Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2015 | Oct. 31, 2015 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2015 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | BGMD | |
Entity Registrant Name | BG MEDICINE, INC. | |
Entity Central Index Key | 1,407,038 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 11,126,579 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Current assets | ||
Cash | $ 2,642 | $ 4,123 |
Accounts receivable (net of allowances for doubtful accounts of $151 and $0, as of September 30, 2015 and December 31, 2014, respectively) | 152 | 174 |
Inventory | 223 | 400 |
Prepaid expenses and other current assets | 139 | 154 |
Total current assets | 3,156 | 4,851 |
Property and equipment, net | 14 | 117 |
Intangible assets, net | 92 | 135 |
Deposits and other assets | 94 | 126 |
Total assets | 3,356 | 5,229 |
Current liabilities | ||
Term loan | 2,960 | |
Accounts payable | 1,332 | 695 |
Accrued expenses | 562 | 906 |
Other current liabilities | 48 | 18 |
Total current liabilities | 1,942 | 4,579 |
Other liabilities | 94 | 93 |
Total liabilities | $ 2,036 | $ 4,672 |
Commitments and contingencies (Note 5) | ||
Convertible preferred stock; $.001 par value; 5,000,000 and 0 shares authorized at September 30, 2015 and December 31, 2014, respectively; 1,474,443 and 0 shares issued and outstanding at September 30, 2015 and December 31, 2014, respectively; liquidation preference of $2,548 at September 30, 2015 | $ 2,594 | |
Stockholders' (deficit) equity | ||
Common stock; $.001 par value; 100,000,000 shares authorized at September 30, 2015 and December 31, 2014; 11,126,579 and 8,632,810 shares issued and outstanding at September 30, 2015 and December 31, 2014, respectively | 11 | $ 9 |
Additional paid-in capital | 164,118 | 161,550 |
Accumulated deficit | (165,403) | (161,002) |
Total stockholders' (deficit) equity | (1,274) | 557 |
Total liabilities and stockholders' (deficit) equity | $ 3,356 | $ 5,229 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Allowances for doubtful accounts | $ 151 | $ 0 |
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 0 |
Preferred stock, shares issued | 1,474,443 | 0 |
Preferred stock, shares outstanding | 1,474,443 | 0 |
Preferred stock, liquidation preference | $ 2,548 | |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 11,126,579 | 8,632,810 |
Common stock, shares outstanding | 11,126,579 | 8,632,810 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Revenues: | ||||
Product revenues | $ 274 | $ 669 | $ 1,160 | $ 2,158 |
Product fee revenues | 60 | 26 | 116 | 75 |
Total revenues | 334 | 695 | 1,276 | 2,233 |
Costs and operating expenses: | ||||
Product and product fee costs | 103 | 234 | 423 | 764 |
Research and development | 333 | 724 | 1,314 | 1,855 |
Selling and marketing | 4 | 647 | 289 | 2,069 |
General and administrative | 920 | 1,323 | 2,978 | 3,696 |
Total costs and operating expenses | 1,360 | 2,928 | 5,004 | 8,384 |
Loss from operations | (1,026) | (2,233) | (3,728) | (6,151) |
Interest income | 2 | |||
Interest expense | (4) | (165) | (159) | (597) |
Other income (loss) | 7 | 1 | (514) | 2 |
Net loss | (1,023) | (2,397) | (4,401) | (6,744) |
Preferred stock dividend | (41) | (41) | ||
Deemed dividend on beneficial conversion feature | (1,507) | (1,507) | ||
Accretion of convertible preferred stock to liquidation value | (56) | (56) | ||
Net loss attributable to common shareholders | $ (2,627) | $ (2,397) | $ (6,005) | $ (6,744) |
Net loss per share attributable to common shareholders - basic and diluted | $ (0.27) | $ (0.28) | $ (0.66) | $ (0.84) |
Weighted-average common shares outstanding used in computing per share amounts - basic and diluted | 9,862,802 | 8,604,312 | 9,057,960 | 8,028,373 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Cash flows from operating activities | ||
Net loss | $ (4,401,000) | $ (6,744,000) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation and amortization | 69,000 | 100,000 |
Stock-based compensation | 630,000 | 489,000 |
Non-cash interest expense | 79,000 | 164,000 |
Provision for doubtful accounts | 151,000 | |
Loss on fair value of secured convertible note | 487,000 | |
Loss on sale of property and equipment | 64,000 | |
Changes in operating assets and liabilities | ||
Accounts receivable | (130,000) | 65,000 |
Inventory | 177,000 | 101,000 |
Prepaid expenses and other assets | 7,000 | 78,000 |
Accounts payable, accrued expenses and other liabilities | 254,000 | (1,349,000) |
Deferred revenue and customer deposits | 63,000 | (1,000) |
Net cash flows used in operating activities | (2,550,000) | (7,097,000) |
Cash flows from investing activities | ||
Proceeds from the sale of property and equipment | 13,000 | |
Net cash flows provided by investing activities | 13,000 | |
Cash flows from financing activities | ||
Proceeds from public offering | 2,500,000 | 9,238,000 |
Payments on term loan | (2,984,000) | (3,360,000) |
Proceeds from ESPP purchases | 2,000 | |
Proceeds from the exercise of stock options | 22,000 | |
Proceeds from secured convertible note | 500,000 | |
Proceeds from issuance of preferred stock | 2,000,000 | |
Net cash flows provided by financing activities | 1,056,000 | 5,659,000 |
Net decrease in cash | (1,481,000) | (1,438,000) |
Cash, beginning of period | 4,123,000 | 7,751,000 |
Cash, end of period | 2,642,000 | 6,313,000 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 81,000 | 433,000 |
Supplemental schedule of non-cash financing activities | ||
Conversion of convertible notes payable to preferred stock | 987,000 | |
Conversion of interest to preferred stock | 7,000 | |
Deemed dividend on beneficial conversion feature | 1,507,000 | |
Accretion of convertible preferred stock to liquidation value | 56,000 | |
Common Stock | ||
Cash flows from financing activities | ||
Costs related to issuance of stock | (504,000) | $ (243,000) |
Preferred Stock | ||
Cash flows from financing activities | ||
Costs related to issuance of stock | $ (456,000) |
Description of Business and Bas
Description of Business and Basis of Presentation | 9 Months Ended |
Sep. 30, 2015 | |
Description of Business and Basis of Presentation | 1. Description of Business and Basis of Presentation Description of Business BG Medicine, Inc. (“BG Medicine” or the “Company”) is a commercial stage company that is focused on the development and delivery of diagnostic solutions to aid in the clinical management of heart failure and related disorders. The Company’s BGM Galectin-3 ® in vitro ® The Company has entered into licensing agreements with leading diagnostic instrument manufacturers to develop and commercialize galectin-3 assays that will be performed on automated platforms that have been incorporated into routine practice in laboratories throughout the world. On December 23, 2014, the FDA granted 510(k) clearance for the ARCHITECT ® ® ® ® Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States and in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, they do not include all of the information and notes required by generally accepted accounting principles for complete financial statements. The interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s financial position at September 30, 2015 and results of operations and cash flows for the interim periods ended September 30, 2015 and 2014. On July 8, 2015, the Company effected a 1-for-4 reverse stock split of its common stock. All previously reported common stock share amounts in the accompanying financial statements and related notes have been retroactively adjusted to reflect the reverse stock split. As a result of the reverse stock split, the stated capital on the Company’s balance sheet attributable to its common stock, which consists of the par value per share of its common stock multiplied by the aggregate number of shares of its common stock issued and outstanding, has been reduced in proportion to the size of the reverse stock split. Correspondingly, the Company’s additional paid-in capital account, which consists of the difference between its stated capital and the aggregate amount paid to the Company upon issuance of all currently outstanding shares of its common stock, has been credited with the amount by which the stated capital is reduced. The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates and to identify matters that require additional disclosure. Subsequent events have been evaluated through the date of issuance of these financial statements. The results for the nine months ended September 30, 2015 are not necessarily indicative of the results to be expected for the year ending December 31, 2015 or for any other interim period or for any other future year. These interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014. At September 30, 2015, the Company had cash totaling $2.6 million, an outstanding balance of $0 under its secured term loan facility, which the Company repaid and which was terminated in July 2015, and stockholders’ deficit of $1.3 million. During the nine months ended September 30, 2015, the Company incurred a net loss of $4.4 million, used $2.6 million of cash in operating activities and used $3.0 million of cash for payments to extinguish the term loan