Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Mar. 20, 2017 | Jun. 30, 2016 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2016 | ||
Document Fiscal Year Focus | 2,016 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | PIRS | ||
Entity Registrant Name | PIERIS PHARMACEUTICALS, INC. | ||
Entity Central Index Key | 1,583,648 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Smaller Reporting Company | ||
Entity Common Stock, Shares Outstanding | 43,058,827 | ||
Entity Public Float | $ 69,324,711 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash | $ 29,355,528 | $ 29,349,124 |
Accounts receivable | 57,582 | |
Prepaid expenses and other current assets | 3,259,503 | 2,311,385 |
Total current assets | 32,672,613 | 31,660,509 |
Property and equipment, net | 2,264,477 | 2,162,771 |
Other non-current assets | 125,741 | 126,781 |
Total assets | 35,062,831 | 33,950,061 |
Current liabilities: | ||
Accounts payable | 2,386,183 | 1,058,536 |
Accrued expenses and other current liabilities | 3,719,457 | 1,739,380 |
Deferred revenues, current portion | 2,274,514 | |
Total current liabilities | 8,380,154 | 2,797,916 |
Deferred revenue, net of current portion | 1,409,483 | |
Other long-term liabilities | 46,667 | 23,852 |
Total liabilities | 9,836,304 | 2,821,768 |
Stockholders' equity: | ||
Preferred stock, $0.001 par value per share, 4,963 shares authorized and 4,963 and zero issued and outstanding at December 31, 2016 and December 31, 2015 | 5 | |
Common stock, $0.001 par value per share, 300,000,000 shares authorized and 43,058,827 and 39,833,023 issued and outstanding at December 31, 2016 and December 31, 2015 | 43,059 | 39,833 |
Additional paid-in capital | 129,349,768 | 112,226,723 |
Accumulated other comprehensive loss | (1,501,452) | (1,272,574) |
Accumulated deficit | (102,664,853) | (79,865,689) |
Total stockholders' equity | 25,226,527 | 31,128,293 |
Total liabilities and stockholders' equity | $ 35,062,831 | $ 33,950,061 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2016 | Dec. 31, 2015 |
Statement of Financial Position [Abstract] | ||
Preferred Stock, par value | $ 0.001 | $ 0.001 |
Preferred Stock, shares authorized | 4,963 | 4,963 |
Preferred Stock, shares issued | 4,963 | 0 |
Preferred Stock, outstanding | 4,963 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 43,058,827 | 39,833,023 |
Common stock, outstanding | 43,058,827 | 39,833,023 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Income Statement [Abstract] | ||
Revenue | $ 5,830,674 | $ 2,931,931 |
Operating expenses | ||
Research and development | 19,698,803 | 8,244,751 |
General and administrative | 8,890,886 | 8,368,215 |
Total operating expenses | 28,589,689 | 16,612,966 |
Loss from operations | (22,759,015) | (13,681,035) |
Interest income (expense), net | 2,320 | (184,645) |
Other income, net | 119,501 | 10,905 |
Loss before income taxes | (22,637,194) | (13,854,775) |
Provision for income tax | 161,970 | 203,866 |
Net Loss | $ (22,799,164) | $ (14,058,641) |
Net loss per share Basic and diluted | $ (0.55) | $ (0.41) |
Weighted average number of common shares outstanding Basic and diluted | 41,713,223 | 34,392,636 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ 22,799,164 | $ 14,058,641 |
Other comprehensive income/(loss) components: | ||
Foreign currency translation | (228,878) | (429,477) |
Total other comprehensive income/(loss) | (228,878) | (429,477) |
Comprehensive loss | $ 23,028,042 | $ 14,488,118 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) | Total | Convertible Series A Preferred Shares [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Deficit [Member] |
Beginning Balance at Dec. 31, 2014 | $ 18,006,418 | $ 29,280 | $ 84,627,283 | $ (843,097) | $ (65,807,048) | |
Beginning Balance shares at Dec. 31, 2014 | 29,279,522 | |||||
Net loss | (14,058,641) | (14,058,641) | ||||
Foreign currency translation adjustment | (429,477) | (429,477) | ||||
Stock based compensation expense | 1,164,633 | 1,164,633 | ||||
Issuance of restricted shares | 446,400 | $ 150 | 446,250 | |||
Issuance of restricted shares,shares | 150,000 | |||||
Issuance of consulting shares | 225,000 | $ 95 | 224,905 | |||
Issuance of consulting shares,shares | 95,765 | |||||
Issuance of Common and Preferred stock, net offering costs | 25,763,960 | $ 10,303 | 25,753,657 | |||
Issuance of Common and Preferred stock, net offering costs, shares | 10,302,736 | |||||
Options exercised | 10,000 | $ 5 | 9,995 | |||
Options exercised,shares | 5,000 | |||||
Ending Balance at Dec. 31, 2015 | 31,128,293 | $ 39,833 | 112,226,722 | (1,272,574) | (79,865,689) | |
Ending Balance shares at Dec. 31, 2015 | 39,833,023 | |||||
Net loss | (22,799,164) | (22,799,164) | ||||
Foreign currency translation adjustment | (228,878) | (228,878) | ||||
Stock based compensation expense | 1,905,256 | 1,905,256 | ||||
Issuance of Common and Preferred stock, net offering costs | 15,221,021 | $ 5 | $ 3,226 | 15,217,790 | ||
Issuance of Common and Preferred stock, net offering costs, shares | 4,963 | 3,225,804 | ||||
Ending Balance at Dec. 31, 2016 | $ 25,226,527 | $ 5 | $ 43,059 | $ 129,349,768 | $ (1,501,452) | $ (102,664,853) |
Ending Balance shares at Dec. 31, 2016 | 4,963 | 43,058,827 |
Consolidated Statements of Cha7
Consolidated Statements of Changes in Stockholders' Equity (Parenthetical) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Offering cost | $ 1,279,419 | $ 2,568,565 |
Convertible Series A Preferred Shares [Member] | ||
Offering cost | 1,279,419 | 2,568,565 |
Common Stock [Member] | ||
Offering cost | 1,279,419 | 2,568,565 |
Additional Paid-in Capital [Member] | ||
Offering cost | 1,279,419 | 2,568,565 |
Accumulated Other Comprehensive Loss [Member] | ||
Offering cost | 1,279,419 | 2,568,565 |
Accumulated Deficit [Member] | ||
Offering cost | $ 1,279,419 | $ 2,568,565 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Operating activities: | ||
Net loss | $ (22,799,164) | $ (14,058,641) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 361,382 | 307,906 |
Stock-based compensation | 1,905,256 | 1,164,633 |
Disposal of fixed assets | 49,437 | |
Non-cash restricted shares | 446,400 | |
Non-cash consulting shares | 225,000 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | (58,651) | |
Prepaid expenses and other assets | (1,019,665) | (1,256,151) |
Deferred Revenue | 3,752,400 | |
Accounts payable | 1,360,274 | (90,924) |
Accrued expenses and other current liabilities | 2,060,797 | 556,297 |
Net cash used in operating activities | (14,387,934) | (12,705,480) |
Investing activities: | ||
Purchase of property and equipment | (580,639) | (620,747) |
Proceeds from sale of property and equipment | 20,968 | |
Net cash used in investing activities | (559,671) | (620,747) |
Financing activities: | ||
Proceeds from exercise of options | 0 | 10,000 |
Issuance of Common and Preferred Stock, net of issuance costs | 15,221,021 | 25,763,960 |
Repayment of debt | (1,157,940) | |
Net cash used in financing activities | 15,221,021 | 24,616,020 |
Effect of exchange rate change on cash and cash equivalents | (267,012) | (414,880) |
Net increase in cash and cash equivalents | 6,404 | 10,874,913 |
Cash and cash equivalents at beginning of year | 29,349,124 | 18,474,211 |
Cash and cash equivalents at end of year | 29,355,528 | 29,349,124 |
Supplemental cash flow disclosures: | ||
Cash paid for interest | 206,269 | |
Cash paid for income taxes | 161,970 | $ 203,866 |
Property and equipment included in accounts payable | $ 21,706 |
Corporate Information
Corporate Information | 12 Months Ended |
Dec. 31, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Corporate Information | 1. Corporate Information Pieris Pharmaceuticals, Inc. was founded in May 2013 and is a holding company. On December 17, 2014 Pieris Pharmaceuticals GmbH (“Pieris GmbH”) (formerly Pieris AG, a German company which was founded in 2001 by Prof. Dr. Arne Skerra, Professor at the Technical University of Munich, Germany, and Claus Schalper) became a wholly owned subsidiary of Pieris Pharmaceuticals, Inc., which was previously named Marika Inc. pursuant to a share exchange transaction (the “Acquisition”). The registered office of Pieris Pharmaceuticals, Inc. and the corporate headquarters is located in Boston, MA and the research facility of Pieris GmbH is located in Freising-Weihenstephan, Germany. Pieris Australia Pty Ltd., a wholly owned subsidiary of Pieris GmbH, was formed on February 14, 2014 to conduct research and development in Australia. Effective as of August 26, 2015 and with notification from the Amtsgericht München as of September 29, 2015, Pieris AG was transformed to Pieris GmbH as a result of a change in the legal entity. Pieris Pharmaceuticals, Inc. and its consolidated subsidiaries (collectively “Pieris” or the “Company”) is a clinical-stage biopharmaceutical company that discovers and develops Anticalin based drugs to target validated disease pathways in a unique and transformative way. The Company’s pipeline includes, among other programs, an immuno-oncology multispecific tailored for the tumor micro-environment, an inhaled Anticalin to treat uncontrolled asthma, and a half-life-optimized Anticalin to treat anemia. The Company’s core Anticalin technology and platform was developed in Germany, and the Company has partnership arrangements with major multi-national pharmaceutical companies headquartered in the U.S., Europe, Japan, and with regional pharmaceutical companies headquartered in India. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Consolidation The accompanying consolidated financial statements of Pieris Pharmaceuticals, Inc. and its wholly owned subsidiaries were prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). The consolidated financial statements include the accounts of all subsidiaries. All intercompany balances and transactions have been eliminated. Use of Estimates The preparation of the financial statements in accordance with U.S. GAAP requires management to make estimates, judgments, and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and the related disclosures at the date of the financial statements and during the reporting period. Significant estimates are used for, but are not limited to, revenue recognition, deferred tax assets, liabilities and valuation allowances, fair value of stock options and various accruals. Management evaluates its estimates on an ongoing basis. Actual results and outcomes could differ materially from management’s estimates, judgments, and assumptions. Foreign Currency Translation The financial statements of Pieris’ foreign subsidiaries are translated from local currency into reporting currency, which is U.S. dollars, using the current exchange rate at the balance sheet date for assets and liabilities, and the average exchange rate prevailing during the period for revenues and expenses. The functional currency for Pieris’ foreign subsidiaries is considered to be the local currency for each entity and, accordingly, translation adjustments for these subsidiaries are included in accumulated other comprehensive loss within stockholders’ equity. Realized and unrealized gains and losses resulting from foreign currency transactions denominated in currencies other than the functional currency are reflected as other income (expense), net in the consolidated statements of operations. Cash, Cash Equivalents, and Restricted Cash Cash and cash equivalents consist of cash on deposit in banks and other cash invested temporarily in money-market funds that are highly liquid and have an original maturity of less than 90 days at the date of purchase. The Company held no restricted cash as of December 31, 2016. As of December 31, 2015 the Company held $17,302 in restricted cash. Such bank balances in 2015 related to prepayments received by the Company pursuant to EU grants under the EUROCALIN program (see Note 3 Revenue We expect that our existing cash and cash equivalents will enable us to fund our operations and capital expenditure requirements through the filing of our 2017 financial statements. Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that subject Pieris to concentrations of credit risk include cash and cash equivalents and accounts receivable. Pieris maintains cash with various major financial institutions. Pieris had no cash equivalents as of December 31, 2016 and 2015. Pieris maintains deposits and owns money market funds only in highly rated financial institutions to minimize the credit risk from the financial institutions. There were no money market funds held at December 31, 2016. Management periodically reviews the credit standing of these financial institutions and believes that Pieris is not exposed to significant credit risk from the institutions in which those deposits are held. As of December 31, 2016 and December 31, 2015, Pieris is not exposed to significant credit risks from accounts receivable. Pieris relies on third parties to conduct preclinical and clinical studies. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, Pieris may not be able to obtain regulatory approval for Pieris’s drug candidates and Pieris’s business could be substantially impacted. Furthermore, Pieris is exposed to the risks associated with third parties formulating and manufacturing its preclinical and clinical drug supplies and any approved product candidates. The development and commercialization of any of its drug candidates could be stopped, delayed or made less profitable if those third parties fail to provide Pieris with sufficient quantities of such drug candidate or fail to do so at acceptable quality levels, including in accordance with applicable regulatory requirements and prices. In line with such third-party risk, Pieris depends significantly on the Research and Licensing Agreement (or the “TUM License Agreement”) with Technische Universität München (“TUM” or “Technical University Munich”), under which certain intellectual property rights are exclusively licensed to Pieris. In the event that the TUM License Agreement is terminated by TUM, Pieris would be significantly hampered in its efforts to develop and commercialize, as well as to sub-license, the drug candidates covered by such exclusive license. Accounts Receivable Accounts receivable are recorded net of allowances for doubtful accounts and represent amounts due from third parties and collaboration partners. Management monitors and evaluates collectability of receivables on an ongoing basis and considers whether an allowance for doubtful accounts is necessary. Management determined that no such reserve is needed as of December 31, 2016 and 2015. Historically, Pieris has not had collectability issues with third parties and collaboration partners. Property and Equipment Property and equipment are recorded at acquisition cost, less accumulated depreciation and impairment. Depreciation on property and equipment is calculated using the straight-line method over the remaining estimated useful lives of the assets. Maintenance and repairs to these assets are charged to expenses as occurred. The estimated useful life of the different groups of property and equipment is as follows: Asset Classification Estimated useful life (in years) Leasehold improvements shorter of useful life or remaining life of the lease Laboratory equipment 1 - 14 Office and computer equipment 1 - 15 Impairment of Long-lived Assets Pieris reviews its long-lived assets to be held and used for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Pieris evaluates the realizability of its long-lived assets based on profitability and cash flow expectations for the related asset. Any write-downs are treated as permanent reductions in the carrying amount of the assets. Pieris believes that, as of each of the balance sheets presented, none of Pieris’ long-lived assets were impaired. Revenue Recognition Pieris has entered into several licensing and development agreements with collaboration partners for the development of Anticalin ® Revenue Recognition—Multiple-Element Arrangements Revenue Recognition—Milestone Method Multiple-Element Arrangements When evaluating multiple-element arrangements, Pieris identifies the deliverables included within the agreement and evaluates which deliverables represent separate units of accounting based on whether the delivered element has stand-alone value to the customer or if the arrangement includes a general right of return for delivered items. The consideration received is allocated among the separate units of accounting using the relative selling price method, and the applicable revenue recognition criteria are applied to each of the separate units of accounting. Pieris has used best estimate of selling price methodology to estimate the selling price for licenses and options to acquire additional licenses to its proprietary technology because Pieris does not have Vendor Specific Objective Evidence or Third Party Evidence of selling price for these deliverables. To determine the estimated selling price of a license to its proprietary technology, Pieris considers market conditions as well as entity-specific factors, including those factors contemplated in negotiating the agreements, terms of previous collaborative agreements, similar agreements entered into by third parties, market opportunity, estimated development costs, probability of success and the time needed to commercialize a product candidate pursuant to the license. In validating Pieris’ best estimate of selling price, Pieris evaluates whether changes in the key assumptions used to determine the best estimate of selling price will have a significant effect on the allocation of arrangement consideration among multiple deliverables. Multiple element arrangements, such as license and development arrangements, are analyzed to determine whether the deliverables, which often include a license and performance obligations such as research and steering committee services, can be separated or whether they must be accounted for as a single unit of accounting in accordance with generally accepted accounting principles, or U.S. GAAP. The Company recognizes up-front license payments as revenue upon delivery of the license only if the license has stand-alone value. If the license is considered to not have stand-alone value, the arrangement would then be accounted for as a single unit of accounting and the license payments and payments for performance obligations are recognized as revenue over the estimated period of when the performance obligations are performed. If the Company is involved in a steering committee as part of a multiple element arrangement, the Company assesses whether its involvement constitutes a performance obligation or a right to participate. Steering committee services that are determined to be performance obligations are combined with other research services or performance obligations required under an arrangement, if any, in determining the level of effort required in an arrangement and the period over which the Company expects to complete its aggregate performance obligations. Whenever the Company determines that an arrangement should be accounted for as a single unit of accounting, it must determine the period over which the performance obligations will be performed and revenue will be recognized. Revenue will be recognized using either a relative performance or straight-line method. The Company recognizes revenue using the relative performance method provided that the Company can reasonably estimate the level of effort required to complete its performance obligations under an arrangement and such performance obligations are provided on a best-efforts basis. Full-time equivalents are typically used as the measure of performance. If the Company cannot reasonably estimate when its performance obligation either ceases or becomes inconsequential and perfunctory, then revenue is deferred until the Company can reasonably estimate when the performance obligation ceases or becomes inconsequential. Revenue is then recognized over the remaining estimated period of performance. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations under an arrangement. The accounting treatment for options granted to collaborators is dependent upon the nature of the option granted to the collaborative partner. Options are considered substantive if, at the inception of an agreement, Pieris is at risk as to whether the collaborative partner will choose to exercise the options to secure additional goods or services. Factors that are considered in evaluating whether options are substantive include the overall objective of the arrangement, the benefit the collaborator might obtain from the agreement without exercising the options, the cost to exercise the options relative to the total upfront consideration, and the additional financial commitments or economic penalties imposed on the collaborator as a result of exercising the options. In arrangements where options to obtain additional deliverables are considered substantive, Pieris determines whether the optional licenses are priced at a significant and incremental discount. If the prices include a significant and incremental discount, the option is considered a deliverable in the arrangement. However, if not priced at a discount, the elements included in the arrangement are considered to be only the non-contingent elements. When a collaborator exercises an option to acquire an additional license, the exercise fee that is attributed to the additional license and any incremental discount allocated at inception are recognized in a manner consistent with the treatment of up-front payments for licenses ( i.e. Payments or reimbursements resulting from Pieris’ research and development efforts in multi-element arrangements in which Pieris’s research and development efforts are considered deliverable are recognized as the services are performed and are presented on a gross basis so long as there is persuasive evidence of an arrangement, the fee is fixed or determinable, and collection of the related receivable is reasonably assured. Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue in the accompanying balance sheets. Milestone Payments and Royalties At the inception of each agreement that includes milestone payments, Pieris evaluates whether each milestone is substantive and at risk to both parties on the basis of the contingent nature of the milestone. This evaluation includes an assessment of whether: (a) the consideration is commensurate with either (1) the entity’s performance to achieve the milestone, or (2) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone, (b) the consideration relates solely to past performance and (c) the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. Pieris evaluates factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required to achieve the respective milestone and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement in making this assessment. Pieris aggregates milestones into four categories: (i) research milestones, (ii) development milestones, (iii) commercial milestones and (iv) sales milestones. Research milestones are typically achieved upon reaching certain success criteria as defined in each agreement related to developing an Anticalin protein against the specified target. Development milestones are typically reached when a compound reaches a defined phase of clinical research or passes such phase, or upon gaining regulatory approvals. Commercial milestones are typically achieved when an approved pharmaceutical product reaches the status for commercial sale or certain defined levels of net sales by the licensee, such as when a product first achieves global sales or annual sales of a specified amount. Sales milestones are typically achieved when an approved pharmaceutical product exceed net sales as defined in each agreement. For revenues from research, development and sales milestone payments, if the milestones are deemed substantive and the milestone payments are nonrefundable, such amounts are recognized entirely upon successful accomplishment of the milestones. Milestones that are not considered substantive are accounted for as license payments and recognized on a straight-line basis over the period of performance. To date, Pieris has determined all milestones are substantive. Revenues from commercial milestone payments are accounted for as royalties and are recorded as revenue upon achievement of the milestone, assuming all other revenue recognition criteria are met. Royalty payments are recognized in revenues based on the timing of royalty payments earned in accordance with the agreements, which typically is the period when the relevant sales occur, assuming all other revenue recognition criteria are met. Government Grants Government grants are recognized when there is reasonable assurance that all conditions will be complied with and the grant will be received. As the government grants generally represent subsidies for specified activities, they are recognized when earned as revenue from grants. Otherwise, government grants are credited against the expenses incurred to receive the grant. Funds received that are not related to research and development expenses that have already been incurred, such as the EUROCALIN grant, are recorded as deferred revenue until such time that the related expenses have been incurred by Pieris or by one of the other members of the EUROCALIN consortium. At the time eligible expenses are incurred, the applicable portion of deferred revenue, according to the respective funding rates, is recorded as revenue from grants. Research and Development Research and development expenses are charged to the statement of operations as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including salaries and benefits, facilities costs, pre-clinical and clinical costs, contract services, consulting, depreciation and amortization expense, and other related costs. Costs associated with acquired technology, in the form of upfront fees or milestone payments, are charged to research and development expense as incurred. Income Taxes The Company applies ASC 740— Income Taxes From time to time, the Company may receive tax credits in the form of cash in our Australian jurisdiction, irrespective of a tax liability. The Australian R&D Tax Incentive credit is a self-assessed, entitlement program that provides a credit for eligible R&D entities engaging in R&D activities. The level of credit for years starting before 1 July 2016 is a 45% refundable credit where the R&D entity’s aggregated turnover for the income tax year is less than $20 million and at any time during the income tax year the R&D entity is not controlled by an exempt entity or combination of exempt entities per s 328-125 of the Income Tax Assessment Act 1997 (ITAA 97). The entity submitted an Advance and Overseas Finding application, which was approved and awarded certificates OF00630 for the year beginning 1 January 2015. The Advance and Overseas finding certification is in force for the following two income years for Australian activities and until completion for overseas activities. This application detailed the R&D activities to be conducted in Australia and overseas. The Company records the Australian R&D tax credit as an offset to research and development expenses in the consolidated statements of operations, as this was where the original expense was recorded. For the years ended December 31, 2016 and 2015 the Company recorded $1.5 million and $0.4 million, respectively. As of December 31, 2016, the Company recorded a receivable for $1.5 million related to the Australian R&D Tax Incentive credit. Stock-based Compensation Pieris measures share-based payments in accordance with ASC Topic 718, Stock Compensation The Company uses the Black-Scholes option pricing model to determine the estimated fair value for stock-based awards. Option-pricing models require the input of various subjective assumptions, including the option’s expected life, expected dividend yield, price volatility, risk free interest rate and forfeitures of the underlying stock. Accordingly, the weighted-average fair value of the options granted during the years ended December 31, 2016 and 2015 was $1.00 and $1.87, respectively based on the following assumptions: Years Ended December 31, 2016 2015 Risk free interest rate 1.13%-2.08% 1.47%-1.89% Expected term 5.0 – 5.7 years 5.0 – 6.1 years Dividend yield — — Expected volatility 74.90%-76.00% 72.65%-75.07% Expected volatility rates are based on historical volatility of the common stock of comparable publicly traded entities, and other factors due to the lack of historic information of the Company’s common stock. The expected life of stock-based options is the period of time for which the stock-based options are expected to be outstanding. Given the lack of historic exercise data, the expected life is determined using the “simplified method” which is defined as the midpoint between the vesting date and the end of the contractual term. Under the new guidance of ASU No. 2016-09, “Compensation—Stock Compensation (Topic 718) Improvements to Employee Share-Based Payment Accounting” Stock-Based Compensation, Pieris recorded stock-based compensation expense of $1.9 million and $1.2 million for the years ended December 31, 2016 and 2015, respectively. Total stock-based compensation expense was recorded in operating expenses based upon the functional responsibilities of the individuals holding the respective options as follows: Years Ended 2016 2015 Research and development $ 599,138 $ 379,066 General and administrative 1,306,118 785,567 Total stock-based compensation $ 1,905,256 $ 1,164,633 Contingencies Accruals are recorded for loss contingencies when it is probable that a liability has been incurred and the amount of the related loss can be reasonably estimated. Pieris evaluates, on a quarterly basis, developments in legal proceedings and other matters that could cause an increase or decrease in the amount of the liability that has been accrued previously. Considering facts known at the time of the assessment, Pieris determines whether potential losses are considered reasonably possible or probable and whether they are estimable. Based upon this assessment, Pieris carries out an evaluation of disclosure requirements and considers possible accruals in the financial statements. Segment Reporting Operating segments are identified as components of an enterprise where separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions on how to allocate resources and assess performance. Pieris operates as a single segment dedicated to the discovery and development of biotechnological applications and the Company’s chief operating decision maker (“CODM”) makes decisions based on the Company as a whole. The Company has determined that its CODM is its Chief Executive Officer. Net Loss per Common Share Basic net loss per share was determined by dividing net loss by the weighted average common shares outstanding during the period. Diluted net loss per share was determined by dividing net loss by diluted weighted average shares outstanding. Diluted weighted average shares reflect the dilutive effect, if any, of common stock options based on the treasury stock method. For all financial statement periods presented the number of basic and diluted weighted average shares outstanding was the same because any increase in the number of shares of common stock equivalents for any period presented would be antidilutive based on the net loss for the period. Shares to be issued upon the exercise of the outstanding options and warrants excluded from the loss per share calculation amounted to $ 8.2 million and 2.6 million for the year ended December 31, 2016 and 2015 respectively, because the awards were anti-dilutive. Recent Accounting Pronouncements Adopted Standards for current period In August 2014, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2014-15, “Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern” which is intended to define management’s responsibility to evaluate whether there is substantial doubt about an organization’s ability to continue as a going concern and to provide related footnote disclosures. Substantial doubt about an entity’s ability to continue as a going concern exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its financial obligations as they become due within one year after the date that the financial statements are issued (or are available to be issued). ASU No. 2014-15 provides guidance to an organization’s management, with principles and definitions intended to reduce diversity in the timing and content of disclosures commonly provided by organizations in the footnotes of their financial statements. ASU No. 2014-15 is effective for annual reporting periods ending after December 15, 2016, and for annual and interim periods thereafter. As of December 31, 2016, the Company has adopted this ASU and the Company is not required to make any additional disclosures. In March 2016, the FASB issued ASU No. 2016-09, “Compensation—Stock Compensation (Topic 718) Improvements to Employee Share-Based Payment Accounting” Standards not yet adopted In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”). Subsequently, the FASB also issued ASU 2015-14, Revenue from Contracts with Customers (Topic 606) , which adjusted the effective date of ASU 2014-09; ASU No. 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net), which amends the principal-versus-agent implementation guidance and illustrations in ASU 2014-09; ASU No. 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing, which clarifies identifying performance obligation and licensing implementation guidance and illustrations in ASU 2014-09; and ASU No. 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients , which addresses implementation issues and is intended to reduce the cost and complexity of applying the new revenue standard in ASU 2014-09 (collectively, the “Revenue ASUs”). The Revenue ASUs provide an accounting standard for a single comprehensive model for use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance. The accounting standard is effective for interim and annual periods beginning after December 15, 2017, with an option to early adopt for interim and annual periods beginning after December 15, 2016. The guidance permits two methods of adoption: retrospectively to each prior reporting period presented (the full retrospective method), or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (the modified retrospective method). We currently anticipate adoption of the new standard effective January 1, 2018 under the modified retrospective method. The Company is in the process of determining the impact of the Revenue Recognition ASUs on its financial statements. In February 2016, the FASB issued ASU No. 2016-02, “ Leases (Topic 842) Pieris has considered other recent accounting pronouncements and concluded that they are either not applicable to the business, or that the effect is not expected to be material to the unaudited condensed consolidated financial statements as a result of future adoption. |
Revenue
Revenue | 12 Months Ended |
Dec. 31, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Revenue | 3. Revenue General The Company has not generated revenue from product sales. The Company has generated revenue pursuant to (i) license and collaboration agreements, which include upfront payments for licenses or options to obtain licenses, payments for research and development services and milestone payments, and (ii) government grants. Years ended December 31, 2016 2015 License fees $ 2,735,794 $ — Research and development services 1,439,513 5,593 Milestone payments 1,655,367 2,538,698 Government grants — 369,200 Other Revenues — 18,440 Total Revenue $ 5,830,674 $ 2,931,931 Revenue from two collaboration partners exceeded 10% of total revenue, amounting to $1.7 million and $4.1 million, respectively, in the year ended December 31, 2016. Revenue from two collaboration partners and from one government grant exceeded 10% of total revenue, amounting to $2.0 million, $0.5 million and $0.4 million, respectively, in the year ended December 31, 2015. Collaborations and Other Agreements Daiichi Sankyo Co., Ltd. In May 2011, Pieris granted an exclusive, worldwide license for the research, development and commercialization of drug candidates identified by the Company for targets selected by Daiichi Sankyo Co., Ltd. (“Daiichi Sankyo”) pursuant to an agreement with Daiichi Sankyo. Under this agreement, Pieris will use its proprietary Anticalin scaffold technology to identify drug candidates against certain selected targets, with further development and commercialization performed by Daiichi Sankyo. Daiichi Sankyo has agreed to pay various upfront payments for certain research programs, payments for services provided by Pieris in conjunction with the research programs, and certain milestone payments as development milestones are achieved. During the years ended December 31, 2016 and 2015, Pieris recorded revenue of $1.7 million and $2.0 million, respectively. The revenues recorded during the year ended December 31, 2016 were associated with achieving a milestone within a research program and to a lesser extent Pieris providing various services in connection with a research program. The revenues recorded during the year ended December 31, 2015 were associated with achieving certain milestones within a research program The milestone payments in 2016 and 2015 are based on successful in vitro and in vivo studies and for the initiation on a toxicity study in non-human primates. The milestones could not be achieved solely upon the passage of time. For revenue recognition purposes, management determined these milestones to be substantive in accordance with applicable accounting guidance related to milestone revenue. Substantive uncertainty existed at the inception of the arrangements as to whether the milestones would be achieved because of the numerous variables, such as the high rate of failure inherent in research and development activities and the uncertainty involved with obtaining regulatory approval. Therefore, each of the milestone payments were recognized net of Japanese withholding tax of 10%, as revenues during the respective years ended December 31, 2016 and 2015 in which they were received. Pieris is able to receive potential milestone payments of $85.9 million, plus royalties on the commercial sales of any commercial products. The total milestones are categorized as follows: research milestones—$2.5 million; development