Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2022 | May 05, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-33650 | |
Entity Registrant Name | CALADRIUS BIOSCIENCES, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 22-2343568 | |
Entity Address, Address Line One | 110 Allen Road, 2nd Floor | |
Entity Address, City or Town | Basking Ridge | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 07920 | |
City Area Code | 908 | |
Local Phone Number | 842-0100 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | CLBS | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Central Index Key | 0000320017 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false | |
Entity Common Stock, Shares Outstanding | 60,518,478 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
ASSETS | ||
Cash and cash equivalents | $ 12,747 | $ 24,647 |
Marketable securities | 75,772 | 70,323 |
Prepaid and other current assets | 2,181 | 1,212 |
Total current assets | 90,700 | 96,182 |
Property and equipment, net | 55 | 62 |
Other assets | 708 | 764 |
Total assets | 91,463 | 97,008 |
Liabilities | ||
Accounts payable | 697 | 1,934 |
Accrued liabilities | 2,104 | 2,589 |
Total current liabilities | 2,801 | 4,523 |
Other long-term liabilities | 421 | 485 |
Total liabilities | 3,222 | 5,008 |
Commitments and Contingencies | ||
Stockholders' Equity | ||
Preferred stock, authorized, 20,000,000 shares Series B convertible redeemable preferred stock liquidation value, 0.001 share of common stock, $0.01 par value; 825,000 shares designated; issued and outstanding, 10,000 shares at March 31, 2022 and December 31, 2021, respectively | 0 | 0 |
Common stock, $0.001 par value, authorized 500,000,000 shares; issued 60,544,144 and 59,800,792 shares at March 31, 2022 and December 31, 2021, respectively; and outstanding, 60,533,064 and 59,789,712 shares at March 31, 2022 and December 31, 2021, respectively | 61 | 60 |
Additional paid-in capital | 546,580 | 545,988 |
Treasury stock, at cost; 11,080 shares at March 31, 2022 and December 31, 2021 | (708) | (708) |
Accumulated deficit | (457,242) | (453,016) |
Accumulated other comprehensive loss | (196) | (70) |
Total Caladrius Biosciences, Inc. stockholders' equity | 88,495 | 92,254 |
Non-controlling interests | (254) | (254) |
Total stockholders' equity | 88,241 | 92,000 |
Liabilities and Equity, Total | $ 91,463 | $ 97,008 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, shares authorized | 20,000,000 | 20,000,000 |
Preferred stock, liquidation value | 0.001 | 0.001 |
Preferred stock, par value (in usd per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares designated | 825,000 | 825,000 |
Preferred stock, shares issued | 10,000 | 10,000 |
Preferred stock, shares outstanding | 10,000 | 10,000 |
Common stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 500,000,000 | 500,000,000 |
Common stock, shares issued | 60,544,144 | 59,800,792 |
Common stock, shares, outstanding | 60,533,064 | 59,789,712 |
Treasury stock (shares) | 11,080 | 11,080 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Operating Expenses: | ||
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) |
Other income (expense): | ||
Investment income, net | 63 | 23 |
Other expense, net | (148) | 0 |
Total other (expense) income | (85) | 23 |
Net loss before benefit from income taxes and noncontrolling interests | (6,705) | (8,063) |
Benefit from income taxes | (2,479) | 0 |
Net loss attributable to Caladrius Biosciences, Inc. common stockholders | $ (4,226) | $ (8,063) |
Basic and diluted loss per share | ||
Caladrius Biosciences, Inc. common stockholders - basic (in usd per share) | $ (0.07) | $ (0.19) |
Caladrius Biosciences, Inc. common stockholders - diluted (in usd per share) | $ (0.07) | $ (0.19) |
Weighted average common shares outstanding | ||
Basic shares | 60,560 | 42,117 |
Diluted shares | 60,560 | 42,117 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (4,226) | $ (8,063) |
Available for sale securities - net unrealized loss | (126) | (59) |
Total other comprehensive loss | (126) | (59) |
Comprehensive loss attributable to Caladrius Biosciences, Inc. common stockholders | $ (4,352) | $ (8,122) |
Consolidated Statements of Equi
Consolidated Statements of Equity - USD ($) $ in Thousands | Total | Total Caladrius Biosciences, Inc. Stockholders' Equity | Series B Convertible Preferred Stock | Common Stock | Additional Paid in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Treasury Stock | Non- Controlling Interest in Subsidiary |
Beginning balance (shares) at Dec. 31, 2020 | 10,000 | 19,389,000 | |||||||
Beginning balance at Dec. 31, 2020 | $ 32,242 | $ 32,496 | $ 0 | $ 19 | $ 458,748 | $ (13) | $ (425,550) | $ (708) | $ (254) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Net loss | (8,063) | (8,063) | (8,063) | 0 | |||||
Unrealized loss on marketable securities | (59) | (59) | (59) | ||||||
Share-based compensation (in shares) | 273,000 | ||||||||
Share-based compensation | 413 | 413 | 413 | ||||||
Net proceeds from issuance of common stock and warrants (in shares) | 39,841,000 | ||||||||
Net proceeds from issuances of common stock and warrants | 85,457 | 85,457 | $ 41 | 85,416 | |||||
Proceeds from option exercises (in shares) | 7,000 | ||||||||
Proceeds from option exercises | 24 | 24 | 24 | ||||||
Ending balance (shares) at Mar. 31, 2021 | 10,000 | 59,510,000 | |||||||
Ending balance at Mar. 31, 2021 | 110,014 | 110,268 | $ 0 | $ 60 | 544,601 | (72) | (433,613) | (708) | (254) |
Beginning balance (shares) at Dec. 31, 2021 | 10,000 | 59,801,000 | |||||||
Beginning balance at Dec. 31, 2021 | 92,000 | 92,254 | $ 0 | $ 60 | 545,988 | (70) | (453,016) | (708) | (254) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Net loss | (4,226) | (4,226) | (4,226) | 0 | |||||
Unrealized loss on marketable securities | (126) | (126) | (126) | ||||||
Share-based compensation (in shares) | 743,000 | ||||||||
Share-based compensation | $ 593 | 593 | $ 1 | 592 | |||||
Proceeds from option exercises (in shares) | 0 | ||||||||
Ending balance (shares) at Mar. 31, 2022 | 10,000 | 60,544,000 | |||||||
Ending balance at Mar. 31, 2022 | $ 88,241 | $ 88,495 | $ 0 | $ 61 | $ 546,580 | $ (196) | $ (457,242) | $ (708) | $ (254) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (4,226) | $ (8,063) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation | 760 | 597 |
Depreciation and amortization | 7 | 16 |
