What changed in this filing

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Item 1. Financial Statements

2022-08-04 compared with 2022-05-05 · 137 added, 89 removed, 359 unchanged (39% of the section changed)

12 unchanged sentences

Property and equipment, net 282 62

Investment in Cend Therapeutics 10,000 —

Other assets 648 764

13 unchanged sentences

issued and outstanding, 10,000 shares at

March 31, 2022 and December 31, 2021, respectively

June 30, 2022 and December 31, 2021, respectively

Common stock, $ 0.001 par value, authorized 500,000,000 shares;

issued 60,594,329

and 59,800,792 shares at March 31, 2022 and December 31, 2021, respectively;

outstanding, 60,533,064 and 59,789,712 shares at March 31, 2022 and December 31, 2021,

and 59,800,792 shares at June 30, 2022 and December 31, 2021, respectively;

outstanding, 60,583,249 and 59,789,712 shares at June 30, 2022 and December 31, 2021,

Additional paid-in capital 546,976 545,988

Treasury stock, at cost;

11,080 shares at March 31, 2022 and December 31, 2021

11,080 shares at June 30, 2022 and December 31, 2021

( 708 ) ( 708 )

11 unchanged sentences

(In thousands, except per share data)

Three Months Ended March 31,

Three Months Ended June 30, Six Months Ended June 30,

2022 2021 2022 2021

Operating Expenses:

6 unchanged sentences

Other expense, net — ( 90 ) ( 149 ) ( 90 )

Total other (expense) income ( 85 ) 23

Total other income (expense) 94 ( 43 ) 9 ( 20 )

Net loss before benefit from income taxes and noncontrolling interests ( 6,626 ) ( 7,190 ) ( 13,331 ) ( 15,253 )

14 unchanged sentences

(In thousands)

Three Months Ended March 31,

Three Months Ended June 30, Six Months Ended June 30,

2022 2021 2022 2021

Net loss $ ( 6,626 ) $ ( 5,682 ) $ ( 10,852 ) $ ( 13,745 )

Other comprehensive loss:

Available for sale securities - net unrealized loss ( 126 ) ( 59 )

Total other comprehensive loss ( 126 ) ( 59 )

Available for sale securities - net unrealized gain (loss) 126 ( 4 ) — ( 4 )

Total other comprehensive gain (loss) 126 ( 4 ) — ( 4 )

Comprehensive loss attributable to Caladrius Biosciences, Inc.

common stockholders

$ ( 6,500 ) $ ( 5,686 ) $ ( 10,852 ) $ ( 13,749 )

See accompanying notes to consolidated financial statements.

13 unchanged sentences

Shares Amount Shares Amount

Balance at Mar 31, 2022 10 $ — 60,544 $ 61 $ 546,580 $ ( 196 ) $ ( 457,242 ) $ ( 708 ) $ 88,495 $ ( 254 ) $ 88,241

Net loss — — — — — — ( 6,626 ) — ( 6,626 ) — ( 6,626 )

Unrealized gain on marketable securities — — — — — 126 — — 126 — 126

Share-based compensation — — ( 15 ) — 367 — — — 367 — 367

Net proceeds from issuance of common stock — 65 — 29 — — — 29 — 29

Balance at June 30, 2022 10 $ — 60,594 $ 61 $ 546,976 $ ( 70 ) $ ( 463,868 ) $ ( 708 ) $ 82,391 $ ( 254 ) $ 82,137

Series B Convertible

Preferred Stock Common Stock Additional

Capital Accumulated

Comprehensive

Loss Accumulated

Deficit Treasury

Caladrius Biosciences,

Stockholders'

Subsidiary Total

Shares Amount Shares Amount

Balance at December 31, 2021 10 $ — 59,801 $ 60 $ 545,988 $ ( 70 ) $ ( 453,016 ) $ ( 708 ) $ 92,254 $ ( 254 ) $ 92,000

Net loss — — — — — — ( 10,852 ) — ( 10,852 ) — ( 10,852 )

Unrealized loss on marketable securities — — — — — ( 126 ) — — ( 126 ) — ( 126 )

