Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2017 | Oct. 31, 2017 | |
Document And Entity Information [Abstract] | ||
Entity Registrant Name | CYTORI THERAPEUTICS, INC. | |
Entity Central Index Key | 1,095,981 | |
Current Fiscal Year End Date | --12-31 | |
Entity Well-known Seasoned Issuer | No | |
Entity Voluntary Filers | No | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 35,119,410 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q3 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2017 |
CONSOLIDATED CONDENSED BALANCE
CONSOLIDATED CONDENSED BALANCE SHEETS (UNAUDITED) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 4,783 | $ 12,560 |
Accounts receivable, net of reserves of $167 in both 2017 and 2016, respectively | 230 | 1,242 |
Restricted cash | 429 | 350 |
Inventories, net | 3,508 | 3,725 |
Other current assets | 892 | 870 |
Total current assets | 9,842 | 18,747 |
Property and equipment, net | 3,308 | 1,157 |
Other assets | 1,854 | 2,336 |
Intangibles, net | 7,520 | 8,447 |
Goodwill | 3,922 | 3,922 |
Total assets | 26,446 | 34,609 |
Current liabilities: | ||
Accounts payable and accrued expenses | 4,907 | 5,872 |
Current portion of long-term obligations, net of discount | 13,497 | 6,629 |
Total current liabilities | 18,404 | 12,501 |
Deferred revenues | 103 | 97 |
Long-term deferred rent and other | 120 | 17 |
Long-term obligations, net of discount, less current portion | 0 | 11,008 |
Total liabilities | 18,627 | 23,623 |
Commitments and contingencies (Note 9) | ||
Stockholders’ equity: | ||
Series A 3.6% convertible preferred stock, $0.001 par value; 5,000,000 shares authorized; 13,500 shares issued; no shares outstanding in 2017 and 2016 | 0 | 0 |
Common stock, $0.001 par value; 75,000,000 shares authorized; 34,716,318 and 21,707,890 shares issued and outstanding in 2017 and 2016, respectively | 35 | 22 |
Additional paid-in capital | 404,047 | 388,769 |
Accumulated other comprehensive income | 1,199 | 1,258 |
Accumulated deficit | (397,462) | (379,063) |
Total stockholders’ equity | 7,819 | 10,986 |
Total liabilities and stockholders’ equity | $ 26,446 | $ 34,609 |
CONSOLIDATED CONDENSED BALANCE3
CONSOLIDATED CONDENSED BALANCE SHEETS (UNAUDITED) (Parenthetical) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2017 | Dec. 31, 2016 | |
Current assets: | ||
Accounts receivable, reserves | $ 167 | $ 167 |
Stockholders’ equity: | ||
Convertible preferred stock | 3.60% | 3.60% |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 13,500 | 13,500 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 75,000,000 | 75,000,000 |
Common stock, shares issued (in shares) | 34,716,318 | 21,707,890 |
Common stock, shares outstanding (in shares) | 34,716,318 | 21,707,890 |
CONSOLIDATED CONDENSED STATEMEN
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Product revenues | $ 467 | $ 731 | $ 2,027 | $ 3,190 |
Cost of product revenues | 181 | 561 | 992 | 1,533 |
Amortization of intangible assets | 306 | 57 | 919 | 237 |
Gross (loss) profit | (20) | 113 | 116 | 1,420 |
Development revenues: | ||||
Government contracts and other | 1,306 | 1,879 | 2,856 | 5,163 |
Total development revenues | 1,306 | 1,879 | 2,856 | 5,163 |
Operating expenses: | ||||
Research and development | 3,004 | 3,960 | 9,284 | 13,334 |
Sales and marketing | 840 | 818 | 3,043 | 2,742 |
General and administrative | 1,785 | 2,011 | 6,012 | 6,623 |
Total operating expenses | 5,629 | 6,789 | 20,025 | 22,699 |
Operating loss | (4,343) | (4,797) | (17,053) | (16,116) |
Other income (expense): | ||||
Interest income | 5 | 4 | 24 | 8 |
Interest expense | (474) | (645) | (1,603) | (1,947) |
Other income, net | 5 | 54 | 233 | 928 |
Total other expense | (464) | (587) | (1,346) | (1,011) |
Net loss | $ (4,807) | $ (5,384) | $ (18,399) | $ (17,127) |
Basic and diluted net loss per share | $ (0.14) | $ (0.26) | $ (0.62) | $ (1.06) |
Basic and diluted weighted average shares used in calculating net loss per share | 34,490,828 | 20,493,840 | 29,564,032 | 16,147,042 |
Comprehensive loss: | ||||
Net loss | $ (4,807) | $ (5,384) | $ (18,399) | $ (17,127) |
Other comprehensive loss – foreign currency translation adjustments | 16 | 58 | (59) | (321) |
Comprehensive loss | $ (4,791) | $ (5,326) | (18,458) | (17,448) |
Azaya Therapeutics, Inc. [Member] | ||||
Operating expenses: | ||||
In process research and development acquired | $ 1,686 | $ 0 |
CONSOLIDATED CONDENSED STATEME5
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Cash flows from operating activities: | ||
Net loss | $ (18,399) | $ (17,127) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,618 | 794 |
Amortization of deferred financing costs and debt discount | 580 | 714 |
Joint Venture acquisition obligation accretion | 0 | 24 |
Provision for expired inventory | 413 | 26 |
Stock-based compensation expense | 588 | 925 |
Loss on asset disposal | 9 | 2 |
Increases (decreases) in cash caused by changes in operating assets and liabilities: | ||
Accounts receivable | 991 | 91 |
Inventories | 457 | 190 |
Other current assets | (284) | 205 |
Other assets | 74 | 32 |
Accounts payable and accrued expenses | (1,746) | (1,013) |
Deferred revenues | 6 | (8) |
Long-term deferred rent | 103 | (227) |
Net cash used in operating activities | (13,904) | (15,372) |
Cash flows from investing activities: | ||
Purchases of property and equipment /long-lived assets | (271) | (110) |
Proceeds from sale of assets | 10 | 0 |
Change in restricted cash | (79) | 0 |
Net cash used in investing activities | (1,541) | (110) |
Cash flows from financing activities: | ||
Principal payments on long-term obligations | (4,720) | 0 |
Joint Venture purchase payments | 0 | (1,774) |
Proceeds from sale of common stock, net | 12,377 | 17,702 |
Net cash provided by financing activities | 7,657 | 15,928 |
Effect of exchange rate changes on cash and cash equivalents | 11 | 140 |
Net (decrease) increase in cash and cash equivalents | (7,777) | 586 |
Cash and cash equivalents at beginning of period | 12,560 | 14,338 |
Cash and cash equivalents at end of period | 4,783 | 14,924 |
Cash paid during period for: | ||
Interest | 1,059 | 1,213 |
Azaya Therapeutics, Inc. [Member] | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||
In process research and development acquired | 1,686 | 0 |
Cash flows from investing activities: | ||
Purchases of property and equipment /long-lived assets | (1,201) | 0 |
Supplemental schedule of non-cash investing and financing activities: | ||
Common stock issued in payment for the assets acquired | $ 2,311 | $ 0 |
Basis of Presentation and New A
Basis of Presentation and New Accounting Standards | 9 Months Ended |
Sep. 30, 2017 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Basis of Presentation and New Accounting Standards | 1. Basis of Presentation and New Accounting Standards Our accompanying unaudited consolidated condensed financial statements as of September 30, 2017 and for the three and nine months ended September 30, 2017 and 2016 have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for annual financial statements. Our consolidated condensed balance sheet at December 31, 2016 has been derived from the audited financial statements at December 31, 2016, but does not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the financial position and results of operations of Cytori Therapeutics, Inc., and our subsidiaries (collectively, the “Company”) have been included. Operating results for the three and nine months ended September 30, 2017 are not necessarily indicative of the results that may be expected for the year ending December 31, 2017. These financial statements should be read in conjunction with the consolidated financial statements and notes therein included in our Annual Report on Form 10-K for the year ended December 31, 2016, filed with the Securities and Exchange Commission on March 24, 2017. On May 10, 2016, following stockholder and Board approval, an amendment (the “Amendment”) to the Company’s amended and restated certificate of incorporation, as amended was filed and declared effective, which Amendment effectuated a one-for-fifteen (1:15) reverse stock split of the Company’s (i) outstanding common stock, and (ii) common stock reserved for issuance upon exercise of outstanding warrants and options (the “1:15 Reverse Stock Split”). Upon effectiveness of the 1:15 Reverse Stock Split, the number of shares of the Company’s common stock (x) issued and outstanding decreased from approximately 200 million shares (as of May 10, 2016) to approximately 13.3 million shares; (y) reserved for issuance upon exercise of outstanding warrants and options decreased from approximately 16 million shares to approximately 1.1 million shares, and (z) reserved