Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Mar. 25, 2020 | Jun. 28, 2019 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | TITAN PHARMACEUTICALS INC | ||
Entity Central Index Key | 0000910267 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Trading Symbol | TTNP | ||
Entity Public Float | $ 17.3 | ||
Entity Common Stock, Shares Outstanding | 93,467,258 | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Small Business | true |
BALANCE SHEETS
BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 5,223 | $ 9,295 |
Restricted cash | 0 | 361 |
Receivables | 993 | 1,737 |
Inventory | 998 | 1,262 |
Contract assets | 0 | 99 |
Prepaid expenses and other current assets | 1,094 | 547 |
Total current assets | 8,308 | 13,301 |
Property and equipment, net | 817 | 794 |
Operating lease right-of-use asset | 397 | 0 |
Total assets | 9,522 | 14,095 |
Current liabilities: | ||
Accounts payable | 1,401 | 1,526 |
Accrued clinical trials expenses | 309 | 620 |
Accrued sales allowances | 809 | 0 |
Other accrued liabilities | 809 | 466 |
Operating lease liability, current | 272 | 0 |
Deferred revenue | 0 | 313 |
Current portion of long-term debt, net of debt discount of $0 and $123 | 0 | 527 |
Total current liabilities | 3,600 | 3,452 |
Long-term debt, net of debt discount of $346 and $543 | 4,019 | 3,787 |
Warrant liability | 320 | 0 |
Derivative liability | 0 | 25 |
Operating lease liability, non-current | 150 | 0 |
Total liabilities | 8,089 | 7,264 |
Commitments and contingencies (Note 5) | ||
Stockholders' (deficit) equity: | ||
Preferred stock, $0.001 par value per share; 5,000,000 shares authorized, none issued and outstanding at December 31, 2019 and 2018. | 0 | 0 |
Common stock, at amounts paid-in, $0.001 par value per share; 125,000,000 shares authorized 57,378,794 and 13,010,292 shares issued and outstanding at December 31, 2019 and 2018, respectively. | 57 | 13 |
Additional paid-in capital | 350,413 | 339,397 |
Accumulated deficit | (349,037) | (332,579) |
Total stockholders' equity | 1,433 | 6,831 |
Total liabilities and stockholders' equity | $ 9,522 | $ 14,095 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
BALANCE SHEETS | ||
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred Stock, Shares Authorized | 5,000,000 | 5,000,000 |
Preferred Stock, Shares Issued | 0 | 0 |
Preferred Stock, Shares Outstanding | 0 | 0 |
Common Stock, Shares Authorized | 125,000,000 | 125,000,000 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock shares, issued | 57,378,794 | 13,010,292 |
Common Stock shares, Outstanding | 57,378,794 | 13,010,292 |
Debt Instrument, Unamortized Discount, Current | $ 0 | $ 123 |
Debt Instrument, Unamortized Discount, Noncurrent | $ 346 | $ 543 |
STATEMENTS OF OPERATIONS AND CO
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS shares in Thousands, $ in Thousands, € in Millions | 12 Months Ended | |
Dec. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2018USD ($)$ / sharesshares | |
Revenues: | ||
Total revenues | $ 3,611 | $ 6,618 |
Operating expenses: | ||
Cost of goods sold | 1,288 | 538 |
Research and development | 7,242 | 7,478 |
Selling, general and administrative | 11,925 | 6,866 |
Total operating expenses | 20,455 | 14,882 |
Loss from operations | (16,844) | (8,264) |
Other income (expense): | ||
Interest income (expense), net | (967) | (887) |
Other expense, net | 17 | 128 |
Non-cash gain on changes in the fair value of warrants | 1,110 | 0 |
Non-cash gain on debt extinguishment | 226 | 0 |
Other income (expense), net | 386 | (759) |
Net loss and comprehensive loss | (16,458) | (9,023) |
Deemed dividend on trigger of down round provision | 0 | (285) |
Net loss applicable to common stockholders | $ (16,458) | $ (9,308) |
Basic net loss per share | $ / shares | $ (0.72) | $ (1.64) |
Diluted net loss per share | $ / shares | $ (0.72) | $ (1.66) |
Weighted average shares used in computing basic net loss per common share | shares | 22,957 | 5,688 |
Weighted average shares used in computing diluted net loss per common share | shares | 22,957 | 5,688 |
License revenue | ||
Revenues: | ||
Total revenues | $ 315 | $ 5,376 |
Product revenue | ||
Revenues: | ||
Total revenues | 1,006 | 535 |
Grant revenue | ||
Revenues: | ||
Total revenues | $ 2,290 | $ 707 |
STATEMENTS OF STOCKHOLDERS' EQU
STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) shares in Thousands, $ in Thousands | Preferred Stock [Member] | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2017 | $ 0 | $ 4 | $ 324,124 | $ (323,271) | $ 857 |
Balance (in shares) at Dec. 31, 2017 | 0 | 3,534 | |||
Net loss | $ 0 | $ 0 | 0 | (9,023) | (9,023) |
Issuance of warrants to purchase common stock, net | 0 | 0 | 527 | 0 | 527 |
Issuance of common stock, net | 0 | $ 2 | 2,435 | 0 | 2,437 |
Issuance of common stock, net (in shares) | 1,815 | ||||
Issuance of preferred stock, net | $ 0 | $ 0 | 7,214 | 0 | 7,214 |
Issuance of preferred stock, net (in shares) | 8 | ||||
Issuance of common stock upon conversion of preferred stock, net | $ 0 | $ 5 | (11) | 0 | (6) |
Issuance of common stock upon conversion of preferred stock, net (in shares) | (8) | 5,483 | |||
Issuance of common stock upon exercise of warrants, net | $ 0 | $ 2 | 3,266 | 0 | 3,268 |
Issuance of common stock upon exercise of warrants, net (in shares) | 0 | 2,178 | |||
Stock-based compensation | $ 0 | $ 0 | 1,557 | 0 | 1,557 |
Deemed dividend resulting from down round provision | 0 | 0 | 285 | (285) | 0 |
Balance at Dec. 31, 2018 | $ 0 | $ 13 | 339,397 | (332,579) | 6,831 |
Balance (in shares) at Dec. 31, 2018 | 0 | 13,010 | |||
Net loss | $ 0 | $ 0 | 0 | (16,458) | (16,458) |
Issuance of common stock upon conversion of convertible dept | $ 0 | $ 1 | 649 | 0 | 650 |
Issuance of common stock upon conversion of convertible dept, (in shares) | 0 | 448 | |||
Issuance of common stock, net | $ 0 | $ 37 | 8,200 | 0 | 8,237 |
Issuance of common stock, net (in shares) | 0 | 37,696 | |||
Issuance of common stock upon exercise of warrants, net | $ 0 | $ 6 | 1,595 | 0 | 1,601 |
Issuance of common stock upon exercise of warrants, net (in shares) | 0 | 6,225 | |||
Stock-based compensation | $ 0 | $ 0 | 572 | 0 | 572 |
Balance at Dec. 31, 2019 | $ 0 | $ 57 | $ 350,413 | $ (349,037) | $ 1,433 |
Balance (in shares) at Dec. 31, 2019 | 0 | 57,379 |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Cash flows from operating activities: | ||
Net loss | $ (16,458) | $ (9,023) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Non-cash gain on inventory received from termination of license agreement | 0 | (1,293) |
Depreciation and amortization | 244 | 380 |
Non-cash interest expense | 613 | 490 |
Non-cash gain on changes in the fair value of warrants | (1,110) | 0 |
Non-cash gain on debt extinguishment | (226) | 0 |
Stock-based compensation | 572 | 1,557 |
Other | (41) | (134) |
Changes in operating assets and liabilities: | ||
Receivables | 744 | (1,672) |
Inventory | 264 | 31 |
Contract assets | 99 | 120 |
Prepaid expenses and other assets | (547) | (185) |
Accounts payable | (125) | 542 |
Accrued sales allowances | 809 | 0 |
Other accrued liabilities | 30 | 443 |
Deferred revenue | (313) | 313 |
Net cash used in operating activities | (15,445) | (8,431) |
Cash flows from investing activities: | ||
Purchases of furniture and equipment | (256) | (416) |
Net cash used in investing activities | (256) | (416) |
Cash flows from financing activities: | ||
Proceeds from equity offerings | 9,665 | 9,651 |
Issuance of warrants | 0 | 51 |
Proceeds from the exercise of warrants | 1,603 | 3,268 |
Proceeds from the issuance of debt | 0 | 650 |
Payments of long-term debt | 0 | (3,000) |
Net cash provided by financing activities | 11,268 | 10,620 |
Net increase (decrease) in cash | (4,433) | 1,773 |
Cash, cash equivalents and restricted cash at beginning of period | 9,656 | 7,883 |
Cash, cash equivalents and restricted cash at end of period | 5,223 | 9,656 |
Supplemental disclosure of cash flow information | ||
Interest paid | 432 | 471 |
Warrants issued | 0 | 6,348 |
Derivatives issued | 0 | 159 |
Deemed dividend on trigger of down round provision | 0 | 285 |
Purchases of property and equipment in accounts payable or accrued expenses | 11 | 163 |
Schedule of non-cash transactions | ||
Cash and cash equivalents | 5,223 | 9,295 |
Restricted cash | 0 | 361 |
Cash, cash equivalents and restricted cash shown in the statement of cash flows | $ 5,223 | $ 9,656 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Organization and Summary of Significant Accounting Policies | |
Organization and Summary of Significant Policies | 1. Organization and Summary of Significant Accounting Policies The Company We are a pharmaceutical company developing therapeutics utilizing our proprietary long-term drug delivery platform, ProNeura, for the treatment of select chronic diseases for which steady state delivery of a drug provides an efficacy and/or safety benefit. We have been transitioning to a commercial stage enterprise following the reacquisition of Probuphine® (buprenorphine) implant, or Probuphine, on May 25, 2018 from our former licensee. Probuphine is the first product based on our ProNeura technology approved in the U.S., Canada and the European Union, or EU, for the maintenance treatment of opioid use disorder, or OUD, in select patients. We operate in only one business segment, the development and commercialization of pharmaceutical products. In January 2019, pursuant to prior stockholder authorization, our board of directors (the “Board”) effected a reverse split of the outstanding shares of our common stock at a ratio of one share for every six shares then outstanding (the “Reverse Split”). Pursuant to their respective terms, the number of shares underlying our outstanding options and warrants was reduced and their respective exercise prices increased by the Reverse Split ratio. The number of shares of common stock authorized and the par value of $0.001 per share did not change as a result of the Reverse Split. All share and per share amounts contained in this Annual Report on Form 10-K give retroactive effect to the Reverse Split. The accompanying financial statements have been prepared assuming we will continue as a going concern. At December 31, 2019, we had cash and cash equivalents of approximately $5.2 million, which we believe, together with the net cash proceeds of approximately $8.0 million received from the registered direct offering of our common stock in January 2020 and exercises of outstanding warrants to purchase shares of our common stock in the first quarter of 2020, are sufficient to fund our planned operations into the fourth quarter of 2020. We will require additional funds to finance our operations. We are exploring several financing alternatives; however, there can be no assurance that our efforts to obtain the funding required to continue our operations will be successful. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. Going concern assessment We assess going concern uncertainty in our financial statements to determine if we have sufficient cash on hand and working capital, including available borrowings on loans, to operate for a period of at least one year from the date the financial statements are issued or available to be issued, which is referred to as the “look-forward period” as defined by Accounting Standard Update ASU No. 2014-15. As part of this assessment, based on conditions that are known and reasonably knowable to us, we will consider various scenarios, forecasts, projections, estimates and will make certain key assumptions, including the timing and nature of projected cash expenditures or programs, and its ability to delay or curtail expenditures or programs, if necessary, among other factors. Based on this assessment, as necessary or applicable, we make certain assumptions around implementing curtailments or delays in the nature and timing of programs and expenditures to the extent we deem probable those implementations can be achieved and we have the proper authority to execute them within the look-forward period in accordance with ASU No. 2014-15. Based upon the above assessment, we concluded that, at the date of filing the financial statements in this Annual Report on Form 10-K for the year ended December 31, 2019, we did not have sufficient cash to fund our operations for the next 12 months without additional funds and, therefore, there was substantial doubt about our ability to continue as a going concern within 12 months after the date the financial statements were issued. Additionally, we have suffered recurring losses from operations and have an accumulated deficit that raises substantial doubt about our ability to continue as a going concern. Inventories Inventories are recorded at the lower of cost or net realizable value. Cost is based on the first in, first out method. We regularly review inventory quantities on hand and write down to its net realizable value any inventory that we believe to be impaired. The determination of net realizable value requires judgment including consideration of many factors, such as estimates of future product demand, product net selling prices, current and future market conditions and potential product obsolescence, among others. The components of inventories are as follows: As of December 31, 2019 2018 Raw materials and supplies $ 563 $ 510 Finished goods 435 752 $ 998 $ 1,262 Stock-Based Compensation We recognize compensation expense using a fair-value based method, for all stock-based payments including stock options and restricted stock awards and stock issued under an employee stock purchase plan. These standards require companies to estimate the fair value of stock-based payment awards on the date of grant using an option pricing model. See Note 9 “Stock Plans,” for a discussion of our stock-based compensation plans. Warrants Issued in Connection with Equity Financing We generally account for warrants issued in connection with equity financings as a component of equity, unless there is a deemed possibility that we may have to settle the warrants in cash. For warrants issued with deemed possibility of cash settlement, we record the fair value of the issued warrants as a liability at each reporting period and record changes in the estimated fair value as a non-cash gain or loss in the Statements of Operations and Comprehensive Loss. Cash and Cash Equivalents Our investment policy emphasizes liquidity and preservation of principal over other portfolio considerations. We select investments that maximize interest income to the extent possible given these two constraints. We satisfy liquidity requirements by investing excess cash in securities with different maturities to match projected cash needs and limit concentration of credit risk by diversifying our investments among a variety of high credit-quality issuers and limit the amount of credit exposure to any one issuer. The estimated fair values have been determined using available market information. We do not use derivative financial instruments in our investment portfolio. All investments with original maturities of three months or less are considered to be cash equivalents. We had money market funds of approximately $4.9 million and $8.9 million as of December 31, 2019 and 2018, respectively, included in our cash and cash equivalents. Property and Equipment Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets ranging from three to five years. