Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2020 | Nov. 03, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2020 | |
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 $0.001 per share | |
Trading Symbol | CLBS | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Central Index Key | 0000320017 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false | |
Entity Common Stock, Shares Outstanding | 19,395,977 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
ASSETS | ||
Cash and cash equivalents | $ 21,156 | $ 14,032 |
Marketable securities | 19,113 | 11,125 |
Prepaid and other current assets | 989 | 815 |
Total current assets | 41,258 | 25,972 |
Property and equipment, net | 67 | 100 |
Other assets | 694 | 1,081 |
Total assets | 42,019 | 27,153 |
Liabilities | ||
Accounts payable | 1,105 | 1,490 |
Accrued liabilities | 3,076 | 4,486 |
Total current liabilities | 4,181 | 5,976 |
Other long-term liabilities | 351 | 624 |
Total liabilities | 4,532 | 6,600 |
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 September 30, 2020 and December 31, 2019, respectively | 0 | 0 |
Common stock, $0.001 par value, authorized 500,000,000 shares; issued and outstanding, 19,407,057 and 10,528,689 shares at September 30, 2020 and December 31, 2019, respectively | 19 | 11 |
Additional paid-in capital | 458,560 | 438,911 |
Treasury stock, at cost; 11,080 shares at September 30, 2020 and December 31, 2019 | (708) | (708) |
Accumulated deficit | (420,119) | (417,400) |
Accumulated other comprehensive (loss) income | (12) | 2 |
Total Caladrius Biosciences, Inc. stockholders' equity | 37,740 | 20,816 |
Noncontrolling interests | (253) | (263) |
Total stockholders' equity | 37,487 | 20,553 |
Liabilities and Equity, Total | $ 42,019 | $ 27,153 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Sep. 30, 2020 | Dec. 31, 2019 |
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 | 19,407,057 | 10,528,689 |
Common stock, shares, outstanding | 19,407,057 | 10,528,689 |
Treasury stock (shares) | 11,080 | 11,080 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Operating Expenses: | ||||
Research and development | $ 3,029 | $ 3,004 | $ 6,346 | $ 8,030 |
General and administrative | 2,321 | 2,068 | 7,353 | 6,980 |
Total operating expenses | 5,350 | 5,072 | 13,699 | 15,010 |
Operating loss | (5,350) | (5,072) | (13,699) | (15,010) |
Other income: | ||||
Investment income, net | 25 | 175 | 118 | 611 |
Total other income | 25 | 175 | 118 | 611 |
Net loss before benefit from income taxes and noncontrolling interests | (5,325) | (4,897) | (13,581) | (14,399) |
Benefit from income taxes | 0 | 0 | (10,872) | 0 |
Net loss | (5,325) | (4,897) | (2,709) | (14,399) |
Less - net income attributable to noncontrolling interests | 2 | 1 | 10 | 6 |
Net (loss) income attributable to Caladrius Biosciences, Inc. common stockholders | $ (5,327) | $ (4,898) | $ (2,719) | $ (14,405) |
Basic and diluted loss per share | ||||
Caladrius Biosciences, Inc. common stockholders (in usd per share) | $ (0.29) | $ (0.47) | $ (0.19) | $ (1.40) |
Weighted average common shares outstanding | ||||
Basic and diluted shares | 18,597 | 10,411 | 14,116 | 10,279 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (5,325) | $ (4,897) | $ (2,709) | $ (14,399) |
Available for sale securities - net unrealized (loss) income | (14) | 2 | (14) | 34 |
Total other comprehensive (loss) income | (14) | 2 | (14) | 34 |
Comprehensive loss | (5,339) | (4,895) | (2,723) | (14,365) |
Comprehensive income attributable to noncontrolling interests | 2 | 1 | 10 | 6 |
Comprehensive loss attributable to Caladrius Biosciences, Inc. common stockholders | $ (5,341) | $ (4,896) | $ (2,733) | $ (14,371) |
Consolidated Statements of Equi
Consolidated Statements of Equity - USD ($) shares in Thousands, $ in Thousands | Total | Adoption of new accounting standard | Total Caladrius Biosciences, Inc. Stockholders' Equity | Total Caladrius Biosciences, Inc. Stockholders' EquityAdoption of new accounting standard | Series B Convertible Preferred Stock | Common Stock | Additional Paid in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Accumulated DeficitAdoption of new accounting standard | Treasury Stock | Non- Controlling Interest in Subsidiary |
Beginning Balance (shares) at Dec. 31, 2018 | 10 | 9,866 | ||||||||||
Beginning Balance at Dec. 31, 2018 | $ 37,454 | $ (62) | $ 37,726 | $ (62) | $ 0 | $ 10 | $ 436,433 | $ (32) | $ (397,977) | $ (62) | $ (708) | $ (272) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||
Net loss | (14,399) | (14,405) | (14,405) | 6 | ||||||||
Unrealized gain (loss) on marketable securities | 34 | 34 | 34 | |||||||||
Share-based compensation (in shares) | 94 | |||||||||||
Share-based compensation | 917 | 917 | 917 | |||||||||
Net proceeds from issuance of common stock (in shares) | 451 | |||||||||||
Net proceeds from issuance of common stock | 1,038 | 1,038 | 1,038 | |||||||||
Ending Balance (shares) at Sep. 30, 2019 | 10 | 10,411 | ||||||||||
Ending Balance at Sep. 30, 2019 | 24,982 | 25,248 | $ 0 | $ 10 | 438,388 | 2 | (412,444) | (708) | (266) | |||
Beginning Balance (shares) at Jun. 30, 2019 | 10 | 10,413 | ||||||||||
Beginning Balance at Jun. 30, 2019 | 29,622 | 29,889 | $ 0 | $ 10 | 438,133 | 0 | (407,546) | (708) | (267) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||
Net loss | (4,897) | (4,898) | (4,898) | 1 | ||||||||
Unrealized gain (loss) on marketable securities | 2 | 2 | 2 | |||||||||
Share-based compensation (in shares) | (2) | |||||||||||
Share-based compensation | 254 | 254 | 254 | |||||||||
Net proceeds from issuance of common stock (in shares) | 0 | |||||||||||
Net proceeds from issuance of common stock | 1 | 1 | 1 | |||||||||
