Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2021 | May 06, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2021 | |
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 $0.001 per share | |
Trading Symbol | CLBS | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Central Index Key | 0000320017 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false | |
Entity Common Stock, Shares Outstanding | 59,498,958 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
ASSETS | ||
Cash and cash equivalents | $ 28,744 | $ 16,512 |
Marketable securities | 82,767 | 18,061 |
Prepaid and other current assets | 2,522 | 758 |
Total current assets | 114,033 | 35,331 |
Property and equipment, net | 41 | 57 |
Other assets | 533 | 614 |
Total assets | 114,607 | 36,002 |
Liabilities | ||
Accounts payable | 2,315 | 1,020 |
Accrued liabilities | 2,123 | 2,486 |
Total current liabilities | 4,438 | 3,506 |
Other long-term liabilities | 155 | 254 |
Total liabilities | 4,593 | 3,760 |
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, 2021 and December 31, 2020, respectively | 0 | 0 |
Common stock, $0.001 par value, authorized 500,000,000 shares; issued 59,510,038 and 19,389,413 shares at March 31, 2021 and December 31, 2020, respectively; and outstanding, 59,498,958 and 19,378,333 shares at March 31, 2021 and December 31, 2020, respectively | 60 | 19 |
Additional paid-in capital | 544,601 | 458,748 |
Treasury stock, at cost; 11,080 shares at March 31, 2021 and December 31, 2020 | (708) | (708) |
Accumulated deficit | (433,613) | (425,550) |
Accumulated other comprehensive loss | (72) | (13) |
Total Caladrius Biosciences, Inc. stockholders' equity | 110,268 | 32,496 |
Noncontrolling interests | (254) | (254) |
Total stockholders' equity | 110,014 | 32,242 |
Liabilities and Equity, Total | $ 114,607 | $ 36,002 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Mar. 31, 2021 | Dec. 31, 2020 |
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 | 59,510,038 | 19,389,413 |
Common stock, shares, outstanding | 59,498,958 | 19,378,333 |
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, 2021 | Mar. 31, 2020 | |
Operating Expenses: | ||
Research and development | $ 5,076 | $ 1,499 |
General and administrative | 3,010 | 2,558 |
Total operating expenses | 8,086 | 4,057 |
Operating loss | (8,086) | (4,057) |
Other income: | ||
Investment income, net | 23 | 71 |
Total other income | 23 | 71 |
Net loss | (8,063) | (3,986) |
Less - net income attributable to noncontrolling interests | 0 | 4 |
Net loss attributable to Caladrius Biosciences, Inc. common stockholders | $ (8,063) | $ (3,990) |
Basic and diluted loss per share | ||
Caladrius Biosciences, Inc. common stockholders - basic (in usd per share) | $ (0.19) | $ (0.38) |
Caladrius Biosciences, Inc. common stockholders - diluted (in usd per share) | $ (0.19) | $ (0.38) |
Weighted average common shares outstanding | ||
Basic shares | 42,117 | 10,623 |
Diluted shares | 42,117 | 10,623 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (8,063) | $ (3,986) |
Available for sale securities - net unrealized loss | (59) | (2) |
Total other comprehensive loss | (59) | (2) |
Comprehensive loss | (8,122) | (3,988) |
Comprehensive income attributable to noncontrolling interests | 0 | 4 |
Comprehensive loss attributable to Caladrius Biosciences, Inc. common stockholders | $ (8,122) | $ (3,992) |
Consolidated Statements of Equi
Consolidated Statements of Equity - USD ($) shares in Thousands, $ in Thousands | Total | Total Caladrius Biosciences, Inc. Stockholders' Equity | Series B Convertible Preferred Stock | Common Stock | Additional Paid in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Treasury Stock | Non- Controlling Interest in Subsidiary |
Beginning Balance (shares) at Dec. 31, 2019 | 10 | 10,529 | |||||||
Beginning Balance at Dec. 31, 2019 | $ 20,553 | $ 20,816 | $ 0 | $ 11 | $ 438,911 | $ 2 | $ (417,400) | $ (708) | $ (263) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Net loss | (3,986) | (3,990) | (3,990) | 4 | |||||
Unrealized loss on marketable securities | (2) | (2) | (2) | ||||||
Share-based compensation (in shares) | 110 | ||||||||
Share-based compensation | 419 | 419 | 419 | ||||||
Ending Balance (shares) at Mar. 31, 2020 | 10 | 10,639 | |||||||
Ending Balance at Mar. 31, 2020 | 16,984 | 17,243 | $ 0 | $ 11 | 439,330 | 0 | (421,390) | (708) | (259) |
Beginning Balance (shares) at Dec. 31, 2020 | 10 | 19,389 | |||||||
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 | ||||||||
Share-based compensation | 413 | 413 | 413 | ||||||
Net proceeds from issuance of common stock and warrants (in shares) | 39,841 | ||||||||
Net proceeds from issuance of common stock and warrants | 85,457 | 85,457 | $ 41 | 85,416 | |||||
Proceeds from option exercises (in shares) | 7 | ||||||||
Proceeds from option exercises | 24 | 24 | 24 | ||||||
Ending Balance (shares) at Mar. 31, 2021 | 10 | 59,510 | |||||||
Ending Balance at Mar. 31, 2021 | $ 110,014 | $ 110,268 | $ 0 | $ 60 | $ 544,601 | $ (72) | $ (433,613) | $ (708) | $ (254) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (8,063,000) | $ (3,986,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation | 597,000 | 567,000 |
Depreciation and amortization | 16,000 | 15,000 |
Accretion on marketable securities | 323,000 | 19,000 |
Changes in operating assets and liabilities: | ||
Prepaid and other current assets | (1,763,000) | 354,000 |
Other assets | 81,000 | 233,000 |
Accounts payable, accrued liabilities and other liabilities | 834,000 | (1,443,000) |
Net cash used in operating activities | (7,975,000) | (4,241,000) |
Cash flows from investing activities: | ||
Purchase of marketable securities | (75,911,000) | 0 |
Sale of marketable securities | 10,821,000 | 11,104,000 |
Purchases of property and equipment | 0 | (2,000) |
Net cash (used in) provided by investing activities | (65,090,000) | 11,102,000 |
Cash flows from financing activities: | ||
Proceeds from exercise of options | 24,000 | 0 |
Tax withholding payments on net share settlement equity awards | (184,000) | (148,000) |
Net proceeds from issuance of common stock | 85,457,000 | 0 |
