x | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
DELAWARE | 22-2343568 |
(State or other jurisdiction of | (I.R.S. Employer |
incorporation or organization) | Identification No.) |
110 Allen Road, 2nd Floor, Basking Ridge, New Jersey | 07920 |
(Address of principal executive offices) | (zip code) |
Title of Each Class | Name of Each Exchange On Which Registered | |
Common Stock, par value $0.001 per share | The Nasdaq Capital Market |
Large accelerated filer o | Accelerated filer o |
Non-accelerated filer o (Do not check if a smaller reporting company) | Smaller reporting company x |
Emerging growth company o |
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS | ||
ITEM 1. BUSINESS | ||
ITEM 1A. RISK FACTORS | 18 | |
ITEM 1B. UNRESOLVED STAFF COMMENTS | 49 | |
ITEM 2. PROPERTIES | 49 | |
ITEM 3. LEGAL PROCEEDINGS | 49 | |
ITEM 4. MINE SAFTEY DISCLOSURES | 49 | |
PART II | ||
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES | 51 | |
ITEM 6. SELECTED FINANCIAL DATA | 52 | |
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS | 53 | |
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK | 60 | |
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA | 61 | |
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE | 88 | |
ITEM 9A. CONTROLS AND PROCEDURES | 88 | |
ITEM 9B. OTHER INFORMATION | 89 | |
PART III | ||
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE | 90 | |
ITEM 11. EXECUTIVE COMPENSATION | 90 | |
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS | 90 | |
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE | 90 | |
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES | 90 | |
PART IV | ||
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES | 90 | |
ITEM 16. FORM 10-K SUMMARY | 94 |
• | our ability to obtain sufficient capital or strategic business arrangements to fund our operations and expansion plans, including meeting our financial obligations under various licensing and other strategic arrangements, the funding of our clinical trials for product candidates, and the commercialization of the relevant technology; |
• | our ability to build and maintain the management and human resources infrastructure necessary to support the growth of our business; |
• | whether a market is established for our cell-based products and services and our ability to capture a meaningful share of this market; |
• | scientific, regulatory and medical developments beyond our control; |
• | our ability to obtain and maintain, as applicable, appropriate governmental licenses, accreditations or certifications or comply with healthcare laws and regulations or any other adverse effect or limitations caused by government regulation of our business; |
• | whether any of our current or future patent applications result in issued patents, the scope of those patents and our ability to obtain and maintain other rights to technology required or desirable for the conduct of our business; and our ability to commercialize products without infringing the claims of third party patents; |
• | whether any potential strategic or financial benefits of various licensing agreements will be realized; |
• | the results of our development activities; and |
• | our ability to complete our other planned clinical trials (or initiate other trials) in accordance with our estimated timelines due to delays associated with enrolling patients due to the novelty of the treatment, the size of the patient population and the need of patients to meet the inclusion criteria of the trial or otherwise. |
• | Eight patents and eight pending patent applications; |
• | Claims covering many facets of Tregs, including: |
• | Methods of Treg isolation, expansion and activation/stimulation as sourced from peripheral blood and cord blood; and |
• | Methods of treating or preventing Type 1 diabetes using Tregs. |
• | Patents and applications cover international geographies (United States, EU, Japan, China, Australia and Canada). |
• | An option on patent licenses to critical reagents employed in Treg therapeutic development. |
• | Nine U.S. patents, two EU patents (each filed in 11 individual countries) and 15 other patents outside the U.S (Japan, South Africa, Malaysia, Philippines, Canada, Russia, Israel, Hong Kong) |
• | Claims cover, inter alia, a pharmaceutical composition that contains a therapeutic concentration of non-expanded CD34 stem cells that move in response to SDF-1 or VEGF, together with a stabilizing amount of serum, and that can be delivered to repair an injury caused by vascular insufficiency. |
• | Issued and pending claims can be applied to a broad range of conditions caused by underlying ischemia, including: AMI, chronic myocardial ischemia post-AMI; chronic heart failure; critical limb ischemia; and ischemic brain injury |
• | 12 patent applications outside the United States are pending. |
• | Portfolio of three granted patents applications for a neurological regeneration product, including: |
• | Methods of Derivation of Neuronal Progenitor Cells from Embryonic Stem Cells; |
• | Human Neuronal Progenitor Cells Co-Expressing Nestin and PAX6, and Co-Expressing NEUN or TUJ1; and |
• | Cellular Therapeutic Approaches to Traumatic Brain and Spinal Cord Injury. |
• | The portfolio is international, including filings in the United States and the EU. |
• | Phase 1: Trials in this phase are initially conducted in a limited population of healthy volunteers to test the product candidate for safety, dose tolerance, absorption, metabolism, distribution and excretion in healthy humans or, on occasion, in patients, such as cancer patients, when the drug or biologic is too toxic to be ethically given to healthy individuals. |
• | Phase 2: These clinical trials are generally conducted in a limited patient population to identify appropriate therapeutic dose and dose frequency as well as any corresponding additional possible adverse effects and safety risks and to determine the presence and approximate magnitude of therapeutic effect of the product for specific targeted indications. Multiple Phase 2 clinical trials may be conducted by the sponsor to obtain information prior to beginning larger and more expensive Phase 3 clinical trials. |
• | Phase 3: These are commonly referred to as pivotal or registration studies. When Phase 2 evaluations demonstrate that a dose range of the product is effective and has an acceptable safety profile, Phase 3 clinical trials are typically undertaken in a larger patient population to further evaluate dosage, to provide substantial evidence of clinical efficacy and to further test for safety in an expanded and diverse patient population at multiple and geographically-dispersed clinical trial sites. In most cases, FDA requires two adequate and well controlled Phase 3 clinical trials to demonstrate the efficacy of the drug as a requirement for registration. |
• | Phase 4: In some cases, FDA may condition approval of an NDA or BLA for a product candidate on the sponsor's agreement to conduct additional clinical trials after NDA or BLA approval. In other cases, a sponsor may voluntarily carry out additional trials post approval to gain more information about the drug or biologic. |
• | state and local licensure, registration and regulation of laboratories, the processing and storage of human cells and tissue, and the development and manufacture of pharmaceuticals and biologics; |
• | other laws and regulations administered by the United States FDA, including the FD&C Act and related laws and |
• | laws and regulations administered by the United States Department of Health and Human Services, including the Office for Human Research Protections; |
• | state laws and regulations governing human subject research; |
• | federal and state coverage and reimbursement laws and regulations, including laws and regulations administered by the Centers for Medicare & Medicaid Services and state Medicaid agencies; |
• | the federal Medicare and Medicaid Anti-Kickback Law and similar state laws and regulations; |
• | the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act and similar state laws and regulations; |
• | the federal physician self-referral prohibition commonly known as the Stark Law, and state equivalents of the Stark Law; |
• | Occupational Safety and Health Administration requirements; |
• | state and local laws and regulations dealing with the handling and disposal of medical waste; and |
• | the Intermediate Sanctions rules of the IRS providing for potential financial sanctions with respect to “Excess Benefit Transactions” with tax-exempt organizations. |
• | the scope, progress, results, costs, timing and outcomes of our cell therapy research and development programs and product candidates; |
• | our ability to enter into any collaboration agreements with third parties for our product candidates and the timing and terms of any such agreements; |
• | the costs associated with the consummation of one or more strategic transactions; |
• | the timing of and the costs involved in obtaining regulatory approvals for our product candidates, a process which could be particularly lengthy or complex given the FDA's limited experience with marketing approval for cell therapy products; |
• | the costs of maintaining, expanding and protecting our intellectual property portfolio, including potential litigation costs and liabilities; and |
• | the cost of expansion of our development operations and personnel. |
• | completing research regarding, and nonclinical and clinical development of, our product candidates; |
• | obtaining regulatory approvals and marketing authorizations for product candidates for which we complete clinical trials; |
• | developing a sustainable and scalable manufacturing process for our product candidates; |
• | identifying and contracting with contract manufacturers that have the ability and capacity to manufacture our development products and make them at an acceptable cost; |
• | launching and commercializing product candidates for which we obtain regulatory approvals and marketing authorizations, either directly or with a collaborator or distributor; |
• | obtaining market acceptance of our product candidates as viable treatment options; |
• | addressing any competing technological and market developments; |
• | identifying, assessing, acquiring and/or developing new product candidates; |
• | negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter; |
• | maintaining, protecting, and expanding our portfolio of intellectual property rights, including patents, trade secrets, and know-how; and |
• | attracting, hiring, and retaining qualified personnel. |
• | suspensions, delays or changes in the design, initiation, enrollment, implementation or completion of required clinical trials; |
• | adverse changes in our financial position or significant and unexpected increases in the cost of our clinical development program; |
• | changes or uncertainties in, or additions to, the regulatory approval process that require us to alter our current development strategy; |
• | clinical trial results that are negative, inconclusive or even less than desired as to safety and/or efficacy, which could result in the need for additional clinical trials or the termination of the product's development; |
• | delays in our ability to manufacture the product in quantities or in a form that is suitable for any required clinical trials; |
• | intellectual property constraints that prevent us from making, using, or commercializing any of our cell therapy product candidates; |
• | the supply or quality of our product candidates or other materials necessary to conduct clinical trials of these product candidates may be insufficient or inadequate: |
• | inability to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation of clinical trials; |
• | delays in reaching agreement on acceptable terms with prospective contract research organizations, or CROs, contract manufacturing organizations or CMOs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs, CMOs and clinical trial sites; |
• | delays in obtaining required IRB approval at each clinical trial site; |
• | inability to file IND's for our development candidates; |
• | imposition of a temporary or permanent clinical hold by the FDA or similar restrictions by other regulatory agencies for a number of reasons, including after review of an IND or amendment, or equivalent application or amendment; as a result of a new safety finding that presents unreasonable risk to clinical trial participants; a negative finding from an inspection of our clinical trial operations or clinical trial sites; developments on trials conducted by competitors or approved products post-market for related technology that raises FDA concerns about risk to patients of the technology broadly; or if FDA finds that the investigational protocol or plan is clearly deficient to meet its stated objectives; |
• | difficulty collaborating with patient groups and investigators; |
• | failure by our CROs, CMOs other third parties, or us to adhere to clinical trial requirements; |
• | failure to perform in accordance with the FDA or international GCP requirements; |
• | failure to reach agreement with the FDA on a satisfactory development path of our development candidates; |
• | delays in having patients qualify for or complete participation in a trial or return for post-treatment follow-up; |
• | patients dropping out of a clinical trial; |
• | occurrence of adverse events associated with the product candidate; |
• | changes in the standard of care on which a clinical development plan was based, which may require new or additional trials or abandoning existing trials; |
• | transfer of manufacturing processes from our academic collaborators to larger-scale facilities operated by either a contract manufacturing organization, or CMO, or by us, and delays or failure by our CMOs or us to make any necessary changes to such manufacturing process; |
• | delays in manufacturing, testing, releasing, validating, or importing/exporting sufficient stable quantities of our product candidates for use in clinical trials or the inability to do any of the foregoing; and |
• | FDA may not accept clinical data from trials that are conducted in countries where the standard of care is potentially different from the United States. |
• | obtain approval for indications that are not as broad as the indications we sought; |
• | have the product removed from the market after obtaining marketing approval; |
• | encounter problems with respect to the manufacturing of commercial supplies |
• | be subject to additional post-marketing testing requirements; and/or |
• | be subject to restrictions on how the product is distributed or used. |
• | patients failing to complete clinical trials due to dissatisfaction with the treatment, side effects or other reasons; |
• | failure by regulators to authorize us to commence a clinical trial; |
• | suspension or termination by regulators of clinical research for many reasons, including concerns about patient safety or failure of our contract manufacturers to comply with cGMP requirements; |
• | delays or failure to obtain clinical supply for our products necessary to conduct clinical trials from contract manufacturers, including commercial grade clinical supply for our trials; |
• | treatment candidates demonstrating a lack of efficacy during clinical trials; |
• | inability to continue to fund clinical trials or to find a partner to fund the clinical trials; |
• | competition with ongoing clinical trials and scheduling conflicts with participating clinicians; and |
• | delays in completing data collection and analysis for clinical trials. |
• | be subject to restrictions on how the product is distributed or used; |
• | our ability to distinguish our products (which involve adult cells) from any ethical and political controversies associated with stem cell products derived from human embryonic or fetal tissue; and |
• | the cost of the product, the reimbursement policies of government and third-party payors and our ability to obtain sufficient third-party coverage or reimbursement. |
• | collaborators have significant discretion in determining the efforts and resources that they will apply to a collaboration; |
• | collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in their strategic focus due to the acquisition of competitive products, availability of funding, or other external factors, such as a business combination that diverts resources or creates competing priorities; |
• | collaborators may delay clinical trials, provide insufficient funding for a clinical trial, stop a clinical trial, abandon a product candidate, repeat or conduct new clinical trials, or require a new formulation of a product candidate for clinical testing; |
• | collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates; |
• | a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to their marketing and distribution; |
• | collaborators may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability; |
• | disputes may arise between us and a collaborator that cause the delay or termination of the research, development or commercialization of our product candidates, or that result in costly litigation or arbitration that diverts management attention and resources; |
• | collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; and |
• | collaborators may own or co-own intellectual property covering our products that results from our collaborating with them, and in such cases, we would not have the exclusive right to commercialize such intellectual property. |
• | the product candidates require significant clinical testing to demonstrate safety and effectiveness before applications for marketing approval can be submitted to the FDA and other regulatory authorities; |
• | data obtained from animal testing and other nonclinical testing and clinical trials can be interpreted in different ways, and regulatory authorities may not agree with our respective interpretations or may require us to conduct additional testing |
• | negative or inconclusive results or the occurrence of serious or unexpected adverse events during a clinical trial could cause us to delay or terminate development efforts for a product candidate; and/or |
• | the FDA and other regulatory authorities may require expansion of the size and scope of the clinical trials. |
• | third-party clinical investigators do not perform the clinical trials on the anticipated schedule or consistent with the clinical trial protocol, good clinical practices required by the FDA and other regulatory requirements, or other third parties do not perform data collection and analysis in a timely or accurate manner; |
• | inspections of clinical trial sites by the FDA or by IRBs of research institutions participating in the clinical trials, reveal regulatory violations that require the sponsor of the trial to undertake corrective action, suspend or terminate one or more sites, or prohibit use of some or all of the data in support of marketing applications; or |
• | the FDA or one or more IRBs suspends or terminates the trial at an investigational site, or precludes enrollment of additional subjects. |