Ending Balance (shares) at Sep. 30, 2019 | 10 | 10,411 | ||||||||||
Ending Balance at Sep. 30, 2019 | 24,982 | 25,248 | $ 0 | $ 10 | 438,388 | 2 | (412,444) | (708) | (266) | |||
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 | (2,709) | (2,719) | (2,719) | 10 | ||||||||
Unrealized gain (loss) on marketable securities | (14) | (14) | (14) | |||||||||
Share-based compensation (in shares) | 81 | |||||||||||
Share-based compensation | 942 | 942 | 942 | |||||||||
Net proceeds from issuance of common stock (in shares) | 8,797 | |||||||||||
Net proceeds from issuance of common stock | 18,715 | 18,715 | $ 8 | 18,707 | ||||||||
Ending Balance (shares) at Sep. 30, 2020 | 10 | 19,407 | ||||||||||
Ending Balance at Sep. 30, 2020 | 37,487 | 37,740 | $ 0 | $ 19 | 458,560 | (12) | (420,119) | (708) | (253) | |||
Beginning Balance (shares) at Jun. 30, 2020 | 10 | 15,585 | ||||||||||
Beginning Balance at Jun. 30, 2020 | 33,556 | 33,811 | $ 0 | $ 16 | 449,302 | (7) | (414,792) | (708) | (255) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||
Net loss | (5,325) | (5,327) | (5,327) | 2 | ||||||||
Unrealized gain (loss) on marketable securities | (5) | (5) | (5) | |||||||||
Share-based compensation (in shares) | (25) | |||||||||||
Share-based compensation | 229 | 229 | 229 | |||||||||
Net proceeds from issuance of common stock (in shares) | 3,847 | |||||||||||
Net proceeds from issuance of common stock | 9,032 | 9,032 | $ 3 | 9,029 | ||||||||
Ending Balance (shares) at Sep. 30, 2020 | 10 | 19,407 | ||||||||||
Ending Balance at Sep. 30, 2020 | $ 37,487 | $ 37,740 | $ 0 | $ 19 | $ 458,560 | $ (12) | $ (420,119) | $ (708) | $ (253) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (2,709) | $ (14,399) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation | 1,090 | 1,047 |
Depreciation and amortization | 46 | 50 |
Accretion on marketable securities | 172 | 172 |
Changes in operating assets and liabilities: | ||
Prepaid and other current assets | (174) | (30) |
Other assets | 387 | 272 |
Accounts payable, accrued liabilities and other liabilities | (2,068) | (1,774) |
Net cash used in operating activities | (3,256) | (14,662) |
Cash flows from investing activities: | ||
Purchase of marketable securities | (21,819) | (32,312) |
Sale of marketable securities | 13,646 | 48,441 |
Purchase of property and equipment | (14) | 0 |
Net cash provided by (used in) investing activities | (8,187) | 16,129 |
Cash flows from financing activities: | ||
Tax withholding payments on net share settlement equity awards | (148) | (130) |
Net proceeds from issuance of common stock | 18,715 | 1,038 |
Net cash provided by financing activities | 18,567 | 908 |
Net increase in cash and cash equivalents | 7,124 | 2,375 |
Cash and cash equivalents at beginning of period | 14,032 | 10,299 |
Cash and cash equivalents at end of period | $ 21,156 | $ 12,674 |
The Business
The Business | 9 Months Ended |
Sep. 30, 2020 | |
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. The Company's 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 and world-recognized scientific achievement in the field of cardiovascular disease, among other therapeutic areas. 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 HONEDRA ® (formerly known as CLBS12), recipient of SAKIGAKE designation and eligible for early conditional approval in Japan for the treatment of critical limb ischemia ("CLI") based on the results of an ongoing clinical trial; CLBS14, a Regenerative Medicine Advanced Therapy ("RMAT") designated therapy for which the Company has finalized with the U.S. Food and Drug Administration (the "FDA") a protocol for a Phase 3 confirmatory trial in subjects with no-option refractory disabling angina ("NORDA"); CLBS16, the subject of a recently completed positive Phase 2 clinical trial in the U.S. for the treatment of coronary microvascular dysfunction ("CMD") and CLBS119, an emergent CD34+ stem cell therapy responding to the COVID-19 pandemic and the potentially permanent damage the virus inflicts on the lungs of many patients. 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. No other native cell discovered to date has demonstrated this same capability. The Company’s proprietary CD34+ cell technology 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. Caladrius believes that a number of conditions caused by underlying ischemic injury can be improved through its CD34+ cell technology, including but not limited to, CLI, CMD, NORDA and COVID-19 induced lung damage. HONEDRA ® for Treatment of Critical Limb Ischemia The Company's open-label, registration-eligible study of HONEDRA ® in Japan for the treatment of critical limb ischemia ("CLI"), a disease with no currently available approved therapy and a higher combined incidence and mortality rate than all cancers but lung cancer, 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. Although the study's enrollment, which is targeted for completion this year, has been slowed by the pandemic's impact in Japan, the Company is encouraged by the patient pre-screening pipeline that has been identified and hopes to conclude trial enrollment during the first quarter of 2021. While the final outcome of the trial will depend on all data from all subjects, data, to date, are very encouraging. CLBS14 for Treatment of No Option Refractory Disabling Angina (NORDA) 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 CLBS14 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, working closely with the FDA, has finalized the design of a confirmatory Phase 3 trial which, in combination with previously filed Phase 1, 2 and 3 data, will be considered for the registration of CLBS14. Notably, this study design includes a 6-month primary endpoint and, with the benefit of the RMAT designation, the biologics license application ("BLA"), once submitted, is expected to receive a 6-month review. The Company has substantially completed the preparatory work for initiation of this trial. Caladrius will not, however, commence enrollment of patients until sufficient capital is acquired and dedicated to this program such that the Company has confidence that it can fund the trial uninterrupted through completion. 