Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2017 | Nov. 07, 2017 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2017 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | PIRS | |
Entity Registrant Name | PIERIS PHARMACEUTICALS, INC. | |
Entity Central Index Key | 1,583,648 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 44,794,308 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash | $ 89,921,213 | $ 29,355,528 |
Accounts receivable | 2,537,265 | 57,582 |
Prepaid expenses and other current assets | 2,817,853 | 3,259,503 |
Total current assets | 95,276,331 | 32,672,613 |
Property and equipment, net | 3,455,541 | 2,264,477 |
Other non-current assets | 129,271 | 125,741 |
Total assets | 98,861,143 | 35,062,831 |
Current liabilities: | ||
Accounts payable | 2,601,736 | 2,386,183 |
Accrued expenses and other current liabilities | 5,099,918 | 3,719,457 |
Deferred revenues, current portion | 31,336,228 | 2,274,514 |
Total current liabilities | 39,037,882 | 8,380,154 |
Deferred revenue, net of current portion | 55,221,586 | 1,409,483 |
Other long-term liabilities | 43,462 | 46,667 |
Total liabilities | 94,302,930 | 9,836,304 |
Stockholders' equity: | ||
Preferred stock, $0.001 par value per share, 4,963 shares authorized and 4,963 and 4,963 issued and outstanding at September 30, 2017 and December 31, 2016 | 5 | 5 |
Common stock, $0.001 par value per share, 300,000,000 shares authorized and 44,704,849 and 43,058,827 issued and outstanding at September 30, 2017 and December 31, 2016 | 44,705 | 43,059 |
Additional paid-in capital | 134,803,118 | 129,349,768 |
Accumulated other comprehensive loss | (2,487,336) | (1,501,452) |
Accumulated deficit | (127,802,279) | (102,664,853) |
Total stockholders' equity | 4,558,213 | 25,226,527 |
Total liabilities and stockholders' equity | $ 98,861,143 | $ 35,062,831 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2017 | Dec. 31, 2016 |
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 | 4,963 |
Preferred Stock, outstanding | 4,963 | 4,963 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 44,704,849 | 43,058,827 |
Common stock, outstanding | 44,704,849 | 43,058,827 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Income Statement [Abstract] | ||||
Revenue | $ 3,927,204 | $ 785,007 | $ 7,123,362 | $ 3,104,513 |
Operating expenses | ||||
Research and development | 6,259,258 | 4,621,957 | 17,014,938 | 12,781,489 |
General and administrative | 2,852,357 | 2,341,010 | 11,189,816 | 6,677,110 |
Total operating expenses | 9,111,615 | 6,962,967 | 28,204,754 | 19,458,599 |
Loss from operations | (5,184,411) | (6,177,960) | (21,081,392) | (16,354,086) |
Interest income, net | 96 | 263 | ||
Other (expense)/income, net | (1,728,812) | (18,243) | (3,096,890) | 113,575 |
Loss before income taxes | (6,913,127) | (6,196,203) | (24,178,019) | (16,240,511) |
Income tax expenses | 145,697 | 959,406 | ||
Net loss | $ (7,058,824) | $ (6,196,203) | $ (25,137,425) | $ (16,240,511) |
Net loss per share Basic and diluted | $ (0.16) | $ (0.14) | $ (0.58) | $ (0.39) |
Weighted average number of shares outstanding Basic and diluted | 44,387,281 | 43,063,790 | 43,624,442 | 41,259,749 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (7,058,824) | $ (6,196,203) | $ (25,137,425) | $ (16,240,511) |
Other comprehensive (loss)/income components: | ||||
Foreign currency translation | (394,814) | 670 | (985,885) | (52,530) |
Total other comprehensive (loss)/income | (394,814) | 670 | (985,885) | (52,530) |
Comprehensive loss | $ (7,453,638) | $ (6,195,533) | $ (26,123,310) | $ (16,293,041) |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Operating activities: | ||
Net loss | $ (25,137,425) | $ (16,240,511) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 268,213 | 175,387 |
Stock-based compensation | 1,962,018 | 1,426,341 |
Loss on disposal of fixed assets | 87,087 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | (2,336,887) | |
Prepaid expenses and other assets | 723,613 | (2,161,864) |
Deferred revenue | 77,980,688 | 4,698,803 |
Accounts payable | (145,232) | 3,304,055 |
Accrued expenses and other current liabilities | 1,046,372 | 1,139,045 |
Net cash provided by (used in) operating activities | 54,448,447 | (7,658,745) |
Investing activities: | ||
Purchase of property and equipment | (1,141,727) | (322,706) |
Proceeds from sale of property and equipment | 10,888 | |
Net cash used in investing activities | (1,130,839) | (322,706) |
Financing activities: | ||
Proceeds from exercise of options | 366,200 | |
Proceeds from exercise of warrants | 3,126,778 | |
Issuance of common and preferred stock, net of issuance costs | 15,221,021 | |
Net cash provided by financing activities | 3,492,978 | 15,221,021 |
Effect of exchange rate change on cash and cash equivalents | 3,755,098 | (30,993) |
Net increase in cash and cash equivalents | 60,565,685 | 7,208,577 |
Cash and cash equivalents at beginning of year | 29,355,528 | 29,349,124 |
Cash and cash equivalents at end of year | 89,921,213 | 36,557,701 |
Supplemental cash flow disclosures: | ||
Property and equipment included in accounts payable | $ 120,727 | $ 83,435 |
Interim Consolidated Financial
Interim Consolidated Financial Statements | 9 Months Ended |
Sep. 30, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Interim Consolidated Financial Statements | 1. Interim Consolidated Financial Statements The accompanying unaudited interim condensed consolidated financial statements of Pieris Pharmaceuticals, Inc. (“Pieris” or the “Company”) were prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial information. All significant intercompany balances and transactions have been eliminated in the consolidation. Certain information and footnotes normally included in financial statement prepared in accordance with U.S. GAAP have been omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Accordingly, the statements do not include all of the information and notes required by U.S. GAAP for complete annual consolidated financial statements. It is recommended that these financial statements be read in conjunction with the consolidated financial statements and related footnotes that appear in the Annual Report on Form 10-K In the opinion of management, the unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited condensed consolidated financial statements for the year ending December 31, 2016, and all adjustments, including normal recurring adjustments, considered necessary for the fair presentation of the Company’s unaudited interim consolidated financial statements have been included. The results of operations, for the three and nine months ended September 30, 2017, are not necessarily indicative of the results that may be expected for the year ending December 31, 2017 or any future period. Use of estimates The preparation of the condensed consolidated financial statements in accordance with U.S. GAAP requires management to make estimates, judgments, and assumptions that affect the reported amounts of assets and liabilities, the reported amounts of revenues, and expenses in the financial statements and disclosures in the accompanying notes. 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. |
Critical Accounting Policies
Critical Accounting Policies | 9 Months Ended |
Sep. 30, 2017 | |
Equity [Abstract] | |