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the assets. Revenue Recognition We generate revenue principally from the sale of Probuphine in the U.S., collaborative research and development arrangements, technology licenses and sales, and government grants. Consideration received for revenue arrangements with multiple components is allocated among the separate performance obligations based upon their relative estimated standalone selling price. In determining the appropriate amount of revenue to be recognized as we fulfill our obligations under our agreements, we perform the following steps for our revenue recognition: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) we satisfy each performance obligation. Net Product Revenue We recognize revenue from product sales when control of the product transfers, generally upon shipment or delivery, to our customers, which include distributors. As customary in the pharmaceutical industry, our gross product revenue is subject to a variety of deductions in the forms of variable consideration, such as rebates, chargebacks, returns and discounts, in arriving at reported net product revenue. This variable consideration is estimated using the most-likely amount method, which is the single most-likely outcome under a contract and is typically at stated contractual rates. The actual outcome of this variable consideration may materially differ from our estimates. From time to time, we will adjust our estimates of this variable consideration when trends or significant events indicate that a change in estimate is appropriate to reflect the actual experience. Additionally, we will continue to assess the estimates of our variable consideration as we continue to accumulate additional historical data. Changes in the estimates of our variable consideration could materially affect our financial statements. Returns – Consistent with the provisions of ASC 606, we estimate returns at the inception of each transaction, based on multiple considerations, including historical sales, historical experience of actual customer returns, levels of inventory in our distribution channel, expiration dates of purchased products and significant market changes which may impact future expected returns to the extent that we would not reverse any receivables, revenues, or contract assets already recognized under the agreement. During the year ended December 31, 2019, we entered into agreements with large national specialty pharmacies with a distribution channel different from that of our existing customers and, therefore, the related reserves have unique considerations. We will continue to evaluate the activities with these specialty pharmacies during upcoming quarters and will update the related reserves accordingly. Rebates – Our provision for rebates is estimated based on our customers’ contracted rebate programs and our historical experience of rebates paid. Discounts –The provision is estimated based upon invoice billings, utilizing historical customer payment experience. The following table provides a summary of activity with respect to our product returns and discounts and rebates, which are included on our balance sheets within accrued sales allowances, and allowance for doubtful accounts, which are included on our balance sheets within receivables (in thousands): Accrued Sales Allowances Discounts and Allowance for Product Return Rebates Doubtful Allowance Allowance Total Accounts Balance at December 31, 2018 $ 33 $ 48 $ 81 $ — Provision 752 224 976 63 Payments/credits (64) (184) (248) — Balance at December 31, 2019 $ 721 $ 88 $ 809 $ 63 Performance Obligations A performance obligation is a promise in a contract to transfer a distinct good or service to the customer. Our performance obligations include commercialization license rights, development services and services associated with the regulatory approval process. We have optional additional items in contracts, which are accounted for as separate contracts when the customer elects such options. Arrangements that include a promise for future commercial product supply and optional research and development services at the customer’s discretion are generally considered as options. We assess if these options provide a material right to the customer and, if so, such material rights are accounted for as separate performance obligations. If we are entitled to additional payments when the customer exercises these options, any additional payments are recorded in revenue when the customer obtains control of the goods or services. Transaction Price We have both fixed and variable consideration. Non-refundable upfront payments are considered fixed, while milestone payments are identified as variable consideration when determining the transaction price. Funding of research and development activities is considered variable until such costs are reimbursed at which point they are considered fixed. We allocate the total transaction price to each performance obligation based on the relative estimated standalone selling prices of the promised goods or services for each performance obligation. At the inception of each arrangement that includes milestone payments, we evaluate whether the milestones are considered probable of being achieved and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone is included in the transaction price. Milestone payments that are not within our control, such as approvals from regulators, are not considered probable of being achieved until those approvals are received. For arrangements that include sales-based royalties or earn-out payments, including milestone payments based on the level of sales, and the license or purchase agreement is deemed to be the predominant item to which the royalties or earn-out payments relate, we recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty or earn-out payment has been allocated has been satisfied (or partially satisfied). Allocation of Consideration As part of the accounting for these arrangements, we must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. Estimated selling prices for license rights are calculated using the residual approach. For all other performance obligations, we use a cost-plus margin approach. Timing of Recognition Significant management judgment is required to determine the level of effort required under an arrangement and the period over which we expect to complete our performance obligations under an arrangement. We estimate the performance period or measure of progress at the inception of the arrangement and re-evaluate it each reporting period. This re-evaluation may shorten or lengthen the period over which revenue is recognized. Changes to these estimates are recorded on a cumulative catch up basis. If we cannot reasonably estimate when our performance obligations either are completed or become inconsequential, then revenue recognition is deferred until we can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. Revenue is recognized for licenses or sales of functional intellectual property at the point in time the customer can use and benefit from the license. For performance obligations that are services, revenue is recognized over time proportionate to the costs that we have incurred to perform the services using the cost-to-cost input method. Research and Development Costs and Related Accrual Research and development expenses include internal and external costs. Internal costs include salaries and employment related expenses, facility costs, administrative expenses and allocations of corporate costs. External expenses consist of costs associated with outsourced contract research organization (“CRO”) activities, sponsored research studies, product registration, patent application and prosecution, and investigator sponsored trials. We also record accruals for estimated ongoing clinical trial costs. Clinical trial costs represent costs incurred by CROs and clinical sites. These costs are recorded as a component of research and development expenses. Under our agreements, progress payments are typically made to investigators, clinical sites and CROs. We analyze the progress of the clinical trials, including levels of patient enrollment, invoices received and contracted costs when evaluating the adequacy of accrued liabilities. Significant judgments and estimates must be made and used in determining the accrued balance in any accounting period. Actual results could differ from those estimates under different assumptions. Revisions are charged to expense in the period in which the facts that give rise to the revision become known. Net Loss Per Share Basic net loss per share excludes the effect of dilution and is computed by dividing net loss by the weighted-average number of shares outstanding for the period. Diluted net loss per share reflects the potential dilution that could occur if securities or other contracts to issue shares were exercised into shares. In calculating diluted net loss per share, the numerator is adjusted for the change in the fair value of the warrant liability (only if dilutive) and the denominator is increased to include the number of potentially dilutive common shares assumed to be outstanding during the period using the treasury stock method. The following table sets forth the reconciliation of the numerator and denominator used in the computation of basic and diluted net loss per common share for the years ended (in thousands, except per share amounts): December 31, 2019 2018 Numerator: Net loss used for basic earnings per share $ (16,458) $ (9,308) Less change in fair value of warrant liability — — Less change in fair value of derivatives — 134 Net loss used for diluted earnings per share $ (16,458) $ (9,442) Denominator: Basic weighted-average outstanding common shares 22,957 5,688 Effect of dilutive potential common shares resulting from warrants — — Weighted-average shares outstanding—diluted 22,957 5,688 Net loss per common share: Basic $ (0.72) $ (1.64) Diluted $ (0.72) $ (1.66) The table below presents common shares underlying stock options and warrants that are excluded from the calculation of the weighted average number of shares of common stock outstanding used for the calculation of diluted net loss per common share. These are excluded from the calculation due to their anti-dilutive effect for the years ended (in thousands): December 31, 2019 2018 Weighted-average anti-dilutive common shares resulting from stock awards 1,074 588 Weighted-average anti-dilutive common shares resulting from warrants 7,679 264 Convertible debt 1,444 — 10,197 852 Leases In February 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standard Update, or ASU, No. 2016-02, Leases (Topic 842), to enhance the transparency and comparability of financial reporting related to leasing arrangements. We adopted the standard effective January 1, 2019. We determine whether the arrangement is or contains a lease at inception. Operating lease right-of-use assets and lease liabilities are recognized at the present value of the future lease payments at commencement date. The interest rate implicit in lease contracts is typically not readily determinable, and therefore, we utilize our incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received. Lease expense is recognized over the expected term on a straight-line basis. Operating leases are recognized on our balance sheet as right-of-use assets, operating lease liabilities current and operating lease liabilities non-current. We no longer recognize deferred rent on our balance sheet. Subsequent Events We have evaluated events that have occurred subsequent to December 31, 2019 and through the date that the financial statements are issued. Fair Value Measurements We measure the fair value of financial assets and liabilities based on authoritative guidance which defines fair value, establishes a framework consisting of three levels for measuring fair value, and requires disclosures about fair value measurements. 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. There are three levels of inputs that may be used to measure fair value: Level 1 – quoted prices in active markets for identical assets or liabilities; Level 2 – quoted prices for similar assets and liabilities in active markets or inputs that are observable; Level 3 – inputs that are unobservable (for example cash flow modeling inputs based on assumptions). Financial instruments, including receivables, accounts payable and accrued liabilities are carried at cost, which we believe approximates fair value due to the short-term nature of these instruments. The approximately $4.9 million and $8.9 million fair values of money market funds as of December 31, 2019 and 2018 included in our cash and cash equivalents are classified as Level 1 and were derived from quoted market prices as active markets for these instruments exists. Our warrant and derivative liabilities are classified within level 3 of the fair value hierarchy because the value is calculated using significant judgment based on our own assumptions in the valuation of these liabilities. The following table rolls forward the fair value of our warrant liability, the fair value of which is determined by Level 3 inputs for the year ended December 31, 2019 (in thousands): Fair value, beginning of period $ — Issuance of warrants 1,430 Change in fair value (1,110) Fair value, end of period $ 320 During the year ended December 31, 2018, we did not have any warrant liability. The following table rolls forward the fair value of our derivative liability, the fair value of which is determined by Level 3 inputs for the years ended (in thousands): December 31, 2019 2018 Fair value, beginning of period $ 25 $ — Issuance of derivative — 159 Change in fair value (25) (134) Fair value, end of period $ — $ 25 Recent Accounting Pronouncements Accounting Standards Adopted In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) . Topic 842 requires most lessees to recognize right of use assets and lease liabilities, but recognize expenses in a manner similar with current accounting standards. Effective January 1, 2019, we adopted the provisions under Topic 842 using a modified retrospective transition approach without adjusting comparative periods. Additionally, as permitted by Topic 842, we elected to apply the following practical expedients: (i) not to reassess whether any expired or existing contracts are or contain leases or the classification of any expired or existing leases and (ii) not to apply the recognition requirements to short-term leases. As a result of this adoption, we recorded operating lease right-of-use asset and operating lease liability associated with our office lease in our balance sheet. We used a discount rate of 12%, which reflects our borrowing rate as of the adoption date, to measure the present value of future lease payments to determine the fair value of our operating lease right-of-use asset and liability. Our office lease expires in June 2021 and we did not include an estimated renewal in the calculation of our operating lease right-of-use asset and liability as we believe that it is less than probable we will renew our office lease. Our adoption of Topic 842 did not result in any cumulative adjustment to the balance of our accumulated deficit as of January 1, 2019. Lease expense for operating lease payments is recognized on a straight-line basis over the lease term, which is consistent with Topic 840. The following table presents maturities of our operating lease as of December 31, 2019 (in thousands): 2020 $ 308 2021 155 Total minimum lease payments (base rent) 463 Less: imputed interest (41) Total operating lease liabilities $ 422 In June 2018, the FASB issued ASU 2018-07, Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting, which aligns the accounting for share-based payment awards issued to nonemployees with the guidance applicable to grants to employees. Under the new standard, equity-classified share-based payment awards issued to nonemployees are measured on the grant date, instead of the current requirement to remeasure the awards through the performance completion date. We adopted ASU 2018-07 during the three months ended March 31, 2019 using the prospective approach. The adoption of ASU 2018-07 did not have any material impact to our financial statements. In August 2018, the SEC published Release No. 33-10532, Disclosure Update and Simplification, or DUSTR, which adopted amendments to certain disclosure requirements that have become redundant, duplicative, overlapping, outdated or superseded, in light of other SEC disclosure requirements, GAAP, or changes in the information environment. While most of the DUSTR amendments eliminate updated or duplicative disclosure requirements, the final rule amends the interim financial statement requirements to include a reconciliation of changes in stockholders’ equity in the notes or as a separate statement for each period for which a statement of comprehensive loss is required to be filed. We adopted ASU 2018-07 during the three months ended March 31, 2019 and included a reconciliation of changes in stockholders’ equity in our interim financial statements, Accounting Standards Not Yet Adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses, which requires an organization to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. Financial institutions and other organizations will now use forward-looking information to better inform their credit loss estimates. The amendments in this ASU are effective for us in our interim period ending March 31, 2023. We are currently assessing the impact of the adoption of Topic 326 on our financial statements and disclosures. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement, which eliminates, adds and modifies certain disclosure requirements for fair value measurements as part of the FASB's disclosure framework project. The ASU is effective for us in our interim period ending March 31, 2020, with early adoption permitted. We do not expect the adoption of this ASU to have any significant impact on our quarterly or annual disclosures. In August 2018, the FASB issued ASU No. 2018-15, Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement that Is a Service Contract. The ASU aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use software license). Adoption of the ASU is either retrospective or prospective. The ASU is effective for us in our interim period ending March 31, 2020, with early adoption permitted. We are currently evaluating the impact of the adoption of ASU No. 2018-15 on our financial statements. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2019 | |
Property and Equipment | |
Property and Equipment | 2. Property and Equipment Property and equipment consisted of the following (in thousands): As of December 31, 2019 2018 Furniture and office equipment $ 388 $ 388 Leasehold improvements 408 408 Laboratory equipment 3,413 3,249 Computer equipment 1,218 1,188 Construction in progress 73 — 5,500 5,233 Less accumulated depreciation and amortization (4,683) (4,439) Property and equipment, net $ 817 $ 794 |
Braeburn License
Braeburn License | 12 Months Ended |
Dec. 31, 2019 | |
Braeburn License | |