milestones—$35.2 million; commercial milestones—$47.3 million; additional diagnostic milestones of $0.7 million. Sanofi-Aventis and Sanofi-Pasteur In September 2010, the Company entered into an agreement with Sanofi-Aventis and Sanofi Pasteur (“Sanofi”), under which the Company agreed to apply its proprietary Anticalin technology to identify drug candidates against certain targets selected by Sanofi, with further development and commercialization performed by Sanofi. The agreement included the initial identification of two targets by Sanofi, with options to select up to four additional targets. For any targets selected by Sanofi, the Company granted an exclusive, worldwide license for the research, development and commercialization of drug candidates identified by the Company. In addition to the two initial targets selected by Sanofi, Sanofi exercised one of the four options and received a license. The remaining three options expired unexercised. Sanofi has agreed to pay various upfront payments for certain research programs, payments for services provided by Pieris in conjunction with the research programs and certain milestone payments as development milestones are achieved. During the years ended December 31, 2016 and 2015, Pieris recorded revenue of zero and $0.5 million, respectively. The revenues recorded during the year ended December 31, 2015 were associated with achieving a development milestone within a research program during the period. No milestone payments were achieved during the year ended December 31, 2016. The milestone payment in 2015 resulted from Sanofi’s decision to continue advancing the tetraspecific Anticalin-based program for infectious disease. The milestone could not be achieved solely upon the passage of time. For revenue recognition purposes, management determined these milestones to be substantive in accordance with applicable accounting guidance related to milestone revenue. Substantive uncertainty existed at the inception of the arrangements as to whether the milestone would be achieved because of the numerous variables, such as the high rate of failure inherent in research and development activities and the uncertainty involved with obtaining regulatory approval. Therefore, the milestone payment was recognized in its entirety as revenue during the respective year ended December 31, 2015 in which it was received. The Company is able to receive milestone payments up to $48.6 million, plus royalties on the sales of any commercial products. The total future potential milestones are categorized as follows: research milestones—$1.8 million; development milestones—$27.9 million; commercial milestones—$18.9 million. F.Hoffmann-La Roche Ltd and Hoffmann- La Roche Inc. In December 2015, the Company entered into a Research Collaboration and License Agreement (the “Roche Agreement”) with F.Hoffmann- La Roche Ltd. and Hoffmann- La Roche Inc., (“Roche”), for the research, development, and commercialization of Anticalin-based drug candidates against a predefined, undisclosed target in cancer immune therapy. The parties will jointly pursue a preclinical research program with respect to the identification and generation of Anticalin proteins that bind to a specific target for an expected period of 20 months, which may be extended by Roche for up to an additional 12 months. Roche has the ability to continue exclusivity rights for up to an additional 5 years. Both Roche and the Company will participate in a joint research committee in connection with this agreement. Following the research program, Roche will be responsible for subsequent pre-clinical and clinical development of any product developed through the research plan and will have worldwide commercialization rights to any such product. Roche has paid $6.5 million of an upfront payment for the research collaboration. Additionally, Roche will pay Pieris for research services provided by Pieris in conjunction with the research program. Roche will also pay Pieris for certain milestones relating to development, regulatory, and sales milestones, as they are achieved. As of December 31, 2016 and December 31, 2015, deferred revenue, related to Roche collaboration, is $3.7 million and $0, respectively. Pieris recorded $4.1 million in revenue for the year ended December 31, 2016, related to the recognition of the upfront Roche payment and the research services provided during those periods. Revenue recognized is associated with the portion of the research services performed during the periods as well as the value of research services provided by Pieris in connection with the ongoing research program. No revenues were recorded for the year ended December 31, 2015. The Company identified the research and commercial licenses, performance of R&D services, and participation in the joint research committee as deliverables under the Roche Agreement. For revenue recognition purposes, management has determined that there are two units of accounting at the inception of the agreement representing (i) the research and commercial licenses and the performance of R&D services which do not have standalone value, and (ii) the participation in the joint research committee. In addition to the upfront payment, under the Roche Agreement, the Company is eligible to receive research funding, development and regulatory and sales based milestone payments up to approximately $399.4 million, plus royalties on future sales of any commercial products. The total potential milestones are categorized as follows: development and regulatory milestones—$277.6 million and sales milestones—$117.7 million. Management has determined that the development milestones are not substantive because they do not relate solely to past performance of the Company and the Company’s involvement in the achievement is limited to progress reports and other updates. Non-substantive milestones will be recognized when achieved to the extent the Company has no remaining performance obligations under the arrangement. Other Collaborations The Company has entered into several other research and collaboration agreements for which the Company could achieve future milestone payments up to $14.0 million. For revenue recognition purposes, management determined these milestones to be substantive in accordance with applicable accounting guidance related to milestone revenue. Substantive uncertainty existed at the inception of the arrangements as to whether the milestones would be achieved because of the numerous variables, such as the high rate of failure inherent in research and development activities and the uncertainty involved with obtaining regulatory approval. No milestones or other revenues related to these agreements were recognized during the years ended December 31, 2016 and 2015, respectively. Government Grants BioCluster m4 In 2011 Pieris applied for a government grant from the German Federal Ministry for Education and Research for the project “Spitzencluster m4, Cooperation personalized medicine: ‘Preclinical development of PRS-110 an Anticalin targeted against c-Met as a monovalent antagonist in the field of oncology (PM18).’” The funding rate amounts to 40% of the actual costs incurred, with an aggregate cap of $1.4 million for the approval period from February 1, 2012 to September 30, 2014. The amounts received are non-refundable, and the grant funds may only be claimed for costs incurred within the approval period. The payments are received quarterly in arrears based on expenses already incurred. The Company recorded zero and $8,654 for the years ended December 31, 2016 and 2015, respectively, which was recorded as grant revenue. Seventh Research Framework Program (“FP7”)—Collaborative Project “EUROCALIN—European consortium for antiCALINs as next generation high-affinity protein therapeutics” (“EUROCALIN”) EUROCALIN is a program that started in August 2011 with the objective of developing and producing new high-affinity protein scaffolds for therapeutic use. The focus is on the development of non-immunoglobulin protein scaffolds as alternatives to antibodies and oligo-nucleotides. The grant involves a consortium of ten companies and universities in Europe and was initiated for a collaboration focused on attaining and completing initial clinical development of a novel Anticalin therapeutic. The consortium is seeking to develop, manufacture and clinically test an Anticalin specific for hepcidin. The program is a small molecule enhancers (“SME”) targeted project, which is funded by the European Union (“EU”) in the amount of $7.3 million and also includes a respective funding rate of approximately 64% of the eligible costs occurred in connection with the research project. All payments received from the EU in connection with the grant are non-refundable. Under this grant agreement, Pieris is the coordinator. The EU has scheduled three tranches of payments. The first tranche (pre-financing) was received as of December 7, 2011 and the second tranche as of August 4, 2013. The third tranche was completed in November 2015. Pieris, as the coordinator, received all payments from the grant. During 2016, at the conclusion of the EUROCALIN program, the Company made all distributions of cash to the members of the consortium that are entitled to payments based on submission of invoices of eligible costs. Under this program, the Company recognized zero and $0.4 million as revenue from grant during the years ended December 31, 2016 and 2015, respectively. The following balance sheet items relate to the FP7 agreement: Years Ended December 31, 2016 2015 Other current assets (receivables from FP7 grant) $ — $ 980,936 Cash (restricted cash) $ — $ 17,302 Accounts payable $ — $ 424,441 |
Fair Value Measurement
Fair Value Measurement | 12 Months Ended |
Dec. 31, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurement | 4. Fair Value Measurement ASC Topic 820 Fair Value Measurement Level 1 inputs are quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 2 utilizes quoted market prices in markets that are not active, broker or dealer quotations, or alternative pricing sources with reasonable levels of price transparency. Level 3 inputs are unobservable inputs for the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date. For the periods presented in these consolidated financial statements, Pieris has no cash equivalents, investments or debt instruments as of each balance sheet date presented. All other current assets and current liabilities on our consolidated balance sheets approximate their respective carrying amounts. |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2016 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | 5. Property and Equipment, net Property and equipment are summarized as follows: Years Ended December 31, 2016 2015 Laboratory equipment $ 3,869,154 $ 3,701,517 Office and computer equipment 499,233 443,562 Leasehold improvements 320,750 304,363 Property and equipment at cost 4,689,137 4,449,442 Accumulated depreciation (2,424,660 ) (2,286,671 ) Property and equipment, net $ 2,264,477 $ 2,162,771 Depreciation expense was $0.4 million and $0.3 million for the years ended December 31, 2016 and 2015, respectively. There were no other changes in accumulated depreciation other than foreign currency impact. 86% of the Company’s property and equipment are located in Germany and the remaining 14% are located in the United States. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 6. Income Taxes (Loss) before income taxes consists of the following: Years Ended December 31, 2016 2015 Domestic $ (8,724,628 ) $ (7,563,300 ) Foreign (13,912,568 ) (6,291,475 ) Loss before income taxes $ (22,637,196 ) $ (13,854,775 ) The components of the provision (benefit) for income taxes are as follows: Years Ended December 31, 2016 2015 Current: Federal $ — $ — State — — Foreign 161,970 203,866 Total current 161,970 203,866 Deferred: Federal — — State — — Foreign — — Total deferred — — Provision (benefit) for income taxes $ 161,970 $ 203,866 The reconciliation of the federal statutory rate to Pieris’ effective tax rate is as follows: 2016 2015 Federal income tax rate 34.0 % 34.0 % Foreign rate differential (2.9 ) (2.1 ) State tax, net of federal benefit 0.9 3.1 Permanent items (2.3 ) (1.7 ) Other (0.9 ) 2.9 Withholding tax (0.7 ) (1.5 ) Change in valuation allowance (28.8 ) (36.2 ) Effective income tax rate (0.7 )% (1.5 )% The components of deferred tax assets and liabilities related to net tax effects of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income taxes purposes were as follows: Years Ended December 31, 2016 2015 Deferred tax assets: Net operating loss carryforwards $ 18,498,365 $ 13,052,809 Share based awards compensation 1,080,314 692,906 Accrued compensation/other 190,799 139,773 Accrued expenses 35,888 4,201 Depreciation 12,065 12,276 Total deferred tax assets 19,817,431 13,901,965 Less: valuation allowance: (19,817,431 ) (13,901,965 ) Net deferred tax asset $ — $ — The Company operates in multiple countries. Accordingly, the Company files federal income tax returns as well as returns in multiple foreign jurisdictions. In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax-planning strategies in making this assessment. Management believes it is more likely than not that the results of future operations will not generate sufficient taxable income in the U.S. or in its foreign jurisdictions to realize the full benefits of its deferred tax assets. As of December 31, 2016, we continue to maintain a full valuation allowance against all net deferred tax assets. The increase in the valuation allowance of deferred tax assets of $5.9 million was primarily influenced by the operating losses generated in current tax year. The overall increase is offset to a lesser extent the impact of foreign currency translation. As of December 31, 2016, the Company had net operating loss carryforwards for United States federal income tax purposes of $12.9 million and net operating loss carryforwards for state income tax purposes of $9.8 million. These tax loss carryforwards, originating subsequent to reverse merger, expire through 2036. In the United States, utilization of the NOL carryforwards may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986 due to ownership change limitations that have occurred previously or that could occur in the future. These ownership changes may limit the amount of NOL carryforwards that can be utilized annually to offset future taxable income and tax, respectively. The Company has not currently completed a study to assess whether an ownership change has occurred, or whether there have been multiple ownership changes since the Acquisition. As of December 31, 2016, the Company had German corporate income tax and trade tax net operating loss carryforwards of approximately $66.3 million and $64.9 million respectively. Based on German tax law, the losses can be carried forward indefinitely. The operating loss carryforwards generated are subject to restrictions under German tax law. These regulations may limit the future use of operating loss carryforwards if there is a change in ownership. The Company files federal income tax returns as well as returns in multiple foreign jurisdictions. Tax years ended December 31, 2013 or later remain subject to examination by the German tax authorities. As of December 31, 2016, the Company had Australia tax net operating loss carryforwards of approximately $0.3 million, originating subsequent to the reverse merger, can be carried forward indefinitely. The Company revised the carrying value as of December 31, 2015 of its deferred tax asset for net operating loss carryforwards in foreign jurisdictions by $8.9 million. The increase in the deferred tax asset was offset by a corresponding increase in the Company’s valuation allowance. This adjustment is to accurately reflect the value of net operating losses that the Company believes it is entitled to benefit from to offset future income, if any, in foreign jurisdictions. The Company accounts for uncertain tax positions pursuant to ASC 740 which prescribes a recognition threshold and measurement process for financial statement recognition of uncertain tax positions taken or expected to be taken in a tax return. If the tax position meets this threshold, the benefit to be recognized is measured at the largest amount of benefit that is more likely than not (determined by cumulative probability) of being realized upon ultimate settlement with the taxing authority. The Company recorded an uncertain tax position related to a prior year position, that if successfully challenged by tax authorities could result in the loss of certain tax attributes. The balance of uncertain tax positions will remain until such time that settlement is reached with the relevant tax authorities or should the statute of limitations expire. The Company recognizes interest and penalties, if any, related to uncertain tax positions in income tax expense. No interest and penalties related to uncertain tax positions were accrued at December 31, 2016 and December 31, 2015. The following table sets forth a reconciliation of the beginning and ending amounts of unrecognized tax benefits, excluding the impact of interest and penalties, for the years ended December 31, 2016 and 2015: Unrecognized tax benefits at December 31, 2015 $ — Increase for tax positions taken during the current period 5,654,803 Unrecognized tax benefits at December 31, 2016 $ 5,654,803 The Company does not expect unrecognized tax benefits to change significantly over the next twelve months. The full amount of unrecognized tax benefits would impact the effective rate, subject to valuation allowance considerations, if recognized. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2016 | |
Debt Disclosure [Abstract] | |
Debt | 7. Debt Unsecured Bank Loan In May 2003, the Company signed an unsecured loan agreement (the “Bank Loan”) under a silent partnership agreement with Technologie-Beteiligungs-Gesellschaft (“TBG”), a minority interest stockholder. As of April 3, 2014, the Company and TBG, the subsidiary of KfW Bank, Frankfurt (“KfW”), signed a repayment agreement concerning the Company’s repayment of its liabilities to TBG outstanding at December 31, 2013 in a total amount of €1.2 million ($1.34 million). The principal amount bore interest at a rate of 10.53%. On December 11, 2014, the Company and TBG entered into an accelerated repayment agreement in respect of the claims of TBG against the Company. Pursuant to terms of the accelerated repayment agreement, conditioned upon closing of the Acquisition, the Company was obligated to pay €1,050,000 ($1.27 million), the outstanding amount under the repayment agreement, in two tranches as follows: €600,000 ($726,060) plus accrued interest on January 31, 2015 and €450,000 ($544,545) on March 31, 2015. The outstanding principal amount for the first and the second tranches, net of capital gain tax withheld, was repaid in full in March 2015 and such next payment was €931,312 ($1,027,051). The capital gain tax withheld in the amount of €118,688 ($130,889) was paid on April 9, 2015 and no further amounts were payable in respect of TBG loan. No payments were made during the year ended December 31, 2016. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2016 | |