but unallocated under our current equity incentive plans (including the stockholder-approved share increase to the Company’s 2014 Equity Incentive Plan) decreased from approximately 6.5 million common shares to approximately 0.4 million common shares. In connection with the 1:15 Reverse Stock Split, the Company also decreased the total number of its authorized shares of common stock from 290 million to 75 million. The number of authorized shares of preferred stock remained unchanged. Following the 1:15 Reverse Stock Split, certain reclassifications have been made to the prior periods’ stockholders’ Reverse Stock Split The Company’s shares of common stock commenced trading on a split-adjusted basis on May 12, 2016. Reclassifications Certain immaterial reclassifications have been made to certain of the prior years’ consolidated financial statements to conform to the current year presentation. Recently Issued and Recently Adopted Accounting Pronouncements Recently Issued Accounting Pronouncements In May 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2016-12, Revenue from Contracts with Customers We performed a preliminary assessment of the impact of ASU 2014-09 and related amendments on the consolidated financial statements, and considered all items outlined in the standard. In assessing the impact, we have outlined all revenue generating activities, mapped those activities to deliverables and traced those deliverables to the standard. We are currently assessing what impact the change in standard will have on those deliverables. We will continue to evaluate the future impact and method of adoption of ASU 2014-09 and related amendments on the consolidated financial statements and related disclosures throughout 2017. We believe the adoption will modify the way we analyze contracts. We will adopt the new standard beginning January 2018. In February 2016, the FASB issued ASU 2016-02, Leases In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230): Classification of certain cash receipts and cash payments In November 2016, the FASB issued Accounting Standards Update No. 2016-18, Restricted Cash In February 2017, the FASB issued ASU 2017-04, Simplifying the Test for Goodwill Impairment In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation , to provide clarity and reduce both 1) diversity in practice and 2) cost and complexity when applying the guidance in Topic 718 to a change in the terms or conditions of a share-based payment award. ASU 2017-09 provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting under Topic 718. The amendments in ASU 2017-09 are effective for fiscal years, and interim periods within those years, beginning after December 15, 2017. Early adoption is permitted, including adoption in any interim period. The amendments in ASU 2017-09 should be applied prospectively to an award modified on or after the adoption date. Recently Adopted Accounting Pronouncements In July 2015, FASB issued ASU 2015-11, Simplifying the Measurement of Inventory In March 2016, the FASB issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting In January 2017, the FASB issued Accounting Standards Update No. 2017-01, Clarifying the Definition of a Business |
Use of Estimates
Use of Estimates | 9 Months Ended |
Sep. 30, 2017 | |
Use Of Estimates [Abstract] | |
Use of Estimates | 2. Use of Estimates The preparation of consolidated financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions affecting the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting period. Our most significant estimates and critical accounting policies involve recognizing revenue, reviewing goodwill and intangible assets for impairment, determining the assumptions used in measuring share-based compensation expense, measuring expense related to our in process research and development Actual results could differ from these estimates. Management’s estimates and assumptions are reviewed regularly, and the effects of revisions are reflected in the consolidated financial statements in the periods they are determined to be necessary. |
Liquidity
Liquidity | 9 Months Ended |
Sep. 30, 2017 | |
Liquidity [Abstract] | |
Liquidity | 3. Liquidity We incurred net losses of $4.8 million and $18.4 million for the three and nine months ended September 30, 2017, and $5.4 million and $17.1 million for the three and nine months ended September 30, 2016. We have an accumulated deficit of $397.5 million as of September 30, 2017. Additionally, we have used net cash of $13.9 million and $15.4 million to fund our operating activities for the nine months ended September 30, 2017 and 2016, respectively. Further, the Loan and Security Agreement, with Oxford Finance, LCC (“Oxford”), as amended and further described in Note 5, requires us to maintain a minimum of $1.5 million in unrestricted cash and cash equivalents on hand to avoid an event of default under the Loan and Security Agreement. Based on our cash and cash equivalents on hand of approximately $4.8 million at September 30, 2017, we estimate that we must raise additional capital and/or obtain a waiver or restructure the Loan and Security Agreement to avoid defaulting under our $1.5 million minimum cash/cash equivalents covenant. To date, these operating losses have been funded primarily from outside sources of invested capital including our recently completed underwritten public offering, Lincoln Park Purchase Agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”) and the 2016 Rights Offering (each defined below), our at-the-market (“ATM”) equity facility, the Loan and Security Agreement and gross profits. We have had, and we will continue to have, an ongoing need to raise additional cash from outside sources to fund our future clinical development programs and other operations. Our inability to raise additional cash will have a material and adverse impact on operations and will cause us to default on our loan. On September 5, 2017, we received a written notice from The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, based upon the closing bid price of our common stock for the last 30 consecutive business days, we no longer meet the requirement to maintain a minimum bid price of $1 per share, as set forth in Nasdaq Listing Rule 5550(a)(2). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have been provided a period of 180 calendar days, or until March 5, 2018, in which to regain compliance. In order to regain compliance with the minimum bid price requirement, the closing bid price of our common stock must be at least $1 per share for a minimum of ten consecutive business days during this 180-day period. In the event we do not regain compliance within this 180-day period, we may be eligible to seek an additional compliance period of 180 calendar days if we meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the bid price requirement, if we provide written notice to Nasdaq of our intent to cure the deficiency during this second compliance period, by effecting a reverse stock split, if necessary. On September 1, 2017, the Company announced a substantial corporate restructuring intended to significantly reduce expenses while maintaining its ability to execute on its U.S. BARDA-sponsored cell therapy program, Japanese cell therapy business and oncology drug program. The restructuring reduced Cytori’s workforce by approximately 50% and significantly reduced the Company’s operational cash burn. On April 11, 2017, we entered into an underwriting agreement (the “Underwriting Agreement”) with Maxim Group LLC “Maxim”) relating to the issuance and sale of 8.6 million shares of our common stock, par value $0.001 per share. The price to the public in this offering was $1.10 per share. Maxim agreed to purchase the shares from us pursuant to the Underwriting Agreement at a price of $1.0395 per share. The net proceeds to us from the offering were approximately $8.7 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by us. The offering closed purchase up to 944,000 additional shares of common stock. On May 31, 2017, Maxim exercised their overallotment option and purchased 849,000 shares at $1.10 per share. The net proceeds to us were $0.8 million, after deducting underwriting costs and offering expenses payable by us. On June 15, 2016, we closed a rights offering originally filed under Form S-1 registration statement in April 2016. Pursuant to the 2016 Rights Offering (as defined in Note 12 below), we sold an aggregate of 6,704,852 units consisting of a total of 6,704,852 shares of common stock and 3,352,306 warrants, with each warrant exercisable for one share of common stock at an exercise price of $3.06 per share, resulting in total gross proceeds of $17.1 million. See Note 12 for further discussion on the 2016 Rights Offering. Should we be unable to raise additional cash from outside sources, this will have a material adverse impact on our operations. The accompanying consolidated financial statements have been prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to its ability to continue as a going concern. |