• | warning letters or untitled letters or other actions requiring changes in product manufacturing processes or restrictions on product marketing or distribution; |
• | product recalls or seizures or the temporary or permanent withdrawal of a product from the market; and |
• | fines, restitution or disgorgement of profits or revenue, the imposition of civil penalties or criminal prosecution. |
• | regulatory authorities may withdraw their approval of the product; |
• | regulatory authorities may require a recall of the product or we may voluntarily recall a product; |
• | regulatory authorities may require the addition of warnings or contradictions in the product labeling, narrowing of the indication in the product label or issuance of field alerts to physicians and pharmacies; |
• | we may be required to create a medication guide outlining the risks of such side effects for distribution to patients or institute a REMS; |
• | we may be subject to limitation as to how we promote the product; |
• | we may be required to change the way the product is administered or modify the product in some other way; |
• | the FDA or applicable foreign regulatory authority may require additional clinical trials or costly post-marketing testing and surveillance to monitor the safety or efficacy of the product; |
• | sales of the product may decrease significantly; |
• | we could be sued and held liable for harm caused to patients; and |
• | our brand and reputation may suffer |
• | differing regulatory requirements in foreign countries; |
• | unexpected changes in tariffs, trade barriers, price and exchange controls, and other regulatory requirements; |
• | economic weakness, including inflation, or political instability in particular foreign economies and markets; |
• | compliance with tax, employment, immigration, and labor laws for employees living or traveling abroad; |
• | foreign taxes, including withholding of payroll taxes; |
• | foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country; |
• | difficulties staffing and managing foreign operations; |
• | workforce uncertainty in countries where labor unrest is more common than in the United States; |
• | potential liability under the Foreign Corrupt Practices Act of 1977 or comparable foreign laws; |
• | challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States; |
• | production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and |
• | business interruptions resulting from geo-political actions, including war and terrorism. |
• | low levels of trading volume for our shares; |
• | capital-raising or other transactions that are, or may in the future be, dilutive to existing stockholders or that involve the issuance of debt securities; |
• | delays in our clinical trials, negative clinical trial results or adverse regulatory decisions relating to our product candidates; |
• | adverse fluctuations in our revenues or operating results or financial results that otherwise fall below the market's expectations; |
• | disappointing developments concerning our cell therapy services clients or other collaborators for our product candidates; and |
• | legal challenges, disputes and/or other adverse developments impacting our patents or other proprietary rights that protect our products. |
2017 | High | Low |
First Quarter | $7.79 | $2.85 |
Second Quarter | $5.54 | $4.10 |
Third Quarter | $4.71 | $3.58 |
Fourth Quarter | $3.93 | $2.63 |
2016 | High | Low |
First Quarter | $13.30 | $4.00 |
Second Quarter | $7.80 | $4.50 |
Third Quarter | $6.50 | $5.10 |
Fourth Quarter | $5.00 | $2.65 |
Equity Compensation Plan Information | ||||
Number of securities to be issued upon exercise of outstanding options (1) | Weighted Average exercise price of outstanding options and rights | Number of securities remaining available for future issuance under equity compensation plan (excluding securities referenced in column (a)) | ||
Equity compensation plans approved by security holders (2) | 1,072,499 | $33.50 | 75,027 | (3) |
(1) | Includes stock options only; does not include purchase rights accruing under the 2012 ESPP Plan because the purchase price (and therefore the number of shares to be purchased) will not be determined until the end of the purchase period. |
(2) | Consists of the 2003 Plan, the 2009 Plan, the 2015 Plan, the 2012 ESPP, and the 2017 ESPP. |
(3) | Includes shares available for future issuance under the 2015 Plan and the 2017 ESPP. |
• | Research and development expenses were approximately $15.8 million for the year ended December 31, 2017 compared to $16.7 million for the year ended December 31, 2016, representing a decrease of approximately $0.9 million, or 5%. |
◦ | Immune Modulation - Immune modulation expenses, primarily related to expenses associated with our Phase 2 study of CLBS03 in T1D, were $13.4 million for the year ended December 31, 2017, representing an increase of $2.9 million compared to the year ended December 31, 2016. The higher expenses are due to higher clinical trial and manufacturing costs in the current year period compared to the prior year period. |
◦ | Ischemic Repair - Ischemic repair expenses were $2.7 million for the year ended December 31, 2017, representing an increase of approximately $0.5 million compared to the year ended December 31, 2016. The expenses for the year ended December 31, 2017 are primarily related to initiation-related program expenses associated with our critical limb ischemia development program in Japan. The expenses for the year ended December 31, 2016 are primarily associated with close-out activities of the PreServe AMI Phase 2 clinical trial for CLBS10. |
◦ | Other - Other research and development expenses during the year ended December 31, 2016 included $2.6 million of close-out activities for the Intus Phase 3 clinical trial for the immunotherapy product candidate CLBS20, announced in January 2016, along with $1.1 million of associated one-time restructuring costs for severance and asset impairments. |
• | General and administrative expenses were approximately $11.8 million for the year ended December 31, 2017, compared to $12.8 million for the year ended December 31, 2016, representing a decrease of approximately $1.1 million, or 8%. The decrease was related to operational and compensation-related cost reductions compared to the prior year period. |
Fair value of consideration received | $ | 79,425 | |
Transaction and retention costs | (6,919 | ) | |
Carrying value of segment non-controlling interest | 3,687 | ||
$ | 76,193 | ||
Less carrying amount of assets and liabilities sold: | |||
Cash | $ | 6,727 | |
Accounts receivable | 3,702 | ||
Deferred costs | 4,685 | ||
Prepaid expenses and other current assets | 743 | ||
Property, plant and equipment, net | 14,900 | ||
Goodwill | 7,013 | ||
Intangibles, net | 2,090 | ||
Other assets | 215 | ||
Accounts payable | (2,278 | ) | |
Accrued liabilities | (2,927 | ) | |
Due from Caladrius | 450 | ||
Unearned revenues | (10,529 | ) | |
Notes payable | (342 | ) | |
$ | 24,449 | ||
Gain on sale of PCT | $ | 51,744 |
Year Ended December 31, | |||||||
2017 | 2016 | ||||||
Revenue | $ | 16,039 | $ | 42,043 | |||
Cost of revenues | (15,321 | ) | (35,519 | ) | |||
Research and development | (257 | ) | (800 | ) | |||
Selling, general, and administrative | (3,251 | ) | (7,558 | ) | |||
Other expense | (14 | ) | (80 | ) | |||
Provision for income taxes | (10,541 | ) | (138 | ) | |||
Gain on sale of segment | 51,744 | — | |||||
Income (loss) from discontinued operations | $ | 38,399 | $ | (2,052 | ) |
Year Ended December 31, | |||||||
2017 | 2016 | ||||||
Net cash used in operating activities - continuing operations | $ | (20,237.8 | ) | $ | (28,225.3 | ) | |
Net cash provided by (used in) investing activities - continuing operations | 41,459.4 | (1,099.5 | ) | ||||
Net cash (used in) provided by financing activities - continuing operations | (857.5 | ) | 16,912.9 |
• | We paid $5.7 million in principal payments on our long-term debt to Oxford Finance, which was fully repaid and retired on May 18, 2017. |
• | We raised gross proceeds of approximately $4.4 million through the issuance of approximately 932,204 shares of our common stock under the conditions of the Second Closing (achievement of the enrollment of 70 subjects in our Phase 2 CLBS03 clinical trial), relating to the September 2016 private placement offering. |
• | We raised gross proceeds of approximately $1.2 million through the issuance of approximately 210,506 shares of our common stock under the provisions of our Common Stock Purchase Agreement with Aspire which expired in November 2017. |
• | We received proceeds of $0.4 million from the issuance of notes payable relating to certain insurance policies and equipment financings, less repayments of $1.0 million. |
• | Hitachi purchased a 19.9% membership interest in PCT for $19.4 million, of which $15.0 million of proceeds was distributed to Caladrius from PCT and $4.4 million remained at PCT. |
• | We raised $4.0 million in a registered direct offering through the issuance of 847,458 shares of our common stock, and $6.6 million in concurrent private placement offerings through the issuance of 1,398,305 shares of our common stock. |
• | We paid $6.3 million in principal payments on our long term debt to Oxford Finance upon our sale of a 19.9% membership interest in PCT to Hitachi, and, in September 2016, we paid an additional $3.0 million in principal payments on our long term debt to Oxford Finance. |
• | We raised $1.0 million in a private placement through the issuance of 141,844 shares of our common stock and two-year warrants to purchase up to an aggregate of 141,844 shares our common stock, at an exercise price of $10.00 per share. |
• | We received proceeds of $0.8 million from the issuance of notes payable relating to certain insurance policies and equipment financings, less repayments of $1.0 million. |
46 |
Report of Independent Registered Public Accounting Firm | 63 | |
Financial Statements: | ||
Consolidated Balance Sheets at December 31, 2017 and 2016 | 64 | |
Consolidated Statements of Operations - Years Ended December 31, 2017 and 2016 | 65 | |
Consolidated Statements of Comprehensive Loss - Years Ended December 31, 2017 and 2016 | 66 | |
Consolidated Statements of Equity - Years Ended December 31, 2017 and 2016 | 67 | |
Consolidated Statements of Cash Flows - Years Ended December 31, 2017 and 2016 | 68 | |
Notes to Consolidated Financial Statements | 70 |
December 31, 2017 | December 31, 2016 | ||||||
ASSETS | |||||||
Current Assets | |||||||
Cash and cash equivalents | $ | 29,163,200 | $ | 7,076,651 | |||
Restricted cash | 5,004,789 | — | |||||
Marketable securities | 25,916,681 | — | |||||
Accounts receivable trade, net of allowance of $0 at December 31, 2017 and 2016, respectively | 234,461 | 138,774 | |||||
Prepaid and other current assets | 790,514 | 1,900,493 | |||||
Assets related to discontinued operations | — | 15,533,043 | |||||
Total current assets | 61,109,645 | 24,648,961 | |||||
Property, plant and equipment, net | 256,905 | 705,438 | |||||
Deferred tax assets | 575,055 | — | |||||
Other assets | 1,434,077 | 1,582,209 | |||||
Assets related to discontinued operations | — | 26,577,834 | |||||
Total assets | $ | 63,375,682 | $ | 53,514,442 | |||
LIABILITIES, REDEEMABLE SECURITIES - NON-CONTROLLING INTERESTS AND EQUITY | |||||||
Current Liabilities | |||||||
Accounts payable | $ | 1,343,089 | $ | 2,226,580 | |||
Accrued liabilities | 7,810,948 | 2,659,433 | |||||
Long-term debt, current | — | 3,126,457 | |||||
Notes payable, current | 159,180 | 563,777 | |||||
Due to PCT | — | 1,681,594 | |||||
Liabilities related to discontinued operations | — | 10,925,052 | |||||
Total current liabilities | 9,313,217 | 21,182,893 | |||||
Notes payable | — | 159,180 | |||||
Long term debt | — | 2,524,897 | |||||
Other long-term liabilities | 3,872,679 | 389,858 | |||||
Liabilities related to discontinued operations | — | 5,791,134 | |||||
Total liabilities | 13,185,896 | 30,047,962 | |||||
Commitments and Contingencies | |||||||
Redeemable Securities - Non-Controlling Interests | — | 19,400,000 | |||||
EQUITY | |||||||
Stockholders' Equity | |||||||
Preferred stock; authorized, 20,000,000 shares Series B convertible redeemable preferred stock liquidation value, 1 share of common stock, $.01 par value; 825,000 shares designated; issued and outstanding, 10,000 shares at December 31, 2017 and December 31, 2016, respectively | 100 | 100 | |||||
Common stock, $.001 par value, authorized 500,000,000 shares; issued and outstanding, 9,483,911 and 8,205,790 shares, at December 31, 2017 and December 31, 2016, respectively | 9,484 | 8,206 | |||||
Additional paid-in capital | 433,044,209 | 410,372,049 | |||||
Treasury stock, at cost; 11,080 shares at December 31, 2017 and December 31, 2016 respectively | (707,637 | ) | (707,637 | ) | |||
Accumulated deficit | (381,810,109 | ) | (404,788,809 | ) | |||
Accumulated other comprehensive loss | (27,978 | ) | — | ||||
Total Caladrius Biosciences, Inc. stockholders' equity | 50,508,069 | 4,883,909 | |||||
Noncontrolling interests | (318,283 | ) | (817,429 | ) | |||
Total equity | 50,189,786 | 4,066,480 | |||||
$ | 63,375,682 | $ | 53,514,442 |
Year Ended December 31, | |||||||
2017 | 2016 | ||||||
Operating Expenses: | |||||||
Research and development | $ | 15,842,959 | $ | 16,699,213 | |||
General, and administrative | 11,750,080 | 12,802,735 | |||||
Operating expenses | 27,593,039 | 29,501,948 | |||||
Operating loss | (27,593,039 | ) | (29,501,948 | ) | |||
Other income (expense): | |||||||
Other income (expense), net | 273,101 | 23,854 | |||||
Interest expense | (377,768 | ) | (1,779,657 | ) | |||
(104,667 | ) | (1,755,803 | ) | ||||
Loss before benefit from income taxes and noncontrolling interests | (27,697,706 | ) | (31,257,751 | ) | |||
Benefit from income taxes | (11,526,557 | ) | — | ||||
Net loss from continuing operations | (16,171,149 | ) | (31,257,751 | ) | |||
Discontinued operations - net | 38,399,236 | (2,051,782 | ) | ||||
Net income (loss) | 22,228,087 | (33,309,533 | ) | ||||
Less - net loss from continuing operations attributable to noncontrolling interests | (182,457 | ) | (241,802 | ) | |||
Less - net loss from discontinued operations attributable to noncontrolling interests | (568,156 | ) | (411,412 | ) | |||
Net income (loss) attributable to Caladrius Biosciences, Inc. common shareholders | 22,978,700 | (32,656,319 | ) | ||||
Amounts Attributable to Caladrius Inc. common shareholders: | |||||||
Loss from continuing operations | (15,988,692 | ) | (31,015,949 | ) | |||
Income (loss) from discontinued operations - net of taxes | 38,967,392 | (1,640,370 | ) | ||||
Net income (loss) attributable to Caladrius Inc. common shareholders | $ | 22,978,700 | $ | (32,656,319 | ) | ||
Basic and diluted income (loss) per share | |||||||
Basic earnings (loss) | |||||||
Continuing operations | $ | (1.78 | ) | $ | (4.74 | ) | |
Discontinued operations | $ | 4.34 | $ | (0.25 | ) | ||
Caladrius Biosciences, Inc. common shareholders | $ | 2.56 | $ | (4.99 | ) | ||
Diluted earnings (loss) | |||||||
Continuing operations | $ | (1.78 | ) | $ | (4.74 | ) | |
Discontinued operations | $ | 4.34 | $ | (0.25 | ) | ||
Caladrius Biosciences, Inc. common shareholders | $ | 2.56 | $ | (4.99 | ) | ||
Weighted average common shares outstanding: | |||||||
Basic shares | 8,968,954 | 6,548,251 | |||||
Diluted shares | 8,968,954 | 6,548,251 |
Year Ended December 31, | |||||||
2017 | 2016 | ||||||
Net income (loss) | $ | 22,228,087 | $ | (33,309,533 | ) | ||
Other comprehensive loss: | |||||||
Available for sale securities - net unrealized loss | (27,978 | ) | (486 | ) | |||
Total other comprehensive loss | (27,978 | ) | (486 | ) | |||
Comprehensive income (loss) | 22,200,109 | (33,310,019 | ) | ||||
Comprehensive loss attributable to noncontrolling interests | (750,613 | ) | (653,214 | ) | |||
Comprehensive income (loss) attributable to Caladrius Biosciences, Inc. common stockholders | $ | 22,950,722 | $ | (32,656,805 | ) |
Series B Convertible Preferred Stock | Common Stock | Additional Paid in Capital | Accumulated Other Comprehensive Income | Accumulated Deficit | Treasury Stock | Total Caladrius Biosciences, Inc. Stockholders' Equity | Non- Controlling Interest in Subsidiary | Total Equity | |||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | ||||||||||||||||||||||||||||||||||||||
Balance at December 31, 2015 | 10,000 | $ | 100 | 5,673,302 | $ | 5,673 | $ | 396,547,401 | $ | 486 | $ | (372,132,490 | ) | $ | (707,637 | ) | $ | 23,713,533 | $ | (429,709 | ) | $ | 23,283,824 | ||||||||||||||||||
Net loss | — | — | — | — | — | — | (32,656,319 | ) | — | (32,656,319 | ) | (653,214 | ) | (33,309,533 | ) | ||||||||||||||||||||||||||
Unrealized loss on marketable securities | — | — | — | — | — | (486 | ) | — | — | (486 | ) | — | (486 | ) | |||||||||||||||||||||||||||
Share-based compensation | — | — | 114,344 | 114 | 2,532,167 | — | — | 2,532,281 | — | 2,532,281 | |||||||||||||||||||||||||||||||
Net proceeds from issuance of common stock | — | — | 2,418,144 | 2,419 | 11,557,975 | — | — | — | 11,560,394 | — | 11,560,394 | ||||||||||||||||||||||||||||||
Change in ownership in subsidiary | — | — | — | — | (265,494 | ) | — | — | — | (265,494 | ) | 265,494 | — | ||||||||||||||||||||||||||||
Balance at December 31, 2016 | 10,000 | $ | 100 | 8,205,790 | $ | 8,206 | $ | 410,372,049 | $ | — | $ | (404,788,809 | ) | $ | (707,637 | ) | $ | 4,883,909 | $ | (817,429 | ) | $ | 4,066,480 | ||||||||||||||||||
Net income | — | — | — | — | — | — | 22,978,700 | — | 22,978,700 | (750,613 | ) | 22,228,087 | |||||||||||||||||||||||||||||
Unrealized loss on marketable securities | — | — | — | — | — | (27,978 | ) | — | — | (27,978 | ) | — | (27,978 | ) | |||||||||||||||||||||||||||
Share-based compensation | — | — | 54,545 | 55 | 2,494,416 | — | — | — | 2,494,471 | — | 2,494,471 | ||||||||||||||||||||||||||||||
Net proceeds from issuance of common stock | — | — | 1,219,741 | 1,219 | 5,700,467 | — | — | — | 5,701,686 | — | 5,701,686 | ||||||||||||||||||||||||||||||
Proceeds from option exercises | — | — | 3,835 | 4 | 13,572 | — | — | — | 13,576 | — | 13,576 | ||||||||||||||||||||||||||||||
Elimination of equity associated with PCT sale | — | — | — | — | — | — | — | — | — | (3,686,536 | ) | (3,686,536 | ) | ||||||||||||||||||||||||||||
Conversion of redeemable securities | — | — | — | — | 14,733,908 | — | — | — | 14,733,908 | 4,666,092 | 19,400,000 | ||||||||||||||||||||||||||||||
Change in ownership in subsidiary | — | — | — | — | (270,203 | ) | — | — | — | (270,203 | ) | 270,203 | — | ||||||||||||||||||||||||||||
Balance at December 31, 2017 | 10,000 | $ | 100 | 9,483,911 | $ | 9,484 | $ | 433,044,209 | $ | (27,978 | ) | $ | (381,810,109 | ) | $ | (707,637 | ) | $ | 50,508,069 | $ | (318,283 | ) | $ | 50,189,786 |
Year Ended December 31, | |||||||
2017 | 2016 | ||||||
Cash flows from operating activities: | |||||||
Net income (loss) | $ | 22,228,087 | $ | (33,309,533 | ) | ||
(Income) loss from discontinued operations | (38,399,236 | ) | 2,051,782 | ||||
Adjustments to reconcile net income (loss) to net cash used in operating activities: | |||||||
Equity-based compensation expense | 1,963,202 | 1,773,691 | |||||
Depreciation and amortization | 372,001 | 450,266 | |||||