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), Caladrius initiated its program for CLBS16 for the treatment of coronary microvascular dysfunction ("CMD"), a disease that potentially afflicts millions of patients with no current targeted treatment options. That study, titled ESCaPE-CMD, was a Phase 2 proof-of-concept study that enrolled patients at the Mayo Clinic in Rochester, MN and Cedars-Sinai Medical Center in Los Angeles, CA. In June 2019, the Company announced the completion of enrollment in this study. Results of the first 17 of 20 patients enrolled in this trial who reached 6-month follow-up were presented as a rapid fire oral presentation on November 16, 2019 at the annual meeting of the American Heart Association in Philadelphia, PA by one of the principal investigators, Dr. Noel Bairey Merz, FACC, FAHA, FESC, the director of the Barbra Streisand Women's Heart Center at Cedars-Sinai 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 from that study was presented at the SCAI 2020 Scientific Sessions Virtual Conference on May 14, 2020 and the Company currently expects to initiate the next CMD trial, a Phase 2b study, by December 2020. CLBS119 for Treatment of COVID -19 Induced Lung Damage COVID-19 appears to damage the vasculature of the lungs and Caladrius believes that repair of that vasculature will prove necessary for patients to achieve a full recovery. Survivors of COVID-19 often remain debilitated even after leaving the hospital due to the damage caused to their lungs, and while many developmental therapies responding to the COVID-19 pandemic are appropriately targeting the SARS-CoV-2 virus itself or the manifestations of the acute phase of the illness, Caladrius is aware of no therapy that has demonstrated the ability to repair COVID-19 induced lung damage. With consistent clinical and pre-clinical evidence that CD34+ cells can repair multiple organs, including models of severe lung inflammation, the Company sought and received FDA authorization for its investigational new drug (“IND”) application for the study of CLBS119, a CD34+ cell therapy for repair of COVID-19 induced lung damage. The study began screening prospective patients for inclusion at NYU Langone Health. The planned 12-patient open-label clinical trial is designed to evaluate the safety and efficacy of a single administration of CLBS119 for the treatment and repair of COVID-19-induced lung damage in adults. The study will target patients who are experiencing hypoxia due to prior infection with SARS-CoV-2 and who require supplemental oxygen. 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. Its 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 the Company 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. While the disruption currently is expected to be temporary, there is uncertainty around the extent and duration of disruption, and any future related financial impact cannot be reasonably estimated at this time. 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 September 30, 2020, 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, 2019 and 2018 included in our 2019 Form 10-K. Operating results for the three and nine months ended September 30, 2020 are not necessarily indicative of the results that may be expected for the year ending December 31, 2020. 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 | 9 Months Ended |
Sep. 30, 2020 | |
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 2019 Form 10-K. There were no changes to these policies during the three and nine months ended September 30, 2020. 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 early adoption was permitted. The adoption of this guidance did not have a material impact on the Company's consolidated financial statements. In July 2019, the FASB issued ASU 2019-07, "Codification Updates to SEC Sections", to codify the SEC releases that clarify and improve the disclosure and presentation requirements of a variety of codification topics, thereby eliminating certain disclosure requirements that were redundant, duplicative, overlapping, outdated, or superseded. For public companies, the amendments are effective upon issuance. 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. 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 believes that the adoption of this new accounting guidance will not have a material impact on its financial statements and footnote disclosures. |
Available-for-Sale-Securities
Available-for-Sale-Securities | 9 Months Ended |
Sep. 30, 2020 | |
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): September 30, 2020 December 31, 2019 Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Corporate debt securities $ 13,506 $ — $ (11) $ 13,495 $ 11,673 $ 3 $ (1) $ 11,675 Money market funds 15,481 — — 15,481 11,093 — — 11,093 Municipal debt securities 8,613 — (1) 8,612 — — — — Sovereign government securities 196 — — 196 — — — — Total $ 37,796 $ — $ (12) $ 37,784 $ 22,766 $ 3 $ (1) $ 22,768 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): September 30, 2020 December 31, 2019 Cash and cash equivalents $ 18,671 $ 11,643 Marketable securities 19,113 11,125 Total $ 37,784 $ 22,768 The following table summarizes our portfolio of available-for-sale securities by contractual maturity (in thousands): September 30, 2020 Amortized Cost Estimated Fair Value Less than one year $ 37,796 $ 37,784 Greater than one year — — Total $ 37,796 $ 37,784 |