Equity [Abstract] | |
Stockholders' Equity | 8. Stockholders’ Equity Common Stock The Company has authorized 300,000,000 shares of common stock, par value $0.001 per share. As of December 31, 2016 and 2015, there were 43,058,827 and 39,833,023 shares of common stock issued and outstanding, respectively. As a result of the Acquisition in 2014, the equity structure of Pieris GmbH was retroactively adjusted using the exchange ratio established pursuant to the Acquisition Agreement to reflect the number of shares of the Company issued in the Acquisition. Each share of the Company’s common stock is entitled to one vote and all shares rank equally as to voting and other matters. Dividends may be declared and paid on the common stock from funds legally available therefor, if, as and when determined by the Board of Directors. Preferred Stock The Company has authorized 10,000,000 shares of preferred stock, par value $0.001 per share. The Company has 4,963 and zero shares of preferred stock issued and outstanding during the years ended December 31, 2016 and 2015, respectively. Shares of preferred stock may be issued in one or more series at such time or times and for such consideration as the Board of Directors may determine. Each of the 4,963 shares of preferred stock are convertible into one share of the Company’s common stock. The stockholders do not have the right to convert any portion of the preferred shares to the extent that they would beneficially own 9.99% of the number of shares of the Company´s common stock outstanding immediately after giving effect of such conversion. The preferred shares do not have any voting rights. The preferred shares are entitled to receive dividends on a pari passu Public Offering In July 2015, the Company closed a public offering of an aggregate of 9,090,909 shares of the Company´s common stock at a purchase price of $2.75 per share. All shares of common stock were offered by the Company. On July 24, 2015, the underwriters exercised their over-allotment option to purchase 1,211,827 additional shares of the Company’s common stock at the public offering price of $2.75, the sale of which closed on July 28, 2015. Gross proceeds raised by the Company in the offering, including the exercise of the over-allotment option, were $28.3 million and net of equity issuance costs are $25.8 million. The Company intends to use the net proceeds from the offering to fund research and development, including preclinical and clinical research and development of its drug candidates, working capital and general corporate purposes. Private Placement In June 2016, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) for a private placement of the Company’s securities with a select group of institutional investors (the “2016 PIPE”). The 2016 PIPE sale transaction, by the Company, consisted of 8,188,804 units at a price of $2.015 per unit for gross proceeds, to the Company, of approximately $16.5 million. After deducting for placement agent fees and offering expenses, the aggregate net proceeds from the private placement was approximately $15.3 million. Each unit consisted of (i) one share of the Company’s Common Stock or non-voting series A convertible preferred stock (the “Series A Convertible Preferred Stock”) which are convertible into one share of common stock, (ii) one warrant to purchase 0.4 shares of Common Stock at an exercise price of $2.00 per share and (iii) one warrant to purchase 0.2 shares of Common Stock at an exercise price of $3.00 per share. The warrants will be exercisable for a period of five years from the date of issuance. Each share of Series A Convertible Preferred Stock was issued at a price of $2.015 per share, and is convertible into 1,000 shares of common stock, provided the holder and/or its affiliates do not own greater than 9.99% of the total number of Pieris common stock then outstanding. The Series A Convertible Preferred Stock has no registration or voting rights. In event of a true liquidation or winding down of the business, holders of Series A Convertible Preferred Stock will be paid prior to the holders of Common Stock. In connection with the 2016 PIPE, the Company issued 3,225,804 shares of Common Stock and 4,963 shares of Series A Convertible Preferred Stock to the 2016 PIPE investors. The Company expects to use the proceeds from the 2016 PIPE towards further development and pre-clinical and clinical work of the Company´s proprietary Anticalin product portfolio, including the lead candidates as well as the development of other programs and product candidates, and general corporate purposes. As a result of the Public Offering, the Consulting Shares (for more information on the Consulting Shares refer to Note 10 Consulting Shares |
Stock and Employee Benefit Plan
Stock and Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock and Employee Benefit Plans | 9. Stock and employee benefit plans In December 2014, the Company adopted the 2014 Employee, Director and Consultant Equity Incentive Plan, (the “2014 Plan”) which provides for the grant of stock options to certain designated employees of the Company, non-employee directors of the Company and certain other persons performing significant services for the Company as designated by the Compensation Committee of the Board of Directors. In June 2016, the Company adopted the 2016 Employee, Director and Consultant Equity Incentive Plan, (the “2016 Plan”) which provides for the grant of stock options, restricted and unrestricted stock awards, and other stock-based awards to employees of the Company, non-employee directors of the Company, and certain other consultants performing services for the Company as designated by the Compensation Committee of the Board of Directors or the Board of Directors. The 2016 Plan authorizes the issuance of up to 3,750,000 shares of common stock plus a number of additional shares, if awards outstanding under the 2014 Plan are cancelled or expire, to be granted under the 2016 Plan. The 2016 Plan does not provide for an “evergreen” provision. The vesting periods of equity incentives issued under the 2016 Plan are determined by the Compensation Committee of the Company´s Board of Directors, with stock options generally vesting over a four-year period. The Company’s stock options have a maximum term of ten years from the date of grant. Stock options granted under the Plans may be either incentive stock options (“ISOs”), or nonqualified stock options. The exercise price of stock options granted under the Plans must be at least equal to the fair market value of the common stock on the date of grant. The Company’s general policy is to issue common shares upon the exercise of stock options. Cash received from option exercises was zero and $10,000 during the years ended December 31, 2016 and 2015, respectively. 2014 Stock Plan Pieris granted 1,157,734 and 755,329 stock options under the 2014 Plan during the years ended December 31, 2016 and 2015, respectively. Of these stock options granted in the 2015 period, a stock option to purchase 450,000 shares of the Company´s common stock, par value $0.001 (the “Common Stock”), was granted to a newly-hired executive officer subject to certain restrictions on exercise that required the Company´s shareholders to approve an increase in the number of shares authorized under the 2014 Plan. Upon the Company´s adoption of the 2016 Plan, this stock option was amended and issued under the 2016 Plan; the total shares available under the 2016 Plan reflects the issuance of this option. No compensation expense was recorded for this option in the 2015 period. The Company granted an option to purchase 500,000 shares outside of the Plan to a newly hired executive officer that was an inducement option, material to the executive officer entering into employment with the Company during the 2015 period. The compensation expense with this inducement option was $0.3 million and $0.1 million and is included in research and development expense for the years ended December 31, 2016 and 2015, respectively. A summary of the status of the Company’s 2014 plan as of December 31, 2016 and changes during the year then ended is as follows: Number of Weighted- Weighted- Aggregate Outstanding, December 31, 2015 2,707,329 $ 2.05 9.17 years $ 741 Granted 1,157,734 1.57 Forfeited (140,000 ) 1.71 Outstanding, December 31, 2016 3,725,063 $ 1.91 8.55 years $ — Vested or expected to vest 3,725,063 $ 1.91 8.55 years $ — Exercisable, December 31, 2016 1,961,811 $ 2.01 7.99 years $ — Excluded from the table above is the option to purchase 500,000 shares outside of the Plan granted to a newly hired executive officer. The weighted-average exercise price of these options amounts to $3.36 with a remaining contractual life of 8.63 years. The 2014 Plan was terminated on June 28, 2016 when the Company adopted its 2016 Plan. Therefore, no options were granted under the 2014 Plan and no options are available for future grant after this date. 2016 Stock Plan The Company granted 265,313 options to employees and directors under the 2016 Plan during the year ended December 31, 2016. No options were granted during the year ended December 31, 2015. As of December 31, 2016, there were 3,124,687 shares available for future grant under the 2016 Plan. The shares available for future grant under the 2016 Plan include 90,000 shares, which were forfeited during the year ended December 31, 2016 under the 2014 Plan. These forfeited shares were added to the 2016 Plan. The Company, in 2016, granted an option to purchase 500,000 shares outside of the Plan to a newly hired executive officer that was an inducement option, material to the executive officer entering into employment with the Company during the 2016 period. The compensation expense with this inducement option was $10,998 and is included in general and administration expense for the year ended December 31, 2016. A summary of the status of the Company’s 2016 plan as of December 31, 2016 and changes during the year then ended is as follows: Number of Weighted- Weighted- Aggregate Outstanding, December 31, 2015 — $ — — $ — Granted 715,313 2.36 Outstanding, December 31, 2016 715,313 $ 2.36 9.62 years $ — Vested or expected to vest 715,313 $ 2.36 9.62 years $ — Exercisable, December 31, 2016 228,774 $ 2.46 8.90 years $ — Excluded from the table above is the option to purchase 500,000 shares outside of the Plan granted to a newly hired executive officer in 2016. The weighted-average exercise price of these options amounts to $1.45 with a remaining contractual life of 9.91 years. 401(k) Savings plan In 2015, the Company established a defined-contribution savings plan under Section 401(k) of the Internal Revenue Code (the “401(k) Plan”). The 401(k) Plan covers all employees who meet defined minimum age and service requirements, and allows participants to defer a portion of their annual compensation on a pretax basis. The Company made matching contributions to participants in this plan which totaled $31,670 and $3,013 for the years ended December 31, 2016 and 2015, respectively. |
Consulting Shares
Consulting Shares | 12 Months Ended |
Dec. 31, 2016 | |
Text Block [Abstract] | |
Consulting Shares | 10. Consulting Shares Del Mar Consulting Group & Alex Partners In March 6 2015, the Company entered into an independent consulting agreement (the “Consulting Agreement”) with the Del Mar Consulting Group, Inc. and Alex Partners, LLC (the “Consultants”), pursuant to which the Company issued 150,000 restricted shares of its common stock (par value $0.01 per share) to the Consultants (the “Consulting Shares”). The Company agreed to retain the Consultants to provide investor relations consulting to the Company for a period commencing on March 6, 2015 (the “Commencement Date”) and ending thirteen months after the Commencement Date (such period, the “Term”). The shares issued in connection with the Consulting Agreement were deemed exempt from registration in reliance upon Section 4(a)(2) of the Securities Act as a transaction by an issuer not involving any public offering. The terms of the Consulting Agreement state that Pieris has the right to terminate this agreement at any time during the Term of the Consulting Agreement, upon providing Consultants ten days’ written notice of the Company’s intention to terminate or immediately upon notice in the event of a breach of this agreement by either consultant. If the Company had elected to terminate this agreement for any reason within one hundred eighty days (180) following the effective date each Consultant would have been required to promptly surrender to the Company forty percent (40%) of the number of Consulting Shares issued to it. The Company uses the Black-Scholes model and estimated the fair value of the 90,000 non-cancellable Consulting Shares to be $0.3 million based on the closing price per share of $3.16 as quoted on the OTCQB tier of the OTC Markets Group Inc., or the OTCQB, on the grant date, March 6, 2015. The remaining 60,000 shares were then marked to market based on the Black-Scholes model at each reporting period with the expense being recorded in the consolidated statement of operations as general and administrative expenses. On September 2, 2015, the remainder of the Consulting Shares vested and the remaining expense was recorded based on the fair value of the shares on that date. The Company recorded expense of $0.4 million for the non-cancellable and cancellable Consulting Shares for the year ended December 31, 2015. No expenses were recognized during the 2016 period as the remaining shares vested on September 2, 2015 and the remaining expense was recorded based on the fair value of the shares on that date. Aquilo Partners In September 2015, the Company entered into a Letter Agreement (the “Letter Agreement”) with Aquilo Partners, L.P. (“Aquilo Partners”). Aquilo Partners has been engaged by the Company as an advisor. Upon execution of the Letter Agreement, the Company recorded a retainer fee of $0.1 million. In addition to the cash retainer fee, the Company issued 27,272 shares of the Company’s common stock equal in value to $0.1 million based on the closing price of $2.75 per share of the Company’s common stock on September 4, 2015, the date of the Letter Agreement. The compensation for Aquilo Partners has been recorded in the consolidated statements of operations as general and administrative expenses for the year ended December 31, 2015. No expenses were recognized during the 2016 period. Trout Capital LLC In November 2015, the Company entered into an Agreement with Trout Capital LLC for advisory services. Upon execution of this agreement, Trout Capital was entitled to receive a one-time transaction fee. The Company issued 68,493 shares of the Company’s common stock equal in value to $0.2 million based on the closing price of $2.19 per share of the Company’s common stock on November 20, 2015, the date of the agreement. The compensation for Trout Capital LLC has been recorded in the consolidated statements of operations as general and administrative expenses for the year ended December 31, 2015. No expenses were recognized during the 2016 period |
License and Transfer Agreement
License and Transfer Agreement | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Changes and Error Corrections [Abstract] | |
License and Transfer Agreement | 11. License and Transfer Agreement In April 2016, the Company entered into a license and transfer agreement (the “Original Agreement”) with Enumeral Biomedical Holdings, Inc. (“Enumeral”), pursuant to which the Company acquired a non-exclusive worldwide license to use specified patent rights and know-how owned by Enumeral to research, develop and market fusion proteins. As contemplated by the terms of the Original Agreement, the Company entered into a definitive license and transfer agreement (the “Definitive Agreement”) with Enumeral on June 6, 2016, to expand the scope of the Company’s option to license additional antibodies from Enumeral. Under the Definitive Agreement, Enumeral has granted Pieris options to license two additional undisclosed Enumeral antibodies (each, a “Subsequent Option”); the Subsequent Options expire on May 31, 2017. If Pieris licenses an additional antibody pursuant to a Subsequent Option, Pieris must pay, to Enumeral, an additional undisclosed option exercise payment; any resulting fusion protein products will be subject to royalties and development and sales milestones in the same amounts applicable to the fusion proteins consisting of an Enumeral’s PD-1 antibody linked to one or more Anticalin proteins. Under the terms of the Original Agreement, the Company agreed to pay Enumeral an upfront license fee of $250,000 upon signing in April 2016 and subsequently elected to pay a $750,000 maintenance fee in May 2016. The terms of the Definitive Agreement, were essentially unchanged from the Original Agreement. The Company has agreed to pay Enumeral development milestones up to an aggregate of $37.8 million and sales milestones up to an aggregate of $67.5 million. Consistent with the terms of the Original Agreement, the Company also agreed to pay Enumeral royalties within a range in the low to lower-middle single digits as a percentage of net sales depending on the amount of net sales in the applicable years. In the event that the Company is required to pay a license fee or royalty to any third party related to the licensed products, the royalty payment due to Enumeral shall be reduced by the amount of such third party fees or payments, up to 50% of the royalty payment for each calendar year due to Enumeral. The term of the Definitive Agreement ends upon the expiration of the last to expire patent covered under the license. The Definitive Agreement may be terminated by the Company on 30 days notice and by Enumeral upon 60 days notice of a material breach by the Company (or 30 days with respect to a breach of payment obligations by the Company), provided the Company has not caused such breach and dispute resolution procedures specified in the Agreement have been followed. All amounts paid related to the Agreement have been expensed as research and development expense as incurred. The Company incurred $1.0 million for year ended December 31, 2016. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2016 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 12. Accrued Expenses The Company has recorded the following accrued expenses as of December 31, 2016 and December 31, 2015, respectively: Years Ended December 31, 2016 2015 Accrued expenses Accrued compensation expense $ 1,198,448 $ 704,597 Accrued audit and tax fees 454,931 179,223 Accrued professional fees 867,969 194,790 Accrued R&D fees 1,040,321 466,076 Accrued other 157,788 194,694 Total amount of accrued expenses 3,719,457 1,739,380 |
Related-Party Transactions
Related-Party Transactions | 12 Months Ended |
Dec. 31, 2016 | |
Related Party Transactions [Abstract] | |