Share-based compensation — — 728 1 959 — — — 960 — 960

Balance at March 31, 2022 10 $ — 60,544 $ 61 $ 546,580 $ ( 196 ) $ ( 457,242 ) $ ( 708 ) $ 88,495 $ ( 254 ) $ 88,241

Net proceeds from issuances of common stock — — 65 — 29 — — — 29 — 29

Balance at June 30, 2022 10 $ — 60,594 $ 61 $ 546,976 $ ( 70 ) $ ( 463,868 ) $ ( 708 ) $ 82,391 $ ( 254 ) $ 82,137

Series B Convertible

2 unchanged sentences

Comprehensive

Loss Accumulated

Deficit Treasury

Caladrius Biosciences,

Stockholders'

Subsidiary Total

Shares Amount Shares Amount

Balance at Mar 31, 2021 10 $ — 59,510 $ 60 $ 544,601 $ ( 72 ) $ ( 433,613 ) $ ( 708 ) $ 110,268 $ ( 254 ) $ 110,014

Net loss — — — — — — ( 5,682 ) — ( 5,682 ) — ( 5,682 )

Unrealized gain on marketable securities — — — — — 55 — — 55 — 55

Share-based compensation — — — — 270 — — — 270 — 270

Net proceeds from issuances of common stock — — 19 — 22 — — — 22 — 22

Balance at June 30, 2021 10 $ — 59,529 $ 60 $ 544,893 $ ( 17 ) $ ( 439,295 ) $ ( 708 ) $ 104,933 $ ( 254 ) $ 104,679

Series B Convertible

Preferred Stock Common Stock Additional

Capital Accumulated

Comprehensive

Income (Loss) Accumulated

10 unchanged sentences

Proceeds from option exercises — — 7 — 24 — — — 24 — 24

Balance at March 31, 2021 10 $ — 59,510 $ 60 $ 544,601 $ ( 72 ) $ ( 433,613 ) $ ( 708 ) $ 110,268 $ ( 254 ) $ 110,014

Balance at June 30, 2021 10 $ — 59,529 $ 60 $ 544,893 $ ( 17 ) $ ( 439,295 ) $ ( 708 ) $ 104,933 $ ( 254 ) $ 104,679

See accompanying notes to consolidated financial statements.

3 unchanged sentences

(In thousands)

Three Months Ended March 31,

Six Months Ended June 30,

Cash flows from operating activities:

12 unchanged sentences

Sale of marketable securities 60,070 29,558

Net cash used in investing activities ( 6,090 ) ( 65,090 )

Purchase of property and equipment ( 235 ) ( 60 )

Investment in Cend Therapeutics ( 10,000 ) —

Net cash provided by (used in) investing activities 19,544 ( 76,294 )

Cash flows from financing activities:

3 unchanged sentences

Net cash (used in) provided by financing activities ( 139 ) 85,319

Net (decrease) increase in cash and cash equivalents ( 11,900 ) 12,232

Net increase (decrease) in cash and cash equivalents 8,701 ( 3,577 )

Cash and cash equivalents at beginning of period 24,647 16,512

20 unchanged sentences

The actual allocation will be subject to adjustment based on our net cash balance at the time of closing and the amount of any transaction expenses of Cend in excess of $ 250 thousand at the time of closing.

See Note 12 below for more information regarding the Merger and related transactions.

Ischemic Repair (CD34+ Cell Technology)

15 unchanged sentences

Timothy Henry, FACC, of the Christ Hospital in Cincinnati, Ohio.

In December 2020, the Company commenced enrollment in its Phase 2b FREEDOM Trial of XOWNA®, a double-blind, randomized and placebo-controlled clinical trial designed to further evaluate the efficacy and safety of intracoronary artery delivery of autologous CD34+ cells in subjects with CMD and without obstructive coronary artery disease.

While early enrollment proceeded to plan with the first patient treated in January 2021, the impact of the COVID-19 pandemic contributed to a general slowing of enrollment, including supply chain disruptions affecting the availability of qualified catheters used in the diagnosis of CMD and/or administration of XOWNA®.

In December 2020, the Company commenced enrollment in its Phase 2b FREEDOM Trial of XOWNA ® , a double-blind, randomized, placebo-controlled clinical trial designed to further evaluate the efficacy and safety of intracoronary artery delivery of autologous CD34+ cells in subjects with CMD and without obstructive coronary artery disease and was expected to complete enrollment in approximately 12 months.