Transactions with Olympus Corpo
Transactions with Olympus Corporation | 9 Months Ended |
Sep. 30, 2017 | |
Joint Venture Termination Agreement [Abstract] | |
Transactions with Olympus Corporation | 4. Transactions with Olympus Corporation Under our Joint Venture Termination Agreement (“Termination Agreement”), dated May 8, 2013, with Olympus Corporation (“Olympus”), we were required to pay Olympus a total purchase price of $6.0 million within two years of the date of the Termination Agreement. Pursuant to amendments to the Joint Venture Termination Agreement, dated April 30, 2015 and January 8, 2016, the Company’s repayment obligations were extended through May 8, 2016. We made payments under the Termination Agreement totaling approximately $4.2 million through December 31, 2015, as well as separate payments of $0.5 million each in January 2016 and April 2016, and paid the remaining balance of $0.8 million before the May 8, 2016 due date. There were no outstanding obligations to Olympus as of September 30, 2017 and December 31, 2016. |
Long-term Debt
Long-term Debt | 9 Months Ended |
Sep. 30, 2017 | |
Debt Disclosure [Abstract] | |
Long-term Debt | 5. Long-term Debt On May 29, 2015, we entered into the Loan and Security Agreement, dated May 29, 2015, with Oxford, pursuant to which it funded an aggregate principal amount of $17.7 million (“Term Loan”), subject to the terms and conditions set forth in the Loan and Security Agreement. The Term Loan accrues interest at a floating rate of at least 8.95% per annum, comprised of three-month LIBOR rate with a floor of 1.00% plus 7.95%. Pursuant to the Loan and Security Agreement, we were previously required to make interest only payments through June 1, 2016 and thereafter we were required to make payments of principal and accrued interest in equal monthly installments sufficient to amortize the Term Loan through June 1, 2019, the maturity date. On February 23, 2016, we received an acknowledgement and agreement from Oxford related to the positive data on our U.S. ACT-OA clinical trial. As a result, pursuant to the Loan and Security Agreement, the period for which we are required to make interest-only payments was extended from July 1, 2016 to January 1, 2017. All unpaid principal and interest with respect to the Term Loan is due and payable in full on June 1, 2019. At maturity of the Term Loan, or earlier repayment in full following voluntary prepayment or upon acceleration, we are required to make a final payment in an aggregate amount equal to approximately $1.1 million. In connection with the Term Loan, on May 29, 2015, we issued to Oxford warrants to purchase an aggregate of 94,441 shares of our common stock at an exercise price of $10.35 per share. These warrants became exercisable as of November 30, 2015 and will expire on May 29, 2025 and, following the authoritative accounting guidance, are equity classified and its respective fair value was recorded as a discount to the debt. On September 20, 2017, we entered into an amendment to the Term Loan, pursuant to which, among other things, Oxford and the Lenders agreed to reduce the minimum liquidity covenant level originally at $5 million to $1.5 million. The Amendment also extends the interest-only period under the Loan Agreement to January 1, 2018, with a further extension through August 1, 2018 if the Company receives unrestricted net cash proceeds of at least $5 million on or before December 29, 2017. The Term Loan, as amended, is collateralized by a security interest in substantially all of the Company’s existing and subsequently acquired assets, including its intellectual property assets, subject to certain exceptions set forth in the Loan and Security Agreement, as amended. The intellectual property asset collateral will be released upon the Company achieving certain liquidity level when the total principal outstanding under the Loan Agreement is less than $3 million. Our interest expense for the three and nine months ended September 30, 2017 was $0.5 million and $1.6 million and for the three and nine months ended September 30, 2016 was $0.6 million and $1.9 million, respectively. Interest expense is calculated using the effective interest method, therefore it is inclusive of non-cash amortization in the amount of $0.2 million and $0.6 million for the three and nine months ended September 30, 2017 and $0.2 million and $0.7 million for the three and nine months ended September 30, 2016, related to the amortization of the debt discount, capitalized loan costs, and accretion of final payment. The Term Loan Agreement contains customary indemnification obligations and customary events of default, including, among other things, our failure to fulfill certain obligations under the Term Loan, as amended, and the occurrence of a material adverse change, which is defined as a material adverse change in our business, operations, or condition (financial or otherwise), a material impairment of the prospect of repayment of any portion of the loan. In the event of default by us or a declaration of material adverse change by our lender, under the Term Loan, the lender would be entitled to exercise its remedies thereunder, including the right to accelerate the debt, upon which we may be required to repay all amounts then outstanding under the Term Loan, which could materially harm our financial condition. As of September 30, 2017, we were in compliance with all covenants under the Term Loan and have not received any notification or indication from the Lenders to invoke the material adverse change clause. However, due to our current cash flow position and the substantial doubt about our ability to continue as a going concern, the entire principal amount of the Term Loan has been reclassified to short-term. We will continue to evaluate the debt classification on a quarterly basis and evaluate for reclassification in the future should our financial condition improve. |
Revenue Recognition
Revenue Recognition | 9 Months Ended |
Sep. 30, 2017 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | 6. Revenue Recognition Concentration of Significant Customers Six direct customers comprised 61% of our revenue recognized for the nine months ended September the Biomedical Advanced Research Development Authority, a division of the U.S. Department of Health and Human Services September Three distributors and two direct customers comprised 80% of our revenue recognized for the nine months ended September September Product revenues, classified by geographic location, are as follows (in thousands): Three months ended Nine months ended September 30, 2017 September 30, 2016 September 30, 2017 September 30, 2016 Product Revenues % of Total Product Revenues % of Total Product Revenues % of Total Product Revenues % of Total Americas $ 112 24 % $ 79 11 % $ 315 15 % $ 670 21 % Japan 279 60 % 575 79 % 1,434 71 % 2,232 70 % EMEA 18 4 % 76 10 % 204 10 % 281 9 % Asia Pacific 58 12 % 1 0 % 74 4 % 7 0 % Total product revenues $ 467 100 % $ 731 100 % $ 2,027 100 % $ 3,190 100 % Research and Development We earn revenue for performing tasks under research and development agreements with governmental agencies like BARDA. Revenues derived from reimbursement of direct out-of-pocket expenses for research costs associated with government contracts are recorded as government contracts and other within development revenues. Government contract revenue is recorded at the gross amount of the reimbursement. The costs associated with these reimbursements are reflected as a component of research and development expense in our statements of operations. We recognized $1.3 million and $2.9 million in BARDA revenue for the three and nine months ended September 30, 2017, as compared to $1.9 million and $5.2 million for the three and nine months ended September 30, 2016. |
Inventories
Inventories | 9 Months Ended |
Sep. 30, 2017 | |
Inventory Disclosure [Abstract] | |
Inventories | 7. Inventories Inventories are carried at the lower of cost or net realizable value, determined on the first-in, first-out (FIFO) method. Inventories consisted of the following (in thousands): September 30, 2017 December 31, 2016 Raw materials $ 907 $ 885 Work in process 839 1,021 Finished goods 1,762 1,819 $ 3,508 $ 3,725 |
Loss per Share
Loss per Share | 9 Months Ended |
Sep. 30, 2017 | |
Earnings Per Share [Abstract] | |