Loss on disposal of assets | 211,813 | 591,307 | |||||
Income tax benefit | (11,526,557 | ) | — | ||||
Deferred income taxes | (575,055 | ) | — | ||||
Amortization/Accretion on marketable securities | 339,964 | — | |||||
Changes in operating assets and liabilities: | |||||||
Prepaid and other current assets | 1,109,979 | 457,390 | |||||
Accounts receivable | (95,686 | ) | (101,882 | ) | |||
Other assets | 148,150 | 222,632 | |||||
Due to PCT | (1,681,593 | ) | 2,784,760 | ||||
Accounts payable, accrued liabilities and other liabilities | 5,667,118 | (3,145,758 | ) | ||||
Net cash used in operating activities - continuing operations | (20,237,813 | ) | (28,225,345 | ) | |||
Net cash (used in) provided by operating activities - discontinued operations | (638,069 | ) | 4,557,663 | ||||
Net cash used in operating activities | (20,875,882 | ) | (23,667,682 | ) | |||
Cash flows from investing activities: | |||||||
Purchase of marketable securities | (60,158,123 | ) | — | ||||
Sales of marketable securities | 33,873,500 | — | |||||
Proceeds from PCT sale | 74,606,591 | — | |||||
Net cash sold in PCT sale | (6,727,263 | ) | — | ||||
Acquisition of property and equipment | (135,281 | ) | (1,099,460 | ) | |||
Net cash provided by (used in) investing activities - continuing operations | 41,459,424 | (1,099,460 | ) | ||||
Net cash used in investing activities - discontinued operations | (188,794 | ) | (1,749,836 | ) | |||
Net cash provided by (used in) investing activities | 41,270,630 | (2,849,296 | ) | ||||
Cash flows from financing activities: | |||||||
Proceeds from exercise of options | 13,576 | — | |||||
Tax withholding payments on net share settlement equity awards | (357,666 | ) | (72,010 | ) | |||
Net proceeds from issuance of capital stock | 5,701,686 | 11,560,394 | |||||
Repayment of long-term debt | (5,651,354 | ) | (9,348,646 | ) | |||
Proceeds from notes payable | 400,998 | 803,498 | |||||
Repayment of notes payable | (964,776 | ) | (1,030,351 | ) | |||
PCT dividend to Caladrius | — | 15,000,000 | |||||
Net cash (used in) provided by financing activities - continuing operations | (857,536 | ) | 16,912,885 | ||||
Net cash (used in) provided by financing activities - discontinued operations | (74,231 | ) | 3,990,690 | ||||
Net cash (used in) provided by financing activities | (931,767 | ) | 20,903,575 | ||||
Net increase (decrease) in cash, cash equivalents and restricted cash | 19,462,981 | (5,613,403 | ) | ||||
Cash and cash equivalents at beginning of year - continuing operations | 7,076,651 | 18,657,971 | |||||
Cash and cash equivalents at beginning of year - discontinued operations | 7,628,357 | 1,660,440 | |||||
Cash, cash equivalents and restricted cash at end of year | $ | 34,167,989 | $ | 14,705,008 | |||
Less cash and cash equivalents of discontinued operations at end of year | — | 7,628,357 | |||||
Cash, cash equivalents and restricted cash of continuing operations at end of year | $ | 34,167,989 | $ | 7,076,651 | |||
Supplemental Disclosure of Cash Flow Information: | |||||||
Cash paid during the period for: | |||||||
Interest | $ | 711,901 | $ | 1,823,424 | |||
Taxes | — | — |
Furniture and fixtures | 10 years |
Computer equipment | 3 years |
Software | 3 years |
Leasehold improvements | Life of lease |
• | Simultaneously with the closing of the 2017 Hitachi Transaction, Caladrius paid to Dr. Preti $1.9 million (the “First Retention Payment”). |
• | As an incentive to remain employed with PCT and to use commercially reasonable efforts to cause PCT to maximize its overall performance and in particular to achieve the Milestone (but not contingent upon achieving the Milestone), Dr. Preti will receive a lump-sum cash retention and incentive payment equal to $1.9 million for the period from the closing date until the date one year after the date of the closing date (the “Anniversary Date”), subject to Dr. Preti’s continued employment with PCT through the Anniversary Date (the “Second Retention Payment”). |
• | Dr. Preti will be entitled to 5% of the Milestone payment if it is successfully earned. |
December 31, 2017 | December 31, 2016 | ||||||||||||||||||||||||||||||
Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | ||||||||||||||||||||||||
Corporate debt securities | $ | 42,701.0 | $ | — | $ | (28.0 | ) | $ | 42,673.0 | $ | — | $ | — | $ | — | $ | — | ||||||||||||||
Money market funds | 9,211.5 | — | — | 9,211.5 | 4,426.8 | — | — | 4,426.8 | |||||||||||||||||||||||
Total | $ | 51,912.5 | $ | — | $ | (28.0 | ) | $ | 51,884.5 | $ | 4,426.8 | $ | — | $ | — | $ | 4,426.8 |
December 31, 2017 | December 31, 2016 | ||||||
Cash and cash equivalents | $ | 25,967.8 | $ | 4,426.8 | |||
Marketable securities | 25,916.7 | — | |||||
Total | $ | 51,884.5 | $ | 4,426.8 |
December 31, 2017 | |||||||
Amortized Cost | Estimated Fair Value | ||||||
Less than one year | $ | 51,912.5 | $ | 51,884.5 | |||
Greater than one year | — | — | |||||
Total | $ | 51,912.5 | $ | 51,884.5 |
December 31, | |||||||
2017 | 2016 | ||||||
Lab equipment | $ | — | $ | 181.6 | |||
Furniture and fixtures | 25.4 | 288.2 | |||||
Computer equipment | 998.3 | 1,173.4 | |||||
Software | — | 99.5 | |||||
Leasehold improvements | 65.6 | 115.7 | |||||
Property, plant and equipment, gross | 1,089.3 | 1,858.4 | |||||
Accumulated depreciation | (832.4 | ) | (1,153.0 | ) | |||
Property, plant and equipment, net | $ | 256.9 | $ | 705.4 |
December 31, | |||||
2017 | 2016 | ||||
Stock Options | 1,072,499 | 953,690 | |||
Warrants | 209,818 | 388,062 | |||
Restricted Shares | 181,908 | 126,849 | |||
Restricted Stock Units | 10,260 | — |
December 31, 2017 | December 31, 2016 | |||||||||||||||||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | Level 1 | Level 2 | Level 3 | Total | |||||||||||||||||||||||||
Assets: | ||||||||||||||||||||||||||||||||
Marketable securities - available for sale | $ | — | $ | 25,916.7 | $ | — | $ | 25,916.7 | $ | — | $ | — | $ | — | $ | — | ||||||||||||||||
$ | — | $ | 25,916.7 | $ | — | $ | 25,916.7 | $ | — | $ | — | $ | — | $ | — |
December 31, | |||||||
2017 | 2016 | ||||||
Salaries, employee benefits and related taxes | $ | 1,389.2 | $ | 1,406.3 | |||
Retention payments | 2,233.0 | — | |||||
Professional fees | 286.7 | 224.5 | |||||
CIRM upfront funding - current | 2,445.9 | — | |||||
Other | 1,456.1 | 1,028.6 | |||||
$ | 7,810.9 | $ | 2,659.4 |
2003 Equity Plan | 2009 Equity Plan | 2015 Equity Plan | ||||||
Shares Authorized for Issuance | 25,000 | 899,500 | 440,000 | |||||
2016 Evergreen increase of shares | — | — | 226,932 | |||||
2017 Evergreen increase of shares | 328,232 | |||||||
Outstanding Stock Options | (5,006 | ) | (432,916 | ) | (634,577 | ) | ||
Exercised Stock Options | (925 | ) | (8,093 | ) | (3,835 | ) | ||
Restricted stock or equity grants issued under Equity Plans | (8,922 | ) | (156,467 | ) | — | |||
Shares Expired | (10,147 | ) | (302,024 | ) | (314,254 | ) | ||
Total common shares remaining to be issued under the Equity Plans | — | — | 42,498 |
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, 2016 | 952,790 | $ | 39.90 | 7.60 | $ | — | 388,062 | $ | 76.50 | 1.24 | $ | — | |||||||||||||
Changes during the Year: | |||||||||||||||||||||||||
Granted | 448,057 | $ | 11.70 | — | $ | — | |||||||||||||||||||
Exercised | (3,835 | ) | $ | 4.70 | — | $ | — | ||||||||||||||||||
Forfeited | (244,413 | ) | $ | 18.80 | (1,937 | ) | $ | 700.00 | |||||||||||||||||
Expired | (80,100 | ) | $ | 35.80 | (176,307 | ) | $ | 103.90 | |||||||||||||||||
Outstanding at December 31, 2017 | 1,072,499 | $ | 33.50 | 4.76 | $ | 0.1 | 209,818 | $ | 53.20 | 0.95 | $ | — | |||||||||||||
Vested at December 31, 2017 or expected to vest in the future | 1,072,107 | $ | 33.5 | 4.76 | $ | 0.1 | 209,818 | $ | 53.20 | 0.95 | $ | — | |||||||||||||
Exercisable at December 31, 2017 | 1,063,759 | $ | 32.9 | 4.77 | $ | 0.1 | 209,818 | $ | 53.20 | 0.95 | $ | — |
2017 | 2016 | ||||||||
Number of Restricted Stock Issued | 181,908 | 126,849 | |||||||
Value of Restricted Stock Issued | $ | 627.7 | $ | 698.1 |
Year Ended December 31, | |||||||
2017 | 2016 | ||||||
Research and development | $ | 268.9 | $ | 262.3 | |||
General and administrative | 1,694.3 | 1,511.5 | |||||
Discontinued operations | 888.9 | 830.6 | |||||
Total share-based compensation expense | $ | 2,852.1 | $ | 2,604.3 |
Stock Options | Restricted Stock | ||||||
Unrecognized compensation cost | $ | 39.5 | $ | 97.2 | |||
Expected weighted-average period in years of compensation cost to be recognized | 0.61 | 1.84 |
Stock Options | ||||||||
Year Ended December 31, | ||||||||
2017 | 2016 | |||||||
Total fair value of shares vested | $ | 5,001.7 | $ | 2,359.8 | ||||
Weighted average estimated fair value of shares granted | 1.72 | 3.23 |
Stock Options | |||
Year Ended December 31, | |||
2017 | 2016 | ||
Expected term - minimum (in years) | 6 | 5 | |
Expected term - maximum (in years) | 6 | 10 | |
Expected volatility - minimum | 71% | 73% | |
Expected volatility - maximum | 74% | 76% | |
Weighted Average volatility | 35% | 74% | |
Expected dividend yield | — | — | |
Risk-free interest rate - minimum | 1.99% | 1.07% | |
Risk-free interest rate - maximum | 2.28% | 2.19% |
Years Ended December 31, | |||||||
2017 | 2016 | ||||||
United States | $ | (27,698 | ) | $ | (31,258 | ) | |
$ | (27,698 | ) | $ | (31,258 | ) |
Years Ended December 31, | ||||||||
2017 | 2016 | |||||||
Current | ||||||||
U.S. Federal | $ | (9,310 | ) | $ | — | |||
State and local | (1,641 | ) | — | |||||
$ | (10,951 | ) | $ | — | ||||
Deferred | ||||||||
U.S. Federal | $ | (576 | ) | $ | — | |||
State and local | — | — | ||||||
$ | (576 | ) | $ | — | ||||
Total | ||||||||
U.S. Federal | $ | (9,886 | ) | $ | — | |||
State and local | (1,641 | ) | — | |||||
$ | (11,527 | ) | $ | — |
Years Ended December 31, | ||||||||
2017 | 2016 | |||||||
U.S. Federal benefit at statutory rate | $ | (9,417 | ) | $ | (10,628 | ) | ||
State and local (benefit) / expense net of U.S. federal tax | (1,641 | ) | 2,759 | |||||
Permanent non deductible expenses for U.S. taxes | 107 | 80 | ||||||
AMT credit benefit | (576 | ) | — | |||||
True-up of prior year net operating loss | — | (2,371 | ) | |||||
Effect of change in deferred tax rate | 29,809 | (44 | ) | |||||
Valuation allowance for deferred tax assets | (29,809 | ) | 10,204 | |||||
Tax provision benefit | $ | (11,527 | ) | $ | — |
December 31, | ||||||||
2017 | 2016 | |||||||
Deferred Tax Assets: | ||||||||
Accumulated net operating losses (tax effected) | $ | 60,171 | $ | 79,131 | ||||
CIRM funding | 1,780 | — | ||||||
Deferred rent | 3 | 314 | ||||||
Share-based compensation | 2,656 | 11,562 | ||||||
Intangibles | 270 | 429 | ||||||
Charitable contributions | 11 | 424 | ||||||
Partnership interest | — | 3,858 | ||||||
Capital loss carry-forward | — | 6,988 | ||||||
Accumulated depreciation | 22 | — | ||||||
Accrued payroll | 682 | — | ||||||
AMT credit | 575 | — | ||||||
Other | 526 | 659 | ||||||
Deferred tax assets | 66,696 | 103,365 | ||||||
Deferred Tax Liabilities: | ||||||||
Accumulated depreciation | $ | — | $ | (119 | ) | |||
Deferred tax liabilities | — | (119 | ) | |||||
66,696 | 103,246 | |||||||
Valuation allowance | (66,121 | ) | (103,246 | ) | ||||
Net deferred tax asset | $ | 575 | $ | — |
Fair value of consideration received | $ | 79,425 | |
Transaction and retention costs | (6,919 | ) | |
Carrying value of segment non-controlling interest | 3,687 | ||
$ | 76,193 | ||
Less carrying amount of assets and liabilities sold: | |||
Cash | $ | 6,727 | |
Accounts receivable | 3,702 | ||
Deferred costs | 4,685 | ||
Prepaid expenses and other current assets | 743 | ||
Property, plant and equipment, net | 14,900 | ||
Goodwill | 7,013 | ||
Intangibles, net | 2,090 | ||
Other assets | 215 | ||
Accounts payable | (2,278 | ) | |
Accrued liabilities | (2,927 | ) | |
Due from Caladrius | 450 | ||
Unearned revenues | (10,529 | ) | |
Notes payable | (342 | ) | |
$ | 24,449 | ||
Gain on sale of PCT | $ | 51,744 |
Year Ended December 31, | |||||||
2017 | 2016 | ||||||
Revenue | $ | 16,039 | $ | 42,043 | |||
Cost of revenues | (15,321 | ) | (35,519 | ) | |||
Research and development | (257 | ) | (800 | ) | |||
Selling, general, and administrative | (3,251 | ) | (7,558 | ) | |||
Other expense | (14 | ) | (80 | ) | |||
Provision for income taxes | (10,541 | ) | (138 | ) | |||
Gain on sale of segment | 51,744 | — | |||||
Income (loss) from discontinued operations | $ | 38,399 | $ | (2,052 | ) |
Years ended | Operating Leases | |||
2018 | 910.0 | |||
2019 | 901.2 | |||
2020 | 827.0 | |||
2021 | 474.4 | |||
2022 and thereafter | 128.6 | |||
Total minimum lease payments | $ | 3,241.2 |
• | Pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the Company; |
• | Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and the board of directors of the Company; and |
• | Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements. |
+ | Director Compensation Policy. |
+ | 2017 Employee Stock Purchase Plan (filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 10, 2017). |
+ | Employment Agreement, dated as of January 5, 2015 and effective on January 5, 2015, by and between the Company and David J. Mazzo, Ph.D. (filed as Exhibit 10.2 to the Company's Current Report on Form 8-K filed on January 5, 2015). |
+ | Amendment, dated as of January 16, 2015, to Employment Agreement, dated as of January 5, 2015 and effective on January 5, 2015, by and between the Company and David J. Mazzo, Ph.D. (filed as Exhibit 10.2 to the Company's Current Report on Form 8-K filed on January 16, 2015). |
+ | Amendment to Employment Agreement, dated as of July 25, 2016, by and between the Company and David J. Mazzo, PhD (filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q. for the quarter ended June 30, 2016, filed with the SEC on August 9, 2016). |
+ | Amendment to Employment Agreement with David J. Mazzo, effective September 18, 2017 (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on September 21, 2017). |
+ | Employment Agreement, dated as of August 9, 2016, by and between Caladrius Biosciences, Inc. and Douglas W. Losordo, MD (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on August 9, 2016). |
+ | Amendment to Employment Letter with Doug Losordo, effective November 1, 2017 (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on November 1, 2017). |
+ | Letter Agreement dated June 28, 2011 between the Company and Joseph Talamo (filed as Exhibit 10.10 to the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2011 as filed with the SEC on August 12, 2011). |
10.30 + | Offer Letter Amendment dated October 6, 2015, to Employment Agreement dated June 28, 2011 and effective October 6, 2015, by and between the Company and Joseph Talamo. |
+ | Amendment to Letter Agreement, dated as of July 25, 2016, by and between the Company and Joseph Talamo (filed as Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, filed with the SEC on August 9, 2016). |
+ | Employment Agreement, dated March 11, 2016, by and between PCT, LLC, a Caladrius Company and Robert A. Preti, PhD (filed as Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, filed with the SEC on May 5, 2016). |
+ | Amendment to Employment Agreement, dated as of July 25, 2016, by and between the Company and Robert Preti, PhD (filed as Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, filed with the SEC on August 9, 2016). |
+ | Retention and Incentive Agreement, by and between Robert A. Preti and Caladrius Biosciences, Inc., dated as of March 16, 2017 (filed as Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the SEC on March 17, 2017). |
† | Code of Ethics for Senior Financial Officers |
† | Subsidiaries of Caladrius Biosciences, Inc. |
† | Consent of Grant Thornton LLP |
† | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
† | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
† | Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
101.INS | † XBRL Instance Document |
101.SCH† | XBRL Taxonomy Extension Schema |
101.CAL† | XBRL Taxonomy Extension Calculation Linkbase |
101.DEF† | XBRL Taxonomy Extension Definition Linkbase |
101.LAB† | XBRL Taxonomy Extension Label Linkbase |
101.PRE | † XBRL Taxonomy Extension Presentation Linkbase |
+ | Management contract or compensatory plan, contract or arrangement required to be filed as an exhibit to this Form 10-K pursuant to Item 15(b) of Form 10-K. |
(1) | Certain portions of this exhibit were omitted based upon a request for confidential treatment, and the omitted portions were filed separately with the SEC on a confidential basis. |
CALADRIUS BIOSCIENCES, INC. | ||
By: /s/ David J. Mazzo, PhD Name: David J. Mazzo Title: President and Chief Executive Officer (Principal Executive Officer) |
Signature | Title | Date | ||
/s/ David J. Mazzo David J. Mazzo, PhD | Director, and President and Chief Executive Officer (Principal Executive Officer) | March 22, 2018 | ||
/s/ Joseph Talamo Joseph Talamo | Senior Vice President, and Chief Financial Officer (Principal Financial and Accounting Officer) | March 22, 2018 | ||
/s/ Gregory B. Brown Gregory B. Brown, MD | Chairman of the Board of Directors | March 22, 2018 | ||
/s/ Steven S. Myers Steven S. Myers | Director | March 22, 2018 | ||
/s/ Steven M. Klosk Steven M. Klosk | Director | March 22, 2018 | ||
/s/ Peter G. Traber Peter G. Traber, MD | Director | March 22, 2018 |
• | each Board member shall be authorized to receive an annual cash compensation retainer of $40,000 for his or her service as a Board member; |
• | the Lead Director shall be authorized to receive an additional annual cash compensation retainer of $10,000 for his or her service as the Lead Director; |
• | the Non-executive Chair shall be authorized to receive an additional annual cash compensation retainer of $30,000 for his or her service as the Non-executive Chair; |
• | each member of the Company’s Audit Committee shall be entitled to receive annual cash compensation of $8,000 for his or her service on such committee; |
• | each member of the Company’s Compensation Committee shall be entitled to receive annual cash compensation of $6,000 for his or her service on such committee; |
• | each member of the Company’s Nominating and Governance Committee shall be entitled to receive annual cash compensation of $4,500 for his or her service on such committee; |
• | each member of the Company’s Science and Technology Committee shall be entitled to receive annual cash compensation of $4,500 for his or her service on such committee; |
• | the Audit Committee Chair shall be authorized to receive annual cash compensation of $18,000 for his or her service as the Chair; |
• | the Compensation Committee Chair shall be authorized to receive annual cash compensation of $12,000 for his or her service as the Chair; |
• | the Nominating and Governance Committee Chair shall be authorized to receive annual cash compensation of $9,000 for his or her service as the Chair; |
• | the Science and Technology Committee Chair shall be authorized to receive annual cash compensation of $9,000 for his or her service as the Chair; |
• | each member of the Board shall receive annually on the second Monday in January a grant of restricted stock with a black scholes value of $30,000 with the number of shares to be issued on the grant date calculated based on the average closing price of the common stock of the Company during the 30 day period of October 15 through November 15 prior to the grant date, vesting at one year from the grant date; and |