Income (Loss) Per Share
Income (Loss) Per Share | 9 Months Ended |
Sep. 30, 2020 | |
Earnings Per Share [Abstract] | |
Income (Loss) Per Share | Income (Loss) Per Share For the three and nine months ended September 30, 2020 and 2019, 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 September 30, 2020 and 2019, the Company excluded the following potentially dilutive securities (in thousands): September 30, 2020 2019 Stock Options 1,105 1,095 Warrants 2,638 30 Restricted Stock Units 348 118 |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2020 | |
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 September 30, 2020, and December 31, 2019 (in thousands). September 30, 2020 December 31, 2019 Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total Assets: Marketable securities - available for sale $ — $ 19,113 $ — $ 19,113 $ — $ 11,125 $ — $ 11,125 $ — $ 19,113 $ — $ 19,113 $ — $ 11,125 $ — $ 11,125 |
Accrued Liabilities
Accrued Liabilities | 9 Months Ended |
Sep. 30, 2020 | |
Accrued Liabilities [Abstract] | |
Accrued Liabilities | Accrued Liabilities Accrued liabilities as of September 30, 2020 and December 31, 2019 were as follows (in thousands): September 30, 2020 December 31, 2019 Salaries, employee benefits and related taxes $ 1,784 $ 1,834 Operating lease liabilities -- current 359 354 CIRM upfront funding -- current — 1,600 Other 933 698 Total $ 3,076 $ 4,486 |
Operating Leases
Operating Leases | 9 Months Ended |
Sep. 30, 2020 | |
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): September 30, 2020 December 31, 2019 Right-of Use Assets: Other assets $ 653 $ 906 Total Right-of-Use Asset $ 653 $ 906 Operating Lease Liabilities: Accrued liabilities $ 359 $ 353 Other long-term liabilities 351 624 Total Operating Lease Liabilities $ 710 $ 977 As of September 30, 2020, the weighted average remaining lease term for our operating leases was 2.1 years, and the weighted average discount rate for our operating leases was 9.625%. Future minimum lease payments under the lease agreements as of September 30, 2020 were as follows (in thousands): Years ended Operating Leases 2020 103 2021 414 2022 239 2023 27 Total lease payments 783 Less: Amounts representing interest (73) Present value of lease liabilities $ 710 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2020 | |
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 September 30, 2020, 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 our Annual Report on Form 10-K for the fiscal year ended December 31, 2018 (the "2018 Form 10-K"), the aggregate market value of our 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 our outstanding common stock held by non-affiliates was below $75.0 million at the time of our 2018 Form 10-K filing, the aggregate amount of securities that we were permitted to offer and sell at such time was reduced to $17.6 million, which was equal to one-third of the aggregate market value of our common stock held by non-affiliates at such time. Subject to the terms and conditions of the Sales Agreement, HCW will use its 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. During the nine months ended September 30, 2020, the Company issued 3,558,778 shares of common stock under the Sales Agreement for net proceeds of $8.5 million. As of September 30, 2020, the Company has issued 3,784,912 shares of common stock under the Sales Agreement for net proceeds of $9.5 million since inception. Registered Direct Offerings In April 2020, the Company entered into a securities purchase agreement (the “April Purchase Agreement”) with certain investors (the “April Purchasers”). Pursuant to the terms of the April Purchase Agreement, the Company agreed to sell to the Purchasers an aggregate of 2,162,166 shares of its common stock at a purchase price equal to $2.3125 per share. In a concurrent private placement, the Company issued to the April Purchasers warrants to purchase an aggregate of 1,081,083 shares of its common stock. In connection with the registered direct offering and concurrent private placement, the Company received gross proceeds of $5.0 million. Each warrant is exercisable for one share of common stock and features an exercise price equal to $2.2500 per share. The warrants are exercisable immediately upon issuance and will expire five and one-half years from the issuance date. In May 2020, the Company entered into a securities purchase agreement (the “May Purchase Agreement”) with certain investors (the “May Purchasers”). Pursuant to the terms of the May Purchase Agreement, the Company agreed to sell to the May Purchasers an aggregate of 2,084,850 shares of its common stock at a purchase price equal to $2.0625 per share. In a concurrent private placement, the Company issued to the Purchasers warrants to purchase an aggregate of 1,042,425 shares of its common stock. In connection with the registered direct offering and concurrent private placement, the Company received gross proceeds of $4.3 million. Each warrant is exercisable for one share of common stock and features an exercise price equal to $2.0625 per share. The warrants are exercisable immediately upon issuance and will expire five and one-half years from the issuance date. Private Placement On July 10, 2020, the Company entered into a securities purchase agreement (the “Private Placement”) with certain investors (the “Private Placement Purchasers”). Pursuant to the terms of the Private