Loss per Share | 8. Loss per Share Basic per share data is computed by dividing net income or loss applicable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted per share data is computed by dividing net income or loss applicable to common stockholders by the weighted average number of common shares outstanding during the period increased to include, if dilutive, the number of additional common shares that would have been outstanding as calculated using the treasury stock method. Potential common shares were related entirely to outstanding but unexercised options and warrants for all periods presented. We have excluded all potentially dilutive securities, including unvested performance-based restricted stock, from the calculation of diluted loss per share attributable to common stockholders for the three and nine month periods ended September 30, 2017 and 2016, as their inclusion would be antidilutive. Potentially dilutive common shares excluded from the calculations of diluted loss per share were 4.8 million for both the three and nine months ended September 30, 2017, which includes 3.7 million outstanding warrants and 1.1 million options and restricted stock awards. Potentially dilutive common shares excluded from the calculation of diluted loss per share were 4.3 million for both the three and nine months ended 30, 2016. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2017 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. Commitments and Contingencies We have entered into agreements with various research organizations for pre-clinical and clinical development studies, which have provisions for cancellation. Under the terms of these agreements, the vendors provide a variety of services including conducting research, recruiting and enrolling patients, monitoring studies and data analysis. Payments under these agreements typically include fees for services and reimbursement of expenses. The timing of payments due under these agreements is estimated based on current study progress. As of September which We are party to an agreement with Roche Diagnostics Corporation which requires us to make certain product purchase minimums. Pursuant to the agreement, as of September 30, 2017 We are subject to various claims and contingencies related to legal proceedings. Due to their nature, such legal proceedings involve inherent uncertainties including, but not limited to, court rulings, negotiations between affected parties and governmental actions. Management assesses the probability of loss for such contingencies and accrues a liability and/or discloses the relevant circumstances, as appropriate. Management believes that any liability to us that may arise as a result of currently pending legal proceedings will not have a material adverse effect on our financial condition, liquidity, or results of operations as a whole. On February 27, 2017, we entered into a Lease Agreement of office space for our corporate headquarters in San Diego, California (the “Lease”). The initial term of the Lease is 63 months and may be extended upon mutual agreement. We are currently scheduled to take possession of the premises on January 1, 2018, unless they are earlier occupied by us or the commencement date is delayed to allow for substantial completion of tenant improvements. In connection with the Lease, we issued a letter of credit, or Letter of Credit, in favor of the Landlord in the initial principal amount of approximately $0.1 million, which Letter of Credit and corresponding restricted cash increased to $0.3 million on June 1, 2017, and will increase to $0.5 million on the commencement date. The Letter of Credit will remain in effect for the term of the Lease. In addition to the base rent, we will also be obligated under the Lease to make certain payments for operating expenses, property taxes, insurance, insurance deductibles and other amounts. On January 27, 2017, we entered into a Lease Agreement of office space for our office in Tokyo, Japan (the “Japan Lease”). The initial term of the Japan Lease is 61 months, and may be extended upon mutual agreement. The Lease commenced on April 15, 2017. We lease facilities for our headquarters office location as well as international office locations. As of September 30, 2017 $7.3 million, |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2017 | |
Fair Value Disclosures [Abstract] | |
Fair Value | 10. Fair Value Measurements Fair value measurements are market-based measurements, not entity-specific measurements. Therefore, fair value measurements are determined based on the assumptions that market participants would use in pricing the asset or liability. We follow a three-level hierarchy to prioritize the inputs used in the valuation techniques to derive fair values. The basis for fair value measurements for each level within the hierarchy is described below: • Level 1: Quoted prices in active markets for identical assets or liabilities. • Level 2: Quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations in which all significant inputs are observable in active markets. • Level 3: Valuations derived from valuation techniques in which one or more significant inputs are unobservable in active markets. As of September 30, 2017, Financial Instruments We disclose fair value information about all financial instruments, whether or not recognized in the balance sheet, for which it is practicable to estimate fair value. The disclosures of estimated fair value of financial instruments at September 30, 2017 and December 31, 2016, were determined using available market information and appropriate valuation methods. Considerable judgment is necessary to interpret market data and develop estimated fair value. The use of different market assumptions or estimation methods may have a material effect on the estimated fair value amounts. The carrying amounts for cash equivalents, accounts receivable, other current assets, accounts payable, accrued expenses and other liabilities approximate fair value due to the short-term nature of these instruments. Further, based on the borrowing rates currently available for loans with similar terms, we believe the fair value of long-term debt approximates its carrying value. |
Asset Purchase Agreement with A
Asset Purchase Agreement with Azaya Therapeutics | 9 Months Ended |
Sep. 30, 2017 | |
Business Combinations [Abstract] | |
Asset Purchase Agreement with Azaya Therapeutics | 11. Asset Purchase Agreement with Azaya Therapeutics On February 15, 2017 (the “Closing Date”), we completed the acquisition from Azaya Therapeutics, Inc. (“Azaya”) of certain tangible assets which consisted of a research lab, equipment and leasehold improvements and the assumption of certain of liabilities of Azaya, pursuant to an Asset Purchase Agreement (the “Agreement”). The book value of the tangible assets acquired was approximately $3.0 million at the acquisition date. The assets acquired are located in a facility rented in San Antonio, TX, by Cytori. In addition, pursuant to the Agreement, we acquired intangible assets comprised of two drug candidates in process research and development (IPR&D) stage (i) ATI-0918, a generic bioequivalent formulation of DOXIL/CAELYX, a chemotherapy drug that is a liposomal formulation of doxorubicin; and (ii) ATI-1123, a chemotherapy drug that is a liposomal formulation of docetaxel. At the closing of the acquisition, we (i) issued 1,173,241 of shares of our common stock in Azaya’s name, (A) 879,931 of which were delivered to Azaya promptly after the Closing, and (B) 293,310 of which were deposited into a 15-month escrow pursuant to a standard escrow agreement; and (ii) assumed the obligation to pay approximately $1.8 million of Azaya’s existing payables, all of which September In addition, as of the Closing Date, the Company committed to certain contingent considerations to: (i) pay Azaya fixed commercialization milestone payments based upon achievement of certain net sales milestones for ATI-0918; (ii) make certain earn-out payments to Azaya equal to a mid-single-digit percentage of net sales of ATI-0918; and (iii) make certain earn-out payments to Azaya equal to a low single-digit percentage of net sales of any product (ATI-0918 is the “Generic Product” and ATI-1123 is the “Patented Product”), including ATI-1123, that practices a claim in the related patent assigned by Azaya to the Company (the “ATI-1123 Patent”). Our aggregate earn-out payment obligations to Azaya from global net sales of both ATI-0918 and any Patented Product will not exceed $100.0 million (the “Earn-Out Cap”). Further, the Agreement provides that if we enter into certain assignments, licenses or other transfers of rights to a