Critical Accounting Policies | 2. Critical Accounting Policies Research and development expenses Research and development expenses are charged to the condensed consolidated statement of operations as incurred. Nonrefundable advance payments for research and development goods or services to be received in the future are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed. Research and development expenses are comprised of costs incurred in performing research and development activities, including salaries and benefits, facilities costs, pre-clinical Revenue Recognition Pieris has entered into several licensing and development agreements with collaboration partners for the development of Anticalin ® 605-25, Revenue Recognition—Multiple-Element Arrangements (“605-25”) 605-28, Revenue Recognition—Milestone Method (“605-28”) 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 (“BESP”) 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 (“VSOE”) or third-party evidence (“TPE”) 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 BESP 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 licenses and performance obligations such as research and development services and steering committee services, can be separated or whether they must be accounted for as a combined unit of accounting in accordance with U.S. GAAP. The Company recognizes the arrangement consideration allocated to licenses as revenue upon delivery of the license only if the license has stand-alone value. If the license is considered not to have stand-alone value, the license would then be combined with other undelivered elements into a combined unit of accounting and the license payments and payments for performance obligations would be recognized as revenue when the revenue recognition criteria have been satisfied for the last deliverable within the unit of accounting. In the case of combined units of accounting that include delivered licenses and undelivered services to be provided over time, revenue would be recognized over the estimated period during which services will be provided. 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. The Company recognizes arrangement consideration allocated to each unit of accounting when all of the revenue recognition criteria in ASC 605-25 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. 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 option(s) to secure additional goods or services. Factors that are considered in evaluating whether options are substantive include the overall objective of the arrangement, benefit the collaborator might obtain from the agreement without exercising the options, cost to exercise the options relative to the total upfront consideration, and 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 option is not considered a deliverable in the arrangement. 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 i.e. un-exercised, non-substantive, Payments or reimbursements resulting from Pieris’ research and development efforts in multi-element arrangements, in which Pieris’ research and development efforts are considered to be a deliverable, are included in allocable consideration and allocated to the units of accounting. These reimbursements 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. Revenue recognized cannot exceed the amount that has been earned and has been billed or is currently billable. 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 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, including regulatory approval. Sales milestones are 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. For revenues from research, development, and commercial 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, assuming all other revenue recognition criteria are met. Milestones that are not considered substantive are accounted for as contingent revenue and will be recognized when achieved to the extent the Company has no remaining performance obligations under the arrangement. Revenues from sales 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. |
Revenues
Revenues | 9 Months Ended |
Sep. 30, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Revenues | 3. Revenues General Pieris has not generated revenues from product sales to date. Pieris has generated revenues from: (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. F.Hoffmann-La 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 are jointly pursuing a preclinical research program with respect to the identification and generation of Anticalin proteins that bind to a specific target. Roche has the ability to continue certain exclusivity rights for up to an additional five years following the end of the research program. 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 Effective September 28, 2017, Roche exercised their option to extend the initial period for the research program until April 30, 2018 and Roche has the option to extend this period until up to August 31, 2018. 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 certain development and sales milestones as they are achieved. Pieris recorded $1.0 million and $2.8 million in revenue, respectively, for the three months ended September 30, 2017 and the nine months ended September 30, 2017, related to the recognition of the upfront payment associated with the portion of the research collaboration as well as the value of research services provided by Pieris in connection with the ongoing research program. For the three months ended September 30, 2016 and the nine months ended September 30, 2016, Pieris recorded $0.8 million and $3.1 million in revenue, related to the recognition of the upfront payment associated with the research collaboration. As of September 30, 2017, and December 31, 2016, deferred revenue, related to Roche collaboration, is 2.0 million and $3.7 million, respectively. The Company identified the research and commercial licenses, performance of research and development (“R&D”) services, and participation in the joint research committee as deliverables under the Roche Agreement. For revenue recognition purposes, management determined there are two units of accounting at inception of the agreement representing (i) the research and commercial licenses and the performance of R&D services, and (ii) the participation in the joint research committee. The consideration received has been allocated to the units of accounting and will be recognized on a proportional performance basis as the activities are conducted over the life of the arrangement. In addition to the upfront payment, related to the Roche Agreement, the Company is eligible to receive research, development, and sales milestone payments up to approximately $413.5 million, plus royalties on future sales of any commercial products. The total potential milestones are categorized as follows: research and development milestones—$290.4 million; and sales milestones of $123.1 million. Management has determined that the development milestones are not substantive as 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 Les Laboratoires Servier and Institut de Recherches Internationales Servier On January 4, 2017, Pieris entered into a License and Collaboration Agreement (“Servier Collaboration Agreement”), and Non-Exclusive PRS-332 PD-1-targeting PRS-332 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 (“Collaboration Products”). The Servier Collaboration Agreement may be expanded by up to three additional therapeutic programs. Pieris has the option to co-develop (“Co-Development Co-Development At inception, Servier was granted the following licenses: (i) development license for the Lead Product, (ii) commercial license for the Lead Product, (iii) individual research