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 ...

Caladrius Biosciences Reports Second Quarter 2021 Financial Results and Provides Business Update August 5, 2021 Conference call begins today at 4:30 p.m. Eastern Time BASKING RIDGE, N.J., Aug. 05, 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, provides a corporate update and reports financial results for the three and six months ended ...

Caladrius Biosciences, Inc. (CLBS) Q2 2021 Earnings Conference Call August 5, 2021 4:30 PM ET Company Participants John Menditto – Vice President-Investor Relations and Corporate Communications David Mazzo – President and Chief Executive Officer James Nisco – Vice President-Finance and Treasury Conference Call Participants Sara Nik – H.C. Wainwright Shubhendu Sen Roy – Brookline Pete Enderlin – MAZ Partners Operator Welcome to the Caladrius Biosciences Second Quarter 2021 Financial Results and Business Upda ...

[Cover Page](index=1&type=section&id=Cover%20Page) [Filing Information](index=1&type=section&id=Filing%20Information) This report is CALADRIUS BIOSCIENCES, INC.'s 10-Q quarterly report for the period ended June 30, 2021, identifying the company as a non-accelerated filer and smaller reporting company listed on The Nasdaq Capital Market - The company filed its 10-Q quarterly report for the period ended June 30, 2021[2](index=2&type=chunk) Company Basic Information | Metric | Information | | :--- | :--- | | **Company Name** | CALADRIUS BIOSCIENCES, INC. | | **Jurisdiction of Incorporation** | Delaware | | **IRS Employer Identification No.** | 22-2343568 | | **Principal Executive Offices** | 110 Allen Road, 2nd Floor, Basking Ridge, New Jersey 07920 | | **Telephone** | 908-842-0100 | | **Stock Symbol** | CLBS | | **Exchange** | The Nasdaq Capital Market | | **Filing Status** | Non-accelerated filer, Smaller reporting company | | **Shell Company** | No | [CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS](index=3&type=section&id=CAUTIONARY%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This quarterly report contains forward-looking statements concerning future expectations for revenue, expenses, cash flows, operating profit/loss, capital needs, management plans, and product development and commercialization, which inherently involve uncertainties and risks that could cause actual results to differ materially from expectations - Forward-looking statements in the report cover expectations for future revenue, expenses, cash flows, operating profit or loss, capital requirements, management plans, and product development and commercialization, including regulatory approvals[6](index=6&type=chunk) - Forward-looking statements are subject to uncertainties and known and unknown risks that could cause actual results to differ materially from expectations[6](index=6&type=chunk) - Factors that could cause actual results to differ include: obtaining sufficient capital, establishing management and human resource infrastructure, market establishment, scientific/regulatory/medical developments, government permits and regulatory compliance, patent acquisition and commercialization, potential benefits of licensing agreements, development activity results, clinical trial progress (affected by patient recruitment and COVID-19), and other risk factors discussed in the 2020 10-K report[9](index=9&type=chunk) [TABLE OF CONTENTS](index=4&type=section&id=TABLE%20OF%20CONTENTS) [Report Structure](index=4&type=section&id=Report%20Structure) This quarterly report is divided into two parts: Part I covers financial information, and Part II covers other information, including legal proceedings and risk factors - The report is divided into two parts: Part I, Financial Information, and Part II, Other Information[11](index=11&type=chunk) - Part I includes financial statements, management's discussion and analysis, market risk disclosures, and controls and procedures[11](index=11&type=chunk) - Part II includes legal proceedings, risk factors, sales of equity securities, defaults upon senior securities, mine safety disclosures, other information, and exhibits[11](index=11&type=chunk) [PART I- FINANCIAL INFORMATION](index=5&type=section&id=PART%20I-%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents the company's consolidated balance sheets as of June 30, 2021, and December 31, 2020, along with consolidated statements of operations, comprehensive loss, equity, and cash flows for the three and six months ended June 30, 2021 and 2020, accompanied by notes to unaudited consolidated financial statements [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2021, total assets significantly increased to **$108,614 thousand**, primarily due to a substantial rise in marketable securities, while total liabilities slightly increased and stockholders' equity grew significantly, reflecting enhanced capital structure through equity financing Consolidated Balance Sheet Key Data (Thousands of USD) | Metric | June 30, 2021 (Unaudited) | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | 12,935 | 16,512 | | Marketable securities | 93,155 | 18,061 | | Prepaid and other current assets | 1,990 | 758 | | **Total current assets** | **108,080** | **35,331** | | Property and equipment, net | 84 | 57 | | Other assets | 450 | 614 | | **Total assets** | **108,614** | **36,002** | | **Liabilities** | | | | Accounts payable | 1,242 | 1,020 | | Accrued liabilities | 2,614 | 2,486 | | **Total current liabilities** | **3,856** | **3,506** | | Other long-term liabilities | 79 | 254 | | **Total liabilities** | **3,935** | **3,760** | | **Stockholders' Equity** | | | | Common stock | 60 | 19 | | Additional paid-in capital | 544,893 | 458,748 | | Accumulated deficit | (439,295) | (425,550) | | **Total stockholders' equity** | **104,679** | **32,242** | | **Total liabilities and stockholders' equity** | **108,614** | **36,002** | - As of June 30, 2021, total assets were **$108,614 thousand**, a significant increase from **$36,002 thousand** as of December 31, 2020[15](index=15&type=chunk) - Marketable securities increased from **$18,061 thousand** as of December 31, 2020, to **$93,155 thousand** as of June 30, 2021[15](index=15&type=chunk) - Total stockholders' equity increased from **$32,242 thousand** as of December 31, 2020, to **$104,679 thousand** as of June 30, 2021[15](index=15&type=chunk) [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations) The company reported net losses for both the second quarter and first half of 2021, with operating losses and R&D expenses significantly increasing compared to 2020, primarily driven by the CLBS16 Phase 2b study, while income tax benefits substantially decreased Consolidated Statements of Operations Key Data (Thousands of USD, except per share data) | Metric | Three Months Ended June 30, 2021 | Three Months Ended June 30, 2020 | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | :--- | :--- | | **Operating Expenses** | | | | | | Research and development | 4,329 | 1,818 | 9,405 | 3,317 | | General and administrative | 2,818 | 2,474 | 5,828 | 5,032 | | **Total operating expenses** | **7,147** | **4,292** | **15,233** | **8,349** | | **Operating loss** | **(7,147)** | **(4,292)** | **(15,233)** | **(8,349)** | | **Other Income (Expense)** | | | | | | Investment income, net | 47 | 22 | 70 | 93 | | Other expense, net | (90) | — | (90) | — | | **Total other (expense) income** | **(43)** | **22** | **(20)** | **93** | | **Net loss before income tax benefit and noncontrolling interest** | **(7,190)** | **(4,270)** | **(15,253)** | **(8,256)** | | **Income tax benefit** | **(1,508)** | **(10,872)** | **(1,508)** | **(10,872)** | | **Net (loss) income** | **(5,682)** | **6,602** | **(13,745)** | **2,616** | | **Net (loss) income attributable to Caladrius Biosciences, Inc. common stockholders** | **(5,682)** | **6,598** | **(13,745)** | **2,608** | | **Basic and diluted (loss) earnings per share** | **(0.10)** | **0.50** | **(0.27)** | **0.22** | | **Weighted average common shares outstanding** | **59,510** | **13,151** | **50,862** | **11,880** | - Net loss for the second quarter of 2021 was **$5,682 thousand**, compared to net income of **$6,602 thousand** for the same period in 2020[18](index=18&type=chunk) - Net loss for the first half of 2021 was **$13,745 thousand**, compared to net income of **$2,616 thousand** for the same period in 2020[18](index=18&type=chunk) - Research and development expenses increased by **138%** and **184%** year-over-year for the second quarter and first half of 2021, respectively, primarily due to increased costs for the CLBS16 Phase 2b study[18](index=18&type=chunk) [Consolidated Statements of Comprehensive Loss](index=7&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Loss) The company reported comprehensive losses for both the second quarter and first half of 2021, primarily reflecting net losses and unrealized losses on marketable securities Consolidated Statements of Comprehensive Loss Key Data (Thousands of USD) | Metric | Three Months Ended June 30, 2021 | Three Months Ended June 30, 2020 | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | :--- | :--- | | **Net (loss) income** | **(5,682)** | **6,602** | **(13,745)** | **2,616** | | **Other comprehensive loss** | | | | | | Available-for-sale securities - net unrealized loss | (4) | (9) | (4) | (9) | | **Total other comprehensive loss** | **(4)** | **(9)** | **(4)** | **(9)** | | **Comprehensive (loss) income** | **(5,686)** | **6,593** | **(13,749)** | **2,607** | | **Comprehensive (loss) income attributable to Caladrius Biosciences, Inc. common stockholders** | **(5,686)** | **6,589** | **(13,749)** | **2,599** | - Comprehensive loss for the second quarter of 2021 was **$5,686 thousand**, compared to comprehensive income of **$6,593 thousand** for the same period in 2020[21](index=21&type=chunk) - Comprehensive loss for the first half of 2021 was **$13,749 thousand**, compared to comprehensive income of **$2,607 thousand** for the same period in 2020[21](index=21&type=chunk) [Consolidated Statements of Equity](index=8&type=section&id=Consolidated%20Statements%20of%20Equity) As of June 30, 2021, the company's stockholders' equity significantly increased to **$104,679 thousand**, primarily due to net proceeds from common stock and warrant issuances, despite recording a net loss during the period Consolidated Statements of Equity Key Changes (Thousands of USD) | Change Item | March 31 to June 30, 2021 | December 31, 2020 to June 30, 2021 | March 31 to June 30, 2020 | December 31, 2019 to June 30, 2020 | | :--- | :--- | :--- | :--- | :--- | | **Beginning balance** | **110,014** | **32,242** | **16,984** | **20,553** | | Net (loss) income | (5,682) | (13,745) | 6,602 | 2,616 | | Unrealized (loss) gain on marketable securities | 55 | (4) | (7) | (9) | | Share-based compensation | 270 | 683 | 294 | 713 | | Net proceeds from common stock issuance | 22 | 85,479 | 9,683 | 9,683 | | Proceeds from option exercise | — | 24 | — | — | | **Ending balance** | **104,679** | **104,679** | **33,556** | **33,556** | - As of June 30, 2021, total stockholders' equity was **$104,679 thousand**, a significant increase from **$32,242 thousand** as of December 31, 2020[23](index=23&type=chunk) - In the first half of 2021, the company received **$85,479 thousand** in net proceeds from the issuance of common stock and warrants[23](index=23&type=chunk) - During the same period, the company recorded a net loss of **$13,745 thousand**, but this was offset by share-based compensation and new stock issuance activities[23](index=23&type=chunk) [Consolidated Statements of Cash Flows](index=10&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) In the first half of 2021, the company experienced a significant increase in cash outflow from operating activities and a substantial increase in cash outflow from investing activities, primarily for marketable securities purchases, while cash inflow from financing activities significantly rose due to common stock and warrant issuances Consolidated Statements of Cash Flows Key Data (Thousands of USD) | Cash Flow Type | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | **Net cash (used in) provided by operating activities** | **(12,602)** | **262** | | **Net cash (used in) provided by investing activities** | **(76,294)** | **2,855** | | **Net cash provided by financing activities** | **85,319** | **9,535** | | **Net (decrease) increase in cash and cash equivalents** | **(3,577)** | **12,652** | | **Cash and cash equivalents at end of period** | **12,935** | **26,684** | - Net cash outflow from operating activities was **$12,602 thousand** in the first half of 2021, compared to a net inflow of **$262 thousand** in the same period of 2020[27](index=27&type=chunk) - Net cash outflow from investing activities was **$76,294 thousand** in the first half of 2021, primarily due to purchases of marketable securities[27](index=27&type=chunk) - Net cash inflow from financing activities was **$85,319 thousand** in the first half of 2021, mainly from the issuance of common stock and warrants[27](index=27&type=chunk) [Notes to Unaudited Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) This section provides detailed explanations of the company's business, accounting policies, financial instruments, equity transactions, R&D funding, income taxes, and contingencies, offering essential context for understanding the consolidated financial statements [Note 1 – The Business](index=11&type=section&id=Note%201%20%E2%80%93%20The%20Business) Caladrius Biosciences is a clinical-stage biopharmaceutical company focused on developing and commercializing CD34+ cell-based therapies to reverse disease and promote regeneration of damaged tissues, with multiple product candidates in various development stages and active pursuit of out-licensing opportunities, while the COVID-19 pandemic continues to negatively impact patient enrollment in clinical trials - The company focuses on developing and commercializing CD34+ cell-based therapies to stimulate new microvascular formation for ischemic diseases[30](index=30&type=chunk)[32](index=32&type=chunk)[33](index=33&type=chunk) - Key product candidates include: CLBS16 (coronary microvascular dysfunction, completed Phase 2a, initiated Phase 2b FREEDOM trial), HONEDRA (CLBS12) (critical limb ischemia and Buerger's disease, in registration study in Japan, received FDA orphan drug designation), CLBS201 (diabetic kidney disease, Phase 2 study planned for H2 2021), and OLOGO (CLBS14) (no-option refractory angina, received RMAT designation but seeking partnership due to high FDA requirements)[31](index=31&type=chunk)[34](index=34&type=chunk)[35](index=35&type=chunk)[36](index=36&type=chunk)[37](index=37&type=chunk)[38](index=38&type=chunk)[39](index=39&type=chunk)[40](index=40&type=chunk) - The COVID-19 pandemic continues to cause significant delays in patient enrollment for HONEDRA's clinical trial in Japan and CLBS16's FREEDOM trial in the US[34](index=34&type=chunk)[37](index=37&type=chunk)[43](index=43&type=chunk) [Note 2 – Summary of Significant Accounting Policies](index=13&type=section&id=Note%202%20%E2%80%93%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines the basis of financial statement preparation, use of accounting estimates, consolidation principles, and significant accounting policies, including concentration of risk, share-based compensation, and adoption of new accounting standards, with no material changes to significant accounting policies in the first half of 2021 - Financial statements are prepared in accordance with US GAAP and SEC Form 10-Q instructions, including all normal and recurring adjustments deemed necessary by management[44](index=44&type=chunk) - The company faces credit risk from its cash, cash equivalents, and marketable securities portfolio, mitigated by investment policies[48](index=48&type=chunk) - Share-based compensation (including stock options, warrants, and restricted stock) for employees, directors, and consultants is expensed over the service period based on fair value at the grant date[49](index=49&type=chunk) - Adoption of Accounting Standards Update (ASU) 2019-12 had no material impact on the company's consolidated financial statements and