Net cash provided by (used in) financing activities | 85,297,000 | (148,000) |
Net increase in cash and cash equivalents | 12,232,000 | 6,713,000 |
Cash and cash equivalents at beginning of period | 16,512,000 | 14,032,000 |
Cash and cash equivalents at end of period | $ 28,744,000 | $ 20,745,000 |
The Business
The Business | 3 Months Ended |
Mar. 31, 2021 | |
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 and commercialization of cellular therapies designed to reverse disease and/or promote the regeneration of damaged tissue. The Company is developing 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 leverages 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 development experience. 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: CLBS16, the subject of both a recently completed positive Phase 2a study and a newly initiated Phase 2b (FREEDOM) study in the U.S. for the treatment of coronary microvascular dysfunction (“CMD”); HONEDRA ® (CLBS12), recipient of SAKIGAKE designation and eligible for early conditional approval in Japan for the treatment of critical limb ischemia (“CLI”) and Buerger’s disease based on the results of an ongoing clinical trial and recipient of orphan drug designation in March 2021 from the U.S. Food and Drug Administration ("FDA") for Buerger's disease; CLBS201, designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for patients with pre-dialysis diabetic kidney disease (“DKD”) and OLOGO ™ (CLBS14), a Regenerative Medicine Advanced Therapy (“RMAT”) designated Phase 3 ready therapy for treatment of no-option refractory disabling angina (“NORDA”). Ischemic Repair (CD34 Cell Technology) The CD34+ cell was discovered as a result of the deliberate search for a stem 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 a stem 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. Through the administration of CD34+ cells, the Company 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 our CD34+ cell technology including but not limited to CLI, CMD, DKD and NORDA. HONEDRA ® for Treatment of Critical Limb Ischemia The Company's randomized and open-label, registration-eligible study of HONEDRA ® in Japan for the treatment of CLI has shown strong results to date. The initial responses observed in the subjects who have reached an endpoint in this open label study are consistent with a positive therapeutic effect and safety profile as reported by previously published clinical trials in Japan. The study's enrollment continues to be slowed by the COVID-19 pandemic's impact in Japan, however, the Company is encouraged by the patient pre-screening pipeline and continues to make progress towards study completion, the exact date of which is impossible to predict given the continuing impact of COVID-19 on clinical trials like ours in Japan. While the final outcome of the trial will depend on all data from all subjects, data, to date, are very encouraging. CLBS16 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 CLBS16 for the treatment of CMD, a disease that afflicts millions of patients with no current targeted treatment options. That study, the ESCaPE-CMD trial, was a Phase 2a proof-of-concept study that enrolled patients at the Mayo Clinic in Rochester, MN and Cedars-Sinai Medical Center in Los Angeles, CA. That data set showed a positive therapeutic effect with a statistically significant improvement in angina frequency, coronary flow reserve, Canadian Cardiovascular Society Angina Class and Seattle Questionnaire score, 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 CLBS16 as a therapy for CMD. The first patient in the study was subsequently treated in January 2021 at The Christ Hospital Health Network in Cincinnati, Ohio. This 105-patient double-blind randomized and placebo-controlled clinical trial (FREEDOM Trial) is designed to further evaluate the efficacy and safety of intracoronary delivery of autologous CD34+ cells in subjects with CMD and without obstructive coronary artery disease. To the Company's knowledge, this is the first controlled regenerative medicine trial in CMD. CLBS201 for Treatment of Diabetic Kidney Disease The Company has prepared an initial development plan for the clinical study of CLBS201, a CD34+ investigational product for administration into the renal arteries to slow the deterioration or reverse the decline of renal function in patients with diabetic kidney disease ("DKD") who, although at a pre-dialysis stage, exhibit rapidly progressive 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. A Phase 2 proof of concept, randomized, placebo-controlled study is planned for initiation in the second half of 2021. OLOGO ™ for Treatment of No Option Refractory Disabling Angina The Company acquired the rights to data and regulatory filings for a CD34+ cell therapy program for refractory angina that had been advanced to Phase 3 by a previous sponsor. Based on the clinical evidence from the completed studies that a single administration of OLOGO ™ reduces mortality, improves angina and increases exercise capacity in patients with otherwise untreatable angina, this product received Regenerative Medicine Advanced Therapy (“RMAT”) designation from the FDA. The Company continues to seek an agreement with the FDA on the design of a Phase 3 study of appropriate and practical size and scope which, in combination with previously filed Phase 1, 2 and 3 data, will be considered for the registration of OLOGO ™ . Notably, the RMAT designation affords the product a 6-month review time for a biologics license application ("BLA"), once submitted. 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. 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. 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 be reasonably estimated at this time. In response to the pandemic, the Company has implemented universal work from home 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 “State of Emergency” that was in effect for most of 2020 in response to COVID-19, and which was re-implemented on January 7, 2021 through March 21, 2021, and again on April 25, 2021 through May 11, 2021 covering Tokyo and other regions. This most recent reinstatement of the “State of Emergency” continues negatively to impact enrollment of the on-going clinical trial. 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, 2021, 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, 2020 and 2019 included in our 2020 Form 10-K. Operating results for the three months ended March 31, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021. 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 amount 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, 2021 | |