Patented Product or the ATI-1123 Patent, we will pay Azaya a percentage in the low to mid-teens of the consideration received by us, provided, that our aggregate payment obligation to Azaya for any such assignment, license or other transfer of rights will not exceed $50.0 million. If the Company or its successors, sublicenses or transferees sells a competing product to ATI-0918 at any time prior to satisfaction of the Earn-Out Cap, other than because ATI-0918 fails to receive marketing authorization from the European Medicines Agency within a certain period of time or fails to generate a minimum threshold of net sales within a pre-determined amount of time, then 50% of the net sales of such competing product would be deemed to be net sales of ATI-0918 under the Agreement for purposes of calculating commercialization milestone payments and earn-out payments. We accounted for the acquisition as an asset acquisition because the acquired set of assets did not meet the definition of a business. The total consideration of $4.3 million, which consists of $2.3 million related to the fair value of the common stock issued to Azaya at the acquisition date, $1.8 million in assumed liabilities and $0.2 million in acquisition costs, was allocated to the assets acquired based on their relative fair values at the time of acquisition. All other future payments were deemed contingent consideration which will be accounted for when the contingency is resolved and the consideration is paid or becomes payable. When determining the fair value of tangible assets acquired, the Company estimated the cost to replace the tangible asset with a new asset, taking into consideration such factors as age, condition and the economic useful life of the asset. When determining the fair value of intangible assets acquired, the Company used a discounted cash flow model with key inputs being the applicable discount rate, market growth rates and the timing and amount of future cash flows. The acquired IPR&D is in the early stage of development. Additional research, pre-clinical studies, and regulatory approvals must be successfully completed prior to selling any product. Because there is no current alternative use for the IPR&D, following the authoritative accounting guidance, the Company has expensed it in full on the Closing Date. The Company measured the fair value of the shares issued as consideration in the acquisition of the assets based on the stock price at the acquisition date. Transaction costs directly related to the acquisition of the assets have been capitalized. The total consideration was allocated on a relative fair value basis to the assets acquired, as follows (in thousands): February 15, 2017 Tangible assets $ 2,586 Intangible assets 1,686 Total assets $ 4,272 Accounts payable $ 1,796 Fair value of the common stock issued 2,311 Transaction costs 165 Total consideration $ 4,272 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2017 | |
Stockholders Equity Note [Abstract] | |
Stockholders' Equity | 12. Pursuant to a registration statement on Form S-1, originally filed on April 6, 2016, as amended (the “Registration Statement”), and declared effective by the U.S. Securities and Exchange Commission (“SEC”) on May 26, 2016, and related prospectus (as supplemented), the Company registered, offered and sold to its participating stockholders of record as of the announced May 20, 2016 record date, one non-transferable subscription right for each share of common stock held by each stockholder as of the record date (the “2016 Rights Offering”). Each right entitled the holder thereof to purchase one unit at the subscription price of $2.55 per unit, composed of one share of common stock and 0.5 of a warrant, with each whole warrant exercisable to purchase one share of common stock at an exercise price of $3.06 per share for 30 months from the date of issuance. Pursuant to the 2016 Rights Offering, which closed on June 15, 2016, the Company sold an aggregate of 6,704,852 units, resulting in total net proceeds to the Company of $15.3 million. The warrants issued pursuant to the 2016 Rights Offering are currently listed on Nasdaq On December 22, 2016, we entered into a Purchase Agreement (the “Lincoln Park Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”) pursuant to which we have the right to sell to Lincoln Park and Lincoln Park is obligated to purchase up to $20.0 million in amounts of shares, of our common stock, over the 30-month period commencing on the date that a registration statement, which we filed with the SEC in December 2016. We may direct Lincoln Park, at its sole discretion and subject to certain conditions, to purchase up to 100,000 shares of common stock on any business day but in no event will the amount of a single Regular Purchase (as defined in the Lincoln Park Purchase Agreement) exceed $1.0 million. The purchase price of shares of common stock related to the Regular Purchases will be based on the prevailing market prices of such shares at the time of sales. Our sales of shares of common stock to Lincoln Park under the Lincoln Park Purchase Agreement are limited to no more than the number of shares that would result in the beneficial ownership by Lincoln Park and its affiliates, at any single point in time, of more than 9.99% of the then outstanding shares of the common stock. There are no trading volume requirements or restrictions under the Lincoln Park Purchase Agreement. There is no upper limit on the price per share that Lincoln Park must pay for common stock under a Regular Purchase or an accelerated purchase and in no event will shares be sold to Lincoln Park on a day our closing price is less than the floor price of $0.50 per share as set forth in the Purchase Agreement. On December 22, 2016, we issued to Lincoln Park 127,419 shares of common stock with a market value on the date of issuance of approximately $0.2 million as commitment shares in consideration for entering into the Lincoln Park Purchase Agreement. We will issue up to an additional 382,258 shares of common stock on a pro rata basis to Lincoln Park only as and when shares are sold under the Lincoln Park Purchase Agreement to Lincoln Park. Through September 30, 2017, we sold a total of 1,490,937 shares under the Lincoln Park Purchase Agreement, for proceeds of approximately $1.5 million. During the nine months ended September 30, 2017, we sold 894,050 shares of our common stock under an ATM program, receiving total net proceeds of approximately $1.5 million. During 2016, we sold 1,840,982 shares of our common stock under an ATM program, receiving total net proceeds of approximately $4.4 million. On April 11, 2017, we entered into an underwriting agreement with Maxim relating to the issuance and sale of 8.6 million shares of our common stock, par value $0.001 per share. The price to the public in the offering is $1.10 per share. Maxim agreed to purchase the shares from us pursuant to the Underwriting Agreement at a price of $1.0395 per share. The net proceeds to us from the offering were approximately $8.7 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by us. The offering closed . In addition, under the terms of the underwriting agreement, we granted Maxim a 45-day overallotment option to purchase up to 944,000 additional shares of common stock. On May 31, 2017, Maxim exercised their overallotment option and purchased 849,000 shares at $1.10 per share. The net proceeds to us were $0.8 million, after deducting underwriting costs and offering expenses payable by us. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2017 | |
Subsequent Events [Abstract] | |
Subsequent Events | 13. Subsequent Events In November 2017, we commenced a public offering in which we distributed to holders of our common stock, at no charge, non-transferable subscription rights to purchase up to 10,000 units, each consisting of one share of our Series B Convertible Preferred Stock and 1,250 warrants to purchase one share of our common stock, at a subscription price of $1,000 per unit (the “2017 Rights Offering”). Each share of Series B Convertible Preferred Stock will be convertible into 2,500 shares of our common stock, subject to adjustment. Sales of the units in the 2017 Rights Offering, if any, will be made under our registration statement on Form S-1, filed on August 14, 2017. |
Basis of Presentation and New19
Basis of Presentation and New Accounting Standards (Policies) | 9 Months Ended |