disclosures[51](index=51&type=chunk) [Note 3 – Available-for-Sale-Securities](index=14&type=section&id=Note%203%20%E2%80%93%20Available-for-Sale-Securities) As of June 30, 2021, the fair value of the company's available-for-sale securities significantly increased to **$102,208 thousand**, primarily comprising corporate bonds, money market funds, and municipal bonds, with most maturing within one year Available-for-Sale Securities Summary (Thousands of USD) | Security Type | Fair Value June 30, 2021 | Fair Value December 31, 2020 | | :--- | :--- | :--- | | Corporate bonds | 53,274 | 8,399 | | Money market funds | 7,922 | 7,591 | | Municipal bonds | 41,012 | 14,747 | | **Total** | **102,208** | **30,737** | - As of June 30, 2021, total available-for-sale securities were **$102,208 thousand**, with **$93,155 thousand** classified as marketable securities and **$9,053 thousand** as cash equivalents[52](index=52&type=chunk) - As of June 30, 2021, the vast majority of available-for-sale securities (**$102,144 thousand**) had contractual maturities of less than one year[52](index=52&type=chunk) [Note 4 – Income (Loss) Per Share](index=14&type=section&id=Note%204%20%E2%80%93%20Income%20(Loss)%20Per%20Share) Due to the company recording a net loss in the first half of 2021, common stock equivalents were excluded from diluted loss per share calculations as they were anti-dilutive; as of June 30, 2021, the company had a significant number of potentially dilutive securities, including stock options, warrants, and restricted stock units - In the first half of 2021, the company excluded common stock equivalents from diluted loss per share calculations due to a net loss[53](index=53&type=chunk) Potentially Dilutive Securities (Thousands of Shares) | Security Type | June 30, 2021 | June 30, 2020 | | :--- | :--- | :--- | | Stock options | 1,005 | 1,161 | | Warrants | 21,357 | 2,154 | | Restricted stock units | 798 | 313 | [Note 5 – Fair Value Measurements](index=15&type=section&id=Note%205%20%E2%80%93%20Fair%20Value%20Measurements) The company classifies and measures financial assets according to a fair value hierarchy (Level 1, Level 2, Level 3); as of June 30, 2021, and December 31, 2020, all of its available-for-sale marketable securities were categorized as Level 2, indicating their fair value is primarily based on observable indirect inputs - Fair value measurements are categorized into three levels: Level 1 (quoted prices in active markets), Level 2 (observable indirect inputs), and Level 3 (unobservable inputs)[56](index=56&type=chunk)[57](index=57&type=chunk)[58](index=58&type=chunk) Financial Assets Classified by Fair Value Hierarchy (Thousands of USD) | Asset Type | June 30, 2021 Level 2 | December 31, 2020 Level 2 | | :--- | :--- | :--- | | Available-for-sale marketable securities | 93,155 | 18,061 | | **Total** | **93,155** | **18,061** | [Note 6 – Accrued Liabilities](index=15&type=section&id=Note%206%20%E2%80%93%20Accrued%20Liabilities) As of June 30, 2021, total accrued liabilities were **$2,614 thousand**, a slight increase from December 31, 2020, primarily composed of salaries, employee benefits and related taxes, operating lease liabilities, and other accrued items Accrued Liabilities Composition (Thousands of USD) | Item | June 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | Salaries, employee benefits and related taxes | 1,389 | 1,716 | | Operating lease liabilities — current | 366 | 370 | | Other | 859 | 400 | | **Total** | **2,614** | **2,486** | [Note 7 – Operating Leases](index=15&type=section&id=Note%207%20%E2%80%93%20Operating%20Leases) The company holds two office operating leases expiring in 2022 and 2023, with total operating lease liabilities of **$445 thousand** as of June 30, 2021, a weighted-average remaining lease term of **1.3 years**, and a weighted-average discount rate of **9.625%** Operating Lease Liabilities and Right-of-Use Assets (Thousands of USD) | Item | June 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | Right-of-use assets (other assets) | 408 | 574 | | Operating lease liabilities (accrued liabilities) | 366 | 370 | | Operating lease liabilities (other long-term liabilities) | 79 | 254 | | **Total operating lease liabilities** | **445** | **624** | - As of June 30, 2021, the weighted-average remaining lease term was **1.3 years**, and the weighted-average discount rate was **9.625%**[64](index=64&type=chunk) Future Minimum Lease Payments (Thousands of USD) | Year | Operating Leases | | :--- | :--- | | 2021 | 208 | | 2022 | 239 | | 2023 | 27 | | **Total lease payments** | **474** | | Less: interest portion | (29) | | **Present value of lease liabilities** | **445** | [Note 8 – Stockholders' Equity](index=16&type=section&id=Note%208%20%E2%80%93%20Stockholders'%20Equity) The company significantly increased stockholders' equity in the first half of 2021 through a series of equity issuance activities, including registered direct offerings and private placements, raising substantial capital, while also managing equity incentive plans such as stock options, warrants, and restricted stock units - In February 2021, the company sold **24,906,134** shares of common stock and **12,453,067** warrants to institutional investors, and **1,632,652** shares of common stock and **816,326** warrants to qualified investors through a registered direct offering, raising approximately **$65.0 million** in gross