Accretion on marketable securities | 515 | 323 |
Changes in operating assets and liabilities: | ||
Prepaid and other current assets | (969) | (1,763) |
Other assets | 57 | 81 |
Accounts payable, accrued liabilities and other liabilities | (1,786) | 834 |
Net cash used in operating activities | (5,642) | (7,975) |
Cash flows from investing activities: | ||
Purchase of marketable securities | (26,546) | (75,911) |
Sale of marketable securities | 20,456 | 10,821 |
Net cash used in investing activities | (6,090) | (65,090) |
Cash flows from financing activities: | ||
Proceeds from exercise of options | 0 | 24 |
Tax withholding payments on net share settlement equity awards | (168) | (184) |
Net proceeds from issuance of common stock | 0 | 85,457 |
Net cash (used in) provided by financing activities | (168) | 85,297 |
Net (decrease) increase in cash and cash equivalents | (11,900) | 12,232 |
Cash and cash equivalents at beginning of period | 24,647 | 16,512 |
Cash and cash equivalents at end of period | $ 12,747 | $ 28,744 |
The Business
The Business | 3 Months Ended |
Mar. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
The Business | The Business Overview Caladrius Biosciences, Inc. (“we,” “us,” "our," “Caladrius” or the “Company”) is a clinical-stage biopharmaceutical company dedicated to the development of treatments and reversal of severe diseases. The Company is developing what are intended to be first-in-class therapeutics based on the characteristics of naturally occurring CD34+ cells and their ability to stimulate the growth of new microvasculature. Its technology is intended to leverage these cells to enable the body's natural repair mechanisms using formulations unique to each medical indication. The Company's leadership team has decades of collective biopharmaceutical product development experience in a variety of therapeutic categories. Its goal is to develop and commercialize products that address important unmet medical needs based on a broad and versatile portfolio of candidates. The Company’s current product candidates include: • XOWNA ® (CLBS16), the subject of both a completed positive Phase 2a study (ESCaPE-CMD) and an ongoing follow on Phase 2b study (FREEDOM Trial) in the United States for the treatment of coronary microvascular dysfunction (“CMD”); • HONEDRA® (CLBS12), recipient of SAKIGAKE designation pursuant to which early conditional approval in Japan for the treatment of critical limb ischemia (“CLI”) and Buerger’s disease is being sought based on the current results of a clinical trial executed in Japan. HONEDRA® was the recipient of orphan drug designation in March 2021 from the U.S. Food and Drug Administration (“FDA”) for Buerger's disease; and • CLBS201, the subject of a study designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for patients with chronic kidney disease related to type 2 diabetes (diabetic kidney disease or “DKD”). • 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 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) The CD34+ cell was discovered as a result of the deliberate search for a cell capable of stimulating the development and/or repair of blood vessels. All tissues in the body maintain their function by replacing cells over time. In addition to the maintenance function, the body must also be capable of building new blood vessels after injury. A CD34+ cell is an endothelial progenitor cell that has the ability to stimulate new blood vessel formation at the level of the microvasculature. No other native cell discovered to date has demonstrated this same capability. The Company's proprietary cell technology using autologous (a patient’s own naturally occurring) CD34+ cells has led to the development of therapeutic product candidates designed to address diseases and conditions caused by ischemia. Ischemia occurs when the supply of oxygenated blood to healthy tissue is restricted or reduced. Through the administration of CD34+ cells, Caladrius seeks to promote the development and formation of new microvasculature and thereby increase blood flow to the impacted area. The Company believes that a number of conditions caused by underlying ischemic injury can be improved through its CD34+ cell technology including but not limited to Buerger's disease, CLI, CMD, and DKD. XOWNA ® for Treatment of Coronary Microvascular Dysfunction In 2017, with the assistance of a $1.9 million grant from the National Institutes of Health (Award Number R44HL135889), the Company initiated its program for XOWNA® for the treatment of CMD, a disease that afflicts as many as 1.6 million patients in the United States alone, with no current targeted treatment options. That study, the ESCaPE-CMD Trial, was a Phase 2a proof-of-concept open label study that enrolled patients at the Mayo Clinic in Rochester, MN and Cedars-Sinai Medical Center in Los Angeles, CA. Those data showed a positive therapeutic effect with a statistically significant improvement in angina frequency, coronary flow reserve, Canadian Cardiovascular Society Angina Class and Seattle Angina Questionnaire scores, as well as an acceptable safety profile. The full data set from that study was presented at the SCAI 2020 Scientific Sessions Virtual Conference on May 14, 2020 by Dr. 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®. 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. HONEDRA ® for Treatment of Critical Limb Ischemia The Company's randomized, open-label, registration-eligible study of HONEDRA ® in Japan for the treatment of CLI and Buerger's disease has, to date, demonstrated positive trends in both safety and efficacy. 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 and 2021. 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. 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. CLBS201 for Treatment of Diabetic Kidney Disease Progressive kidney failure is associated with attrition of the microcirculation of the kidney. 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. 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's broad intellectual property portfolio of cell therapy assets includes notable programs available for out-licensing in order to continue their clinical development. The Company's current long-term strategy focuses on advancing its therapies through development with the ultimate objective of obtaining market authorizations and entering commercialization, either alone or with partners, to provide treatment options to patients suffering from life-threatening medical conditions. 