Braeburn License | 3 . Braeburn License Until its termination in May 2018, we were party to a license agreement (as amended, the “License Agreement”) pursuant to which we had granted Braeburn the exclusive commercialization rights to Probuphine in the United States and its territories and Canada. Under the License Agreement, we received certain milestone payments, as well as royalties on net sales of Probuphine. The License Agreement provided for us to be reimbursed by Braeburn for any development services and activities undertaken at Braeburn’s request. Under ASC 606, there was no change in the amount or timing of revenue recognized under the License Agreement. In February 2016, Braeburn sublicensed rights to develop and commercialize Probuphine in Canada to Knight. On May 25, 2018, we entered into the Transition Agreement with Braeburn pursuant to which we regained all rights to the commercialization and clinical development of Probuphine in the United States and Canada. Braeburn paid us $1.0 million, transferred inventory to us with a value of approximately $1.1 million and agreed to provide support services through December 28, 2018. In addition, the Transition Agreement provided for the immediate transfer to us of all regulatory documentation and development data related to Probuphine. The estimated fair value of the inventory received was determined using available inputs such as existing supply agreements, prior selling prices and remaining life to expiration. We recognized approximately $2.1 million of license related revenue related to this transaction during the three month period ended June 30, 2018. The sublicense to Knight was assigned to Titan as part of the Transition Agreement. As of December 31, 2018, we have recognized approximately $15.0 million in license revenue related to the up-front payment we received upon execution of the License Agreement. In addition, we received a $15.0 million milestone payment from Braeburn following the achievement of FDA approval of the product NDA. As such, upon receipt of FDA approval our obligation was fulfilled and we recognized the $15.0 million regulatory milestone payment from Braeburn in accordance with the milestone method of revenue recognition. We have recognized approximately $312,000 of royalty revenue on net sales of Probuphine prior to termination of the License Agreement. Internal and external research and development costs related to this product have been expensed in the period incurred. |
Molteni Purchase Agreement
Molteni Purchase Agreement | 12 Months Ended |
Dec. 31, 2019 | |
Molteni Purchase Agreement | |
Molteni Purchase Agreement | 4 . Molteni Purchase Agreement On March 21, 2018, we entered into a purchase agreement (“Molteni Purchase Agreement”) with L. Molteni & C. Dei Frattelli Alitti Società Di Esercizio S.P.A. (“Molteni”) pursuant to which Molteni acquired the European intellectual property related to Probuphine, including the marketing authorization application under review by the European Medicines Agency (“EMA”), and gained the exclusive right to commercialize the Probuphine product supplied by us in the EU, as well as certain countries of the Commonwealth of Independent States, the Middle East and North Africa (the “Molteni Territory”). We received an initial payment of €2.0 million (approximately $2.4 million) for the purchased assets and will receive additional potential payments upon achievement of certain regulatory and product label milestones. Additionally, we are entitled to receive earn-out payments for up to 15 years on net sales of Probuphine in the Molteni Territory in percentages ranging from the low-teens to the mid-twenties. We concluded that the performance obligations identified in the Molteni Purchase Agreement included the transfer of the intellectual property and our efforts towards an approval by the EMA and other regulatory bodies. The initial payment was allocated between the property transfer and our EMA efforts as set forth below. We used the expected cost-plus approach to estimate the standalone selling price of approximately $1.4 million related to our efforts towards an approval by the EMA and other regulatory bodies (“Titan Services”). This includes employee related expenses as well as other manufacturing, regulatory and clinical costs, which are incurred as part of our efforts. We recognized revenue associated with Titan Services ratably over the estimated service period. As of March 31, 2019, we fully recognized the revenue associated with the Titan Services under the Molteni Purchase Agreement as we completed the Titan Services. We used the residual approach to value the transfer of the intellectual property at approximately $1.0 million as we had not established and had no reliable way to establish a standalone selling price for the intellectual property. As a result of the outcome of the milestone and earn-out payments being unpredictable due to the involvement of third parties, we believe that using the most likely amount method is appropriate. Any subsequent revenue related to milestone and earn-out payments will be recognized at the time the milestones are achieved or when the related net sales have occurred. The Molteni Purchase Agreement provides that we supply Molteni with semi-finished product (i.e., the implant, the applicator and related technology) on an exclusive basis at a fixed price through December 31, 2019, with subsequent price increases not to exceed annual cost increases to us for the active pharmaceutical ingredient and under our current manufacturing agreement. Revenue is recognized when the semi-finished product has been transferred to Molteni. Molteni will be prohibited from marketing a competitor product as defined in the Molteni Purchase Agreement in the Molteni Territory for the five year period following approval of the marketing authorization application. Thereafter, Molteni will be required to pay us a low single digit royalty on net sales of any competitor product. The following table presents changes in contract assets and liabilities during the years ended December 31, 2019 and 2018 (in thousands): Beginning Ending Balance Additions Deductions Balance Year ended December 31, 2019 Contract assets $ 99 — (99) $ — Contract liabilities: Deferred revenue $ 313 — (313) $ — Year ended December 31, 2018 Contract assets $ — 291 (192) $ 99 Contract liabilities: Deferred revenue $ — 2,448 (2,135) $ 313 In August 2018, we entered into an amendment to the Molteni Purchase Agreement , pursuant to which Molteni made an immediate payment of €950,000 (approximately $1.1 million) and a convertible loan of €550,000 (approximately $0.6 million) (“Molteni Convertible Loan”) (see Note 7) to us, both in exchange for the elimination of an aggregate of €2.0 million (approximately $2.3 million) of regulatory milestones provided for in the Molteni Purchase Agreement. We concluded that the approximately $1.1 million immediate payment by Molteni reflected a milestone payment with no additional obligations to us and, therefore, was recognized as revenue during the year ended December 31, 2018. In September 2019, we entered into an additional amendment to the Molteni Purchase Agreement, pursuant to which the percentage earn-out payments on net sales was reduced from the original range of low-teens to mid-twenties to the current range of low-teens to mid-teens. We also agreed to delay payment of any earn-outs until the later of (i) January 1, 2021 or (ii) the one year anniversary of completion of compliance by our manufacturer with EU requirements (currently anticipated to occur during the second quarter of this year). The milestone payments under the Molteni Purchase Agreement remain unchanged. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 5. Commitments and Contingencies Lease Commitments We lease our office facility under operating lease that expires in June 2021. Rent expense associated with this lease was approximately $0.3 million each year for years ended December 31, 2019 and 2018, respectively. Guarantees and Indemnifications As permitted under Delaware law and in accordance with our Bylaws, we indemnify our officers and directors for certain events or occurrences while the officer or director is or was serving at our request in such capacity. The term of the indemnification period is for the officer’s or director’s lifetime. The maximum amount of potential future indemnification is unlimited; however, we have a director and officer insurance policy that limits our exposure and may enable us to recover a portion of any future amounts paid. We believe the fair value of these indemnification agreements is minimal. Accordingly, we have not recorded any liabilities for these agreements as of December 31, 2019. In the normal course of business, we have commitments to make certain milestone payments to various clinical research organizations in connection with our clinical trial activities. Payments are contingent upon the achievement of specific milestones or events as defined in the agreements, and we have made appropriate accruals in our financial statements for those milestones that were achieved as of December 31, 2019. We also provide indemnifications of varying scope to our CROs and investigators against claims made by third parties arising from the use of our products and processes in clinical trials. Historically, costs related to these indemnification provisions were immaterial. We also maintain various liability insurance policies that limit our exposure. We are unable to estimate the maximum potential impact of these indemnification provisions on our future results of operations. Legal Proceedings There are no ongoing legal proceedings against our company. |
Warrant Liability
Warrant Liability | 12 Months Ended |
Dec. 31, 2019 | |
Warrant Liability | |
Warrant Liability | 6 . Warrant Liability August 2019 Warrant Liability In August 2019, we completed a registered direct offering (the “August 2019 Offering”) and issued warrants to purchase 2,852,314 shares of our common stock with an exercise price of $1.07 per share (the “Placement Warrants”) in a concurrent private placement (see Note 9). The Placement Warrants agreement contains a provision where the warrant holder has the option to receive cash, equal to the Black Scholes fair value of the remaining unexercised portion of the warrant, as cash settlement in the event that there is a fundamental transaction (contractually defined to include various merger, acquisition or stock transfer activities). As a result of this provision, in accordance with ASC 480, “Distinguishing Liabilities from Equity,” the Placement Warrants are required to be classified as liabilities. The fair value of the Placement Warrants is determined using the Black-Scholes Option Pricing model to calculate the call option and Binomial Option Pricing model to calculate the put option with changes in the fair value recorded in our statements of operations and comprehensive loss. As of December 31, 2019, total fair value of the Placement Warrants was approximately $0.3 million, which is included within warrant liabilities in our balance sheet. The warrant liability associated with the Placement Warrants is classified within level 3 of the fair value hierarchy. The below table represents the weighted-average key assumptions used to calculate the fair value of the Placement Warrants: As of August 7, 2019 December 31, 2019 Expected volatility 87 % 125 % Risk-free interest rate 1.5 % 1.7 % Dividend yield — — Expected term (in years) 4.9 4.6 Weighted-average fair value per share warrant $ 0.50 $ 0.11 |
Debt Agreements
Debt Agreements | 12 Months Ended |
Dec. 31, 2019 | |
Debt Agreements | |
Debt Agreements | 7. Debt Agreements Horizon and Molteni Loan In July 2017, we entered into a venture loan and security agreement (the “Horizon Loan Agreement”) with Horizon Technology Finance Corporation (“Horizon”), which provided up to $10.0 million in loans, including an initial loan in the amount of $7.0 million funded upon signing of the Horizon Loan Agreement. In connection with the Horizon Loan Agreement, we issued Horizon seven-year warrants to purchase common stock (the “Horizon Warrants”). The Horizon Warrants were classified as equity and the fair value of the Horizon Warrants at the time of issuance was determined using a Lattice valuation model. Our obligations under the Loan Agreement are secured by a first priority security interest in all of our assets, with the exception of our intellectual property. We agreed not to pledge or otherwise encumber our intellectual property assets, subject to certain exceptions. In February 2018, we entered into an amendment to the Original Loan Agreement (the “Amended Loan Agreement”) pursuant to which we prepaid $3.0 million of the outstanding $7.0 million principal amount and provided Horizon with a lien on our intellectual property. In March 2018, we entered into an Amended and Restated Venture Loan and Security Agreement (the “Restated Loan Agreement”) with Horizon and Molteni pursuant to which Horizon assigned approximately $2.4 million of the $4.0 million outstanding principal balance of the loan to Molteni and Molteni was appointed as the collateral agent and assumed majority and administrative control of the loan. Under the Restated Loan Agreement, Molteni had the right to convert its portion of the debt into shares of our common stock at a conversion price of $7.20 per share and was required to effect this conversion of debt to equity if we complete an equity financing resulting in gross proceeds of at least $10.0 million at a price per share of common stock in excess of $7.20 and repay the $1.6 million balance of Horizon’s loan amount. In connection with the Restated Loan Agreement, we issued additional warrants to purchase an aggregate of 6,667 shares of our common stock with an exercise price per share of $7.20 to Horizon (collectively, the “Horizon Warrants”). These warrants were classified as equity and the key assumptions used to value these warrants as of the date of the issuance were as follows: Expected price volatility 86 % Expected term (in years) 7.0 Risk-free interest rate 2.8 % Dividend yield 0.0 % Weighted-average fair value per share warrant $ 4.86 In consideration of Molteni’s entry into the Horizon Loan Agreement and the Molteni Purchase Agreement (see Note 4), in March 2018, we entered into a rights agreement (the “Rights Agreement”) with Molteni pursuant to which we agreed to (i) issue Molteni seven-year warrants to purchase 90,000 shares of our common stock at an exercise price of $7.20 per share (the “Molteni Warrants”), (ii) provide Molteni customary demand and piggy-back registration rights with respect to the shares of common stock issuable upon conversion of its loan and exercise of the Molteni Warrants, (iii) designate one member of our board of directors following conversion of the loan in full and (iv) provide board observer rights to Molteni if it has not designated a board nominee as well as certain information rights. The board designation, observer and information rights will terminate at such time as Molteni ceases to beneficially own at least one percent of our outstanding capital stock (inclusive of the shares issuable upon conversion of debt under the Restated Loan Agreement and exercise of the Molteni Warrants). The Molteni Warrants have been classified as equity and their fair value at the time of issuance was determined using a Black Scholes valuation model. The amount was allocated equally between the Restated Loan Agreement and the Purchase Agreement and was recorded in the Balance Sheets as a discount to the Molteni loan and a contract asset, respectively. The key assumptions used to value the Molteni Warrants were as follows: Expected price volatility 86 % Expected term (in years) 7.0 Risk-free interest rate 2.8 % Dividend yield 0.0 % Weighted-average fair value of warrants $ 4.86 Repayment of the loans was on an interest-only basis, followed by monthly payments of principal and accrued interest for the balance of the 46‑month term. The loans bear interest at a floating coupon rate of one-month LIBOR (floor of 1.10%) plus 8.40%. A final payment equal to 5.0% of each loan tranche will be due on the scheduled maturity date for such loan. In addition, if we repay all or a portion of the loan prior to the applicable maturity date, we will pay Horizon and Molteni prepayment penalty fees. In connection with our equity offering in September 2018, the Horizon Warrants to purchase 366,668 shares of our common stock at $1.50 per share became exercisable. In accordance with the guidance in ASU 2017-11, we recognized the effect of triggering the down round feature as a dividend in our Balance Sheets at December 31, 2018 and as an addition to net loss attributable to common stockholders and in our calculation of basic and fully diluted earnings per share in our Statements of Operations and Comprehensive Loss for the year ended December 31, 2018. We calculated the dividend of approximately $0.3 million resulting from the trigger of the down round provision in September 2018 using the Black Scholes Option Pricing Model and the assumptions indicated in the table below: Pre-reset Post-reset Exercise price per share $ 11.76 $ 1.50 Expected price volatility 71 % 71 % Expected term (in years) 5.8 5.8 Risk-free interest rate 3.0 % 3.0 % Dividend yield 0.0 % 0.0 % Weighted-average fair value of warrants $ 0.30 $ 0.84 In September 2019, we entered into an amendment to the Restated Loan Agreement pursuant to which the interest-only payment and forbearance periods were extended by one year to December 31, 2020 and the maturity date was extended by one year to June 1, 2022. In connection with the amendment to the Restated Loan Agreement (as clarified by a second amendment in March 2020), the final payments to the lenders were increased by an aggregate of approximately $0.3 million (exclusive of a restructuring fee payable to Horizon) and the conversion provisions related to Molteni’s portion of the loan amount were revised to eliminate the mandatory conversion feature, to reduce the conversion price to $0.225 and to cap the number of shares issuable upon conversion to 3,422,777. As of December 31, 2019, the loan from Molteni under the amendment to the Restated Loan Agreement was convertible into 3,422,777 shares of our common stock. In accordance with ASC 470, “Debt,” the amendment to the loan from Molteni is accounted for under debt extinguishment accounting, which required us to extinguish the carrying amount of the loan prior to the amendment and reacquire the loan after the amendment. As a result, during the year ended December 31, 2019, we recorded approximately $0.3 million gain on debt extinguishment related to the write-off of the balance of the accreted final payment of the loan. The modification to the loan from Horizon did not constitute debt extinguishment and, therefore, did not have any impact to our financial statements. Molteni Convertible Loan Due to the conversion provision of the Molteni Convertible Loan, ASC 815, Derivatives and Hedging required us to classify the conversion provision as an embedded derivative with changes in the fair value recorded in the statement of operations and comprehensive loss. The key assumptions used to value the Convertible Loan embedded derivative were as follows: As of September 18, 2018 December 31, 2018 Expected volatility 87 % 135 % Expected term (in years) 0.75 0.50 Risk-free interest rate 2.32 % 2.51 % Dividend yield — — Fair value of conversion provision (in thousands) $ 159 $ 25 In connection with the amendment to the Molteni Purchase Agreement (see Note 4), in June 2019, the Molteni Convertible Loan, together with unpaid accrued interest, was converted in full into 448,287 shares of our common stock at $1.50 per share upon the receipt of EMA approval of Sixmo. As a result, we recorded approximately $0.1 million loss on debt extinguishment. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2019 | |
