x | QUARTERLY 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 incorporation or organization) | (I.R.S. Employer Identification No.) |
110 Allen Road, 2nd Floor, Liberty Corner, New Jersey | 07920 |
(Address of principal executive offices) | (zip code) |
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 o |
• | potential adverse reactions or changes to business relationships resulting from the announcement or completion of the sale of PCT, LLC to Hitachi Chemical Co., America, Ltd. (as described more fully below, the “Sale”); |
• | unexpected costs, charges or expenses relating to or resulting from the Sale; |
• | litigation or adverse judgments relating to the Sale; |
• | 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; |
• | 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; and |
• | other factors discussed in "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on March 16, 2017 (our "2016 Form 10-K"). |
Page No. | ||
Financial Statements: | ||
Consolidated Balance Sheets at June 30, 2017 (unaudited) and December 31, 2016 | ||
Consolidated Statements of Operations for the three and six months ended June 30, 2017 and 2016 (unaudited) | ||
Consolidated Statements of Comprehensive Loss for the three and six months ended June 30, 2017 and 2016 (unaudited) | ||
Consolidated Statements of Equity for the six months ended June 30, 2017 and 2016 (unaudited) | ||
Consolidated Statements of Cash Flows for the six months ended June 30, 2017 and 2016 (unaudited) | ||
June 30, 2017 | December 31, 2016 | ||||||
ASSETS | (Unaudited) | ||||||
Current Assets | |||||||
Cash and cash equivalents | $ | 23,044,844 | $ | 7,076,651 | |||
Restricted cash | 5,000,722 | — | |||||
Marketable securities | 36,324,936 | — | |||||
Accounts receivable, net of allowances of $0 at June 30, 2017 and December 31, 2016, respectively | 335,646 | 138,774 | |||||
Prepaid and other current assets | 5,706,396 | 1,900,493 | |||||
Current assets related to discontinued operations | — | 15,533,043 | |||||
Total current assets | 70,412,544 | 24,648,961 | |||||
Property, plant and equipment, net | 432,853 | 705,439 | |||||
Other assets | 1,402,463 | 1,582,209 | |||||
Other assets related to discontinued operations | — | 26,577,834 | |||||
Total assets | $ | 72,247,860 | $ | 53,514,442 | |||
LIABILITIES, REDEEMABLE SECURITIES - NON-CONTROLLING INTERESTS AND EQUITY | |||||||
Current Liabilities | |||||||
Accounts payable | $ | 1,114,122 | $ | 2,226,580 | |||
Accrued liabilities | 12,408,604 | 2,659,433 | |||||
Long-term debt, current | — | 3,126,457 | |||||
Notes payable, current | 578,353 | 563,777 | |||||
Due to PCT | 450,315 | 1,681,594 | |||||
Current liabilities related to discontinued operations | — | 10,925,052 | |||||
Total current liabilities | 14,551,394 | 21,182,893 | |||||
Notes payable | 23,290 | 159,180 | |||||
Long-term debt | — | 2,524,897 | |||||
Other long-term liabilities | 3,636,538 | 389,858 | |||||
Liabilities related to discontinued operations | — | 5,791,134 | |||||
Total liabilities | $ | 18,211,222 | $ | 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 June 30, 2017 and December 31, 2016 | 100 | 100 | |||||
Common stock, $.001 par value, authorized 500,000,000 shares; issued and outstanding, 8,912,602 and 8,205,791 shares, at June 30, 2017 and December 31, 2016, respectively | 8,913 | 8,206 | |||||
Additional paid-in capital | 430,606,930 | 410,372,049 | |||||
Treasury stock, at cost; 11,080 shares at June 30, 2017 and December 31, 2016, respectively | (707,637 | ) | (707,637 | ) | |||
Accumulated deficit | (375,429,627 | ) | (404,788,809 | ) | |||
Accumulated other comprehensive income | (57,860 | ) | — | ||||
Total Caladrius Biosciences, Inc. stockholders' equity | 54,420,819 | 4,883,909 | |||||
Noncontrolling interests | (384,181 | ) | (817,429 | ) | |||
Total equity | 54,036,638 | 4,066,480 | |||||
Total liabilities, redeemable securities - non-controlling interests, and equity | $ | 72,247,860 | $ | 53,514,442 |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||
Operating Expenses: | |||||||||||||||
Research and development | $ | 4,277,783 | $ | 4,488,603 | $ | 8,003,915 | $ | 10,537,452 | |||||||
General and administrative | 3,432,534 | 2,917,221 | 6,138,928 | 7,744,643 | |||||||||||
Total operating expenses | 7,710,317 | 7,405,824 | 14,142,843 | 18,282,095 | |||||||||||
Operating loss | (7,710,317 | ) | (7,405,824 | ) | (14,142,843 | ) | (18,282,095 | ) | |||||||
Other income (expense): | |||||||||||||||
Other income (expense), net | 4,828 | 8,757 | (39,567 | ) | 14,442 | ||||||||||
Interest expense | (204,484 | ) | (335,884 | ) | (363,412 | ) | (1,233,057 | ) | |||||||
(199,656 | ) | (327,127 | ) | (402,979 | ) | (1,218,615 | ) | ||||||||
Loss from continuing operations before provision for income taxes and noncontrolling interests | (7,909,973 | ) | (7,732,951 | ) | (14,545,822 | ) | (19,500,710 | ) | |||||||
Benefit from income taxes | (5,887,543 | ) | — | (5,887,543 | ) | — | |||||||||
Net loss from continuing operations | (2,022,430 | ) | (7,732,951 | ) | (8,658,279 | ) | (19,500,710 | ) | |||||||
Discontinued operations - net of taxes | 40,487,438 | (151,819 | ) | 37,329,963 | (431,856 | ) | |||||||||
Net income (loss) | $ | 38,465,008 | $ | (7,884,770 | ) | $ | 28,671,684 | $ | (19,932,566 | ) | |||||
Less - net loss from continuing operations attributable to noncontrolling interests | (54,676 | ) | (63,931 | ) | (119,342 | ) | (127,703 | ) | |||||||
Less - net (loss) income from discontinued operations attributable to noncontrolling interests | (199,325 | ) | 13,877 | (568,156 | ) | 10,770 | |||||||||
Net income (loss) attributable to Caladrius Biosciences, Inc. common stockholders | $ | 38,719,009 | $ | (7,834,716 | ) | $ | 29,359,182 | $ | (19,815,633 | ) | |||||
Amounts Attributable to Caladrius Inc. common stockholders: | |||||||||||||||
Loss from continuing operations | (1,967,754 | ) | (7,669,020 | ) | (8,538,937 | ) | (19,373,007 | ) | |||||||
Income (loss) from discontinued operations - net of taxes | 40,686,763 | (165,696 | ) | 37,898,119 | (442,626 | ) | |||||||||
Net income (loss) attributable to Caladrius Inc. common stockholders | $ | 38,719,009 | $ | (7,834,716 | ) | $ | 29,359,182 | $ | (19,815,633 | ) | |||||
Basic and diluted income (loss) per share | |||||||||||||||
Continuing operations | $ | (0.22 | ) | $ | (1.30 | ) | $ | (0.99 | ) | $ | (3.32 | ) | |||
Discontinued operations | $ | 4.56 | $ | (0.03 | ) | $ | 4.38 | $ | (0.08 | ) | |||||
Caladrius Biosciences, Inc. common stockholders | $ | 4.34 | $ | (1.33 | ) | $ | 3.39 | $ | (3.39 | ) | |||||
Weighted average common shares outstanding: | |||||||||||||||
Basic and diluted shares | 8,926,783 | 5,907,013 | 8,657,334 | 5,839,963 |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||
Net income (loss) | $ | 38,465,008 | $ | (7,884,770 | ) | $ | 28,671,684 | $ | (19,932,566 | ) | |||||
Other comprehensive loss: | |||||||||||||||
Available for sale securities - net unrealized loss | (57,860 | ) | (486 | ) | (57,860 | ) | (486 | ) | |||||||
Total other comprehensive loss | (57,860 | ) | (486 | ) | (57,860 | ) | (486 | ) | |||||||
Comprehensive income (loss) | 38,407,148 | (7,885,256 | ) | 28,613,824 | (19,933,052 | ) | |||||||||
Comprehensive loss attributable to noncontrolling interests | (254,001 | ) | (50,054 | ) | (687,498 | ) | (116,933 | ) | |||||||
Comprehensive income (loss) attributable to Caladrius Biosciences, Inc. common stockholders | $ | 38,661,149 | $ | (7,835,202 | ) | $ | 29,301,322 | $ | (19,816,119 | ) |
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 | — | — | — | — | — | — | (19,815,633 | ) | — | (19,815,633 | ) | (116,933 | ) | (19,932,566 | ) | ||||||||||||||||||||||||||
Unrealized gain/loss on marketable securities | — | — | — | — | — | (486 | ) | — | — | (486 | ) | — | (486 | ) | |||||||||||||||||||||||||||
Share-based compensation | — | — | 95,355 | 95 | 1,235,049 | — | — | 1,235,144 | — | 1,235,144 | |||||||||||||||||||||||||||||||
Net proceeds from issuance of common stock | — | — | 158,092 | 159 | 1,050,553 | — | — | — | 1,050,712 | — | 1,050,712 | ||||||||||||||||||||||||||||||
Change in Ownership in Subsidiary | — | — | — | — | (133,012 | ) | — | — | — | (133,012 | ) | 133,012 | — | ||||||||||||||||||||||||||||
Balance at June 30, 2016 | 10,000 | $ | 100 | 5,926,749 | $ | 5,927 | $ | 398,699,991 | $ | — | $ | (391,948,123 | ) | $ | (707,637 | ) | $ | 6,050,258 | $ | (413,630 | ) | $ | 5,636,628 | ||||||||||||||||||