• | each newly appointed Board member shall receive an initial grant of restricted stock with a black scholes value of $60,000 with the number of shares to be issued on the grant date calculated based on the grant date fair value with one-third vesting annually on each of the first, second and third anniversaries of the grant date. |
I. | PURPOSE |
II. | INTRODUCTION |
• | Loyalty. Senior Financial Officers should not be, or appear to be, subject to influences, interests or relationships that conflict with the best interests of the Company. |
• | Compliance with Applicable Laws. Senior Financial Officers are expected to comply with all laws, rules and regulations applicable to the Company's activities. |
• | Observance of Ethical Standards. Senior Financial Officers must adhere to high ethical standards in the conduct of their duties. These include honesty and fairness. |
III. | DUTY TO REPORT VIOLATIONS |
IV. | INTEGRITY OF RECORDS AND FINANCIAL REPORTING |
1. | Defects, deficiencies, or discrepancies related to the design or operation of internal controls which may affect the Company's ability to accurately record, process, summarize, report and disclose its financial data; or |
2. | Any fraud, whether or not material, that involves management or other employees who have roles in the Company's financial reporting, disclosures or internal controls. |
V. | CONFLICT OF INTEREST |
• | Improper conduct and activities. Senior Financial Officers may not engage in any conduct or activities that are inconsistent with the Company's best interests or that disrupt or impair the Company's relationship with any person or entity with which the Company has, or proposes to enter into, a business or contractual relationship. |
• | Compensation from non-Company Sources. Senior Financial Officers may not accept compensation for services performed for the Company from any source other than the Company. |
• | Gifts. Senior Financial Officers and members of their immediate families may not accept gifts from persons or entities where any such gift is being made in order to influence their actions in their position with the Company, or where acceptance of the gifts could create the appearance of a conflict of interest. |
• | Personal use of Company assets. Senior Financial Officers may not use Company assets, labor or information for personal use, other than incidental personal use, unless approved by the Audit Committee or as part of a compensation or expense reimbursement program. |
• | Financial Interests in other Businesses. Senior Financial Officers should avoid having an ownership interest in any other enterprises, such as a customer, supplier or competitor, if that interest compromises the officer's loyalty to the Company. |
I. | CONFIDENTIALITY |
II. | COMPLIANCE WITH LAWS, RULES AND REGULATIONS |
I. | ENCOURAGING THE REPORTING OF ANY ILLEGAL OR UNETHICAL BEHAVIOR |
Entity | Percentage of Ownership | Location | ||
Amorcyte, LLC | 100% | United States of America | ||
Athelos Corporation (1) | 97% | United States of America | ||
NeoStem Oncology, LLC | 100% | United States of America |
Dated: | March 22, 2018 | /s/ David J. Mazzo |
David J. Mazzo, PhD | ||
President and Chief Executive Officer | ||
(Principal Executive Officer) | ||
Dated: | March 22, 2018 | /s/ Joseph Talamo |
Joseph Talamo | ||
Senior Vice President and Chief Financial Officer | ||
(Principal Financial Officer) |
Document and Entity Information - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2017 |
Mar. 22, 2018 |
Jun. 30, 2017 |
|
Document and Entity Information [Abstract] | |||
Entity Registrant Name | CALADRIUS BIOSCIENCES, INC. | ||
Entity Central Index Key | 0000320017 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Smaller Reporting Company | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2017 | ||
Document Fiscal Year Focus | 2017 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Entity Common Stock, Shares Outstanding | 9,552,653 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Public Float | $ 39,628,118 |
Consolidated Balance Sheets (Parenthetical) - USD ($) |
Dec. 31, 2017 |
Dec. 31, 2016 |
---|---|---|
Statement of Financial Position [Abstract] | ||
Allowance for doubtful accounts | $ 0 | $ 0 |
Preferred Stock | ||
Preferred stock, shares authorized (shares) | 20,000,000 | 20,000,000 |
Preferred stock, liquidation preference (shares) | 1 | 1 |
Preferred stock, par value (USD per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares designated (shares) | 825,000 | 825,000 |
Preferred stock, shares issued (shares) | 10,000 | 10,000 |
Preferred stock, shares outstanding (shares) | 10,000 | 10,000 |
Common Stock | ||
Common stock, par value (USD per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (shares) | 500,000,000 | 500,000,000 |
Common stock, shares, issued (shares) | 9,483,911 | 8,205,790 |
Common stock, shares, outstanding (shares) | 9,483,911 | 8,205,790 |
Treasury Stock | ||
Treasury stock (shares) | 11,080 | 11,080 |
Consolidated Statements of Comprehensive Income (Loss) - USD ($) |
12 Months Ended | |
---|---|---|
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Statement of Comprehensive Income [Abstract] | ||
Net income (loss) | $ 22,228,087 | $ (33,309,533) |
Other comprehensive loss: | ||
Available for sale securities - net unrealized loss | (27,978) | (486) |
Total other comprehensive loss | (27,978) | (486) |
Comprehensive income (loss) | 22,200,109 | (33,310,019) |
Comprehensive loss attributable to noncontrolling interests | (750,613) | (653,214) |
Comprehensive income (loss) attributable to Caladrius Biosciences, Inc. common stockholders | $ 22,950,722 | $ (32,656,805) |
Consolidated Statements of Equity - USD ($) |
Total |
Total Caladrius Biosciences, Inc. Stockholders' Equity |
Series B Convertible Preferred Stock |
Common Stock |
Additional Paid in Capital |
Accumulated Other Comprehensive Income |
Accumulated Deficit |
Treasury Stock |
Non- Controlling Interest in Subsidiary |
---|---|---|---|---|---|---|---|---|---|
Beginning Balance (in shares) at Dec. 31, 2015 | 10,000 | 5,673,302 | |||||||
Beginning Balance at Dec. 31, 2015 | $ 23,283,824 | $ 23,713,533 | $ 100 | $ 5,673 | $ 396,547,401 | $ 486 | $ (372,132,490) | $ (707,637) | $ (429,709) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Net income (loss) | (33,309,533) | (32,656,319) | (32,656,319) | (653,214) | |||||
Unrealized loss on marketable securities | (486) | (486) | (486) | ||||||
Share-based compensation (in shares) | 114,344 | ||||||||
Share-based compensation | (2,532,281) | (2,532,281) | $ (114) | (2,532,167) | |||||
Net proceeds from issuance of common stock (in shares) | 2,418,144 | ||||||||
Net proceeds from issuance of common stock | 11,560,394 | 11,560,394 | $ 2,419 | 11,557,975 | |||||
Change in ownership in subsidiary | 0 | (265,494) | (265,494) | 265,494 | |||||
Ending Balance (in shares) at Dec. 31, 2016 | 10,000 | 8,205,790 | |||||||
Ending Balance at Dec. 31, 2016 | 4,066,480 | 4,883,909 | $ 100 | $ 8,206 | 410,372,049 | 0 | (404,788,809) | (707,637) | (817,429) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Net income (loss) | 22,228,087 | 22,978,700 | 22,978,700 | (750,613) | |||||
Unrealized loss on marketable securities | (27,978) | (27,978) | (27,978) | ||||||
Share-based compensation (in shares) | 54,545 | ||||||||
Share-based compensation | (2,494,471) | (2,494,471) | $ (55) | (2,494,416) | |||||
Net proceeds from issuance of common stock (in shares) | 1,219,741 | ||||||||
Net proceeds from issuance of common stock | 5,701,686 | 5,701,686 | $ 1,219 | 5,700,467 | |||||
Proceeds from option exercises (in shares) | 3,835 | ||||||||
Proceeds from option exercises | 13,576 | 13,576 | $ 4 | 13,572 | |||||
Elimination of equity associated with PCT sale | (3,686,536) | 0 | 0 | (3,686,536) | |||||
Conversion of redeemable securities | 19,400,000 | 14,733,908 | 14,733,908 | 4,666,092 | |||||
Change in ownership in subsidiary | 0 | (270,203) | (270,203) | 270,203 | |||||
Ending Balance (in shares) at Dec. 31, 2017 | 10,000 | 9,483,911 | |||||||
Ending Balance at Dec. 31, 2017 | $ 50,189,786 | $ 50,508,069 | $ 100 | $ 9,484 | $ 433,044,209 | $ (27,978) | $ (381,810,109) | $ (707,637) | $ (318,283) |
The Business |
12 Months Ended |
---|---|
Dec. 31, 2017 | |
The Business [Abstract] | |
The Business | The Business OVERVIEW Caladrius Biosciences, Inc. (“we,” “us,” "our," “Caladrius” or the “Company”) is a company developing cellular therapeutics to treat certain diseases. We leverage specialized development expertise to selectively advance therapeutic product candidates to their next significant development milestone and, if appropriate, partner such candidates. Our most advanced product candidate, CLBS03, is an autologous polyclonal regulatory T cell ("Treg") clinical phase 2 therapy targeting children aged 8-17 with recent-onset type 1 diabetes mellitus ("T1D"). We also have phase 2 studies either underway or due to commence shortly involving our CD34 cell therapy for ischemic repair. Immunomodulation (Treg Technology) We are developing strategically, through the utilization of our core development expertise, a product candidate (CLBS03) that has the potential to be an innovative therapy for T1D. This therapy is based on a proprietary platform technology for immunomodulation. We have selected as an initial target the unmet medical need of patients who are newly diagnosed with T1D, most of whom will be under the age of 18. This program is based on the use of Tregs to treat diseases caused by imbalances in an individual's immune system. This novel approach seeks to restore immune balance by enhancing Treg number and function. Tregs are a natural part of the human immune system and regulate the activity of effector T cells, the cells that are responsible for protecting the body from pathogens and foreign antigens. When Tregs function properly, only harmful foreign materials are attacked by effector T cells. In autoimmune disease, however, it is thought that deficient Treg activity and numbers permit the effector T cells to attack the body's own beneficial cells. In the case of T1D, the beta cells in the pancreas are attacked, thereby reducing and/or eliminating over time the patient's ability to produce insulin. Insulin is necessary to regulate sugar metabolism and maintain proper sugar levels in the blood. Inconsistent or unnatural insulin levels can lead to many complications, including blindness, vascular disease and, if no insulin supplement is provided, even death. There are currently no curative treatments for TID, only lifelong insulin therapy, which often does not prevent serious co-morbidities. Two Phase 1 clinical trials of Treg technology in T1D, taken together demonstrated safety and tolerance, feasibility of manufacturing, an implied durability of effect as well as an early indication of potential therapeutic effect through the preservation of beta cell function. In the first quarter of 2016, we commenced patient enrollment in the first of two cohorts in The Sanford Project: T-Rex Study, a Phase 2 prospective, randomized, placebo-controlled, double-blind clinical trial (the "TRex Study") to evaluate the safety and efficacy of CLBS03 in adolescents with recent onset TID. We entered into a strategic collaboration with Sanford Research to support the execution of this trial. Sanford Research is a U.S.-based non-profit research organization that supports an emerging translational research center focused on finding a cure for T1D. On February 23, 2017, the California Institute for Regenerative Medicine ("CIRM") awarded us funds of up to $12.2 million to support the T-Rex Study. The funding will be 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. We received $5.7 million in initial funding on May 4, 2017. CLBS03 has been granted Fast Track and orphan drug designations from the U.S. Food and Drug Administration ("FDA") as well as Advanced Therapeutic Medicinal Product ("ATMP") classification from the European Medicines Agency ("EMA"). In October 2016, we received a satisfactory safety evaluation by our independent Data Safety Monitoring Board based on safety data then available from the first 19 patients enrolled in the trial. A subsequent interim analysis was conducted after approximately 50% of patients reached the six-month follow-up milestone, the results of which were publicly released on March 8, 2018 that the therapy continued to be well tolerated and was deemed non-futile for therapeutic effect. On January 18, 2018, we announced completion of enrollment (110 patients) of the TRex Study. Ischemic Repair (CD34 Cell Technology) Our 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, we seek to promote the development and formation of new blood vessels and thereby increase blood flow to the impacted area. We believe that conditions caused by underlying ischemic injury can be improved through our CD34 cell technology, including critical limb ischemia ("CLI"), coronary microvascular disfunction ("CMD") and refractory angina ("RfA"). Published reports in Circulation Cardiovascular Interventions, Atherosclerosis, Stem Cells and Circulation Journal, provide preliminary evidence that CD34 cell therapy is safe and can exert significant therapeutic effects in patients with CLI, a condition in which blood flow to the legs is severely impaired, causing pain and non-healing ulcers and, ultimately, potentially resulting in the need for amputation. Our Clinical Trial Notification for a pivotal Phase 2 trial investigating our product candidate in CLI CLBS12 was submitted to the Japanese Pharmaceutical and Medical Device Agency ("PMDA") and was cleared to proceed. The protocol design was agreed to with PMDA, the study was opened for enrollment in December 2017 and treatment or the first patient was announced in March 2018. Based on our discussions with the PMDA, we expect that a successful outcome of this trial will qualify CLBS12 for consideration of early conditional approval in Japan. In anticipation of a successful trial outcome and the possibility of conditional approval, we continue to seek a local partner for CLBS12 in Japan. Furthermore, we submitted grant applications in an effort to seek non-dilutive financing to investigate the CD34 technology for additional clinical indications in the United States and on October 2, 2017 we announced the award of a $1.9 million grant from the National Institutes of Health to support a clinical study of CD34 cells in patients with coronary microvascular dysfunction and we are targeting the initiation of the study by the second quarter of 2018. Additional Out-licensing Opportunities Our broad intellectual property portfolio of cell therapy assets includes notable programs available for out-licensing in order to continue their clinical development. These include additional indications for our Treg product and additional indications for our CD34 cell technology. Our current long-term strategy focuses on advancing our therapies through development with the aim of eventually obtaining market authorization, either alone or with partners, to provide treatment options to patients suffering from life-threatening medical conditions. We believe that we are positioned to realize potentially meaningful value increases within our own proprietary pipeline if we are successful advancing our product candidates to their next significant development milestones. Discontinued Operations On May 18, 2017, we completed the previously announced sale of our remaining 80.1% membership interest in PCT, LLC, a Caladrius company ("PCT") to Hitachi Chemical Co. America, Ltd. ("Hitachi"), pursuant to the Interest Purchase Agreement (the "Purchase Agreement") dated as of March 16, 2017, by and among us, PCT and Hitachi (the "2017 Hitachi Transaction"), for $75.0 million in cash plus an additional cash adjustment of $4.4 million based on PCT’s cash and outstanding indebtedness as of the closing date and a potential future milestone payment (see Note 3). The sale of PCT represented a strategic shift that has had a major effect on our operations, and therefore, all periods presented were adjusted to reflect PCT as discontinued operations. PCT is now known as Hitachi Chemical Advanced Therapeutic Systems (HCATS). Basis of Presentation The accompanying Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). In the opinion of management, the accompanying Consolidated Financial Statements of the Company and its subsidiaries include all normal and recurring adjustments considered necessary to present fairly the Company’s financial position as of December 31, 2017 and 2016, and the results of its operations and its cash flows for the years then ended. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements. Estimates also affect the reported amounts of revenues and 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 and income taxes. Accordingly, actual results could differ from those estimates and assumptions. An accounting policy is considered to be critical if it is important to the Company’s financial condition and results of operations and if it requires management’s most difficult, subjective and complex judgments in its application. Principles of Consolidation The Consolidated Financial Statements include the accounts of Caladrius Biosciences, Inc. and its wholly-owned and partially-owned subsidiaries and affiliates, as well as the operations of our former subsidiaries PCT, LLC, a Caladrius company, NeoStem Family Storage, LLC, and PCT Allendale, LLC entities (collectively the "PCT Segment") through May 18, 2017, representing the date which these entities were sold to Hitachi (see Note 3). The PCT Segment is reported in discontinued operations. All intercompany activities have been eliminated in consolidation, except for intercompany activities between Caladrius and the PCT Segment, which are reported without intercompany eliminations in continuing operations and discontinued operations, respectively. |
Summary of Significant Accounting Policies |
12 Months Ended | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2017 | |||||||||||||
Accounting Policies [Abstract] | |||||||||||||