Stockholders' Equity | |
Stockholders' Equity | 8. Stockholders’ Equity Common Stock October 2019 Public Offering In October 2019, we completed an underwritten public offering pursuant to which we issued 40,276,000 units at an offering price of $0.225 per unit, consisting of 35,886,000 shares of our common stock and pre-funded warrants to purchase 4,390,000 shares of our common stock with an exercise price of $0.01 per share, and class B warrants to purchase 40,276,000 shares of our common stock at $0.225 per share (the “Class B Warrants”). The pre-funded warrants, which were exercised for common stock in October 2019, were issued in lieu of common stock in order to ensure the investor did not exceed certain beneficial ownership limitations. The Class B Warrants are immediately exercisable and will expire in October 2024. The Class B Warrant agreement contains a provision where the warrant holder has the option to receive cash equal to the Black Scholes fair value of the remaining unexercised portion of the Class B Warrant only in the event that there is a fundamental transaction approved by the Board (contractually defined to include various merger, acquisition or stock transfer activities). The Class B Warrants issued in connection with the October 2019 public offering were classified as equity. August 2019 Offering In August 2019, we completed an offering with a single accredited institutional investor pursuant to which we issued 1,480,000 shares of our common stock and pre-funded warrants to purchase 1,372,314 shares of our common stock with an exercise price of $0.01 per share in a registered direct offering and the Placement Warrants to purchase 2,852,314 shares of our common stock with an exercise price of $1.07 per share in a concurrent private placement. The pre-funded warrants, which were exercised for common stock in September 2019, were issued in lieu of common stock in order to ensure the investor did not exceed certain beneficial ownership limitations. The Placement Warrants became exercisable in February 2020 and will expire in February 2025. The Placement Warrants contain a provision where the warrant holder has the option to receive cash, equal to the Black Scholes fair value of the remaining unexercised portion of the warrant, as cash settlement in the event that there is a fundamental transaction (contractually defined to include various merger, acquisition or stock transfer activities). The Placement Warrants are classified as a liability (see Note 6). At-the-Market Offering (the “ATM”) In April 2019, we implemented the ATM for the sale of up to $8.6 million of our common stock. During the year ended December 31, 2019, we issued a total of 329,656 shares of our common stock at a weighted-average price of $1.60 per share for total net proceeds of approximately $0.5 million under the ATM. In August 2019, we reduced the dollar amount that can be sold under ATM to $4.0 million. September 2018 Public Offering In September 2018, we entered into an underwriting agreement with A.G.P./Alliance Global Partners, as representative (the “Representative”) of the underwriters (the “Underwriters”) pursuant to which we sold to the Underwriters in a public offering an aggregate of (i) 850,000 Class A Units at a public offering price of $1.50 per unit, with each unit consisting of one share of common stock and a Warrant to purchase one share of common stock, and (ii) 8,225 Class B Units at a public offering price of $1,000 per unit, with each unit consisting of one share of Series A Convertible Preferred Stock (the “Preferred Shares”) and Warrants to purchase 667 shares of common stock. The Warrants have an exercise price of $1.50 and expire five years from the date of issuance. The Preferred Shares, which were fully converted into 5,483,334 shares of common stock during the year ended December 31, 2018, included a beneficial ownership blocker but had no dividend rights (except to the extent that dividends were also paid on the common stock), liquidation preference or other preferences over common stock, and had no voting rights. The warrants in connection with the September 2018 Public Offering were classified as equity. In connection with the September 2018 Public Offering, the Underwriters exercised their option to purchase 950,000 additional Warrants at a price of $0.06 per warrant and exercised the over-allotment option to purchase 950,000 shares of our common stock at $1.44 per share. Additionally, warrants to purchase an aggregate of 2,178,484 shares of common stock associated with the September 2018 Public Offering were exercised, resulting in proceeds to us of approximately $3.3 million. We also agreed to issue to the Representative and its designees warrants to purchase an aggregate of 253,334 shares of common stock at an exercise price of $1.68 per share. As of December 31, 2019, the following warrants to purchase shares of our common stock were outstanding (in thousands, except per share price): Date Issued Expiration Date Exercise Price Outstanding 10/08/2014 10/08/2020 $ 19.80 141 07/27/2017 07/27/2024 $ 1.50 367 03/21/2018 03/21/2025 $ 7.20 7 03/21/2018 03/21/2025 $ 7.20 90 09/25/2018 09/25/2023 $ 0.60 4,632 09/25/2018 09/25/2023 $ 1.68 253 08/09/2019 02/09/2025 $ 1.07 2,852 10/18/2019 10/18/2024 $ 0.23 40,276 48,618 Shares Reserved for Future Issuance As of December 31, 2019, shares of common stock reserved by us for future issuance consisted of the following (in thousands): Stock options outstanding 1,191 Shares issuable upon the exercise of warrants 48,618 49,809 |
Stock Plans
Stock Plans | 12 Months Ended |
Dec. 31, 2019 | |
Stock Plans | |
Stock Plans | 9. Stock Plans In August 2015, our stockholders approved the 2015 Omnibus Equity Incentive Plan (the “2015 Plan”). The 2015 Plan, as subsequently amended, authorized a total of 1,666,667 shares of our common stock for issuance to employees, directors, officers, consultants and advisors. As of December 31, 2019, options to purchase 577,879 shares of our common stock were available for grant and 1,088,788 shares of our common stock outstanding under the 2015 Plan. In February 2014, our Board adopted the 2014 Incentive Plan (the “2014 Plan”), pursuant to which 75,758 shares of our common stock were authorized for issuance to employees, directors, officers, consultants and advisors. The 2014 Plan was terminated upon the approval of the 2015 Plan. As of December 31, 2019, options to purchase 41,345 shares of our common stock were outstanding under the 2014 Plan. In July 2002, we adopted the 2002 Stock Incentive Plan (the “2002 Plan”). The 2002 Plan, as amended in 2005, authorized a total of approximately 217,000 shares of our common stock for issuance to employees, officers, directors, consultants, and advisers. The exercise prices of options granted under the 2002 Plan were 100% of the fair market value of our common stock on the date of grant. The 2002 Plan expired by its terms in July 2012. As of December 31, 2019, options to purchase an aggregate of 49,344 shares of our common stock were outstanding under the 2002 Plan. In August 2001, we adopted the 2001 Employee Non-Qualified Stock Option Plan (the “2001 NQ Plan”) pursuant to which 53,031 shares of common stock were authorized for issuance for option grants to employees and consultants who are not officers or directors of Titan. The exercise prices of options granted under the 2001 NQ Plan were 100% of the fair market value of our common stock on the date of grant. The 2001 Stock Option Plan expired by its terms in August 2011. As of December 31, 2019, options to purchase an aggregate of 12,246 shares of our common stock were outstanding under the 2001 NQ Plan. In January 2019, our stockholders approved a repricing of 122,115 fully-vested stock options with exercise prices in excess of $21.00 held by employees and consultants other than the named executive officers or members of the Board. The effected options were repriced at $1.55. As a result of the repricing of these stock options, we incurred a total of approximately $81,000 of additional stock-based compensation expense during the year ended December 31, 2019, of which approximately $54,000 was recorded within research and development and approximately $27,000 within selling, general and administrative in our statement of operations and comprehensive loss. The following table summarizes option activity for the year ended December 31, 2019: Weighted Weighted Average Average Aggregate Exercise Remaining Intrinsic Shares Price per Contractual Value (in thousands) Share Term (years) (in thousands) Outstanding at January 1, 2019 665 $ 6.44 $ Granted 854 Cancelled/expired (327) Outstanding at December 31, 2019 1,192 $ $ — Exercisable at December 31, 2019 738 $ $ — We use the Black-Scholes-Merton option-pricing model with the following assumptions to estimate the stock-based compensation expense: Years Ended December 31, 2019 2018 Weighted-average risk-free interest rate 2.21 % 2.84 % Expected dividend payments — — Expected holding period (years)(1) 6.39 Weighted-average volatility factor(2) 0.94 0.88 Estimated forfeiture rates for options granted 21 % 26 % (1) Expected holding period is based on historical experience of similar awards, giving consideration to the contractual terms of the stock-based awards, vesting schedules and the expectations of future employee behavior. (2) Weighted average volatility is based on the historical volatility of our common stock. (3) Based upon the above methodology, the weighted-average fair value of options and awards granted during the years ended December 31, 2019 and 2018 was $1.64 and $3.21 , respectively. The following table summarizes the stock-based compensation expense (in thousands): Years Ended December 31, 2019 2018 Research and development $ 91 $ 575 General and administrative 481 982 Total stock-based compensation expenses $ 572 $ 1,557 As of December 31, 2019, there was approximately $0.3 million of total unrecognized compensation expense related to non-vested stock options. This expense is expected to be recognized over a weighted-average period of 1.5 years. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Taxes | |
Income Taxes | 10. Income Taxes As of December 31, 2019, we had federal net operating loss carryforwards of approximately $244.8 million that expire at various dates through 2037 and approximately $23.5 million which do not expire but are subject to 80% taxable income limitations. As of December 31, 2019, we had federal research and development tax credits of approximately $8.5 million that expire at various dates through 2039. We also had net operating loss carryforwards for California income tax purposes of approximately $108.2 million that expire at various dates through 2039 and state research and development tax credits of approximately $9.1 million which do not expire. Current federal and California tax laws include substantial restrictions on the utilization of net operating losses and tax credits in the event of an ownership change of a corporation under Internal Revenue Code Section 382 and 383. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes and operating loss and credit carryforwards. Significant components of our deferred tax assets are as follows (in thousands): As of December 31, 2019 2018 Deferred tax assets: Net operating loss carryforwards $ 63,910 $ 62,863 Research credit carryforwards 15,683 15,886 Other, net 1,303 1,321 Total deferred tax assets 80,896 80,070 Deferred tax liabilities: Other, net (84) — Total deferred tax liabilities (84) — Valuation allowance (80,812) (80,070) Net deferred tax assets $ — $ — ASC 740 requires that the tax benefit of net operating losses, temporary differences and credit carryforwards be recorded as an asset to the extent that management assesses that realization is "more likely than not." Realization of the future tax benefits is dependent on our ability to generate sufficient taxable income within the carryforward period. Because of our recent history of operating losses, our management believes that recognition of the deferred tax assets arising from the above-mentioned future tax benefits is currently not likely to be realized and, accordingly, has provided a valuation allowance. Realization of deferred tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain. Accordingly, the net deferred tax assets have been fully offset by a valuation allowance. The valuation allowance increased by approximately $0.7 million during 2019 and increased by approximately $0.2 million during 2018. The provision for income taxes consists of state minimum taxes due. The effective tax rate of our provision (benefit) for income taxes differs from the federal statutory rate as follows (in thousands): Years Ended December 31, 2019 2018 Computed at 21% $ (3,451) $ (1,879) State taxes (146) (167) Change in valuation allowance 768 197 Other 56 121 Revaluation of warrant liability (238) (30) Research and development credits (54) 144 Tax attributes expirations 2,698 975 Impact of IRC 162m 367 639 Total $ — $ — We had no unrecognized tax benefits or any amounts accrued for interest and penalties for the three years ended December 31, 2019. Our policy is to recognize interest and penalties related to income taxes as a component of income tax expense. We do not expect the amount of unrecognized tax benefits will materially change in the next twelve months. We file tax returns in the U.S. federal jurisdiction and various state jurisdictions. We are subject to the U.S. federal and state income tax examination by tax authorities for such years 2000 through 2019, due to net operating losses that are being carried forward for tax purposes. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2019 | |
Subsequent Events | |
Subsequent Events | 11. Subsequent Events In January 2020, we completed a registered direct offering with several institutional investors pursuant to which we issued 8,700,000 shares of our common stock and warrants to purchase 8,700,000 shares of our common stock with an exercise price of $0.25 per share in a concurrent private placement. The private placement warrants will become exercisable in July 2020 and will expire in July 2025. As a result, we received net cash proceeds of approximately $1.9 million, after deduction of underwriting fees and other offering expenses. During January, February and March 2020, we received approximately $6.2 million in cumulative net cash proceeds from the exercise of outstanding warrants to purchase 27,388,464 shares of our common stock. In March 2020, we amended certain outstanding warrants to purchase an aggregate of 11,552,314 shares of common stock to modify the provision requiring derivative liability treatment and qualify them for equity treatment. As a result of the aforementioned receipt of proceeds and warrant amendments and an estimate of revenues and expenses from January 1, 2020 through March 16, 2020, we reported our belief that at March 16, 2020 we had stockholders' equity of approximately $5.3 million. On January 30, 2020, the World Health Organization (“WHO”) announced a global health emergency because of a new strain of coronavirus originating in Wuhan, China (the “COVID-19 outbreak”) and the risks to the international community as the virus spreads globally beyond its point of origin. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic, based on the rapid increase in exposure globally. The full impact of the COVID-19 outbreak continues to evolve as of the date of this report. As such, it is uncertain as to the full magnitude that the pandemic will have on our financial condition, liquidity, and future results of operations. Management is actively monitoring the impact of the global situation on our financial condition, liquidity, operations, suppliers, industry, and workforce. Given the daily evolution of the COVID-19 outbreak and the global responses to curb its spread, we are not able to estimate the effects of the COVID-19 outbreak on our results of operations, financial condition, or liquidity for the year ended December 31, 2020. |