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, 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 | — | — | — | — | — | — | 29,359,182 | — | 29,359,182 | (687,498 | ) | 28,671,684 | |||||||||||||||||||||||||||||
Unrealized gain/loss on marketable securities | — | — | — | — | — | (57,860 | ) | — | — | (57,860 | ) | — | (57,860 | ) | |||||||||||||||||||||||||||
Share-based compensation | — | — | 54,545 | 55 | 2,350,597 | — | — | — | 2,350,652 | — | 2,350,652 | ||||||||||||||||||||||||||||||
Net proceeds from issuance of common stock | — | — | 648,432 | 648 | 3,277,984 | — | — | — | 3,278,632 | — | 3,278,632 | ||||||||||||||||||||||||||||||
Proceeds from option exercises | — | — | 3,835 | 4 | 13,572 | — | — | — | 13,576 | — | 13,576 | ||||||||||||||||||||||||||||||
Elimination of non-controlling interests associated with PCT sale | — | — | — | — | — | — | — | — | — | (3,686,526 | ) | (3,686,526 | ) | ||||||||||||||||||||||||||||
Reclassification of redeemable securities | — | — | — | — | 14,733,908 | — | — | — | 14,733,908 | 4,666,092 | 19,400,000 | ||||||||||||||||||||||||||||||
Change in Ownership in Subsidiary | — | — | — | — | (141,180 | ) | — | — | — | (141,180 | ) | 141,180 | — | ||||||||||||||||||||||||||||
Balance at June 30, 2017 | 10,000 | $ | 100 | 8,912,602 | $ | 8,913 | $ | 430,606,930 | $ | (57,860 | ) | $ | (375,429,627 | ) | $ | (707,637 | ) | $ | 54,420,819 | $ | (384,181 | ) | $ | 54,036,638 | |||||||||||||||||
Six Months Ended June 30, | |||||||
2017 | 2016 | ||||||
Cash flows from operating activities: | |||||||
Net income (loss) | $ | 28,671,684 | $ | (19,932,566 | ) | ||
(Income) loss from discontinued operations | (37,329,963 | ) | 431,856 | ||||
Share-based compensation | 1,819,382 | 883,143 | |||||
Depreciation and amortization | 193,845 | 252,237 | |||||
Loss on disposal of assets | 175,793 | 591,307 | |||||
Accretion on marketable securities | 39,175 | — | |||||
Changes in operating assets and liabilities: | |||||||
Restricted cash | (5,000,722 | ) | — | ||||
Prepaid and other current assets | 619,528 | 405,619 | |||||
Accounts receivable | (196,872 | ) | (97,904 | ) | |||
Other assets | 179,763 | 147,107 | |||||
Due to/from PCT | (1,231,258 | ) | 2,681,195 | ||||
Accounts payable, accrued liabilities and other liabilities | (2,879,408 | ) | (2,540,199 | ) | |||
Net cash used in operating activities - continuing operations | (14,939,053 | ) | (17,178,205 | ) | |||
Net cash (used in) provided by operating activities - discontinued operations | (638,069 | ) | 2,602,650 | ||||
Net cash used in operating activities | (15,577,122 | ) | (14,575,555 | ) | |||
Cash flows from investing activities: | |||||||
Purchase of marketable securities | (36,421,971 | ) | — | ||||
Proceeds from PCT sale | 70,264,395 | — | |||||
Net cash sold in PCT sale | (6,727,263 | ) | — | ||||
Acquisition of property, plant and equipment | (97,052 | ) | (1,068,129 | ) | |||
Net cash provided by (used in) investing activities - continuing operations | 27,018,109 | (1,068,129 | ) | ||||
Net cash used in investing activities - discontinued operations | (188,794 | ) | (635,168 | ) | |||
Net cash provided by (used in) investing activities | 26,829,315 | (1,703,297 | ) | ||||
Cash flows from financing activities: | |||||||
Proceeds from exercise of options | 13,576 | — | |||||
Tax withholding payments on net share settlement equity awards | (357,665 | ) | — | ||||
Net proceeds from issuance of common stock | 3,278,632 | 1,050,712 | |||||
Repayment of long-term debt | (5,651,354 | ) | (6,348,646 | ) | |||
Proceeds from notes payable | 400,998 | 368,615 | |||||
Repayment of notes payable | (522,313 | ) | (489,925 | ) | |||
PCT dividend to Caladrius | — | 15,000,000 | |||||
Net cash (used in) provided by financing activities - continuing operations | (2,838,126 | ) | 9,580,756 | ||||
Net cash (used in) provided by financing activities - discontinued operations | (74,231 | ) | 4,079,371 | ||||
Net cash (used in) provided by financing activities | (2,912,357 | ) | 13,660,127 | ||||
Net increase (decrease) in cash and cash equivalents | 8,339,836 | (2,618,725 | ) | ||||
Cash and cash equivalents at beginning of period - continuing operations | 7,076,651 | 18,657,971 | |||||
Cash and cash equivalents at beginning of period - discontinued operations | 7,628,357 | 1,660,440 | |||||
Cash and cash equivalents at end of period | $ | 23,044,844 | $ | 17,699,686 | |||
Less cash and cash equivalents of discontinued operations at end of period | — | 7,355,294 | |||||
Cash and cash equivalents of continuing operations at end of period | 23,044,844 | 10,344,392 | |||||
Supplemental Disclosure of Cash Flow Information: | |||||||
Cash paid during the period for: | |||||||
Interest | $ | 697,544 | $ | 973,729 |
• | 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. |
June 30, 2017 | December 31, 2016 | ||||||||||||||||||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | ||||||||||||||||||||||||
Certificate of deposits | $ | 1,489.6 | $ | — | $ | — | $ | 1,489.6 | $ | — | $ | — | $ | — | $ | — | |||||||||||||||
Corporate debt securities | 46,724.4 | — | (57.6 | ) | 46,666.8 | — | — | — | — | ||||||||||||||||||||||
Money market funds | 7,188.6 | 0.1 | — | 7,188.7 | 4,426.8 | — | — | 4,426.8 | |||||||||||||||||||||||
Municipal debt securities | 75.0 | — | — | 75.0 | — | — | — | — | |||||||||||||||||||||||
Sovereign government securities | 350.4 | — | (0.2 | ) | 350.2 | — | — | — | — | ||||||||||||||||||||||
Total | $ | 55,828.0 | $ | 0.1 | $ | (57.8 | ) | $ | 55,770.3 | $ | 4,426.8 | $ | — | $ | — | $ | 4,426.8 |
June 30, 2017 | December 31, 2016 | ||||||
Cash and cash equivalents | $ | 19,445.3 | $ | 4,426.8 | |||
Marketable securities | 36,325.0 | — | |||||
Total | $ | 55,770.3 | $ | 4,426.8 |
June 30, 2017 | |||||||
Amortized Cost | Estimated Fair Value | ||||||
Less than one year | $ | 55,828.0 | $ | 55,770.3 | |||
Greater than one year | — | — | |||||
Total | $ | 55,828.0 | $ | 55,770.3 |
June 30, | |||||
2017 | 2016 | ||||
Stock Options | 1,119,580 | 692,205 | |||
Warrants | 285,462 | 460,047 | |||
Restricted Stock Awards | 8,000 | 70,046 | |||
Restricted Stock Units | 10,260 | — |
June 30, 2017 | December 31, 2016 | |||||||||||||||||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | Level 1 | Level 2 | Level 3 | Total | |||||||||||||||||||||||||
Assets: | ||||||||||||||||||||||||||||||||
Marketable securities - available for sale | $ | — | $ | 36,325.0 | $ | — | $ | 36,325.0 | $ | — | $ | — | $ | — | $ | — | ||||||||||||||||
$ | — | $ | 36,325.0 | $ | — | $ | 36,325.0 | $ | — | $ | — | $ | — | $ | — |
June 30, 2017 | December 31, 2016 | ||||||
Salaries, employee benefits and related taxes | $ | 1,129.6 | $ | 1,406.3 | |||
Retention payments | 2,233.1 | — | |||||
Professional fees | 192.5 | 224.5 | |||||
Income tax payable | 6,791.5 | — | |||||
CIRM upfront funding - current | 1,745.5 | — | |||||
Other | 316.4 | 1,028.6 | |||||
Total | $ | 12,408.6 | $ | 2,659.4 |
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 period: | ||||||||||||||||||||||||||
Granted | 447,157 | 11.80 | — | — | ||||||||||||||||||||||
Exercised | (3,835 | ) | 4.70 | — | — | |||||||||||||||||||||
Forfeited | (244,413 | ) | 18.70 | (1,691 | ) | 700.00 | ||||||||||||||||||||
Expired | (32,119 | ) | 37.00 | (100,909 | ) | 128.60 | ||||||||||||||||||||
Outstanding at June 30, 2017 | 1,119,580 | $ | 33.50 | 5.58 | $ | 231.8 | 285,462 | $ | 57.80 | 1.10 | $ | — | ||||||||||||||
Vested at June 30, 2017 or expected to vest in the future | 1,119,152 | $ | 33.60 | 5.58 | $ | 231.8 | 285,462 | $ | 57.80 | 1.10 | $ | — | ||||||||||||||
Vested at June 30, 2017 | 1,111,740 | $ | 32.90 | 5.59 | $ | 231.5 | 285,462 | $ | 57.80 | 1.10 | $ | — |
Six Months Ended June 30, | ||||||||
2017 | 2016 | |||||||
Number of restricted stock issued | 132,726 | 107,719 | ||||||
Value of restricted stock issued | $ | 469.9 | $ | 651.7 |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||
Research and development | $ | 162.0 | $ | — | $ | 208.2 | $ | 71.0 | |||||||
General and administrative | 1,261.7 | 253.5 | 1,611.2 | 812.0 | |||||||||||
Discontinued operations | 751.4 | 82.0 | 888.9 | 352.0 | |||||||||||
Total share-based compensation expense | $ | 2,175.1 | $ | 335.5 | $ | 2,708.3 | $ | 1,235.0 | |||||||
Stock Options | Restricted Stock | ||||||
Unrecognized compensation cost | $ | 38.8 | $ | 13.6 | |||
Expected weighted-average period in years of compensation cost to be recognized | 0.69 | 0.39 |
Stock Options | |||||||