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Cash and Cash Equivalents Cash and cash equivalents include short-term, highly liquid, investments with maturities of ninety days or less when purchased. Concentration of Risks We are subject to credit risk from our portfolio of cash, cash equivalents, restricted cash, and marketable securities. Under our investment policy, we limit 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 our 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. Marketable Securities The Company determines the appropriate classification of our marketable securities at the time of purchase and reevaluates such designation at each balance sheet date. All of our marketable securities are considered as available-for-sale and carried at estimated fair values and reported in cash equivalents. Unrealized gains and losses on available-for-sale securities are excluded from net income and reported in accumulated other comprehensive income (loss) as a separate component of stockholders' equity. Other income (expense), net, includes interest, dividends, amortization of purchase premiums and discounts, realized gains and losses on sales of securities and other-than-temporary declines in the fair value of securities, if any. The cost of securities sold is based on the specific identification method. We regularly review all of our investments for other-than-temporary declines in fair value. Our review includes the consideration of the cause of the impairment, including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and duration of the unrealized losses, whether we have the intent to sell the securities and whether it is more likely than not that we will be required to sell the securities before the recovery of their amortized cost basis. When we determine that the decline in fair value of an investment is below our accounting basis and this decline is other-than-temporary, we reduce the carrying value of the security we hold and record a loss for the amount of such decline. Property, Plant, and Equipment The cost of property, plant and equipment is depreciated over the estimated useful lives of the related assets. Depreciation is computed on the straight-line method. Repairs and maintenance expenditures that do not extend original asset lives are charged to expense as incurred. The estimated useful lives of property, plant and equipment are as follows:
Long-lived Assets Long-lived assets consist of property, plant and equipment. The assets are amortized on a straight line basis over their respective useful lives. The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset exceeds the fair value of the asset. If other events or changes in circumstances indicate that the carrying amount of an asset that the Company expects to hold and use may not be recoverable, the Company will estimate the undiscounted future cash flows expected to result from the use of the asset and/or its eventual disposition, and recognize an impairment loss, if any. The impairment loss, if determined to be necessary, would be measured as the amount by which the carrying amount of the assets exceeds the fair value of the assets. 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. Income (Loss) Per Share Basic income (loss) per share is based on the weighted effect of all common shares issued and outstanding, and is calculated by dividing net income (loss) attributable to common stockholders by the weighted average shares outstanding during the period. Diluted loss per share, which is calculated by dividing net income (loss) attributable to common stockholders by the weighted average number of common shares used in the basic income (loss) per share calculation plus the number of common shares that would be issued assuming conversion of all potentially dilutive securities outstanding. Diluted income (loss) per share is not presented as such potentially dilutive securities are anti-dilutive to losses incurred from continuing operations in all periods presented. Income Taxes The Company recognizes (a) the amount of taxes payable or refundable for the current year and (b) deferred tax liabilities and assets for the future tax consequences of events that have been recognized in the Company’s financial statements or tax returns. The Tax Cuts and Jobs Act (“the Act”) was enacted on December 22, 2017. The income tax effects of changes in tax laws are recognized in the period when enacted. The Act provides for significant tax law changes and modifications with varying effective dates, which include reducing the U.S. federal corporate income tax rate from 35% to 21%, creating a territorial tax system (with a one-time mandatory repatriation tax on previously deferred foreign earnings), and allowing for immediate capital expensing of certain qualified property acquired and placed in service after September 27, 2017 and before January 1, 2023. In response to the enactment of the Act in late 2017, the U.S. Securities and Exchange Commission issued Staff Accounting Bulletin No. 118 (“SAB 118”) to address situations where the accounting is incomplete for certain income tax effects of the Tax Act upon issuance of an entity’s financial statements for the reporting period in which the Tax Act was enacted. Under SAB 118, a company may record provisional amounts during a measurement period for specific income tax effects of the Tax Act for which the accounting is incomplete but a reasonable estimate can be determined, and when unable to determine a reasonable estimate for any income tax effects, report provisional amounts in the first reporting period in which a reasonable estimate can be determined. The Company continues to evaluate the accounting for uncertainty in tax positions at the end of each reporting period. The guidance requires companies to recognize in their financial statements the impact of a tax position if the position is more likely than not of being sustained if the position were to be challenged by a taxing authority. The position ascertained inherently requires judgment and estimates by management. The Company recognizes interest and penalties as a component of income tax expense. Treasury Stock Treasury stock purchases are accounted for under the cost method whereby the entire cost of the acquired stock is recorded as treasury stock. Gains or losses on the subsequent reissuance of shares are credited or charged to additional paid in capital. Research and Development Costs Research and development (“R&D”) expenses include salaries, benefits, and other headcount related costs, clinical trial and related clinical manufacturing costs, contract and other outside service fees including sponsored research agreements, and facilities and overhead costs. The Company expenses the costs associated with research and development activities when incurred. To further drive the Company’s cell therapy initiatives, the Company will continue targeting key governmental agencies, congressional committees and not-for-profit organizations to contribute funds for the Company’s research and development programs. The Company accounts for such grants as a deduction to the related expense in research and development operating expenses when earned. New Accounting Pronouncements In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). This ASU requires that a lessee recognize lease assets and lease liabilities for those leases classified as operating leases. The guidance is effective for interim and annual periods beginning after December 15, 2018, and will be applied at the beginning of the earliest period presented using a modified retrospective approach. This ASU may have a material impact on the Company’s financial statements. The impact on the Company’s results of operations is currently being evaluated. The impact of the ASU is non-cash in nature and will not affect the Company’s cash position. In March 2016, the FASB issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting. This ASU simplifies several aspects of the accounting for share-based payment transactions, including the income tax consequences, accounting for forfeitures, classification of awards as either equity or liabilities, and classification on the statement of cash flows. The guidance was effective for interim and annual periods beginning after December 15, 2016. The adoption of this new guidance did not have a material effect on the consolidated results of operations, cash flows, and financial position. In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments. ASU 2016-15 clarifies how companies present and classify certain cash receipts and cash payments in the statement of cash flows where diversity in practice exists. ASU 2016-15 is effective in first quarter of fiscal 2018 and earlier adoption is permitted. The Company is currently evaluating the effect that the updated standard will have on the consolidated financial statements and related disclosures. In October 2016, the FASB issued ASU 2016-16, Intra-Entity Transfers of Assets Other Than Inventory. ASU 2016-16 requires the income tax consequences of intra-entity transfers of assets other than inventory to be recognized as current period income tax expense or benefit at the transaction date and removes the option to defer and amortize the consolidated tax consequences of intra-entity transfers. The new standard will be effective on January 1, 2018 and will be adopted using a modified retrospective approach which requires a cumulative effect adjustment to retained earnings as of the beginning of the period of adoption. Early adoption is permitted at the beginning of a fiscal year. The Company is currently evaluating the effect that the updated standard will have on the consolidated financial statements and related disclosures. In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash. ASU 2016-18 requires that a statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. The new standard will be effective on January 1, 2018 and the Company early adopted the standard in 2017, with all adjustments reflected as of the beginning of the fiscal years reported. In May 2017, the FASB issued ASU 2017-09, "Compensation – Stock Compensation (Topic 718): Scope of Modification Accounting," to provide clarity and reduce both diversity in practice and cost complexity when applying the guidance in Topic 718 to a change to the terms and conditions of a stock-based payment award. ASU 2017-09 also provides guidance about the types of changes to the terms or conditions of a share-based payment award that require an entity to apply modification accounting in accordance with Topic 718. For all entities, including emerging growth companies, the standard is effective for annual periods beginning after December 15, 2017, and for interim periods therein. Early adoption is permitted. The Company does not expect the adoption of this ASU to have a material impact on its consolidated financial statements. |
Collaboration and Hitachi License Agreement |
12 Months Ended | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2017 | |||||||||||||
Business Combinations [Abstract] | |||||||||||||
Collaboration and Hitachi License Agreement | Collaboration and Hitachi License Agreement 2016 Hitachi Transaction On March 11, 2016, PCT entered into a global collaboration with Hitachi (the "2016 Hitachi Transaction"). This collaboration consists of an equity investment in and a license agreement with PCT. Under the equity investment agreement, Hitachi purchased a 19.9% membership interest in PCT for $19.4 million of which $15.0 million of proceeds was distributed to Caladrius from PCT and $4.4 million remained at PCT to be used for the continued expansion and improvements at PCT in support of commercial product launch readiness as well as for general corporate purposes. PCT and Hitachi also entered into an exclusive license agreement for the acceleration of the creation of a global commercial cell therapy development and manufacturing expertise in Asia pursuant to which PCT received $5.6 million from Hitachi in 2016. PCT licensed certain cell therapy technology and know-how (including an exclusive license in Asia) and agreed to provide Hitachi with certain training and support. As additional consideration, Hitachi agreed to pay PCT royalties on contract revenue generated in Asia for a minimum of ten years. In connection with the 2017 Hitachi Transaction below, this exclusive license agreement was terminated. 2017 Hitachi Transaction On May 18, 2017, the Company sold its remaining 80.1% membership interest in PCT to Hitachi pursuant to the Purchase Agreement, dated March 16, 2017, by and among Caladrius PCT and Hitachi (the "2017 Hitachi Transaction"). The aggregate purchase price to the Company consisted of (i) $75.0 million in cash, (ii) $4.4 million, representing additional consideration based on PCT’s cash and outstanding indebtedness as of the closing date, and (iii) a potential future milestone payment of $5.0 million if PCT achieves $125 million in cumulative revenue (excluding clinical service reimbursables) (the “Milestone”) for the period from January 1, 2017 through December 31, 2018 (the “Milestone Period”). Hitachi paid the Company $5.0 million in March 2017 as an advance payment pending shareholder approval of the transaction and other closing conditions. On the closing date, the Company received $65.0 million, with an additional $5.0 million of the purchase consideration (the "Escrow Amount") deposited into an escrow account to cover potential indemnification claims against Caladrius. The Escrow Amount is classified as restricted cash on the balance sheet as of December 31, 2017. In June 2018, the escrow agent will disburse to the Company the Escrow Amount less (i) that portion of the Escrow Amount previously paid in satisfaction of claims for indemnification pursuant to the terms of the Purchase Agreement and (ii) that portion of the Escrow Amount that is determined, in the reasonable judgment of Hitachi, to be necessary to satisfy all unsatisfied or disputed claims for indemnification specified in any claim notice delivered to the Company. The Company also received the $4.4 million additional consideration payment in July 2017. The Company incurred approximately $6.9 million in transaction costs related to the 2017 Hitachi Transaction, including $4.3 million in retention payments to PCT employees, of which 50% was paid in June 2017, and the other 50% payable on the one year anniversary of the closing date. Concurrent with the signing of the Purchase Agreement, on March 16, 2017, Caladrius entered into a Retention and Incentive Agreement with Robert A. Preti, a former Caladrius director and a co-founder and the President of PCT, (the “Retention Agreement”). The Retention Agreement superseded all prior agreements and understandings between Dr. Preti and Caladrius regarding the subject matter of the Retention Agreement. Among other things, the Retention Agreement provided for:
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Available-for-Sale-Securities |
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Available-for-sale Securities [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 in our Consolidated Balance Sheets (in thousands):
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 debt securities on our Consolidated Balance Sheets (in thousands):
The following table summarizes our portfolio of available-for-sale securities by contractual maturity (in thousands):
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Property, Plant and Equipment |
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Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, Plant and Equipment | Property, Plant and Equipment Property, plant, and equipment consisted of the following (in thousands):
The Company’s results included depreciation expense of approximately $0.4 million and $0.5 million for the years ended December 31, 2017 and 2016, respectively. |
Loss Per Share |
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Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||
Loss Per Share | Loss Per Share For the years ended December 31, 2017 and 2016 the Company incurred net losses from continuing operations and therefore no common stock equivalents were utilized in the calculation of loss per share as they are anti-dilutive in the periods presented. At December 31, 2017 and 2016 the Company excluded the following potentially dilutive securities:
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Fair Value Measurements |
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Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Measurements | Fair Value Measurements 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 Company's financial assets and liabilities that were accounted for at fair value on a recurring basis as of December 31, 2017 and December 31, 2016 were as follows (in thousands):
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Accrued Liabilities |
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Accrued Liabilities | Accrued Liabilities Accrued liabilities were as follow (in thousands):
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Debt |
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Dec. 31, 2017 | |
Debt Disclosure [Abstract] | |
Debt | Debt Notes Payable As of December 31, 2017 and December 31, 2016, the Company had notes payable of approximately $0.2 million and $0.7 million, respectively. The notes relate to certain insurance policies and equipment financings, require monthly payments, and mature within one year. Long-Term Debt On September 26, 2014, the Company entered into a loan and security agreement (the “Loan and Security Agreement”) with Oxford Finance LLC (together with its successors and assigns, the “Lender”) pursuant to which the Lender disbursed $15.0 million (the “Loan”). The debt offering/issuance costs have been recorded as debt issuance costs in other assets in the consolidated balance sheet, and were amortized to interest expense throughout the life of the Loan using the effective interest rate method. In March 2016, concurrent with the 2016 Hitachi Transaction (see Note 3), the Company and the Lender entered into an amendment to the Loan and Security Agreement whereby (i) the Company paid $7.0 million to Lender, comprising principal, interest and early termination fees, (ii) the Company's subsidiaries PCT, PCT Allendale, LLC, and NeoStem Family Storage, LLC (collectively the "Removed Borrowers") were removed as borrowers under the Loan, (iii) Lender's security interests in any and all assets of the Removed Borrowers were released, (iv) the interest only period on the remaining outstanding Loan balance was extended until January 1, 2017, and (v) in the event the Company received gross proceeds from the sale or issuance of any equity securities or subordinated debt, or any partnership, licenses, collaboration, dividend, grant or asset sale through March 31, 2017, 20% of such proceeds will be paid to Lender, up to a $3.0 million maximum as additional partial repayment of Loan. On September 14, 2016, concurrent with the Company's September 2016 Registered Direct Offering and Concurrent Private Placement (see Note 11), the Company repaid $3.0 million of such proceeds to the Lender. The outstanding balance was approximately $5.7 million at December 31, 2016. In May 2017, concurrent with the 2017 Hitachi Transaction (see Note 3), the Company retired the Loan in full, and paid $4.9 million to Lender, comprising principal, interest and early termination fees. The Company was making interest-only payments on the outstanding amount of the Loan on a monthly basis at a rate of 8.50% per annum. During the years ended December 31, 2017 and 2016, the Company recognized $0.4 million and $1.7 million of interest expense, respectively, related to the Loan and Security Agreement. |
Redeemable Securities - Non-Controlling Interests |
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Dec. 31, 2017 | |
Investments, Debt and Equity Securities [Abstract] | |