Placement, the Company agreed to sell to the Private Placement Purchasers an aggregate of 969,694 shares of its common stock at a purchase price equal to $2.0625 per share, along with warrants to purchase an aggregate of 484,847 shares of its common stock. In connection with the Private Placement, the Company received gross proceeds of $2.0 million. Each warrant is exercisable for one share of common stock and features an exercise price equal to $2.0625 per share. The warrants are exercisable immediately upon issuance and will expire five and one-half years from the issuance date. Stock Options and Warrants The following table summarizes the activity for stock options and warrants for the nine months ended September 30, 2020: 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, 2019 1,044,417 $ 18.31 6.06 $ — 30,000 $ 5.89 3.19 $ — Changes during the period: Granted 245,776 3.22 2,608,355 2.14 Exercised — — — — Forfeited (44,150) 3.79 — — Expired (140,635) 27.33 — — Outstanding at September 30, 2020 1,105,408 $ 14.39 6.24 $ — 2,638,355 $ 2.18 4.98 $ — Vested at September 30, 2020 1,083,355 $ 14.61 6.18 $ — 2,638,355 $ 2.18 4.98 $ — Vested at September 30, 2020 816,133 $ 18.13 5.34 $ — 2,638,355 $ 2.18 4.98 $ — Restricted Stock During the nine months ended September 30, 2020 and 2019, the Company issued restricted stock for services as follows ($ in thousands): Nine Months Ended September 30, 2020 2019 Number of restricted stock issued 156,184 123,564 Value of restricted stock issued $ 512 $ 612 Restricted Stock Units During the nine months ended September 30, 2020 and 2019, the Company issued restricted stock units for services as follows ($ in thousands, except share data): Nine Months Ended September 30, 2020 2019 Number of restricted stock units issued 246,383 184,454 Value of restricted stock units issued $ 743 $ 909 |
Share-Based Compensation
Share-Based Compensation | 9 Months Ended |
Sep. 30, 2020 | |
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 and nine months ended September 30, 2020 and 2019 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Research and development $ 58 $ 54 $ 240 $ 229 General and administrative 171 200 850 818 Total share-based compensation expense $ 229 $ 254 $ 1,090 $ 1,047 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 September 30, 2020 were as follows (in thousands): Stock Options Restricted Stock Units Restricted Stock Unrecognized compensation cost $ 530 $ 221 $ 76 Expected weighted-average period in years of compensation cost to be recognized 1.69 1.67 0.25 Total fair value of shares vested and the weighted average estimated fair values of shares granted for the nine months ended September 30, 2020 and 2019 were as follows (in thousands): Stock Options Nine Months Ended September 30, 2020 2019 Total fair value of shares vested $ 535 $ 398 Weighted average estimated fair value of shares granted $ 2.12 $ 3.18 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 | 9 Months Ended |
Sep. 30, 2020 | |
Research and Development [Abstract] | |
Research Funding | Research Funding California Institute of Regenerative Medicine Grant Award In 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 and nine |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2020 | |
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, 2019, the Company had approximately $246 million of federal NOLs available to offset future taxable income expiring from 2030 through 2036. 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 it has had ownership changes of greater than 50% over a 3-year testing period. The last ownership change was determined to be in 2015. Based on a market capitalization of $124.5 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 2, 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 certain tax positions as a component of income tax expense. As of September 30, 2020, 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 2016, 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 | 9 Months Ended |
Sep. 30, 2020 | |
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 | 9 Months Ended |
Sep. 30, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent EventsOn November 1, 2020 Anne Whitaker became a member of the Company’s Board of Directors. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
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 early adoption was permitted. The adoption of this guidance did not have a material impact on the Company's consolidated financial statements. In July 2019, the FASB issued ASU 2019-07, "Codification Updates to SEC Sections", to codify the SEC releases that clarify and improve the disclosure and presentation requirements of a variety of codification topics, thereby eliminating certain disclosure requirements that were redundant, duplicative, overlapping, outdated, or superseded. For public companies, the amendments are effective upon issuance. 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. 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 believes that the adoption of this new accounting guidance will not have a material impact on its financial statements and footnote disclosures. |
Available-for-Sale-Securities (
Available-for-Sale-Securities (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
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): September 30, 2020 December 31, 2019 Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Corporate debt securities $ 13,506 $ — $ (11) $ 13,495 $ 11,673 $ 3 $ (1) $ 11,675 Money market funds 15,481 — — 15,481 11,093 — — 11,093 Municipal debt securities 8,613 — (1) 8,612 — — — — Sovereign government securities 196 — — 196 — — — — Total $ 37,796 $ — $ (12) $ 37,784 $ 22,766 $ 3 $ (1) $ 22,768 |