Six Months Ended June 30, | |||||||
2017 | 2016 | ||||||
Total fair value of shares vested | $ | 5,001.7 | $ | 1,153.1 | |||
Weighted average estimated fair value of shares granted | $ | 1.72 | $ | 4.02 |
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 |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||
Revenue | $ | 5,729 | $ | 10,002 | $ | 16,039 | $ | 19,116 | |||||||
Cost of revenues | (5,268 | ) | (8,125 | ) | (15,321 | ) | (15,640 | ) | |||||||
Research and development | (143 | ) | (168 | ) | (257 | ) | (333 | ) | |||||||
Selling, general, and administrative | (8 | ) | (1,789 | ) | (3,251 | ) | (3,420 | ) | |||||||
Other expense | (8 | ) | (26 | ) | (16 | ) | (55 | ) | |||||||
Provision for income taxes | (11,559 | ) | (47 | ) | (11,608 | ) | (100 | ) | |||||||
Gain on sale of segment | 51,744 | — | 51,744 | — | |||||||||||
Income (loss) from discontinued operations | $ | 40,487 | $ | (152 | ) | $ | 37,330 | $ | (432 | ) |
Years ended | Operating Leases | |||
2017 | $ | 655.1 | ||
2018 | 817.4 | |||
2019 | 786.2 | |||
2020 | 801.6 | |||
2021 and thereafter | 603.0 | |||
Total minimum lease payments | $ | 3,663.3 |
• | Research and development expenses were approximately $4.3 million for the three months ended June 30, 2017, compared to $4.5 million for the three months ended June 30, 2016, representing a decrease of approximately $0.2 million, or 5%. |
◦ | Immune Modulation - Immune modulation expenses, primarily related to expenses associated with our Phase 2 study of CLBS03 in T1D, were $3.9 million for the three months ended June 30, 2017, compared to $2.4 million for the three months ended June 30, 2016. |
◦ | Ischemic Repair - Ischemic repair expenses were $0.2 million for the three months ended June 30, 2017, compared to $0.8 million for the three months ended June 30, 2016. The decrease is primarily due to lower program expenses associated with the decision to only conduct clinical study activity for a critical limb ischemia development program in Japan with a partner, and diminishing wind down expenses associated with the close-out activities of the PreSERVE-AMI Phase 2 study for CLBS10. |
◦ | Other - Other research and development expenses were $0.1 million for the three months ended June 30, 2017, compared to $1.3 million for the three months ended June 30, 2016. The decrease is related to $1.2 million of close-out activities for the Intus Phase 3 clinical trial for the immunotherapy product candidate CLBS20, announced in January 2016. |
• | General and administrative expenses were approximately $3.4 million for the three months ended June 30, 2017, compared to $2.9 million for the three months ended June 30, 2016, representing an increase of approximately $0.5 million, or 18%. The increase was due to higher equity-based compensation of $1.3 million during the three months ended June 30, 2017, compared with $0.3 million for the three months ended June 30, 2016, reflecting the acceleration of vesting of all options and restricted stock outstanding as of May 18, 2017 (the PCT Closing Date), as the transaction was determined to qualify as a change in control under our employee compensation plans which triggered the vesting. The increase was partially offset by lower overall administrative expenses. |
• | Research and development expenses were approximately $8.0 million for the six months ended June 30, 2017, compared to $10.5 million for the six months ended June 30, 2016, representing a decrease of approximately $2.5 million, or 24%. |
◦ | Immune Modulation - Immune modulation expenses, including expenses associated with our Phase 2 study of CLBS03 in T1D, were $8.0 million for the six months ended June 30, 2017, compared to $4.7 million for the six months ended June 30, 2016. |
◦ | Ischemic Repair - Ischemic repair expenses were $0.3 million for the six months ended June 30, 2017, compared to $2.0 million for the six months ended June 30, 2016. The decrease is primarily due to lower program expenses associated with the decision to only conduct clinical study activity for a critical limb ischemia development program in Japan with a partner, and diminishing wind down expenses associated with the close-out activities of the PreSERVE-AMI Phase 2 study for CLBS10 during the six months ended June 30, 2016. |
◦ | Other - Other research and development expenses were $0.3 million for the six months ended June 30, 2017, compared to $3.9 million for the six months ended June 30, 2016. The decrease is related to $2.5 million of close-out activities for the Intus Phase 3 clinical trial for the immunotherapy product candidate CLBS20, announced in January 2016, along with $1.2 million of associated one-time restructuring costs for severance and asset impairments during the six months ended June 30, 2016. |
• | General and administrative expenses were approximately $6.1 million for the six months ended June 30, 2017 compared to $7.7 million for the six months ended June 30, 2016, representing a decrease of approximately $1.6 million, or 21%. The decrease was primarily related to operational and compensation-related cost reductions compared to the prior year period, but offset by higher transaction-related expenses associated with the PCT Sale. Equity-based compensation of $1.6 million was also higher during the six months ended June 30, 2017, compared with $0.8 million for the six months ended June 30, 2016, reflecting the acceleration of vesting of all options and restricted stock outstanding as of May 18, 2017 (the PCT Closing Date), as the transaction was determined to qualify as a change in control under our employee compensation plan which triggered the vesting. |
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 |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||
Revenue | $ | 5,729 | $ | 10,002 | $ | 16,039 | $ | 19,116 | |||||||
Cost of revenues | (5,268 | ) | (8,125 | ) | (15,321 | ) | (15,640 | ) | |||||||
Research and development | (143 | ) | (168 | ) | (257 | ) | (333 | ) | |||||||
Selling, general, and administrative | (8 | ) | (1,789 | ) | (3,251 | ) | (3,420 | ) | |||||||
Other expense | (8 | ) | (26 | ) | (16 | ) | (55 | ) | |||||||
Provision for income taxes | (11,559 | ) | (47 | ) | (11,608 | ) | (100 | ) | |||||||
Gain on sale of segment | 51,744 | — | 51,744 | — | |||||||||||
Income (loss) from discontinued operations | $ | 40,487 | $ | (152 | ) | $ | 37,330 | $ | (432 | ) |
Six Months Ended June 30, | |||||||
2017 | 2016 | ||||||
Net cash used in operating activities - continuing operations | $ | (14,939.1 | ) | $ | (17,178.2 | ) | |
Net cash provided by (used in) investing activities - continuing operations | 27,018.1 | (1,068.1 | ) | ||||
Net cash (used in) provided by financing activities - continuing operations | (2,838.1 | ) | 9,580.8 |
• | We paid $5.7 million in principal payments on our long term debt to Oxford Finance. |
• | On March 22, 2017, Sanford Health agreed to waive the conditions for the Second Closing (achievement of the enrollment of 70 subjects in our Phase 2 CLBS03 clinical trial) and purchased 423,729 shares of our common stock, relating to the September 2016 private placement offering, resulting in gross proceeds to us of $2.0 million. |
• | 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. |
• | 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 $1.0 million in a private placement through the issuance of 141,844 shares of 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. |
• | Upon execution of the March 2016 Hitachi Transaction, we paid $6.3 million in principal payments on our long term debt to Oxford Finance. |
CALADRIUS BIOSCIENCES, INC. | ||
August 10, 2017 | By: /s/ David J. Mazzo, PhD Name: David J. Mazzo, PhD Title: Chief Executive Officer (Principal Executive Officer) | |
August 10, 2017 | By: /s/ Joseph Talamo Name: Joseph Talamo Title: Senior Vice President and Chief Financial Officer(Principal Financial and Accounting Officer) |
10.1* | 2017 Employee Stock Purchase Plan |
31.1* | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
31.2* | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
32.1** | Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
32.2** | Certification of 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 |
* | Filed herewith. |
** | Furnished herewith. |
1. | I hereby elect to participate in the Caladrius Biosciences, Inc. 2017 Employee Stock Purchase Plan (the “Employee Stock Purchase Plan”) and subscribe to purchase shares of the Company's Common Stock in accordance with this Subscription Agreement and the Employee Stock Purchase Plan. |