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. Coronavirus Considerations In December 2019, a novel strain of coronavirus (SARS-CoV-2), which causes COVID-19, was reported to have surfaced in China. In March 2020, the World Health Organization declared the outbreak of COVID-19 to be a pandemic, and the world's economies began to experience pronounced effects. Despite the FDA approval of multiple COVID-19 vaccines in late 2020, there remains uncertainty around the extent and duration of disruption and any future related financial impact cannot reasonably be estimated at this time. 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. has also experienced delays in enrolling patients as a result of COVID-19. Basis of Presentation The accompanying unaudited Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the SEC for interim financial information. 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. 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. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements. Estimates also affect the reported amounts of expenses during the reporting period. The Company bases its estimates on historical experience and other assumptions believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. The Company makes critical estimates and assumptions in determining stock-based awards values. Accordingly, actual results could differ from those estimates and assumptions. Principles of Consolidation The Consolidated Financial Statements include the accounts of Caladrius Biosciences, Inc. and its wholly owned and majority owned subsidiaries and affiliates. All intercompany activities have been eliminated in consolidation. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies 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. Concentration of Risks The Company is subject to credit risk from its portfolio of cash, cash equivalents and marketable securities. Under its investment policy, the Company limits amounts invested in such securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. Cash is held at major banks in the United States. Therefore, the Company is not exposed to any significant concentrations of credit risk from these financial instruments. The goals of the Company's investment policy, in order of priority, are as follows: safety and preservation of principal and diversification of risk, liquidity of investments sufficient to meet cash flow requirements, and a competitive after-tax rate of return. Share-Based Compensation |
Available-for-Sale-Securities
Available-for-Sale-Securities | 3 Months Ended |
Mar. 31, 2022 | |
Debt Securities, Available-for-sale [Abstract] | |
Available-for-Sale-Securities | 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 Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Corporate debt securities $ 62,770 $ — $ (162) $ 62,608 $ 53,135 $ — $ (65) $ 53,070 Money market funds 6,578 — — 6,578 18,124 — — 18,124 Municipal debt securities 17,267 — (34) 17,233 20,263 — (5) 20,258 Total $ 86,615 $ — $ (196) $ 86,419 $ 91,522 $ — $ (70) $ 91,452 Estimated fair values of available-for-sale securities are generally based on prices obtained from commercial pricing services. 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 Cash equivalents $ 10,647 $ 21,129 Marketable securities 75,772 70,323 Total $ 86,419 $ 91,452 The following table summarizes our portfolio of available-for-sale securities by contractual maturity (in thousands): March 31, 2022 Amortized Cost Estimated Fair Value Less than one year $ 86,615 $ 86,419 Greater than one year — Total $ 86,615 $ 86,419 |
Income (Loss) Per Share
Income (Loss) Per Share | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
Income (Loss) Per Share | 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): March 31, 2022 2021 Stock Options 2,640 1,022 Warrants 21,357 21,357 Restricted Stock Units 1,460 798 |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The fair value of financial assets and liabilities that are being measured and reported are defined as the exchange price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants in the principal market at the measurement date (exit price). The Company is required to classify fair value measurements in one of the following categories: Level 1 inputs are defined as quoted prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 2 inputs are defined as inputs other than quoted prices included within Level 1 that are observable for the assets or liabilities, either directly or indirectly. Level 3 inputs are defined as unobservable inputs for the assets or liabilities. Financial assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurement. 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 Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total Assets: Marketable securities - available for sale $ — $ 75,772 $ — $ 75,772 $ — $ 70,323 $ — $ 70,323 $ — $ 75,772 $ — $ 75,772 $ — $ 70,323 $ — $ 70,323 |
Accrued Liabilities
Accrued Liabilities | 3 Months Ended |
Mar. 31, 2022 | |
Accrued Liabilities [Abstract] | |
Accrued Liabilities | Accrued Liabilities Accrued liabilities as of March 31, 2022 and December 31, 2021 were as follows (in thousands): March 31, 2022 December 31, 2021 Salaries, employee benefits and related taxes $ 1,005 $ 2,034 Operating lease liabilities — current 205 229 Other 894 326 Total $ 2,104 $ 2,589 |
Operating Leases
Operating Leases | 3 Months Ended |
Mar. 31, 2022 | |
Leases [Abstract] | |