Protocol amendments to the initial FREEDOM Trial protocol, as agreed to by the FDA, were implemented with the goal of enhancing breadth and speed of subject enrollment.

In May 2022, the Company announced that enrollment in the FREEDOM Trial had been suspended and that it intends to conduct an interim analysis of the data from not less than the first 20 patients enrolled using the 6-month follow-up data to evaluate the efficacy and safety of XOWNA ® in subjects with CMD and corroborate the ESCaPE-CMD study results.

The interim analysis is expected to be completed in the third quarter of 2022, and the next steps in development of XOWNA ® will subsequently be determined after appropriate regulatory and business review, expected to be announced prior to year-end 2022.

HONEDRA ® for Treatment of Critical Limb Ischemia

1 unchanged sentence

The HONEDRA ® study's enrollment, however, has been significantly curtailed by the COVID-19 pandemic's impact in Japan, including the States of Emergency in Japan that have persisted for much of 2020, 2021, and 2022.

Due to the significant and continued operational and financial burden incurred as a result of these COVID-19 delays, coupled with the unpredictability of the timing of site enrollment re-initiation, Caladrius suspended further enrollment and is focusing its efforts on consummating a partnership for the product in Japan.

Such a partnership may become the basis for the completion of development and registration of HONEDRA ® in Japan and may include the completion of enrollment of the four remaining no-option CLI subjects stipulated in the original protocol, if necessary, and/or exploration of the possibility of submitting the existing data to Japan's Pharmaceuticals and Medical Devices Agency (“PMDA”) under Japan's regenerative medicine regulations, which allow for conditional approval of innovative regenerative medicine products.

Despite receipt from FDA in March 2021 of orphan designation in the U.S.

Following study suspension, the Company completed all protocol-defined patient observations and is preparing the clinical study report.

HONEDRA ® is now in the pre-consultation phase of the registration process with the Pharmaceuticals and Medical Devices Agency (“PMDA”) in Japan.

Data from the follow-up of all patients completed in the registration-eligible clinical trial in Japan has been compiled and is expected to be reviewed by PMDA during the third quarter of 2022 after which the PMDA is expected to provide important perspective to be considered in preparation for the formal consultation meetings which precede the Japanese new drug application.

The Company is focusing its efforts on consummating a partnership for the product in Japan.

Such a partnership may become the basis for the completion of development and registration of HONEDRA ® in Japan.

This may include the completion of enrollment of the four-remaining no-option CLI subjects stipulated in the original protocol, if necessary, and/or exploration of the possibility of submitting the existing data to Japan's PMDA under Japan's regenerative medicine regulations, which allow for conditional approval of innovative regenerative medicine products.

Despite receipt of orphan designation from FDA in March 2021 in the U.S.

for CLBS12 as a potential treatment for Buerger's disease, based on a response from the FDA in October 2021 regarding a development plan for U.S.

registration the Company decided not to pursue United States development in Buerger's disease at this time.

registration the Company decided not to pursue U.S.

development in Buerger's disease at this time.

CLBS201 for Treatment of Diabetic Kidney Disease

1 unchanged sentence

Pre-clinical studies in kidney disease and injury models have demonstrated that protection or replenishment of the microcirculation results in improved kidney function.

Based on these observations, the Company has elected to move forward with a Phase 1b, open-label, proof-of-concept trial evaluating CLBS201 dosed via intra-renal artery injections in subjects with DKD.

This protocol is expected to include six subjects in total with the first two subjects sequentially dosed and followed for a two-week safety observation period.

Clearance by the independent Data Safety Monitoring Board (“DSMB”) overseeing the study will then permit the treatment of the next four patients, with all patients being followed for safety and therapeutic effect.

Based on these observations, the Company elected to move forward with a Phase 1b, open-label, proof-of-concept trial evaluating CLBS201 dosed via intra-renal artery injections in subjects with DKD.

This protocol includes six subjects in total with the first two subjects sequentially dosed and followed for a two-week safety observation period.