2. | I hereby authorize payroll deductions from each paycheck in the amount of ____% of my covered cash Compensation on each payday (FROM 1 TO 15%) during the Offering Period in accordance with the Employee Stock Purchase Plan. (Please note that no fractional percentages are permitted.) |
3. | I understand that these payroll deductions shall be accumulated for the purchase of shares of Common Stock at the applicable Purchase Price determined in accordance with the Employee Stock Purchase Plan and that all of my payroll deductions received or held by the Company under the Plan may be used by the Company for any corporate purpose, and the Company shall not be obligated to segregate such payroll deductions. I understand that no interest or other earnings will accrue on my payroll deductions. |
4. | I understand that if I do not withdraw from an Offering Period, any accumulated payroll deductions will be used to automatically exercise my Option. |
5. | I have received and read the Prospectus for the Plan and am subscribing for the purchase shares of the Company's Common Stock after having considered the risks associated with an investment in such Common Stock. I have received a copy of the complete Employee Stock Purchase Plan. I understand that my participation in the Employee Stock Purchase Plan is in all respects subject to the terms of the Plan. |
6. | I understand that my ability to exercise the Option under this Subscription Agreement is subject to shareholder approval of the Employee Stock Purchase Plan. |
7. | Shares purchased for me under the Employee Stock Purchase Plan should be issued in the name(s) of (Employee or Employee and Spouse only):_______________________. |
8. | I understand that if I dispose of any shares received by me pursuant to the Plan within 2 years after the Enrollment Date (the first day of the Offering Period during which I purchased such shares) or one year after the Exercise Date, I will be treated for federal income tax purposes as having received ordinary income at the time of such disposition in an amount equal to the excess of the amount I received in such disposition over the price which I paid for the shares. I hereby agree to notify the Company in writing within 30 days after the date of any disposition of my shares and I will make adequate provision for Federal, state or other tax withholding obligations, if any, which arise upon the disposition of the Common Stock. The Company may, but will not be obligated to, withhold from my compensation the amount necessary to meet any applicable withholding obligation including any withholding necessary to make available to the Company any tax deductions or benefits attributable to sale or early disposition of Common Stock by me. If I dispose of such shares at any time after the expiration of the 2-year and 1-year holding periods, I understand that I will be treated for federal income tax purposes as having received income only at the time of such disposition, and that such income will be taxed as ordinary income only to the extent of an amount equal to the lesser of: (l) the excess of the fair market value of the shares at the time of such disposition over the purchase price which I paid for the shares; or (2) the excess of the fair market value of the shares at the time the Enrollment Date (the first day of the Offering Period during which I purchased such shares) over the purchase price which I paid for the shares. The remainder of the gain, if any, recognized on such disposition will be taxed as capital gain. |
9. | I hereby agree to be bound by the terms of the Employee Stock Purchase Plan. The effectiveness of this Subscription Agreement is dependent upon my eligibility to participate in the Employee Stock Purchase Plan. |
10. | In the event of my death, I hereby designate the following as my beneficiary(ies) to receive all payments and shares due me under the Employee Stock Purchase Plan: |
1. | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 as amended; and |
2. | The information contained in the Report fairly presents, in all material respects, the financial condition of the Company as of the dates presented and the results of operations of the Company for the periods presented. |
/s/ David J. Mazzo, PhD | |
David J. Mazzo, PhD | |
Chief Executive Officer (Principal Executive Officer) |
1. | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 as amended; and |
2. | The information contained in the Report fairly presents, in all material respects, the financial condition of the Company as of the dates presented and the results of operations of the Company for the periods presented. |
/s/ Joseph Talamo | |
Joseph Talamo | |
Senior Vice President and Chief Financial Officer (Principal Financial and Accounting Officer) |
Document and Entity Information - shares |
6 Months Ended | |
---|---|---|
Jun. 30, 2017 |
Aug. 08, 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-Q | |
Document Period End Date | Jun. 30, 2017 | |
Document Fiscal Year Focus | 2017 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false | |
Entity Common Stock, Shares Outstanding | 8,912,602 |
Consolidated Balance Sheets (Parentheticals) - USD ($) |
Jun. 30, 2017 |
Dec. 31, 2016 |
---|---|---|
Statement of Financial Position [Abstract] | ||
Allowance for doubtful accounts on accounts receivable | $ 0 | $ 0 |
Preferred stock, shares authorized | 20,000,000 | 20,000,000 |
Preferred stock, Series B convertible redeemable preferred stock liquidation value, share of common stock | 1 | 1 |
Preferred stock, par value (in usd per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares designated | 825,000 | 825,000 |
Preferred stock, shares issued | 10,000 | 10,000 |
Preferred stock, shares outstanding | 10,000 | 10,000 |
Common stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 500,000,000 | 500,000,000 |
Common stock, shares issued | 8,912,602 | 8,205,791 |
Common stock, shares, outstanding | 8,912,602 | 8,205,791 |
Treasury stock (shares) | 11,080 | 11,080 |
Consolidated Statements of Comprehensive Income (Loss) - USD ($) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2017 |
Jun. 30, 2016 |
Jun. 30, 2017 |
Jun. 30, 2016 |
|
Statement of Comprehensive Income [Abstract] | ||||
Net income (loss) | $ 38,465,008 | $ (7,884,770) | $ 28,671,684 | $ (19,932,566) |
Available for sale securities - net unrealized loss | (57,860) | (486) | (57,860) | (486) |
Total other comprehensive loss | (57,860) | (486) | (57,860) | (486) |
Comprehensive income (loss) | 38,407,148 | (7,885,256) | 28,613,824 | (19,933,052) |
Comprehensive loss attributable to noncontrolling interests | (254,001) | (50,054) | (687,498) | (116,933) |
Comprehensive income (loss) attributable to Caladrius Biosciences, Inc. common stockholders | $ 38,661,149 | $ (7,835,202) | $ 29,301,322 | $ (19,816,119) |
Consolidated Statements of Equity - USD ($) |
Total |
Total NeoStem, Inc. Shareholders' Equity [Member] |
Series B Convertible Preferred Stock
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 (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) | (19,932,566) | (19,815,633) | (19,815,633) | (116,933) | |||||
Unrealized gain/loss on marketable securities | (486) | (486) | (486) | ||||||
Share-based compensation (in shares) | 95,355 | ||||||||
Share-based compensation | 1,235,144 | 1,235,144 | $ 95 | 1,235,049 | |||||
Net proceeds from issuance of common stock (in shares) | 158,092 | ||||||||
Net proceeds from issuance of common stock | 1,050,712 | 1,050,712 | $ 159 | 1,050,553 | |||||
Change in Ownership in Subsidiary | 0 | (133,012) | (133,012) | 133,012 | |||||
Ending Balance at Jun. 30, 2016 | 5,636,628 | 6,050,258 | $ 100 | $ 5,927 | 398,699,991 | 0 | (391,948,123) | (707,637) | (413,630) |
Ending Balance (shares) at Jun. 30, 2016 | 10,000 | 5,926,749 | |||||||
Beginning Balance (shares) at Dec. 31, 2016 | 10,000 | 8,205,790 | |||||||
Beginning 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) | 28,671,684 | 29,359,182 | 29,359,182 | (687,498) | |||||
Unrealized gain/loss on marketable securities | (57,860) | (57,860) | (57,860) | ||||||
Share-based compensation (in shares) | 54,545 | ||||||||
Share-based compensation | 2,350,652 | 2,350,652 | $ 55 | 2,350,597 | |||||
Net proceeds from issuance of common stock (in shares) | 648,432 | ||||||||
Net proceeds from issuance of common stock | 3,278,632 | 3,278,632 | $ 648 | 3,277,984 | |||||