Redeemable Securities - Non-Controlling Interests | Redeemable Securities - Non-Controlling Interests Under the 2016 Hitachi Transaction (see Note 3), Hitachi, at any time following the tenth anniversary of the 2016 Hitachi Transaction closing date on March 11, 2016, had the right on one occasion to require Caladrius or PCT to purchase all or some of the equity securities in PCT then held by Hitachi ("Hitachi Put Right") for an amount equal to the lower of (i) the fair market value of the Hitachi equity holdings and (ii) the original purchase price paid of $19.4 million on March 11, 2016 for its 19.9% ownership interest, plus interest at a rate of 2.0% per annum compounded annually; provided, however, that if Hitachi's ownership interests increased subsequent to its initial ownership interest, and it offered to sell its equity holdings in excess of 21% of PCT’s outstanding equity securities, then the Company would have been required to purchase all such equity holdings of Hitachi Chemical but in no event would the aggregate purchase price of such Hitachi Chemical equity holdings exceed $20.5 million plus interest at the rate of 2.0% per annum compounded annually. As of December 31, 2016, since Hitachi had the right to deliver the equity interests in PCT it held in exchange for cash from Caladrius or PCT, the initial $19.4 million value of the non-controlling interest was considered redeemable equity, requiring it to be treated as mezzanine equity. Redeemable non-controlling interest is required to be initially measured at the initial carrying amount. If the non-controlling interest is not currently redeemable and also not probable of becoming redeemable (e.g., it is not probable a contingency that triggers redemption will be met), the non-controlling interest should be classified in mezzanine equity. Concurrent with 2017 Hitachi Transaction (see Note 3), the Hitachi Put Right was eliminated, and $14.7 million previously classified as Redeemable Securities was classified to Additional Paid in Capital. In addition, the remaining portion classified as Redeemable Securities of $4.7 million was classified to Non-Controlling Interests, representing Hitachi's ownership interest in PCT at the time of the 2016 Hitachi Transaction, which was subsequently eliminated upon the 2017 Hitachi transaction and included the PCT gain on sale. |
Stockholders' Equity |
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Equity [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stockholders' Equity | Stockholders' Equity Reverse Stock Split On July 28, 2016, the Company implemented the Reverse Stock Split, as authorized at the annual meeting of stockholders on June 22, 2016 and unanimously approved by the Company’s board of directors on July 22, 2016. The Reverse Stock Split became effective on July 27, 2016 at 5:00pm and the common stock of the Company began trading on The Nasdaq Capital Market on a post-split basis at the open of business on July 28, 2016. As of July 28, 2016, every ten shares of the Company’s issued and outstanding common stock were combined into one share of its common stock, except to the extent that the Reverse Stock Split resulted in any of the Company’s stockholders owning a fractional share, which was rounded up to the next highest whole share. In connection with the Reverse Stock Split, there was no change in the nominal par value per share of $0.001. All share and per share amounts of common stock, options and warrants in the accompanying financial statements have been restated for all periods presented to give retroactive effect to the Reverse Stock Split. Accordingly, the consolidated statements of equity reflect the impact of the Reverse Stock Split by reclassifying from “common stock” to “Additional paid-in capital” in an amount equal to the par value of the decreased shares resulting from the Reverse Stock Split. Equity Plans The Company's 2015 Equity Compensation Plan (the "2015 Equity Plan") was adopted by the stockholders of the Company on July 14, 2015, with 440,000 shares initially reserved for future awards under the 2015 Equity Plan (as adjusted in the manner described below, the “Share Reserve”). These shares will be available for issuance pursuant to non-qualified stock options, incentive stock options, stock appreciation rights, restricted stock, restricted stock units, unrestricted shares, deferred share units, or other kinds of equity based compensation awards. Concurrent with the adoption of the 2015 Equity Plan, no future awards will occur under the 2009 Amended and Restated Equity Compensation Plan (the “2009 Plan”). The 2015 Equity Plan’s initial reserve of shares will automatically increase for 10 years, on each January 1st beginning with 2016, by a number of shares equal to the lesser of (i) four percent (4%) of the total number of our shares outstanding on December 31st of the preceding calendar year, (ii) such lesser number as the 2015 Plan’s administrator may earlier designate in writing, and (iii) 17,600 shares, which equals four percent (4%) of the initial reserve of 440,000 shares. In addition, the Share Reserve will include shares that are currently subject to awards under our 2009 Equity Plan but that are not issued due to their forfeiture, cancellation, or other settlement. The 2009 Equity Plan was originally adopted by the stockholders of the Company on May 8, 2009. On October 29, 2009, the stockholders of the Company approved an amendment to the 2009 Equity Plan to increase the number of shares of common stock available for issuance thereunder from 38,000 to 97,500. At the 2010 Annual Meeting of Stockholders of the Company held on June 2, 2010, the stockholders approved an amendment to increase this number to 137,500. At a Special Meeting of Stockholders of the Company held on January 18, 2011, the stockholders approved an amendment to increase this number to 177,500. At the 2011 Annual Meeting of Stockholders of the Company held on October 14, 2011, the stockholders approved an amendment to increase this number to 237,500. At the 2012 Annual Meeting of Stockholders of the Company held on October 5, 2012, the stockholders approved an amendment to (i) merge the 57,000 shares reserved for issuance under the Company's 2009 Non-U.S. Based Equity Compensation Plan (the "Non-U.S. Plan") with and into the 2009 Equity Plan, and (ii) increase by 45,000 the aggregate number of shares authorized for issuance under the 2009 Equity Plan (the “2009 Amended & Restated Equity Plan”). At the Company's 2013 Annual Meeting held October 3, 2013, the Company's stockholders approved an amendment to the 2009 Amended & Restated Equity Plan to increase the number of shares authorized for issuance to 599,500. At the Company's 2014 Annual Meeting held October 6, 2014, the Company's stockholders approved an amendment to the 2009 Amended & Restated Equity Plan to increase the number of shares authorized for issuance to 899,500. The Company's 2003 Equity Participation Plan (the “2003 Equity Plan”) expired in 2013 and accordingly, equity awards under the 2003 Equity Plan can no longer be issued. The Company's 2009 Equity Compensation Plan (the “2009 Equity Plan”) makes up to 899,500 shares of common stock of the Company (as of December 31, 2017) available for issuance to employees, consultants, advisors and directors of the Company and its subsidiaries pursuant to incentive or non-statutory stock options, restricted and unrestricted stock awards and stock appreciation rights. All stock options under the 2003 Equity Plan and 2009 Equity Plan were granted and the 2015 Equity Plan are granted at the fair market value of the common stock at the grant date. Stock options vest either on the date of grant, ratably over a period determined at time of grant, or upon the accomplishment of specified business milestones, and generally expire 2, 3, or 10 years from the grant date depending on the status of the recipient as a consultant, employee or director of the Company. The number of remaining shares authorized to be issued under the various equity plans are as follows as of December 31, 2017:
The Company adopted an employee stock purchase plan effective January 1, 2013, and authorized 50,000 shares under the plan (the "2012 ESPP"). The plan has two six-month offering periods per year under which eligible employees may contribute up to 15% of their compensation toward the purchase of the Company's common stock per offering period (with a $25,000 cap per calendar year). The employee's purchase price is equal to (i) 85% of the closing price of a share of the Company's common stock on the enrollment date of such offering period or (ii) 85% of the closing price of a share of the Company's common stock on the Exercise Date of such Offering Period, whichever is lower. On May 16, 2017, the Company's stockholders approved an amendment and restatement to the 2012 ESPP (the "2017 ESPP") in order to effect an increase of authorized shares from 50,000 to 100,000. During the year ended December 31, 2017, 21,924 shares were issued under the 2017 ESPP. At December 31, 2017, the Company had 32,530 shares of the Company's common stock available for future grant in connection with this plan. Equity Issuances March 2016 Private Placement On March 10, 2016, the Company entered into a securities purchase agreement with certain investors, pursuant to which the Company issued and sold in a private placement an aggregate of 141,844 shares of common stock and two-year warrants to purchase up to an aggregate of 141,844 shares of the Company's common stock, at an exercise price of $10.00 per share. The unit purchase price for a share of the Company's common stock and warrant to purchase one share of the Company's common stock was $7.05 per unit, with $1.0 million of gross proceeds received by the Company. On April 8, 2016, the Company filed a registration statement on Form S-3 to register the shares of common stock and the shares of common stock issuable upon exercise of the warrants acquired in the private placement, which registration statement became effective on June 7, 2016. September 2016 Registered Direct Offering and Concurrent Private Placement On September 14, 2016, the Company entered into a securities purchase agreement (the “RD Purchase Agreement”) with a single institutional investor (the “Purchaser”), pursuant to which the Company issued and sold to the Purchaser, in a registered direct offering, an aggregate of 847,458 shares of the Company’s common stock at a purchase price of $4.72 per share. The gross proceeds to the Company from the registered direct offering of the shares of common stock were $4.0 million. In concurrent private placements, on September 14, 2016, the Company entered into Securities Purchase Agreements (each a “Private Placement Purchase Agreement” and, collectively, the “Private Placement Purchase Agreements”) with certain accredited investors (the “Investors”) with whom it had a substantive, pre-existing relationship, including certain existing stockholders, for the sale by the Company of an aggregate of 4,449,153 shares of common stock, at a purchase price of $4.72 per share. The investments will be placed in two tranches: (i) $12.6 million upon an initial closing (the “Initial Closing”), and (ii) $8.4 million, subject to certain conditions, including the enrollment of 70 subjects in the Company’s Phase 2 CLBS03 clinical trial, in a second closing (the “Second Closing”). As of March 31, 2017, $6.0 million of the Initial Closing tranche had not been received from a single investor, who was in breach of his obligations under the Private Placement Purchase Agreement. This investor had also committed to fund $4.0 million in the Second Closing. As a result, the Company terminated the Private Placement Purchase Agreement with this investor in the first quarter of 2017. In 2017, the Company met the conditions of the Second Closing, and received the remaining $4.4 million in proceeds in accordance with the terms of the Second Closing tranche and issued 932,204 shares of common stock. Aspire Purchase Agreement In November 2015, the Company entered into a common stock purchase agreement (the "Purchase Agreement") with Aspire Capital Fund, LLC, an Illinois limited liability company (“Aspire Capital”), which provided that, subject to certain terms and conditions and Nasdaq rules, Aspire Capital was committed to purchase up to an aggregate of $30 million of shares (limited to a maximum of approximately 1.1 million shares, unless stockholder approval was obtained or certain minimum sale price levels were reached) of the Company's common stock over a 24-month term. The Company issued 319,776 shares of common stock under the Purchase Agreement with Aspire for gross proceeds of $1.5 million, which Purchase Agreement expired in November 2017. Stock Options and Warrants The following table summarizes the activity for stock options and warrants for the year ended December 31, 2017:
Restricted Stock During the years ended December 31, 2017 and 2016, the Company issued restricted stock for services as follows ($ in thousands, except share data):
The weighted average estimated fair value of restricted stock issued for services in the years ended December 31, 2017 and 2016 was $3.45 and $5.50 per share, respectively. The fair value of the restricted stock was determined using the Company’s closing stock price on the date of issuance. The vesting terms of restricted stock issuances are generally between one to four years. |
Share-Based Compensation |
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Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-Based Compensation | Share-Based Compensation Share-based Compensation We utilize share-based compensation in the form of stock options and restricted stock. The following table summarizes the components of share-based compensation expense for the years ended December 31, 2017 and 2016 ($ in thousands):
The approval of the 2017 Hitachi Transaction (see Note 3) by our stockholders resulted in a change in control under our equity compensation plans (as defined in the 2009 Plan and the 2015 Equity Plan, and, together with the 2009 Plan, the “Equity Compensation Plans”). Accordingly, all outstanding unvested equity awards were accelerated upon the Closing Date, resulting in an acceleration of $1.9 million of equity compensation for the years ended December 31, 2017. In addition, in connection with the 2017 Hitachi Transaction, the Company agreed to extend the post-termination option exercise period for all PCT employees transitioning to Hitachi from 90 days to the earlier of (i) two years (May 18, 2019) or (ii) the date of the employees' termination from PCT. The post-termination option exercise period modification resulted in an additional expense of $0.3 million which was recorded entirely during the three months ended June 30, 2017 and recorded in discontinued operations, since there were no future service requirements to receive the extended benefit. Total compensation cost related to nonvested awards not yet recognized and the weighted-average periods over which the awards are expected to be recognized at December 31, 2017 were as follows ($ in thousands):
Total fair value of shares vested and the weighted average estimated fair values of shares granted for the years ended December 31, 2017 and 2016 were as follows ($ in thousands):
Valuation Assumptions The fair value of stock options 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 range of assumptions made in calculating the fair values of stock options was as follow:
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Research Funding |
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Dec. 31, 2017 | |
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 us funds of up to $12.2 million to support the T-Rex Study. The funding will be 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. We received $5.7 million in initial funding in May 2017, and a $1.9 million milestone payment in December 2017, of which the total will be amortized over the estimated award period through July 2020 as a reduction to the related research and development expenses. As of December 31, 2017, $2.4 million of the funding received is recorded in accrued liabilities, representing the amount expected to be recognized over the next 12 months, and $3.9 million of the funding received is recorded in other long-term liabilities. During the year ended December 31, 2017, the Company amortized and recognized a $1.3 million credit to research and development related to CIRM funds received. |
Income Taxes |
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Income Tax Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Income Taxes | Income Taxes The Tax Cuts and Jobs Act (“the Act”) was enacted on December 22, 2017. The income tax effects of changes in tax laws are recognized in the period when enacted. The Act provides for significant tax law changes and modifications with varying effective dates, which include reducing the U.S. federal corporate income tax rate from 35% to21%, creating a territorial tax system (with a one-time mandatory repatriation tax on previously deferred foreign earnings), and allowing for immediate capital expensing of certain qualified property acquired and placed in service after September 27, 2017 and before January 1, 2023. In response to the enactment of the Act in late 2017, the U.S. Securities and Exchange Commission issued Staff Accounting Bulletin No. 118 (“SAB 118”) to address situations where the accounting is incomplete for certain income tax effects of the Tax Act upon issuance of an entity’s financial statements for the reporting period in which the Tax Act was enacted. Under SAB 118, a company may record provisional amounts during a measurement period for specific income tax effects of the Tax Act for which the accounting is incomplete but a reasonable estimate can be determined, and when unable to determine a reasonable estimate for any income tax effects, report provisional amounts in the first reporting period in which a reasonable estimate can be determined. While the Company was able to make reasonable estimates of the impact of the tax effects of the Tax Act, the final impact of the Tax Act may differ from those estimates, including, but not limited to changes in our interpretations and assumptions, additional guidance that may be issued by the IRS, return to provision differences and state rate adjustments. As guidance and technical corrections are issued in the upcoming quarters, the Company will record updates to its original provisional estimates. The Company remeasured certain U.S. deferred tax assets and liabilities based on the rates at which they are expected to reverse in the future, which is generally 21%. The provisional amount recorded related to the remeasurement of the deferred tax balance was tax expense of $30 million which was offset by a reduction in the valuation allowance resulting in no tax expense. The provision (benefit) for income taxes is based on loss from operations before provision for income taxes and noncontrolling interests as follows ($ in thousands):
The provision (benefit) for income taxes was as follows ($ in thousands):