Related-Party Transactions | 13. Related-Party Transactions Research and License Agreement with Technische Universität München On July 4, 2003, the Company entered into the TUM License Agreement, which was subsequently renewed and, on July 26, 2007, superseded and replaced. The agreement established a joint research effort led by Prof. Arne Skerra, Chair of Biological Chemistry of TUM, to optimize Anticalin technologies for use in therapeutic, prophylactic and diagnostic applications and as research reagents, and to gain fundamental insights in lipocalin scaffolds. Prof. Dr. Skerra was a member of the Company’s supervisory board when the parties entered into such agreement and during the period covered by the consolidated financial statements in this report. The Company provided certain funding for TUM research efforts performed under the agreement. As a result of research efforts to date under the agreement, the Company holds a worldwide exclusive license under its license agreement with TUM to multiple patents and patent applications. The Company bears the costs of filing, prosecution and maintenance of patents assigned or licensed to the Company under the agreement. As consideration for the assigned patents and licenses above, the Company is required to pay certain development milestones to TUM. The Company is also obliged to pay low-single-digit royalties, including annual minimum royalties, on sales of such products incorporating patented technologies. If the Company grants licenses or sublicenses to those patents to third parties, the Company will be obliged to pay a percentage of the resulting revenue to TUM. The Company’s payment obligations are reduced by the Company´s proportionate contribution to a joint invention. Payment obligations terminate on expiration or annulment of the last patent covered by the TUM License Agreement. The Company can terminate the licenses to any or all licensed patents upon specified advance notice to TUM. TUM may terminate the license provisions of the agreement only for cause. Termination of the agreement does not terminate the rights in patents assigned to the Company. The Company has incurred expenses related to TUM in connection with the transfer of licenses and protective rights of $41,791 during the nine-month period ended September 30, 2015. Effective as of the fourth quarter of 2015, Pieris no longer deems TUM a related party due to Prof. Dr. Skerra no longer having a supervisory board position in Pieris GmbH or other direct relationship with the Company after the Acquisition. Therefore, no expenses have been incurred during the 2016 period. The part of the agreement requiring the Company to make payments for research conducted by TUM expired in February 2013 with no further obligations by the Company. EUROCALIN/FP7 Government Grant TUM is a member of the EUROCALIN consortium and thus is entitled to receive payments under the grant agreement for research activities. Research activities are carried out by Prof. Dr. Skerra, who was a member of the Company’s supervisory board when the parties entered into such agreement and during the period covered by the financial statements in this report. As Pieris AG was transformed to Pieris GmbH, the change in legal entity removed the requirement of having a supervisory board; accordingly, Prof. Dr. Skerra no longer holds a seat on the supervisory board. The government grant agreement with FP7 is further discussed in Note 3—Revenue. Consulting Contract between Prof. Dr. Arne Skerra and the Company In 2001, the Company entered into a Consulting Agreement with Prof. Dr. Skerra, pursuant to which Prof. Dr. Skerra provides advice regarding the use of new proteins, in particular Anticalin proteins and antibodies, for the purpose of research and development. The Consulting Agreement has an unlimited term but can be terminated by the Company upon three months’ notice with effect from the end of a month and by Prof. Dr. Skerra upon one year’s notice with effect from the end of a year. Under the Consulting Agreement, the Company incurred and paid to Prof. Dr. Skerra consulting fees of $16,717 during the nine months ended September 30, 2015. As of the fourth quarter of 2015 Pieris no longer deems Prof. Dr. Skerra a related party due to Prof. Dr. Skerra no longer having a supervisory board position in Pieris GmbH or other direct relationship with the Company after the Acquisition. Therefore, no expenses have been incurred during the 2016 period. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 14. Commitments and Contingencies Licensing Commitments The Company has license agreements with three parties under which the Company is obliged to pay annual license fees. One agreement, between IBA GmbH and the Company, requires annual license payments of $32,718 and relates to licenses for Strep-tag technology that represent tool technologies used for research purposes only. The agreement expires in 2024. The second license agreement is between TUM and the Company (see Note 13 Related-Party Transactions The table below shows the minimum annual license fee commitments under the two agreements as of December 31, 2016: License 2017 $ 84,124 2018 84,124 2019 84,124 2020 84,124 2021 84,124 Thereafter 410,105 Total minimum license payments $ 830,725 Leases The Company leases office and laboratory space in Freising, Germany. The first lease agreement has a defined termination date, which is the end of a notification period of eight months at the end of each quarter. In June 2016, we entered into a second lease agreement for additional office space in Freising, which has a fixed term of one year. As we have not cancelled this lease agreement by December 12, 2016, the term of the lease extended by one year until June 2018. On August 27, 2015, the Company entered into an Agreement of Sublease (the “Sublease Agreement”) with Berenberg Capital Markets LLC (the “Sublandlord”). Under the Sublease Agreement, the Sublandlord will sublease to the Company approximately 3,950 square feet in Boston, MA. The term of the lease will expire on February 27, 2022. The Sublease Agreement provides free rent for the first two months in addition to scheduled rent increases that are not dependent on future events. The Company records rent expense on a straight-line basis over the lease term period. For the years ended December 31, 2016 and 2015 respectively, the Company has recognized rent expense in an amount of $0.2 million and $18,399 under the Sublease Agreement. Rent expense under the Company’s operating lease for its Freising, Germany based facility was $0.3 million and $0.4 million for the years ended December 31, 2016 and 2015, respectively. The Company’s contractual commitments of the non-cancellable portion under theses operating leases as of December 31, 2016 are as follows: Total 2017 $ 391,042 2018 209,590 2019 195,909 2020 199,859 2021 203,809 Thereafter 34,563 Total minimum lease payments $ 1,234,772 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2016 | |
Subsequent Events [Abstract] | |
Subsequent Events | 15. Subsequent Events License and Collaboration Agreement On January 4, 2017, Pieris entered into a License and Collaboration Agreement (the “Collaboration Agreement”) and a Non-Exclusive Anticalin Platform Technology License Agreement (the “License Agreement” and together with the Collaboration Agreement, the “Agreements”) with Les Laboratoires Servier and Institut de Recherches Internationales Servier (collectively, “Servier”), pursuant to which Pieris and Servier will initially pursue five bispecific therapeutic programs, led by Pieris’ PRS-332 program, a PD-1-targeting bispecific checkpoint inhibitor. Pieris and Servier will jointly develop PRS-332 and split commercial rights geographically, with Pieris retaining all commercial rights in the United States and Servier having commercial rights in the rest of the world. The four additional committed programs have been defined, which may combine antibodies from the Servier portfolio with one or more Anticalin proteins based on Pieris’ proprietary platform to generate innovative immuno-oncology bispecific drug candidates. The collaboration may be expanded by up to three additional therapeutic programs. Pieris has the option to co-develop and retain commercial rights in the United States for up to three programs beyond PRS-332, while Servier will be responsible for development and commercialization of the other programs worldwide. Under the Agreements, Pieris will receive an upfront payment of €30.0 million (approximately $31.3 million). Pieris may also receive FTE funding for specific projects, as well as development-dependent and commercial milestone payments for PRS-332 and each additional program. The total development, regulatory, and sales-based milestone payments to Pieris could exceed €1.7 billion (approximately $1.8 billion) over the life of the collaboration and are dependent on the final number of projects pursued and the number of co-development options exercised by Pieris. Pieris and Servier will share preclinical and clinical development costs for each co-developed program. In addition, Pieris will be entitled to receive tiered royalties up to low double digits on the sales of commercialized products in the Servier territories. The term of each Agreement ends upon the expiration of all of Servier’s payment obligations under such Agreement. The Agreements may be terminated by Servier for convenience beginning 12 months after their effective date upon 180 days’ notice. The Agreements may also be terminated by Servier or Pieris for material breach upon 90 days or 120 days notice of a material breach, with respect to the Collaboration Agreement and License Agreement, respectively, provided that the applicable party has not cured such breach by the applicable 90-day or 120-day permitted cure period, and dispute resolution procedures specified in the applicable Agreement have been followed. The Agreements may also be terminated due to the other party’s insolvency or for a safety issue and may in certain instances be terminated on a product-by-product and/or country-by-country basis. The License Agreement will terminate upon termination of the Collaboration Agreement, on a product-by-product and/or country-by-country basis. Option Agreement On February 27, 2017, Pieris entered into an Exclusive Option Agreement (the “Option Agreement”) with ASKA Pharmaceutical Co. Ltd. (“ASKA”), pursuant to which ASKA will have an exclusive option to obtain an exclusive license to develop and commercialize Pieris’ PRS-080 drug candidate targeting hepcidin in Japan and certain other Asian markets. Under the terms of the Option Agreement, Pieris will receive an option payment of $2.75 million USD from ASKA. Following an analysis period after completion of the planned Phase 2a study of PRS-080 in dialysis-dependent anemia patients to be conducted by Pieris, ASKA may exercise its option to obtain an exclusive license to develop and commercialize PRS-080 in Japan, South Korea and certain other Asian markets (excluding China). Should ASKA exercise the option, Pieris would be eligible for more than $80 million USD in combined option exercise fee and milestone payments associated with development and commercialization of PRS-080 in the first indication in Japan. Pieris may receive further development milestones in additional indications, as well as in other countries within the ASKA territory. Pieris may also receive double-digit royalties on net sales of PRS-080 in the licensed territory up to the mid- to high-teens. The term of the Option Agreement, including the option rights granted therein, ends on the earlier of (i) ASKA’s written notice to Pieris of ASKA’s decision not to exercise the option rights granted under the Option Agreement, (ii) ASKA’s failure to exercise its option rights within sixty (60) days after the final results of the phase 2a study are made available to ASKA, (iii) three (3) months from date on which Pieris delivers to ASKA the final results of the phase 2a study in the European Union, or (iv) Pieris and ASKA’s execution of the definitive agreements granting ASKA licenses to develop and commercialize PRS-080 in the Japan, South Korea and certain other Asian countries as contemplated under the Option Agreement. |
Summary of Significant Accoun24
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Basis of Consolidation | Basis of Consolidation The accompanying consolidated financial statements of Pieris Pharmaceuticals, Inc. and its wholly owned subsidiaries were prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). The consolidated financial statements include the accounts of all subsidiaries. All intercompany balances and transactions have been eliminated. |
Use of Estimates | Use of Estimates The preparation of the financial statements in accordance with U.S. GAAP requires management to make estimates, judgments, and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and the related disclosures at the date of the financial statements and during the reporting period. Significant estimates are used for, but are not limited to, revenue recognition, deferred tax assets, liabilities and valuation allowances, fair value of stock options and various accruals. Management evaluates its estimates on an ongoing basis. Actual results and outcomes could differ materially from management’s estimates, judgments, and assumptions. |
Foreign Currency Translation | Foreign Currency Translation The financial statements of Pieris’ foreign subsidiaries are translated from local currency into reporting currency, which is U.S. dollars, using the current exchange rate at the balance sheet date for assets and liabilities, and the average exchange rate prevailing during the period for revenues and expenses. The functional currency for Pieris’ foreign subsidiaries is considered to be the local currency for each entity and, accordingly, translation adjustments for these subsidiaries are included in accumulated other comprehensive loss within stockholders’ equity. Realized and unrealized gains and losses resulting from foreign currency transactions denominated in currencies other than the functional currency are reflected as other income (expense), net in the consolidated statements of operations. |
Cash Equivalents and Restricted Cash | Cash, Cash Equivalents, and Restricted Cash Cash and cash equivalents consist of cash on deposit in banks and other cash invested temporarily in money-market funds that are highly liquid and have an original maturity of less than 90 days at the date of purchase. The Company held no restricted cash as of December 31, 2016. As of December 31, 2015 the Company held $17,302 in restricted cash. Such bank balances in 2015 related to prepayments received by the Company pursuant to EU grants under the EUROCALIN program (see Note 3 Revenue We expect that our existing cash and cash equivalents will enable us to fund our operations and capital expenditure requirements through the filing of our 2017 financial statements. |
Concentration of Credit Risk and Other Risks and Uncertainties | Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that subject Pieris to concentrations of credit risk include cash and cash equivalents and accounts receivable. Pieris maintains cash with various major financial institutions. Pieris had no cash equivalents as of December 31, 2016 and 2015. Pieris maintains deposits and owns money market funds only in highly rated financial institutions to minimize the credit risk from the financial institutions. There were no money market funds held at December 31, 2016. Management periodically reviews the credit standing of these financial institutions and believes that Pieris is not exposed to significant credit risk from the institutions in which those deposits are held. As of December 31, 2016 and December 31, 2015, Pieris is not exposed to significant credit risks from accounts receivable. Pieris relies on third parties to conduct preclinical and clinical studies. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, Pieris may not be able to obtain regulatory approval for Pieris’s drug candidates and Pieris’s business could be substantially impacted. Furthermore, Pieris is exposed to the risks associated with third parties formulating and manufacturing its preclinical and clinical drug supplies and any approved product candidates. The development and commercialization of any of its drug candidates could be stopped, delayed or made less profitable if those third parties fail to provide Pieris with sufficient quantities of such drug candidate or fail to do so at acceptable quality levels, including in accordance with applicable regulatory requirements and prices. In line with such third-party risk, Pieris depends significantly on the Research and Licensing Agreement (or the “TUM License Agreement”) with Technische Universität München (“TUM” or “Technical University Munich”), under which certain intellectual property rights are exclusively licensed to Pieris. In the event that the TUM License Agreement is terminated by TUM, Pieris would be significantly hampered in its efforts to develop and commercialize, as well as to sub-license, the drug candidates covered by such exclusive license. |
Accounts Receivable | Accounts Receivable Accounts receivable are recorded net of allowances for doubtful accounts and represent amounts due from third parties and collaboration partners. Management monitors and evaluates collectability of receivables on an ongoing basis and considers whether an allowance for doubtful accounts is necessary. Management determined that no such reserve is needed as of December 31, 2016 and 2015. Historically, Pieris has not had collectability issues with third parties and collaboration partners. |
Property and Equipment | Property and Equipment Property and equipment are recorded at acquisition cost, less accumulated depreciation and impairment. Depreciation on property and equipment is calculated using the straight-line method over the remaining estimated useful lives of the assets. Maintenance and repairs to these assets are charged to expenses as occurred. The estimated useful life of the different groups of property and equipment is as follows: Asset Classification Estimated useful life (in years) Leasehold improvements shorter of useful life or remaining life of the lease Laboratory equipment 1 - 14 Office and computer equipment 1 - 15 |
Impairment of Long-lived Assets | Impairment of Long-lived Assets Pieris reviews its long-lived assets to be held and used for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Pieris evaluates the realizability of its long-lived assets based on profitability and cash flow expectations for the related asset. Any write-downs are treated as permanent reductions in the carrying amount of the assets. Pieris believes that, as of each of the balance sheets presented, none of Pieris’ long-lived assets were impaired. |
Revenue Recognition | Revenue Recognition Pieris has entered into several licensing and development agreements with collaboration partners for the development of Anticalin ® Revenue Recognition—Multiple-Element Arrangements Revenue Recognition—Milestone Method |