licenses for each of the four Collaboration Products, and (iv) individual non-exclusive Co-Development The Servier Agreements will be managed on an overall basis by a joint executive committee (“JEC”) formed by an equal number of members from the Company and Servier. Decisions by the JEC will be made by consensus, however, in the event of a disagreement, each party will have final-decision making authority as it relates to the applicable territory in which such party has commercialization rights for the applicable product. In addition to the JEC, the Collaboration Agreement requires the participation of both parties on: (i) a Joint Steering Committee (“JSC”), (ii) a Joint Development Committee (“JDC”), (iii) a Joint Intellectual Property Committee (“JIPC”), and (iv) a Joint Research Committee (“JRC”). The responsibilities of these committees vary, depending on the stage of development and commercialization of the Lead Product and each of the Collaboration Products. For the Lead Product and Co-Development co-develop Co-Development Under the Servier Agreements, the Company received an upfront, non-refundable The initial research collaboration term, as it relates to the Lead Product and Collaboration Products, shall continue for three years from the effective date, and may be mutually extended for two one-year The term of the individual Servier Agreements end upon the expiration of all of Servier’s payment obligations under such Servier Collaboration Agreement. The Servier Collaboration Agreements may be terminated by Servier for convenience beginning 12 months after their effective date upon 180 days’ notice. The Servier Collaboration 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 Servier Collaboration Agreement and License Agreement, respectively, provided that the applicable party has not cured such breach by the applicable 90-day 120-day product-by-product country-by-country product-by-product country-by-country The Company accounted for the Servier Agreements as a multiple element arrangement under ASC 605-25. non-exclusive Management considered whether any of the deliverables could be considered separate units of accounting. The Company determined the licenses granted, at arrangement inception, did not have standalone value from the research and development services to be provided for the Lead Product and Collaboration Products, over the term of the Servier Agreements, due to the specific nature of the intellectual property and knowledge required to perform the research and development services. The Company determined that the participation on the various committees did have standalone value from the delivered licenses as the services could be performed by an outside party. As a result, management concluded there are ten units of accounting at inception of the agreement: (i) combined unit of accounting representing a non-exclusive non-exclusive The Company determined that neither VSOE nor TPE is available for any of the units of accounting identified at arrangement inception. Accordingly, the selling price of each unit of accounting was developed using BESP. The Company developed its best estimate of selling price for licenses by applying a risk adjusted, net present value, estimate of future potential cash flows approach, which included the cost of obtaining research and development services at arm’s length from a third-party provider, as well as internal full time equivalent costs to support these services. The Company developed the BESP for committee participation by using management’s best estimate of the anticipated participation hours multiplied by a market rate for comparable participants. The Company developed the BESP for the discounts granted on the licenses by probability weighting multiple cash flow scenarios using the income approach. Allocable arrangement consideration at inception is comprised of the upfront fee of €30.0 million (approximately $32.0 million) and was allocated among the separate units of accounting using the relative selling price method. The amounts allocated to the combined unit of accounting for the Lead Product and four units of accounting for the four Collaboration Products will be recognized on a proportional performance basis as the activities are conducted over the life of the arrangement. The term of the performance at inception of the agreement for the Lead Product and each of the Co-Developed Additionally, the Company evaluated payments required to be made between both parties as a result of the shared development costs of the Lead Product and Co-Development Under the Servier Agreements the Company is eligible to receive various research, development, commercial, and sales milestones. Management determined certain research, development and commercial milestones, which may be received under the Servier Agreements, are substantive when the Company is involved in the development and commercialization of the applicable product. Payments related to the achievement of such milestones, if any, will be recognized as revenue when the milestone is achieved. Total potential substantive research, development and commercial milestones are up to € 163.0 million. Research, development, and commercial milestones are deemed non-substantive Non-substantive The Company will recognize royalty revenue in the period of sale for the related product(s), based on the underlying contract terms, provided that the reported sales are reliably measurable and the Company has no remaining performance obligations, assuming all other revenue recognition criteria are met. Pieris recorded $0.5 million and $1.2 million in revenue, respectively, for the three months ended September 30, 2017 and the nine months ended September 30, 2017, respectively, with respect to the Servier Agreements which includes recognition of the upfront payment received and reimbursement for research and development expenses. No revenue was recorded during the three and nine months ended September 30, 2016. As of September 30, 2017, there is $3.6 million and $30.7 million of deferred revenue and non-current ASKA Pharmaceutical Co. Ltd. On February 27, 2017 the Company entered into an Exclusive Option Agreement (the “ASKA Agreement”) with ASKA Pharmaceutical Co., Ltd. (“ASKA”) to grant ASKA an option to acquire (1) a non-exclusive PRS-080 PRS-080, ASKA has paid $2.75 million of an upfront option payment. Pieris is obliged to use commercially reasonable efforts to complete the Phase IIa Study for PRS-080 “Break-Up Pieris has an obligation to use all reasonable commercial efforts to complete the Phase IIa Study for the Licensed Product and to submit to ASKA, in writing, the final results of the Phase IIa study. The completed Phase IIa Study represents a deliverable under the arrangement. As the arrangement only contains one deliverable, there is only one unit of accounting to be considered at the inception of the contract. The total allocable arrangement consideration at inception is $2.75 million and this is allocated to the single unit of accounting. The Company noted that while the completion of the Phase IIa trial requires the completion of a number of actions, the finalization of the data and evaluation of results is of such significance that the value of the Phase IIa study results is realized at this point. As a result, the Company will recognize revenue for this unit of accounting upon delivery of the Phase IIa Study Results to ASKA. Therefore, no revenue in connection with this arrangement was recognized for the three