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): September 30, 2020 December 31, 2019 Cash and cash equivalents $ 18,671 $ 11,643 Marketable securities 19,113 11,125 Total $ 37,784 $ 22,768 |
Investments Classified by Contractual Maturity Date | The following table summarizes our portfolio of available-for-sale securities by contractual maturity (in thousands): September 30, 2020 Amortized Cost Estimated Fair Value Less than one year $ 37,796 $ 37,784 Greater than one year — — Total $ 37,796 $ 37,784 |
Income (Loss) Per Share (Tables
Income (Loss) Per Share (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Earnings Per Share [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | At September 30, 2020 and 2019, the Company excluded the following potentially dilutive securities (in thousands): September 30, 2020 2019 Stock Options 1,105 1,095 Warrants 2,638 30 Restricted Stock Units 348 118 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
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 September 30, 2020, and December 31, 2019 (in thousands). September 30, 2020 December 31, 2019 Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total Assets: Marketable securities - available for sale $ — $ 19,113 $ — $ 19,113 $ — $ 11,125 $ — $ 11,125 $ — $ 19,113 $ — $ 19,113 $ — $ 11,125 $ — $ 11,125 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Accrued Liabilities [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities as of September 30, 2020 and December 31, 2019 were as follows (in thousands): September 30, 2020 December 31, 2019 Salaries, employee benefits and related taxes $ 1,784 $ 1,834 Operating lease liabilities -- current 359 354 CIRM upfront funding -- current — 1,600 Other 933 698 Total $ 3,076 $ 4,486 |
Operating Leases (Tables)
Operating Leases (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
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): September 30, 2020 December 31, 2019 Right-of Use Assets: Other assets $ 653 $ 906 Total Right-of-Use Asset $ 653 $ 906 Operating Lease Liabilities: Accrued liabilities $ 359 $ 353 Other long-term liabilities 351 624 Total Operating Lease Liabilities $ 710 $ 977 |
Schedule of Future Minimum Lease Payments Under Lease Agreements | Future minimum lease payments under the lease agreements as of September 30, 2020 were as follows (in thousands): Years ended Operating Leases 2020 103 2021 414 2022 239 2023 27 Total lease payments 783 Less: Amounts representing interest (73) Present value of lease liabilities $ 710 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Equity [Abstract] | |
Schedule of Stock Option Activity | The following table summarizes the activity for stock options and warrants for the nine months ended September 30, 2020: 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, 2019 1,044,417 $ 18.31 6.06 $ — 30,000 $ 5.89 3.19 $ — Changes during the period: Granted 245,776 3.22 2,608,355 2.14 Exercised — — — — Forfeited (44,150) 3.79 — — Expired (140,635) 27.33 — — Outstanding at September 30, 2020 1,105,408 $ 14.39 6.24 $ — 2,638,355 $ 2.18 4.98 $ — Vested at September 30, 2020 1,083,355 $ 14.61 6.18 $ — 2,638,355 $ 2.18 4.98 $ — Vested at September 30, 2020 816,133 $ 18.13 5.34 $ — 2,638,355 $ 2.18 4.98 $ — |
Nonvested Restricted Stock Shares Activity [Table Text Block] | During the nine months ended September 30, 2020 and 2019, the Company issued restricted stock for services as follows ($ in thousands): Nine Months Ended September 30, 2020 2019 Number of restricted stock issued 156,184 123,564 Value of restricted stock issued $ 512 $ 612 |
Schedule of Restricted Stock Units Activity | During the nine months ended September 30, 2020 and 2019, the Company issued restricted stock units for services as follows ($ in thousands, except share data): Nine Months Ended September 30, 2020 2019 Number of restricted stock units issued 246,383 184,454 Value of restricted stock units issued $ 743 $ 909 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
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 and nine months ended September 30, 2020 and 2019 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Research and development $ 58 $ 54 $ 240 $ 229 General and administrative 171 200 850 818 Total share-based compensation expense $ 229 $ 254 $ 1,090 $ 1,047 |
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 September 30, 2020 were as follows (in thousands): Stock Options Restricted Stock Units Restricted Stock Unrecognized compensation cost $ 530 $ 221 $ 76 Expected weighted-average period in years of compensation cost to be recognized 1.69 1.67 0.25 |
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 nine months ended September 30, 2020 and 2019 were as follows (in thousands): Stock Options Nine Months Ended September 30, 2020 2019 Total fair value of shares vested $ 535 $ 398 Weighted average estimated fair value of shares granted $ 2.12 $ 3.18 |
The Business - Narrative (Detai
The Business - Narrative (Details) - USD ($) $ in Millions | Sep. 30, 2020 | Dec. 31, 2017 | Feb. 28, 2017 |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Grants awarded | $ 8.6 | $ 12.2 | |
CD34 cell technology | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Grants awarded | $ 1.9 |
Available-for-Sale-Securities -
Available-for-Sale-Securities - Schedule of Available-for-Sale Securities Reconciliation (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Debt Securities, Available-for-sale [Line Items] | ||
Cost | $ 37,796 | $ 22,766 |
Gross Unrealized Gains | 0 | 3 |
Gross Unrealized Losses | (12) | (1) |
Estimated Fair Value | 37,784 | 22,768 |