facility. The Company expects to continue to incur losses and use cash in operating activities for the foreseeable future. The Company is in the early stages of commercializing its BGM Galectin-3 Test and assisting with the commercialization of the ARCHITECT® Galectin-3 assay. Interest in the testing for galectin-3 is increasing as a result of the Company’s market development activities, although it has not yet translated into significant revenue. In order to achieve profitability, the Company will need to generate significant product revenues. Effective January 1, 2014, the payment rate at which testing for galectin-3 is reimbursed by the Centers for Medicare and Medicaid Services (“CMS”), was increased to $30.01 from $17.80 per test. In 2015, the national limitation amount for testing for galectin-3 was reduced to $29.93 and applies across the U.S., except in Ohio and West Virginia where rates of $23.93 and $26.33, respectively, apply. Since September 11, 2014, the Company has implemented a reduction of approximately 77% of its workforce, or 17 people (the “Restructuring”), leaving 5 employees. The Company took this step in order to reduce its operating expenses and extend its cash runway in anticipation of the commercial launch of automated versions of the Company’s galectin-3 test. The automated galectin-3 tests are being developed and commercialized by the Company’s diagnostic instrument manufacturing partners and will be performed on the partners’ automated platforms. The Restructuring primarily eliminated the Company’s sales and marketing organization and removed certain positions in other functional areas, while preserving some senior management and other critical roles to support the clinical and commercial adoption of galectin-3 testing by providing support to the marketing and selling efforts of its automated partners, clinical research studies that have incorporated galectin-3 testing and by expanding the BGM Galectin-3 Test’s labeling indications for use through additional clinical studies and clearances by the FDA. Employees affected by the Restructuring were provided with severance arrangements including outplacement assistance. As a result of the Restructuring, the Company has recorded total charges with respect to severance payments and benefits continuation of approximately $404,000 and $98,000 during 2014 and 2015, respectively. Of the total $404,000 charges in 2014, $128,000 was recorded in research and development, $114,000 was recorded in sales and marketing, and $162,000 was recorded in general and administrative expense. Of the $98,000 charges in 2015, $41,000 was recorded in research and development and $57,000 was recorded in sales and marketing expense. The Company paid approximately $277,000 of such expenses during the third and fourth quarters of 2014 and $225,000 during the first three quarters of 2015. As a result of the Restructuring, the Company estimates it will generate annualized expense savings of approximately $2.4 million primarily from savings in employee salaries and benefits. In May 2015, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with the Company’s principal stockholders, Pursuant to the terms and subject to the conditions contained in the Purchase Agreement, the Company issued and sold to the purchasers (the “Purchasers”) secured convertible promissory notes in an aggregate principal amount of $500,000. In addition and pursuant to the terms of the Purchase Agreement, and as approved by the Company’s stockholders at the Company’s 2015 annual meeting of stockholders (the “2015 Annual Meeting”) and the satisfaction or waiver of other closing conditions, the Company issued and sold to the purchasers $2,000,000 of shares of newly created Series A Preferred Stock, $0.001 par value per share of the Company at the second closing that was held on July 14, 2015 following the Company’s 2015 Annual Meeting. In June 2015, the Company entered into a sublease agreement with a third party for the 880 Winter Street office space. The term of the sublease is from June 1, 2015 through December 31, 2018 covering the balance of the underlying lease term. The Company has recorded in operating costs total charges of $153,000 with respect to the net present value of the net costs that will continue to be incurred under the lease for its remaining term and the real estate brokerage commissions on the sublease. The Company has obtained office space on a short term rental basis and expects to generate annualized savings of approximately $240,000. As further described in Note 4, the Company had a term loan facility that was secured by substantially all of the Company’s assets. On July 14, 2015 the Company paid off all of its outstanding obligations under the term loan. In August 2015, the Company closed on an underwritten public offering of (i) 2,315,654 Series A units, each consisting of one share of common stock and one half of a warrant to purchase one share of common stock, at a purchase price of $1.00 per Series A unit, and (ii) 184,346 Series B units, in lieu of Series A units, at a purchase price of $1.00 per Series B unit to those purchasers whose purchase of additional Series A units in the offering would result in the purchaser beneficially owning more than 9.99% of the Company’s outstanding common stock following the completion of the offering. Each Series B unit consists of one fully pre-funded warrant to purchase one share of common stock and one half of a warrant to purchase one share of common stock. The warrants (other than the fully pre-funded warrants) have an exercise price of $1.00 per share. The net offering proceeds received by the Company, after deducting discounts and commissions and expenses incurred with the offering were approximately $2.0 million. The Company’s common stock had been listed for trading on The NASDAQ Capital Market until September 15, 2015, when it was suspended for failure to comply with The NASDAQ Capital Market continued listing standards. On September 16, 2015, the Company’s common stock began trading on the OTC Markets’ OTCQB market tier under the trading symbol “BGMD.” The delisting of the Company’s common stock from The NASDAQ Capital Market could substantially further reduce the liquidity of the Company’s common stock and result in a corresponding material reduction in the price of the Company’s common stock. In addition, the delisting could negatively affect the Company by reducing the number of investors willing to hold or acquire the Company’s common stock, which could negatively affect the Company’s ability to raise capital, and may result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities. The Company believes that its existing cash will be sufficient to fund its operations into July 2016. For the foreseeable future and until the Company generates significant product revenues to reach cash breakeven, the Company will need to raise additional funds to finance its operations beyond July 2016. The Company may not be able to obtain adequate financing to do so when necessary, and the terms of any financings may not be advantageous to the Company and any financings may result in dilution to the Company’s stockholders. The above circumstances along with the Company’s history, the near term forecast of incurring net losses and negative operating cash flows, the Company’s dependence on near-term revenues generated from product fees due from a single automated partner, the Company’s limited experience with the amount and timing of sales made by its automated partners and its inability to predict the timing of the market introduction of automated tests and product fees generated by the sale of automated tests by its other automated partners raise substantial doubt regarding the Company’s ability to continue as a going concern for a reasonable period of time. The accompanying unaudited condensed 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. |
Significant Accounting Policies
Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2015 | |