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 2020 Form 10-K. There were no changes to these policies during the three months ended March 31, 2021. 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 The Company expenses all share-based payment awards to employees, directors, and consultants, including grants of stock options, warrants, and restricted stock, over the requisite service period based on the grant date fair value of the awards. Consultant awards are remeasured each reporting period through vesting. For awards with performance-based vesting criteria, the Company estimates the probability of achievement of the performance criteria and recognizes compensation expense related to those awards expected to vest. 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. 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. New Accounting Pronouncements In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses, which will require companies to present assets held at amortized cost and available for sale debt securities net of the amount expected to be collected. The guidance requires the measurement of expected credit losses to be based on relevant information from past events, including historical experiences, current conditions and reasonable and supportable forecasts that affect collectability. The guidance was effective for fiscal years and interim periods beginning after December 15, 2019 and adopted January 1, 2020. The adoption of this guidance did not have a material impact on the Company's consolidated financial statements. In October 2019, the FASB issued ASU 2019-12, which affects general principles within Topic 740, Income Taxes. The amendments of ASU 2019-12 are meant to simplify and reduce the cost of accounting for income taxes. For public business entities, the amendments in this Update are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. The Company determined that the adoption of this new accounting guidance did not have a material impact on its consolidated financial statements and footnote disclosures. |
Available-for-Sale-Securities
Available-for-Sale-Securities | 3 Months Ended |
Mar. 31, 2021 | |
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, 2021 December 31, 2020 Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Corporate debt securities $ 59,937 $ — $ (61) $ 59,876 $ 8,406 $ — $ (7) $ 8,399 Money market funds 18,044 — — 18,044 7,591 — — 7,591 Municipal debt securities 29,016 — (12) 29,004 14,753 — (6) 14,747 Total $ 106,997 $ — $ (73) $ 106,924 $ 30,750 $ — $ (13) $ 30,737 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, 2021 December 31, 2020 Cash and cash equivalents $ 24,157 $ 12,676 Marketable securities 82,767 18,061 Total $ 106,924 $ 30,737 The following table summarizes our portfolio of available-for-sale securities by contractual maturity (in thousands): March 31, 2021 Amortized Cost Estimated Fair Value Less than one year $ 106,997 $ 106,924 Greater than one year — — Total $ 106,997 $ 106,924 |
Income (Loss) Per Share
Income (Loss) Per Share | 3 Months Ended |
Mar. 31, 2021 | |
Earnings Per Share [Abstract] | |
Income (Loss) Per Share | Income (Loss) Per Share For the three months ended March 31, 2021 and 2020, 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, 2021 and 2020, the Company excluded the following potentially dilutive securities (in thousands): March 31, 2020 2020 Stock Options 1,022 1,280 Warrants 21,357 30 Restricted Stock Units 798 313 |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2021 | |
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, 2021, and December 31, 2020 (in thousands). March 31, 2021 December 31, 2020 Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total Assets: Marketable securities - available for sale $ — $ 82,767 $ — $ 82,767 $ — $ 18,061 $ — $ 18,061 $ — $ 82,767 $ — $ 82,767 $ — $ 18,061 $ — $ 18,061 |
Accrued Liabilities
Accrued Liabilities | 3 Months Ended |
Mar. 31, 2021 | |
Accrued Liabilities [Abstract] | |
Accrued Liabilities | Accrued Liabilities Accrued liabilities as of March 31, 2021 and December 31, 2020 were as follows (in thousands): March 31, 2021 December 31, 2020 Salaries, employee benefits and related taxes $ 1,119 $ 1,716 Operating lease liabilities - current 381 370 Other 623 400 Total $ 2,123 $ 2,486 |
Operating Leases
Operating Leases | 3 Months Ended |
Mar. 31, 2021 | |
Leases [Abstract] | |
Operating Leases | Operating Leases The Company has operating leases for two offices with terms that expire in 2022 and 2023. The Company estimates its incremental borrowing rate, at lease commencement, to determine the present value of lease payments, since 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 include 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, 2021 December 31, 2020 Right-of Use Assets: Other assets $ 492 $ 574 Total Right-of-Use Asset $ 492 $ 574 Operating Lease Liabilities: Accrued liabilities $ 381 $ 370 Other long-term liabilities 155 254 Total Operating Lease Liabilities $ 536 $ 624 As of March 31, 2021, the weighted average remaining lease term for our operating leases was 1.6 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, 2021 were as follows (in thousands): Years ended Operating Leases 2021 312 2022 239 2023 27 Total lease payments 578 Less: Amounts representing interest (42) Present value of lease liabilities $ 536 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2021 | |