Proceeds from option exercises (in shares) | 3,835 | ||||||||
Proceeds from option exercises | 13,576 | 13,576 | $ 4 | 13,572 | |||||
Elimination of non-controlling interests associated with PCT sale | (3,686,526) | (3,686,526) | |||||||
Reclassification of redeemable securities | 19,400,000 | 14,733,908 | 14,733,908 | 4,666,092 | |||||
Change in Ownership in Subsidiary | 0 | (141,180) | (141,180) | 141,180 | |||||
Ending Balance at Jun. 30, 2017 | $ 54,036,638 | $ 54,420,819 | $ 100 | $ 8,913 | $ 430,606,930 | $ (57,860) | $ (375,429,627) | $ (707,637) | $ (384,181) |
Ending Balance (shares) at Jun. 30, 2017 | 10,000 | 8,912,602 |
The Business |
6 Months Ended |
---|---|
Jun. 30, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
The Business | The Business Overview Caladrius Biosciences, Inc. (“we,” “us,” "our," “Caladrius” or the “Company”), is a company developing cellular therapeutics to treat certain diseases. We leverage specialized cell therapy clinical development expertise to select and develop early-stage cell therapy candidates with the intention of partnering these candidates post proof-of-concept in humans. Our current lead 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"). Immunomodulation (Treg Technology) We are developing strategically, through the utilization of our core clinical development expertise, a product candidate (CLBS03) that is 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, only lifelong insulin therapy, which therapy often does not prevent serious co-morbidities. Two Phase 1 clinical trials of this technology in T1D 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. 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 of early therapeutic effect is planned after approximately 50% of patients reach the six-month follow-up milestone, which analysis is expected in late 2017 or early 2018. 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"). Ischemic Repair (CD34 Cell Technology) Our CD34 cell technology has led to the development of therapeutic 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"). 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 CLBS12 (a candidate for CLI) was submitted to the Japanese Pharmaceutical and Medical Device Agency ("PMDA") and was cleared to proceed. The protocol design was agreed with PMDA and, if successful, could provide the basis for conditional approval under Japan's favorable regenerative medicine law. We are seeking to collaborate on CLBS12 with development and/or manufacturing partners. 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 expect to learn the results of those applications in 2017. We intend to develop this platform if capital becomes available through grants, partnerships or licensing, as well as potentially using reasonable amounts of our own capital. 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, additional indications for our CD34 cell technology and a platform using tumor cell/dendritic cell technology for immuno-oncology application. The immuno-oncology program has the benefit of promising Phase 2 clinical data and applicability to multiple indications. In 2016, we completed multiple out-licensing agreements for this and other technology platforms in an effort to monetize non-core assets. Our current long-term strategy focuses on advancing cell-based therapies to the market and assisting patients suffering from life-threatening medical conditions. We believe that we are positioned to realize potentially meaningful value increases within our own proprietary pipeline based on demonstration of proof-of-concept in man as well as process and manufacturing advancements. Discontinued Operations On May 18, 2017 (the "Closing Date"), the Company completed the previously announced sale of its 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 Caladrius, PCT and Hitachi (the "2017 Hitachi Transaction"), for $75.0 million in cash, plus an additional cash adjustment based on PCT’s cash and outstanding indebtedness as of the Closing Date ("Additional Consideration") and a potential future milestone payment (see Note 3). The sale of PCT represents a strategic shift that has a major effect on the Company’s operations, and therefore, PCT is accounted for as discontinued operations. All periods presented were adjusted to reflect PCT as discontinued operations. Basis of Presentation The accompanying unaudited Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the SEC for interim financial information. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, the accompanying Consolidated Financial Statements of the Company and its subsidiaries, which are unaudited, include all normal and recurring adjustments considered necessary to present fairly the Company’s financial position as of June 30, 2017 and the results of its operations and its cash flows for the periods presented. The unaudited consolidated financial statements herein should be read together with the historical consolidated financial statements of the Company for the years ended December 31, 2016 and 2015 included in our 2016 Form 10-K. Operating results for the six months ended June 30, 2017 are not necessarily indicative of the results that may be expected for the year ending December 31, 2017. 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 useful lives of our long lived assets, allowances for doubtful accounts, and stock-based awards values. 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 |
6 Months Ended |
---|---|
Jun. 30, 2017 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies In addition to the policies below, our significant accounting policies are described in Note 2 of the Notes to Consolidated Financial Statements included in our 2016 Form 10-K. There were no changes to these policies during the three and six months ended June 30, 2017. Concentration of Risks We are subject to credit risk from our portfolio of cash and cash equivalents, 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. Share-Based Compensation The Company expenses all share-based payment awards to employees, directors, 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. Long-Lived Assets Long-lived assets consist of property, plant and equipment. The assets are depreciated 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. No triggering events were noted in the three and six months ended June 30, 2017 or June 30, 2016 that would require interim impairment assessment. Recently Issued Accounting Pronouncement 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 is effective for interim and annual periods beginning after December 15, 2016, with early adoption permitted. The guidance will be applied prospectively, retrospectively, or by means of a cumulative-effect adjustment to equity as of the beginning of the period in which the guidance is adopted, dependent upon the specific amendment that is adopted within the ASU. 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 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 License Agreement |
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Business Combinations [Abstract] | |||||||||||||
Collaboration and License Agreement | Collaboration and License Agreement 2016 Hitachi Transaction On March 11, 2016, PCT entered into a global collaboration with Hitachi. 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 Chemical with certain training and support. As additional consideration, Hitachi Chemical agreed to pay PCT royalties on contract revenue generated in Asia for a minimum of ten years. 2017 Hitachi Transaction On May 18, 2017, the Company completed the previously announced sale of its remaining 80.1% membership interest in PCT to Hitachi pursuant to the Purchase Agreement, dated as of 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. 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 an additional $4.4 million cash adjustment 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 [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Available-for-Sale Securities | Available-for-Sale-Securities The following table is a summary of available-for-sale securities recorded in cash and cash equivalents or marketable securities in our Consolidated Balance Sheets (in thousands):
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 debt securities by contractual maturity (in thousands):
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Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||