Significant Accounting Policies | 2. Significant Accounting Policies Product Revenues Product revenues are recognized when the following criteria have been met: (i) persuasive evidence of an arrangement exists; (ii) delivery has occurred and risk of loss has passed; (iii) the seller’s price to the buyer is fixed or determinable; and (iv) collectability is reasonably assured. The Company sells its products through supply agreements with laboratory testing services and diagnostic testing distributors and directly to hospitals and clinics. The Company recognizes revenue when products are received by customers, at which time both title and risk of loss have passed to the customers. The Company negotiates credit terms on a customer-by-customer basis and products are shipped at an agreed-upon price. Revenue is recorded net of taxes collected from customers that are remitted to governmental authorities, with the collected taxes recorded as current liabilities until remitted to the relevant government authority. Freight costs billed to customers are recorded as revenue. In the past the Company did not provide an allowance for doubtful accounts or a reserve for sales returns as the Company has not experienced any credit losses, and returns are only allowed for defects in workmanship. On June 7, 2015, Health Diagnostic Laboratory, Inc. (“HDL”), which is the Company’s largest customer of its BGM Galectin-3 ® Product Fee Revenues The Company recognizes product fee revenue when it receives quarterly test sales reporting and payments thereunder from its partners. The Company has entered into worldwide license, development and commercialization agreements with Abbott Laboratories, (“Abbott”), bioMérieux SA, (“bioMérieux”), Siemens Healthcare Diagnostics Inc., (“Siemens”), and Alere Inc., (“Alere”). As consideration for the rights and licenses granted by the Company to its partners, the licensees pay to the Company a product fee, as set forth in the respective agreements, for tests sold to third parties. To date, only Abbott and bioMérieux have paid product fees to the Company. Product Fee Reclassification Beginning in the third quarter of 2015, the Company began disclosing product fee revenue separately from product revenue. To maintain comparability, all previously reported product revenue figures in the accompanying unaudited condensed consolidated financial statements have been retroactively adjusted to break out the product fee revenue recognized during those periods. Management evaluated the amount and nature of the change and concluded that it was not material to either the previously reported annual or quarterly financial statement results of operations. Nonetheless, the Company has reclassified the historical statement of operations amounts included in this filing as follows (in thousands): As reported Three months ended September 30, 2014 As reclassified Three months ended September 30, 2014 As reported Nine months ended September 30, 2014 As reclassified Nine months ended September 30, 2014 Product Revenues $ 695 $ 669 $ 2,233 $ 2,158 Product Fee Revenues — 26 — 75 Total Revenues $ 695 $ 695 $ 2,233 $ 2,233 Inventory Inventory is stated at the lower of cost or market. Costs are determined under the first-in, first-out (FIFO) method. Inventories consisted of the following: (in thousands) September 30, 2015 December 31, 2014 Raw materials $ 45 $ 64 Finished goods 178 336 Total inventories $ 223 $ 400 Net Loss Per Share Attributable to Common Shareholders Basic and diluted net loss per share attributable to common shareholders is computed by dividing net loss attributable to common shareholders by the weighted average number of common shares outstanding for the period. The Company applied the two-class method to calculate its basic and diluted net loss per share of common stock, as its convertible preferred stock, common stock, and warrants to purchase common stock are participating securities. The two-class method is an earnings allocation formula that treats a participating security as having rights to earnings that otherwise would have been available to common shareholders. However, the two-class method does not impact the net loss per share of common stock as the Company was in a loss position for each of the periods presented, and neither preferred shareholders nor warrant holders participate in losses. The following table summarizes the computation of basic and diluted net loss per share for the three and nine months ended September 30, 2015 and 2014: Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 (in thousands, except share and per share data) Net loss $ (1,023 ) $ (2,397 ) $ (4,401 ) $ (6,744 ) Preferred stock dividend (41 ) — (41 ) — Deemed dividend on beneficial conversion feature (1,507 ) — (1,507 ) — Accretion of convertible preferred stock to liquidation value (56 ) — (56 ) — Net loss attributable to common shareholders $ (2,627 ) $ (2,397 ) $ (6,005 ) $ (6,744 ) Weighted average number of shares - basic and diluted 9,862,802 8,604,312 9,057,960 8,028,373 Net loss per share attributable to common shareholders - basic and diluted $ (0.27 ) $ (0.28 ) $ (0.66 ) $ (0.84 ) As of September 30, 2015 and 2014, the following potential common shares were excluded from the computation of diluted net loss per share because they had an antidilutive impact due to the losses reported: September 30, 2015 2014 Options to purchase common stock 699,513 644,789 Warrants to purchase common stock 1,536,929 216,156 |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 9 Months Ended |
Sep. 30, 2015 | |
Fair Value of Financial Instruments | 3. Fair Value of Financial Instruments At September 30, 2015, the Company’s financial instruments consisted of cash, accounts receivable, and accounts payable. The carrying amounts of accounts receivable and accounts payable are considered reasonable estimates of their fair value, due to the short maturity of these instruments. In accordance with U.S. generally accepted accounting standards, fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value which are the following: Level 1—Quoted prices in active markets for identical assets or liabilities. Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The assets or liabilities fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques used need to maximize the use of observable inputs and minimize the use of unobservable inputs. The table below sets forth a summary of changes in the fair value of the Company’s level 3 liability (preferred stock liability) for the three and nine months ending September 30, 2015: Three Months Ended Nine Months Ended (in thousands) Beginning balance $ 31 $ — Loss on recognition of preferred stock liability — 79 Gain on revaluation of preferred stock liability (31 ) (79 ) Ending balance $ — $ — The resulting initial recognition and subsequent revaluation were recorded as other income (expense) in the unaudited condensed consolidated statements of operations The table below sets forth a summary of changes in the fair value of the Company’s secured convertible notes for the three and nine months ended September 30, 2015: Three Months Ended Nine Months Ended (in thousands) Beginning balance $ 929 $ — Proceeds from secured convertible note — 500 Loss on fair value adjustment 58 487 Conversion of secured convertible notes (987 ) (987 ) Ending balance $ — $ — The resulting fair value adjustment was recorded as other income (expense) in the unaudited condensed consolidated statements of operations. The preferred stock liability was valued using the Black-Scholes option pricing model as of May 12, 2015, the issuance date of the secured convertible note, resulting in a fair value of $79,000. This valuation considered an underlying security price of $2.12, strike price of $2.68, risk-free interest rate of 0.02%, expected dividend yield of 0%, volatility factor of 73.8%, and expected term of 0.22 years. The preferred stock liability was revalued as of June 30, 2015 resulting in a fair value of $31,000. This valuation considered an underlying security price of $2.00, strike price of $2.68, risk-free interest rate of 0.03%, expected dividend yield of 0%, volatility factor of 73.8%, and expected term of 0.08 years. As of July 14, 2015, the mandatory conversion of the preferred stock occurred, resulting in a remaining term of zero and thereby a fair value of zero. The secured convertible promissory notes valuation analysis was based on the probability-weighted expected return method (“PWERM”) utilizing various scenarios for the expected payout of the instrument covering the full range of the potential outcomes. The PWERM determines the value of an instrument, based upon an analysis of future values for the subject instruments, which takes into consideration the full range of the potential cash flows available to the subject instrument. The instrument value is based upon the present value of the probability of each future outcome becoming available to the instrument, and the economic rights and preferences of the instrument. Due to the lack of relevant and market reflective Level 1 and Level 2 inputs, the Company valued the instruments using Level 3 inputs, which require significant judgment and estimates on behalf of management in developing model assumptions. The fair value model used in valuing the convertible debt instrument as of June 30, 2015 utilized the following inputs: conversion price per share, current and future stock prices, discount rate, and volatility. The following assumptions were made in the model: (1) conversion price of $2.68 per share, (2) current common stock price of $2.36 per share, (3) simulated future common stock price of $2.14 per share, (4) discount rate of 18.0%, (5) expected stock price volatility related to the current common stock price of 51.0%, and (6) expected stock price volatility related to the simulated future common stock price of 55.0%. At the conversion date of July 14, 2015, the following inputs were utilized in valuing the convertible debt instrument: (1) conversion price of $3.33 per share, (2) current common stock price of $1.54 per share, (3) discount rate of 18.0%, and (4) expected stock price volatility of 56.2%. |
Term Loan
Term Loan | 9 Months Ended |
Sep. 30, 2015 | |