Quarterly Financial Data (Unaud
Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Data (Unaudited) | |
Quarterly Financial Data (Unaudited) | 12. Quarterly Financial Data (Unaudited) First Quarter Second Quarter Third Quarter Fourth Quarter (in thousands, except per share amount) Year ended December 31, 2019 Total revenue $ 945 $ 502 $ 947 $ 1,217 Net loss $ (4,517) $ (5,197) $ (2,803) $ (3,941) Basic net loss per share $ (0.34) $ (0.38) $ (0.18) $ (0.08) Diluted net loss per share $ (0.34) $ (0.38) $ (0.18) $ (0.08) Year ended December 31, 2018 Total revenue $ 1,064 $ 2,668 $ 1,650 $ 1,236 Net loss $ (2,605) $ (869) $ (2,330) $ (3,504) Basic net loss per share $ (0.74) $ (0.25) $ (0.64) $ (0.29) Diluted net loss per share $ (0.74) $ (0.25) $ (0.68) $ (0.29) |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Organization and Summary of Significant Accounting Policies | |
The Company | The Company We are a pharmaceutical company developing therapeutics utilizing our proprietary long-term drug delivery platform, ProNeura, for the treatment of select chronic diseases for which steady state delivery of a drug provides an efficacy and/or safety benefit. We have been transitioning to a commercial stage enterprise following the reacquisition of Probuphine® (buprenorphine) implant, or Probuphine, on May 25, 2018 from our former licensee. Probuphine is the first product based on our ProNeura technology approved in the U.S., Canada and the European Union, or EU, for the maintenance treatment of opioid use disorder, or OUD, in select patients. We operate in only one business segment, the development and commercialization of pharmaceutical products. In January 2019, pursuant to prior stockholder authorization, our board of directors (the “Board”) effected a reverse split of the outstanding shares of our common stock at a ratio of one share for every six shares then outstanding (the “Reverse Split”). Pursuant to their respective terms, the number of shares underlying our outstanding options and warrants was reduced and their respective exercise prices increased by the Reverse Split ratio. The number of shares of common stock authorized and the par value of $0.001 per share did not change as a result of the Reverse Split. All share and per share amounts contained in this Annual Report on Form 10-K give retroactive effect to the Reverse Split. The accompanying financial statements have been prepared assuming we will continue as a going concern. At December 31, 2019, we had cash and cash equivalents of approximately $5.2 million, which we believe, together with the net cash proceeds of approximately $8.0 million received from the registered direct offering of our common stock in January 2020 and exercises of outstanding warrants to purchase shares of our common stock in the first quarter of 2020, are sufficient to fund our planned operations into the fourth quarter of 2020. We will require additional funds to finance our operations. We are exploring several financing alternatives; however, there can be no assurance that our efforts to obtain the funding required to continue our operations will be successful. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. |
Going concern assessment | Going concern assessment We assess going concern uncertainty in our financial statements to determine if we have sufficient cash on hand and working capital, including available borrowings on loans, to operate for a period of at least one year from the date the financial statements are issued or available to be issued, which is referred to as the “look-forward period” as defined by Accounting Standard Update ASU No. 2014-15. As part of this assessment, based on conditions that are known and reasonably knowable to us, we will consider various scenarios, forecasts, projections, estimates and will make certain key assumptions, including the timing and nature of projected cash expenditures or programs, and its ability to delay or curtail expenditures or programs, if necessary, among other factors. Based on this assessment, as necessary or applicable, we make certain assumptions around implementing curtailments or delays in the nature and timing of programs and expenditures to the extent we deem probable those implementations can be achieved and we have the proper authority to execute them within the look-forward period in accordance with ASU No. 2014-15. Based upon the above assessment, we concluded that, at the date of filing the financial statements in this Annual Report on Form 10-K for the year ended December 31, 2019, we did not have sufficient cash to fund our operations for the next 12 months without additional funds and, therefore, there was substantial doubt about our ability to continue as a going concern within 12 months after the date the financial statements were issued. Additionally, we have suffered recurring losses from operations and have an accumulated deficit that raises substantial doubt about our ability to continue as a going concern. |
Inventories | Inventories Inventories are recorded at the lower of cost or net realizable value. Cost is based on the first in, first out method. We regularly review inventory quantities on hand and write down to its net realizable value any inventory that we believe to be impaired. The determination of net realizable value requires judgment including consideration of many factors, such as estimates of future product demand, product net selling prices, current and future market conditions and potential product obsolescence, among others. The components of inventories are as follows: As of December 31, 2019 2018 Raw materials and supplies $ 563 $ 510 Finished goods 435 752 $ 998 $ 1,262 |
Stock-Based Compensation | Stock-Based Compensation We recognize compensation expense using a fair-value based method, for all stock-based payments including stock options and restricted stock awards and stock issued under an employee stock purchase plan. These standards require companies to estimate the fair value of stock-based payment awards on the date of grant using an option pricing model. See Note 9 “Stock Plans,” for a discussion of our stock-based compensation plans. |
Warrants Issued in Connection with Equity Financing | Warrants Issued in Connection with Equity Financing We generally account for warrants issued in connection with equity financings as a component of equity, unless there is a deemed possibility that we may have to settle the warrants in cash. For warrants issued with deemed possibility of cash settlement, we record the fair value of the issued warrants as a liability at each reporting period and record changes in the estimated fair value as a non-cash gain or loss in the Statements of Operations and Comprehensive Loss. |
Cash and Cash Equivalents | Cash and Cash Equivalents Our investment policy emphasizes liquidity and preservation of principal over other portfolio considerations. We select investments that maximize interest income to the extent possible given these two constraints. We satisfy liquidity requirements by investing excess cash in securities with different maturities to match projected cash needs and limit concentration of credit risk by diversifying our investments among a variety of high credit-quality issuers and limit the amount of credit exposure to any one issuer. The estimated fair values have been determined using available market information. We do not use derivative financial instruments in our investment portfolio. All investments with original maturities of three months or less are considered to be cash equivalents. We had money market funds of approximately $4.9 million and $8.9 million as of December 31, 2019 and 2018, respectively, included in our cash and cash equivalents. |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets ranging from three to five years. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the assets. |
Revenue Recognition | Revenue Recognition We generate revenue principally from the sale of Probuphine in the U.S., collaborative research and development arrangements, technology licenses and sales, and government grants. Consideration received for revenue arrangements with multiple components is allocated among the separate performance obligations based upon their relative estimated standalone selling price. In determining the appropriate amount of revenue to be recognized as we fulfill our obligations under our agreements, we perform the following steps for our revenue recognition: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) we satisfy each performance obligation. Net Product Revenue We recognize revenue from product sales when control of the product transfers, generally upon shipment or delivery, to our customers, which include distributors. As customary in the pharmaceutical industry, our gross product revenue is subject to a variety of deductions in the forms of variable consideration, such as rebates, chargebacks, returns and discounts, in arriving at reported net product revenue. This variable consideration is estimated using the most-likely amount method, which is the single most-likely outcome under a contract and is typically at stated contractual rates. The actual outcome of this variable consideration may materially differ from our estimates. From time to time, we will adjust our estimates of this variable consideration when trends or significant events indicate that a change in estimate is appropriate to reflect the actual experience. Additionally, we will continue to assess the estimates of our variable consideration as we continue to accumulate additional historical data. Changes in the estimates of our variable consideration could materially affect our financial statements. Returns – Consistent with the provisions of ASC 606, we estimate returns at the inception of each transaction, based on multiple considerations, including historical sales, historical experience of actual customer returns, levels of inventory in our distribution channel, expiration dates of purchased products and significant market changes which may impact future expected returns to the extent that we would not reverse any receivables, revenues, or contract assets already recognized under the agreement. During the year ended December 31, 2019, we entered into agreements with large national specialty pharmacies with a distribution channel different from that of our existing customers and, therefore, the related reserves have unique considerations. We will continue to evaluate the activities with these specialty pharmacies during upcoming quarters and will update the related reserves accordingly. Rebates – Our provision for rebates is estimated based on our customers’ contracted rebate programs and our historical experience of rebates paid. Discounts –The provision is estimated based upon invoice billings, utilizing historical customer payment experience. The following table provides a summary of activity with respect to our product returns and discounts and rebates, which are included on our balance sheets within accrued sales allowances, and allowance for doubtful accounts, which are included on our balance sheets within receivables (in thousands): Accrued Sales Allowances Discounts and Allowance for Product Return Rebates Doubtful Allowance Allowance Total Accounts Balance at December 31, 2018 $ 33 $ 48 $ 81 $ — Provision 752 224 976 63 Payments/credits (64) (184) (248) — Balance at December 31, 2019 $ 721 $ 88 $ 809 $ 63 Performance Obligations A performance obligation is a promise in a contract to transfer a distinct good or service to the customer. Our performance obligations include commercialization license rights, development services and services associated with the regulatory approval process. We have optional additional items in contracts, which are accounted for as separate contracts when the customer elects such options. Arrangements that include a promise for future commercial product supply and optional research and development services at the customer’s discretion are generally considered as options. We assess if these options provide a material right to the customer and, if so, such material rights are accounted for as separate performance obligations. If we are entitled to additional payments when the customer exercises these options, any additional payments are recorded in revenue when the customer obtains control of the goods or services. Transaction Price We have both fixed and variable consideration. Non-refundable upfront payments are considered fixed, while milestone payments are identified as variable consideration when determining the transaction price. Funding of research and development activities is considered variable until such costs are reimbursed at which point they are considered fixed. We allocate the total transaction price to each performance obligation based on the relative estimated standalone selling prices of the promised goods or services for each performance obligation. At the inception of each arrangement that includes milestone payments, we evaluate whether the milestones are considered probable of being achieved and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone is included in the transaction price. Milestone payments that are not within our control, such as approvals from regulators, are not considered probable of being achieved until those approvals are received. For arrangements that include sales-based royalties or earn-out payments, including milestone payments based on the level of sales, and the license or purchase agreement is deemed to be the predominant item to which the royalties or earn-out payments relate, we recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty or earn-out payment has been allocated has been satisfied (or partially satisfied). Allocation of Consideration As part of the accounting for these arrangements, we must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. Estimated selling prices for license rights are calculated using the residual approach. For all other performance obligations, we use a cost-plus margin approach. Timing of Recognition Significant management judgment is required to determine the level of effort required under an arrangement and the period over which we expect to complete our performance obligations under an arrangement. We estimate the performance period or measure of progress at the inception of the arrangement and re-evaluate it each reporting period. This re-evaluation may shorten or lengthen the period over which revenue is recognized. Changes to these estimates are recorded on a cumulative catch up basis. If we cannot reasonably estimate when our performance obligations either are completed or become inconsequential, then revenue recognition is deferred until we can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. Revenue is recognized for licenses or sales of functional intellectual property at the point in time the customer can use and benefit from the license. For performance obligations that are services, revenue is recognized over time proportionate to the costs that we have incurred to perform the services using the cost-to-cost input method. |
Research and Development Costs and Related Accrual | Research and Development Costs and Related Accrual Research and development expenses include internal and external costs. Internal costs include salaries and employment related expenses, facility costs, administrative expenses and allocations of corporate costs. External expenses consist of costs associated with outsourced contract research organization (“CRO”) activities, sponsored research studies, product registration, patent application and prosecution, and investigator sponsored trials. We also record accruals for estimated ongoing clinical trial costs. Clinical trial costs represent costs incurred by CROs and clinical sites. These costs are recorded as a component of research and development expenses. Under our agreements, progress payments are typically made to investigators, clinical sites and CROs. We analyze the progress of the clinical trials, including levels of patient enrollment, invoices received and contracted costs when evaluating the adequacy of accrued liabilities. Significant judgments and estimates must be made and used in determining the accrued balance in any accounting period. Actual results could differ from those estimates under different assumptions. Revisions are charged to expense in the period in which the facts that give rise to the revision become known. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share excludes the effect of dilution and is computed by dividing net loss by the weighted-average number of shares outstanding for the period. Diluted net loss per share reflects the potential dilution that could occur if securities or other contracts to issue shares were exercised into shares. In calculating diluted net loss per share, the numerator is adjusted for the change in the fair value of the warrant liability (only if dilutive) and the denominator is increased to include the number of potentially dilutive common shares assumed to be outstanding during the period using the treasury stock method. The following table sets forth the reconciliation of the numerator and denominator used in the computation of basic and diluted net loss per common share for the years ended (in thousands, except per share amounts): December 31, 2019 2018 Numerator: Net loss used for basic earnings per share $ (16,458) $ (9,308) Less change in fair value of warrant liability — — Less change in fair value of derivatives — 134 Net loss used for diluted earnings per share $ (16,458) $ (9,442) Denominator: Basic weighted-average outstanding common shares 22,957 5,688 Effect of dilutive potential common shares resulting from warrants — — Weighted-average shares outstanding—diluted 22,957 5,688 Net loss per common share: Basic $ (0.72) $ (1.64) Diluted $ (0.72) $ (1.66) The table below presents common shares underlying stock options and warrants that are excluded from the calculation of the weighted average number of shares of common stock outstanding used for the calculation of diluted net loss per common share. These are excluded from the calculation due to their anti-dilutive effect for the years ended (in thousands): December 31, 2019 2018 Weighted-average anti-dilutive common shares resulting from stock awards 1,074 588 Weighted-average anti-dilutive common shares resulting from warrants 7,679 264 Convertible debt 1,444 — 10,197 852 |