Loss Per Share | Loss Per Share For the three and six months ended June 30, 2017 and 2016, the Company incurred net losses from continuing operations and therefore no common stock equivalents were utilized in the calculation of diluted loss per share as they are anti-dilutive. At June 30, 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 The fair value of financial assets and liabilities that are being measured and reported are defined as the exchange price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants in the principal market at the measurement date (exit price). The Company is required to classify fair value measurements in one of the following categories: Level 1 inputs are defined as quoted prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 2 inputs are defined as inputs other than quoted prices included within Level 1 that are observable for the assets or liabilities, either directly or indirectly. Level 3 inputs are defined as unobservable inputs for the assets or liabilities. Financial assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment, and may affect the valuation of the fair value of assets and liabilities and their placement within the fair value hierarchy levels. The following table sets forth by level within the fair value hierarchy the Company's financial assets that were accounted for at fair value on a recurring basis as of June 30, 2017, and December 31, 2016 (in thousands).
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Accrued Liabilities |
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Accrued Liabilities | Accrued Liabilities Accrued liabilities as of June 30, 2017 and December 31, 2016 were as follows (in thousands):
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Debt Disclosure [Abstract] | |
Debt | Debt Notes Payable As of June 30, 2017 and December 31, 2016, the Company had notes payable of approximately $0.6 million and $0.7 million, respectively. The notes relate to certain insurance policies and equipment financings, require monthly payments, and mature within one to three years. 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 will be 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 10), 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 three and six months ended June 30, 2017, the Company recognized $0.2 million and $0.4 million of interest expense, respectively, related to the Loan and Security Agreement. During the three and six months ended June 30, 2016, the Company recognized $0.3 million and $0.5 million of interest expense, respectively, related to the Loan and Security Agreement. |
Redeemable Securities |
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Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Redeemable Securities | Redeemable Securities Under the 2016 Hitachi Transaction (see Note 3), Hitachi had the right, at any time following the tenth anniversary of the 2016 Hitachi Transaction 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 lesser 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 ownership interests increased subsequent to its initial ownership interest, and it offers to sell its equity holdings in excess of 21% of PCT’s outstanding equity securities, then the Company would be required to purchase all such equity holdings of Hitachi but in no event would the aggregate purchase price of such Hitachi 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. |
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Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Shareholders' Equity | Shareholders' 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 5:00 pm 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 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 Issuances 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 has terminated the Private Placement Purchase Agreement with this investor in the first quarter of 2017. On March 22, 2017, Sanford Health agreed to waive the conditions for the Second Closing and purchased 423,729 shares of common stock resulting in gross proceeds to the Company of $2.0 million. Aspire Purchase Agreements 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 provides that, subject to certain terms and conditions, Aspire Capital is 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 is obtained or certain minimum sale price levels are reached) of the Company's common stock over a 24-month term. As consideration for entering into the Purchase Agreement, the Company issued 84,270 shares of its common stock to Aspire Capital. During the six months ended June 30, 2017, the Company issued 210,506 shares of common stock under the Purchase Agreement for gross proceeds of $1.2 million. Overall, as of June 30, 2017, the Company has issued 319,776 shares under the Purchase Agreement for gross proceeds of $1.5 million. Under the Purchase Agreement, at the Company’s discretion, it may present Aspire Capital with purchase notices from time to time to purchase the Company’s common stock, provided certain price, trading volume and conditions, including NASDAQ's trading requirements, are met. The purchase price for the shares of common stock is based upon one of two formulas set forth in the Purchase Agreement depending on the type of purchase notice the Company submits to Aspire Capital, and is based on market prices of the Company’s common stock (in the case of regular purchases) or a discount of 5% applied to volume weighted average prices (in the case of VWAP purchases), in each case as determined by parameters defined in the Purchase Agreements. We have filed a registration statement with the SEC and a related prospectus supplement that covers the offering of shares of our common stock subject to the Purchase Agreement, and therefore can initiate sales to Aspire Capital at any time, subject to the limitation discussed above. The Company is party to one other existing agreement with Aspire Capital (the "May 2015 Purchase Agreement"). The registration statement we previously filed with the SEC to cover offerings of shares of our common stock subject to the May 2015 Purchase Agreement has expired, and we have not, and currently have no intention to include such shares in a registration statement filed with the SEC. Unless and until we include such shares in a registration statement filed with the SEC, we are unable to initiate sales to Aspire under the May 2015 Purchase Agreement. Under the May 2015 Purchase Agreement, Aspire Capital is committed to purchase up to an aggregate of $30 million of shares. As consideration for entering into the May 2015 Purchase Agreement, the Company issued 36,484 shares of its common stock to Aspire Capital. The Company has not issued any additional shares under the May 2015 Purchase Agreement. Stock Options and Warrants The following table summarizes the activity for stock options and warrants for the six months ended June 30, 2017, as adjusted for the Reverse Stock Split:
Restricted Stock During the six months ended June 30, 2017 and 2016, the Company issued restricted stock for services as follows (in thousands, except share data):
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Share-Based Compensation |
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Share-based Compensation [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-Based Compensation | Share-Based Compensation Share-based Compensation We utilize share-based compensation in the form of stock options, warrants and restricted stock. The following table summarizes the components of share-based compensation expense for the three and six months ended June 30, 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 three and six months ended June 30, 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 June 30, 2017 were as follows (in thousands):
Total fair value of shares vested and the weighted average estimated fair values of shares granted for the six months ended June 30, 2017 and 2016 were as follows, as adjusted for the Reverse Stock Split (in thousands):
Valuation Assumptions The fair value of stock options and warrants at the date of grant was estimated using the Black-Scholes option pricing model. The expected volatility is based upon historical volatility of the Company’s stock. The expected term for the options is based upon observation of actual time elapsed between date of grant and exercise of options for all employees. The expected term for the warrants is based upon the contractual term of the warrants. |
Research Funding |