Clearance by the independent Data Safety Monitoring Board (“DSMB”) overseeing the study then permitted the treatment of the next four patients, with all patients being followed for safety and therapeutic effect.

A read-out of data will occur after at the six-month follow-up visit for all patients.

A key criterion for continued development of CLBS201 will be its ability to demonstrate a therapeutic effect that will make it competitive in the field of DKD treatment, i.e., kidney function regeneration, as indicated by increased glomerular filtration rate.

As announced recently, the Company has treated the first patient in the CLBS201 proof-of-concept study and targets treatment completion for all six subjects during the third quarter of 2022.

Additional Out-licensing Opportunities and Pipeline Diversification

The Company treated the first patient in the CLBS201 proof-of-concept study in April 2022 and completed treatment for all six subjects during the third quarter of 2022.

Top-line data is anticipated from all subjects by the first quarter of 2023.

Additional Out-licensing Opportunities

The Company's broad intellectual property portfolio of cell therapy assets includes notable programs available for out-licensing in order to continue their clinical development.

1 unchanged sentence

The Company believes that it is well-positioned to realize potentially meaningful value increases within its own proprietary pipeline if it is successful in advancing its product candidates to their next significant development milestones.

In addition, the Company further desires to diversify its pipeline of development products candidates and is exploring a range of strategic transactions in furtherance of that goal.

The Company has taken, and intends to continue to take, active steps to identify assets and/or companies for acquisition and/or partnership that would enhance and de-risk its current development portfolio.

Such assets could target indications beyond cardiovascular disease as well as product categories outside of cell therapy.

The range of possible transactions includes an acquisition, merger, business combination, in-license or other strategic transaction, any of which could result in the issuance of securities that could significantly dilute the shares of its existing stockholders.

There can be no assurance that this exploration of strategic alternatives will result in Caladrius entering into or completing any transaction or that such transaction, if completed, will add to shareholder value.

C end Merger Agreement

On April 26, 2022, the Company and Cend entered into the Merger Agreement.

Consummation of the Merger is subject to certain closing conditions, including, among other things, approval by the stockholders of the Company and Cend and the Company’s satisfaction of a minimum net cash threshold at closing, expected to be approximately $ 64.9 million assuming a closing at the end of the third quarter of 2022, and as described further in the Merger Agreement.

The Merger Agreement contains certain termination rights for both the Company and Cend, and further provides that, upon termination of the Merger Agreement under specified circumstances, the Company may be required to pay Cend a termination fee of $ 1.0 million, Cend may be required to pay the Company a termination fee of $ 4.0 million, or in some circumstances reimburse the other party’s expenses up to a maximum of $ 1.0 million.

At the effective time of the Merger, the Company’s Board of Directors is expected to consist of nine members, four of whom will be designated by the Company, four of whom will be designated by Cend and one member who will be mutually agreed between the Company and Cend.

Stock Purchase Agreement

In order to provide Cend with capital for its development programs prior to the closing of the Merger, the Company and Cend entered into a Series D Preferred Stock Purchase Agreement (the “Purchase Agreement”), pursuant to which the Company purchased from Cend 1,135,628 shares of Series D Preferred Stock, $ 0.00001 par value per share (the “Series D Preferred Stock”), of Cend at a purchase price per share equal to $ 8.8057 per share (the “Series D Original Issue Price”), or approximately $ 10 million in the aggregate.

The Series D Preferred Stock ranks senior to Cend’s common stock and the other series of preferred stock with respect to rights on the distribution of assets on any voluntary or involuntary liquidation, dissolution or winding up of Cend.

The Series D Preferred Stock has a liquidation preference equal to the Series D Original Issue Price plus an amount equal to any accrued and unpaid dividends to the date of payment and will participate with Cend’s common stockholders and other preferred stockholders thereafter on an as-converted basis.

The Series D Preferred Stock shall vote with the common stock on an as-converted basis on any matters presented to the stockholders of Cend.

Each share of Series D Preferred Stock is convertible, at the option of the holder thereof, into such number of shares of Cend common stock as is determined by dividing the Original Issue Price by the conversion price in effect at the time of conversion, which conversion price shall be the Original Issue Price as appropriately adjusted for stock splits, stock dividends, combinations, and subdivisions of Cend common stock, and as adjusted pursuant to a weighted-average antidilution adjustment.