Corporate debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 13,506 | 11,673 |
Gross Unrealized Gains | 0 | 3 |
Gross Unrealized Losses | (11) | (1) |
Estimated Fair Value | 13,495 | 11,675 |
Money market funds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 15,481 | 11,093 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | 15,481 | 11,093 |
Municipal debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 8,613 | 0 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (1) | 0 |
Estimated Fair Value | 8,612 | 0 |
Sovereign government securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 196 | 0 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | $ 196 | $ 0 |
Available-for-Sale-Securities_2
Available-for-Sale-Securities - Classification of Available-for-Sale Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Debt Securities, Available-for-sale [Abstract] | ||
Cash and cash equivalents | $ 18,671 | $ 11,643 |
Marketable securities | 19,113 | 11,125 |
Total | $ 37,784 | $ 22,768 |
Available-for-Sale-Securities_3
Available-for-Sale-Securities - Available-for-Sale Securities by Contractual Maturity (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Amortized Cost | ||
Less than one year | $ 37,796 | |
Greater than one year | 0 | |
Cost | 37,796 | $ 22,766 |
Estimated Fair Value | ||
Less than one year | 37,784 | |
Greater than one year | 0 | |
Total estimated fair value | $ 37,784 | $ 22,768 |
Income (Loss) Per Share (Detail
Income (Loss) Per Share (Details) - shares shares in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Stock Options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 1,105 | 1,095 |
Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 2,638 | 30 |
Restricted Stock Units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 348 | 118 |
Fair Value Measurements - Asset
Fair Value Measurements - Assets Measured at Fair Value on Recurring Basis (Details) - Recurring - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities - available for sale | $ 19,113 | $ 11,125 |
Assets, fair value disclosure | 19,113 | 11,125 |
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 | 19,113 | 11,125 |
Assets, fair value disclosure | 19,113 | 11,125 |
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 | Sep. 30, 2020 | Dec. 31, 2019 |
Accrued Liabilities [Abstract] | ||
Salaries, employee benefits and related taxes | $ 1,784 | $ 1,834 |
Operating lease liabilities -- current | 359 | 354 |
CIRM upfront funding -- current | 0 | 1,600 |
Other | 933 | 698 |
Total accrued liabilities | $ 3,076 | $ 4,486 |
Operating Leases - Narrative (D
Operating Leases - Narrative (Details) | Sep. 30, 2020office |
Leases [Abstract] | |
Number of offices under operating leases | 2 |
Weighted average remaining lease term for operating leases (in years) | 2 years 1 month 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 | Sep. 30, 2020 | Dec. 31, 2019 |
Balance Sheet Captions | ||
Right-of-use assets | $ 653 | $ 906 |
Operating lease liabilities, current | 359 | 354 |
Operating lease liabilities | 710 | 977 |
Other assets | ||
Balance Sheet Captions | ||
Right-of-use assets | 653 | 906 |
Accrued liabilities | ||
Balance Sheet Captions | ||
Operating lease liabilities, current | 359 | 353 |
Other long-term liabilities | ||
Balance Sheet Captions | ||
Operating lease liabilities, noncurrent | $ 351 | $ 624 |
Operating Leases - Future Minim
Operating Leases - Future Minimum Lease Payments (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Finance Minimum Lease Payments | ||
2020 | $ 103 | |
2021 | 414 | |
2022 | 239 | |
2023 | 27 | |
Total lease payments | 783 | |
Less: Amounts representing interest | (73) | |
Present value of lease liabilities | $ 710 | $ 977 |
Stockholders' Equity - Equity I
Stockholders' Equity - Equity Issuances (Details) - USD ($) | Jul. 10, 2020 | May 31, 2020 | Apr. 30, 2020 | Mar. 31, 2019 | Feb. 28, 2018 | Sep. 30, 2020 | Sep. 30, 2020 | Jun. 30, 2019 | Aug. 31, 2018 |
Class of Stock [Line Items] | |||||||||
Aggregate market of common stock held by non-affiliates | $ 52,800,000 | ||||||||
Lincoln Park Agreement | |||||||||
Class of Stock [Line Items] | |||||||||
Aggregate offering amount authorized per agreement | $ 26,000,000 | ||||||||
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 | $ 1,000,000 | ||||||||
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 | $ 2,500,000 | ||||||||
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 | $ 17,600,000 | $ 25,000,000 | |||||||
Commission on gross proceeds due to third party (percent) | 3.00% | ||||||||
Stock issued (shares) | 3,558,778 | 3,784,912 | |||||||
Proceeds from issuance of stock | $ 8,500,000 | $ 9,500,000 | |||||||
April Purchase Agreement | |||||||||
Class of Stock [Line Items] | |||||||||
Number of shares sold (in shares) | 2,162,166 | ||||||||
Price of shares sold (in dollars per share) | $ 2.3125 | ||||||||
Proceeds from issuance of stock | $ 5,000,000 | ||||||||
Number of shares called by warrants issued | 1,081,083 | ||||||||
Warrant exercise price (in dollars per share) | $ 2.2500 | ||||||||
Warrants expiration term | 5 years 6 months | ||||||||
May Purchase Agreement | |||||||||
Class of Stock [Line Items] | |||||||||
Number of shares sold (in shares) | 2,084,850 | ||||||||
Price of shares sold (in dollars per share) | $ 2.0625 | ||||||||
Proceeds from issuance of stock | $ 4,300,000 | ||||||||
Number of shares called by warrants issued | 1,042,425 | ||||||||
Warrant exercise price (in dollars per share) | $ 2.0625 | ||||||||
Warrants expiration term | 5 years 6 months | ||||||||
July Purchase Agreement | |||||||||
Class of Stock [Line Items] | |||||||||