and nine months ended September 30, 2017. As of September 30, 2017, there is $3.0 million of non-current AstraZeneca AB On May 2, 2017, Pieris entered into a License and Collaboration Agreement (“AstraZeneca Collaboration Agreement”), and a Non-Exclusive In addition to the Company’s lead inhaled drug candidate, PRS-060 co-develop co-commercialize co-develop pre-defined co-commercialize The term of the AstraZeneca Agreement ends upon the expiration of all of AstraZeneca’s payment obligations under such AstraZeneca Agreement. The AstraZeneca Collaboration Agreement may be terminated by AstraZeneca in its entirety for convenience beginning 12 months after its effective date upon 90 days’ notice or, if Pieris has obtained marketing approval for the marketing and sale of a product, a 180 days’ notice. Each program may be terminated at AstraZeneca’s option; if any program is terminated by AstraZeneca, Pieris will have full rights to such program. The AstraZeneca Collaboration Agreement may also be terminated by AstraZeneca or Pieris for material breach upon 180 days’ notice of a material breach (or 30 days with respect to payment breach), provided that the applicable party has not cured such breach by the permitted cure period (including an additional 180 days if the breach is not susceptible to cure during the initial 180-day product-by-product country-by-country product-by-product country-by-country At inception, AstraZeneca is granted the following licenses: (i) research and development license for the AstraZeneca Lead Product, (ii) commercial license for the AstraZeneca Lead Product, (iii) individual research licenses for each of the four AstraZeneca Collaboration Products, (iv) individual commercial licenses for each of the four AstraZeneca Collaboration Products, and (v) individual non-exclusive The collaboration will be managed on an overall basis by a JSC formed by an equal number of representatives from the Company and AstraZeneca. In addition to the JSC, the AstraZeneca Collaboration Agreement also requires each party to designate an Alliance Manager to facilitate communication and coordination of the Parties activities under that AstraZeneca Agreement, as well as requires participation of both parties on: (i) a JDC and (ii) a Commercialization Committee. The responsibilities of these committees vary, depending on the stage of development and commercialization of each Product. Under the AstraZeneca Agreements, the Company received an upfront, non-refundable co-developed The Company accounted for the AstraZeneca Agreements, as a multiple element arrangement under ASC 605-25. non-exclusive Management considered whether any of the deliverables could be considered separate units of accounting. The Company determined that the licenses granted for the AstraZeneca Lead Product at the inception of the arrangement did not have standalone value from the research services related to the Lead Product and the licenses granted for the AstraZeneca Collaboration Products did not have standalone value from the research services for the AstraZeneca Collaboration Products, due to the specific nature of the intellectual property and knowledge required to perform the services. The Company determined that the licenses granted at the inception of the arrangement did have standalone value from the development and manufacturing services for the AstraZeneca Lead Product and also determined that the participation on the various committees had standalone value as the development and manufacturing services and committee service could be performed by an outside party. The Company determined that the commercial licenses for the AstraZeneca Collaboration Products granted at the inception of the arrangement did not have standalone value from the development licenses for the AstraZeneca Collaboration Products as the company would not benefit from the commercial license without the ability to develop each product. As a result, management concluded that there were eleven units of accounting at the inception of the AstraZeneca Agreements: (i) combined unit of accounting representing a non-exclusive (iv-vii) non-exclusive (viii-xi) The Company determined that neither VSOE nor TPE is available for any of the units of accounting identified at the inception of the arrangement. Accordingly, the selling price of each unit of accounting was developed using management’s BESP. The Company developed the BESP for licenses and corresponding research services by applying a risk adjusted, net present value, estimate of future potential cash flow approach, which included the cost of obtaining research services at arm’s length from a third-party provider, as well as internal full time equivalent costs to support these services. The Company developed the BESP for development and manufacturing services, and technology transfer services for the AstraZeneca Lead Product using estimated internal and external costs to be incurred. The Company developed the BESP for committee participation by using management’s best estimate of the anticipated participation hours multiplied by a market rate for comparable participants. The Company developed the BESP for the commercial licenses and discounts granted on the development licenses by probability weighting multiple cash flow scenarios using the income approach. Allocable arrangement consideration at inception is comprised of the upfront fee of $45.0 million and the estimated development and manufacturing services to be reimbursed by AstraZeneca for the Lead Product of $8.2 million. The aggregate allocable consideration of $53.2 million is allocated among the separate units of accounting using the relative selling price method. The amounts allocated to the unit of accounting for the AstraZeneca Lead Product and four units of accounting for the four AstraZeneca Collaboration Products will be recognized on a proportional performance basis as the activities are conducted over the life of the arrangement. The amounts allocated to the development and manufacturing services, and technology transfer services for the AstraZeneca Lead Product will be recognized on a proportional performance basis over the estimated term of development through Phase IIa trial. The amounts allocated to the participation on each of the committees will be recognized on a straight-line basis over the expected term of development of the AstraZeneca Lead Product and the AstraZeneca Collaboration Products. The term of performance at the inception of the arrangement is approximately five years. The amounts allocated to the commercial licenses and discounts on the development licenses granted in the future for the AstraZeneca Collaboration Products will be recognized upon delivery of each of the development licenses assuming all other revenue recognition criteria have been met. Additionally, the Company evaluated payments required to be made between both parties as a result of the shared development costs of the AstraZeneca Lead Product and the two AstraZeneca Collaboration Products for which Pieris has a co-development Under the AstraZeneca Agreements the Company is eligible to receive various research, development, commercial, and sales milestones. Management determined certain of the research, development, and commercial milestones that may be received under the AstraZeneca Agreements are substantive when the Company is involved in the development and commercialization of the applicable AstraZeneca Products. Payment related to achievement of such milestones, if any, will be recognized as revenue when the milestone is achieved. Total potential substantive development milestones range from $72.2 million to $611.4 million, dependent on the Company’s decision, on a product-by-product co-develop non-substantive Non-substantive non-substantive co-develop co-development The Company will recognize royalty and gross margin share revenue in the period of sale of the related AstraZeneca Product, based on the underlying contract terms, provided that the reported sales are reliably measurable and the Company has no remaining performance obligations, assuming all other revenue recognition criteria are met. Pieris recorded $2.5 million and $3.1 million in revenue for the three and nine months ended September 30, 2017, with respect to the AstraZeneca Agreements, which includes recognition of the upfront payment received and reimbursement for Phase I trial costs. As of September 30, 2017, there is $25.7 million and $21.5 million of deferred revenue and non-current |