Term Loan | 4. Term Loan On February 10, 2012, the Company entered into a secured term loan facility, and a term loan in the aggregate principal amount of $10.0 million was funded upon the closing of the transaction. On July 14, 2015, the Company paid off all of its outstanding obligations under that certain Loan and Security Agreement by and among the Company, General Electric Capital Corporation (“GECC”) as agent and the lenders and the guarantors thereto dated as of February 10, 2012, as amended (the “GECC Agreement”), and terminated the GECC Agreement. The security interest granted by the Company to GECC in its assets in connection with the GECC Agreement was also terminated at the time of the payoff. Notwithstanding the payoff, the warrants to purchase the Company’s common stock that the Company previously issued to GECC’s affiliate, GE Capital Equity Investments, Inc., and Comerica Bank in connection with the GECC Agreement, continue to remain outstanding in accordance with their terms and are not affected by the payoff. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2015 | |
Commitments and Contingencies | 5. Commitments and Contingencies From time to time, the Company may be subject to various legal proceedings and claims arising in the ordinary course of business. The Company assesses contingencies to determine the degree of probability and range of possible loss for potential accrual in its financial statements. An estimated loss contingency is accrued in the financial statements if it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated. No amounts related to contingencies are accrued at September 30, 2015, as there are no ongoing proceedings. |
Follow-on Public Offerings
Follow-on Public Offerings | 9 Months Ended |
Sep. 30, 2015 | |
Follow-on Public Offerings | 6. Follow-on Public Offerings On April 8, 2014, the Company closed a follow-on underwritten public offering of 1,613,000 shares of its common stock, at an offering price of $6.20 per share, for gross proceeds of $10.0 million. The net offering proceeds received by the Company, after deducting underwriting discounts and commissions and expenses incurred in connection with the offering, were approximately $9.0 million. On August 18, 2015, the Company closed on an underwritten public offering of (i) 2,315,654 Series A units, each consisting of one share of common stock and one half of a warrant to purchase one share of common stock, at a purchase price of $1.00 per Series A unit, and (ii) 184,346 Series B units, in lieu of Series A units, at a purchase price of $1.00 per Series B unit to those purchasers whose purchase of additional Series A units in the offering would result in the purchaser beneficially owning more than 9.99% of the Company’s outstanding common stock following the completion of the offering. Each Series B unit consists of one fully pre-funded warrant to purchase one share of common stock and one half of a warrant to purchase one share of common stock. The warrants (other than the fully pre-funded warrants) have an exercise price of $1.00 per share. The net offering proceeds received by the Company, after deducting discounts and commissions and expenses incurred with the offering were approximately $2.0 million. |
Convertible Promissory Notes an
Convertible Promissory Notes and Series A Preferred Stock | 9 Months Ended |
Sep. 30, 2015 | |
Convertible Promissory Notes and Series A Preferred Stock | 7. Convertible Promissory Notes and Series A Preferred Stock On May 12, 2015, the Company entered into a Securities Purchase Agreement (the “Series A Purchase Agreement”) with the Company’s principal stockholders. On May 12, 2015 (the “Initial Closing”), pursuant to the terms and subject to the conditions contained in the Series A Purchase Agreement, the Company issued and sold to the Purchasers secured convertible promissory notes in the aggregate principal amount of $0.5 million (the “Notes”). In addition, the Company agreed to issue to the Purchasers, and the Purchasers agreed to purchase from the Company, an aggregate of $2.0 million of shares of Series A Preferred Stock, $0.001 par value per share (the “Series A Preferred Stock”), at the second closing. The Company determined that the liability to issue the Series A Preferred Stock (the “Preferred Stock Liability”) at a future date was a freestanding instrument and should be accounted for as a liability. The Company remeasures the Preferred Stock Liability at fair value at each reporting period, with changes being recorded within other (loss) income in the unaudited condensed consolidated statements of operations. During the three month period ending September 30, 2015, the Company recorded other income of $31,000 upon remeasurement of the Preferred Stock Liability. The Notes contained a compound embedded derivative that requires separate accounting from the host debt instrument. The Company elected the fair value option for the Notes as management believes recording the Notes at fair value better reflects the underlying economics of the transaction. The Company remeasures the Notes at fair value at each reporting period, with changes being recorded within other (loss) income in the unaudited condensed consolidated statements of operations. Upon consummation of the Series A Purchase Agreement, the Company allocated the total principal proceeds of $0.5 million between the Preferred Stock Liability and the fair-valued Notes and recorded a loss of $0.5 million in other (loss) income in the unaudited condensed consolidated statements of operations. Pursuant to the terms of the Series A Purchase Agreement, and as approved by the Company’s stockholders at the Company’s 2015 Annual Meeting, the Company issued and sold to the Purchasers $2.0 million in shares of Series A Preferred Stock at the second closing that was held on July 14, 2015 (the “Second Closing”). Secured Convertible Promissory Notes and Related Agreements At the Second Closing, the Notes were automatically converted pursuant to their terms into that number of shares of Series A Preferred Stock equal to the principal amount of the Notes plus all accrued but unpaid interest thereon divided by the purchase price of the Series A Preferred Stock of $1.7003 per share (the “Purchase Price”). Contemporaneously with the execution and delivery of the Series A Purchase Agreement and the issuance of the Notes by the Company to the Purchasers, the Company and the Purchasers entered into a Security Agreement (the “Security Agreement”), dated May 12, 2015, pursuant to which the Company granted to the Purchasers a security interest in substantially all of the Company’s assets, other than the Company’s intellectual property, to secure the Company’s obligations under the Notes. Pursuant to the terms of the Security Agreement, the Company’s intellectual property would have become subject to the security interest granted by the Company to the Purchasers upon repayment of all amounts owed under that certain Loan and Security Agreement by and among the Company, General Electric Capital Corporation (“GECC”) as Agent, the Lenders and the Guarantors dated as of February 10, 2012, as amended (“the “GECC Agreement”) referred as the “Term Loan” (See Note 4). Pursuant to a Subordination and Intercreditor Agreement by and among the Company, the Purchasers and GECC, dated May 12, 2015, entered into contemporaneously with the execution and delivery of the Series A Purchase Agreement, the Company’s payment obligations under the Notes were subordinated to the Company’s payment obligations under the GECC Agreement and the security interest granted by the Company to the Purchasers to secure the Company’s obligations under the Notes was subordinated to the security interest granted by the Company to GECC to secure the Company’s obligations under the GECC Agreement. In connection with the entry into the Series A Purchase Agreement, the Company and GECC amended the GECC Agreement, dated May 12, 2015, to, among other things, permit the Company to enter into the Series A Purchase Agreement and related agreements. Upon the conversion of the Notes into shares of Series A Preferred Stock at the Second Closing, the security interest granted under the Security Agreement was terminated. The Second Closing was subject to the approval of the Company’s stockholders at the 2015 Annual Meeting in July 2015 and the satisfaction or waiver of other closing conditions. The Company’s stockholders approved the issuance of shares of Series A Preferred Stock, shares of Series A Preferred Stock issuable upon conversion of the Notes and common stock issuable upon conversion of Series A Preferred Stock, at the 2015 Annual Meeting held on July 7, 2015. On July 14, 2015, the Company and the Purchasers entered into the First Amendment to the Series A Purchase Agreement (the “First Amendment”) pursuant to which the Company and the Purchasers agreed to extend the period of time following the Company’s 2015 Annual Meeting for the Second Closing to occur until July 14, 2015. At the Second Closing, pursuant to the terms of the Series A Purchase Agreement, the Company issued and sold to the Purchasers 1,176,262 shares of newly designated Series A Preferred Stock of the Company at the Purchase Price of $1.7003 per share for aggregate gross cash proceeds of approximately $2.0 million. In addition, at the Second