Operating Leases | Operating LeasesThe Company has operating leases for two offices with terms that expire in 2023 and 2025, respectively. The Company estimates its incremental borrowing rate at lease commencement to determine the present value of lease payments as most of the Company's leases do not provide an implicit rate of return. The Company recognizes lease expense on a straight-line basis over the lease term. For lease agreements entered into or reassessed after the adoption of Topic 842, the Company elected to account for non-lease components associated with its leases and lease components as a single lease component. Each of the Company's leases includes options for the Company to extend the lease term and/or sub-lease space in whole or in part. 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 Right-of Use Assets: Other assets $ 667 $ 724 Total Right-of-Use Asset $ 667 $ 724 Operating Lease Liabilities: Accrued liabilities $ 205 $ 229 Other long-term liabilities 421 485 Total Operating Lease Liabilities $ 626 $ 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): Years ended Operating Leases 2022 181 2023 217 2024 190 2025 143 Total lease payments 731 Less: Amounts representing interest (105) Present value of lease liabilities $ 626 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders' Equity Equity Issuances Purchase Agreement In March 2019, the Company and Lincoln Park Capital Fund, LLC (“Lincoln Park”) entered into a purchase agreement (the “Purchase Agreement”) and a registration rights agreement (the “Registration Rights Agreement”), pursuant to which the Company has the right to sell to Lincoln Park shares of the Company’s common stock having an aggregate value of up to $26.0 million, subject to certain limitations and conditions set forth in the Purchase Agreement (the “Offering”). As consideration for entering into the Purchase Agreement, the Company issued to Lincoln Park an additional 181,510 shares of common stock as commitment shares. Pursuant to the Purchase Agreement, Lincoln Park purchased 250,000 shares of common stock, at a price of $4.00 per share, for a total gross purchase price of $1.0 million (the “Initial Purchase”) upon commencement. Thereafter, as often as every business day from and after one business day following the date of the Initial Purchase and over the 36-month term of the Purchase Agreement the Company has the right, from time to time, at its sole discretion and subject to certain conditions, to direct Lincoln Park to purchase up to 100,000 shares of common stock, with such amount increasing as the closing sale price of the common stock increases; provided Lincoln Park’s obligation under any single such purchase will not exceed $2.5 million, unless the Company and Lincoln Park mutually agree to increase the maximum amount of such single purchase (each, a “Regular Purchase”). If the Company directs Lincoln Park to purchase the maximum number of shares of common stock it then may sell in a Regular Purchase, then in addition to such Regular Purchase, and subject to certain conditions and limitations in the Purchase Agreement, the Company may direct Lincoln Park in an “accelerated purchase” to purchase an additional amount of common stock that may not exceed the lesser of (i) 300% the number of shares purchased pursuant to the corresponding Regular Purchase or (ii) 30% of the total number of shares of the Company’s common stock traded during a specified period on the applicable purchase date as set forth in the Purchase Agreement. Under certain circumstances and in accordance with the Purchase Agreement, the Company may direct Lincoln Park to purchase shares in multiple accelerated purchases on the same trading day. The Company controls the timing and amount of any sales of its common stock to Lincoln Park. There is no upper limit on the price per share that Lincoln Park must pay for its common stock under the Purchase Agreement, but in no event will shares be sold to Lincoln Park on a day the closing price is less than the floor price specified in the Purchase Agreement. In all instances, the Company may not sell shares of its common stock to Lincoln Park under the purchase agreement if it would result in Lincoln Park beneficially owning more than 9.99% of its common stock. The Purchase Agreement does not limit the Company’s ability to raise capital from other sources at the Company’s sole discretion, except that (subject to certain exceptions) the Company may not enter into any Variable Rate Transaction (as defined in the Purchase Agreement, including the issuance of any floating conversion rate or variable priced equity-like securities) during the 36 months after the date of the Purchase Agreement. 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. The agreement expired on April 1, 2022. At The Market Offering Agreement 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 not 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. Compliance may be reestablished by various mechanisms, including stock price appreciation at or above $1.00 for a requisite period of time and reverse stock split. Stock Options and Warrants The following table summarizes the activity for stock options and warrants for the three months ended March 31, 2022: Stock Options Warrants Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (In Thousands) Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (In Thousands) Outstanding at December 31, 2021 2,131,849 $ 5.64 7.97 $ — 21,356,600 $ 2.84 4.37 $ — Changes during the period: Granted 540,600 0.91 — — Exercised — — — — Forfeited (9,565) 1.90 — — Expired (23,275) 26.00 — — Outstanding at March 31, 2022 2,639,609 $ 4.51 7.83 $ — 21,356,600 $ 2.84 4.13 $ — Vested at March 31, 2022 2,594,630 $ 4.57 7.80 $ — 21,356,600 $ 2.84 4.13 $ — Vested at March 31, 2022 1,408,083 $ 7.36 6.41 $ — 21,356,600 $ 2.84 4.13 $ — 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, 2022 2021 Number of restricted stock issued 1,061,175 300,450 Value of restricted stock issued $ 973 $ 478 The vesting terms of restricted stock issuances are generally between one 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, 2022 2021 Number of restricted stock units issued 1,379,860 458,245 Value of restricted stock units issued $ 1,265 $ 729 |
Share-Based Compensation
Share-Based Compensation | 3 Months Ended |
Mar. 31, 2022 | |
Share-based Payment Arrangement, Noncash Expense [Abstract] | |