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, 2021, the Company had not made any sales of common stock to Lincoln Park under the Purchase Agreement other than the Initial Purchase. Common Stock Sales Agreement In February 2018, the Company entered into a common stock sales agreement with H.C. Wainwright & Co., LLC ("HCW") as sales agent, which was subsequently amended in August 2018 (the "Sales Agreement"), 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 not more than $25.0 million. In March 2019, subsequent to the filing of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2018 (the "2018 Form 10-K"), the aggregate market value of its outstanding common stock held by non-affiliates was approximately $52.8 million. Pursuant to General Instruction I.B.6 of Form S-3, since the aggregate market value of the Company's outstanding common stock held by non-affiliates was below $75.0 million at the time of its 2018 Form 10-K filing, the aggregate amount of securities that the Company was permitted to offer and sell at such time was reduced to $17.6 million (or a maximum of 4.8 million shares), which was equal to one-third of the aggregate market value of its common stock held by non-affiliates at such time. Subject to the terms and conditions of the Sales Agreement, HCW will use commercially reasonable efforts consistent with its normal trading and sales practices to sell the shares from time to time, based upon the Company's instructions, including any price, time or size limits specified by the Company. The Company has provided HCW with customary indemnification rights, and HCW will be entitled to a commission at a fixed commission rate equal to 3.0% of the gross proceeds per share sold. The Company has no obligation to sell any of the shares and may at any time suspend sales under the Sales Agreement or terminate the Sales Agreement. The Sales Agreement will terminate upon the sale of all of the shares under the Sales Agreement unless terminated earlier by either party as permitted under the Sales Agreement. On February 12, 2021, the Company suspended the use of the at-the-market transactions facility (the “ATM”) and terminated the continuous offering pursuant to the Common Stock Sales Agreement (“Sales Agreement”) entered into in February 2018 with H.C. Wainwright & Co., LLC (“HCW”). The Company will no longer make any sales of its common stock pursuant to the Sales Agreement unless and until a new prospectus supplement is filed with the Securities and Exchange Commission. As of February 12, 2021, the Company had sold an aggregate of 3,784,912 shares of its common stock pursuant to the Sales Agreement for net proceeds of $9.5 million. During the three months ended March 31, 2021, the Company had not issued any shares under the Sales Agreement. Registered Direct Offerings In February 2021, the Company entered into a Securities Purchase Agreement (the “Institutional Purchase Agreement”) with certain institutional investors (the “Institutional Purchasers”). Pursuant to the terms of the Institutional Purchase Agreement, the Company sold to the Institutional Purchasers in a registered direct offering an aggregate of 24,906,134 shares of its common stock and warrants to purchase an aggregate of 12,453,067 shares of its common stock at a combined purchase price equal to $2.45 per share and associated warrant. Each warrant features an exercise price equal to $2.90 per share, is exercisable immediately upon issuance and will expire five years from the issuance date. Additionally, in a concurrent non-brokered registered direct offering, the Company entered into a Securities Purchase Agreement (the “Additional Purchase Agreement”) with certain accredited investors (the “Additional Purchasers”). Pursuant to the terms of the Additional Purchase Agreement, the Company sold to the Additional Purchasers an aggregate of 1,632,652 shares of its common stock and warrants to purchase an aggregate of 816,326 shares of its common stock at a combined purchase price equal to $2.45 per share and associated warrant. Each warrant features an exercise price equal to $2.90 per share, is exercisable immediately upon issuance and will expire five years from the issuance date. In connection with the registered direct offerings, the Company received gross proceeds of approximately $65.0 million. Private Placement In January 2021, the Company entered into a securities purchase agreement (the “January Private Placement”) with certain investors (the “January Purchasers”). Pursuant to the terms of the January Private Placement, the Company agreed to sell to the January Purchasers an aggregate of 12,500,000 shares of its common stock at a purchase price equal to $2.00 per share, along with warrants to purchase an aggregate of 6,250,000 shares of its common stock. In connection with the January Private Placement, the Company received gross proceeds of $25.0 million. Each warrant is exercisable for one share of common stock and features an exercise price equal to $2.90 per share. The warrants are exercisable immediately upon issuance and will expire five and one-half years from the issuance date. Warrant Exercises In January 2021, the Company issued 801,148 shares of common stock for net proceeds of $1.8 million in connection with warrant exercises associated with the April 23, 2020 securities purchase agreement and the May 25, 2020 securities purchase agreement. Stock Options and Warrants The following table summarizes the activity for stock options and warrants for the three months ended March 31, 2021: 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, 2020 963,700 $ 14.64 5.86 $ — 2,638,355 $ 2.18 4.98 $ — Changes during the period: Granted 155,150 1.60 19,519,393 2.90 Exercised (7,250) 3.28 (801,148) 2.19 Forfeited (7,017) 2.20 — — Expired (82,359) 6.54 — — Outstanding at March 31, 2021 1,022,224 $ 13.48 6.67 $ — 21,356,600 $ 2.84 4.98 $ — Vested at March 31, 2021 996,573 $ 13.77 6.60 $ — 21,356,600 $ 2.84 4.98 $ — Vested at March 31, 2021 765,479 $ 17.08 5.87 $ — 21,356,600 $ 2.80 4.98 $ — Restricted Stock During the three months ended March 31, 2021 and 2020, the Company issued restricted stock for services as follows ($ in thousands): Three Months Ended March 31, 2021 2020 Number of restricted stock issued 300,450 156,184 Value of restricted stock issued $ 478 $ 512 Restricted Stock Units During the three months ended March 31, 2021 and 2020, the Company issued restricted stock units for services as follows ($ in thousands, except share data): Three Months Ended March 31, 2021 2020 Number of restricted stock units issued 458,245 195,320 Value of restricted stock units issued $ 729 $ 623 |