Closing, the $500,000 in aggregate principal amount of Notes, plus accrued but unpaid interest, that the Company had issued to the Purchasers in the Initial Closing, converted into 298,181 shares of Series A Preferred Stock at the Purchase Price. Following the Second Closing in July 2015, the Company had issued an aggregate of 1,474,443 shares of Series A Preferred Stock, which remain outstanding and held by the Purchasers. The shares of Series A Preferred Stock have the rights, preferences and privileges set forth in the Restated Certificate of Designations to the Company’s Restated Certificate of Incorporation (the “Certificate of Designations”) that was filed by the Company on August 18, 2015 with the Secretary of State of the State of Delaware. The rights, preferences and privileges of the Series A Preferred Stock are as follows: Dividends Holders of Series A Preferred Stock will be entitled to receive, out of funds legally available for the payment of dividends under Delaware law, cumulative dividends that accrue daily at an annual rate of 8%, compounded and payable quarterly in cash or in additional shares of Series A Preferred Stock at the election of each holder. The holders of Series A Preferred Stock will also be entitled to participate in cash dividends and in-kind distributions made on shares of common stock. The Board of Directors has not declared any dividends on common or preferred stock. At September 30, 2015, the cumulative undeclared dividends on preferred stock total $41,000, and are included as a deduction in determining net loss per share attributable to common shareholders. The carrying value of the Series A Preferred Stock was not adjusted for the cumulative undeclared dividends as the Series A Preferred Stock is not probable of becoming redeemable. Voting Rights Holders of Series A Preferred Stock will be entitled to vote with the holders of the common stock on an as-converted basis, except that no holder of Series A Preferred Stock will be entitled to cast votes for the number of shares of common stock issuable upon conversion of the Series A Preferred Stock held by such holder that exceeds (subject to a proportionate adjustment in the event of a stock split, stock dividend, combination or other proportionate recapitalization) the quotient of (A) the aggregate purchase price paid by such holder for its Series A Preferred Stock, divided by (B) the greater of (i) $3.20 and (ii) the closing price of the common stock on the trading day immediately prior to the date its Series A Preferred Stock is issued, which was $1.40. In addition, prior to the conversion of the Series A Preferred Stock, the consent of the holders of at least a majority of the Series A Preferred Stock then outstanding, voting together as a single class, will be required for the Company to take certain actions, including, among other things: liquidating, dissolving or winding up the business and affairs of the Company or effecting any merger, consolidation or other liquidation event; amending, altering or repealing any provision of the Certificate of Incorporation, the Certificate of Designations or the Bylaws of the Company; creating or authorizing any class or series of capital stock ranking senior to or on parity with the Series A Preferred Stock or increasing the number of authorized shares of Series A Preferred Stock; purchasing, redeeming, paying or declaring dividends on any shares of capital stock of the Company, with certain exceptions; increasing or decreasing the size of the Board of Directors of the Company (the “Board”); and certain other actions. Conversion Rights Each share of Series A Preferred Stock is convertible into one share of common stock at any time at the option of each holder and automatically upon the written consent of the holders of a majority of the outstanding shares of Series A Preferred Stock. The conversion price will be subject to adjustment in connection with stock splits, combinations, dividends and other corporate transactions affecting the common stock. All other anti-dilution protections that had been provided to the Series A Preferred Stock upon issuance terminated following the Second Closing. A contingent beneficial conversion feature was recognized during the three months ending September 30, 2015 as a result of the conversion price being adjusted from $1.7003 to $1.00 at the time of the Second Closing. The Company recorded $1.5 million relating to the contingent beneficial conversion as a deemed dividend. The $1.5 million was included within additional paid-in capital in the condensed consolidated financial statements, and reduced the carrying value of the Series A Preferred Stock. Since the Series A Preferred Stock has no stated redemption date and is immediately convertible, the $1.5 million deemed dividend was immediately accreted, resulting in an increase in the carrying value of the Series A Preferred Stock. The deemed dividend was included as a deduction in determining net loss per share attributable to common shareholders. The conversion price adjustment feature expired following the Second Closing. Redemption Rights All redemption rights that had been provided to the Series A Preferred Stock upon issuance terminated following the Second Closing. Ranking The Series A Preferred Stock will rank senior in preference and priority to the Company’s common stock and each other class or series of capital stock of the Company, except for any class or series of capital stock issued in compliance with the terms of the Restated Certificate of Designations. Liquidation Preference Upon liquidation, including deemed liquidations pursuant to a merger, consolidation or a sale of all or substantially all of the Company’s assets, the holders of Series A Preferred Stock will be entitled to be paid first out of any proceeds in an amount per share equal to the price at which shares of Series A Preferred Stock were sold in the Series A Preferred Stock financing, plus all accrued but unpaid dividends on each share of Series A Preferred Stock, and prior to payment of any amounts on the Company’s common stock. Thereafter, the holders of Series A Preferred Stock will also share pro rata on an as converted to common stock basis in payments made to the holders the Company’s common stock. Accordingly, the holders of the Series A Preferred Stock will be entitled to receive the proceeds out of any sale or liquidation of the Company before any such proceeds are paid to holders of the Company’s common stock and then share in any proceeds paid to holders of the Company’s common stock. As a result, only the sale or liquidation proceeds in excess of the liquidation preference plus accrued but unpaid dividends would be available for distribution to holders of the Company’s common stock. The commissions and issuance costs associated with the Series A Preferred Stock financing were deducted from the carrying value of the Series A Preferred Stock, resulting in the carrying value of the Series A Preferred Stock being reduced below its liquidation value. The Company accretes the carrying value of the Series A Preferred Stock over the period from the date of issuance to the earliest redemption date using the effective interest method. During the nine months ending September 30, 2015, the Company recorded one month of accretion, totaling $56,000, at which point the Company ceased accretion as the Series A Preferred stock was not probable of becoming redeemable. Board of Directors Holders of Series A Preferred Stock will be entitled to nominate one director to the Board (the “Series A Director”). Subject to applicable law and stock exchange requirements, the Series A Director will be entitled to serve as a member of each committee of the Board. The rights to nominate a Series A Director will terminate if less than 20% of the shares of Series A Preferred Stock issued under the Securities Purchase Agreement dated May 12, 2015, as amended, by and between the Company and the Series A Holders are no longer outstanding. Registration Rights The Company shall comply with all federal and state laws, rules and regulations and applicable rules and regulations of the Exchange on which shares of the common are then listed. If any shares of common to be reserved for the purpose of conversion of Series A Preferred Stock require registration with or approval of any Person or group (as such term is defined in Section 13(d)(3) of the Exchange Act) under any federal or state law or the rules and regulations of the Exchange on which shares of the common stock are then listed before such shares may be validly issued or delivered upon conversion, then the Company will, as expeditiously as reasonably practicable, use commercially reasonable efforts to secure such registration or approval, as the case may be. So long as any common stock into which the of Series A Preferred Stock are then convertible is then listed on an Exchange, the Company will list and keep listed on any such Exchange, upon official notice of issuance, all shares of such common stock issuable upon conversion. As the holders of the Series A Preferred Stock are entitled to receive liquidation preferences that other equity holders are not entitled to, the