Share-Based Compensation | Share-Based Compensation Share-Based Compensation 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, 2022 2021 Research and development $ 218 $ 96 General and administrative 542 501 Total share-based compensation expense $ 760 $ 597 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): Stock Options Restricted Stock Units Restricted Stock Unrecognized compensation cost $ 814 $ 444 $ 1,004 Expected weighted-average period in years of compensation cost to be recognized 1.77 0.96 2.25 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): Stock Options Three Months Ended March 31, 2022 2021 Total fair value of shares vested $ 377 $ 397 Weighted average estimated fair value of shares granted $ 0.62 $ 1.08 Valuation Assumptions The fair value of stock options and warrants at the date of grant was estimated using the Black-Scholes option pricing model. The expected volatility is based upon historical volatility of the Company’s stock. The expected term for the options is based upon observation of actual time elapsed between date of grant and exercise of options for all employees. The expected term for the warrants is based upon the contractual term of the warrants. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes In assessing the realizability of deferred tax assets, including the net operating loss carryforwards ("NOLs"), the Company assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to utilize its existing deferred tax assets. Based on its assessment, the Company has provided a full valuation allowance against its net deferred tax assets as their future utilization remains uncertain at this time. As of December 31, 2021 and 2020, the Company had approximately $281 million and $264 million, respectively of federal NOLs available to offset future taxable income expiring from 2030 through 2036. The Company performed an analysis and determined that they had an ownership change of greater than 50% over a 3-year testing period on January 25, 2021. As a result, $169 million of the $281 million of federal NOLs will expire unutilized. The Company wrote off that portion of the deferred tax asset and reduced the corresponding valuation allowance resulting in $112 million of remaining federal NOL. The write off of the deferred tax asset and the corresponding reduction in valuation allowance has no impact to the balance sheet or income statement. Losses incurred before the ownership change on January 25, 2021 will be subject to an annual limitation of $173k under Internal Revenue Code Section 382, while losses incurred after January 25, 2021 will not be subject to limitations. The Company may be able to utilize additional NOLs of approximately $1.1 million per year for the first five years after this ownership change as a result of the application of the Net Unrealized Built-in Gain rules. As of December 31, 2021 and 2020 the Company had State NOLs available in New Jersey of $97 million and $99 million, respectively, California of $70 million and $70 million, respectively, and New York City of $13 million and $13 million, respectively, to offset future taxable income expiring from 2031 through 2041. In accordance with Section 382 of the Internal Revenue code, the usage of the Company’s NOLs would be limited given the change in ownership. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the period when those temporary differences become deductible. The Company applies the FASB’s provisions for uncertain tax positions. The Company utilizes the two-step process to determine the amount of recognized tax benefit. For tax positions meeting the more-likely-than-not threshold, the amount recognized in the consolidated financial statements is the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement with the relevant tax authority. 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. 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. The Company does not believe there will be any material changes in its unrecognized tax positions over the next year. For years prior to 2018, the federal statute of limitations is closed for assessing tax. The Company’s state tax returns remain open to examination for a period of three to four years from date of filing. In December 2021, the Company received preliminary approval from the New Jersey Economic Development Authority (“NJEDA”) to participate in the Technology Business Tax Certificate Transfer Program (the “Program”). The Program permits qualified companies to sell a percentage of their New Jersey net operating losses (“NJ NOLs”) to unrelated profitable corporations. On February 22, 2022, the Company received final approval from NJEDA to sell $2.5 million of its NJ NOLs related tax benefits ("NJ NOL Tax Benefits"), which was subsequently sold to a qualifying and approved buyer pursuant to the Program for net proceeds of $2.3 million. The gross proceeds of $2.5 million have been recorded as a benefit from income taxes and the loss on sale of NJ NOLs of $0.1 million recorded in other income (expense) in the consolidated financial statements. |
Contingencies
Contingencies | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Contingencies | Contingencies Contingencies From time to time, the Company is subject to legal proceedings and claims, either asserted or unasserted, that arise in the ordinary course of business. 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. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | 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. 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 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 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. 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. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the SEC for interim financial information. 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. 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. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements. Estimates also affect the reported amounts of expenses during the reporting period. The Company bases its estimates on historical experience and other assumptions believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. The Company makes critical estimates and assumptions in determining stock-based awards values. Accordingly, actual results could differ from those estimates and assumptions. |
Principles of Consolidation | Principles of ConsolidationThe Consolidated Financial Statements include the accounts of Caladrius Biosciences, Inc. and its wholly owned and majority owned subsidiaries and affiliates. All intercompany activities have been eliminated in consolidation |
Concentration of Risks | Concentration of Risks The Company is subject to credit risk from its portfolio of cash, cash equivalents and marketable securities. Under its investment policy, the Company limits amounts invested in such securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. Cash is held at major banks in the United States. Therefore, the Company is not exposed to any significant concentrations of credit risk from these financial instruments. The goals of the Company's investment policy, in order of priority, are as follows: safety and preservation of principal and diversification of risk, liquidity of investments sufficient to meet cash flow requirements, and a competitive after-tax rate of return. |