Share-Based Compensation
Share-Based Compensation | 3 Months Ended |
Mar. 31, 2021 | |
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, 2021 and 2020 (in thousands): Three Months Ended March 31, 2021 2020 Research and development $ 96 $ 125 General and administrative 501 442 Total share-based compensation expense $ 597 $ 567 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, 2021 were as follows (in thousands): Stock Options Restricted Stock Units Restricted Stock Unrecognized compensation cost $ 395 $ 537 $ 575 Expected weighted-average period in years of compensation cost to be recognized 1.82 1.39 2.21 Total fair value of shares vested and the weighted average estimated fair values of shares granted for the three months ended March 31, 2021 and 2020 were as follows (in thousands): Stock Options Three Months Ended March 31, 2021 2020 Total fair value of shares vested $ 397 $ 502 Weighted average estimated fair value of shares granted 1.08 2.16 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. |
Research Funding
Research Funding | 3 Months Ended |
Mar. 31, 2021 | |
Research and Development [Abstract] | |
Research Funding | Research FundingCalifornia Institute of Regenerative Medicine Grant AwardIn February 2017, the California Institute for Regenerative Medicine ("CIRM") awarded the Company funds of up to $12.2 million to support the T-Rex Study. The funding is based upon the achievement of certain milestones related to the proportion of subjects enrolled in California, as well as manufacturing and development costs incurred in California. Based on the actual number of subjects enrolled in California, the total amount of funding was revised to $8.6 million, of which $8.2 million has been received through the grant project period completion. The Company received $5.7 million in initial funding in May 2017, a $1.9 million milestone payment in December 2017, a $0.3 million progress payment in March 2018, and a $0.2 million progress payment in May 2019, of which the total was amortized over the estimated award period through July 2020 as a reduction to the related research and development expenses, with the final true up payment of $46 thousand received in September 2020 and recorded as a reduction to the related research and development expenses. During the three months ended March 31, 2021 and March 31, 2020, the Company amortized and recognized $0.0 million and $0.7 million in credits, respectively, to research and development related to CIRM funds received. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2021 | |
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, 2020, the Company had approximately $264 million of federal NOLs available to offset future taxable income expiring from 2030 through 2036. As of December 31, 2020, the Company had State NOLs available in New Jersey of $99 million, California of $70 million, and New York City of $13 million to offset future taxable income expiring from 2030 through 2040. In accordance with Section 382 of the Internal Revenue code, the usage of the Company’s NOLs could be limited in the event of a 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 performed an analysis and determined that they did not have an ownership change of greater than 50% over a 3-year testing period. The last ownership change was determined to be on June 3, 2015. Based on a market capitalization of $125 million and using an applicable federal rate of 2.5%, the annual limitation would be approximately $3.0 million. Post change losses generated after June 3, 2015 would not be subject to 382 limitations. 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, 2021, 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 2017, 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. |
Contingencies
Contingencies | 3 Months Ended |
Mar. 31, 2021 | |
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. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2021 | |
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, 2021, 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, 2020 and 2019 included in our 2020 Form 10-K. Operating results for the three months ended March 31, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021. |
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 amount 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 |
New Accounting Pronouncements | New Accounting Pronouncements In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses, which will require companies to present assets held at amortized cost and available for sale debt securities net of the amount expected to be collected. The guidance requires the measurement of expected credit losses to be based on relevant information from past events, including historical experiences, current conditions and reasonable and supportable forecasts that affect collectability. The guidance was effective for fiscal years and interim periods beginning after December 15, 2019 and adopted January 1, 2020. The adoption of this guidance did not have a material impact on the Company's consolidated financial statements. In October 2019, the FASB issued ASU 2019-12, which affects general principles within Topic 740, Income Taxes. The amendments of ASU 2019-12 are meant to simplify and reduce the cost of accounting for income taxes. For public business entities, the amendments in this Update are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. The Company determined that the adoption of this new accounting guidance did not have a material impact on its consolidated financial statements and footnote disclosures. |
Available-for-Sale-Securities (
Available-for-Sale-Securities (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