Multiple-Element Arrangements | Multiple-Element Arrangements When evaluating multiple-element arrangements, Pieris identifies the deliverables included within the agreement and evaluates which deliverables represent separate units of accounting based on whether the delivered element has stand-alone value to the customer or if the arrangement includes a general right of return for delivered items. The consideration received is allocated among the separate units of accounting using the relative selling price method, and the applicable revenue recognition criteria are applied to each of the separate units of accounting. Pieris has used best estimate of selling price methodology to estimate the selling price for licenses and options to acquire additional licenses to its proprietary technology because Pieris does not have Vendor Specific Objective Evidence or Third Party Evidence of selling price for these deliverables. To determine the estimated selling price of a license to its proprietary technology, Pieris considers market conditions as well as entity-specific factors, including those factors contemplated in negotiating the agreements, terms of previous collaborative agreements, similar agreements entered into by third parties, market opportunity, estimated development costs, probability of success and the time needed to commercialize a product candidate pursuant to the license. In validating Pieris’ best estimate of selling price, Pieris evaluates whether changes in the key assumptions used to determine the best estimate of selling price will have a significant effect on the allocation of arrangement consideration among multiple deliverables. Multiple element arrangements, such as license and development arrangements, are analyzed to determine whether the deliverables, which often include a license and performance obligations such as research and steering committee services, can be separated or whether they must be accounted for as a single unit of accounting in accordance with generally accepted accounting principles, or U.S. GAAP. The Company recognizes up-front license payments as revenue upon delivery of the license only if the license has stand-alone value. If the license is considered to not have stand-alone value, the arrangement would then be accounted for as a single unit of accounting and the license payments and payments for performance obligations are recognized as revenue over the estimated period of when the performance obligations are performed. If the Company is involved in a steering committee as part of a multiple element arrangement, the Company assesses whether its involvement constitutes a performance obligation or a right to participate. Steering committee services that are determined to be performance obligations are combined with other research services or performance obligations required under an arrangement, if any, in determining the level of effort required in an arrangement and the period over which the Company expects to complete its aggregate performance obligations. Whenever the Company determines that an arrangement should be accounted for as a single unit of accounting, it must determine the period over which the performance obligations will be performed and revenue will be recognized. Revenue will be recognized using either a relative performance or straight-line method. The Company recognizes revenue using the relative performance method provided that the Company can reasonably estimate the level of effort required to complete its performance obligations under an arrangement and such performance obligations are provided on a best-efforts basis. Full-time equivalents are typically used as the measure of performance. If the Company cannot reasonably estimate when its performance obligation either ceases or becomes inconsequential and perfunctory, then revenue is deferred until the Company can reasonably estimate when the performance obligation ceases or becomes inconsequential. Revenue is then recognized over the remaining estimated period of performance. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations under an arrangement. The accounting treatment for options granted to collaborators is dependent upon the nature of the option granted to the collaborative partner. Options are considered substantive if, at the inception of an agreement, Pieris is at risk as to whether the collaborative partner will choose to exercise the options to secure additional goods or services. Factors that are considered in evaluating whether options are substantive include the overall objective of the arrangement, the benefit the collaborator might obtain from the agreement without exercising the options, the cost to exercise the options relative to the total upfront consideration, and the additional financial commitments or economic penalties imposed on the collaborator as a result of exercising the options. In arrangements where options to obtain additional deliverables are considered substantive, Pieris determines whether the optional licenses are priced at a significant and incremental discount. If the prices include a significant and incremental discount, the option is considered a deliverable in the arrangement. However, if not priced at a discount, the elements included in the arrangement are considered to be only the non-contingent elements. When a collaborator exercises an option to acquire an additional license, the exercise fee that is attributed to the additional license and any incremental discount allocated at inception are recognized in a manner consistent with the treatment of up-front payments for licenses ( i.e. Payments or reimbursements resulting from Pieris’ research and development efforts in multi-element arrangements in which Pieris’s research and development efforts are considered deliverable are recognized as the services are performed and are presented on a gross basis so long as there is persuasive evidence of an arrangement, the fee is fixed or determinable, and collection of the related receivable is reasonably assured. Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue in the accompanying balance sheets. |
Milestone Payments and Royalties | Milestone Payments and Royalties At the inception of each agreement that includes milestone payments, Pieris evaluates whether each milestone is substantive and at risk to both parties on the basis of the contingent nature of the milestone. This evaluation includes an assessment of whether: (a) the consideration is commensurate with either (1) the entity’s performance to achieve the milestone, or (2) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone, (b) the consideration relates solely to past performance and (c) the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. Pieris evaluates factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required to achieve the respective milestone and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement in making this assessment. Pieris aggregates milestones into four categories: (i) research milestones, (ii) development milestones, (iii) commercial milestones and (iv) sales milestones. Research milestones are typically achieved upon reaching certain success criteria as defined in each agreement related to developing an Anticalin protein against the specified target. Development milestones are typically reached when a compound reaches a defined phase of clinical research or passes such phase, or upon gaining regulatory approvals. Commercial milestones are typically achieved when an approved pharmaceutical product reaches the status for commercial sale or certain defined levels of net sales by the licensee, such as when a product first achieves global sales or annual sales of a specified amount. Sales milestones are typically achieved when an approved pharmaceutical product exceed net sales as defined in each agreement. For revenues from research, development and sales milestone payments, if the milestones are deemed substantive and the milestone payments are nonrefundable, such amounts are recognized entirely upon successful accomplishment of the milestones. Milestones that are not considered substantive are accounted for as license payments and recognized on a straight-line basis over the period of performance. To date, Pieris has determined all milestones are substantive. Revenues from commercial milestone payments are accounted for as royalties and are recorded as revenue upon achievement of the milestone, assuming all other revenue recognition criteria are met. Royalty payments are recognized in revenues based on the timing of royalty payments earned in accordance with the agreements, which typically is the period when the relevant sales occur, assuming all other revenue recognition criteria are met. |
Government Grants | Government Grants Government grants are recognized when there is reasonable assurance that all conditions will be complied with and the grant will be received. As the government grants generally represent subsidies for specified activities, they are recognized when earned as revenue from grants. Otherwise, government grants are credited against the expenses incurred to receive the grant. Funds received that are not related to research and development expenses that have already been incurred, such as the EUROCALIN grant, are recorded as deferred revenue until such time that the related expenses have been incurred by Pieris or by one of the other members of the EUROCALIN consortium. At the time eligible expenses are incurred, the applicable portion of deferred revenue, according to the respective funding rates, is recorded as revenue from grants. |
Research and Development | Research and Development Research and development expenses are charged to the statement of operations as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including salaries and benefits, facilities costs, pre-clinical and clinical costs, contract services, consulting, depreciation and amortization expense, and other related costs. Costs associated with acquired technology, in the form of upfront fees or milestone payments, are charged to research and development expense as incurred. |
Income Taxes | Income Taxes The Company applies ASC 740— Income Taxes From time to time, the Company may receive tax credits in the form of cash in our Australian jurisdiction, irrespective of a tax liability. The Australian R&D Tax Incentive credit is a self-assessed, entitlement program that provides a credit for eligible R&D entities engaging in R&D activities. The level of credit for years starting before 1 July 2016 is a 45% refundable credit where the R&D entity’s aggregated turnover for the income tax year is less than $20 million and at any time during the income tax year the R&D entity is not controlled by an exempt entity or combination of exempt entities per s 328-125 of the Income Tax Assessment Act 1997 (ITAA 97). The entity submitted an Advance and Overseas Finding application, which was approved and awarded certificates OF00630 for the year beginning 1 January 2015. The Advance and Overseas finding certification is in force for the following two income years for Australian activities and until completion for overseas activities. This application detailed the R&D activities that were to be conducted in Australia and overseas. The Company records the Australian R&D tax credit as an offset to research and development expenses in the consolidated statements of operations, as this was where the original expense was recorded. For the years ended December 31, 2016 and 2015 the Company recorded $1.5 million and $0.4 million, respectively. As of December 31, 2016, the Company recorded a receivable for $1.5 million related to the Australian R&D Tax Incentive credit. |
Stock-based Compensation | Stock-based Compensation Pieris measures share-based payments in accordance with ASC Topic 718, Stock Compensation The Company uses the Black-Scholes option pricing model to determine the estimated fair value for stock-based awards. Option-pricing models require the input of various subjective assumptions, including the option’s expected life, expected dividend yield, price volatility, risk free interest rate and forfeitures of the underlying stock. Accordingly, the weighted-average fair value of the options granted during the years ended December 31, 2016 and 2015 was $1.00 and $1.87, respectively based on the following assumptions: Years Ended December 31, 2016 2015 Risk free interest rate 1.13%-2.08% 1.47%-1.89% Expected term 5.0 – 5.7 years 5.0 – 6.1 years Dividend yield — — Expected volatility 74.90%-76.00% 72.65%-75.07% Expected volatility rates are based on historical volatility of the common stock of comparable publicly traded entities, and other factors due to the lack of historic information of the Company’s common stock. The expected life of stock-based options is the period of time for which the stock-based options are expected to be outstanding. Given the lack of historic exercise data, the expected life is determined using the “simplified method” which is defined as the midpoint between the vesting date and the end of the contractual term. Under the new guidance of ASU No. 2016-09, “Compensation—Stock Compensation (Topic 718) Improvements to Employee Share-Based Payment Accounting” Stock-Based Compensation, Pieris recorded stock-based compensation expense of $1.9 million and $1.2 million for the years ended December 31, 2016 and 2015, respectively. Total stock-based compensation expense was recorded in operating expenses based upon the functional responsibilities of the individuals holding the respective options as follows: Years Ended 2016 2015 Research and development $ 599,138 $ 379,066 General and administrative 1,306,118 785,567 Total stock-based compensation $ 1,905,256 $ 1,164,633 |
Contingencies | Contingencies Accruals are recorded for loss contingencies when it is probable that a liability has been incurred and the amount of the related loss can be reasonably estimated. Pieris evaluates, on a quarterly basis, developments in legal proceedings and other matters that could cause an increase or decrease in the amount of the liability that has been accrued previously. Considering facts known at the time of the assessment, Pieris determines whether potential losses are considered reasonably possible or probable and whether they are estimable. Based upon this assessment, Pieris carries out an evaluation of disclosure requirements and considers possible accruals in the financial statements. |
Segment Reporting | Segment Reporting Operating segments are identified as components of an enterprise where separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions on how to allocate resources and assess performance. Pieris operates as a single segment dedicated to the discovery and development of biotechnological applications and the Company’s chief operating decision maker (“CODM”) makes decisions based on the Company as a whole. The Company has determined that its CODM is its Chief Executive Officer. |
Net Loss per Common Share | Net Loss per Common Share Basic net loss per share was determined by dividing net loss by the weighted average common shares outstanding during the period. Diluted net loss per share was determined by dividing net loss by diluted weighted average shares outstanding. Diluted weighted average shares reflect the dilutive effect, if any, of common stock options based on the treasury stock method. For all financial statement periods presented the number of basic and diluted weighted average shares outstanding was the same because any increase in the number of shares of common stock equivalents for any period presented would be antidilutive based on the net loss for the period. Shares to be issued upon the exercise of the outstanding options and warrants excluded from the loss per share calculation amounted to $ 8.2 million and 2.6 million for the year ended December 31, 2016 and 2015 respectively, because the awards were anti-dilutive. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Adopted Standards for current period In August 2014, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2014-15, “Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern” which is intended to define management’s responsibility to evaluate whether there is substantial doubt about an organization’s ability to continue as a going concern and to provide related footnote disclosures. Substantial doubt about an entity’s ability to continue as a going concern exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its financial obligations as they become due within one year after the date that the financial statements are issued (or are available to be issued). ASU No. 2014-15 provides guidance to an organization’s management, with principles and definitions intended to reduce diversity in the timing and content of disclosures commonly provided by organizations in the footnotes of their financial statements. ASU No. 2014-15 is effective for annual reporting periods ending after December 15, 2016, and for annual and interim periods thereafter. As of December 31, 2016, the Company has adopted this ASU and the Company is not required to make any additional disclosures. In March 2016, the FASB issued ASU No. 2016-09, “Compensation—Stock Compensation (Topic 718) Improvements to Employee Share-Based Payment Accounting” Standards not yet adopted In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”). Subsequently, the FASB also issued ASU 2015-14, Revenue from Contracts with Customers (Topic 606) , which adjusted the effective date of ASU 2014-09; ASU No. 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net), which amends the principal-versus-agent implementation guidance and illustrations in ASU 2014-09; ASU No. 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing, which clarifies identifying performance obligation and licensing implementation guidance and illustrations in ASU 2014-09; and ASU No. 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients , which addresses implementation issues and is intended to reduce the cost and complexity of applying the new revenue standard in ASU 2014-09 (collectively, the “Revenue ASUs”). The Revenue ASUs provide an accounting standard for a single comprehensive model for use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance. The accounting standard is effective for interim and annual periods beginning after December 15, 2017, with an option to early adopt for interim and annual periods beginning after December 15, 2016. The guidance permits two methods of adoption: retrospectively to each prior reporting period presented (the full retrospective method), or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (the modified retrospective method). We currently anticipate adoption of the new standard effective January 1, 2018 under the modified retrospective method. The Company is in the process of determining the impact of the Revenue Recognition ASUs on its financial statements. In February 2016, the FASB issued ASU No. 2016-02, “ Leases (Topic 842) Pieris has considered other recent accounting pronouncements and concluded that they are either not applicable to the business, or that the effect is not expected to be material to the unaudited condensed consolidated financial statements as a result of future adoption. |
Summary of Significant Accoun25
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Property And Equipment Estimated Useful Lives | The estimated useful life of the different groups of property and equipment is as follows: Asset Classification Estimated useful life (in years) Leasehold improvements shorter of useful life or remaining life of the lease Laboratory equipment 1 - 14 Office and computer equipment 1 - 15 |