Sep. 30, 2017 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Basis of Presentation and New Accounting Standards | Our accompanying unaudited consolidated condensed financial statements as of September 30, 2017 and for the three and nine months ended September 30, 2017 and 2016 have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for annual financial statements. Our consolidated condensed balance sheet at December 31, 2016 has been derived from the audited financial statements at December 31, 2016, but does not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the financial position and results of operations of Cytori Therapeutics, Inc., and our subsidiaries (collectively, the “Company”) have been included. Operating results for the three and nine months ended September 30, 2017 are not necessarily indicative of the results that may be expected for the year ending December 31, 2017. These financial statements should be read in conjunction with the consolidated financial statements and notes therein included in our Annual Report on Form 10-K for the year ended December 31, 2016, filed with the Securities and Exchange Commission on March 24, 2017. On May 10, 2016, following stockholder and Board approval, an amendment (the “Amendment”) to the Company’s amended and restated certificate of incorporation, as amended was filed and declared effective, which Amendment effectuated a one-for-fifteen (1:15) reverse stock split of the Company’s (i) outstanding common stock, and (ii) common stock reserved for issuance upon exercise of outstanding warrants and options (the “1:15 Reverse Stock Split”). Upon effectiveness of the 1:15 Reverse Stock Split, the number of shares of the Company’s common stock (x) issued and outstanding decreased from approximately 200 million shares (as of May 10, 2016) to approximately 13.3 million shares; (y) reserved for issuance upon exercise of outstanding warrants and options decreased from approximately 16 million shares to approximately 1.1 million shares, and (z) reserved but unallocated under our current equity incentive plans (including the stockholder-approved share increase to the Company’s 2014 Equity Incentive Plan) decreased from approximately 6.5 million common shares to approximately 0.4 million common shares. In connection with the 1:15 Reverse Stock Split, the Company also decreased the total number of its authorized shares of common stock from 290 million to 75 million. The number of authorized shares of preferred stock remained unchanged. Following the 1:15 Reverse Stock Split, certain reclassifications have been made to the prior periods’ stockholders’ Reverse Stock Split The Company’s shares of common stock commenced trading on a split-adjusted basis on May 12, 2016. |
Reclassifications | Reclassifications Certain immaterial reclassifications have been made to certain of the prior years’ consolidated financial statements to conform to the current year presentation. |
Recently Issued and Recently Adopted Accounting Pronouncements | Recently Issued and Recently Adopted Accounting Pronouncements Recently Issued Accounting Pronouncements In May 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2016-12, Revenue from Contracts with Customers We performed a preliminary assessment of the impact of ASU 2014-09 and related amendments on the consolidated financial statements, and considered all items outlined in the standard. In assessing the impact, we have outlined all revenue generating activities, mapped those activities to deliverables and traced those deliverables to the standard. We are currently assessing what impact the change in standard will have on those deliverables. We will continue to evaluate the future impact and method of adoption of ASU 2014-09 and related amendments on the consolidated financial statements and related disclosures throughout 2017. We believe the adoption will modify the way we analyze contracts. We will adopt the new standard beginning January 2018. In February 2016, the FASB issued ASU 2016-02, Leases In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230): Classification of certain cash receipts and cash payments In November 2016, the FASB issued Accounting Standards Update No. 2016-18, Restricted Cash In February 2017, the FASB issued ASU 2017-04, Simplifying the Test for Goodwill Impairment In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation , to provide clarity and reduce both 1) diversity in practice and 2) cost and complexity when applying the guidance in Topic 718 to a change in the terms or conditions of a share-based payment award. ASU 2017-09 provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting under Topic 718. The amendments in ASU 2017-09 are effective for fiscal years, and interim periods within those years, beginning after December 15, 2017. Early adoption is permitted, including adoption in any interim period. The amendments in ASU 2017-09 should be applied prospectively to an award modified on or after the adoption date. Recently Adopted Accounting Pronouncements In July 2015, FASB issued ASU 2015-11, Simplifying the Measurement of Inventory In March 2016, the FASB issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting In January 2017, the FASB issued Accounting Standards Update No. 2017-01, Clarifying the Definition of a Business |
Use of Estimates | The preparation of consolidated financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions affecting the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting period. Our most significant estimates and critical accounting policies involve recognizing revenue, reviewing goodwill and intangible assets for impairment, determining the assumptions used in measuring share-based compensation expense, measuring expense related to our in process research and development Actual results could differ from these estimates. Management’s estimates and assumptions are reviewed regularly, and the effects of revisions are reflected in the consolidated financial statements in the periods they are determined to be necessary. |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Revenue Recognition [Abstract] | |
Product Revenues, Classified by Geographic Location | Product revenues, classified by geographic location, are as follows (in thousands): Three months ended Nine months ended September 30, 2017 September 30, 2016 September 30, 2017 September 30, 2016 Product Revenues % of Total Product Revenues % of Total Product Revenues % of Total Product Revenues % of Total Americas $ 112 24 % $ 79 11 % $ 315 15 % $ 670 21 % Japan 279 60 % 575 79 % 1,434 71 % 2,232 70 % EMEA 18 4 % 76 10 % 204 10 % 281 9 % Asia Pacific 58 12 % 1 0 % 74 4 % 7 0 % Total product revenues $ 467 100 % $ 731 100 % $ 2,027 100 % $ 3,190 100 % |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventories consisted of the following (in thousands): September 30, 2017 December 31, 2016 Raw materials $ 907 $ 885 Work in process 839 1,021 Finished goods 1,762 1,819 $ 3,508 $ 3,725 |
Asset Purchase Agreement with22
Asset Purchase Agreement with Azaya Therapeutics (Table) | 9 Months Ended |
Sep. 30, 2017 | |
Business Combinations [Abstract] | |
Summery of Purchase Price Allocation on Fair Value Basis to Identifiable Net Assets | The total consideration was allocated on a relative fair value basis to the assets acquired, as follows (in thousands): February 15, 2017 Tangible assets $ 2,586 Intangible assets 1,686 Total assets $ 4,272 Accounts payable $ 1,796 Fair value of the common stock issued 2,311 Transaction costs 165 Total consideration $ 4,272 |
Basis of Presentation and New23
Basis of Presentation and New Accounting Standards (Details) | May 10, 2016shares | Sep. 30, 2017shares | Dec. 31, 2016shares | Jun. 15, 2016shares | May 11, 2016shares |
Basis Of Presentation And New Accounting Standards [Line Items] | |||||
Reverse stock split of common stock | 15 | ||||
Common stock, shares outstanding (in shares) | 200,000,000 | 34,716,318 | 21,707,890 | 13,300,000 | |
Number of shares callable by warrants (in shares) | 16,000,000 | 1 | 1,100,000 | ||
Common stock, shares authorized (in shares) | 290,000,000 | 75,000,000 | 75,000,000 | 75,000,000 | |
2014 Equity Incentive Plan [Member] | |||||
Basis Of Presentation And New Accounting Standards [Line Items] | |||||
Number of shares callable by warrants (in shares) | 6,500,000 | 400,000 |
Liquidity (Details)
Liquidity (Details) - USD ($) | Sep. 05, 2017 | Sep. 01, 2017 | May 31, 2017 | Apr. 11, 2017 | Jun. 16, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | Jun. 15, 2016 | May 11, 2016 | May 10, 2016 | Dec. 31, 2015 |
Liquidity [Line Items] | ||||||||||||||
Net loss | $ 4,807,000 | $ 5,384,000 | $ 18,399,000 | $ 17,127,000 | ||||||||||
Accumulated deficit | 397,462,000 | 397,462,000 | $ 379,063,000 | |||||||||||
Net cash used in operating activities | 13,904,000 | 15,372,000 | ||||||||||||
Cash and cash equivalents | 4,783,000 | $ 14,924,000 | 4,783,000 | 14,924,000 | $ 12,560,000 | $ 14,338,000 | ||||||||