Number of shares sold (in shares) | 969,694 | ||||||||
Price of shares sold (in dollars per share) | $ 2.0625 | ||||||||
Proceeds from issuance of stock | $ 2,000,000 | ||||||||
Number of shares called by warrants issued | 484,847 | ||||||||
Warrant exercise price (in dollars per share) | $ 2.0625 |
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, 2020 | Sep. 30, 2020 | Dec. 31, 2019 | |
Warrants, Number of Shares [Roll Forward] | |||
Warrants, Outstanding, Beginning of Period (in shares) | 30,000 | 30,000 | |
Warrants, Granted (in shares) | 2,608,355 | ||
Warrants, Exercised (in shares) | 0 | ||
Warrants, Forfeited (in shares) | 0 | ||
Warrants, Expired (in shares) | 0 | ||
Warrants, Outstanding, End of Period (in shares) | 2,638,355 | ||
Warrants Weighted Average Exercise Price [Roll Forward] | |||
Warrants Outstanding, Beginning of Period (in dollars per share) | $ 5.89 | $ 5.89 | |
Warrants, Granted (in dollars per share) | 2.14 | ||
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) | $ 2.18 | ||
Warrants, Outstanding, Weighted Average Remaining Contractual Term | 3 years 2 months 8 days | 4 years 11 months 23 days | |
Warrants Outstanding, Aggregate Intrinsic Value | $ 0 | $ 0 | |
Warrants, Vested and expected to vest (in shares) | 2,638,355 | ||
Weighted Average Exercise Price, Warrants Vested And Expected To Vest | $ 2.18 | ||
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) | 2,638,355 | ||
Warrants, Vested, Weighted Average Exercise Price (in dollars per share) | $ 2.18 | ||
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) | 1,044,417 | 1,044,417 | |
Options, Granted (in shares) | 245,776 | ||
Options, Exercised (in shares) | 0 | ||
Options, Forfeited (in shares) | (44,150) | ||
Options, Expired (in shares) | (140,635) | ||
Options, Outstanding, End of Period (in shares) | 1,105,408 | ||
Options, Outstanding, Weighted Average Exercise Price [Abstract] | |||
Options, Outstanding. Beginning of Period (in dollars per share) | $ 18.31 | $ 18.31 | |
Options, Granted (in dollars per share) | 3.22 | ||
Options, Exercised (in dollars per share) | 0 | ||
Options, Forfeited (in dollars per share) | 3.79 | ||
Options, Expired (in dollars per share) | 27.33 | ||
Options, Outstanding, End of Period (in dollars per share) | $ 14.39 | ||
Options, Outstanding, Weighted Average Remaining Contractual Term | 6 years 21 days | 6 years 2 months 26 days | |
Options, Outstanding, Aggregate Intrinsic Value | $ 0 | $ 0 | |
Options, Vested and expected to vest (in shares) | 1,083,355 | ||
Options, Vested and expected to vest, Weighted Average Exercise Price (in dollars per share) | $ 14.61 | ||
Options, Vested and expected to vest, Weighted Average Remaining Contractual Term | 6 years 2 months 4 days | ||
Options, Vested and expected to vest, Aggregate Intrinsic Value | $ 0 | ||
Options, Vested (in shares) | 816,133 | ||
Options, Vested, Weighted Average Exercise Price (in dollars per share) | $ 18.13 | ||
Options, Vested, Weighted Average Remaining Contractual Term | 5 years 4 months 2 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 | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Restricted Stock | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of restricted stock issued | 156,184 | 123,564 |
Value of restricted stock issued | $ 512 | $ 612 |
Weighted average estimated fair value of restricted stock issued | $ 3.02 | $ 4.93 |
Restricted Stock Units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of restricted stock issued | 246,383 | 184,454 |
Value of restricted stock issued | $ 743 | $ 909 |
Vesting terms (years) | 1 year |
Share-Based Compensation (Detai
Share-Based Compensation (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | $ 229 | $ 254 | $ 1,090 | $ 1,047 |
Stock Options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized compensation cost | $ 530 | $ 530 | ||
Expected weighted-average period in years of compensation cost to be recognized | 1 year 8 months 8 days | |||
Total fair value of shares vested | $ 535 | $ 398 | ||
Weighted average estimated fair value of shares granted (in dollars per share) | $ 2.12 | $ 3.18 | $ 2.12 | $ 3.18 |
Restricted Stock Units | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized compensation cost | $ 221 | $ 221 | ||
Expected weighted-average period in years of compensation cost to be recognized | 1 year 8 months 1 day | |||
Restricted Stock | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized compensation cost | 76 | $ 76 | ||
Expected weighted-average period in years of compensation cost to be recognized | 3 months | |||
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | 58 | $ 54 | $ 240 | $ 229 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | $ 171 | $ 200 | $ 850 | $ 818 |
Research Funding (Details)
Research Funding (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 41 Months Ended | |||||||
Sep. 30, 2020 | May 31, 2019 | Mar. 31, 2018 | Dec. 31, 2017 | May 31, 2017 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Feb. 28, 2017 | |
Research and Development [Abstract] | |||||||||||
Grants awarded | $ 8,600 | $ 8,600 | $ 8,600 | $ 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 | $ 300 | $ 700 | $ 1,600 | $ 2,000 |
Income Taxes - Net Operating Lo
Income Taxes - Net Operating Loss Carry Forward (Details) - USD ($) $ in Millions | Apr. 21, 2020 | Mar. 31, 2020 | Dec. 31, 2019 |
Operating Loss Carryforwards [Line Items] | |||
Market capitalization used in net operating loss analysis | $ 124.5 | ||
Annual limitation on usage of net operating losses | $ 3 | ||
Sale of NOLs, value | $ 11.5 | ||
Proceeds from sale of NOLs | $ 10.9 | ||
Federal | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards | $ 246 |