Share-Based Compensation | Share-Based Compensation |
Available-for-Sale-Securities (
Available-for-Sale-Securities (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Debt Securities, Available-for-sale [Abstract] | |
Schedule of Available-for-sale Securities Reconciliation | 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 Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Corporate debt securities $ 62,770 $ — $ (162) $ 62,608 $ 53,135 $ — $ (65) $ 53,070 Money market funds 6,578 — — 6,578 18,124 — — 18,124 Municipal debt securities 17,267 — (34) 17,233 20,263 — (5) 20,258 Total $ 86,615 $ — $ (196) $ 86,419 $ 91,522 $ — $ (70) $ 91,452 |
Schedule of Marketable Securities | Estimated fair values of available-for-sale securities are generally based on prices obtained from commercial pricing services. 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 Cash equivalents $ 10,647 $ 21,129 Marketable securities 75,772 70,323 Total $ 86,419 $ 91,452 |
Investments Classified by Contractual Maturity Date | The following table summarizes our portfolio of available-for-sale securities by contractual maturity (in thousands): March 31, 2022 Amortized Cost Estimated Fair Value Less than one year $ 86,615 $ 86,419 Greater than one year — Total $ 86,615 $ 86,419 |
Income (Loss) Per Share (Tables
Income (Loss) Per Share (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | At March 31, 2022 and 2021, the Company excluded the following potentially dilutive securities (in thousands): March 31, 2022 2021 Stock Options 2,640 1,022 Warrants 21,357 21,357 Restricted Stock Units 1,460 798 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets Measured at Fair Value on Recurring Basis | 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 Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total Assets: Marketable securities - available for sale $ — $ 75,772 $ — $ 75,772 $ — $ 70,323 $ — $ 70,323 $ — $ 75,772 $ — $ 75,772 $ — $ 70,323 $ — $ 70,323 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Accrued Liabilities [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities as of March 31, 2022 and December 31, 2021 were as follows (in thousands): March 31, 2022 December 31, 2021 Salaries, employee benefits and related taxes $ 1,005 $ 2,034 Operating lease liabilities — current 205 229 Other 894 326 Total $ 2,104 $ 2,589 |
Operating Leases (Tables)
Operating Leases (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Leases [Abstract] | |
Schedule of Operating Lease Liabilities and Right-of-Use Assets on Balance Sheet | 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 Right-of Use Assets: Other assets $ 667 $ 724 Total Right-of-Use Asset $ 667 $ 724 Operating Lease Liabilities: Accrued liabilities $ 205 $ 229 Other long-term liabilities 421 485 Total Operating Lease Liabilities $ 626 $ 714 |
Schedule of Future Minimum Lease Payments Under Lease Agreements | Future minimum lease payments under the lease agreements as of March 31, 2022 were as follows (in thousands): Years ended Operating Leases 2022 181 2023 217 2024 190 2025 143 Total lease payments 731 Less: Amounts representing interest (105) Present value of lease liabilities $ 626 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
Schedule of Stock Option and Warrants Activity | The following table summarizes the activity for stock options and warrants for the three months ended March 31, 2022: Stock Options Warrants Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (In Thousands) Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (In Thousands) Outstanding at December 31, 2021 2,131,849 $ 5.64 7.97 $ — 21,356,600 $ 2.84 4.37 $ — Changes during the period: Granted 540,600 0.91 — — Exercised — — — — Forfeited (9,565) 1.90 — — Expired (23,275) 26.00 — — Outstanding at March 31, 2022 2,639,609 $ 4.51 7.83 $ — 21,356,600 $ 2.84 4.13 $ — Vested at March 31, 2022 2,594,630 $ 4.57 7.80 $ — 21,356,600 $ 2.84 4.13 $ — Vested at March 31, 2022 1,408,083 $ 7.36 6.41 $ — 21,356,600 $ 2.84 4.13 $ — |
Schedule of Restricted Stock Activity | 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, 2022 2021 Number of restricted stock issued 1,061,175 300,450 Value of restricted stock issued $ 973 $ 478 |
Schedule of Restricted Stock Units Activity | 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, 2022 2021 Number of restricted stock units issued 1,379,860 458,245 Value of restricted stock units issued $ 1,265 $ 729 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Share-based Payment Arrangement, Noncash Expense [Abstract] | |
Schedule Share-based Compensation Expense | 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, 2022 2021 Research and development $ 218 $ 96 General and administrative 542 501 Total share-based compensation expense $ 760 $ 597 |
Schedule of Total Compensation Cost Related to Nonvested Awards | 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): Stock Options Restricted Stock Units Restricted Stock Unrecognized compensation cost $ 814 $ 444 $ 1,004 Expected weighted-average period in years of compensation cost to be recognized 1.77 0.96 2.25 |
Schedule of Fair Value of Share-based Compensation Awards | 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): Stock Options Three Months Ended March 31, 2022 2021 Total fair value of shares vested $ 377 $ 397 Weighted average estimated fair value of shares granted $ 0.62 $ 1.08 |
The Business (Details)
The Business (Details) - USD ($) $ in Thousands | Apr. 26, 2022 | Dec. 31, 2017 |
Subsequent event | Merger Agreement | Cend | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Expected post-merger ownership in Company by Cend stockholders (percent) | 50.00% | |
Expected post-merger ownership in Company by Company stockholders (percent) | 50.00% | |
Transaction expenses threshold for allocation | $ 250 | |
CLBS16 Treatment of CMD | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Grants awarded | $ 1,900 |
Available-for-Sale-Securities -
Available-for-Sale-Securities - Schedule of Available-for-Sale Securities Reconciliation (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-sale [Line Items] | ||
Cost | $ 86,615 | $ 91,522 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (196) | (70) |