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, 2021 December 31, 2020 Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Corporate debt securities $ 59,937 $ — $ (61) $ 59,876 $ 8,406 $ — $ (7) $ 8,399 Money market funds 18,044 — — 18,044 7,591 — — 7,591 Municipal debt securities 29,016 — (12) 29,004 14,753 — (6) 14,747 Total $ 106,997 $ — $ (73) $ 106,924 $ 30,750 $ — $ (13) $ 30,737 |
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, 2021 December 31, 2020 Cash and cash equivalents $ 24,157 $ 12,676 Marketable securities 82,767 18,061 Total $ 106,924 $ 30,737 |
Investments Classified by Contractual Maturity Date | The following table summarizes our portfolio of available-for-sale securities by contractual maturity (in thousands): March 31, 2021 Amortized Cost Estimated Fair Value Less than one year $ 106,997 $ 106,924 Greater than one year — — Total $ 106,997 $ 106,924 |
Income (Loss) Per Share (Tables
Income (Loss) Per Share (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | At March 31, 2021 and 2020, the Company excluded the following potentially dilutive securities (in thousands): March 31, 2020 2020 Stock Options 1,022 1,280 Warrants 21,357 30 Restricted Stock Units 798 313 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
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, 2021, and December 31, 2020 (in thousands). March 31, 2021 December 31, 2020 Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total Assets: Marketable securities - available for sale $ — $ 82,767 $ — $ 82,767 $ — $ 18,061 $ — $ 18,061 $ — $ 82,767 $ — $ 82,767 $ — $ 18,061 $ — $ 18,061 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Accrued Liabilities [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities as of March 31, 2021 and December 31, 2020 were as follows (in thousands): March 31, 2021 December 31, 2020 Salaries, employee benefits and related taxes $ 1,119 $ 1,716 Operating lease liabilities - current 381 370 Other 623 400 Total $ 2,123 $ 2,486 |
Operating Leases (Tables)
Operating Leases (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
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, 2021 December 31, 2020 Right-of Use Assets: Other assets $ 492 $ 574 Total Right-of-Use Asset $ 492 $ 574 Operating Lease Liabilities: Accrued liabilities $ 381 $ 370 Other long-term liabilities 155 254 Total Operating Lease Liabilities $ 536 $ 624 |
Schedule of Future Minimum Lease Payments Under Lease Agreements | Future minimum lease payments under the lease agreements as of March 31, 2021 were as follows (in thousands): Years ended Operating Leases 2021 312 2022 239 2023 27 Total lease payments 578 Less: Amounts representing interest (42) Present value of lease liabilities $ 536 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Equity [Abstract] | |
Schedule of Stock Option Activity | The following table summarizes the activity for stock options and warrants for the three months ended March 31, 2021: 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, 2020 963,700 $ 14.64 5.86 $ — 2,638,355 $ 2.18 4.98 $ — Changes during the period: Granted 155,150 1.60 19,519,393 2.90 Exercised (7,250) 3.28 (801,148) 2.19 Forfeited (7,017) 2.20 — — Expired (82,359) 6.54 — — Outstanding at March 31, 2021 1,022,224 $ 13.48 6.67 $ — 21,356,600 $ 2.84 4.98 $ — Vested at March 31, 2021 996,573 $ 13.77 6.60 $ — 21,356,600 $ 2.84 4.98 $ — Vested at March 31, 2021 765,479 $ 17.08 5.87 $ — 21,356,600 $ 2.80 4.98 $ — |
Schedule of Restricted Stock Activity | During the three months ended March 31, 2021 and 2020, the Company issued restricted stock for services as follows ($ in thousands): Three Months Ended March 31, 2021 2020 Number of restricted stock issued 300,450 156,184 Value of restricted stock issued $ 478 $ 512 |
Schedule of Restricted Stock Units Activity | During the three months ended March 31, 2021 and 2020, the Company issued restricted stock units for services as follows ($ in thousands, except share data): Three Months Ended March 31, 2021 2020 Number of restricted stock units issued 458,245 195,320 Value of restricted stock units issued $ 729 $ 623 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
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, 2021 and 2020 (in thousands): Three Months Ended March 31, 2021 2020 Research and development $ 96 $ 125 General and administrative 501 442 Total share-based compensation expense $ 597 $ 567 |
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, 2021 were as follows (in thousands): Stock Options Restricted Stock Units Restricted Stock Unrecognized compensation cost $ 395 $ 537 $ 575 Expected weighted-average period in years of compensation cost to be recognized 1.82 1.39 2.21 |
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, 2021 and 2020 were as follows (in thousands): Stock Options Three Months Ended March 31, 2021 2020 Total fair value of shares vested $ 397 $ 502 Weighted average estimated fair value of shares granted 1.08 2.16 |
The Business - Narrative (Detai
The Business - Narrative (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2017 | Feb. 28, 2017 |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Grants awarded | $ 8,600 | $ 12,200 | |
CD34 cell technology | |||
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, 2021 | Dec. 31, 2020 |
Debt Securities, Available-for-sale [Line Items] | ||
Cost | $ 106,997 | $ 30,750 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (73) | (13) |
Estimated Fair Value | 106,924 | 30,737 |
Corporate debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 59,937 | 8,406 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (61) | (7) |
Estimated Fair Value | 59,876 | 8,399 |
Money market funds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 18,044 | 7,591 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | 18,044 | 7,591 |
Municipal debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 29,016 | 14,753 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (12) | (6) |
Estimated Fair Value | $ 29,004 | $ 14,747 |
Available-for-Sale-Securities_2