The provision (benefit) for income taxes is determined by applying the U.S. Federal statutory rate of 34% to income before income taxes as a result of the following ($ in thousands):
Deferred income taxes at December 31, 2017 and 2016 consist of the following ($ in thousands):
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, 2017 and 2016, the Company had approximately $210.3 million and $232.7 million, respectively 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 they have had ownership change 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 $124.5M and using an applicable federal rate of 2.5% the annual limitation would be approximately $3.0 million. Post change losses from June 3, 2015 through December 31, 2016 would not be subject to 382 limitations. Additionally the Company would be able to further increase NOL limitations by the realized built in gain on the sale of PCT in May of 2017. 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 December 31, 2017, 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. The Company completed the audit of its federal tax returns for the years 2012 and 2013 during the fourth quarter of 2016. The audit resulted in an adjustment to the Company’s NOL carryforward. For years prior to 2014 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. The Company ceased doing business in China in 2012. After 2012, the Company had no foreign tax filing obligations. The foreign returns filed for 2012 and prior are subject to examination for five years. |
Discontinued Operations |
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Discontinued Operations and Disposal Groups [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Discontinued Operations | Discontinued Operations PCT Segment On May 18, 2017, the Company sold its remaining 80.1% membership interest in PCT to Hitachi pursuant to the 2017 Hitachi Transaction (see Note 3). The aggregate purchase price to the Company consisted of (i) $75.0 million in cash, (ii) $4.4 million, representing additional consideration based on PCT’s cash and outstanding indebtedness as of the closing date, and (iii) a potential future milestone payment of $5.0 million if PCT achieves $125 million in cumulative revenue (excluding clinical service reimbursables) for the period from January 1, 2017 through December 31, 2018. The Company has determined that the fair value of the milestone payment as of the closing date was valued at zero. Hitachi paid the Company $5.0 million in March 2017 as an advance payment pending shareholder approval of the transaction and other closing conditions. On the Closing Date, the Company received $65.0 million, with an additional $5.0 million of the purchase consideration (the "Escrow Amount") deposited into an escrow account to cover potential indemnification claims against Caladrius. The Escrow Amount is classified as restricted cash on the balance sheet as of December 31, 2017. In June 2018, the escrow agent will disburse to the Company the Escrow Amount less (i) that portion of the Escrow Amount previously paid in satisfaction of claims for indemnification pursuant to the terms of the Purchase Agreement and (ii) that portion of the Escrow Amount that is determined, in the reasonable judgment of Hitachi, to be necessary to satisfy all unsatisfied or disputed claims for indemnification specified in any claim notice delivered to the Company. The Company also received the $4.4 million Additional Consideration payment in July 2017. The Company incurred approximately $6.9 million in transaction costs related to the 2017 Hitachi Transaction, including $4.3 million in retention payments to PCT employees, of which 50% was paid in June 2017, and the other 50% payable on the one year anniversary of the closing date. The Company recognized the following gain on the date of sale of its 80.1% interest in PCT (in thousands):
The operations and cash flows of the PCT Segment were eliminated from ongoing operations with the sale of the Company's PCT Interest. The operating results of the PCT Segment for the years ended December 31, 2017 and 2016 were as follows (in thousands):
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Commitments and Contingencies |
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Dec. 31, 2017 | ||||||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies | Commitments and Contingencies Lease Commitments We lease facilities under various operating lease agreements in Basking Ridge, NJ, Rye Brook, NY, and Irvine, CA, of which certain have escalation clauses and renewal options. We also lease equipment under certain noncancelable operating leases. Our leases expire from time to time through 2021. A summary of future minimum rental payments required under operating leases that have initial or remaining terms in excess of one year as of December 31, 2017 are as follows (in thousands):
Expense incurred under operating leases were approximately $1.4 million and $1.4 million for the years ended December 31, 2017 and 2016, respectively. Contingencies We have entered into a strategic collaboration with Sanford Research with the goal of developing a therapy for the treatment of T1D. The initial focus of the collaboration will be the execution of a prospective, randomized, placebo-controlled, double-blind clinical trial (The Sanford Project: T-Rex Study) to evaluate the safety and efficacy of the Company’s T regulatory cell product candidate, CLBS03, in adolescents with recent onset T1D. The Phase 2 study has an open and active IND in place and subject enrollment commenced in the first quarter of 2016. We were initially responsible for the supply of all study drug to the first 19 enrolled patients while Sanford assumed all patient and clinical site costs for subjects enrolled in their two centers as well as the expense associated with general clinical monitoring services. For the remaining 92 patients in the study, we will continue to be responsible for the supply of all study drug and the costs of study enrollment for sites outside of the Sanford centers. Under license agreements with third parties the Company is typically required to pay maintenance fees, make milestone payments and/or pay other fees and expenses and pay royalties upon commercialization of products. The Company also sponsors research at various academic institutions, which research agreements generally provide us with an option to license new technology discovered during the course of the sponsored research. 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 |
12 Months Ended |
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Dec. 31, 2017 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events Common Stock Sales Agreement On February 8, 2018, we entered into a Common Stock Sales Agreement with H.C. Wainwright & Co., LLC ("HCW"), as sales agent, in connection with an “at the market offering” under which we from time to time may offer and sell shares of our common stock, having an aggregate offering price of up to $12 million. 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 our instructions, including any price, time or size limits specified by us. We have 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. We have 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. |
Summary of Significant Accounting Policies (Policies) |
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Accounting Policies [Abstract] | |||||||||||||
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents include short-term, highly liquid, investments with maturities of ninety days or less when purchased. |
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Concentration of Risk | Concentration of Risks We are subject to credit risk from our portfolio of cash, cash equivalents, restricted cash, and marketable securities. Under our investment policy, we limit 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 our 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. |
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Marketable Securities | Marketable Securities The Company determines the appropriate classification of our marketable securities at the time of purchase and reevaluates such designation at each balance sheet date. All of our marketable securities are considered as available-for-sale and carried at estimated fair values and reported in cash equivalents. Unrealized gains and losses on available-for-sale securities are excluded from net income and reported in accumulated other comprehensive income (loss) as a separate component of stockholders' equity. Other income (expense), net, includes interest, dividends, amortization of purchase premiums and discounts, realized gains and losses on sales of securities and other-than-temporary declines in the fair value of securities, if any. The cost of securities sold is based on the specific identification method. We regularly review all of our investments for other-than-temporary declines in fair value. Our review includes the consideration of the cause of the impairment, including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and duration of the unrealized losses, whether we have the intent to sell the securities and whether it is more likely than not that we will be required to sell the securities before the recovery of their amortized cost basis. When we determine that the decline in fair value of an investment is below our accounting basis and this decline is other-than-temporary, we reduce the carrying value of the security we hold and record a loss for the amount of such decline. |
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Property, Plant and Equipment | Property, Plant, and Equipment The cost of property, plant and equipment is depreciated over the estimated useful lives of the related assets. Depreciation is computed on the straight-line method. Repairs and maintenance expenditures that do not extend original asset lives are charged to expense as incurred. The estimated useful lives of property, plant and equipment are as follows:
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Long-lived Assets | Long-lived Assets Long-lived assets consist of property, plant and equipment. The assets are amortized on a straight line basis over their respective useful lives. The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset exceeds the fair value of the asset. If other events or changes in circumstances indicate that the carrying amount of an asset that the Company expects to hold and use may not be recoverable, the Company will estimate the undiscounted future cash flows expected to result from the use of the asset and/or its eventual disposition, and recognize an impairment loss, if any. The impairment loss, if determined to be necessary, would be measured as the amount by which the carrying amount of the assets exceeds the fair value of the assets. |
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Share-Based Compensation | 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. |
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Income (Loss) Per Share | Income (Loss) Per Share Basic income (loss) per share is based on the weighted effect of all common shares issued and outstanding, and is calculated by dividing net income (loss) attributable to common stockholders by the weighted average shares outstanding during the period. Diluted loss per share, which is calculated by dividing net income (loss) attributable to common stockholders by the weighted average number of common shares used in the basic income (loss) per share calculation plus the number of common shares that would be issued assuming conversion of all potentially dilutive securities outstanding. Diluted income (loss) per share is not presented as such potentially dilutive securities are anti-dilutive to losses incurred from continuing operations in all periods presented. |
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Income Taxes | Income Taxes The Company recognizes (a) the amount of taxes payable or refundable for the current year and (b) deferred tax liabilities and assets for the future tax consequences of events that have been recognized in the Company’s financial statements or tax returns. The Tax Cuts and Jobs Act (“the Act”) was enacted on December 22, 2017. The income tax effects of changes in tax laws are recognized in the period when enacted. The Act provides for significant tax law changes and modifications with varying effective dates, which include reducing the U.S. federal corporate income tax rate from 35% to 21%, creating a territorial tax system (with a one-time mandatory repatriation tax on previously deferred foreign earnings), and allowing for immediate capital expensing of certain qualified property acquired and placed in service after September 27, 2017 and before January 1, 2023. In response to the enactment of the Act in late 2017, the U.S. Securities and Exchange Commission issued Staff Accounting Bulletin No. 118 (“SAB 118”) to address situations where the accounting is incomplete for certain income tax effects of the Tax Act upon issuance of an entity’s financial statements for the reporting period in which the Tax Act was enacted. Under SAB 118, a company may record provisional amounts during a measurement period for specific income tax effects of the Tax Act for which the accounting is incomplete but a reasonable estimate can be determined, and when unable to determine a reasonable estimate for any income tax effects, report provisional amounts in the first reporting period in which a reasonable estimate can be determined. The Company continues to evaluate the accounting for uncertainty in tax positions at the end of each reporting period. The guidance requires companies to recognize in their financial statements the impact of a tax position if the position is more likely than not of being sustained if the position were to be challenged by a taxing authority. The position ascertained inherently requires judgment and estimates by management. The Company recognizes interest and penalties as a component of income tax expense. |
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Treasury Stock | Treasury Stock Treasury stock purchases are accounted for under the cost method whereby the entire cost of the acquired stock is recorded as treasury stock. Gains or losses on the subsequent reissuance of shares are credited or charged to additional paid in capital. |
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Research and Development Costs | Research and Development Costs Research and development (“R&D”) expenses include salaries, benefits, and other headcount related costs, clinical trial and related clinical manufacturing costs, contract and other outside service fees including sponsored research agreements, and facilities and overhead costs. The Company expenses the costs associated with research and development activities when incurred. To further drive the Company’s cell therapy initiatives, the Company will continue targeting key governmental agencies, congressional committees and not-for-profit organizations to contribute funds for the Company’s research and development programs. The Company accounts for such grants as a deduction to the related expense in research and development operating expenses when earned. |
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New Accounting Pronouncements | New Accounting Pronouncements In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). This ASU requires that a lessee recognize lease assets and lease liabilities for those leases classified as operating leases. The guidance is effective for interim and annual periods beginning after December 15, 2018, and will be applied at the beginning of the earliest period presented using a modified retrospective approach. This ASU may have a material impact on the Company’s financial statements. The impact on the Company’s results of operations is currently being evaluated. The impact of the ASU is non-cash in nature and will not affect the Company’s cash position. In March 2016, the FASB issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting. This ASU simplifies several aspects of the accounting for share-based payment transactions, including the income tax consequences, accounting for forfeitures, classification of awards as either equity or liabilities, and classification on the statement of cash flows. The guidance was effective for interim and annual periods beginning after December 15, 2016. The adoption of this new guidance did not have a material effect on the consolidated results of operations, cash flows, and financial position. In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments. ASU 2016-15 clarifies how companies present and classify certain cash receipts and cash payments in the statement of cash flows where diversity in practice exists. ASU 2016-15 is effective in first quarter of fiscal 2018 and earlier adoption is permitted. The Company is currently evaluating the effect that the updated standard will have on the consolidated financial statements and related disclosures. In October 2016, the FASB issued ASU 2016-16, Intra-Entity Transfers of Assets Other Than Inventory. ASU 2016-16 requires the income tax consequences of intra-entity transfers of assets other than inventory to be recognized as current period income tax expense or benefit at the transaction date and removes the option to defer and amortize the consolidated tax consequences of intra-entity transfers. The new standard will be effective on January 1, 2018 and will be adopted using a modified retrospective approach which requires a cumulative effect adjustment to retained earnings as of the beginning of the period of adoption. Early adoption is permitted at the beginning of a fiscal year. The Company is currently evaluating the effect that the updated standard will have on the consolidated financial statements and related disclosures. In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash. ASU 2016-18 requires that a statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. The new standard will be effective on January 1, 2018 and the Company early adopted the standard in 2017, with all adjustments reflected as of the beginning of the fiscal years reported. In May 2017, the FASB issued ASU 2017-09, "Compensation – Stock Compensation (Topic 718): Scope of Modification Accounting," to provide clarity and reduce both diversity in practice and cost complexity when applying the guidance in Topic 718 to a change to the terms and conditions of a stock-based payment award. ASU 2017-09 also provides guidance about the types of changes to the terms or conditions of a share-based payment award that require an entity to apply modification accounting in accordance with Topic 718. For all entities, including emerging growth companies, the standard is effective for annual periods beginning after December 15, 2017, and for interim periods therein. Early adoption is permitted. The Company does not expect the adoption of this ASU to have a material impact on its consolidated financial statements. |
Summary of Significant Accounting Policies (Tables) |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Property, Plant and Equipment |
Property, plant, and equipment consisted of the following (in thousands):