Estimated Fair Value | 86,419 | 91,452 |
Corporate debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 62,770 | 53,135 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (162) | (65) |
Estimated Fair Value | 62,608 | 53,070 |
Money market funds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 6,578 | 18,124 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | 6,578 | 18,124 |
Municipal debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 17,267 | 20,263 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (34) | (5) |
Estimated Fair Value | $ 17,233 | $ 20,258 |
Available-for-Sale-Securities_2
Available-for-Sale-Securities - Classification of Available-for-Sale Securities (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-sale [Abstract] | ||
Cash equivalents | $ 10,647 | $ 21,129 |
Marketable securities | 75,772 | 70,323 |
Total | $ 86,419 | $ 91,452 |
Available-for-Sale-Securities_3
Available-for-Sale-Securities - Available-for-Sale Securities by Contractual Maturity (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Amortized Cost | ||
Less than one year | $ 86,615 | |
Greater than one year | ||
Cost | 86,615 | $ 91,522 |
Estimated Fair Value | ||
Less than one year | 86,419 | |
Greater than one year | 0 | |
Total estimated fair value | $ 86,419 | $ 91,452 |
Income (Loss) Per Share (Detail
Income (Loss) Per Share (Details) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Stock Options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 2,640 | 1,022 |
Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 21,357 | 21,357 |
Restricted Stock Units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 1,460 | 798 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities - available for sale | $ 75,772 | $ 70,323 |
Assets, fair value disclosure | 75,772 | 70,323 |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities - available for sale | 0 | 0 |
Assets, fair value disclosure | 0 | 0 |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities - available for sale | 75,772 | 70,323 |
Assets, fair value disclosure | 75,772 | 70,323 |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities - available for sale | 0 | 0 |
Assets, fair value disclosure | $ 0 | $ 0 |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Accrued Liabilities [Abstract] | ||
Salaries, employee benefits and related taxes | $ 1,005 | $ 2,034 |
Operating lease liabilities — current | 205 | 229 |
Other | 894 | 326 |
Total accrued liabilities | $ 2,104 | $ 2,589 |
Operating Leases - Narrative (D
Operating Leases - Narrative (Details) | Mar. 31, 2022office |
Leases [Abstract] | |
Number of offices under operating leases | 2 |
Weighted average remaining lease term for operating leases (in years) | 2 years 3 months 18 days |
Weighted average discount rate for operating leases (percent) | 9.625% |
Operating Leases - Balance Shee
Operating Leases - Balance Sheet Presentation (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Right-of Use Assets: | ||
Right-of-use assets | $ 667 | $ 724 |
Right-of-use assets, balance sheet line item | Other assets | Other assets |
Operating Lease Liabilities: | ||
Operating lease liabilities, current | $ 205 | $ 229 |
Operating lease liabilities, noncurrent | 421 | 485 |
Operating lease liabilities | $ 626 | $ 714 |
Operating lease liabilities, current, balance sheet line item | Accrued liabilities | Accrued liabilities |
Operating lease liabilities, noncurrent, balance sheet line item | Other long-term liabilities | Other long-term liabilities |
Operating Leases - Future Minim
Operating Leases - Future Minimum Lease Payments (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Finance Minimum Lease Payments | ||
2022 | $ 181 | |
2023 | 217 | |
2024 | 190 | |
2025 | 143 | |
Total lease payments | 731 | |
Less: Amounts representing interest | (105) | |
Present value of lease liabilities | $ 626 | $ 714 |
Stockholders' Equity - Equity I
Stockholders' Equity - Equity Issuances (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2022 | Jun. 04, 2021 | |
Lincoln Park Agreement | |||
Class of Stock [Line Items] | |||
Aggregate offering amount authorized per agreement | $ 26 | ||
Commitment shares issued as consideration per agreement (in shares) | 181,510 | ||
Number of shares sold (in shares) | 250,000 | ||
Price of shares sold (in dollars per share) | $ 4 | ||
Gross price for stock transaction | $ 1 | ||
Term of agreement (in months) | 36 months | ||
Number of shares allowable to direct for Regular Purchase (in shares) | 100,000 | ||
Maximum obligation per directed purchase transaction for Regular Purchase | $ 2.5 | ||
Maximum shares allowed in Accelerated Purchase as percent of shares In Regular Purchase (percent) | 300.00% | ||
Maximum shares allowed in Accelerated Purchase as percent of shares traded during specified period (percent) | 30.00% | ||
Maximum beneficial ownership allowable per agreement (percent) | 9.99% | ||
ATM Agreement | |||
Class of Stock [Line Items] | |||
Aggregate offering amount authorized per agreement | $ 50 | ||
Stock issued (shares) | 0 |
Stockholders' Equity - Stock Op
Stockholders' Equity - Stock Options and Warrants (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Stock Options, Shares | ||
Options, Outstanding, Beginning of Period (in shares) | 2,131,849 | |
Options, Granted (in shares) | 540,600 | |
Options, Exercised (in shares) | 0 | |
Options, Forfeited (in shares) | (9,565) | |
Options, Expired (in shares) | (23,275) | |
Options, Outstanding, End of Period (in shares) | 2,639,609 | 2,131,849 |
Options, Vested and expected to vest (in shares) | 2,594,630 | |
Options, Vested (in shares) | 1,408,083 | |
Stock Options, Weighted Average Exercise Price | ||
Options, Outstanding. Beginning of Period (in dollars per share) | $ 5.64 | |
Options, Granted (in dollars per share) | 0.91 | |
Options, Exercised (in dollars per share) | 0 | |
Options, Forfeited (in dollars per share) | 1.90 | |
Options, Expired (in dollars per share) | 26 | |
Options, Outstanding, End of Period (in dollars per share) | 4.51 | $ 5.64 |
Options, Vested and expected to vest (in dollars per share) | 4.57 | |
Options, Vested (in dollars per share) | $ 7.36 | |
Stock Options, Weighted Average Contractual Term and Intrinsic Value | ||
Options, Outstanding, Weighted Average Remaining Contractual Term | 7 years 9 months 29 days | 7 years 11 months 19 days |