Minimum cash/cash equivalents covenant | $ 1,500,000 | $ 1,500,000 | ||||||||||||
Common stock issued (in shares) | 6,704,852 | |||||||||||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | |||||||||||
Proceeds from sale of common stock, net | $ 12,377,000 | $ 17,702,000 | ||||||||||||
Each unit consist of number of warrant | 3,352,306 | |||||||||||||
Number of shares callable by warrants (in shares) | 1 | 1,100,000 | 16,000,000 | |||||||||||
Warrant exercise price (in dollars per share) | $ 3.06 | |||||||||||||
Proceeds from issuance warrants | $ 17,100,000 | |||||||||||||
Common Stock [Member] | ||||||||||||||
Liquidity [Line Items] | ||||||||||||||
Common stock issued (in shares) | 6,704,852 | |||||||||||||
Share issued, price per share | $ 1.10 | |||||||||||||
Each unit consist of number of warrant | 0.5 | |||||||||||||
Number of shares callable by warrants (in shares) | 1 | 1 | ||||||||||||
Warrant exercise price (in dollars per share) | $ 3.06 | $ 3.06 | ||||||||||||
Common Stock [Member] | Maxim Group LLC [Member] | ||||||||||||||
Liquidity [Line Items] | ||||||||||||||
Common stock issued (in shares) | 849,000 | 8,600,000 | ||||||||||||
Common stock, par value (in dollars per share) | $ 0.001 | |||||||||||||
Share issued, price per share | $ 1.10 | $ 1.0395 | ||||||||||||
Proceeds from sale of common stock, net | $ 800,000 | $ 8,700,000 | ||||||||||||
Closing of offering date | Apr. 17, 2017 | |||||||||||||
Number of days granted as option to purchase additional shares of common stock to underwriter | 45 days | |||||||||||||
Additional shares of common stock | 944,000 | |||||||||||||
Nasdaq Stock Market LLC [Member] | ||||||||||||||
Liquidity [Line Items] | ||||||||||||||
Number of consecutive business days no longer able to meet the required closing bid price of common stock | 30 days | |||||||||||||
Minimum bid price of common stock required for Nasdaq listing rule | $ 1 | |||||||||||||
Grace period provided with minimum bid price for Nasdaq listing rule | 180 days | |||||||||||||
Grace date for minimum bid price requirement for Nasdaq listing | Mar. 5, 2018 | |||||||||||||
Common stock minimum bid price required to regain compliance | $ 1 | |||||||||||||
Number of consecutive business days required to regain compliance | 10 days | |||||||||||||
Additional grace period provided with minimum bid price to regain compliance | 180 days | |||||||||||||
Nasdaq Stock Market LLC [Member] | Corporate Restructuring [Member] | ||||||||||||||
Liquidity [Line Items] | ||||||||||||||
Workforce reduction, percentage | 50.00% | |||||||||||||
Minimum [Member] | ||||||||||||||
Liquidity [Line Items] | ||||||||||||||
Unrestricted cash and cash equivalents | $ 1,500,000 | $ 1,500,000 |
Transactions with Olympus Cor25
Transactions with Olympus Corporation (Details) - USD ($) | Apr. 30, 2015 | Sep. 30, 2017 | Dec. 31, 2016 |
Termination of Olympus' Interest in the Joint Venture [Abstract] | |||
Total purchase price | $ 6,000,000 | ||
Purchase price payment agreement term | 2 years | ||
Amendment One to Joint Venture Termination Agreement [Member] | |||
Termination of Olympus' Interest in the Joint Venture [Abstract] | |||
Purchase price payment termination agreement total | 4,200,000 | ||
Purchase price principal amount payable on January 31, 2016 | 500,000 | ||
Purchase price principal amount payable on April 30, 2016 | 500,000 | ||
Purchase price principal amount and accrued interest payable on May 8, 2016 | $ 800,000 | ||
Purchase price payable obligations outstanding balance. | $ 0 | $ 0 |
Long-term Debt (Details)
Long-term Debt (Details) - USD ($) | Dec. 29, 2017 | May 29, 2015 | Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Sep. 20, 2017 | Jun. 15, 2016 | May 11, 2016 | May 10, 2016 |
Debt Instrument [Line Items] | ||||||||||
Number of shares callable by warrants (in shares) | 1 | 1,100,000 | 16,000,000 | |||||||
Warrant exercise price (in dollars per share) | $ 3.06 | |||||||||
Minimum liquidity covenant | $ 1,500,000 | $ 1,500,000 | ||||||||
Interest expense | 474,000 | $ 645,000 | 1,603,000 | $ 1,947,000 | ||||||
Non-cash amortization | $ 200,000 | $ 200,000 | $ 600,000 | $ 700,000 | ||||||
LIBOR [Member] | Interest Rate Floor [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Basis variable rate | 1.00% | |||||||||
Term Loan [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Origination Date | May 29, 2015 | |||||||||
Original Loan Amount | $ 17,700,000 | |||||||||
Basis variable rate | 7.95% | |||||||||
Maturity date | Jun. 1, 2019 | |||||||||
Fees amount associated with loan | $ 1,100,000 | |||||||||
Number of shares callable by warrants (in shares) | 94,441 | |||||||||
Warrant exercise price (in dollars per share) | $ 10.35 | |||||||||
Date from which warrants are exercisable | Nov. 30, 2015 | |||||||||
Warrant expiration date | May 29, 2025 | |||||||||
Minimum liquidity covenant | $ 5,000,000 | $ 1,500,000 | ||||||||
Extended interest-only period | Jan. 1, 2018 | |||||||||
Further extension period | Aug. 1, 2018 | |||||||||
Debt instrument, interest-only period | The Amendment also extends the interest-only period under the Loan Agreement to January 1, 2018, with a further extension through August 1, 2018 if the Company receives unrestricted net cash proceeds of at least $5 million on or before December 29, 2017. | |||||||||
Debt instrument, covenant compliance | we were in compliance with all of the debt covenants under the Loan and Security Agreement. | |||||||||
Minimum [Member] | Term Loan [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Interest rate | 8.95% | |||||||||
Minimum [Member] | Term Loan [Member] | Scenario Forecast [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Net proceeds receives from unrestricted cash | $ 5,000,000 | |||||||||
Maximum [Member] | Term Loan [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Original Loan Amount | $ 3,000,000 |
Revenue Recognition (Details)
Revenue Recognition (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2017USD ($)Customer | Sep. 30, 2016USD ($)CustomerDistributor | |
Concentration Risk [Line Items] | ||||
Concentration risk percentage | 100.00% | 100.00% | 100.00% | 100.00% |
Revenue recognized | $ | $ 1,306 | $ 1,879 | $ 2,856 | $ 5,163 |
BARDA Contract [Member] | ||||
Concentration Risk [Line Items] | ||||
Revenue recognized | $ | $ 1,300 | $ 1,900 | $ 2,900 | $ 5,200 |
Customer Concentration Risk [Member] | Revenue Recognized [Member] | ||||
Concentration Risk [Line Items] | ||||
Number of customers | Customer | 6 | 2 | ||
Concentration risk percentage | 61.00% | 80.00% | ||
Number of distributors | Distributor | 3 | |||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | ||||
Concentration Risk [Line Items] | ||||
Number of customers | Customer | 4 | 1 | ||
Concentration risk percentage | 78.00% | 28.00% | ||
Number of distributors | Distributor | 2 |
Revenue Recognition - Product R
Revenue Recognition - Product Revenues, Classified by Geographic Location (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Concentration Risk [Line Items] | ||||
Revenues | $ 467 | $ 731 | $ 2,027 | $ 3,190 |
Concentration risk percentage | 100.00% | 100.00% | 100.00% | 100.00% |
Americas [Member] | ||||
Concentration Risk [Line Items] | ||||
Revenues | $ 112 | $ 79 | $ 315 | $ 670 |
Concentration risk percentage | 24.00% | 11.00% | 15.00% | 21.00% |
Japan [Member] | ||||
Concentration Risk [Line Items] | ||||
Revenues | $ 279 | $ 575 | $ 1,434 | $ 2,232 |
Concentration risk percentage | 60.00% | 79.00% | 71.00% | 70.00% |
EMEA [Member] | ||||
Concentration Risk [Line Items] | ||||
Revenues | $ 18 | $ 76 | $ 204 | $ 281 |
Concentration risk percentage | 4.00% | 10.00% | 10.00% | 9.00% |
Asia Pacific [Member] | ||||
Concentration Risk [Line Items] | ||||
Revenues | $ 58 | $ 1 | $ 74 | $ 7 |
Concentration risk percentage | 12.00% | 0.00% | 4.00% | 0.00% |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 907 | $ 885 |
Work in process | 839 | 1,021 |
Finished goods | 1,762 | 1,819 |
Inventory, net | $ 3,508 | $ 3,725 |
Loss per Share (Details)
Loss per Share (Details) - shares shares in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Dilutive common shares excluded from the calculations of diluted loss per share (in shares) | 4.8 | 4.3 | 4.8 | 4.3 |
Outstanding Warrants [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Dilutive common shares excluded from the calculations of diluted loss per share (in shares) | 3.7 | 3.7 | ||
Options and Restricted Stock [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Dilutive common shares excluded from the calculations of diluted loss per share (in shares) | 1.1 | 1.1 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) $ in Millions | Feb. 27, 2017 | Jan. 27, 2017 | Sep. 30, 2017 | Jan. 01, 2018 | Jun. 01, 2017 |