The Series D Preferred Stock will automatically convert into shares of Cend common stock upon the closing of a firm-commitment underwritten initial public offering implying a pre-equity offering value of at least $ 250 million, resulting in at least $ 50 million of gross proceeds to Cend.

Collaboration Agreement

In connection with such Purchase Agreement, Cend entered into a Collaboration Agreement (the “Collaboration Agreement”), pursuant to which the Company agreed to collaborate with Cend on certain developmental and clinical activities prior to the closing of the Merger.

Pursuant to the Collaboration Agreement, the Company and Cend have formed a joint steering committee (the “Committee”) comprised of individuals from both entities.

The Committee meets regularly and is responsible for monitoring ongoing studies and making recommendations for development activity and trial planning.

Cend has agreed to pay each member of the Committee from the Company an hourly consulting fee for such service.

As of June 30, 2022 the cumulative services provided under the agreement totaled $ 0.2 million.

Coronavirus Considerations

3 unchanged sentences

In response to the COVID-19 pandemic, the Company implemented a universal work from home policy as well as stringent social distancing and other hygiene policies for employees when they must be in the office.

The Company's clinical study of HONEDRA ® in Japan has experienced significant delays in enrollment due to the States of Emergency in effect in Japan for most of 2020 2021 covering Tokyo and other regions in response to an increased number of COVID-19 infections.

With the Company's expectation that COVID-19 in Japan would continue to impact negatively clinical site operations and enrollment of patients in the HONEDRA ® clinical trial, it elected to suspend trial enrollment, seek a development partner and consult with the Japanese regulatory authorities regarding the submission of patient data already accrued.

Caladrius' phase 2b trial of XOWNA ® in the U.S.

The Company's clinical study of HONEDRA ® in Japan experienced significant delays in enrollment due to the States of Emergency in effect in Japan for most of 2020, 2021, and 2022 covering Tokyo and other regions in response to an increased number of COVID-19 infections.

With the Company's expectation that COVID-19 in Japan will continue to impact negatively clinical site operations and enrollment of patients in the HONEDRA ® clinical trial, it elected to suspend trial enrollment, seek a development partner and consult with the Japanese regulatory authorities regarding the submission of patient data already accrued.

Caladrius' phase 2b FREEDOM Trial of XOWNA ® in the U.S.

has also experienced delays in enrolling patients as a result of COVID-19.

agent typically used in many catheter laboratories.

In May 2022, the Company announced that enrollment in the FREEDOM Trial had been suspended and that it intended to conduct an interim analysis of the data from not less than the first 20 patients enrolled using the 6-month follow-up data to evaluate the efficacy and safety of XOWNA ® in subjects with CMD and corroborate the ESCaPE-CMD study results.

Basis of Presentation

1 unchanged sentence

Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements.

In the opinion of management, the accompanying Consolidated Financial Statements of the Company and its subsidiaries, which are unaudited, include all normal and recurring adjustments considered necessary to present fairly the Company’s financial position as of March 31, 2022, and the results of its operations and its cash flows for the periods presented.

In the opinion of management, the accompanying Consolidated Financial Statements of the Company and its subsidiaries, which are unaudited, include all normal and recurring adjustments considered necessary to present fairly the Company’s financial position as of June 30, 2022, and the results of its operations and its cash flows for the periods presented.

The unaudited consolidated financial statements herein should be read together with the historical consolidated financial statements of the Company for the years ended December 31, 2021 and 2020 included in our 2021 Form 10-K.

Operating results for the three months ended March 31, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022.

Operating results for the three and six months ended June 30, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022.

Use of Estimates

10 unchanged sentences

In addition to the policies below, the Company's significant accounting policies are described in Note 2 of the Notes to Consolidated Financial Statements included in its 2021 Form 10-K.

There were no changes to these policies during the three months ended March 31, 2022.

There were no changes to these policies during the three and six months ended June 30, 2022.

Concentration of Risks

10 unchanged sentences

The Company determines the fair value of option awards using the Black-Scholes option-pricing model which uses both historical and current market data to estimate the fair value.