Income taxes
Income taxes | 9 Months Ended |
Sep. 30, 2017 | |
Income Tax Disclosure [Abstract] | |
Income taxes | 4. Income taxes During the three months ended September 30, 2017 and the nine months ended September 30, 2017 the Company recorded income tax expenses of 0.1 million and $1.0 million, respectively, representing an effective tax rate of (3.97%). The income tax expense is related the Company´s Australian jurisdiction, net of loss carryforwards, resulting from taxable income from the AstraZeneca Agreements. |
Net Loss per Share
Net Loss per Share | 9 Months Ended |
Sep. 30, 2017 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 5. Net Loss per Share Basic net loss per share was determined by dividing net loss by the weighted average 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 remained the same as an increase in the number of shares of common stock equivalents for the periods presented would be antidilutive. For the nine months ended September 30, 2017 and 2016, approximately 0.7 million and 7.4 million weighted average shares, subject to stock options and warrants, respectively, as calculated using the treasury stock method, were excluded from the calculation of diluted weighted average shares outstanding as their effect was antidilutive. |
Fair Value Measurement
Fair Value Measurement | 9 Months Ended |
Sep. 30, 2017 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurement | 6. 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, Pieris has no cash equivalents and debt instruments. All other current assets and current liabilities on our consolidated balance sheets, for the periods presented, approximate their respective carrying amounts. |
Accrued expenses
Accrued expenses | 9 Months Ended |
Sep. 30, 2017 | |
Payables and Accruals [Abstract] | |
Accrued expenses | 7. Accrued expenses The Company has recorded the following accrued expenses as of September 30, 2017 and December 31, 2016, respectively: September 30, December 31, Accrued expenses Accrued compensation expense $ 1,412,121 $ 1,198,448 Accrued professional fees 1,208,945 867,969 Accrued R&D fees 932,542 1,040,321 Accrued taxes 1,062,072 — Accrued audit and tax fees 314,656 454,931 Accrued other 169,582 157,788 Total amount of accrued expenses $ 5,099,918 $ 3,719,457 |
Stock-based compensation
Stock-based compensation | 9 Months Ended |
Sep. 30, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-based compensation | 8. Stock-based compensation 2014 Stock Plan Pieris granted zero and 1,157,734 options to employees, consultants, and directors under its 2014 employee, director, and consultant equity incentive plan, (the “2014 Plan”) during the three and nine months ended September 30, 2016, respectively. The 2014 Plan was terminated on June 28, 2016 when the Company adopted its 2016 employee, director and consultant equity incentive plan, (the “2016 Plan”). Therefore, no options were granted for the three and nine months ended September 30, 2017 under the 2014 Plan. 2016 Stock Plan In June 2016, the Company adopted the 2016 Plan which provides for the granting of stock options, restricted and unrestricted stock awards, and other stock-based awards to employees of the Company, non-employee The Company granted 148,306 and 1,407,061 options to employees and directors under the 2016 Plan during the three months ended September 30, 2017 and the nine months ended September 30, 2017, respectively. The Company granted 114,378 options to employees and directors under the 2016 Plan during the three and nine months ended September 30, 2016. As of September 30, 2017, there were 1,951,052 shares available for future grant under the 2016 Plan. The shares available for future grant under the 2016 Plan include 218,467 shares forfeited under the 2016 Plan and 14,958 shares forfeited under the 2014 Plan. These forfeited shares are available for future issuance under the 2016 Plan. During the three months ended September 30, 2017, the Company granted an option to purchase 450,000 shares of common stock outside of the Plan to a newly-hired executive officer as an inducement and was material to the executive officer entering into employment with the Company. The compensation expense associated with this inducement option was $54,270 and is included in general and administrative expense for both, the three and nine months periods ended September 30, 2017. Stock-based compensation expense was $0.6 million and $2.0 million for the three and nine months ended September 30, 2017, respectively. For the three and nine months ended September 30, 2016 stock based compensation expense was $0.4 million and $1.4 million, respectively. Total stock-based compensation expense was recorded to operating expenses based upon the functional responsibilities of the individuals holding the respective options as follows: Three months ended September 30, Nine months ended September 30, 2017 2016 2017 2016 Research and Development $ 216,328 $ 142,254 $ 573,758 $ 444,193 General and administrative 433,620 303,859 1,388,260 982,148 Total stock-based compensation expense $ 649,948 $ 446,113 $ 1,962,018 $ 1,426,341 There were 95,625 and 110,625 options exercised under the 2014 Plan during the three and nine months ended September 30, 2017 respectively, for which the Company received $188,250 and $218,250 in cash. There were 46,930 and 121,392 options exercised under the 2016 Plan during the three and nine months ended September 30, 2017 respectively, for which the Company received zero and $147,950 in cash. No options were exercised during the 2016 periods. 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 was $3.34 and $2.02 for the three months ended September 30, 2017 and the nine months ended September 30, 2017. The weighted-average fair value of the options granted was $1.05 and $1.01 for the three months ended September 30, 2016 and the nine months ended September 30, 2016. The calculation was based on the following assumptions: Three months ended September 30, Nine months ended September 30, 2017 2016 2017 2016 Dividend yield 0.0% 0.0% 0.0% 0.0% Expected volatility 77.34% - 78.89% 74.90% - 75.12% 75.09% - 78.89% 74.90% - 76.00% Weighted average risk-free interest rate 1.77% - 2.02% 1.25% - 1.35% 1.77% - 2.16% 1.13% - 1.61% Expected term 5.0 - 5.7 5.0 - 5.7 5.0 - 5.7 5.0 - 5.7 Option-pricing models require the input of various subjective assumptions, including the option’s expected life and the price volatility of the underlying stock. Pieris’ estimated expected stock price volatility is based on the average volatilities of other guideline companies in the same industry. Pieris’ expected term of options granted during the three and nine months ended September 30, 2017 and 2016, respectively was derived using the SEC’s simplified method. The risk-free rate for the expected term of the option is based on the U.S. Treasury yield curve in effect at the time of grant. The Company’s stock options have a maximum term of ten years from the date of grant. Stock options granted under the 2016 Plan may be either incentive stock options, or nonqualified stock options. The exercise price of stock options granted under the 2016 Plan must be at least equal to the fair market value of the common stock on the date of grant. |