Recorded Unconditional Purchase Obligation [Line Items] | |||||
Initial term of lease | 63 months | ||||
Lease commencement date | Jan. 1, 2018 | ||||
Letter of Credit [Member] | |||||
Recorded Unconditional Purchase Obligation [Line Items] | |||||
Letter of credit amount required by lease agreement | $ 0.1 | $ 0.3 | |||
Letter of Credit [Member] | Scenario Forecast [Member] | |||||
Recorded Unconditional Purchase Obligation [Line Items] | |||||
Letter of credit amount required by lease agreement | $ 0.5 | ||||
Japan Lease [Member] | |||||
Recorded Unconditional Purchase Obligation [Line Items] | |||||
Initial term of lease | 61 months | ||||
Lease commencement date | Apr. 15, 2017 | ||||
Pre-clinical Research Study Obligations [Member] | |||||
Recorded Unconditional Purchase Obligation [Line Items] | |||||
Contractual obligation, due in next twelve months | $ 0.8 | ||||
Roche Diagnostics Corporation [Member] | |||||
Recorded Unconditional Purchase Obligation [Line Items] | |||||
Purchase obligation | 4.5 | ||||
Purchase obligation, due in next twelve months | 0.5 | ||||
Operating Lease Obligations [Member] | |||||
Recorded Unconditional Purchase Obligation [Line Items] | |||||
Contractual obligation, due in next twelve months | 1.2 | ||||
Contractual obligation | $ 7.3 |
Asset Purchase Agreement with32
Asset Purchase Agreement with Azaya Therapeutics - Additional Information (Details) - Azaya Therapeutics, Inc. [Member] | Feb. 15, 2017USD ($)CandidateEmployeeshares | Sep. 30, 2017USD ($) |
Business Acquisition [Line Items] | ||
Obligation to pay on existing payables assumed | $ 1,796,000 | |
Total consideration | 4,272,000 | |
Fair value of the common stock issued | 2,311,000 | |
Assumed liabilities | 1,800,000 | |
Acquisition costs | 200,000 | |
Asset Purchase Agreement | ||
Business Acquisition [Line Items] | ||
Book value of tangible assets acquired | $ 3,000,000 | |
Common stock, shares issued | shares | 1,173,241 | |
Common stock, shares issued after closing date | shares | 879,931 | |
Common stock deposited in escrow | shares | 293,310 | |
Obligation to pay on existing payables assumed | $ 1,800,000 | |
Existing payables, paid during the period | $ 1,800,000 | |
Number of employees | Employee | 0 | |
Maximum earn-out payment obligations | $ 100,000,000 | |
Aggregate payment obligation threshold limit | $ 50,000,000 | |
Percentage of net sales deemed for purposes of calculating payments | 50.00% | |
Asset Purchase Agreement | IPR&D [Member] | ||
Business Acquisition [Line Items] | ||
Number of drug candidates acquired | Candidate | 2 |
Asset Purchase Agreement with33
Asset Purchase Agreement with Azaya Therapeutics - Summery of Purchase Price Allocation on Fair Value Basis to Identifiable Net Assets (Details) - Azaya Therapeutics, Inc. [Member] $ in Thousands | Feb. 15, 2017USD ($) |
Business Acquisition [Line Items] | |
Tangible assets | $ 2,586 |
Intangible assets | 1,686 |
Total assets | 4,272 |
Accounts payable | 1,796 |
Fair value of the common stock issued | 2,311 |
Transaction costs | 165 |
Total consideration | $ 4,272 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | May 31, 2017 | Apr. 11, 2017 | Dec. 22, 2016 | Jun. 16, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | Jun. 15, 2016 | May 11, 2016 | May 10, 2016 |
Common Stock [Abstract] | ||||||||||
Each unit consist of number of warrant | 3,352,306 | |||||||||
Number of shares callable by warrants (in shares) | 1 | 1,100,000 | 16,000,000 | |||||||
Warrant exercise price (in dollars per share) | $ 3.06 | |||||||||
Common stock issued (in shares) | 6,704,852 | |||||||||
Proceeds from sale of common stock, net | $ 12,377,000 | $ 17,702,000 | ||||||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | ||||||||
Common Stock [Member] | ||||||||||
Common Stock [Abstract] | ||||||||||
Common Stock Subscription Price | $ 2.55 | |||||||||
Each unit consist of number of common stock | 1 | |||||||||
Each unit consist of number of warrant | 0.5 | |||||||||
Number of shares callable by warrants (in shares) | 1 | |||||||||
Warrant exercise price (in dollars per share) | $ 3.06 | |||||||||
Period exercisable from the date of issuance | 30 months | |||||||||
Common stock issued (in shares) | 6,704,852 | |||||||||
Gross proceeds from private placement of stock | $ 15,300,000 | |||||||||
Redemption price of warrant prior to expiration | $ 0.01 | |||||||||
Common stock price per share for warrant redemption | $ 7.65 | |||||||||
Number of consecutive trading days for warrant redemption | 10 days | |||||||||
Share issued, price per share | $ 1.10 | |||||||||
Common Stock [Member] | Maxim Group LLC [Member] | ||||||||||
Common Stock [Abstract] | ||||||||||
Common stock issued (in shares) | 849,000 | 8,600,000 | ||||||||
Proceeds from sale of common stock, net | $ 800,000 | $ 8,700,000 | ||||||||
Common stock, par value (in dollars per share) | $ 0.001 | |||||||||
Share issued, price per share | $ 1.10 | $ 1.0395 | ||||||||
Closing of offering date | Apr. 17, 2017 | |||||||||
Number of days granted as option to purchase additional shares of common stock to underwriter | 45 days | |||||||||
Additional shares of common stock | 944,000 | |||||||||
Common Stock [Member] | Lincoln Park Capital Fund, LLC [Member] | ||||||||||
Common Stock [Abstract] | ||||||||||
Period exercisable from the date of issuance | 30 months | |||||||||
Common stock issued, value | $ 20,000,000 | |||||||||
Common Stock [Member] | Purchase Agreement [Member] | Lincoln Park Capital Fund, LLC [Member] | ||||||||||
Common Stock [Abstract] | ||||||||||
Common stock issued (in shares) | 1,490,937 | |||||||||
Common stock issued, value | $ 200,000 | |||||||||
Proceeds from sale of common stock, net | $ 1,500,000 | |||||||||
Common Stock [Member] | Securities Purchase Agreement [Member] | Lincoln Park Capital Fund, LLC [Member] | ||||||||||
Common Stock [Abstract] | ||||||||||
Common stock issued (in shares) | 127,419 | |||||||||
Trading Volume of Common Shares | 0 | |||||||||
Common stock issued (in shares) | 382,258 | |||||||||
Common Stock [Member] | Maximum [Member] | Purchase Agreement [Member] | Lincoln Park Capital Fund, LLC [Member] | ||||||||||
Common Stock [Abstract] | ||||||||||
Floor price of per share | $ 0.50 | |||||||||
Common Stock [Member] | Maximum [Member] | Single Regular Purchase [Member] | Lincoln Park Capital Fund, LLC [Member] | ||||||||||
Common Stock [Abstract] | ||||||||||
Common stock issued (in shares) | 100,000 | |||||||||
Common Stock [Member] | Minimum [Member] | Lincoln Park Capital Fund, LLC [Member] | ||||||||||
Common Stock [Abstract] | ||||||||||
Beneficial ownership percentage of common stock outstanding | 9.99% | |||||||||
Common Stock [Member] | Minimum [Member] | Single Regular Purchase [Member] | Lincoln Park Capital Fund, LLC [Member] | ||||||||||
Common Stock [Abstract] | ||||||||||
Common stock issued, value | $ 1,000,000 | |||||||||
ATM [Member] | ||||||||||
Common Stock [Abstract] | ||||||||||
Common stock issued (in shares) | 894,050 | 1,840,982 | ||||||||
Proceeds from sale of common stock, net | $ 1,500,000 | $ 4,400,000 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | Nov. 09, 2017 | Sep. 30, 2017 | Jun. 15, 2016 | May 11, 2016 | May 10, 2016 |
Subsequent Event [Line Items] | |||||
Subscription rights to purchase number of units and warrants | 1 | 1,100,000 | 16,000,000 | ||
Warrants subscription price per share | $ 3.06 | ||||
Common Stock [Member] | |||||
Subsequent Event [Line Items] | |||||
Subscription rights to purchase number of units and warrants | 1 | ||||
Warrants subscription price per share | $ 3.06 | ||||
2017 Rights Offering [Member] | Subsequent Event [Member] | |||||
Subsequent Event [Line Items] | |||||
Charge on Non Transferable Subscription Rights | $ 0 | ||||
Subscription rights to purchase number of units and warrants | 1,250 | ||||
2017 Rights Offering [Member] | Subsequent Event [Member] | Common Stock [Member] | |||||
Subsequent Event [Line Items] | |||||
Number of shares per subscription rights and warrants | 1 | ||||
Warrants subscription price per share | $ 1,000 | ||||
Number of convertible preferred stock | 2,500 | ||||
2017 Rights Offering [Member] | Subsequent Event [Member] | Series B Convertible Preferred Stock [Member] | |||||
Subsequent Event [Line Items] | |||||
Number of shares per subscription rights and warrants | 1 | ||||
2017 Rights Offering [Member] | Subsequent Event [Member] | Series B Convertible Preferred Stock [Member] | Maximum [Member] | |||||
Subsequent Event [Line Items] | |||||
Subscription rights to purchase number of units and warrants | 10,000 |