Leases | Leases In February 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standard Update, or ASU, No. 2016-02, Leases (Topic 842), to enhance the transparency and comparability of financial reporting related to leasing arrangements. We adopted the standard effective January 1, 2019. We determine whether the arrangement is or contains a lease at inception. Operating lease right-of-use assets and lease liabilities are recognized at the present value of the future lease payments at commencement date. The interest rate implicit in lease contracts is typically not readily determinable, and therefore, we utilize our incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received. Lease expense is recognized over the expected term on a straight-line basis. Operating leases are recognized on our balance sheet as right-of-use assets, operating lease liabilities current and operating lease liabilities non-current. We no longer recognize deferred rent on our balance sheet. |
Subsequent Events | Subsequent Events We have evaluated events that have occurred subsequent to December 31, 2019 and through the date that the financial statements are issued. |
Fair Value Measurements | Fair Value Measurements We measure the fair value of financial assets and liabilities based on authoritative guidance which defines fair value, establishes a framework consisting of three levels for measuring fair value, and requires disclosures about fair value measurements. 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. There are three levels of inputs that may be used to measure fair value: Level 1 – quoted prices in active markets for identical assets or liabilities; Level 2 – quoted prices for similar assets and liabilities in active markets or inputs that are observable; Level 3 – inputs that are unobservable (for example cash flow modeling inputs based on assumptions). Financial instruments, including receivables, accounts payable and accrued liabilities are carried at cost, which we believe approximates fair value due to the short-term nature of these instruments. The approximately $4.9 million and $8.9 million fair values of money market funds as of December 31, 2019 and 2018 included in our cash and cash equivalents are classified as Level 1 and were derived from quoted market prices as active markets for these instruments exists. Our warrant and derivative liabilities are classified within level 3 of the fair value hierarchy because the value is calculated using significant judgment based on our own assumptions in the valuation of these liabilities. The following table rolls forward the fair value of our warrant liability, the fair value of which is determined by Level 3 inputs for the year ended December 31, 2019 (in thousands): Fair value, beginning of period $ — Issuance of warrants 1,430 Change in fair value (1,110) Fair value, end of period $ 320 During the year ended December 31, 2018, we did not have any warrant liability. The following table rolls forward the fair value of our derivative liability, the fair value of which is determined by Level 3 inputs for the years ended (in thousands): December 31, 2019 2018 Fair value, beginning of period $ 25 $ — Issuance of derivative — 159 Change in fair value (25) (134) Fair value, end of period $ — $ 25 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Accounting Standards Adopted In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) . Topic 842 requires most lessees to recognize right of use assets and lease liabilities, but recognize expenses in a manner similar with current accounting standards. Effective January 1, 2019, we adopted the provisions under Topic 842 using a modified retrospective transition approach without adjusting comparative periods. Additionally, as permitted by Topic 842, we elected to apply the following practical expedients: (i) not to reassess whether any expired or existing contracts are or contain leases or the classification of any expired or existing leases and (ii) not to apply the recognition requirements to short-term leases. As a result of this adoption, we recorded operating lease right-of-use asset and operating lease liability associated with our office lease in our balance sheet. We used a discount rate of 12%, which reflects our borrowing rate as of the adoption date, to measure the present value of future lease payments to determine the fair value of our operating lease right-of-use asset and liability. Our office lease expires in June 2021 and we did not include an estimated renewal in the calculation of our operating lease right-of-use asset and liability as we believe that it is less than probable we will renew our office lease. Our adoption of Topic 842 did not result in any cumulative adjustment to the balance of our accumulated deficit as of January 1, 2019. Lease expense for operating lease payments is recognized on a straight-line basis over the lease term, which is consistent with Topic 840. The following table presents maturities of our operating lease as of December 31, 2019 (in thousands): 2020 $ 308 2021 155 Total minimum lease payments (base rent) 463 Less: imputed interest (41) Total operating lease liabilities $ 422 In June 2018, the FASB issued ASU 2018-07, Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting, which aligns the accounting for share-based payment awards issued to nonemployees with the guidance applicable to grants to employees. Under the new standard, equity-classified share-based payment awards issued to nonemployees are measured on the grant date, instead of the current requirement to remeasure the awards through the performance completion date. We adopted ASU 2018-07 during the three months ended March 31, 2019 using the prospective approach. The adoption of ASU 2018-07 did not have any material impact to our financial statements. In August 2018, the SEC published Release No. 33-10532, Disclosure Update and Simplification, or DUSTR, which adopted amendments to certain disclosure requirements that have become redundant, duplicative, overlapping, outdated or superseded, in light of other SEC disclosure requirements, GAAP, or changes in the information environment. While most of the DUSTR amendments eliminate updated or duplicative disclosure requirements, the final rule amends the interim financial statement requirements to include a reconciliation of changes in stockholders’ equity in the notes or as a separate statement for each period for which a statement of comprehensive loss is required to be filed. We adopted ASU 2018-07 during the three months ended March 31, 2019 and included a reconciliation of changes in stockholders’ equity in our interim financial statements, Accounting Standards Not Yet Adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses, which requires an organization to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. Financial institutions and other organizations will now use forward-looking information to better inform their credit loss estimates. The amendments in this ASU are effective for us in our interim period ending March 31, 2023. We are currently assessing the impact of the adoption of Topic 326 on our financial statements and disclosures. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement, which eliminates, adds and modifies certain disclosure requirements for fair value measurements as part of the FASB's disclosure framework project. The ASU is effective for us in our interim period ending March 31, 2020, with early adoption permitted. We do not expect the adoption of this ASU to have any significant impact on our quarterly or annual disclosures. In August 2018, the FASB issued ASU No. 2018-15, Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement that Is a Service Contract. The ASU aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use software license). Adoption of the ASU is either retrospective or prospective. The ASU is effective for us in our interim period ending March 31, 2020, with early adoption permitted. We are currently evaluating the impact of the adoption of ASU No. 2018-15 on our financial statements. |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Organization and Summary of Significant Accounting Policies | |
Schedule of components of inventories | As of December 31, 2019 2018 Raw materials and supplies $ 563 $ 510 Finished goods 435 752 $ 998 $ 1,262 |
Summary of activity with respect to our product returns, and discounts and rebates | The following table provides a summary of activity with respect to our product returns and discounts and rebates, which are included on our balance sheets within accrued sales allowances, and allowance for doubtful accounts, which are included on our balance sheets within receivables (in thousands): Accrued Sales Allowances Discounts and Allowance for Product Return Rebates Doubtful Allowance Allowance Total Accounts Balance at December 31, 2018 $ 33 $ 48 $ 81 $ — Provision 752 224 976 63 Payments/credits (64) (184) (248) — Balance at December 31, 2019 $ 721 $ 88 $ 809 $ 63 |
Schedule of computation of basic and diluted net income (loss) per common share | The following table sets forth the reconciliation of the numerator and denominator used in the computation of basic and diluted net loss per common share for the years ended (in thousands, except per share amounts): December 31, 2019 2018 Numerator: Net loss used for basic earnings per share $ (16,458) $ (9,308) Less change in fair value of warrant liability — — Less change in fair value of derivatives — 134 Net loss used for diluted earnings per share $ (16,458) $ (9,442) Denominator: Basic weighted-average outstanding common shares 22,957 5,688 Effect of dilutive potential common shares resulting from warrants — — Weighted-average shares outstanding—diluted 22,957 5,688 Net loss per common share: Basic $ (0.72) $ (1.64) Diluted $ (0.72) $ (1.66) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The table below presents common shares underlying stock options and warrants that are excluded from the calculation of the weighted average number of shares of common stock outstanding used for the calculation of diluted net loss per common share. These are excluded from the calculation due to their anti-dilutive effect for the years ended (in thousands): December 31, 2019 2018 Weighted-average anti-dilutive common shares resulting from stock awards 1,074 588 Weighted-average anti-dilutive common shares resulting from warrants 7,679 264 Convertible debt 1,444 — 10,197 852 |
Schedule of Fair Value of Warrant Liability | The following table rolls forward the fair value of our warrant liability, the fair value of which is determined by Level 3 inputs for the year ended December 31, 2019 (in thousands): Fair value, beginning of period $ — Issuance of warrants 1,430 Change in fair value (1,110) Fair value, end of period $ 320 During the year ended December 31, 2018, we did not have any warrant liability. The following table rolls forward the fair value of our derivative liability, the fair value of which is determined by Level 3 inputs for the years ended (in thousands): December 31, 2019 2018 Fair value, beginning of period $ 25 $ — Issuance of derivative — 159 Change in fair value (25) (134) Fair value, end of period $ — $ 25 |
Schedule of maturities of operating lease | The following table presents maturities of our operating lease as of December 31, 2019 (in thousands): 2020 $ 308 2021 155 Total minimum lease payments (base rent) 463 Less: imputed interest (41) Total operating lease liabilities $ 422 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property and Equipment | |
Schedule of Property and Equipment | Property and equipment consisted of the following (in thousands): As of December 31, 2019 2018 Furniture and office equipment $ 388 $ 388 Leasehold improvements 408 408 Laboratory equipment 3,413 3,249 Computer equipment 1,218 1,188 Construction in progress 73 — 5,500 5,233 Less accumulated depreciation and amortization (4,683) (4,439) Property and equipment, net $ 817 $ 794 |
Molteni Purchase Agreement (Tab
Molteni Purchase Agreement (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Molteni Purchase Agreement | |
Schedule of changes in contract assets and liabilities | The following table presents changes in contract assets and liabilities during the years ended December 31, 2019 and 2018 (in thousands): Beginning Ending Balance Additions Deductions Balance Year ended December 31, 2019 Contract assets $ 99 — (99) $ — Contract liabilities: Deferred revenue $ 313 — (313) $ — Year ended December 31, 2018 Contract assets $ — 291 (192) $ 99 Contract liabilities: Deferred revenue $ — 2,448 (2,135) $ 313 |
Warrant Liability (Tables)
Warrant Liability (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Warrant Liability | |
Schedule of weighted-average key assumptions used to calculate the fair value of the Placement Warrants | The below table represents the weighted-average key assumptions used to calculate the fair value of the Placement Warrants: As of August 7, 2019 December 31, 2019 Expected volatility 87 % 125 % Risk-free interest rate 1.5 % 1.7 % Dividend yield — — Expected term (in years) 4.9 4.6 Weighted-average fair value per share warrant $ 0.50 $ 0.11 |
Debt Agreements (Tables)
Debt Agreements (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Schedule of key assumptions used for valuation | The below table represents the weighted-average key assumptions used to calculate the fair value of the Placement Warrants: As of August 7, 2019 December 31, 2019 Expected volatility 87 % 125 % Risk-free interest rate 1.5 % 1.7 % Dividend yield — — Expected term (in years) 4.9 4.6 Weighted-average fair value per share warrant $ 0.50 $ 0.11 |
Restatement Due To Trigger Down Round Provision [Member] | |
Schedule of key assumptions used for valuation | We calculated the dividend of approximately $0.3 million resulting from the trigger of the down round provision in September 2018 using the Black Scholes Option Pricing Model and the assumptions indicated in the table below: Pre-reset Post-reset Exercise price per share $ 11.76 $ 1.50 Expected price volatility 71 % 71 % Expected term (in years) 5.8 5.8 Risk-free interest rate 3.0 % 3.0 % Dividend yield 0.0 % 0.0 % Weighted-average fair value of warrants $ 0.30 $ 0.84 |
Convertible Debt | |
Schedule of key assumptions used for valuation | As of September 18, 2018 December 31, 2018 Expected volatility 87 % 135 % Expected term (in years) 0.75 0.50 Risk-free interest rate 2.32 % 2.51 % Dividend yield — — Fair value of conversion provision (in thousands) $ 159 $ 25 |
Horizon Warrants | |
Schedule of key assumptions used for valuation | Expected price volatility 86 % Expected term (in years) 7.0 Risk-free interest rate 2.8 % Dividend yield 0.0 % Weighted-average fair value per share warrant $ 4.86 |
Molteni Warrants | |
Schedule of key assumptions used for valuation | The key assumptions used to value the Molteni Warrants were as follows: Expected price volatility 86 % Expected term (in years) 7.0 Risk-free interest rate 2.8 % Dividend yield 0.0 % Weighted-average fair value of warrants $ 4.86 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Stockholders' Equity | |
Schedule of warrants to purchase shares | As of December 31, 2019, the following warrants to purchase shares of our common stock were outstanding (in thousands, except per share price): Date Issued Expiration Date Exercise Price Outstanding 10/08/2014 10/08/2020 $ 19.80 141 07/27/2017 07/27/2024 $ 1.50 367 03/21/2018 03/21/2025 $ 7.20 7 03/21/2018 03/21/2025 $ 7.20 90 09/25/2018 09/25/2023 $ 0.60 4,632 09/25/2018 09/25/2023 $ 1.68 253 08/09/2019 02/09/2025 $ 1.07 2,852 10/18/2019 10/18/2024 $ 0.23 40,276 48,618 |
Schedule of shares of common stock reserved for future issuance | As of December 31, 2019, shares of common stock reserved by us for future issuance consisted of the following (in thousands): Stock options outstanding 1,191 Shares issuable upon the exercise of warrants 48,618 49,809 |