Common Stock
Common Stock | 9 Months Ended |
Sep. 30, 2017 | |
Equity [Abstract] | |
Common Stock | 9. Common Stock The Company has authorized 300,000,000 shares of common stock, $0.001 par value, per share, of which 44,704,849 shares were issued and outstanding as of September 30, 2017 and 43,058,827 shares were issued and outstanding as of December 31, 2016. During the nine months ended September 30, 2017, the Company issued an aggregate of 232,017 shares of common stock upon exercise of stock options, including stock options to purchase 150,000 shares of common stock exercised through net exercise provisions resulting in the issuance of 66,392 shares of common stock and stock options to purchase 165,625 shares of common stock exercised for cash, providing cash proceeds of $0.4 million. No stock options were exercised during the 2016 period. During the nine months ended September 30, 2017, the Company issued an aggregate of 1,414,005 shares of common stock due to warrant exercises. Net exercise of 89,330 shares of common stock underlying the warrants resulted in the issuance of 49,127 shares of common stock. Additionally, 1,364,878 were exercised resulting in cash proceeds of $3.1 million. No warrants were exercised during the 2016 period. |
Private Placement
Private Placement | 9 Months Ended |
Sep. 30, 2017 | |
Equity [Abstract] | |
Private Placement | 10. 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. As a result of the 2016 PIPE, the number of common stock outstanding increased by 3,225,804 shares and the number of Series A convertible preferred stock outstanding increased by 4,963 shares. |
License and Transfer Agreement
License and Transfer Agreement with Enumeral Biomedical Corporation | 9 Months Ended |
Sep. 30, 2017 | |
Accounting Changes and Error Corrections [Abstract] | |
License and Transfer Agreement with Enumeral Biomedical Corporation | 11. License and Transfer Agreement with Enumeral Biomedical Corporation On April 18, 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 know-how 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. All amounts paid related to the Agreement have been expensed as research and development expense as incurred. The Company incurred zero and $1.0 million in upfront fees for the three and nine months ended September 30, 2016. No amounts were incurred for the three and nine-month period end September 30, 2017. |
Liquidity and Going Concern
Liquidity and Going Concern | 9 Months Ended |
Sep. 30, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Liquidity and Going Concern | 12. Liquidity and Going Concern The Company believes its cash of $89.9 million, as of September 30, 2017, will be sufficient to fund the Company’s current operating plan for at least twelve months from date of filing. The Company may need to raise additional funds in order to execute the current operating plan in the future. There can be no assurance that the Company will be able to obtain future additional debt, equity financing, or generate product revenue or revenues from collaborative partners, on terms acceptable to the Company, on a timely basis or at all. The failure of the Company to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on the Company’s business, results of operations, and financial condition. |
Recent Accounting Pronouncement
Recent Accounting Pronouncements | 9 Months Ended |
Sep. 30, 2017 | |
Accounting Changes and Error Corrections [Abstract] | |
Recent Accounting Pronouncements | 13. Recent Accounting Pronouncements The Company, an emerging growth company (“EGC”), has elected to take advantage of the benefits of the extended transition period provided for in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting standards which allows the Company to defer adoption of certain accounting standards until those standards would otherwise apply to private companies. Standards not yet adopted In May 2014, the FASB issued Accounting Standard Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606) Revenue from Contracts with Customers (Topic 606) Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net) Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients 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 public EGC companies like the Company, for interim and annual periods beginning after December 15, 2018, with an option to early adopt for interim and annual periods beginning after December 15, 2017. 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). The Company is in the process of determining the date and method of adoption and the impact of the Revenue Recognition ASUs on its financial statements. In February 2016, the FASB issued ASU No. 2016-02, ASU 2016-02 Leases (Topic 842) (“ASU 2016-02”) In May 2017, the FASB issued ASU No. 2017-09, Compensation – Stock compensation (Topic 718) (“ASU 2017-09”) 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. |
Interim Consolidated Financia20
Interim Consolidated Financial Statements (Policies) | 9 Months Ended |
Sep. 30, 2017 | |
Equity [Abstract] | |
Use of estimates | Use of estimates The preparation of the condensed consolidated financial statements in accordance with U.S. GAAP requires management to make estimates, judgments, and assumptions that affect the reported amounts of assets and liabilities, the reported amounts of revenues, and expenses in the financial statements and disclosures in the accompanying notes. 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. |
Research and development expenses | Research and development expenses Research and development expenses are charged to the condensed consolidated statement of operations as incurred. Nonrefundable advance payments for research and development goods or services to be received in the future are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed. Research and development expenses are comprised of costs incurred in performing research and development activities, including salaries and benefits, facilities costs, pre-clinical |
Revenue Recognition | Revenue Recognition Pieris has entered into several licensing and development agreements with collaboration partners for the development of Anticalin ® 605-25, Revenue Recognition—Multiple-Element Arrangements (“605-25”) 605-28, Revenue Recognition—Milestone Method (“605-28”) |