Company determined that the preferred stock should be classified as temporary equity in the condensed consolidated financial statements. The Company reviews the rights and preferences of its equity securities for any changes in terms, rights or preferences to determine if such change is a modification or an extinguishment. The Company evaluates amendments to equity securities using a qualitative method which considers the business purpose for the amendment and whether it adds, deletes or significantly changes a substantive contractual term or the nature of the equity securities. An amendment that changes a substantive contractual term or fundamentally changes the nature of the share of preferred stock is considered an extinguishment. If considered an extinguishment, the Company accounts for the removal of the carrying value of the old securities and recognizes the new securities at their current fair value. An amendment that does not meet these criteria is a modification. If considered a modification, the Company estimates the fair value of the equity security pre- and post- modification and recognizes the incremental fair value, if any, resulting from the modified terms. During the nine months ending September 30, 2015, the Company determined that all changes to the terms of the Series A Preferred Stock resulting from amendments made to the Certificates of Designations were not substantive and should be accounted for as a modification. The amendments did not result in a material change to the fair value of the Series A Preferred Stock. |
Significant Accounting Polici13
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2015 | |
Product Revenues | Product Revenues Product revenues are recognized when the following criteria have been met: (i) persuasive evidence of an arrangement exists; (ii) delivery has occurred and risk of loss has passed; (iii) the seller’s price to the buyer is fixed or determinable; and (iv) collectability is reasonably assured. The Company sells its products through supply agreements with laboratory testing services and diagnostic testing distributors and directly to hospitals and clinics. The Company recognizes revenue when products are received by customers, at which time both title and risk of loss have passed to the customers. The Company negotiates credit terms on a customer-by-customer basis and products are shipped at an agreed-upon price. Revenue is recorded net of taxes collected from customers that are remitted to governmental authorities, with the collected taxes recorded as current liabilities until remitted to the relevant government authority. Freight costs billed to customers are recorded as revenue. In the past the Company did not provide an allowance for doubtful accounts or a reserve for sales returns as the Company has not experienced any credit losses, and returns are only allowed for defects in workmanship. On June 7, 2015, Health Diagnostic Laboratory, Inc. (“HDL”), which is the Company’s largest customer of its BGM Galectin-3 ® Product Fee Revenues The Company recognizes product fee revenue when it receives quarterly test sales reporting and payments thereunder from its partners. The Company has entered into worldwide license, development and commercialization agreements with Abbott Laboratories, (“Abbott”), bioMérieux SA, (“bioMérieux”), Siemens Healthcare Diagnostics Inc., (“Siemens”), and Alere Inc., (“Alere”). As consideration for the rights and licenses granted by the Company to its partners, the licensees pay to the Company a product fee, as set forth in the respective agreements, for tests sold to third parties. To date, only Abbott and bioMérieux have paid product fees to the Company. Product Fee Reclassification Beginning in the third quarter of 2015, the Company began disclosing product fee revenue separately from product revenue. To maintain comparability, all previously reported product revenue figures in the accompanying unaudited condensed consolidated financial statements have been retroactively adjusted to break out the product fee revenue recognized during those periods. Management evaluated the amount and nature of the change and concluded that it was not material to either the previously reported annual or quarterly financial statement results of operations. Nonetheless, the Company has reclassified the historical statement of operations amounts included in this filing as follows (in thousands): As reported Three months ended September 30, 2014 As reclassified Three months ended September 30, 2014 As reported Nine months ended September 30, 2014 As reclassified Nine months ended September 30, 2014 Product Revenues $ 695 $ 669 $ 2,233 $ 2,158 Product Fee Revenues — 26 — 75 Total Revenues $ 695 $ 695 $ 2,233 $ 2,233 |
Inventory | Inventory Inventory is stated at the lower of cost or market. Costs are determined under the first-in, first-out (FIFO) method. Inventories consisted of the following: (in thousands) September 30, 2015 December 31, 2014 Raw materials $ 45 $ 64 Finished goods 178 336 Total inventories $ 223 $ 400 |
Net Loss Per Share Attributable to Common Shareholders | Net Loss Per Share Attributable to Common Shareholders Basic and diluted net loss per share attributable to common shareholders is computed by dividing net loss attributable to common shareholders by the weighted average number of common shares outstanding for the period. The Company applied the two-class method to calculate its basic and diluted net loss per share of common stock, as its convertible preferred stock, common stock, and warrants to purchase common stock are participating securities. The two-class method is an earnings allocation formula that treats a participating security as having rights to earnings that otherwise would have been available to common shareholders. However, the two-class method does not impact the net loss per share of common stock as the Company was in a loss position for each of the periods presented, and neither preferred shareholders nor warrant holders participate in losses. The following table summarizes the computation of basic and diluted net loss per share for the three and nine months ended September 30, 2015 and 2014: Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 (in thousands, except share and per share data) Net loss $ (1,023 ) $ (2,397 ) $ (4,401 ) $ (6,744 ) Preferred stock dividend (41 ) — (41 ) — Deemed dividend on beneficial conversion feature (1,507 ) — (1,507 ) — Accretion of convertible preferred stock to liquidation value (56 ) — (56 ) — Net loss attributable to common shareholders $ (2,627 ) $ (2,397 ) $ (6,005 ) $ (6,744 ) Weighted average number of shares - basic and diluted 9,862,802 8,604,312 9,057,960 8,028,373 Net loss per share attributable to common shareholders - basic and diluted $ (0.27 ) $ (0.28 ) $ (0.66 ) $ (0.84 ) As of September 30, 2015 and 2014, the following potential common shares were excluded from the computation of diluted net loss per share because they had an antidilutive impact due to the losses reported: September 30, 2015 2014 Options to purchase common stock 699,513 644,789 Warrants to purchase common stock 1,536,929 216,156 |
Significant Accounting Polici14
Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Summary of Reclassified Amounts of Historical Statement of Operations | Nonetheless, the Company has reclassified the historical statement of operations amounts included in this filing as follows (in thousands): As reported Three months ended September 30, 2014 As reclassified Three months ended September 30, 2014 As reported Nine months ended September 30, 2014 As reclassified Nine months ended September 30, 2014 Product Revenues $ 695 $ 669 $ 2,233 $ 2,158 Product Fee Revenues — 26 — 75 Total Revenues $ 695 $ 695 $ 2,233 $ 2,233 |
Summary of Inventories | Inventory Inventory is stated at the lower of cost or market. Costs are determined under the first-in, first-out (FIFO) method. Inventories consisted of the following: (in thousands) September 30, 2015 December 31, 2014 Raw materials $ 45 $ 64 Finished goods 178 336 Total inventories $ 223 $ 400 |
Summary of Computation of Basic and Diluted Net Loss per Share | The following table summarizes the computation of basic and diluted net loss per share for the three and nine months ended September 30, 2015 and 2014: Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 (in thousands, except share and per share data) Net loss $ (1,023 ) $ (2,397 ) $ (4,401 ) $ (6,744 ) Preferred stock dividend (41 ) — (41 ) — Deemed dividend on beneficial conversion feature (1,507 ) — (1,507 ) — Accretion of convertible preferred stock to liquidation value (56 ) — (56 ) — Net loss attributable to common shareholders $ (2,627 ) $ (2,397 ) $ (6,005 ) $ (6,744 ) Weighted average number of shares - basic and diluted 9,862,802 8,604,312 9,057,960 8,028,373 Net loss per share attributable to common shareholders - basic and diluted $ (0.27 ) $ (0.28 ) $ (0.66 ) $ (0.84 ) |
Common Shares Excluded from Computation of Diluted Net Loss per Share | As of September 30, 2015 and 2014, the following potential common shares were excluded from the computation of diluted net loss per share because they had an antidilutive impact due to the losses reported: September 30, 2015 2014 Options to purchase common stock 699,513 644,789 Warrants to purchase common stock 1,536,929 216,156 |