This method incorporates various assumptions such as the risk-free interest rate, expected volatility, expected dividend yield and expected life of the options or warrants.

This method incorporates various assumptions such as the risk-free interest rate, expected volatility, expected dividend yield and expected life of the options or

The fair value of the Company’s restricted stock and restricted stock units is based on the closing market price of the Company’s common stock on the date of grant.

Investment in Cend Therapeutics

Investments in which the Company has no significant influence (generally less than a 20% ownership interest) or does not have the ability to exercise significant influence are accounted for under the measurement alternative method pursuant to ASC 321, Investments — Equity Securities (“ASC 321”) as these investments do not have readily determinable fair values.

Under the measurement alternative method, the Company records the investment at cost less impairment losses, if any, unless it identifies observable price changes in orderly transactions for the identical or a similar investment of the same issuer, in which case the Company will measure its investments at fair value as of the date that the observable transaction occurred.

Such investments are presented as investments on the consolidated balance sheets and any impairment recognized related to these investments are presented in other income (expense), on the consolidated statements of operations (see Note 5, “Fair Value Measurements”).

Note 3 – Available-for-Sale-Securities

The following table is a summary of available-for-sale securities recorded in cash and cash equivalents or marketable securities in our Consolidated Balance Sheets (in thousands):

March 31, 2022 December 31, 2021

June 30, 2022 December 31, 2021

Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value

Corporate debt securities $ 26,966 $ — $ ( 66 ) $ 26,900 $ 53,135 $ — $ ( 65 ) $ 53,070

Commercial paper 2,978 — — 2,978 — — — —

Money market funds 22,727 — — 22,727 18,124 — — 18,124

3 unchanged sentences

The following table summarizes the classification of the available-for-sale securities in our Consolidated Balance Sheets (in thousands):

March 31, 2022 December 31, 2021

June 30, 2022 December 31, 2021

Cash equivalents $ 30,045 $ 21,129

2 unchanged sentences

The following table summarizes our portfolio of available-for-sale securities by contractual maturity (in thousands):

March 31, 2022

June 30, 2022

Amortized Cost Estimated Fair Value

3 unchanged sentences

Note 4 – Income (Loss) Per Share

For the three months ended March 31, 2022 and 2021, the Company incurred net losses and therefore no common stock equivalents were utilized in the calculation of diluted loss per share as they are anti-dilutive.

At March 31, 2022 and 2021, the Company excluded the following potentially dilutive securities (in thousands):

For the six months ended June 30, 2022 and 2021, the Company incurred net losses and therefore no common stock equivalents were utilized in the calculation of diluted loss per share as they are anti-dilutive.

At June 30, 2022 and 2021, the Company excluded the following potentially dilutive securities (in thousands):

Stock Options 2,612 1,005

9 unchanged sentences

The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the valuation of the fair value of assets and liabilities and their placement within the fair value hierarchy levels.

The following table sets forth by level within the fair value hierarchy the Company's financial assets that were accounted for at fair value on a recurring basis as of March 31, 2022 and December 31, 2021 (in thousands).

March 31, 2022 December 31, 2021

The following table sets forth by level within the fair value hierarchy the Company's financial assets that were accounted for at fair value on a recurring basis as of June 30, 2022 and December 31, 2021 (in thousands).

June 30, 2022 December 31, 2021

Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total

Marketable securities - available for sale $ — $ 39,643 $ — $ 39,643 $ — $ 70,323 $ — $ 70,323

Investment in Cend Therapeutics $ — $ — $ 10,000 $ 10,000 $ — $ — $ — $ —

$ — $ 39,643 $ 10,000 $ 49,643 $ — $ 70,323 $ — $ 70,323

Note 6 – Accrued Liabilities

Accrued liabilities as of March 31, 2022 and December 31, 2021 were as follows (in thousands):

March 31, 2022 December 31, 2021

Accrued liabilities as of June 30, 2022 and December 31, 2021 were as follows (in thousands):

June 30, 2022 December 31, 2021

Salaries, employee benefits and related taxes $ 1,397 $ 2,034

9 unchanged sentences

Operating lease liabilities and right-of-use assets were recorded in the following captions of our balance sheet were as follows (in thousands):

March 31, 2022 December 31, 2021

June 30, 2022 December 31, 2021

Right-of Use Assets:

5 unchanged sentences

Total Operating Lease Liabilities $ 561 $ 714

As of March 31, 2022, the weighted average remaining lease term for our operating leases was 2.3 years, and the weighted average discount rate for our operating leases was 9.625 %.