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Available-for-Sale-Securities (Tables) |
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Available-for-sale Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Available-for-sale Securities Reconciliation [Table Text Block] | The following table is a summary of available-for-sale securities recorded in cash and cash equivalents in our Consolidated Balance Sheets (in thousands):
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Marketable Securities [Table Text Block] | 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 debt securities on our Consolidated Balance Sheets (in thousands):
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Investments Classified by Contractual Maturity Date [Table Text Block] | The following table summarizes our portfolio of available-for-sale securities by contractual maturity (in thousands):
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Property, Plant and Equipment (Tables) |
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Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Property, Plant and Equipment |
Property, plant, and equipment consisted of the following (in thousands):
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Loss Per Share (Tables) |
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Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Potentially Dilutive Securities Excluded from Calculation of Loss Per Share | At December 31, 2017 and 2016 the Company excluded the following potentially dilutive securities:
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Fair Value Measurements (Tables) |
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Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Fair Value of Assets Measured on Recurring Basis | The Company's financial assets and liabilities that were accounted for at fair value on a recurring basis as of December 31, 2017 and December 31, 2016 were as follows (in thousands):
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Accrued Liabilities (Tables) |
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Schedule of Accrued Liabilities | Accrued liabilities were as follow (in thousands):
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Stockholders' Equity (Tables) |
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Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Compensation Cost for Share-based Payment Arrangements, Allocation of Share-based Compensation Costs by Plan | The number of remaining shares authorized to be issued under the various equity plans are as follows as of December 31, 2017:
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Schedule of Share-based Compensation, Stock Options, Activity | The following table summarizes the activity for stock options and warrants for the year ended December 31, 2017:
The following table summarizes the components of share-based compensation expense for the years ended December 31, 2017 and 2016 ($ in thousands):
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Restricted Stock | During the years ended December 31, 2017 and 2016, the Company issued restricted stock for services as follows ($ in thousands, except share data):
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Share-Based Compensation (Tables) |
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Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Share-based Compensation, Stock Options, Activity | The following table summarizes the activity for stock options and warrants for the year ended December 31, 2017:
The following table summarizes the components of share-based compensation expense for the years ended December 31, 2017 and 2016 ($ in thousands):
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Disclosure of Share-based Compensation Arrangements by Share-based Payment Award [Table Text Block] | Total compensation cost related to nonvested awards not yet recognized and the weighted-average periods over which the awards are expected to be recognized at December 31, 2017 were as follows ($ in thousands):
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Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value [Table Text Block] | Total fair value of shares vested and the weighted average estimated fair values of shares granted for the years ended December 31, 2017 and 2016 were as follows ($ in thousands):
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Range of Fair Value of Stock Options and Warrants | The range of assumptions made in calculating the fair values of stock options was as follow:
|
Income Taxes (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2017 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Income Tax Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Income before Income Tax, Domestic and Foreign | The provision (benefit) for income taxes is based on loss from operations before provision for income taxes and noncontrolling interests as follows ($ in thousands):
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Components of Income Tax Expense (Benefit) | The provision (benefit) for income taxes was as follows ($ in thousands):
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Unrecognized Tax Benefits Roll Forward | The provision (benefit) for income taxes is determined by applying the U.S. Federal statutory rate of 34% to income before income taxes as a result of the following ($ in thousands):
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Deferred Tax Assets and Liabilities | Deferred income taxes at December 31, 2017 and 2016 consist of the following ($ in thousands):
|
Discontinued Operations (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Discontinued Operations and Disposal Groups [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Discontinued Operations | The Company recognized the following gain on the date of sale of its 80.1% interest in PCT (in thousands):
The operations and cash flows of the PCT Segment were eliminated from ongoing operations with the sale of the Company's PCT Interest. The operating results of the PCT Segment for the years ended December 31, 2017 and 2016 were as follows (in thousands):
|
Commitments and Contingencies (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2017 | ||||||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Future Minimum Rental Payments for Operating Leases | A summary of future minimum rental payments required under operating leases that have initial or remaining terms in excess of one year as of December 31, 2017 are as follows (in thousands):
|
The Business - CLBS03 (Details) $ in Millions |
1 Months Ended | 3 Months Ended | ||||
---|---|---|---|---|---|---|
Jan. 18, 2018
patient
|
Oct. 31, 2016
patient
|
Mar. 31, 2016
cohort
|
May 04, 2017
USD ($)
|
Feb. 28, 2017
USD ($)
|
Feb. 23, 2017
USD ($)
|
|
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Grants Receivable | $ | $ 12.2 | $ 12.2 | ||||
Grants Receivable, Current | $ | $ 5.7 | |||||
Number of patients enrolled | patient | 19 | |||||
Interim efficacy analysis, percentage threshold | 50.00% | |||||
Interim efficacy analysis, follow-up milestone period | 6 years | |||||
The Sanford Project: T-Rex Study [Member] | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Number of cohorts (cohort) | cohort | 2 | |||||
Subsequent Event [Member] | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Number of patients enrolled | patient | 110 |
The Business - Cell Therapy Development and Manufacturing (Details) - USD ($) $ in Millions |
1 Months Ended | |||
---|---|---|---|---|
Oct. 02, 2017 |
Dec. 31, 2017 |
May 31, 2017 |
Mar. 11, 2016 |
|
Subsidiary or Equity Method Investee [Line Items] | ||||
Revenue from grants | $ 1.9 | $ 1.9 | $ 5.7 | |
Equity Method Investment, Ownership Percentage | 19.90% | |||
Hitachi America [Member] | ||||
Subsidiary or Equity Method Investee [Line Items] | ||||
Equity Method Investment, Ownership Percentage | 21.00% |
The Business - Principles of Consolidation (Details) - USD ($) |
12 Months Ended | |||
---|---|---|---|---|
May 18, 2017 |
Dec. 31, 2017 |
Dec. 31, 2016 |
Mar. 11, 2016 |
|
Subsidiary or Equity Method Investee [Line Items] | ||||
Equity Method Investment, Ownership Percentage | 19.90% | |||
Change in ownership in subsidiary | $ 0 | $ 0 | ||
Hitachi America [Member] | ||||
Subsidiary or Equity Method Investee [Line Items] | ||||
Equity Method Investment, Ownership Percentage | 21.00% | |||
Discontinued Operations, Held-for-sale or Disposed of by Sale [Member] | PCT Segment [Member] | ||||
Subsidiary or Equity Method Investee [Line Items] | ||||
Subsidiary, Ownership Interest by Parent | 80.10% | |||
Discontinued Operations, Held-for-sale or Disposed of by Sale [Member] | PCT Segment [Member] | PCT Allendale, LLC [Member] | Hitachi America [Member] | ||||
Subsidiary or Equity Method Investee [Line Items] | ||||
Purchase Agreement, Aggregate Purchase Price | $ 75,000,000 |
Summary of Significant Accounting Policies (Details) |
3 Months Ended | 12 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2015
reporting_unit
|
Dec. 31, 2017 |
Dec. 31, 2016
USD ($)
reporting_unit
|
Mar. 11, 2016
USD ($)
|
|
Property, Plant and Equipment [Line Items] | ||||
Number of reporting units (reporting_unit) | reporting_unit | 2 | 2 | ||
Impairment of intangible assets | $ 0 | |||
Furniture and fixtures | ||||
Property, Plant and Equipment [Line Items] | ||||
Property, Plant and Equipment, Estimated Useful Lives | P10Y | |||
Computer equipment | ||||
Property, Plant and Equipment [Line Items] | ||||
Property, Plant and Equipment, Estimated Useful Lives | P3Y | |||
Software | ||||
Property, Plant and Equipment [Line Items] | ||||
Property, Plant and Equipment, Estimated Useful Lives | P3Y | |||
Leasehold improvements | ||||
Property, Plant and Equipment [Line Items] | ||||
Property, Plant and Equipment, Estimated Useful Lives | life of lease | |||
PCT Allendale, LLC [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Contract Receivable | $ 5,600,000 |
Collaboration and Hitachi License Agreement - 2016 Hitachi Transaction (Details) - USD ($) $ in Millions |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2017 |
Mar. 31, 2016 |
Mar. 11, 2016 |
|
Business Acquisition [Line Items] | |||
Equity Method Investment, Ownership Percentage | 19.90% | ||
Hitachi Chemical Co., LTD [Member] | |||
Business Acquisition [Line Items] | |||
Equity Method Investment, Ownership Percentage | 21.00% | ||
Recorded Unconditional Purchase Obligation | $ 20.5 | $ 19.4 | |
Unrecorded Unconditional Purchase Obligation, Maximum Quantity | 15.0 | ||
PCT Allendale, LLC [Member] | |||
Business Acquisition [Line Items] | |||
Contract Receivable | $ 5.6 | ||
PCT Allendale, LLC [Member] | |||
Business Acquisition [Line Items] | |||
Purchase Obligation | $ 4.4 | ||
Minimum [Member] | PCT Allendale, LLC [Member] | |||
Business Acquisition [Line Items] | |||
Length of Contract for Royalty Payments from Revenue Generated in Asia | 10 years |
Property, Plant and Equipment (Details) - USD ($) |
12 Months Ended | |
---|---|---|
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Property, Plant and Equipment, Net, by Type [Abstract] | ||
Property, plant and equipment, gross | $ 1,089,300 | $ 1,858,400 |
Accumulated depreciation | (832,400) | (1,153,000) |
Property, plant and equipment, net | 256,905 | 705,438 |
Depreciation expense | 400,000 | 500,000 |
Lab equipment | ||
Property, Plant and Equipment, Net, by Type [Abstract] | ||
Property, plant and equipment, gross | 0 | 181,600 |
Furniture and fixtures | ||
Property, Plant and Equipment, Net, by Type [Abstract] | ||
Property, plant and equipment, gross | 25,400 | 288,200 |
Computer equipment | ||
Property, Plant and Equipment, Net, by Type [Abstract] | ||
Property, plant and equipment, gross | 998,300 | 1,173,400 |
Software | ||
Property, Plant and Equipment, Net, by Type [Abstract] | ||
Property, plant and equipment, gross | 0 | 99,500 |
Leasehold improvements | ||
Property, Plant and Equipment, Net, by Type [Abstract] | ||
Property, plant and equipment, gross | $ 65,600 | $ 115,700 |
Loss Per Share (Details) - shares |
9 Months Ended | 12 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2017 |
Sep. 30, 2016 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Stock Options [Member] | ||||
Class of Stock [Line Items] | ||||
Dilutive Securities Excluded From Computation Of Earnings Per Share, Shares | 1,072,499 | 953,690 | ||
Warrant [Member] | ||||
Class of Stock [Line Items] | ||||
Dilutive Securities Excluded From Computation Of Earnings Per Share, Shares | 209,818 | 388,062 | ||
Restricted Stock [Member] | ||||
Class of Stock [Line Items] | ||||
Dilutive Securities Excluded From Computation Of Earnings Per Share, Shares | 10,260 | 0 | 181,908 | 126,849 |
Fair Value Measurements (Details) - Fair Value, Measurements, Recurring [Member] - USD ($) |
Dec. 31, 2017 |
Dec. 31, 2016 |
---|---|---|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments, Fair Value Disclosure | $ 25,916,700 | $ 0 |
Assets, Fair Value Disclosure | 25,916,700 | 0 |
Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments, Fair Value Disclosure | 0 | 0 |
Assets, Fair Value Disclosure | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments, Fair Value Disclosure | 25,916,700 | 0 |
Assets, Fair Value Disclosure | 25,916,700 | 0 |
Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments, Fair Value Disclosure | 0 | 0 |
Assets, Fair Value Disclosure | $ 0 | $ 0 |
Accrued Liabilities (Details) - USD ($) |
Dec. 31, 2017 |
Dec. 31, 2016 |
---|---|---|
Accrued Liabilities [Abstract] | ||
Salaries, employee benefits and related taxes | $ 1,389,200 | $ 1,406,300 |
Retention Payable | 2,233,000 | 0 |
Professional fees | 286,700 | 224,500 |
Grants Receivable, Current | 2,445,900 | 0 |
Other | 1,456,100 | 1,028,600 |
Accrued Liabilities | $ 7,810,900 | $ 2,659,400 |
Debt (Details) - USD ($) |
1 Months Ended | 12 Months Ended | |||||
---|---|---|---|---|---|---|---|
May 18, 2017 |
Mar. 11, 2016 |
Sep. 30, 2016 |
Dec. 31, 2017 |
Dec. 31, 2016 |
Sep. 30, 2017 |
Sep. 26, 2014 |
|
Debt Instrument [Line Items] | |||||||
Notes Payable | $ 200,000 | $ 700,000 | |||||
Interest Expense | 377,768 | 1,779,657 | |||||
Loan and Security Agreement [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Interest Expense | 400,000 | $ 1,700,000 | |||||
Long-term Debt [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Long-term Debt, Gross | $ 15,000,000 | ||||||
Oxford Finance LLC [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Repayments of debt | $ 7,000,000 | $ 3,000,000 | |||||
Long-term Debt | $ 5,700,000 | ||||||
Debt Instrument, Payment To Lender Based On Receipt Of Proceeds From Eligible Events, Percent | 20.00% | ||||||
Oxford Finance LLC [Member] | Loans Payable [Member] | Loan and Security Agreement [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Repayments of debt | $ 4,900,000 | ||||||
Debt Instrument, Interest Rate, Effective Percentage | 8.50% | ||||||
Minimum [Member] | Notes Payable [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt Instrument, Term | 1 year |
Redeemable Securities - Non-Controlling Interests (Details) - USD ($) |
12 Months Ended | |||
---|---|---|---|---|
May 18, 2017 |
Mar. 11, 2016 |
Dec. 31, 2017 |
Mar. 31, 2016 |
|
Business Acquisition [Line Items] | ||||
Equity Method Investment, Ownership Percentage | 19.90% | |||
Conversion of redeemable securities | $ 19,400,000 | |||
Hitachi Chemical Co., LTD [Member] | ||||
Business Acquisition [Line Items] | ||||
Recorded Unconditional Purchase Obligation | $ 19,400,000 | $ 20,500,000 | ||
Equity Method Investment, Ownership Percentage | 21.00% | |||
Business Combination, Consideration Transfered, Interest Rate | 2.00% | |||
Conversion of redeemable securities | $ 14,700,000 | |||
Redeemable Securities, Classified to Non-Controlling Interests | $ 4,700,000 |
Stockholders' Equity - Compensation Cost Related to Nonvested Awards (Details) - USD ($) |
12 Months Ended | |
---|---|---|
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | 181,908 | 126,849 |
Stock Issued During Period, Value, Restricted Stock Award, Gross | $ 627,700 | $ 698,100 |
Restricted Stock [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
weighted average estimated fair value of restricted stock | $ 3.45 | $ 5.50 |
Share-Based Compensation (Details) |
12 Months Ended |
---|---|
Dec. 31, 2017
USD ($)
| |
Stock Option [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation cost | $ 39,500 |
Excepted weighted-average period in years of compensation cost to be recognized | 7 months 10 days |
Restricted Stock [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation cost | $ 97,200 |
Excepted weighted-average period in years of compensation cost to be recognized | 1 year 10 months 2 days |
Research Funding (Details) - USD ($) $ in Millions |
1 Months Ended | 12 Months Ended | ||||
---|---|---|---|---|---|---|
Oct. 02, 2017 |
Dec. 31, 2017 |
May 31, 2017 |
Dec. 31, 2017 |
Feb. 28, 2017 |
Feb. 23, 2017 |
|
Deferred Revenue Arrangement [Line Items] | ||||||
Grants receivable | $ 12.2 | $ 12.2 | ||||
Grant payments received | $ 1.9 | $ 1.9 | $ 5.7 | |||
Grant revenue recognized | $ 1.3 | |||||
Accrued Liabilities | ||||||
Deferred Revenue Arrangement [Line Items] | ||||||
Deferred grant revenue | 2.4 | 2.4 | ||||
Other Long-term Liabilities | ||||||
Deferred Revenue Arrangement [Line Items] | ||||||
Deferred grant revenue | $ 3.9 | $ 3.9 |
Discontinued Operations - Operating Results of PCT Segment (Details) - USD ($) |
12 Months Ended | ||
---|---|---|---|
May 18, 2017 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Income (loss) from discontinued operations | $ 38,399,236 | $ (2,051,782) | |
PCT Segment [Member] | Discontinued Operations [Member] | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Revenue | 16,039,000 | 42,043,000 | |
Cost of revenues | (15,321,000) | (35,519,000) | |
Research and development | (257,000) | (800,000) | |
Selling, general, and administrative | (3,251,000) | (7,558,000) | |
Other expense | (14,000) | (80,000) | |
Provision for income taxes | (10,541,000) | (138,000) | |
Gain on sale of segment | $ 51,744,000 | 51,744,000 | 0 |
Income (loss) from discontinued operations | $ 38,399,000 | $ (2,052,000) |
Commitments and Contingencies (Details) |
1 Months Ended | 12 Months Ended | |
---|---|---|---|
Oct. 31, 2016
patient
|
Dec. 31, 2017
USD ($)
patient
|
Dec. 31, 2016
USD ($)
|
|
Commitments and Contingencies Disclosure [Abstract] | |||
Number of patients enrolled | patient | 19 | ||
Number of patients still active in study | patient | 92 | ||
Operating Leases, Future Minimum Payments Due [Abstract] | |||
2018 | $ 910,000 | ||
2019 | 901,200 | ||
2020 | 827,000 | ||
2021 | 474,400 | ||
2022 and thereafter | 128,600 | ||
Total minimum lease payments | 3,241,200 | ||
Operating leases expenses | $ 1,400,000 | $ 1,400,000 |
Subsequent Events (Details) - Subsequent Event [Member] $ in Millions |
Feb. 08, 2018
USD ($)
|
---|---|
Subsequent Event [Line Items] | |
Aggregate offering price of shares authorized for sale per agreement | $ 12 |
Commission due to HCW upon gross proceeds of sale of stock (percent) | 3.00% |
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