Stock Plans (Tables)
Stock Plans (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Stock Plans | |
Schedule of option activity | The following table summarizes option activity for the year ended December 31, 2019: Weighted Weighted Average Average Aggregate Exercise Remaining Intrinsic Shares Price per Contractual Value (in thousands) Share Term (years) (in thousands) Outstanding at January 1, 2019 665 $ 6.44 $ Granted 854 Cancelled/expired (327) Outstanding at December 31, 2019 1,192 $ $ — Exercisable at December 31, 2019 738 $ $ — |
Schedule of assumptions to estimate the stock-based compensation expense: | We use the Black-Scholes-Merton option-pricing model with the following assumptions to estimate the stock-based compensation expense: Years Ended December 31, 2019 2018 Weighted-average risk-free interest rate 2.21 % 2.84 % Expected dividend payments — — Expected holding period (years)(1) 6.39 Weighted-average volatility factor(2) 0.94 0.88 Estimated forfeiture rates for options granted 21 % 26 % (1) Expected holding period is based on historical experience of similar awards, giving consideration to the contractual terms of the stock-based awards, vesting schedules and the expectations of future employee behavior. (2) Weighted average volatility is based on the historical volatility of our common stock. (3) |
Schedule of the stock-based compensation expense | The following table summarizes the stock-based compensation expense (in thousands): Years Ended December 31, 2019 2018 Research and development $ 91 $ 575 General and administrative 481 982 Total stock-based compensation expenses $ 572 $ 1,557 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Taxes | |
Schedule of components of deferred tax assets | Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes and operating loss and credit carryforwards. Significant components of our deferred tax assets are as follows (in thousands): As of December 31, 2019 2018 Deferred tax assets: Net operating loss carryforwards $ 63,910 $ 62,863 Research credit carryforwards 15,683 15,886 Other, net 1,303 1,321 Total deferred tax assets 80,896 80,070 Deferred tax liabilities: Other, net (84) — Total deferred tax liabilities (84) — Valuation allowance (80,812) (80,070) Net deferred tax assets $ — $ — |
Schedule of provision for income taxes differs from federal statutory rate | The provision for income taxes consists of state minimum taxes due. The effective tax rate of our provision (benefit) for income taxes differs from the federal statutory rate as follows (in thousands): Years Ended December 31, 2019 2018 Computed at 21% $ (3,451) $ (1,879) State taxes (146) (167) Change in valuation allowance 768 197 Other 56 121 Revaluation of warrant liability (238) (30) Research and development credits (54) 144 Tax attributes expirations 2,698 975 Impact of IRC 162m 367 639 Total $ — $ — |
Quarterly Financial Data (Una_2
Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Data (Unaudited) | |
Schedule of Quarterly Financial Information | First Quarter Second Quarter Third Quarter Fourth Quarter (in thousands, except per share amount) Year ended December 31, 2019 Total revenue $ 945 $ 502 $ 947 $ 1,217 Net loss $ (4,517) $ (5,197) $ (2,803) $ (3,941) Basic net loss per share $ (0.34) $ (0.38) $ (0.18) $ (0.08) Diluted net loss per share $ (0.34) $ (0.38) $ (0.18) $ (0.08) Year ended December 31, 2018 Total revenue $ 1,064 $ 2,668 $ 1,650 $ 1,236 Net loss $ (2,605) $ (869) $ (2,330) $ (3,504) Basic net loss per share $ (0.74) $ (0.25) $ (0.64) $ (0.29) Diluted net loss per share $ (0.74) $ (0.25) $ (0.68) $ (0.29) |
Organization and Summary of S_4
Organization and Summary of Significant Accounting Policies - Componemts of Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 | May 25, 2018 |
Organization and Summary of Significant Accounting Policies | |||
Raw materials and supplies | $ 563 | $ 510 | |
Finished goods | 435 | 752 | |
Total inventories | $ 998 | $ 1,262 | $ 1,100 |
Organization and Summary of S_5
Organization and Summary of Significant Accounting Policies - Summary of Activity Product Returns and Discounts and Rebates (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Balance at December 31, 2018 | $ 81 |
Provision | 976 |
Payments/credits | (248) |
Balance at December 31, 2019 | 809 |
Product Returns Allowance [Member] | |
Balance at December 31, 2018 | 33 |
Provision | 752 |
Payments/credits | (64) |
Balance at December 31, 2019 | 721 |
Discounts and Rebates Allowance [Member] | |
Balance at December 31, 2018 | 48 |
Provision | 224 |
Payments/credits | (184) |
Balance at December 31, 2019 | 88 |
Allowance for Doubtful Accounts [Member] | |
Balance at December 31, 2018 | 0 |
Provision | 63 |
Payments/credits | 0 |
Balance at December 31, 2019 | $ 63 |
Organization and Summary of S_6
Organization and Summary of Significant Accounting Policies - computation of basic and diluted net income (loss) per common share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | |
Numerator: | ||||||||||
Net loss used for basic earnings per share | $ (3,941) | $ (2,803) | $ (5,197) | $ (4,517) | $ (3,504) | $ (2,330) | $ (869) | $ (2,605) | $ (16,458) | $ (9,308) |
Less change in fair value of warrant liability | 0 | 0 | ||||||||
Less change in fair value of derivatives | 0 | 134 | ||||||||
Net loss used for diluted earnings per share | $ (16,458) | $ (9,442) | ||||||||
Denominator: | ||||||||||
Basic weighted-average outstanding common shares | 22,957 | 5,688 | ||||||||
Effect of dilutive potential common shares resulting from warrants | 0 | 0 | ||||||||
Weighted-average shares outstanding-diluted | 22,957 | 5,688 | ||||||||
Net loss per common share: | ||||||||||
Basic | $ (0.08) | $ (0.18) | $ (0.38) | $ (0.34) | $ (0.29) | $ (0.64) | $ (0.25) | $ (0.74) | $ (0.72) | $ (1.64) |
Diluted | $ (0.08) | $ (0.18) | $ (0.38) | $ (0.34) | $ (0.29) | $ (0.68) | $ (0.25) | $ (0.74) | $ (0.72) | $ (1.66) |
Organization and Summary of S_7
Organization and Summary of Significant Accounting Policies - Antidilutive Securities Excluded from Computation of Earnings Per Shares (Details) - shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 10,197 | 852 |
Stock Awards | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 1,074 | 588 |
Warrant | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 7,679 | 264 |
Convertible Debt | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 1,444 | 0 |
Organization and Summary of S_8
Organization and Summary of Significant Accounting Policies - Fair Value of Warrant and Derivative Liability (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Warrant Liability [Member] | ||
Schedule of Organization and Summary of Significant Accounting Policies [Line Items] | ||
Fair value, beginning of period | $ 0 | |
Issuance of warrants | 1,430 | |
Change in fair value | (1,110) | |
Fair value, end of period | 320 | $ 0 |
Derivative Liability [Member] | ||
Schedule of Organization and Summary of Significant Accounting Policies [Line Items] | ||
Fair value, beginning of period | 25 | 0 |
Issuance of derivatives | 0 | 159 |
Change in fair value | (25) | (134) |
Fair value, end of period | $ 0 | $ 25 |
Organization and Summary of S_9
Organization and Summary of Significant Accounting Policies - Summary of Maturities of Operating Lease (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Organization and Summary of Significant Accounting Policies | |
2020 | $ 308 |
2021 | 155 |
Total minimum lease payments (base rent) | 463 |
Less: imputed interest | (41) |
Total operating lease liabilities | $ 422 |
Organization and Summary of _10
Organization and Summary of Significant Accounting Policies - Additional information (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||
Jan. 31, 2020USD ($) | Jan. 31, 2019$ / shares | Sep. 30, 2020USD ($) | Dec. 31, 2019USD ($)segment$ / shares | Jan. 01, 2019 | Dec. 31, 2018USD ($)$ / shares | |
Schedule of Organization and Summary of Significant Accounting Policies [Line Items] | ||||||
Number of Operating Segments | segment | 1 | |||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 0.1667 | |||||
Common Stock, Par or Stated Value Per Share | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | |||
Substantial Doubt about Going Concern, Management's Evaluation | We assess going concern uncertainty in our financial statements to determine if we have sufficient cash on hand and working capital, including available borrowings on loans, to operate for a period of at least one year from the date the financial statements are issued or available to be issued, which is referred to as the "look-forward period" as defined by Accounting Standard Update ASU No. 2014-15. As part of this assessment, based on conditions that are known and reasonably knowable to us, we will consider various scenarios, forecasts, projections, estimates and will make certain key assumptions, including the timing and nature of projected cash expenditures or programs, and its ability to delay or curtail expenditures or programs, if necessary, among other factors. Based on this assessment, as necessary or applicable, we make certain assumptions around implementing curtailments or delays in the nature and timing of programs and expenditures to the extent we deem probable those implementations can be achieved and we have the proper authority to execute them within the look-forward period in accordance with ASU No. 2014-15.Based upon the above assessment, we concluded that, at the date of filing the financial statements in this Annual Report on Form 10-K for the year ended December 31, 2019, we did not have sufficient cash to fund our operations for the next 12 months without additional funds and, therefore, there was substantial doubt about our ability to continue as a going concern within 12 months after the date the financial statements were issued. | |||||
Money Market Funds, at Carrying Value | $ 4,900 | $ 8,900 | ||||
Cash and Cash Equivalents, at Carrying Value | 5,223 | 9,295 | ||||
Subsequent Event | ||||||
Schedule of Organization and Summary of Significant Accounting Policies [Line Items] | ||||||
Net cash proceeds from common stock and exercises of warrants | $ 1,900 | $ 8,000 | ||||
Accounting Standards Update 2016-02 [Member] | ||||||
Schedule of Organization and Summary of Significant Accounting Policies [Line Items] | ||||||
Lessee, Operating Lease, Discount Rate | 12.00% | |||||
Fair Value, Recurring [Member] | Money Market Funds [Member] | ||||||
Schedule of Organization and Summary of Significant Accounting Policies [Line Items] | ||||||
Cash Equivalents, at Carrying Value | $ 4,900 | $ 8,900 | ||||
Minimum [Member] | ||||||
Schedule of Organization and Summary of Significant Accounting Policies [Line Items] | ||||||
Property, Plant and Equipment, Estimated Useful Lives | P3Y | |||||
Maximum [Member] | ||||||
Schedule of Organization and Summary of Significant Accounting Policies [Line Items] | ||||||
Property, Plant and Equipment, Estimated Useful Lives | P5Y |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 5,500 | $ 5,233 |
Less accumulated depreciation and amortization | (4,683) | (4,439) |
Property and equipment, net | 817 | 794 |
Furniture and office equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 388 | 388 |
Leasehold improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 408 | 408 |
Laboratory equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 3,413 | 3,249 |
Computer equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 73 | 0 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 1,218 | $ 1,188 |
Braeburn License (Details)
Braeburn License (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |
May 25, 2018 | Jun. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2019 | |
Braeburn License | ||||
License Revenue | $ 2,100,000 | $ 312,000 | ||
Additional amount received upon achievement of sales milestones | 15,000,000 | |||
Additional amount in regulatory milestones | 15,000,000 | |||
Revenues to be recognized per month for upfront payment | 15,000,000 | |||
Proceeds From Exclusive Commercialization Rights | $ 1,000,000 | |||
Inventory, Net | $ 1,100,000 | $ 1,262,000 | $ 998,000 |
Molteni Purchase Agreement - ch
Molteni Purchase Agreement - changes in contract assets and liabilities (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Molteni Purchase Agreement | ||
Contract assets | $ 99 | $ 0 |
Contract with Customer, Asset additions | 0 | 291 |
Contract with Customer, Asset Deductions | (99) | (192) |
Contract with Customer, Asset | 0 | 99 |
Deferred Revenue | 313 | 0 |
Deferred Revenue, Additions | 0 | 2,448 |
Deferred Revenue, Deductions | (313) | (2,135) |
Deferred Revenue | $ 0 | $ 313 |
Molteni Purchase Agreement - Ad
Molteni Purchase Agreement - Additional Information (Details) $ in Thousands | Mar. 21, 2018EUR (€) | Mar. 21, 2018USD ($) | Aug. 31, 2018USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Aug. 31, 2018EUR (€) | Aug. 31, 2018USD ($) |
Purchase Agreement | |||||||
Proceeds from Sale of Productive Assets | € 2,000,000 | $ 2,400 | |||||
Revenue from Contract with Customer, Including Assessed Tax | € 2,000,000 | $ 2,300 | $ 1,100 | $ 3,611 | $ 6,618 | ||
Estimated Selling Price | 1,400 | ||||||
Amount Received Under Amendment To Purchase Agreement | € 950,000 | $ 1,100 | |||||
Convertible Debt | € 550,000 | $ 600 | |||||
Intellectual Property [Member] | |||||||
Purchase Agreement | |||||||
Finite-Lived Intangible Assets, Translation and Purchase Accounting Adjustments | $ 1,000 | ||||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2019-04-01 | |||||||
Purchase Agreement | |||||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period | 15 years |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Commitments and Contingencies. | |||
Operating Leases, Rent Expense | $ 0.3 | $ 0.3 | |
Operating Leases, Rent expense | $ 0.3 |
Warrant Liability (Details)
Warrant Liability (Details) | Dec. 31, 2019 | Aug. 07, 2019 |
Expected volatility | ||
Class of Warrant or Right [Line Items] | ||
Warrants and rights outstanding | 125 | 87 |
Risk-free Interest Rate | ||
Class of Warrant or Right [Line Items] | ||
Warrants and rights outstanding | 1.7 | 1.5 |
Dividend Rate | ||
Class of Warrant or Right [Line Items] | ||
Warrants and rights outstanding | 0 | 0 |
Expected Term (in years) | ||
Class of Warrant or Right [Line Items] | ||
Warrants and rights outstanding | 4.6 | 4.9 |
Weighted-Average Fair Value per share warrant | ||
Class of Warrant or Right [Line Items] | ||
Warrants and rights outstanding | 0.11 | 0.50 |
Warrant Liability - Additional
Warrant Liability - Additional Information (Details) - August 2019 Offering - USD ($) $ / shares in Units, $ in Millions | Dec. 31, 2019 | Aug. 31, 2019 |
Class of Warrant or Right [Line Items] | ||
Total fair value of placement warrants | $ 0.3 | |
Common Stock [Member] | ||
Class of Warrant or Right [Line Items] | ||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 2,852,314 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 1.07 |
Debt Agreements - Horizon and M
Debt Agreements - Horizon and Molteni warrants (Details) | 12 Months Ended |
Dec. 31, 2019$ / shares | |
Horizon Warrants | |
Assumption | |
Weighted-average fair value of warrants | $ 4.86 |
Horizon Warrants | Measurement Input, Price Volatility [Member] | |
Assumption | |
Fair Value Assumptions Rate | 86.00% |
Horizon Warrants | Expected Term (in years) | |
Assumption | |
Fair Value Assumptions Term | 7 years |
Horizon Warrants | Risk-free Interest Rate | |
Assumption | |
Fair Value Assumptions Rate | 2.80% |
Horizon Warrants | Dividend Rate | |
Assumption | |
Fair Value Assumptions Rate | 0.00% |
Molteni Warrants | |
Assumption | |
Weighted-average fair value of warrants | $ 4.86 |
Molteni Warrants | Measurement Input, Price Volatility [Member] | |
Assumption | |
Fair Value Assumptions Rate | 86.00% |
Molteni Warrants | Expected Term (in years) | |
Assumption | |
Fair Value Assumptions Term | 7 years |
Molteni Warrants | Risk-free Interest Rate | |
Assumption | |
Fair Value Assumptions Rate | 2.80% |
Molteni Warrants | Dividend Rate | |
Assumption | |
Fair Value Assumptions Rate | 0.00% |
Debt Agreements - Pre-reset and
Debt Agreements - Pre-reset and post-reset (Details) | 12 Months Ended |
Dec. 31, 2019$ / shares | |
Pre Reset [Member] | |
Weighted Average Fair Value Assumptions of Warrants | $ 0.30 |
Pre Reset [Member] | Measurement Input, Exercise Price [Member] | |
Fair Value Assumptions Price Per Share | $ 11.76 |
Pre Reset [Member] | Measurement Input, Price Volatility [Member] | |
Fair Value Assumptions Rate | 71.00% |
Pre Reset [Member] | Expected Term (in years) | |
Fair Value Assumptions Term | 5 years 9 months 18 days |
Pre Reset [Member] | Risk-free Interest Rate | |
Fair Value Assumptions Rate | 3.00% |
Pre Reset [Member] | Dividend Rate | |
Fair Value Assumptions Rate | 0.00% |
Post Reset [Member] | |
Weighted Average Fair Value Assumptions of Warrants | $ 0.84 |
Post Reset [Member] | Measurement Input, Exercise Price [Member] | |
Fair Value Assumptions Price Per Share | $ 1.50 |
Post Reset [Member] | Measurement Input, Price Volatility [Member] | |
Fair Value Assumptions Rate | 71.00% |
Post Reset [Member] | Expected Term (in years) | |
Fair Value Assumptions Term | 5 years 9 months 18 days |
Post Reset [Member] | Risk-free Interest Rate | |
Fair Value Assumptions Rate | 3.00% |
Post Reset [Member] | Dividend Rate | |