proceeds[75](index=75&type=chunk) - In January 2021, the company sold **12,500,000** shares of common stock and **6,250,000** warrants through a private placement, raising **$25.0 million** in gross proceeds[76](index=76&type=chunk) - As of June 30, 2021, the company had **1,005,209** stock options and **21,356,600** warrants outstanding[78](index=78&type=chunk) - In the first half of 2021, the company issued **300,450** shares of restricted stock and **458,245** restricted stock units for service compensation[79](index=79&type=chunk)[80](index=80&type=chunk) [Note 9 – Share-Based Compensation](index=19&type=section&id=Note%209%20%E2%80%93%20Share-Based%20Compensation) The company recognized **$867 thousand** in share-based compensation expense in the first half of 2021, primarily within general and administrative expenses; as of June 30, 2021, total unrecognized share-based compensation costs were **$1,238 thousand**, expected to be recognized over the next 1 to 2 years Share-Based Compensation Expense (Thousands of USD) | Item | Three Months Ended June 30, 2021 | Three Months Ended June 30, 2020 | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | :--- | :--- | | Research and development | 24 | 56 | 120 | 18 | | General and administrative | 246 | 239 | 747 | 68 | | **Total share-based compensation expense** | **270** | **295** | **867** | **86** | Unrecognized Compensation Cost and Weighted-Average Recognition Period (Thousands of USD) | Incentive Type | Unrecognized Compensation Cost | Expected Weighted-Average Recognition Period (Years) | | :--- | :--- | :--- | | Stock options | 338 | 1.73 | | Restricted stock units | 407 | 1.26 | | Restricted stock | 493 | 2.01 | | **Total** | **1,238** | | - The fair value of stock options and warrants is estimated using the Black-Scholes option pricing model, considering historical volatility, risk-free interest rates, expected dividend yield, and expected term[83](index=83&type=chunk) [Note 10 – Research Funding](index=20&type=section&id=Note%2010%20%E2%80%93%20Research%20Funding) The company previously received up to **$12.2 million** in funding from the California Institute for Regenerative Medicine (CIRM) for CLBS03's Phase 2 clinical trial for new-onset Type 1 diabetes; as of September 2020, **$8.2 million** had been received, and **$0.7 million** in R&D expense offset was recognized in the first half of 2020 - The company previously received up to **$12.2 million** in funding from CIRM for the Phase 2 clinical trial of CLBS03 for new-onset Type 1 diabetes[84](index=84&type=chunk) - As of September 2020, **$8.2 million** in funding had been received, and **$0.7 million** in R&D expense offset was recognized in the first half of 2020[84](index=84&type=chunk) [Note 11 – Income Taxes](index=20&type=section&id=Note%2011%20%E2%80%93%20Income%20Taxes) The company has a full valuation allowance against its deferred tax assets, including net operating losses (NOLs), due to uncertainty regarding their future utilization; in April 2021, the company sold a portion of its New Jersey NOLs through an NJEDA program, generating **$1.4 million** in net proceeds and recognizing **$1.5 million** in income tax benefit - The company has a full valuation allowance against its deferred tax assets, including NOLs, due to uncertainty regarding their future utilization[85](index=85&type=chunk) - As of December 31, 2020, the company had approximately **$264 million** in federal NOLs and a total of **$182 million** in state NOLs[86](index=86&type=chunk)[87](index=87&type=chunk) - In April 2021, the company sold a portion of its New Jersey NOLs through the NJEDA program, generating **$1.4 million** in net proceeds and recognizing **$1.5 million** in income tax benefit[92](index=92&type=chunk) [Note 12 – Contingencies](index=21&type=section&id=Note%2012%20%E2%80%93%20Contingencies) The company periodically faces legal proceedings and claims, but management believes the outcome of any pending claims will not have a material adverse effect on its financial condition or results of operations - The company periodically faces legal proceedings and claims, but management believes their outcome will not have a material adverse effect on financial condition or results of operations[93](index=93&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's detailed analysis of the company's financial condition and results of operations for the three and six months ended June 30, 2021, focusing on operating expenses, net loss, liquidity sources, and capital requirements, and discussing the ongoing impact of the COVID-19 pandemic [Overview](index=22&type=section&id=Overview) Caladrius Biosciences is a clinical-stage biopharmaceutical company focused on developing CD34+ cell-based therapies to reverse disease and promote regeneration of damaged tissues, with multiple product candidates aimed at addressing diseases caused by ischemic injury - The company is a clinical-stage biopharmaceutical company dedicated to developing and commercializing CD34+ cell-based therapies[95](index=95&type=chunk) - Key product candidates include CLBS16 (coronary microvascular dysfunction), HONEDRA (CLBS12) (critical limb ischemia and Buerger's disease), CLBS201 (diabetic kidney disease), and OLOGO (CLBS14) (no-option refractory angina)[96](index=96&type=chunk) - The company's proprietary CD34+ cell technology aims to increase blood flow to affected areas by promoting new microvascular