Schedule of Fair Value Assumptions | Accordingly, the weighted-average fair value of the options granted during the years ended December 31, 2016 and 2015 was $1.00 and $1.87, respectively based on the following assumptions: Years Ended December 31, 2016 2015 Risk free interest rate 1.13%-2.08% 1.47%-1.89% Expected term 5.0 – 5.7 years 5.0 – 6.1 years Dividend yield — — Expected volatility 74.90%-76.00% 72.65%-75.07% |
Schedule of Stock-Based Compensation Expense | Total stock-based compensation expense was recorded in operating expenses based upon the functional responsibilities of the individuals holding the respective options as follows: Years Ended 2016 2015 Research and development $ 599,138 $ 379,066 General and administrative 1,306,118 785,567 Total stock-based compensation $ 1,905,256 $ 1,164,633 |
Revenue (Tables)
Revenue (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Revenue from Product Sales | The Company has not generated revenue from product sales. The Company has generated revenue pursuant to (i) license and collaboration agreements, which include upfront payments for licenses or options to obtain licenses, payments for research and development services and milestone payments, and (ii) government grants. Years ended December 31, 2016 2015 License fees $ 2,735,794 $ — Research and development services 1,439,513 5,593 Milestone payments 1,655,367 2,538,698 Government grants — 369,200 Other Revenues — 18,440 Total Revenue $ 5,830,674 $ 2,931,931 |
Balance Sheet Items Related to FP7 Agreement | The following balance sheet items relate to the FP7 agreement: Years Ended December 31, 2016 2015 Other current assets (receivables from FP7 grant) $ — $ 980,936 Cash (restricted cash) $ — $ 17,302 Accounts payable $ — $ 424,441 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Property, Plant and Equipment [Abstract] | |
Property Plant and Equipment | Property and equipment are summarized as follows: Years Ended December 31, 2016 2015 Laboratory equipment $ 3,869,154 $ 3,701,517 Office and computer equipment 499,233 443,562 Leasehold improvements 320,750 304,363 Property and equipment at cost 4,689,137 4,449,442 Accumulated depreciation (2,424,660 ) (2,286,671 ) Property and equipment, net $ 2,264,477 $ 2,162,771 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Schedule of Loss Before Income Taxes | (Loss) before income taxes consists of the following: Years Ended December 31, 2016 2015 Domestic $ (8,724,628 ) $ (7,563,300 ) Foreign (13,912,568 ) (6,291,475 ) Loss before income taxes $ (22,637,196 ) $ (13,854,775 ) |
Schedule of Components of Provision (Benefit) for Income Taxes | The components of the provision (benefit) for income taxes are as follows: Years Ended December 31, 2016 2015 Current: Federal $ — $ — State — — Foreign 161,970 203,866 Total current 161,970 203,866 Deferred: Federal — — State — — Foreign — — Total deferred — — Provision (benefit) for income taxes $ 161,970 $ 203,866 |
Summary of Reconciliation of U.S. Statutory Rate to Company's Effective Tax Rate | The reconciliation of the federal statutory rate to Pieris’ effective tax rate is as follows: 2016 2015 Federal income tax rate 34.0 % 34.0 % Foreign rate differential (2.9 ) (2.1 ) State tax, net of federal benefit 0.9 3.1 Permanent items (2.3 ) (1.7 ) Other (0.9 ) 2.9 Withholding tax (0.7 ) (1.5 ) Change in valuation allowance (28.8 ) (36.2 ) Effective income tax rate (0.7 )% (1.5 )% |
Components of Deferred Tax Assets and Liabilities | The components of deferred tax assets and liabilities related to net tax effects of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income taxes purposes were as follows: Years Ended December 31, 2016 2015 Deferred tax assets: Net operating loss carryforwards $ 18,498,365 $ 13,052,809 Share based awards compensation 1,080,314 692,906 Accrued compensation/other 190,799 139,773 Accrued expenses 35,888 4,201 Depreciation 12,065 12,276 Total deferred tax assets 19,817,431 13,901,965 Less: valuation allowance: (19,817,431 ) (13,901,965 ) Net deferred tax asset $ — $ — |
Schedule of Reconciliation of Unrecognized Tax Benefits Excluding Impact of Interest and Penalties | The following table sets forth a reconciliation of the beginning and ending amounts of unrecognized tax benefits, excluding the impact of interest and penalties, for the years ended December 31, 2016 and 2015: Unrecognized tax benefits at December 31, 2015 $ — Increase for tax positions taken during the current period 5,654,803 Unrecognized tax benefits at December 31, 2016 $ 5,654,803 |
Stock and Employee Benefit Pl29
Stock and Employee Benefit Plans (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
2014 Stock Plan [Member] | |
Schedule of Information Regarding Stock Option Plans | A summary of the status of the Company’s 2014 plan as of December 31, 2016 and changes during the year then ended is as follows: Number of Weighted- Weighted- Aggregate Outstanding, December 31, 2015 2,707,329 $ 2.05 9.17 years $ 741 Granted 1,157,734 1.57 Forfeited (140,000 ) 1.71 Outstanding, December 31, 2016 3,725,063 $ 1.91 8.55 years $ — Vested or expected to vest 3,725,063 $ 1.91 8.55 years $ — Exercisable, December 31, 2016 1,961,811 $ 2.01 7.99 years $ — |
2016 Stock Plan [Member] | |
Schedule of Information Regarding Stock Option Plans | A summary of the status of the Company’s 2016 plan as of December 31, 2016 and changes during the year then ended is as follows: Number of Weighted- Weighted- Aggregate Outstanding, December 31, 2015 — $ — — $ — Granted 715,313 2.36 Outstanding, December 31, 2016 715,313 $ 2.36 9.62 years $ — Vested or expected to vest 715,313 $ 2.36 9.62 years $ — Exercisable, December 31, 2016 228,774 $ 2.46 8.90 years $ — |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | The Company has recorded the following accrued expenses as of December 31, 2016 and December 31, 2015, respectively: Years Ended December 31, 2016 2015 Accrued expenses Accrued compensation expense $ 1,198,448 $ 704,597 Accrued audit and tax fees 454,931 179,223 Accrued professional fees 867,969 194,790 Accrued R&D fees 1,040,321 466,076 Accrued other 157,788 194,694 Total amount of accrued expenses 3,719,457 1,739,380 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Schedule of Contractual Commitments of the Non-cancellable Portion | The Company’s contractual commitments of the non-cancellable portion under theses operating leases as of December 31, 2016 are as follows: Total 2017 $ 391,042 2018 209,590 2019 195,909 2020 199,859 2021 203,809 Thereafter 34,563 Total minimum lease payments $ 1,234,772 |
License Agreement [Member] | |
Schedule of Minimum License Fee Commitment | The table below shows the minimum annual license fee commitments under the two agreements as of December 31, 2016: License 2017 $ 84,124 2018 84,124 2019 84,124 2020 84,124 2021 84,124 Thereafter 410,105 Total minimum license payments $ 830,725 |
Summary of Significant Accoun32
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Summary Of Significant Accounting Policies [Line Items] | ||
Restricted cash | $ 0 | $ 17,302 |
Cash equivalents | 0 | 0 |
Money market funds held | 0 | |
Allowance for doubtful accounts | 0 | 0 |
Impairments loss | $ 0 | |
Milestones arrangement, categories description | Pieris aggregates milestones into four categories (i) research milestones, (ii) development milestones, (iii) commercial milestones and (iv) sales milestones. | |
Revenue | $ 5,830,674 | $ 2,931,931 |
Weighted average grant date fair value | $ 1 | $ 1.87 |
Stock based compensation expense | $ 1,905,256 | $ 1,164,633 |
Anti-dilutive securities excluded from computation of net income loss per share | 8,200,000 | 2,600,000 |
Stock-based compensation expense | $ 1,905,256 | 1,164,633 |
Australia [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Percentage of refundable credit | 45.00% | |
Australia [Member] | Research And Development [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Revenue | $ 20,000,000 | |
Tax credits | 1,500,000 | 400,000 |
Income tax receivable | $ 1,500,000 | |
Accounting Standards Update 2016-09 [Member] | New Accounting Pronouncement, Early Adoption, Effect [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Stock-based compensation expense | $ 100,000 |
Summary of Significant Accoun33
Summary of Significant Accounting Policies - Property and Equipment Useful Life (Detail) | 12 Months Ended |
Dec. 31, 2016 | |
Leasehold Improvements [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, estimated Lives | Shorter of useful life or remaining life of the lease |
Laboratory Equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, estimated Lives | 1 year |
Laboratory Equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, estimated Lives | 14 years |
Office and Computer Equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, estimated Lives | 1 year |
Office and Computer Equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, estimated Lives | 15 years |
Summary of Significant Accoun34
Summary of Significant Accounting Policies - Schedule of Weighted-Average Assumptions Used for Calculating Value of Options Granted (Detail) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options Outstanding, Weighted Average Exercise Price, and Additional Disclosures [Abstract] | ||
Risk free interest rate | 1.13% | 1.47% |
Risk free interest rate | 2.08% | 1.89% |
Dividend yield | 0.00% | 0.00% |
Expected volatility | 74.90% | 72.65% |
Expected volatility | 76.00% | 75.07% |
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options Outstanding, Weighted Average Exercise Price, and Additional Disclosures [Abstract] | ||
Expected term | 5 years | 5 years |
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options Outstanding, Weighted Average Exercise Price, and Additional Disclosures [Abstract] | ||
Expected term | 5 years 8 months 12 days | 6 years 1 month 6 days |
Summary of Significant Accoun35
Summary of Significant Accounting Policies - Schedule of Total Stock-Based Compensation Expense Related to Share-Based Awards Under the Pieris Plan (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-option expense | $ 1,905,256 | $ 1,164,633 |
Research and Development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-option expense | 599,138 | 379,066 |
General and Administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-option expense | $ 1,306,118 | $ 785,567 |
Revenue - Additional Informatio
Revenue - Additional Information (Detail) | 1 Months Ended | 12 Months Ended | |
Aug. 31, 2011USD ($)Tranches | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | |
Deferred Revenue Arrangement [Line Items] | |||
Revenues from product sales | $ 0 | ||
Revenue | 5,830,674 | $ 2,931,931 | |
Collaboration agreement, milestone payments | $ 1,655,367 | $ 2,538,698 | |
Withholding tax | (0.70%) | (1.50%) | |
Collaboration agreement, license upfront payment | $ 2,735,794 | ||
BIO Cluster M4 [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Funding rate | 40.00% | ||
Grant received | $ 0 | $ 8,654 | |
BIO Cluster M4 [Member] | Maximum [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Contractual agreement, potential payments | 1,400,000 | ||
European Union [Member] | Seventh Research Framework Program (FP7 Agreement) [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Contractual agreement, potential payments | $ 7,300,000 | ||
Funding rate | 64.00% | ||
Grant received | 0 | 400,000 | |
Tranches of payments | Tranches | 3 | ||
Collaborative Arrangement [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Collaboration agreement, milestone payments | 0 | 0 | |
Contractual agreement, potential payments | 14,000,000 | ||
Sanofi [Member] | Maximum [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Contractual agreement, potential payments | 48,600,000 | ||
Sanofi [Member] | Maximum [Member] | Research Milestones [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Contractual agreement, potential payments | 1,800,000 | ||
Sanofi [Member] | Maximum [Member] | Development Milestones [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Contractual agreement, potential payments | 27,900,000 | ||
Sanofi [Member] | Maximum [Member] | Commercial Milestones [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Contractual agreement, potential payments | 18,900,000 | ||
Sanofi [Member] | Collaborative Arrangement [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Collaboration agreement, milestone payments | 0 | ||
Collaboration agreement, revenue recognized | $ 0 | $ 500,000 | |
Daiichi Sankyo Inc [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Withholding tax | 10.00% | 10.00% | |
Daiichi Sankyo Inc [Member] | Collaborative Arrangement [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Collaboration agreement, milestone payments | $ 1,700,000 | $ 2,000,000 | |
Daiichi Sankyo Inc [Member] | Collaborative Arrangement [Member] | Maximum [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Contractual agreement, potential payments | 85,900,000 | ||
Daiichi Sankyo Inc [Member] | Collaborative Arrangement [Member] | Maximum [Member] | Research Milestones [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Contractual agreement, potential payments | 2,500,000 | ||
Daiichi Sankyo Inc [Member] | Collaborative Arrangement [Member] | Maximum [Member] | Development Milestones [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Contractual agreement, potential payments | 35,200,000 | ||
Daiichi Sankyo Inc [Member] | Collaborative Arrangement [Member] | Maximum [Member] | Commercial Milestones [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Contractual agreement, potential payments | 47,300,000 | ||
Daiichi Sankyo Inc [Member] | Collaborative Arrangement [Member] | Maximum [Member] | Additional Diagnostic Milestones [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Contractual agreement, potential payments | 700,000 | ||
FHoffmann La Roche Ltd and Hoffmann La Roche Inc [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Deferred revenue | 3,700,000 | 0 | |
FHoffmann La Roche Ltd and Hoffmann La Roche Inc [Member] | Upfront Payment Arrangement [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Collaboration agreement, license upfront payment | 6,500,000 | ||
FHoffmann La Roche Ltd and Hoffmann La Roche Inc [Member] | Research Services [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Collaboration agreement, revenue recognized | $ 4,100,000 | 0 | |
Research collaboration agreement, estimated period | 20 months | ||
FHoffmann La Roche Ltd and Hoffmann La Roche Inc [Member] | Research Services [Member] | Extension Term [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Research collaboration agreement, estimated period | 5 years | ||
FHoffmann La Roche Ltd and Hoffmann La Roche Inc [Member] | Collaborative Arrangement [Member] | Maximum [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Contractual agreement, potential payments | $ 399,400,000 | ||
FHoffmann La Roche Ltd and Hoffmann La Roche Inc [Member] | Collaborative Arrangement [Member] | Maximum [Member] | Development Milestones [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Contractual agreement, potential payments | 277,600,000 | ||
FHoffmann La Roche Ltd and Hoffmann La Roche Inc [Member] | Collaborative Arrangement [Member] | Maximum [Member] | Sales Milestone Payments [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Contractual agreement, potential payments | 117,700,000 | ||
Collaboration Partner One [Member] | Sales Revenue, Net [Member] | Revenue From Partners [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Revenue | 1,700,000 | 2,000,000 | |
Collaboration Partner Two [Member] | Sales Revenue, Net [Member] | Revenue From Partners [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Revenue | $ 4,100,000 | 500,000 | |
Government Grant [Member] | Sales Revenue, Net [Member] | Revenue From Partners [Member] | |||
Deferred Revenue Arrangement [Line Items] | |||
Revenue | $ 400,000 |
Revenue - Revenue from Product
Revenue - Revenue from Product Sales (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Income Statement [Abstract] | ||
License fees | $ 2,735,794 | |
Research and development services | 1,439,513 | $ 5,593 |
Milestone payments | 1,655,367 | 2,538,698 |
Government grants | 369,200 | |
Other Revenues | 18,440 | |
Total Revenue | $ 5,830,674 | $ 2,931,931 |
Revenue - Balance Sheet Items R
Revenue - Balance Sheet Items Related to FP7 Agreement (Detail) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Cash (restricted cash) | $ 0 | $ 17,302 |
Seventh Research Framework Program (FP7 Agreement) [Member] | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Other current assets (receivables from FP7 grant) | 980,936 | |
Cash (restricted cash) | 17,302 | |
Accounts payable | $ 424,441 |
Fair Value Measurement - Additi
Fair Value Measurement - Additional Information (Detail) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Fair Value Disclosures [Abstract] | ||
Debt instruments fair value | $ 0 | $ 0 |
Cash equivalents | $ 0 | $ 0 |
Property and Equipment, Net - S
Property and Equipment, Net - Summary of Property and Equipment (Detail) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment at cost | $ 4,689,137 | $ 4,449,442 |
Accumulated depreciation | (2,424,660) | (2,286,671) |
Property and equipment, net | 2,264,477 | 2,162,771 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment at cost | 3,869,154 | 3,701,517 |
Office and Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment at cost | 499,233 | 443,562 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment at cost | $ 320,750 | $ 304,363 |
Property and Equipment, Net - P
Property and Equipment, Net - Property and Equipment - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Property, Plant and Equipment [Line Items] | ||
Depreciation expense | $ 361,382 | $ 307,906 |
Germany [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Percentage of property and equipment | 86.00% | |
United States [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Percentage of property and equipment | 14.00% |
Income Taxes - Schedule of Loss
Income Taxes - Schedule of Loss Before Income Taxes (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | ||
Domestic | $ (8,724,628) | $ (7,563,300) |
Foreign | (13,912,568) | (6,291,475) |
Loss before income taxes | $ (22,637,196) | $ (13,854,775) |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Components of Provision (Benefit) for Income Taxes (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Current: | ||
Federal | $ 0 | $ 0 |
State | 0 | 0 |
Foreign | 161,970 | 203,866 |
Total current | 161,970 | 203,866 |
Deferred: | ||
Federal | 0 | 0 |
State | 0 | 0 |
Foreign | 0 | 0 |
Total deferred | 0 | 0 |
Provision (benefit) for income taxes | $ 161,970 | $ 203,866 |
Income Taxes - Summary of Recon
Income Taxes - Summary of Reconciliation of U.S. Statutory Rate to Company's Effective Tax Rate (Detail) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | ||
Federal income tax rate | 34.00% | 34.00% |
Foreign rate differential | (2.90%) | (2.10%) |
State tax, net of federal benefit | 0.90% | 3.10% |
Permanent items | (2.30%) | (1.70%) |
Other | (0.90%) | 2.90% |
Withholding tax | (0.70%) | (1.50%) |
Change in valuation allowance | (28.80%) | (36.20%) |