Fair Value Assumptions Rate | 0.00% |
Debt Agreements - Convertible L
Debt Agreements - Convertible Loan (Details) $ in Thousands | Dec. 31, 2018USD ($) | Sep. 18, 2018USD ($) |
Fair value of conversion provision | $ 25 | $ 159 |
Measurement Input, Price Volatility [Member] | ||
Convertible loan embedded derivative, assumptions used | 135 | 87 |
Expected Term (in years) | ||
Convertible loan embedded derivative, assumptions used | 0.50 | 0.75 |
Risk-free Interest Rate | ||
Convertible loan embedded derivative, assumptions used | 2.51 | 2.32 |
Dividend Rate | ||
Convertible loan embedded derivative, assumptions used | 0 | 0 |
Debt Agreements - Additional in
Debt Agreements - Additional information (Details) - USD ($) $ / shares in Units, $ in Thousands | Jul. 27, 2017 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2018 | Feb. 28, 2018 | Jul. 27, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Mar. 21, 2018 |
Deemed Dividend On Trigger Down Round Provision | $ 0 | $ 285 | ||||||||
Gain (Loss) on Extinguishment of Debt | $ 226 | $ 0 | ||||||||
Horizon Technology Finance Corporation | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 1.50 | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 366,668 | |||||||||
Class Of Warrant Or Right Terms | 7 years | |||||||||
Venture Loan | ||||||||||
Debt Instrument, Face Amount | $ 7,000 | $ 7,000 | ||||||||
Debt Instrument Final Payment On Each Loan Tranche percentage | 5.00% | |||||||||
Early Repayment of Subordinated Debt | $ 3,000 | |||||||||
Long-term Debt | $ 7,000 | |||||||||
Venture Loan | Horizon Technology Finance Corporation | ||||||||||
Debt Instrument, Term | 46 months | |||||||||
Debt Instrument, Description of Variable Rate Basis | one-month LIBOR (floor of 1.10%) plus 8.40% | |||||||||
Molteni Loan | ||||||||||
Class Of Warrant Or Right Terms | 7 years | |||||||||
Long-term Debt | $ 4,000 | |||||||||
Conversion Price, (in dollars per share) | $ 0.225 | |||||||||
Debt Conversion, Converted Instrument, Shares Issued | 3,422,777 | 3,422,777 | ||||||||
Gain (Loss) on Extinguishment of Debt | $ 300 | |||||||||
Increase in Repayment of Long-term Debt | $ 300 | |||||||||
Horizon Loan | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 7.20 | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 6,667 | |||||||||
Long-term Debt | $ 2,400 | |||||||||
Conversion Price, (in dollars per share) | $ 7.20 | |||||||||
Stockholders' Equity Note, Changes in Capital Structure, Subsequent Changes to Number of Common Shares, Amount | $ 10,000 | |||||||||
Debt Instrument, Periodic Payment | $ 1,600 | |||||||||
Molteni Purchase Agreement | ||||||||||
Conversion Price, (in dollars per share) | $ 1.50 | |||||||||
Debt Conversion, Converted Instrument, Shares Issued | 448,287 | |||||||||
Gain (Loss) on Extinguishment of Debt | $ 100 | |||||||||
Minimum [Member] | Venture Loan | Horizon Technology Finance Corporation | ||||||||||
Debt Instrument Additional Face Amount | $ 10,000 | $ 10,000 | ||||||||
New Horizon Warrants | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 7.20 | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 90,000 |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants to purchase shares (Details) shares in Thousands | 12 Months Ended |
Dec. 31, 2019$ / sharesshares | |
Class of Warrant or Right | |
Outstanding | 48,618 |
Class of Warrant or Right Issued Date One [Member] | |
Class of Warrant or Right | |
Date Issued | Oct. 8, 2014 |
Expiration Date | Oct. 8, 2020 |
Exercise Price (in dollars per share) | $ / shares | $ 19.80 |
Outstanding | 141 |
Class of Warrant or Right Issued Date Two [Member] | |
Class of Warrant or Right | |
Date Issued | Jul. 27, 2017 |
Expiration Date | Jul. 27, 2024 |
Exercise Price (in dollars per share) | $ / shares | $ 1.50 |
Outstanding | 367 |
Class of Warrant or Right Issued Date Three [Member] | |
Class of Warrant or Right | |
Date Issued | Mar. 21, 2018 |
Expiration Date | Mar. 21, 2025 |
Exercise Price (in dollars per share) | $ / shares | $ 7.20 |
Outstanding | 7 |
Class Of Warrant or Right Issued Date Four [Member] | |
Class of Warrant or Right | |
Date Issued | Mar. 21, 2018 |
Expiration Date | Mar. 21, 2025 |
Exercise Price (in dollars per share) | $ / shares | $ 7.20 |
Outstanding | 90 |
Class Of Warrant or Right Issued Date Five [Member] | |
Class of Warrant or Right | |
Date Issued | Sep. 25, 2018 |
Expiration Date | Sep. 25, 2023 |
Exercise Price (in dollars per share) | $ / shares | $ 0.60 |
Outstanding | 4,632 |
Class Of Warrant or Right Issued Date Six [Member] | |
Class of Warrant or Right | |
Date Issued | Sep. 25, 2018 |
Expiration Date | Sep. 25, 2023 |
Exercise Price (in dollars per share) | $ / shares | $ 1.68 |
Outstanding | 253 |
Class Of Warrant or Right Issued Date Seven [Member] | |
Class of Warrant or Right | |
Date Issued | Aug. 9, 2019 |
Expiration Date | Feb. 9, 2025 |
Exercise Price (in dollars per share) | $ / shares | $ 1.07 |
Outstanding | 2,852 |
Class Of Warrant or Right Issued Date Eight [Member] | |
Class of Warrant or Right | |
Date Issued | Oct. 18, 2019 |
Expiration Date | Oct. 18, 2024 |
Exercise Price (in dollars per share) | $ / shares | $ 0.23 |
Outstanding | 40,276 |
Stockholders' Equity - Common s
Stockholders' Equity - Common stock reserved for future issuance (Details) shares in Thousands | Dec. 31, 2019shares |
Schedule of common stock reserved for future issuance | |
Common Stock, Capital Shares Reserved for Future Issuance | 49,809 |
Warrant | |
Schedule of common stock reserved for future issuance | |
Common Stock, Capital Shares Reserved for Future Issuance | 48,618 |
Employee Stock Option | |
Schedule of common stock reserved for future issuance | |
Common Stock, Capital Shares Reserved for Future Issuance | 1,191 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||||
Oct. 31, 2019 | Aug. 31, 2019 | Apr. 30, 2019 | Sep. 30, 2018 | Sep. 20, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Nov. 09, 2018 | |
Class of Warrant or Right [Line Items] | ||||||||
Issuance of common stock, net | $ 8,237 | $ 2,437 | ||||||
Conversion of Stock, Shares Issued | 5,483,334 | |||||||
Class of Warrant or Right, Outstanding | 48,618,000 | |||||||
Warrants, Expiration Period | 5 years | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 854,000 | |||||||
Sale of Stock, Price Per Share | $ 1.44 | |||||||
Proceeds from Warrant Exercises | $ 3,300 | $ 1,603 | $ 3,268 | |||||
Class A Units [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Issuance of common stock, net (in shares) | 850,000 | |||||||
Sale of Stock, Price Per Share | $ 1.50 | |||||||
Class B Units [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Issuance of common stock, net (in shares) | 8,225 | |||||||
Sale of Stock, Price Per Share | $ 1,000 | |||||||
Common Stock [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Issuance of common stock, net (in shares) | 37,696,000 | 1,815,000 | ||||||
Issuance of common stock, net | $ 37 | $ 2 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 950,000 | |||||||
Representatives Purchase Warrant [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 253,334 | |||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 1.68 | |||||||
Warrant | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 950,000 | 2,178,484 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.06 | |||||||
Warrant | Class B Units [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 667 | |||||||
August 2019 Offering | Common Stock [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Issuance of common stock, net (in shares) | 1,480,000 | |||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 2,852,314 | |||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 1.07 | |||||||
August 2019 Offering | Pre-Funded Warrants [Member] | Common Stock [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,372,314 | |||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.01 | |||||||
August 2019 Offering | Placement Warrants [Member] | Common Stock [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 2,852,314 | |||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 1.07 | |||||||
October 2019 Offering | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Issuance of common stock, net (in shares) | 40,276,000 | |||||||
Shares Issued, Price Per Share | $ 0.225 | |||||||
October 2019 Offering | Common Stock [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Issuance of common stock, net (in shares) | 35,886,000 | |||||||
October 2019 Offering | Pre-Funded Warrants [Member] | Common Stock [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 4,390,000 | |||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.01 | |||||||
October 2019 Offering | Placement Warrants [Member] | Class B Units [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 40,276,000 | |||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.225 | |||||||
ATM | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Issuance of common stock, net (in shares) | 329,656 | |||||||
Shares Issued, Price Per Share | $ 1.60 | |||||||
Proceeds from Issuance of Common Stock | $ 500 | |||||||
ATM | Maximum [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Issuance of common stock, net | $ 4,000 | $ 8,600 |
Stock Plans - stock option acti
Stock Plans - stock option activity (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Stock Plans | ||
Number of options outstanding at Beginning of year | 665 | |
Shares, Granted | 854 | |
Shares, Cancelled | (327) | |
Number of Options and Awards outstanding at end of year | 1,192 | 665 |
Shares, Exercisable at end of year | 738 | |
Weighted Average Exercise Price, Outstanding at Beginning of year | $ 17.94 | |
Weighted Average Exercise Price, Granted | 1.64 | |
Weighted Average Exercise Price, Cancelled | 18.06 | |
Weighted Average Exercise Price, Outstanding at End of year | 6.23 | $ 17.94 |
Weighted Average Exercise Price, Exercisable at end of year | $ 9.05 | |
Weighted Average Remaining Contractual Term, Outstanding (Years) | 7 years 10 months 6 days | 6 years 5 months 9 days |
Weighted Average Remaining Contractual Term, Exercisable at end of year | 6 years 11 months 23 days | |
Aggregate Intrinsic Value, Outstanding at Beginning of year | $ 4 | |
Aggregate Intrinsic Value, Outstanding at End of year | $ 4 |
Stock Plans - Fair value of sto
Stock Plans - Fair value of stock options (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Stock Plans | ||
Weighted-average risk-free interest rate | 2.21% | 2.84% |
Expected dividend payments | $ 0 | $ 0 |
Expected holding period (years) | 5 years 4 months 28 days | 6 years 4 months 21 days |
Weighted-average volatility factor | 0.94% | 0.88% |
Estimated forfeiture rates for options granted | 21.00% | 26.00% |
Stock Plans - Stock-based compe
Stock Plans - Stock-based compensation expense and impact (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost | ||
Total stock-based compensation expense | $ 572 | $ 1,557 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost | ||
Total stock-based compensation expense | 91 | 575 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost | ||
Total stock-based compensation expense | $ 481 | $ 982 |
Stock Plans - Additional inform
Stock Plans - Additional information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||
Jan. 31, 2019 | Jul. 31, 2002 | Aug. 31, 2001 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Aug. 31, 2015 | Feb. 28, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Weighted-average period for recognizing non-vested stock option | 1 year 6 months | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 1,192,000 | 665,000 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 1.64 | $ 3.21 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Number of Shares | 122,115 | |||||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Lower Range Limit | $ 21 | |||||||
Increase In The Price In Respect Of Lower Range In Respect Of Shares Authorised Under Compensation Plan | $ 1.55 | |||||||
Employee Stock Option | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized | $ 300,000 | |||||||
Common Stock [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Shares, Outstanding | 57,379,000 | 13,010,000 | 3,534,000 | |||||
2002 Plan [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 217,000 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 49,344 | |||||||
Share Based Compensation Arrangement By Share Based Payment Award Percentage Of Fair Market Value Of Common Stock For Calculating Exercise Price | 100.00% | |||||||
2001 Non-Qualified Plan [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 53,031 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 12,246 | |||||||
Share Based Compensation Arrangement By Share Based Payment Award Percentage Of Fair Market Value Of Common Stock For Calculating Exercise Price | 100.00% | |||||||
2015 Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 1,666,667 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 577,879 | |||||||
2015 Plan | Common Stock [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Shares, Outstanding | 1,088,788 | |||||||
2014 Plan [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 75,758 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 41,345 | |||||||
Stock Compensation Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Plan Modification, Incremental Compensation Cost | $ 81,000 | |||||||
Research and development | Stock Compensation Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Plan Modification, Incremental Compensation Cost | 54,000 | |||||||
General and administrative | Stock Compensation Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Plan Modification, Incremental Compensation Cost | $ 27,000 |
Income Taxes - Deferred tax ass
Income Taxes - Deferred tax assets (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 63,910 | $ 62,863 |
Research credit carryforwards | 15,683 | 15,886 |
Other, net | 1,303 | 1,321 |
Total deferred tax assets | 80,896 | 80,070 |
Other, net | (84) | |
Total deferred tax liabilities | (84) | |
Valuation allowance | (80,812) | (80,070) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Provision for in
Income Taxes - Provision for income taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Effective Income Tax Rate Reconciliation, Amount [Abstract] | ||
Computed at 21% | $ (3,451) | $ (1,879) |
State taxes | (146) | (167) |
Change in valuation allowance | 768 | 197 |
Other | 56 | 121 |
Revaluation of warrant liability | (238) | (30) |
Research and development credits | (54) | 144 |
Tax attributes expirations | 2,698 | 975 |
Impact of IRC 162m | 367 | 639 |
Total | $ 0 | $ 0 |
Income Taxes - Additional infor
Income Taxes - Additional information (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Line Items] | ||
Operating Loss Carry forwards Not Subject To Expiration | $ 23.5 | |
Operating Loss Carryforwards, Limitations on Use Percentage | 80.00% | |
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | $ 0.7 | $ 0.2 |
California Franchise Tax Board [Member] | ||
Income Tax Disclosure [Line Items] | ||
Operating Loss Carry Forwards Expiration Year | 2039 | |
Operating Loss Carryforwards | $ 108.2 | |
Domestic Tax Authority [Member] | ||
Income Tax Disclosure [Line Items] | ||
Operating Loss Carry Forwards Expiration Year | 2037 | |
Operating Loss Carryforwards | $ 244.8 | |
Domestic Tax Authority [Member] | Research Tax Credit Carryforward [Member] | ||
Income Tax Disclosure [Line Items] | ||
Operating Loss Carry Forwards Expiration Year | 2039 | |
Operating Loss Carryforwards | $ 8.5 | |
State and Local Jurisdiction [Member] | Research Tax Credit Carryforward [Member] | ||
Income Tax Disclosure [Line Items] | ||
Tax Credit Carryforward, Amount | $ 9.1 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||
Mar. 31, 2020 | Feb. 29, 2020 | Jan. 31, 2020 | Sep. 30, 2018 | Sep. 20, 2018 | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Mar. 16, 2020 | Dec. 31, 2017 | |
Subsequent Event [Line Items] | ||||||||||
Cumulative net cash proceeds from exercise of warrants | $ 3,300 | $ 1,603 | $ 3,268 | |||||||
Stockholders' equity | $ 1,433 | $ 6,831 | $ 857 | |||||||
Class B Units [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Issuance of common stock, net (in shares) | 8,225 | |||||||||
Subsequent Event | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Issuance of common stock, net (in shares) | 8,700,000 | |||||||||
Number of warrants to purchase | 8,700,000 | |||||||||
Exercise price | $ 0.25 | |||||||||
Net cash proceeds | $ 1,900 | $ 8,000 | ||||||||
Stockholders' equity | $ 5,300 | |||||||||
Subsequent Event | Placement Warrants [Member] | Class B Units [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Number of warrants to purchase | 27,388,464 | 27,388,464 | 27,388,464 | |||||||
Cumulative net cash proceeds from exercise of warrants | $ 6,200 | $ 6,200 | $ 6,200 |
Quarterly Financial Data (Una_3
Quarterly Financial Data (Unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | |
Quarterly Financial Data (Unaudited) | ||||||||||
Total revenue | $ 1,217 | $ 947 | $ 502 | $ 945 | $ 1,236 | $ 1,650 | $ 2,668 | $ 1,064 | ||
Net loss | $ (3,941) | $ (2,803) | $ (5,197) | $ (4,517) | $ (3,504) | $ (2,330) | $ (869) | $ (2,605) | $ (16,458) | $ (9,308) |
Basic net loss per share | $ (0.08) | $ (0.18) | $ (0.38) | $ (0.34) | $ (0.29) | $ (0.64) | $ (0.25) | $ (0.74) | $ (0.72) | $ (1.64) |
Diluted net loss per share | $ (0.08) | $ (0.18) | $ (0.38) | $ (0.34) | $ (0.29) | $ (0.68) | $ (0.25) | $ (0.74) | $ (0.72) | $ (1.66) |