Options, Vested and expected to vest, Weighted Average Remaining Contractual Term | 7 years 9 months 18 days | |
Options, Vested, Weighted Average Remaining Contractual Term | 6 years 4 months 28 days | |
Options, Outstanding, Aggregate Intrinsic Value | $ 0 | $ 0 |
Options, Vested and expected to vest, Aggregate Intrinsic Value | 0 | |
Options, Vested, Aggregate Intrinsic Value | $ 0 | |
Warrants, Shares | ||
Warrants, Outstanding, Beginning of Period (in shares) | 21,356,600 | |
Warrants, Granted (in shares) | 0 | |
Warrants, Exercised (in shares) | 0 | |
Warrants, Forfeited (in shares) | 0 | |
Warrants, Expired (in shares) | 0 | |
Warrants, Outstanding, End of Period (in shares) | 21,356,600 | 21,356,600 |
Warrants, Vested and expected to vest (in shares) | 21,356,600 | |
Warrants, Vested (in shares) | 21,356,600 | |
Warrants, Weighted Average Exercise Price | ||
Warrants Outstanding, Beginning of Period (in dollars per share) | $ 2.84 | |
Warrants, Granted (in dollars per share) | 0 | |
Warrants, Exercised (in dollars per share) | 0 | |
Warrants, Forfeited (in dollars per share) | 0 | |
Warrants, Expired (in dollars per share) | 0 | |
Warrants Outstanding, End of Period (in dollars per share) | 2.84 | $ 2.84 |
Weighted Average Exercise Price, Warrants Vested And Expected To Vest | 2.84 | |
Warrants, Vested, Weighted Average Exercise Price (in dollars per share) | $ 2.84 | |
Warrants, Weighted Average Contractual Term and Intrinsic Value | ||
Warrants, Outstanding, Weighted Average Remaining Contractual Term | 4 years 1 month 17 days | 4 years 4 months 13 days |
Warrants, Vested and expected to vest, Weighted Average Remaining Contractual Term | 4 years 1 month 17 days | |
Warrants, Vested, Weighted Average Remaining Contractual Term | 4 years 1 month 17 days | |
Warrants Outstanding, Aggregate Intrinsic Value | $ 0 | $ 0 |
Warrants, Vested and expected to vest, Aggregate Intrinsic Value | 0 | |
Warrants, Vested, Aggregate Intrinsic Value | $ 0 |
Stockholders' Equity - Restrict
Stockholders' Equity - Restricted Stock and Restricted Stock Units (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Restricted Stock | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares issued | 1,061,175 | 300,450 |
Value of shares issued | $ 973 | $ 478 |
Weighted average estimated fair value | $ 0.92 | $ 1.59 |
Restricted Stock | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting terms (years) | 1 year | |
Restricted Stock | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting terms (years) | 4 years | |
Restricted Stock Units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares issued | 1,379,860 | 458,245 |
Value of shares issued | $ 1,265 | $ 729 |
Vesting terms (years) | 1 year |
Share-Based Compensation - Shar
Share-Based Compensation - Share-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation expense | $ 760 | $ 597 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation expense | 218 | 96 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation expense | $ 542 | $ 501 |
Share-Based Compensation - Comp
Share-Based Compensation - Compensation Cost Not Yet Recognized (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2022USD ($) | |
Stock Options | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation cost | $ 814 |
Expected weighted-average period in years of compensation cost to be recognized | 1 year 9 months 7 days |
Restricted Stock Units | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation cost | $ 444 |
Expected weighted-average period in years of compensation cost to be recognized | 11 months 15 days |
Restricted Stock | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation cost | $ 1,004 |
Expected weighted-average period in years of compensation cost to be recognized | 2 years 3 months |
Share-Based Compensation - Fair
Share-Based Compensation - Fair Value of Shares Vested and Weighted Average Estimated Fair Value of Shares Granted (Details) - Stock Options - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total fair value of shares vested | $ 377 | $ 397 |
Weighted average estimated fair value of shares granted | $ 0.62 | $ 1.08 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | Feb. 22, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Operating Loss Carryforwards [Line Items] | |||
Possible additional NOLs for five years resulting from Net Unrealized Built-in Gain rules | $ 1,100 | ||
Proceeds from sale of NOLs, gross | $ 2,500 | ||
Net proceeds from sale of NOLs | 2,300 | ||
Loss on sale of NOLs | $ 100 | ||
Federal | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards, prior to write down | 281,000 | ||
Net operating loss carryforwards | 112,000 | $ 264,000 | |
Write down of NOLs set to expire unutilized | 169,000 | ||
State | New Jersey | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | 97,000 | 99,000 | |
State | California | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | 70,000 | 70,000 | |
State | New York | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | $ 13,000 | $ 13,000 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ / shares in Units, $ in Thousands | Apr. 26, 2022 | Mar. 31, 2022 | Dec. 31, 2021 |
Subsequent Event [Line Items] | |||
Preferred stock, par value (in usd per share) | $ 0.01 | $ 0.01 | |
Subsequent event | Merger Agreement | Cend | |||
Subsequent Event [Line Items] | |||
Expected post-merger ownership in Company by Cend stockholders (percent) | 50.00% | ||
Expected post-merger ownership in Company by Company stockholders (percent) | 50.00% | ||
Transaction expenses threshold for allocation | $ 250 | ||
Minimum net cash threshold at closing per agreement | 64,900 | ||
Potential termination fee payable | 1,000 | ||
Potential termination fee receivable | 4,000 | ||
Potential expense reimbursement per agreement | $ 1,000 | ||
Subsequent event | Cend Purchase Agreement | |||
Subsequent Event [Line Items] | |||
Series D original issue price (in usd per share) | $ 8.8057 | ||
Aggregate price | $ 10,000 | ||
Pre-Equity Offering Value After Conversion | $ 250,000 | ||
Subsequent event | Cend Purchase Agreement | Cend Series D preferred stock | |||
Subsequent Event [Line Items] | |||
Number of shares purchased | 1,135,628 | ||
Preferred stock, par value (in usd per share) | $ 0.00001 | ||
Subsequent event | Cend Purchase Agreement | Cend | |||
Subsequent Event [Line Items] | |||
Potential gross proceeds | $ 50,000 |