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Jun. 30, 2017 | |
Research Funding [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, which will be amortized over the estimated award period through July 2020 as a reduction to the related research and development expenses. As of June 30, 2017, $1.7 million of the funding received is recorded in Accrued Liabilities, representing the amount expected to be recognized over the next 12 months, and $3.6 million of the funding received is recorded in Other Long-Term Liabilities. During the three months ended June 30, 2017, the Company amortized and recognized a $0.3 million credit to research and development related to CIRM funds received. |
Income Taxes |
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Jun. 30, 2017 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes As of December 31, 2016, the Company had approximately $232.7 million of federal net operating loss carryforwards ("NOLs") available to offset future taxable income expiring from 2027 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. If a change of ownership did occur, there would be an annual limitation on the usage of the Company’s losses which are available through 2036. In assessing the ability to realize deferred tax assets, including the 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. During the quarter ended June 30, 2017, the Company generated a gain from the sale of 80.1% of their ownership in PCT. The gain from the sale of PCT is included in discontinued operations. The Company for the six months ended June 30, 2017 has generated losses from continuing operations and has forecasted losses for the remainder of the year. Based on generating taxable income for the 2017 year, the Company will utilize net operating losses which were offset by a full valuation allowance. The Company anticipates that they will maintain a valuation allowance on the remaining deferred tax assets at the end of the year. Deferred tax liabilities were $0 and $1.1 million as of June 30, 2017 and December 31, 2016, respectively, and relate to the taxable temporary differences on the goodwill recognized in the PCT acquisition in 2011. The taxable temporary differences, which were tax deductible and were to be amortized over 15 years. The deferred tax liability was reversed during the three months ended June 30, 2017, as a result of the divestiture of PCT. The Company applies ASC 740-10 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 June 30, 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. During the second quarter the Company has both continuing and discontinued operations. ASC 740-20-45-7 addresses the income tax accounting treatment when there is a loss from continuing operations and income from discontinuing operations. The Company must consider the gain from discontinued operations for purposes of allocating a tax benefit to the current year loss from continuing operations. The Company has adopted a method in which the income from discontinued operations are recognized as a discrete item in the period in which it occurs and apply the concepts of the annual effective tax rate (AETR) during each period in computing the income tax provision from continuing operations. This method results in a tax expense for discontinued operations and an income tax benefit for the loss generated from continuing operations. The Company is forecasting losses from continuing operations for the remainder of 2017 against which an income tax benefit will be recorded. 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 | Discontinued Operations PCT Segment On May 18, 2017, the Company completed the previously announced Sale of its remaining 80.1% membership interest in PCT to Hitachi. Pursuant to the Purchase Agreement, by and among Caladrius, PCT and Hitachi, the aggregate purchase price to the Company consisted of (i) $75.0 million in cash, (ii) a cash adjustment, based on PCT’s cash and outstanding indebtedness as of the Closing Date, of approximately $4.4 million, 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”). The Company has determined that the fair value of the milestone payment as of the closing date was valued at zero. Pursuant to the terms of the Purchase Agreement, Hitachi paid the Company $5.0 million in March 2017 as an advance payment pending shareholder approval of the transaction and other closing conditions included in the Purchase Agreement. 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. 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 additional $4.4 million cash adjustment payment in July 2017. The Company incurred approximately $6.9 million in transaction costs related to the Sale, 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 three and six months ended June 30, 2017 and June 30, 2016 were as follows (in thousands):
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Commitments and Contingencies |
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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, New York, NY, and Irvine, CA, of which certain leases 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 June 30, 2017 are as follows (in thousands):
Expense incurred under operating leases was approximately $0.4 million and $0.7 million for the three and six months ended June 30, 2017, respectively. Expense incurred under operating leases was approximately $0.3 million and $0.7 million for the three and six months ended June 30, 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. |
Summary of Significant Accounting Policies (Policies) |
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Jun. 30, 2017 | |
Accounting Policies [Abstract] | |
Concentration of Risks | Concentration of Risks We are subject to credit risk from our portfolio of cash and cash equivalents, 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. |
Share-Based Compensation | Share-Based Compensation The Company expenses all share-based payment awards to employees, directors, 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. |
Long-Lived Assets | Long-Lived Assets Long-lived assets consist of property, plant and equipment. The assets are depreciated 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. No triggering events were noted in the three and six months ended June 30, 2017 or June 30, 2016 that would require interim impairment assessment. |
Recently Issued Accounting Pronouncement | Recently Issued Accounting Pronouncement 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 is effective for interim and annual periods beginning after December 15, 2016, with early adoption permitted. The guidance will be applied prospectively, retrospectively, or by means of a cumulative-effect adjustment to equity as of the beginning of the period in which the guidance is adopted, dependent upon the specific amendment that is adopted within the ASU. 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 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. |
Available-for-Sale-Securities (Tables) |
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Schedule of Available-for-sale Securities Reconciliation | The following table is a summary of available-for-sale securities recorded in cash and cash equivalents or marketable securities in our Consolidated Balance Sheets (in thousands):
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Schedule of Marketable Securities | Estimated fair values of available-for-sale securities are generally based on prices obtained from commercial pricing services. The following table summarizes the classification of the available-for-sale debt securities on our Consolidated Balance Sheets (in thousands):
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Investments Classified by Contractual Maturity Date | The following table summarizes our portfolio of available-for-sale debt securities by contractual maturity (in thousands):
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Loss Per Share (Tables) |
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Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | At June 30, 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] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value, Assets Measured on Recurring Basis | The following table sets forth by level within the fair value hierarchy the Company's financial assets that were accounted for at fair value on a recurring basis as of June 30, 2017, and December 31, 2016 (in thousands).