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 (“BESP”) 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 (“VSOE”) or third-party evidence (“TPE”) 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 BESP 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 licenses and performance obligations such as research and development services and steering committee services, can be separated or whether they must be accounted for as a combined unit of accounting in accordance with U.S. GAAP. The Company recognizes the arrangement consideration allocated to licenses as revenue upon delivery of the license only if the license has stand-alone value. If the license is considered not to have stand-alone value, the license would then be combined with other undelivered elements into a combined unit of accounting and the license payments and payments for performance obligations would be recognized as revenue when the revenue recognition criteria have been satisfied for the last deliverable within the unit of accounting. In the case of combined units of accounting that include delivered licenses and undelivered services to be provided over time, revenue would be recognized over the estimated period during which services will be provided. 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. The Company recognizes arrangement consideration allocated to each unit of accounting when all of the revenue recognition criteria in ASC 605-25 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. 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 option(s) to secure additional goods or services. Factors that are considered in evaluating whether options are substantive include the overall objective of the arrangement, benefit the collaborator might obtain from the agreement without exercising the options, cost to exercise the options relative to the total upfront consideration, and 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 option is not considered a deliverable in the arrangement. 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 i.e. un-exercised, non-substantive, Payments or reimbursements resulting from Pieris’ research and development efforts in multi-element arrangements, in which Pieris’ research and development efforts are considered to be a deliverable, are included in allocable consideration and allocated to the units of accounting. These reimbursements 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. Revenue recognized cannot exceed the amount that has been earned and has been billed or is currently billable. 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 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, including regulatory approval. Sales milestones are 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. For revenues from research, development, and commercial 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, assuming all other revenue recognition criteria are met. Milestones that are not considered substantive are accounted for as contingent revenue and will be recognized when achieved to the extent the Company has no remaining performance obligations under the arrangement. Revenues from sales 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. |
Recent Pronouncements | The Company, an emerging growth company (“EGC”), has elected to take advantage of the benefits of the extended transition period provided for in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting standards which allows the Company to defer adoption of certain accounting standards until those standards would otherwise apply to private companies. Standards not yet adopted In May 2014, the FASB issued Accounting Standard Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606) Revenue from Contracts with Customers (Topic 606) Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net) Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients 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 public EGC companies like the Company, for interim and annual periods beginning after December 15, 2018, with an option to early adopt for interim and annual periods beginning after December 15, 2017. 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). The Company is in the process of determining the date and method of adoption and the impact of the Revenue Recognition ASUs on its financial statements. In February 2016, the FASB issued ASU No. 2016-02, ASU 2016-02 Leases (Topic 842) (“ASU 2016-02”) In May 2017, the FASB issued ASU No. 2017-09, Compensation – Stock compensation (Topic 718) (“ASU 2017-09”) 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. |
Accrued expenses (Tables)
Accrued expenses (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | The Company has recorded the following accrued expenses as of September 30, 2017 and December 31, 2016, respectively: September 30, December 31, Accrued expenses Accrued compensation expense $ 1,412,121 $ 1,198,448 Accrued professional fees 1,208,945 867,969 Accrued R&D fees 932,542 1,040,321 Accrued taxes 1,062,072 — Accrued audit and tax fees 314,656 454,931 Accrued other 169,582 157,788 Total amount of accrued expenses $ 5,099,918 $ 3,719,457 |
Stock-based compensation (Table
Stock-based compensation (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Stock-Based Compensation Expense | Total stock-based compensation expense was recorded to operating expenses based upon the functional responsibilities of the individuals holding the respective options as follows: Three months ended September 30, Nine months ended September 30, 2017 2016 2017 2016 Research and Development $ 216,328 $ 142,254 $ 573,758 $ 444,193 General and administrative 433,620 303,859 1,388,260 982,148 Total stock-based compensation expense $ 649,948 $ 446,113 $ 1,962,018 $ 1,426,341 |
Schedule of Fair Value Assumptions | The weighted-average fair value of the options granted was $1.05 and $1.01 for the three months ended September 30, 2016 and the nine months ended September 30, 2016. The calculation was based on the following assumptions: Three months ended September 30, Nine months ended September 30, 2017 2016 2017 2016 Dividend yield 0.0% 0.0% 0.0% 0.0% Expected volatility 77.34% - 78.89% 74.90% - 75.12% 75.09% - 78.89% 74.90% - 76.00% Weighted average risk-free interest rate 1.77% - 2.02% 1.25% - 1.35% 1.77% - 2.16% 1.13% - 1.61% Expected term 5.0 - 5.7 5.0 - 5.7 5.0 - 5.7 5.0 - 5.7 |
Critical Accounting Policies -
Critical Accounting Policies - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2017 | |
Accounting Policies [Abstract] | |
Milestones arrangement, categories description | Pieris aggregates milestones into four categories (i) research milestones, (ii) development milestones, (iii) commercial milestones, and (iv) sales milestones. |
Revenues - Additional Informati
Revenues - Additional Information (Detail) | Feb. 27, 2017USD ($) | Jan. 04, 2017USD ($) | Jan. 04, 2017EUR (€) | Sep. 30, 2017USD ($)Product | Sep. 30, 2016USD ($) | Sep. 30, 2017USD ($)Product | Sep. 30, 2017EUR (€) | Sep. 30, 2016USD ($) | Dec. 31, 2016USD ($) |
Deferred Revenue Arrangement [Line Items] | |||||||||
Revenues from product sales | $ 0 | ||||||||
Non-current deferred revenue | $ 55,221,586 | 55,221,586 | $ 1,409,483 | ||||||
FHoffmann La Roche Ltd and Hoffmann La Roche Inc [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Collaboration agreement, revenue recognized | $ 800,000 | $ 3,100,000 | |||||||
Deferred revenue | 2,000,000 | 2,000,000 | $ 3,700,000 | ||||||
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 | 1,000,000 | $ 2,800,000 | |||||||
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 | 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 | 413,500,000 | $ 413,500,000 | |||||||
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 | 123,100,000 | 123,100,000 | |||||||
FHoffmann La Roche Ltd and Hoffmann La Roche Inc [Member] | Collaborative Arrangement [Member] | Maximum [Member] | Research And Development Milestone Payments [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Contractual agreement, potential payments | 290,400,000 | 290,400,000 | |||||||