formation, thereby improving diseases caused by ischemic injury[98](index=98&type=chunk) [HONEDRA for Treatment of Critical Limb Ischemia](index=22&type=section&id=HONEDRA%20for%20Treatment%20of%20Critical%20Limb%20Ischemia) HONEDRA's registration study in Japan for critical limb ischemia has shown positive results to date, but the COVID-19 pandemic continues to cause significant delays in patient enrollment, making the study completion date unpredictable - HONEDRA's registration study in Japan for CLI has shown positive results to date, demonstrating positive therapeutic effects and safety characteristics[99](index=99&type=chunk) - The COVID-19 pandemic, including ongoing states of emergency in Japan, continues to severely impact patient enrollment for this study, leading to slow progress and an unpredictable completion date[99](index=99&type=chunk) [CLBS16 for Treatment of Coronary Microvascular Dysfunction](index=23&type=section&id=CLBS16%20for%20Treatment%20of%20Coronary%20Microvascular%20Dysfunction) CLBS16's Phase 2a study for coronary microvascular dysfunction showed positive efficacy, and the Phase 2b FREEDOM trial was initiated in December 2020; however, the COVID-19 pandemic has slowed patient enrollment, with enrollment for the FREEDOM trial now expected to complete in Q3 2022 and final data in Q2 2023 - CLBS16's Phase 2a ESCaPE-CMD trial showed positive efficacy, significantly improving angina frequency, coronary flow reserve, and other metrics[100](index=100&type=chunk) - The Phase 2b FREEDOM trial was initiated in December 2020, aiming to further evaluate the efficacy and safety of autologous CD34+ cells in CMD patients[100](index=100&type=chunk) - The COVID-19 pandemic has slowed patient enrollment for the FREEDOM trial, with enrollment now expected to complete in Q3 2022 and final data in Q2 2023[101](index=101&type=chunk) [CLBS201 for Treatment of Diabetic Kidney Disease](index=23&type=section&id=CLBS201%20for%20Treatment%20of%20Diabetic%20Kidney%20Disease) The company has developed an initial development plan for CLBS201 to treat diabetic kidney disease, aiming to slow or reverse renal function decline through CD34+ cell therapy; a Phase 2 proof-of-concept study is planned for initiation in the second half of 2021, with safety data from a six-subject run-in period expected in Q2 2022 - CLBS201 aims to slow or reverse the decline in renal function in patients with diabetic kidney disease through CD34+ cell therapy[102](index=102&type=chunk) - A Phase 2 proof-of-concept study is planned for initiation in the second half of 2021, including an open-label run-in period for six subjects[102](index=102&type=chunk) - Safety data from the six-subject run-in period is expected to be completed in Q2 2022[102](index=102&type=chunk) [OLOGO for Treatment of No Option Refractory Disabling Angina](index=23&type=section&id=OLOGO%20for%20Treatment%20of%20No%20Option%20Refractory%20Disabling%20Angina) OLOGO™ received FDA Regenerative Medicine Advanced Therapy (RMAT) designation, but due to FDA requirements for a large 400-patient Phase 3 study, the company decided not to independently advance the project and is seeking partners - OLOGO™ received FDA RMAT designation, with clinical evidence showing reduced mortality, improved angina, and increased exercise capacity[104](index=104&type=chunk) - Due to FDA requirements for a large 400-patient Phase 3 study, the company decided not to independently advance the project and is seeking partners[104](index=104&type=chunk) [Additional Out-licensing Opportunities](index=23&type=section&id=Additional%20Out-licensing%20Opportunities) The company possesses a broad intellectual property portfolio in cell therapy and actively seeks out-licensing opportunities to advance clinical development, with a long-term strategy to commercialize products independently or with partners to provide therapeutic options for patients - The company possesses a broad intellectual property portfolio in cell therapy and actively seeks out-licensing opportunities to advance clinical development[105](index=105&type=chunk) - The long-term strategy is to commercialize products independently or with partners, ultimately providing therapeutic options for patients[105](index=105&type=chunk) [Coronavirus Considerations](index=24&type=section&id=Coronavirus%20Considerations) The COVID-19 pandemic continues to impact the company's business, particularly causing significant patient enrollment delays for HONEDRA's clinical trial in Japan due to multiple states of emergency - The COVID-19 pandemic continues to impact the company's business, including clinical trials and financial condition[106](index=106&type=chunk) - HONEDRA's clinical trial in Japan faces significant patient enrollment delays due to multiple states of emergency and hospital bed shortages in Japan[106](index=106&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) The company reported net losses for both the second quarter and first half of 2021, primarily due to significant increases in research and development and general and administrative expenses, coupled with a reduction in income tax benefits [Three Months Ended June 30, 2021 Compared to Three Months Ended June 30, 2020](index=24&type=section&id=Three%20Months%20Ended%20June%2030%2C%202021%20Compared%20to%20Three%20Months%20Ended%20June%2030%2C%202020) In Q2 2021, the company reported a net loss of **$5.7 