeutics, where former Cend stockholders and current Caladrius stockholders will each own about **50%** of the combined company, subject to adjustments based on Caladrius's net cash at closing[93](index=93&type=chunk)[95](index=95&type=chunk) - Caladrius agreed to purchase approximately **$10 million** of Cend's Series D Preferred Stock to provide Cend with capital for its development programs before the merger closes[101](index=101&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Caladrius reported a net loss of **$4.2 million** for Q1 2022, a significant improvement from **$8.1 million** in Q1 2021, driven by reduced R&D expenses and a **$2.5 million** tax benefit Comparison of Operating Results (in thousands) | Account | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | Change | | :--- | :--- | :--- | :--- | | Research and development | $3,278 | $5,076 | $(1,798) | | General and administrative | $3,342 | $3,010 | $332 | | **Total operating expenses** | **$6,620** | **$8,086** | **$(1,466)** | | **Net loss** | **$(4,226)** | **$(8,063)** | **$3,837** | - The **35%** decrease in R&D expenses was primarily due to a reduction in manufacturing start-up and process development costs for the XOWNA® Phase 2b study[115](index=115&type=chunk) - The company received a **$2.5 million** tax benefit from the sale of its New Jersey Net Operating Loss (NOL) tax benefits, which significantly reduced the net loss for the quarter[119](index=119&type=chunk) [Analysis of Liquidity and Capital Resources](index=30&type=section&id=Analysis%20of%20Liquidity%20and%20Capital%20Resources) As of March 31, 2022, the company held **$88.5 million** in cash and equivalents, with sufficient liquidity for the next 12 months, despite a Nasdaq listing deficiency impacting ATM offering access - As of March 31, 2022, the company held cash, cash equivalents, and marketable securities of approximately **$88.5 million**[121](index=121&type=chunk) - Management believes that the current cash on hand will be sufficient to fund operating expenses for at least the next **12 months**[128](index=128&type=chunk) - The company received a Nasdaq deficiency notice on February 18, 2022, for its stock trading below the **$1.00** minimum bid price, which prevents it from selling shares under its ATM Agreement until compliance is regained[130](index=130&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable for the reporting period - The company states that this item is not applicable[136](index=136&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2022, with no material changes to internal control over financial reporting - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2022[138](index=138&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[139](index=139&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) There have been no material changes to the legal proceedings disclosures previously reported in the company's 2021 Form 10-K - No material changes to legal proceedings were reported since the 2021 Form 10-K[142](index=142&type=chunk) [Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including potential Nasdaq delisting due to minimum bid price non-compliance and various uncertainties related to the proposed merger with Cend Therapeutics - The company received a deficiency letter from Nasdaq on February 18, 2022, for failing to maintain a minimum closing bid price of **$1.00** per share, giving it until August 17, 2022, to regain compliance[143](index=143&type=chunk) - There is no assurance that the merger with Cend will be completed or that it will enhance stockholder value. The merger is subject to numerous closing conditions and termination rights[144](index=144&type=chunk) - Failure to complete the merger could result in Caladrius paying Cend a termination fee of **$1.0 million** or, in other specified circumstances, Cend paying Caladrius a termination fee of **$4.0 million**[99](index=99&type=chunk)[146](index=146&type=chunk)[150](index=150&type=chunk) - Following the merger, current Caladrius stockholders will have reduced ownership (approximately **50%**) and voting interest, thereby exercising less influence over the combined organization's management[153](index=153&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=36&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the reporting period - None[157](index=157&type=chunk) [Defaults Upon Senior Securities](index=37&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the reporting period - None[158](index=158&type=chunk) [Mine Safety Disclosures](index=37&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company - Not applicable[159](index=159&type=chunk) [Other Information](index=37&type=section&id=Item%205.%20Other%20Information) There is no other information to report for this period - None[160](index=160&type=chunk) [Exhibits](index=37&type=section&id=Item%206.%20Exhibits) This section lists key exhibits filed with the Form 10-Q, including the Merger Agreement with Cend Therapeutics and related financial agreements - Key exhibits filed include the Merger Agreement with Cend Therapeutics (2.1), the Series D Preferred Stock Purchase Agreement (10.1), and the Collaboration Agreement (10.2)[168](index=168&type=chunk)