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Accrued Liabilities (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued Liabilities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Accrued Liabilities | Accrued liabilities as of June 30, 2017 and December 31, 2016 were as follows (in thousands):
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Shareholders' Equity (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based Compensation, Stock Options, Activity | The following table summarizes the activity for stock options and warrants for the six months ended June 30, 2017, as adjusted for the Reverse Stock Split:
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Schedule of Restricted Stock | During the six months ended June 30, 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) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based Compensation [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs | The following table summarizes the components of share-based compensation expense for the three and six months ended June 30, 2017 and 2016 (in thousands):
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Disclosure of Share-based Compensation Arrangements by Share-based Payment Award | 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 June 30, 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 | Total fair value of shares vested and the weighted average estimated fair values of shares granted for the six months ended June 30, 2017 and 2016 were as follows, as adjusted for the Reverse Stock Split (in thousands):
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Discontinued Operations (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Discontinued Operations and Disposal Groups [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Disposal Groups, Including 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 three and six months ended June 30, 2017 and June 30, 2016 were as follows (in thousands):
|
Commitments and Contingencies (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 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 June 30, 2017 are as follows (in thousands):
|
The Business Immunomodulation (Treg Technology) (Details) $ in Millions |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2016
cohort
|
May 04, 2017
USD ($)
|
Feb. 23, 2017
USD ($)
|
|
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Interim Efficacy Analysis, Percentage Threshold | 50.00% | ||
Interim Efficacy Analysis, Follow-up Milestone Period | 6 years | ||
Grants Receivable | $ 12.2 | ||
Grants Receivable, Current | $ 5.7 | ||
The Sanford Project: T-Rex Study [Member] | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Number of Cohorts | cohort | 2 |
Available-for-Sale-Securities Classification of Available-for-Sale Securities (Details) - USD ($) |
Jun. 30, 2017 |
Dec. 31, 2016 |
---|---|---|
Available-for-sale Securities [Abstract] | ||
Cash and cash equivalents | $ 19,445,300 | $ 4,426,800 |
Marketable securities | 36,324,936 | 0 |
Total | $ 55,770,300 | $ 4,426,800 |
Available-for-Sale-Securities Available-for-Sale Securities by Contractual Maturity (Details) - USD ($) |
Jun. 30, 2017 |
Dec. 31, 2016 |
---|---|---|
Amortized Cost | ||
Less than one year | $ 55,828,000 | |
Greater than one year | 0 | |
Amortized Cost, Total | 55,828,000 | |
Estimated Fair Value | ||
Less than one year | 55,770,300 | |
Greater than one year | 0 | |
Estimated Fair Value, Total | $ 55,770,300 | $ 4,426,800 |
Fair Value Measurements Assets Measured at Fair Value on Recurring Basis (Details) - Fair Value, Measurements, Recurring [Member] - USD ($) |
Jun. 30, 2017 |
Dec. 31, 2016 |
---|---|---|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities - available for sale | $ 36,325,000 | $ 0 |
Assets, fair value disclosure | 36,325,000 | 0 |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities - available for sale | 0 | 0 |
Assets, fair value disclosure | 0 | 0 |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities - available for sale | 36,325,000 | 0 |
Assets, fair value disclosure | 36,325,000 | 0 |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities - available for sale | 0 | 0 |
Assets, fair value disclosure | $ 0 | $ 0 |
Accrued Liabilities (Details) - USD ($) |
Jun. 30, 2017 |
Dec. 31, 2016 |
---|---|---|
Accrued Liabilities [Abstract] | ||
Salaries, employee benefits and related taxes | $ 1,129,600 | $ 1,406,300 |
Retention payments | 2,233,100 | 0 |
Professional fees | 192,500 | 224,500 |
Income tax payable | 6,791,500 | 0 |
CIRM upfront funding - current | 1,745,500 | 0 |
Other | 316,400 | 1,028,600 |
Total accrued liabilities | $ 12,408,600 | $ 2,659,400 |
Redeemable Securities (Details) - USD ($) $ in Millions |
May 18, 2017 |
Mar. 11, 2016 |
---|---|---|
Business Acquisition [Line Items] | ||
Equity Method Investment, Ownership Percentage | 19.90% | |
Hitachi Chemical Co., LTD [Member] | ||
Business Acquisition [Line Items] | ||
Recorded Unconditional Purchase Obligation | $ 19.4 | |
Equity Method Investment, Ownership Percentage | 21.00% | |
Business Combination, Consideration Transfered, Interest Rate | 2.00% | |
Redeemable Securities Agreement, Required Purchase Based on Equity Event, Maximum | $ 20.5 | |
Redeemable Securities, Classified to Additional Paid In Capital | $ 14.7 | |
Redeemable Securities, Classified to Non-Controlling Interests | $ 4.7 |
Shareholders' Equity - Reverse Stock Split (Details) |
Jul. 28, 2016
$ / shares
|
Jun. 30, 2017
$ / shares
|
Dec. 31, 2016
$ / shares
|
---|---|---|---|
Equity [Abstract] | |||
Common stock, par value (in usd per share) | $ 0.001 | $ 0.001 | $ 0.001 |
Reverse Stock Split, Conversion Ratio | 0.1 |
Shareholders' Equity - Restricted Stock (Details) - USD ($) |
6 Months Ended | |
---|---|---|
Jun. 30, 2017 |
Jun. 30, 2016 |
|
Equity [Abstract] | ||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | 132,726 | 107,719 |
Stock Issued During Period, Value, Restricted Stock Award, Gross | $ 469,900 | $ 651,700 |
Research Funding (Details) - USD ($) $ in Millions |
3 Months Ended | ||
---|---|---|---|
Jun. 30, 2017 |
May 04, 2017 |
Feb. 23, 2017 |
|
Deferred Revenue Arrangement [Line Items] | |||
Grants Receivable | $ 12.2 | ||
Grants Receivable, Current | $ 5.7 | ||
Grant Revenue Recognized | $ 0.3 | ||
Accrued Liabilities [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Deferred Grant Revenue | 1.7 | ||
Other Long-Term Liabilities [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Deferred Grant Revenue | $ 3.6 |
Income Taxes Net Operating Loss Carry Forward (Details) - USD ($) $ in Millions |
Jun. 30, 2017 |
Dec. 31, 2016 |
---|---|---|
Operating Loss Carryforwards [Line Items] | ||
Operating Loss Carryforwards | $ 232.7 | |
Deferred Tax Liabilities, Net, Noncurrent | $ 0.0 | $ 1.1 |
Discontinued Operations Operating Results of PCT Segment (Details) - USD ($) |
3 Months Ended | 6 Months Ended | |||
---|---|---|---|---|---|
May 18, 2017 |
Jun. 30, 2017 |
Jun. 30, 2016 |
Jun. 30, 2017 |
Jun. 30, 2016 |
|
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Income (loss) from discontinued operations | $ 40,487,438 | $ (151,819) | $ 37,329,963 | $ (431,856) | |
PCT Segment [Member] | Discontinued Operations [Member] | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Revenue | 5,729,000 | 10,002,000 | 16,039,000 | 19,116,000 | |
Cost of revenues | (5,268,000) | (8,125,000) | (15,321,000) | (15,640,000) | |
Research and development | (143,000) | (168,000) | (257,000) | (333,000) | |
Selling, general, and administrative | (8,000) | (1,789,000) | (3,251,000) | (3,420,000) | |
Other expense | (8,000) | (26,000) | (16,000) | (55,000) | |
Provision for income taxes | (11,559,000) | (47,000) | (11,608,000) | (100,000) | |
Gain on sale of segment | $ 51,744,000 | 51,744,000 | 0 | 51,744,000 | 0 |
Income (loss) from discontinued operations | $ 40,487,000 | $ (152,000) | $ 37,330,000 | $ (432,000) |
Commitments and Contingencies (Details) - USD ($) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2017 |
Jun. 30, 2016 |
Jun. 30, 2017 |
Jun. 30, 2016 |
|
Commitments and Contingencies Disclosure [Abstract] | ||||
2017 | $ 655,100 | $ 655,100 | ||
2018 | 817,400 | 817,400 | ||
2019 | 786,200 | 786,200 | ||
2020 | 801,600 | 801,600 | ||
2021 and thereafter | 603,000 | 603,000 | ||
Total minimum lease payments | 3,663,300 | 3,663,300 | ||
Operating lease expense | $ 400,000 | $ 300,000 | $ 700,000 | $ 700,000 |
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