Effective income tax rate | (0.70%) | (1.50%) |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets and Liabilities (Detail) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 18,498,365 | $ 13,052,809 |
Share based awards compensation | 1,080,314 | 692,906 |
Accrued compensation/other | 190,799 | 139,773 |
Accrued expenses | 35,888 | 4,201 |
Depreciation | 12,065 | 12,276 |
Total deferred tax assets | 19,817,431 | 13,901,965 |
Less: valuation allowance: | (19,817,431) | (13,901,965) |
Net deferred tax asset | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Income Taxes [Line Items] | ||
Uncertain tax position accrued | $ 0 | $ 0 |
Uncertain tax positions interest and penalties accrued | 0 | 0 |
Increase in the valuation allowance | 5,900,000 | |
Deferred tax asset for net operating loss carryforwards | $ 8,900,000 | |
Federal [Member] | ||
Income Taxes [Line Items] | ||
Net operating loss carryforward | 12,900,000 | |
State [Member] | ||
Income Taxes [Line Items] | ||
Net operating loss carryforward | 9,800,000 | |
Australia [Member] | ||
Income Taxes [Line Items] | ||
Net operating loss carryforward | 300,000 | |
Germany [Member] | Corporate Income Tax [Member] | ||
Income Taxes [Line Items] | ||
Net operating loss carryforward | 66,300,000 | |
Germany [Member] | Trade Tax [Member] | ||
Income Taxes [Line Items] | ||
Net operating loss carryforward | $ 64,900,000 |
Income Taxes - Schedule of Reco
Income Taxes - Schedule of Reconciliation of Unrecognized Tax Benefits Excluding Impact of Interest and Penalties (Detail) | 12 Months Ended |
Dec. 31, 2016USD ($) | |
Income Tax Uncertainties [Abstract] | |
Increase for tax positions taken during the current period | $ 5,654,803 |
Unrecognized tax benefits at December 31, 2016 | $ 5,654,803 |
Debt - Additional Information (
Debt - Additional Information (Detail) - TBG [Member] | Dec. 31, 2016USD ($) | Apr. 09, 2015EUR (€) | Apr. 09, 2015USD ($) | Mar. 31, 2015EUR (€) | Mar. 31, 2015USD ($) | Jan. 31, 2015EUR (€) | Jan. 31, 2015USD ($) | Dec. 11, 2014EUR (€)Tranches | Mar. 31, 2015EUR (€) | Mar. 31, 2015USD ($) | Dec. 11, 2014USD ($) | Apr. 03, 2014EUR (€) | Apr. 03, 2014USD ($) |
Debt Instrument [Line Items] | |||||||||||||
Amount of repayment to TBG outstanding | € 1,050,000 | $ 1,270,000 | € 1,200,000 | $ 1,340,000 | |||||||||
Principal amount, interest rate | 10.53% | 10.53% | |||||||||||
Repayments of Unsecured Debt | $ | $ 0 | ||||||||||||
Number of tranches | Tranches | 2 | ||||||||||||
Debt Instrument, Redemption, Period One [Member] | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Principal Payment Unsecured Debt | € 600,000 | $ 726,060 | |||||||||||
Repayments of Unsecured Debt | € 931,312 | $ 1,027,051 | |||||||||||
Debt Instrument, Redemption, Period Two [Member] | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Principal Payment Unsecured Debt | € 450,000 | $ 544,545 | |||||||||||
Repayments of Unsecured Debt | € 118,688 | $ 130,889 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) $ / shares in Units, $ in Millions | Jul. 24, 2015$ / sharesshares | Jun. 30, 2016USD ($)$ / sharesshares | Jul. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2016$ / sharesshares | Dec. 31, 2015$ / sharesshares |
Schedule Of Stockholders Equity [Line Items] | |||||
Common stock, shares authorized | 300,000,000 | 300,000,000 | |||
Common stock, par value | $ / shares | $ 0.001 | $ 0.001 | |||
Common stock, shares issued | 43,058,827 | 39,833,023 | |||
Common stock, outstanding | 43,058,827 | 39,833,023 | |||
Preferred Stock, shares issued | 4,963 | 0 | |||
Preferred Stock, shares outstanding | 4,963 | 0 | |||
Preferred Stock, shares authorized | 4,963 | 4,963 | |||
Preferred Stock, par value | $ / shares | $ 0.001 | $ 0.001 | |||
Gross proceeds from issuance initial public offering | $ | $ 28.3 | ||||
Net proceeds from issuance initial public offering | $ | $ 25.8 | ||||
Number of shares in a unit | 1 | ||||
Warrant exercisable period | 5 years | ||||
Securities Purchase Agreement [Member] | |||||
Schedule Of Stockholders Equity [Line Items] | |||||
Per unit price of private placement | $ / shares | $ 2.015 | ||||
Number of units in the transaction | 8,188,804 | ||||
Gross proceeds from private placement | $ | $ 16.5 | ||||
Net proceeds from private placement | $ | $ 15.3 | ||||
2016 PIPE [Member] | |||||
Schedule Of Stockholders Equity [Line Items] | |||||
Common stock, shares issued | 3,225,804 | ||||
IPO [Member] | |||||
Schedule Of Stockholders Equity [Line Items] | |||||
Common stock, shares issued | 9,090,909 | ||||
Per unit price of private placement | $ / shares | $ 2.75 | ||||
Over-Allotment Option [Member] | |||||
Schedule Of Stockholders Equity [Line Items] | |||||
Per unit price of private placement | $ / shares | $ 2.75 | ||||
Number of shares, Options exercised | 1,211,827 | ||||
Private Placement [Member] | 2016 PIPE [Member] | |||||
Schedule Of Stockholders Equity [Line Items] | |||||
Common stock, shares issued | 43,058,827 | ||||
Common stock, outstanding | 43,058,827 | ||||
Preferred Stock [Member] | |||||
Schedule Of Stockholders Equity [Line Items] | |||||
Number of preferred stock convertible into common stock shares | 4,963 | ||||
Convertible preferred stock, shares issued upon conversion | 1,000 | ||||
Percentage of beneficial ownership | 9.99% | ||||
Percentage of voting or approval rights | The preferred shares do not have any voting rights. | ||||
Convertible preferred stock conversion basis | Each of the 4,963 shares of preferred stock are convertible into one share of the Company's common stock. | ||||
Convertible Series A Preferred Shares [Member] | |||||
Schedule Of Stockholders Equity [Line Items] | |||||
Convertible preferred stock, shares issued upon conversion | 1,000 | ||||
Number of shares in a unit | 1 | ||||
Shares issued price per share | $ / shares | $ 2.015 | ||||
Convertible Series A Preferred Shares [Member] | 2016 PIPE [Member] | |||||
Schedule Of Stockholders Equity [Line Items] | |||||
Preferred Stock, shares issued | 4,963 | ||||
Convertible Series A Preferred Shares [Member] | Private Placement [Member] | 2016 PIPE [Member] | |||||
Schedule Of Stockholders Equity [Line Items] | |||||
Preferred Stock, shares issued | 4,963 | ||||
Preferred Stock, shares outstanding | 4,963 | ||||
Tranche A Warrant [Member] | |||||
Schedule Of Stockholders Equity [Line Items] | |||||
Number of warrants | 1 | ||||
Number of shares to be purchased by a warrant | 0.4 | ||||
Exercise price | $ / shares | $ 2 | ||||
Tranche B Warrant [Member] | |||||
Schedule Of Stockholders Equity [Line Items] | |||||
Number of warrants | 1 | ||||
Number of shares to be purchased by a warrant | 0.2 | ||||
Exercise price | $ / shares | $ 3 |
Stock and Employee Benefit Pl50
Stock and Employee Benefit Plans - Additional Information (Detail) - USD ($) | Jun. 29, 2016 | Jun. 30, 2016 | Dec. 31, 2016 | Dec. 31, 2015 |
Defined Benefit Plan Disclosure [Line Items] | ||||
Cash received from option exercises | $ 0 | $ 10,000 | ||
Common stock, par value | $ 0.001 | $ 0.001 | ||
Stock based compensation expense | $ 1,905,256 | $ 1,164,633 | ||
Research and Development [Member] | ||||
Defined Benefit Plan Disclosure [Line Items] | ||||
Stock based compensation expense | 599,138 | $ 379,066 | ||
Newly Hired Executive [Member] | ||||
Defined Benefit Plan Disclosure [Line Items] | ||||
Number of options granted | 500,000 | |||
Newly Hired Executive [Member] | Research and Development [Member] | ||||
Defined Benefit Plan Disclosure [Line Items] | ||||
Stock based compensation expense | $ 300,000 | $ 100,000 | ||
2014 Stock Plan [Member] | ||||
Defined Benefit Plan Disclosure [Line Items] | ||||
Number of options granted | 0 | 1,157,734 | 755,329 | |
Weighted-average price of options | $ 1.57 | |||
Weighted-average remaining contractual life | 8 years 6 months 18 days | 9 years 2 months 1 day | ||
Number of shares, Forfeited | 140,000 | |||
2014 Stock Plan [Member] | Newly Hired Executive [Member] | ||||
Defined Benefit Plan Disclosure [Line Items] | ||||
Number of options granted | 500,000 | 450,000 | ||
Common stock, par value | $ 0.001 | |||
Stock based compensation expense | $ 0 | |||
Weighted-average price of options | $ 3.36 | |||
Weighted-average remaining contractual life | 8 years 7 months 17 days | |||
2016 Stock Plan [Member] | ||||
Defined Benefit Plan Disclosure [Line Items] | ||||
Common shares authorized for issuance | 3,750,000 | |||
Stock options vesting period | 4 years | |||
Maximum term of stock options | 10 years | |||
Number of options granted | 715,313 | 0 | ||
Weighted-average price of options | $ 2.36 | |||
Weighted-average remaining contractual life | 9 years 7 months 13 days | 0 years | ||
Common stock available for grant | 3,124,687 | |||
Number of shares, Forfeited | 90,000 | |||
2016 Stock Plan [Member] | Newly Hired Executive [Member] | ||||
Defined Benefit Plan Disclosure [Line Items] | ||||
Number of options granted | 500,000 | |||
Weighted-average price of options | $ 1.45 | |||
Weighted-average remaining contractual life | 9 years 10 months 28 days | |||
2016 Stock Plan [Member] | Newly Hired Executive [Member] | Research and Development [Member] | ||||
Defined Benefit Plan Disclosure [Line Items] | ||||
Stock based compensation expense | $ 10,998 | |||
2016 Stock Plan [Member] | Employees Consultants And Directors [Member] | ||||
Defined Benefit Plan Disclosure [Line Items] | ||||
Number of options granted | 265,313 | |||
401 (k) Plan [Member] | ||||
Defined Benefit Plan Disclosure [Line Items] | ||||
Contributions employee benefit plans | $ 31,670 | $ 3,013 |
Stock and Employee Benefit Pl51
Stock and Employee Benefit Plans- Schedule of Information Regarding Stock Option Plans (Detail) - USD ($) $ / shares in Units, $ in Thousands | Jun. 29, 2016 | Dec. 31, 2016 | Dec. 31, 2015 |
2014 Stock Plan [Member] | |||
Defined Benefit Plan Disclosure [Line Items] | |||
Number of shares, Outstanding at beginning balance | 2,707,329 | ||
Number of shares, Options granted | 0 | 1,157,734 | 755,329 |
Number of shares, Forfeited | (140,000) | ||
Number of shares, Outstanding at ending balance | 3,725,063 | 2,707,329 | |
Number of shares, Vested or expected to vest | 3,725,063 | ||
Number of shares, Exercisable at ending balance | 1,961,811 | ||
Weighted-Average Exercise Price, Outstanding at beginning balance | $ 2.05 | ||
Weighted-Average Exercise Price, Options granted | 1.57 | ||
Weighted-Average Exercise Price, Forfeited | 1.71 | ||
Weighted-Average Exercise Price, Outstanding ending balance | 1.91 | $ 2.05 | |
Weighted-Average Exercise Price, Vested or expected to vest | 1.91 | ||
Weighted-Average Exercise Price, Exercisable at ending balance | $ 2.01 | ||
Weighted Average Remaining Contractual Life, Outstanding | 8 years 6 months 18 days | 9 years 2 months 1 day | |
Weighted Average Remaining Contractual Life, Vested or expected to vest | 8 years 6 months 18 days | ||
Weighted Average Remaining Contractual Life, Exercisable | 7 years 11 months 27 days | ||
Aggregate Intrinsic Value, Outstanding | $ 741 | ||
Aggregate Intrinsic Value, Outstanding | 741 | ||
Aggregate Intrinsic Value, Vested or expect to vest | 0 | ||
Aggregate Intrinsic Value, Exercisable | $ 0 | ||
2016 Stock Plan [Member] | |||
Defined Benefit Plan Disclosure [Line Items] | |||
Number of shares, Options granted | 715,313 | 0 | |
Number of shares, Forfeited | (90,000) | ||
Number of shares, Outstanding at ending balance | 715,313 | ||
Number of shares, Vested or expected to vest | 715,313 | ||
Number of shares, Exercisable at ending balance | 228,774 | ||
Weighted-Average Exercise Price, Options granted | $ 2.36 | ||
Weighted-Average Exercise Price, Outstanding ending balance | 2.36 | ||
Weighted-Average Exercise Price, Vested or expected to vest | 2.36 | ||
Weighted-Average Exercise Price, Exercisable at ending balance | $ 2.46 | ||
Weighted Average Remaining Contractual Life, Outstanding | 9 years 7 months 13 days | 0 years | |
Weighted Average Remaining Contractual Life, Vested or expected to vest | 9 years 7 months 13 days | ||
Weighted Average Remaining Contractual Life, Exercisable | 8 years 10 months 24 days | ||
Aggregate Intrinsic Value, Vested or expect to vest | $ 0 | ||
Aggregate Intrinsic Value, Exercisable | $ 0 |
Consulting Shares - Additional
Consulting Shares - Additional Information (Detail) - USD ($) | Nov. 20, 2015 | Sep. 04, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Mar. 06, 2015 |
Related Party Transaction [Line Items] | ||||||
Common stock, shares issued | 43,058,827 | 39,833,023 | ||||
Common stock par value of issued shares | $ 0.001 | $ 0.001 | ||||
Stock based compensation expense | $ 1,905,256 | $ 1,164,633 | ||||
Advisory fee paid in equity, value | 225,000 | |||||
Del Mar Consulting Group and Alex Partners [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Stock based compensation expense | $ 0 | $ 400,000 | ||||
Trout Capital L L C [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Market price on day of agreement | $ 2.19 | |||||
Advisory fee paid in equity, shares | 68,493 | |||||
Advisory fee paid in equity, value | $ 200,000 | |||||
Consulting Agreement [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Common stock, shares issued | 150,000 | |||||
Common stock par value of issued shares | $ 0.01 | |||||
Agreement termination notice period | 180 days | |||||
Termination agreement percentage of shares returned | 40.00% | |||||
Estimated fair value of non-cancellable shares, Shares | 90,000 | |||||
Estimated fair value of non-cancellable shares, Value | $ 300,000 | |||||
Estimated fair value cancellable shares, Shares | 60,000 | |||||
Consulting Agreement [Member] | Non Cancellable Shares [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Market price on day of agreement | $ 3.16 | |||||
Letter Agreement [Member] | Aquilo Partners [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Market price on day of agreement | $ 2.75 | |||||
Letter of agreement retainer fee | $ 100,000 | |||||
Advisory fee paid in equity, shares | 27,272 | |||||
Advisory fee paid in equity, value | $ 100,000 |
License and Transfer Agreement
License and Transfer Agreement - Additional Information (Detail) - USD ($) | Apr. 18, 2016 | Dec. 31, 2016 | Dec. 31, 2015 |
Contingencies And Commitments [Line Items] | |||
Research and development expense | $ 19,698,803 | $ 8,244,751 | |
License And Transfer Agreement [Member] | |||
Contingencies And Commitments [Line Items] | |||
Agreement termination notice period | 30 days | ||
License And Transfer Agreement [Member] | Enumeral Biomedical Holdings Inc [Member] | |||
Contingencies And Commitments [Line Items] | |||
Upfront license fee payment | $ 250,000 | ||
Maintenance fee payment | $ 750,000 | ||
Agreement termination notice period upon material breach by the Company | 60 days | ||
Agreement termination notice period upon breach of payment obligations by the Company | 30 days | ||
Agreement termination description | The Definitive Agreement may be terminated by the Company on 30 days notice and by Enumeral upon 60 days notice of a material breach by the Company (or 30 days with respect to a breach of payment obligations by the Company), provided the Company has not caused such breach and dispute resolution procedures specified in the Agreement have been followed. | ||
Research and development expense | $ 1,000,000 | ||
Maximum [Member] | License And Transfer Agreement [Member] | Enumeral Biomedical Holdings Inc [Member] | |||
Contingencies And Commitments [Line Items] | |||
Development milestones payment | $ 37,800,000 | ||
Sales milestones payment | $ 67,500,000 | ||
Percentage of reduction in royalty payment | 50.00% |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Accrued expenses | ||
Accrued compensation expense | $ 1,198,448 | $ 704,597 |
Accrued audit and tax fees | 454,931 | 179,223 |
Accrued professional fees, and other | 867,969 | 194,790 |
Accrued R&D fees | 1,040,321 | 466,076 |
Accrued other | 157,788 | 194,694 |
Total amount of accrued expenses | $ 3,719,457 | $ 1,739,380 |
Related-Party Transactions - Ad
Related-Party Transactions - Additional Information (Detail) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2015 | Dec. 31, 2016 | |
Related Party Transaction [Line Items] | ||
Total expenses | $ 0 | |
Consulting Agreement [Member] | ||
Related Party Transaction [Line Items] | ||
Consulting agreement fees paid to Prof. Dr. Skerra | $ 16,717 | |
TUM [Member] | ||
Related Party Transaction [Line Items] | ||
Total expenses | $ 41,791 | $ 0 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | Aug. 27, 2015ft² | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) |
Loss Contingencies [Line Items] | |||
Area of lease property | ft² | 3,950 | ||
Lease expiration date | Feb. 27, 2022 | ||
Lease commencement date | Aug. 27, 2015 | ||
Rent expenses recognized | $ 200,000 | $ 18,399 | |
Rent expense | $ 300,000 | $ 400,000 | |
Freising [Member] | |||
Loss Contingencies [Line Items] | |||
Additional office space fixed lease term | 1 year | ||
Lease extension term | 1 year | ||
Lease expiration period | 2018-06 | ||
Lease agreement exit option expiry date. | Dec. 12, 2016 | ||
License Agreement [Member] | IBA GmbH [Member] | |||
Loss Contingencies [Line Items] | |||
Annual license payment | $ 32,718 | ||
Agreement expiration date | 2,024 | ||
License Agreement [Member] | TUM [Member] | |||
Loss Contingencies [Line Items] | |||
Annual license payment | $ 100,000 | ||
Agreement expiration date | 2,027 |
Commitments and Contingencies57
Commitments and Contingencies - Annual License Fee Commitments (Detail) - License Agreement [Member] | Dec. 31, 2016USD ($) |
2,017 | $ 84,124 |
2,018 | 84,124 |
2,019 | 84,124 |
2,020 | 84,124 |
2,021 | 84,124 |
Thereafter | 410,105 |
Total minimum license payments | $ 830,725 |
Commitments and Contingencies58
Commitments and Contingencies - Contractual Commitment Under Operating Lease (Detail) | Dec. 31, 2016USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2,017 | $ 391,042 |
2,018 | 209,590 |
2,019 | 195,909 |
2,020 | 199,859 |
2,021 | 203,809 |
Thereafter | 34,563 |
Total minimum lease payments | $ 1,234,772 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) | Feb. 27, 2017USD ($) | Jan. 04, 2017EUR (€) | Jan. 04, 2017USD ($) | Dec. 31, 2016USD ($) | Jan. 04, 2017USD ($) |
Subsequent Event [Line Items] | |||||
Collaboration agreement, license upfront payment | $ 2,735,794 | ||||
Subsequent Event [Member] | FHoffmann La Roche Ltd and Hoffmann La Roche Inc [Member] | Upfront Payment Arrangement [Member] | |||||
Subsequent Event [Line Items] | |||||
Collaboration agreement, license upfront payment | € 30,000,000 | $ 31,300,000 | |||
Subsequent Event [Member] | FHoffmann La Roche Ltd and Hoffmann La Roche Inc [Member] | Minimum [Member] | |||||
Subsequent Event [Line Items] | |||||
Contractual agreement, potential payments | € 1,700,000,000 | $ 1,800,000,000 | |||
Subsequent Event [Member] | Option Agreement [Member] | ASKA Pharmaceutical Co Ltd [Member] | |||||
Subsequent Event [Line Items] | |||||
Option payment receivable | $ 2,750,000 | ||||
Subsequent Event [Member] | Collaborative Arrangement, Product [Member] | ASKA Pharmaceutical Co Ltd [Member] | |||||
Subsequent Event [Line Items] | |||||
Option exercise fee and milestone payments | $ 80,000,000 |