Available-for-Sale-Securities - Classification of Available-for-Sale Securities (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Debt Securities, Available-for-sale [Abstract] | ||
Cash and cash equivalents | $ 24,157 | $ 12,676 |
Marketable securities | 82,767 | 18,061 |
Total | $ 106,924 | $ 30,737 |
Available-for-Sale-Securities_3
Available-for-Sale-Securities - Available-for-Sale Securities by Contractual Maturity (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Amortized Cost | ||
Less than one year | $ 106,997 | |
Greater than one year | 0 | |
Cost | 106,997 | $ 30,750 |
Estimated Fair Value | ||
Less than one year | 106,924 | |
Greater than one year | 0 | |
Total estimated fair value | $ 106,924 | $ 30,737 |
Income (Loss) Per Share (Detail
Income (Loss) Per Share (Details) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Stock Options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 1,022 | 1,280 |
Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 21,357 | 30 |
Restricted Stock Units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 798 | 313 |
Fair Value Measurements - Asset
Fair Value Measurements - Assets Measured at Fair Value on Recurring Basis (Details) - Recurring - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities - available for sale | $ 82,767 | $ 18,061 |
Assets, fair value disclosure | 82,767 | 18,061 |
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 | 82,767 | 18,061 |
Assets, fair value disclosure | 82,767 | 18,061 |
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, 2021 | Dec. 31, 2020 |
Accrued Liabilities [Abstract] | ||
Salaries, employee benefits and related taxes | $ 1,119 | $ 1,716 |
Operating lease liabilities - current | 381 | 370 |
Other | 623 | 400 |
Total accrued liabilities | $ 2,123 | $ 2,486 |
Operating Leases - Narrative (D
Operating Leases - Narrative (Details) | Mar. 31, 2021office |
Leases [Abstract] | |
Number of offices under operating leases | 2 |
Weighted average remaining lease term for operating leases (in years) | 1 year 7 months 6 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, 2021 | Dec. 31, 2020 |
Balance Sheet Captions | ||
Right-of-use assets | $ 492 | $ 574 |
Operating lease liabilities, current | 381 | 370 |
Operating lease liabilities | 536 | 624 |
Other assets | ||
Balance Sheet Captions | ||
Right-of-use assets | 492 | 574 |
Accrued liabilities | ||
Balance Sheet Captions | ||
Operating lease liabilities, current | 381 | 370 |
Other long-term liabilities | ||
Balance Sheet Captions | ||
Operating lease liabilities, noncurrent | $ 155 | $ 254 |
Operating Leases - Future Minim
Operating Leases - Future Minimum Lease Payments (Details) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Finance Minimum Lease Payments | ||
2021 | $ 312,000 | |
2022 | 239,000 | |
2023 | 27,000 | |
Total lease payments | 578,000 | |
Less: Amounts representing interest | (42,000) | |
Present value of lease liabilities | $ 536,000 | $ 624,000 |
Stockholders' Equity - Equity I
Stockholders' Equity - Equity Issuances (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 38 Months Ended | ||||
Feb. 28, 2021 | Jan. 31, 2021 | Mar. 31, 2019 | Aug. 31, 2018 | Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | |
Class of Stock [Line Items] | |||||||
Aggregate market of common stock held by non-affiliates | $ 52,800 | ||||||
Net proceeds from issuance of common stock | $ 65,000 | $ 85,457 | $ 0 | ||||
Shares issued upon exercise of warrants | 801,148 | ||||||
Net proceeds from warrant exercises | $ 1,800 | ||||||
Lincoln Park Agreement | |||||||
Class of Stock [Line Items] | |||||||
Aggregate offering amount authorized per agreement | $ 26,000 | ||||||
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 | $ 1,000 | ||||||
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 | $ 2,500 | ||||||
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% | ||||||
H.C. Wainwright Sales Amended Agreement | |||||||
Class of Stock [Line Items] | |||||||
Aggregate offering amount authorized per agreement | $ 17,600 | $ 25,000 | |||||
Maximum number of shares authorized per agreement (in shares) | 4,800,000 | ||||||
Commission on gross proceeds due to third party (percent) | 3.00% | ||||||
Stock issued (shares) | 3,784,912 | ||||||
Net proceeds from issuance of common stock | $ 9,500 | ||||||
Institutional Purchase Agreement | |||||||
Class of Stock [Line Items] | |||||||
Number of shares sold (in shares) | 24,906,134 | ||||||
Price of shares sold (in dollars per share) | $ 2.45 | ||||||
Number of shares called by warrants issued | 12,453,067 | ||||||
Warrant exercise price (in dollars per share) | $ 2.90 | ||||||
Warrants expiration term | 5 years | ||||||
Additional Purchase Agreement | |||||||
Class of Stock [Line Items] | |||||||
Number of shares sold (in shares) | 1,632,652 | ||||||
Price of shares sold (in dollars per share) | $ 2.45 | ||||||
Number of shares called by warrants issued | 816,326 | ||||||
Warrant exercise price (in dollars per share) | $ 2.90 | ||||||
Warrants expiration term | 5 years | ||||||
January 2021 Private Placement | |||||||
Class of Stock [Line Items] | |||||||
Number of shares sold (in shares) | 12,500,000 | ||||||
Price of shares sold (in dollars per share) | $ 2 | ||||||
Net proceeds from issuance of common stock | $ 25,000 | ||||||
Number of shares called by warrants issued | 6,250,000 | ||||||
Warrant exercise price (in dollars per share) | $ 2.90 | ||||||
Warrants expiration term | 5 years 6 months | ||||||
Number of shares called by each warrant | 1 |
Stockholders' Equity - Stock Op
Stockholders' Equity - Stock Options and Warrants (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |
Mar. 31, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Warrants, Number of Shares [Roll Forward] | |||
Warrants, Outstanding, Beginning of Period (in shares) | 2,638,355 | ||
Warrants, Granted (in shares) | 19,519,393 | ||
Warrants, Exercised (in shares) | (801,148) | ||
Warrants, Forfeited (in shares) | 0 | ||
Warrants, Expired (in shares) | 0 | ||
Warrants, Outstanding, End of Period (in shares) | 21,356,600 | ||