Fair Value of Financial Instr15
Fair Value of Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Convertible Debt Instrument | |
Summary of Changes in Fair Value of Company' Level 3 Liability | The table below sets forth a summary of changes in the fair value of the Company’s secured convertible notes for the three and nine months ended September 30, 2015: Three Months Ended Nine Months Ended (in thousands) Beginning balance $ 929 $ — Proceeds from secured convertible note — 500 Loss on fair value adjustment 58 487 Conversion of secured convertible notes (987 ) (987 ) Ending balance $ — $ — |
Preferred Stock Liability | |
Summary of Changes in Fair Value of Company' Level 3 Liability | The table below sets forth a summary of changes in the fair value of the Company’s level 3 liability (preferred stock liability) for the three and nine months ending September 30, 2015: Three Months Ended Nine Months Ended (in thousands) Beginning balance $ 31 $ — Loss on recognition of preferred stock liability — 79 Gain on revaluation of preferred stock liability (31 ) (79 ) Ending balance $ — $ — |
Description of Business and B16
Description of Business and Basis of Presentation - Additional Information (Detail) | Aug. 18, 2015USD ($)shares$ / shares | Jul. 08, 2015shares | Jun. 30, 2015USD ($) | Sep. 30, 2015USD ($)$ / shares | Sep. 30, 2014USD ($) | Dec. 31, 2014USD ($)$ / shares | Sep. 30, 2015USD ($)$ / shares$ / Patient | Sep. 30, 2014USD ($) | Dec. 31, 2014USD ($)$ / shares$ / Patient | Dec. 31, 2013USD ($)$ / Patient | Sep. 30, 2015USD ($)Employee$ / shares | Jul. 14, 2015$ / shares | May. 12, 2015USD ($)$ / shares |
Description Of Business Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Reverse stock split | On July 8, 2015, the Company effected a 1-for-4 reverse stock split of its common stock. All previously reported common stock share amounts in the accompanying financial statements and related notes have been retroactively adjusted to reflect the reverse stock split. | ||||||||||||
Common stock splits ratio | shares | 0.25 | ||||||||||||
Cash | $ 2,642,000 | $ 6,313,000 | $ 4,123,000 | $ 2,642,000 | $ 6,313,000 | $ 4,123,000 | $ 7,751,000 | $ 2,642,000 | |||||
Loan facility | 2,960,000 | 2,960,000 | |||||||||||
Stockholders' deficit | (1,274,000) | $ 557,000 | (1,274,000) | 557,000 | $ (1,274,000) | ||||||||
Net loss | (1,023,000) | $ (2,397,000) | (4,401,000) | (6,744,000) | |||||||||
Net cash flows used in operating activities | (2,550,000) | (7,097,000) | |||||||||||
Cash for payments on term loan facility | 2,984,000 | 3,360,000 | |||||||||||
Reduction in workforce, percentage | 77.00% | ||||||||||||
Number of employees eliminated | Employee | 17 | ||||||||||||
Number of employees remaining after restructuring activities | Employee | 5 | ||||||||||||
Severance payments and benefits continuation | 98,000 | $ 404,000 | |||||||||||
Savings in employee salaries and benefits | 2,400,000 | 2,400,000 | $ 2,400,000 | ||||||||||
Preferred stock issued, value | $ 2,594,000 | $ 2,594,000 | $ 2,594,000 | ||||||||||
Preferred stock, par value | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||
Sublease expiration date | Dec. 31, 2018 | ||||||||||||
Short term rental basis, expected annualized savings | $ 240,000 | ||||||||||||
Exercise price of warrants | $ / shares | $ 1 | ||||||||||||
Proceeds from public offering | $ 2,000,000 | $ 2,500,000 | $ 9,238,000 | ||||||||||
Percentage of common shares outstanding owned | 9.99% | ||||||||||||
Series A | |||||||||||||
Description Of Business Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Preferred stock issued, value | $ 2,000,000 | 2,000,000 | $ 2,000,000 | $ 2,000,000 | |||||||||
Preferred stock sold, value | $ 2,000,000 | $ 2,000,000 | $ 2,000,000 | $ 2,000,000 | |||||||||
Preferred stock, par value | $ / shares | $ 1.7003 | $ 0.001 | |||||||||||
Purchase price | $ / shares | $ 1.40 | $ 1.40 | $ 1.40 | ||||||||||
Series A Units | |||||||||||||
Description Of Business Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Shares of common stock under public offering | shares | 2,315,654 | ||||||||||||
Purchase price | $ / shares | $ 1 | ||||||||||||
Series B Units | |||||||||||||
Description Of Business Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Shares of common stock under public offering | shares | 184,346 | ||||||||||||
Purchase price | $ / shares | $ 1 | ||||||||||||
Total costs and operating expenses | |||||||||||||
Description Of Business Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Sublease rental charges | $ 153,000 | ||||||||||||
Research and development | |||||||||||||
Description Of Business Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Severance payments and benefits continuation | $ 41,000 | $ 128,000 | |||||||||||
Selling and marketing | |||||||||||||
Description Of Business Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Severance payments and benefits continuation | 57,000 | 114,000 | |||||||||||
General and administrative | |||||||||||||
Description Of Business Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Severance payments and benefits continuation | $ 162,000 | ||||||||||||
Employee Severance | |||||||||||||
Description Of Business Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Payment for severance payments and benefits continuation | $ 277,000 | 225,000 | |||||||||||
Common Stock | Series A Units | |||||||||||||
Description Of Business Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Proportion of each unit of shares | shares | 1 | ||||||||||||
Common Stock | Series B Units | |||||||||||||
Description Of Business Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Proportion of each unit of shares | shares | 1 | ||||||||||||
Warrants to purchase common stock | Series A Units | |||||||||||||
Description Of Business Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Proportion of each unit of shares | shares | 0.5 | ||||||||||||
Warrants to purchase common stock | Series B Units | |||||||||||||
Description Of Business Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Proportion of each unit of shares | shares | 0.5 | ||||||||||||
Secured convertible promissory notes | |||||||||||||
Description Of Business Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Principal amount of secured convertible promissory notes issued and sold | $ 500,000 | ||||||||||||
Term loans | |||||||||||||
Description Of Business Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Loan facility | $ 0 | $ 0 | $ 0 | ||||||||||
Loan facility, maturity date | Jul. 14, 2015 | ||||||||||||
Centers for Medicare And Medicaid Services | |||||||||||||
Description Of Business Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Reimbursed price per test | $ / Patient | 29.93 | 30.01 | 17.80 | ||||||||||
Centers for Medicare And Medicaid Services | Ohio | |||||||||||||
Description Of Business Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Reimbursed price per test | $ / Patient | 23.93 | ||||||||||||
Centers for Medicare And Medicaid Services | WEST VIRGINIA | |||||||||||||
Description Of Business Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Reimbursed price per test | $ / Patient | 26.33 |
Significant Accounting Polici17
Significant Accounting Policies - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended |
Jun. 30, 2015 | Sep. 30, 2015 | |
Significant Accounting Policies [Line Items] | ||
Provision for doubtful accounts | $ 151,000 | $ 151,000 |
Summary of Reclassified Amounts
Summary of Reclassified Amounts of Historical Statement of Operations (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||
Product revenues | $ 274 | $ 669 | $ 1,160 | $ 2,158 |
Product fee revenues | 60 | 26 | 116 | 75 |
Total revenues | $ 334 | 695 | $ 1,276 | 2,233 |
Scenario, Previously Reported | ||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||
Product revenues | 695 | 2,233 | ||
Total revenues | $ 695 | $ 2,233 |
Summary of Inventories (Detail)
Summary of Inventories (Detail) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Inventory [Line Items] | ||
Raw materials | $ 45 | $ 64 |
Finished goods | 178 | 336 |
Total inventories | $ 223 | $ 400 |
Summary of Computation of Basic
Summary of Computation of Basic and Diluted Net Loss Per Share (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Schedule Of Computation Of Basic And Diluted Earnings Per Common Share [Line Items] | ||||
Net loss | $ (1,023) | $ (2,397) | $ (4,401) | $ (6,744) |
Preferred stock dividend | (41) | (41) | ||
Deemed dividend on beneficial conversion feature | (1,507) | (1,507) | ||
Accretion of convertible preferred stock to liquidation value | (56) | (56) | ||
Net loss attributable to common shareholders | $ (2,627) | $ (2,397) | $ (6,005) | $ (6,744) |
Weighted average number of shares - basic and diluted | 9,862,802 | 8,604,312 | 9,057,960 | 8,028,373 |
Net loss per share attributable to common shareholders - basic and diluted | $ (0.27) | $ (0.28) | $ (0.66) | $ (0.84) |
Common Shares Excluded From Com
Common Shares Excluded From Computation of Diluted Net Loss Per Share (Detail) - shares | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 699,513 | 644,789 |