Financial Data and Key Metrics Changes - Research and development expenses for Q4 2021 were $4.2 million, a 43% increase compared to $2.9 million in Q4 2020, and $17.7 million for the full year 2021, up approximately 91% from $9.3 million in 2020 [8][10] - General and administrative expenses for Q4 2021 were $2.7 million, a 6% increase from $2.5 million in Q4 2020, and $11.4 million for the full year 2021, a 15% increase from $9.9 million in 2020 [10] - Net losses were $27.5 million for the year ended December 31, 2021, compared to $8.1 million for 2020 [10] Business Line Data and Key Metrics Changes - The company focused on advancing its ischemic repair platform, including the FREEDOM trial, XOWNA, CLBS16, and the Phase 1 trial for CLBS201 [9][34] - HONEDRA in Japan received SAKIGAKE Designation, which allows for prioritized consultation and a reduced review time for registration applications [21][22] Market Data and Key Metrics Changes - The company successfully raised $90 million in new capital growth proceeds in 2021, providing financial security to focus on its business plan [13] - As of December 31, 2021, the company had cash, cash equivalents, and marketable securities of approximately $95 million, projected to fund operations for several years [14] Company Strategy and Development Direction - The company aims to identify and evaluate strategic development opportunities to enhance shareholder value beyond its current pipeline [7] - There is a focus on securing additional development assets to diversify the product candidate portfolio [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating challenges posed by the COVID-19 pandemic and financial markets while advancing development programs [7] - The company is optimistic about its prospects and sees a bright future ahead, driven by the advancement of its existing portfolio and potential new assets [37] Other Important Information - The company has suspended enrollment efforts for HONEDRA to minimize operational and financial burdens due to delays caused by the pandemic [25] - The FREEDOM trial for XOWNA is experiencing enrollment challenges due to COVID-19 and changes in diagnostic technology [32][59] Q&A Session Summary Question: Strategic development options and stage of development - Management prefers assets that are already in the clinic, ideally with Phase 1 data, and is looking at numerous assets due to market volatility [42][44] Question: Alternative avenues for HONEDRA - Management is exploring various strategies, including using existing data for potential partnerships, rather than incurring additional costs for enrollment [47][49] Question: Near-term trend of R&D spending - R&D spending is expected to be conservative, with completed capital spend on HONEDRA and limited costs anticipated for the DKD study [51] Question: Clarity on CMD program enrollment - Enrollment challenges are attributed to COVID-19 impacts on hospital staffing and changes in diagnostic technology, with hopes for improvement by late summer or early fall [55][60] Question: Stock repurchase consideration - Management believes that developing assets is a better use of capital than repurchasing stock, as share price is currently tied to cash balance [62][63] Question: Future direction regarding assets or corporate acquisitions - The company is evaluating both asset acquisitions and potential corporate purchases, depending on the situation and available opportunities [65]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION FOR THE FISCAL YEAR ENDED December 31, 2021 OR 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 ☐ 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. Delaware 22-2343568 (State or other jurisdiction of (I ...

Financial Data and Key Metrics Changes - Research and development expenses for Q3 2021 were approximately $4.1 million, an increase from $3 million in Q3 2020, reflecting ongoing efforts in clinical programs [12] - General and administrative expenses rose to approximately $2.8 million in Q3 2021 from $2.3 million in Q3 2020, a 22% increase primarily due to higher D&O insurance premiums and strategic consulting expenses [14] - Overall net losses for Q3 2021 were $6.9 million, compared to $5.3 million in Q3 2020 [14] - As of September 30, 2021, the company had cash, cash equivalents, and marketable securities of approximately $100.1 million, sufficient to fund operations for the next several years [18] Business Line Data and Key Metrics Changes - The company is advancing its CD34+ cell technology-based clinical programs, focusing on ischemic repair and related treatments [9] - The HONEDRA product candidate for CLI and Buerger's disease in Japan has shown positive results, but enrollment has been challenging due to COVID-19 restrictions [27][28] - The XOWNA product for coronary microvascular disease is currently in a Phase 2b clinical trial, with efforts to expand enrollment through protocol amendments [35][36] Market Data and Key Metrics Changes - The company has successfully secured $90 million in new capital gross proceeds year-to-date in 2021, providing financial security amid the pandemic [17] - The HONEDRA program in Japan has been impacted by multiple states of emergency, affecting patient enrollment and operational costs [27][66] Company Strategy and Development Direction - The company aims to identify and secure additional development assets to complement its current portfolio, focusing on maximizing clinical and commercial success while minimizing capital outlay [40] - The strategic focus includes advancing autologous cellular therapies designed to treat and reverse diseases, particularly those caused by ischemia [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial position and operational strategy despite the challenges posed by the COVID-19 pandemic [9][42] - The company is optimistic about the potential for regenerative therapies to improve patient outcomes, particularly in the context of diabetic kidney disease [49] Other Important Information - The company has received SAKIGAKE Designation for HONEDRA in Japan, which allows for prioritized regulatory consultation and potentially expedited approval processes [24] - The FDA granted Orphan Designation to CLBS12 for Buerger's disease, but further clinical programs in the U.S. are currently not being pursued due to regulatory feedback [31][32] Q&A Session Summary Question: Impact of HONEDRA on near-term expenses - Management expects to save several million dollars in 2022 due to the decision to suspend enrollment efforts in Japan, which has incurred significant expenses without patient enrollment [45] Question: Deterioration of diabetic kidney disease patients if untreated - Management indicated that identifying the rate of deterioration is challenging, but the goal is to demonstrate regeneration of kidney function rather than merely slowing disease progression [46][49] Question: Enrollment issues across different programs - Management noted that enrollment challenges are due to a combination of staff shortages, patient reluctance to seek treatment, and COVID-related restrictions across all geographies [62][64] Question: Regulatory discussions for HONEDRA - Management highlighted the difficulty in having discussions with Japanese regulatory authorities due to travel restrictions, emphasizing the need for a local partner to facilitate these discussions [69] Question: Funding opportunities for strategic partnerships - Management discussed the challenges in obtaining non-dilutive funding and the competitive nature of grant applications, noting that public companies often face difficulties in securing such funding [78][81]

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 September 30, 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) D ...