Warrants Weighted Average Exercise Price [Roll Forward] | |||
Warrants Outstanding, Beginning of Period (in dollars per share) | $ 2.18 | ||
Warrants, Granted (in dollars per share) | 2.90 | ||
Warrants, Exercised (in dollars per share) | 2.19 | ||
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 | ||
Warrants, Outstanding, Weighted Average Remaining Contractual Term | 4 years 11 months 23 days | 4 years 11 months 23 days | |
Warrants Outstanding, Aggregate Intrinsic Value | $ 0 | $ 0 | |
Warrants, Vested and expected to vest (in shares) | 21,356,600 | ||
Weighted Average Exercise Price, Warrants Vested And Expected To Vest | $ 2.84 | ||
Warrants, Vested and expected to vest, Weighted Average Remaining Contractual Term | 4 years 11 months 23 days | ||
Warrants, Vested and expected to vest, Aggregate Intrinsic Value | $ 0 | ||
Warrants, Vested (in shares) | 21,356,600 | ||
Warrants, Vested, Weighted Average Exercise Price (in dollars per share) | $ 2.80 | ||
Warrants, Vested, Weighted Average Remaining Contractual Term | 4 years 11 months 23 days | ||
Warrants, Vested, Aggregate Intrinsic Value | $ 0 | ||
US Equity Plan [Member] | |||
Options, Outstanding [Roll Forward] | |||
Options, Outstanding, Beginning of Period (in shares) | 963,700 | ||
Options, Granted (in shares) | 155,150 | ||
Options, Exercised (in shares) | (7,250) | ||
Options, Forfeited (in shares) | (7,017) | ||
Options, Expired (in shares) | (82,359) | ||
Options, Outstanding, End of Period (in shares) | 1,022,224 | ||
Options, Outstanding, Weighted Average Exercise Price [Abstract] | |||
Options, Outstanding. Beginning of Period (in dollars per share) | $ 14.64 | ||
Options, Granted (in dollars per share) | 1.60 | ||
Options, Exercised (in dollars per share) | 3.28 | ||
Options, Forfeited (in dollars per share) | 2.20 | ||
Options, Expired (in dollars per share) | 6.54 | ||
Options, Outstanding, End of Period (in dollars per share) | $ 13.48 | ||
Options, Outstanding, Weighted Average Remaining Contractual Term | 6 years 8 months 1 day | 5 years 10 months 9 days | |
Options, Outstanding, Aggregate Intrinsic Value | $ 0 | $ 0 | |
Options, Vested and expected to vest (in shares) | 996,573 | ||
Options, Vested and expected to vest, Weighted Average Exercise Price (in dollars per share) | $ 13.77 | ||
Options, Vested and expected to vest, Weighted Average Remaining Contractual Term | 6 years 7 months 6 days | ||
Options, Vested and expected to vest, Aggregate Intrinsic Value | $ 0 | ||
Options, Vested (in shares) | 765,479 | ||
Options, Vested, Weighted Average Exercise Price (in dollars per share) | $ 17.08 | ||
Options, Vested, Weighted Average Remaining Contractual Term | 5 years 10 months 13 days | ||
Options, 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, 2021 | Mar. 31, 2020 | |
Restricted Stock | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of restricted stock issued | 300,450 | 156,184 |
Value of restricted stock issued | $ 478 | $ 512 |
Weighted average estimated fair value of restricted stock issued | $ 1.59 | $ 3.19 |
Restricted Stock Units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of restricted stock issued | 458,245 | 195,320 |
Value of restricted stock issued | $ 729 | $ 623 |
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, 2021 | Mar. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation expense | $ 597 | $ 567 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation expense | 96 | 125 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation expense | $ 501 | $ 442 |
Share-Based Compensation - Comp
Share-Based Compensation - Compensation Cost Not Yet Recognized (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2021USD ($) | |
Stock Options | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation cost | $ 395 |
Expected weighted-average period in years of compensation cost to be recognized | 1 year 9 months 25 days |
Restricted Stock Units | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation cost | $ 537 |
Expected weighted-average period in years of compensation cost to be recognized | 1 year 4 months 20 days |
Restricted Stock | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation cost | $ 575 |
Expected weighted-average period in years of compensation cost to be recognized | 2 years 2 months 15 days |
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, 2021 | Mar. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total fair value of shares vested | $ 397 | $ 502 |
Weighted average estimated fair value of shares granted | $ 1.08 | $ 2.16 |
Research Funding (Details)
Research Funding (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 41 Months Ended | ||||||
Sep. 30, 2020 | May 31, 2019 | Mar. 31, 2018 | Dec. 31, 2017 | May 31, 2017 | Mar. 31, 2021 | Mar. 31, 2020 | Sep. 30, 2020 | Feb. 28, 2017 | |
Research and Development [Abstract] | |||||||||
Grants awarded | $ 8,600 | $ 12,200 | |||||||
Funding of grant award | $ 5,700 | $ 8,200 | |||||||
Milestone payment received on grant award | $ 1,900 | ||||||||
Progress payment received on grant award | $ 300 | ||||||||
Research and Development Arrangement with Federal Government, Customer Funding to Offset Costs Incurred | $ 46 | $ 200 | |||||||
Amortization of accrued grant funding to offset expense | $ 0 | $ 700 |
Income Taxes - Net Operating Lo
Income Taxes - Net Operating Loss Carry Forward (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Operating Loss Carryforwards [Line Items] | |
Market capitalization used in net operating loss analysis | $ 125 |
Annual limitation on usage of net operating losses | 3 |
Federal | |
Operating Loss Carryforwards [Line Items] | |
Operating loss carryforwards | 264 |
State and Local Jurisdiction | New Jersey Division of Taxation | |
Operating Loss Carryforwards [Line Items] | |
Operating loss carryforwards | 99 |
State and Local Jurisdiction | California Franchise Tax Board | |
Operating Loss Carryforwards [Line Items] | |
Operating loss carryforwards | 70 |
State and Local Jurisdiction | New York State Division of Taxation and Finance | |
Operating Loss Carryforwards [Line Items] | |
Operating loss carryforwards | $ 13 |