million**, compared to net income of **$6.6 million** in Q2 2020; operating expenses grew **67%**, driven by a **138%** increase in R&D expenses due to the CLBS16 Phase 2b study and a **14%** increase in general and administrative expenses, while income tax benefits significantly decreased - Net loss for the second quarter of 2021 was **$5.7 million**, compared to net income of **$6.6 million** for the same period in 2020[107](index=107&type=chunk) - Total operating expenses increased by **67%** year-over-year, from **$4.3 million** in 2020 to **$7.1 million** in 2021[108](index=108&type=chunk) - Research and development expenses increased by **138%** to **$4.3 million**, primarily due to increased costs for the CLBS16 Phase 2b study[108](index=108&type=chunk) - General and administrative expenses increased by **14%** to **$2.8 million**, mainly due to higher director and officer insurance premiums and strategic consulting fees[110](index=110&type=chunk) - Income tax benefit decreased from **$10.9 million** in 2020 to **$1.5 million** in 2021, primarily due to reduced gains from the sale of New Jersey NOLs[112](index=112&type=chunk)[113](index=113&type=chunk) [Six Months Ended June 30, 2021 Compared to Six Months Ended June 30, 2020](index=25&type=section&id=Six%20Months%20Ended%20June%2030%2C%202021%20Compared%20to%20Six%20Months%20Ended%20June%2030%2C%202020) In the first half of 2021, the company reported a net loss of **$13.7 million**, compared to net income of **$2.6 million** in the first half of 2020; operating expenses grew **82%**, driven by a **184%** increase in R&D expenses due to the CLBS16 Phase 2b study and a **16%** increase in general and administrative expenses, while income tax benefits significantly decreased - Net loss for the first half of 2021 was **$13.7 million**, compared to net income of **$2.6 million** for the same period in 2020[114](index=114&type=chunk) - Total operating expenses increased by **82%** year-over-year, from **$8.3 million** in 2020 to **$15.2 million** in 2021[115](index=115&type=chunk) - Research and development expenses increased by **184%** to **$9.4 million**, primarily due to increased costs for the CLBS16 Phase 2b study[115](index=115&type=chunk) - General and administrative expenses increased by **16%** to **$5.8 million**, mainly due to higher director and officer insurance premiums and strategic consulting fees[117](index=117&type=chunk) - Income tax benefit decreased from **$10.9 million** in 2020 to **$1.5 million** in 2021, primarily due to reduced gains from the sale of New Jersey NOLs[119](index=119&type=chunk)[120](index=120&type=chunk) [Analysis of Liquidity and Capital Resources](index=27&type=section&id=Analysis%20of%20Liquidity%20and%20Capital%20Resources) As of June 30, 2021, the company had ample cash, cash equivalents, and marketable securities totaling approximately **$106.1 million**, and **$104.2 million** in working capital; in the first half of 2021, the company secured substantial cash through equity financing activities to support operations and investments [Operating Activities](index=27&type=section&id=Operating%20Activities) In the first half of 2021, cash outflow from operating activities was **$12.6 million**, primarily driven by net loss and changes in working capital; in contrast, the same period in 2020 saw a net inflow of **$0.3 million** - Net cash outflow from operating activities was **$12.6 million** in the first half of 2021, primarily due to a **$13.7 million** net loss and **$0.9 million** in working capital changes[123](index=123&type=chunk) - Net cash inflow from operating activities was **$0.3 million** in the first half of 2020, primarily due to **$2.6 million** net income and **$3.3 million** in working capital changes[124](index=124&type=chunk) [Investing Activities](index=27&type=section&id=Investing%20Activities) In the first half of 2021, cash outflow from investing activities was **$76.3 million**, mainly for marketable securities purchases, whereas the same period in 2020 saw a net inflow of **$2.9 million** from net sales of marketable securities - Net cash outflow from investing activities was **$76.3 million** in the first half of 2021, primarily due to purchases of marketable securities[125](index=125&type=chunk) - Net cash inflow from investing activities was **$2.9 million** in the first half of 2020, primarily due to net sales of marketable securities[125](index=125&type=chunk) [Financing Activities](index=27&type=section&id=Financing%20Activities) In the first half of 2021, cash inflow from financing activities was **$85.3 million**, primarily from the January 2021 private placement and February 2021 registered direct offering, which raised significant capital through common stock and warrant issuances - Net cash inflow from financing activities was **$85.3 million** in the first half of 2021[126](index=126&type=chunk) - This primarily included **$23.1 million** in net proceeds from the January 2021 private placement and **$60.6 million** in net proceeds from the February 2021 registered direct offering[126](index=126&type=chunk) - Net cash inflow from financing activities was **$9.5 million** in the first half of 2020, primarily from registered direct offerings in April and May 2020 and the common stock sales agreement with H.C. Wainwright[127](index=127&type=chunk) [Liquidity and Capital Requirements