Future minimum lease payments under the lease agreements as of March 31, 2022 were as follows (in thousands):

As of June 30, 2022, the weighted average remaining lease term for our operating leases was 2.0 years, and the weighted average discount rate for our operating leases was 9.625 %.

Future minimum lease payments under the lease agreements as of June 30, 2022 were as follows (in thousands):

Years ended Operating Leases

17 unchanged sentences

The Company has the right to terminate the Purchase Agreement at any time, at no cost to the Company.

As of March 31, 2022, the Company had not made any sales of common stock to Lincoln Park under the Purchase Agreement other than the Initial Purchase.

As of June 30, 2022, the Company had not made any sales of common stock to Lincoln Park under the Purchase Agreement other than the Initial Purchase.

The agreement expired on April 1, 2022.

1 unchanged sentence

On June 4, 2021, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with HCW, as sales agent, in connection with an “at the market offering” under which the Company from time to time may offer and sell shares of its common stock, having an aggregate offering price of up to $ 50.0 million.

During the three months ended March 31, 2022 and since inception the Company had no t issued any shares under the ATM Agreement.

During the six months ended June 30, 2022 and since inception the Company had no t issued any shares under the ATM Agreement.

Having received a listing deficiency notice from Nasdaq on February 18, 2022 after the Company’s shares traded below $1.00 for 30 consecutive trading days, the Company will not be permitted to sell additional shares under the ATM Agreement until it re-establishes timely compliance.

1 unchanged sentence

Stock Options and Warrants

The following table summarizes the activity for stock options and warrants for the three months ended March 31, 2022:

The following table summarizes the activity for stock options and warrants for the six months ended June 30, 2022:

Stock Options Warrants

6 unchanged sentences

Expired ( 49,664 ) 27.37 — —

Outstanding at March 31, 2022 2,639,609 $ 4.51 7.83 $ — 21,356,600 $ 2.84 4.13 $ —

Vested at March 31, 2022

Outstanding at June 30, 2022 2,612,285 $ 4.26 7.63 $ — 21,356,600 $ 2.84 3.88 $ —

Vested at June 30, 2022

or expected to vest in the future 2,574,724 $ 4.31 7.61 $ — 21,356,600 $ 2.84 3.88 $ —

Vested at March 31, 2022 1,408,083 $ 7.36 6.41 $ — 21,356,600 $ 2.84 4.13 $ —

Vested at June 30, 2022 1,388,935 $ 6.92 6.24 $ — 21,356,600 $ 2.84 3.88 $ —

Restricted Stock

During the three months ended March 31, 2022 and 2021, the Company issued restricted stock for services as follows ($ in thousands):

Three Months Ended March 31,

During the six months ended June 30, 2022 and 2021, the Company issued restricted stock for services as follows ($ in thousands):

Six Months Ended June 30,

Number of restricted stock issued 1,061,175 300,450

2 unchanged sentences

Restricted Stock Units

During the three months ended March 31, 2022 and 2021, the Company issued restricted stock units for services as follows ($ in thousands, except share data):

Three Months Ended March 31,

During the six months ended June 30, 2022 and 2021, the Company issued restricted stock units for services as follows ($ in thousands, except share data):

Six Months Ended June 30,

Number of restricted stock units issued 1,379,860 458,245

Value of restricted stock units issued $ 1,265 $ 729

The weighted average estimated fair value of restricted stock issued for services in the three months ended March 31, 2022 and 2021 was $ 0.92 and $ 1.59 per share, respectively.

The weighted average estimated fair value of restricted stock issued for services in the six months ended June 30, 2022 and 2021 was $ 0.92 and $ 1.59 per share, respectively.

The fair value of the restricted stock units was determined using the Company’s closing stock price on the date of issuance.

3 unchanged sentences

We utilize share-based compensation in the form of stock options, restricted stock, and restricted stock units.