Warrants to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 1,536,929 | 216,156 |
Summary of Changes in Fair Valu
Summary of Changes in Fair Value of Company's Level 3 Liability (Detail) - Preferred Stock Liability - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2015 | Sep. 30, 2015 | |
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] | ||
Beginning balance | $ 31 | |
Loss on recognition of preferred stock liability | $ 79 | |
Gain on revaluation of preferred stock liability | $ (31) | $ (79) |
Summary of Changes in the Fair
Summary of Changes in the Fair Value of Company's Secured Convertible Notes (Detail) - Convertible Debt Instrument - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2015 | Sep. 30, 2015 | |
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] | ||
Beginning balance | $ 929 | |
Proceeds from secured convertible note | $ 500 | |
Loss on fair value adjustment | 58 | 487 |
Conversion of secured convertible promissory notes | $ (987) | $ (987) |
Fair Value of Financial Instr24
Fair Value of Financial Instruments - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Jul. 14, 2015 | May. 12, 2015 | Jun. 30, 2015 |
Preferred Stock Liability | |||
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] | |||
Preferred stock liability, fair value | $ 0 | $ 79 | $ 31 |
Underlying security price | $ 2.12 | $ 2 | |
Conversion price per share | $ 2.68 | $ 2.68 | |
Risk-free interest rate | 0.02% | 0.03% | |
Expected dividend yield | 0.00% | 0.00% | |
Expected stock price volatility | 73.80% | 73.80% | |
Expected term | 0 years | 2 months 19 days | 29 days |
Convertible Debt Instrument | |||
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] | |||
Preferred stock liability, fair value | $ 929 | ||
Conversion price per share | $ 3.33 | $ 2.68 | |
Discount rate | 18.00% | 18.00% | |
Convertible Debt Instrument | Current Common Stock Price | |||
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] | |||
Expected stock price volatility | 56.20% | 51.00% | |
Stock price per share | $ 1.54 | $ 2.36 | |
Convertible Debt Instrument | Future Common Stock Price | |||
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] | |||
Expected stock price volatility | 55.00% | ||
Stock price per share | $ 2.14 |
Term Loan - Additional Informat
Term Loan - Additional Information (Detail) | Feb. 10, 2012USD ($) |
Term loans | |
Debt Instrument [Line Items] | |
Loan facility amount borrowed | $ 10,000,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | Sep. 30, 2015USD ($) |
Commitments and Contingencies [Line Items] | |
Accrued other contingencies | $ 0 |
Follow-on Public Offerings - Ad
Follow-on Public Offerings - Additional Information (Detail) $ / shares in Units, $ in Thousands | Aug. 18, 2015USD ($)shares$ / shares | Apr. 08, 2014USD ($)$ / sharesshares | Sep. 30, 2015USD ($) | Sep. 30, 2014USD ($) |
Equity [Line Items] | ||||
Gross proceeds offering | $ | $ 2,000 | $ 2,500 | $ 9,238 | |
Exercise price of warrants | $ / shares | $ 1 | |||
Percentage of common shares outstanding owned | 9.99% | |||
Series A Units | ||||
Equity [Line Items] | ||||
Shares of common stock under public offering | 2,315,654 | |||
Purchase price | $ / shares | $ 1 | |||
Series A Units | Common Stock | ||||
Equity [Line Items] | ||||
Proportion of each unit of shares | 1 | |||
Series A Units | Warrants to purchase common stock | ||||
Equity [Line Items] | ||||
Proportion of each unit of shares | 0.5 | |||
Series B Units | ||||
Equity [Line Items] | ||||
Shares of common stock under public offering | 184,346 | |||
Purchase price | $ / shares | $ 1 | |||
Series B Units | Common Stock | ||||
Equity [Line Items] | ||||
Proportion of each unit of shares | 1 | |||
Series B Units | Warrants to purchase common stock | ||||
Equity [Line Items] | ||||
Proportion of each unit of shares | 0.5 | |||
Underwritten Public Offering | ||||
Equity [Line Items] | ||||
Shares of common stock under public offering | 1,613,000 | |||
Common stock offering price | $ / shares | $ 6.20 | |||
Gross proceeds offering | $ | $ 10,000 | |||
Offering proceeds net of underwriting discounts, commissions and expenses | $ | $ 9,000 |
Convertible Promissory Notes 28
Convertible Promissory Notes and Series A Preferred Stock - Additional Information (Detail) - USD ($) | Jul. 14, 2015 | Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | Jul. 31, 2015 | May. 12, 2015 | Dec. 31, 2014 |
Debt Conversion [Line Items] | ||||||||
Preferred stock issues and sold, purchase price | $ 0.001 | $ 0.001 | $ 0.001 | |||||
Other income recorded upon remeasurement of preferred stock liability | $ 31,000 | |||||||
Other (loss) income | 7,000 | $ 1,000 | $ (514,000) | $ 2,000 | ||||
Preferred stock issued, value | $ 2,594,000 | $ 2,594,000 | ||||||
Preferred stock, shares issued | 1,474,443 | 1,474,443 | 0 | |||||
Aggregate gross cash proceeds from issuance of preferred shares | $ 2,000,000 | |||||||
Debt amount converted in to preferred shares | 987,000 | |||||||
Deemed dividend on beneficial conversion feature | $ 1,507,000 | 1,507,000 | ||||||
Additional paid in capital, preferred stock | 1,500,000 | 1,500,000 | ||||||
Accretion of convertible preferred stock to liquidation value | 56,000 | 56,000 | ||||||
Secured convertible promissory notes | ||||||||
Debt Conversion [Line Items] | ||||||||
Principal amount of secured convertible promissory notes issued and sold | $ 500,000 | |||||||
Aggregate principal amount of Notes, plus accrued unpaid interest | ||||||||
Debt Conversion [Line Items] | ||||||||
Debt amount converted in to preferred shares | $ 500,000 | |||||||
Series A | ||||||||
Debt Conversion [Line Items] | ||||||||
Preferred stock approved to issue | $ 2,000,000 | |||||||
Preferred stock issues and sold, purchase price | $ 1.7003 | $ 0.001 | ||||||
Preferred stock issued, value | 2,000,000 | 2,000,000 | $ 2,000,000 | |||||
Preferred stock sold, value | $ 2,000,000 | $ 2,000,000 | $ 2,000,000 | |||||
Preferred stock, shares issued | 1,176,262 | 1,474,443 | ||||||
Preferred stock, shares sold | 1,176,262 | |||||||
Aggregate gross cash proceeds from issuance of preferred shares | $ 2,000,000 | |||||||
Number of preferred shares issued upon debt conversion | 298,181 | |||||||
Preferred stock, voting rights | Holders of Series A Preferred Stock will be entitled to vote with the holders of the common stock on an as-converted basis, except that no holder of Series A Preferred Stock will be entitled to cast votes for the number of shares of common stock issuable upon conversion of the Series A Preferred Stock held by such holder that exceeds (subject to a proportionate adjustment in the event of a stock split, stock dividend, combination or other proportionate recapitalization) the quotient of (A) the aggregate purchase price paid by such holder for its Series A Preferred Stock, divided by (B) the greater of (i) $3.20 and (ii) the closing price of the common stock on the trading day immediately prior to the date its Series A Preferred Stock is issued, which was $1.40. In addition, prior to the conversion of the Series A Preferred Stock, the consent of the holders of at least a majority of the Series A Preferred Stock then outstanding, voting together as a single class, will be required for the Company to take certain actions, including, among other things: liquidating, dissolving or winding up the business and affairs of the Company or effecting any merger, consolidation or other liquidation event; amending, altering or repealing any provision of the Certificate of Incorporation, the Certificate of Designations or the Bylaws of the Company; creating or authorizing any class or series of capital stock ranking senior to or on parity with the Series A Preferred Stock or increasing the number of authorized shares of Series A Preferred Stock; purchasing, redeeming, paying or declaring dividends on any shares of capital stock of the Company, with certain exceptions; increasing or decreasing the size of the Board of Directors of the Company (the “Board”); and certain other actions. | |||||||
Convertible preferred stock voting rights threshold | $ 3.20 | $ 3.20 | ||||||
Purchase price | 1.40 | $ 1.40 | ||||||
Convertible preferred stock, terms of conversion | Each share of Series A Preferred Stock is convertible into one share of common stock at any time at the option of each holder and automatically upon the written consent of the holders of a majority of the outstanding shares of Series A Preferred Stock. The conversion price will be subject to adjustment in connection with stock splits, combinations, dividends and other corporate transactions affecting the common stock. | |||||||
Series A | Minimum | ||||||||
Debt Conversion [Line Items] | ||||||||
Rights to nominate director will terminate if share of preferred stock fall bellow the threshold | 20.00% | |||||||
Series A | Adjustment | ||||||||
Debt Conversion [Line Items] | ||||||||
Preferred stock issues and sold, purchase price | $ 1 | $ 1 | ||||||
Cumulative Preferred Stock | ||||||||
Debt Conversion [Line Items] | ||||||||
Preferred stock, annual dividend rate, percentage | 8.00% | |||||||
Undeclared dividends | $ 41,000 |