Outlook](index=27&type=section&id=Liquidity%20and%20Capital%20Requirements%20Outlook) The company expects existing cash to support operations for at least the next 12 months; to meet long-term liquidity needs, it plans to utilize current cash balances and may raise additional funds through debt or equity securities, partnerships, or asset sales, having entered into an ATM agreement with HCW in June 2021 to issue up to **$50.0 million** in common stock - As of June 30, 2021, the company had approximately **$106.1 million** in cash, cash equivalents, and marketable securities, and approximately **$104.2 million** in working capital[121](index=121&type=chunk) - The company expects existing cash to support operating expenses for at least the next 12 months[129](index=129&type=chunk) - The company entered into an ATM agreement with H.C. Wainwright & Co., LLC on June 4, 2021, to issue up to **$50.0 million** of common stock, none of which had been issued as of June 30, 2021[130](index=130&type=chunk) - The company raised approximately **$90.0 million** in gross proceeds in February 2021 through a registered direct offering and in January 2021 through a private placement[132](index=132&type=chunk)[134](index=134&type=chunk) [Seasonality](index=29&type=section&id=Seasonality) The company believes its operations are not seasonal - The company believes its operations are not seasonal[137](index=137&type=chunk) [Off-Balance Sheet Arrangements](index=29&type=section&id=Off-Balance%20Sheet%20Arrangements) The company has no off-balance sheet arrangements - The company has no off-balance sheet arrangements[138](index=138&type=chunk) [Critical Accounting Policies and Estimates](index=29&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) There were no material changes to the company's critical accounting policies and estimates for the three and six months ended June 30, 2021, compared to those disclosed in the 2020 10-K report - There were no material changes to the company's critical accounting policies and estimates for the three and six months ended June 30, 2021[139](index=139&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable - This section is not applicable[140](index=140&type=chunk) [Item 4. Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) As of June 30, 2021, the company's management assessed and determined its disclosure controls and procedures to be effective, with no material changes in internal control over financial reporting during the quarter - As of June 30, 2021, the company's management, including the Chief Executive Officer and Chief Financial Officer, assessed and determined its disclosure controls and procedures to be effective[142](index=142&type=chunk) - There were no material changes in internal control over financial reporting during the quarter[143](index=143&type=chunk) [PART II- OTHER INFORMATION](index=30&type=section&id=PART%20II-%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) Legal proceedings disclosures in this quarterly report show no material changes from those reported in the company's 2020 10-K report - Legal proceedings disclosures show no material changes from those reported in the company's 2020 10-K report[145](index=145&type=chunk) [Item 1A. Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) Risk factor disclosures in this quarterly report show no material changes from those reported in the company's 2020 10-K report - Risk factor disclosures show no material changes from those reported in the company's 2020 10-K report[146](index=146&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds during this quarter - There were no unregistered sales of equity securities or use of proceeds during this quarter[146](index=146&type=chunk) [Item 3. Defaults Upon Senior Securities](index=30&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during this quarter - There were no defaults upon senior securities during this quarter[147](index=147&type=chunk) [Item 4. Mine Safety Disclosures](index=30&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable - This section is not applicable[148](index=148&type=chunk) [Item 5. Other Information](index=30&type=section&id=Item%205.%20Other%20Information) There were no other information disclosures during this quarter - There were no other information disclosures during this quarter[149](index=149&type=chunk) [Item 6. Exhibits](index=30&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q report, including certifications from the CEO, CFO, and Chief Accounting Officer, as well as XBRL files - Exhibits include certifications from the Chief Executive Officer, Chief Financial Officer, and Chief Accounting Officer under Sections 302 and 906 of the Sarbanes-Oxley Act[157](index=157&type=chunk) - Exhibits also include XBRL instance documents and taxonomy extension files (Schema, Calculation Linkbase, Definition Linkbase, Label Linkbase, Presentation Linkbase)[157](index=157&type=chunk) [Signatures](index=31&type=section&id=Signatures) This report was formally signed by Caladrius Biosciences, Inc. on August 5, 2021, by Dr. David J. Mazzo, President and Chief Executive Officer (also Chief Financial Officer and Chief Accounting Officer) - This report was signed by Caladrius Biosciences, Inc. on August 5, 2021[155](index=155&type=chunk) - The signatory is Dr. David J. Mazzo, serving as President and Chief Executive Officer (also Chief Financial Officer and Chief Accounting Officer)[155](index=155&type=chunk)