The following table summarizes the components of share-based compensation expense for the three months ended March 31, 2022 and 2021 (in thousands):

Three Months Ended March 31,

The following table summarizes the components of share-based compensation expense for the three and six months ended June 30, 2022 and 2021 (in thousands):

Three Months Ended June 30, Six Months Ended June 30,

2022 2021 2022 2021

Research and development $ 141 $ 24 $ 359 $ 120

1 unchanged sentence

Total share-based compensation expense $ 367 $ 270 $ 1,128 $ 867

Total compensation cost related to non-vested awards not yet recognized and the weighted-average periods over which the awards were expected to be recognized at March 31, 2022 were as follows (in thousands):

Total compensation cost related to non-vested awards not yet recognized and the weighted-average periods over which the awards were expected to be recognized at June 30, 2022 were as follows (in thousands):

Stock Options Restricted Stock Units Restricted Stock

1 unchanged sentence

Expected weighted-average period in years of compensation cost to be recognized 1.56 0.74 2.04

Total fair value of shares vested and the weighted average estimated fair values of shares granted for the three months ended March 31, 2022 and 2021 were as follows (in thousands):

Total fair value of shares vested and the weighted average estimated fair values of shares granted for the six months ended June 30, 2022 and 2021 were as follows (in thousands):

Stock Options

Three Months Ended March 31,

Six Months Ended June 30,

Total fair value of shares vested $ 385 $ 407

23 unchanged sentences

The Company recognizes interest and penalties associated with uncertain tax positions as a component of income tax expense.

As of March 31, 2022, management does not believe the Company has any material uncertain tax positions that would require it to measure and reflect the potential lack of sustainability of a position on audit in its financial statements.

As of June 30, 2022, management does not believe the Company has any material uncertain tax positions that would require it to measure and reflect the potential lack of sustainability of a position on audit in its financial statements.

The Company will continue to evaluate its uncertain tax positions in future periods to determine if measurement and recognition in its financial statements is necessary.

10 unchanged sentences

While the outcome of pending claims cannot be predicted with certainty, the Company does not believe that the outcome of any pending claims will have a material adverse effect on the Company's financial condition or operating results.

Note 12 – Subsequent Event

Cend Merger Agreement

On April 26, 2022, the Company and Cend Therapeutics, Inc., a Delaware corporation (“Cend”), entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”), pursuant to which, among other matters, and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, a wholly-owned subsidiary of Caladrius will merge with and into Cend, with Cend surviving as a wholly-owned subsidiary of the Company (the “Merger”), subject to the terms of the Merger Agreement and stockholder approval of the transaction.

Under the exchange ratio formula, as of immediately after the Merger, the former Cend stockholders are expected to own approximately 50 % of the outstanding shares of Caladrius Common Stock and the Company’s stockholders as of immediately prior to the Merger are expected to own approximately 50 % of the outstanding shares of Caladrius Common Stock.

The actual allocation will be subject to adjustment based on the Company’s net cash balance at the time of closing and the amount of any transaction expenses of Cend in excess of $ 250 thousand at the time of closing.

Consummation of the Merger is subject to certain closing conditions, including, among other things, approval by the stockholders of the Company and Cend, and the Company’s satisfaction of a minimum net cash threshold at closing, expected to be approximately $ 64.9 million assuming a closing at the end of the third quarter of 2022, and as described further in the Merger Agreement.

Stock Purchase Agreement

Company agreed to purchase from Cend 1,135,628 shares of Series D Preferred Stock, $ 0.00001 par value per share (the “Series D Preferred Stock”), of Cend at a purchase price per share equal to $ 8.8057 per share (the “Series D Original Issue Price”), or approximately $ 10 million in the aggregate.

The Series D Preferred Stock shall vote with the common stock on an as-converted basis on any matters presented to the stockholders of Cend.

Collaboration Agreement

Under the Collaboration Agreement, the Company and Cend will form a joint steering committee (the “Committee”) comprised of individuals from both entities.

The Committee will meet regularly and be responsible for monitoring ongoing studies and making recommendations for development activity and trial planning.

Cend has agreed to pay each member of the Committee from the Company an hourly consulting fee for such service.

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

What changed 10-Q

Item 1. Financial Statements