Les Laboratoires Servier and Institut de Recherches Internationales Servier [Member] | Upfront Payment Arrangement [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Total allocable arrangement consideration | 32,000,000 | € 30,000,000 | |||||||
Les Laboratoires Servier and Institut de Recherches Internationales Servier [Member] | Collaborative Arrangement [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Deferred revenue | $ 3,600,000 | $ 3,600,000 | |||||||
Period after effective date agreements may be terminated | 12 months | 12 months | |||||||
Contract termination advance notice period | 180 days | 180 days | |||||||
Number of collaboration products | Product | 4 | 4 | |||||||
Number of worldwide collaboration products | Product | 2 | 2 | |||||||
Non-current deferred revenue | $ 30,700,000 | $ 30,700,000 | |||||||
Les Laboratoires Servier and Institut de Recherches Internationales Servier [Member] | Collaborative Arrangement [Member] | Upfront Payment Arrangement [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Collaboration agreement, license upfront payment | $ 32,000,000 | € 30,000,000 | |||||||
Collaboration agreement, revenue recognized | 500,000 | $ 0 | $ 1,200,000 | $ 0 | |||||
Les Laboratoires Servier and Institut de Recherches Internationales Servier [Member] | Collaborative Arrangement [Member] | Maximum [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Contract termination due to material breach, advance notice period | 120 days | 120 days | |||||||
Les Laboratoires Servier and Institut de Recherches Internationales Servier [Member] | Collaborative Arrangement [Member] | Minimum [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Contract termination due to material breach, advance notice period | 90 days | 90 days | |||||||
Les Laboratoires Servier and Institut de Recherches Internationales Servier [Member] | Collaborative Arrangement [Member] | Future Lead Product [Member] | Maximum [Member] | Sales Milestone Payments [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Contractual agreement, potential payments | € | 515,000,000 | ||||||||
Les Laboratoires Servier and Institut de Recherches Internationales Servier [Member] | Collaborative Arrangement [Member] | Future Lead Product [Member] | Maximum [Member] | Research, Development And Commercial Milestones [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Contractual agreement, potential payments | € | 569,000,000 | ||||||||
Les Laboratoires Servier and Institut de Recherches Internationales Servier [Member] | Collaborative Arrangement [Member] | Other Programs [Member] | Maximum [Member] | Research, Development And Commercial Milestones [Member] | Substantive [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Contractual agreement, potential payments | € | € 163,000,000 | ||||||||
ASKA Pharmaceutical Co Ltd [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Deferred revenue | 3,000,000 | $ 3,000,000 | |||||||
Total allocable arrangement consideration | $ 2,750,000 | ||||||||
Evaluation Period | 60 days | ||||||||
ASKA Pharmaceutical Co Ltd [Member] | Upfront Payment Arrangement [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Upfront option payment | $ 2,750,000 | ||||||||
ASKA Pharmaceutical Co Ltd [Member] | Collaborative Arrangement [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Collaboration agreement, milestone payments | 0 | 0 | |||||||
AstraZeneca [Member] | Upfront Payment Arrangement [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Collaboration agreement, revenue recognized | 2,500,000 | 3,100,000 | |||||||
AstraZeneca [Member] | Collaborative Arrangement [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Deferred revenue | 25,700,000 | 25,700,000 | |||||||
Non-current deferred revenue | 21,500,000 | $ 21,500,000 | |||||||
AstraZeneca [Member] | License and Collaboration Agreement [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Period after effective date agreements may be terminated | 12 months | 12 months | |||||||
Contract termination advance notice period | 90 days | 90 days | |||||||
Contract termination due to material breach, advance notice period | 180 days | 180 days | |||||||
Contract termination advance notice period if marketing approval obtained | 180 days | 180 days | |||||||
Contract termination due to Payment breach, advance notice period | 30 days | 30 days | |||||||
Contract termination due to material breach, additional notice period if the breach is not susceptible | 180 days | 180 days | |||||||
Collaborative arrangement license description | (i) research and development license for the AstraZeneca Lead Product, (ii) commercial license for the AstraZeneca Lead Product, (iii) individual research licenses for each of the four AstraZeneca Collaboration Products, (iv) individual commercial licenses for each of the four AstraZeneca Collaboration Products, and (v) individual non-exclusive platform technology licenses for the AstraZeneca Lead Product and the four AstraZeneca Collaboration Products. | (i) research and development license for the AstraZeneca Lead Product, (ii) commercial license for the AstraZeneca Lead Product, (iii) individual research licenses for each of the four AstraZeneca Collaboration Products, (iv) individual commercial licenses for each of the four AstraZeneca Collaboration Products, and (v) individual non-exclusive platform technology licenses for the AstraZeneca Lead Product and the four AstraZeneca Collaboration Products. | |||||||
AstraZeneca [Member] | License and Collaboration Agreement [Member] | Upfront Payment Arrangement [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Total allocable arrangement consideration | $ 45,000,000 | ||||||||
AstraZeneca [Member] | License and Collaboration Agreement [Member] | Upfront Payment Arrangement [Member] | Estimated Development and Manufacturing Services [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Total allocable arrangement consideration | 8,200,000 | ||||||||
AstraZeneca [Member] | License and Collaboration Agreement [Member] | Upfront Payment Arrangement [Member] | Relative Selling Price Method [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Total allocable arrangement consideration | 53,200,000 | ||||||||
AstraZeneca [Member] | License and Collaboration Agreement [Member] | Maximum [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Contractual agreement, potential payments | 45,000,000 | 45,000,000 | |||||||
AstraZeneca [Member] | License and Collaboration Agreement [Member] | Maximum [Member] | Development Milestones [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Contractual agreement, potential payments | 1,100,000,000 | 1,100,000,000 | |||||||
AstraZeneca [Member] | License and Collaboration Agreement [Member] | Maximum [Member] | Sales Milestone Payments [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Contractual agreement, potential payments | $ 1,000,000,000 | 1,000,000,000 | |||||||
AstraZeneca [Member] | Substantive Development and Sales Milestone [Member] | Maximum [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Collaboration agreement, milestone payments | 611,400,000 | ||||||||
AstraZeneca [Member] | Substantive Development and Sales Milestone [Member] | Minimum [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Collaboration agreement, milestone payments | 72,200,000 | ||||||||
AstraZeneca [Member] | Non Substantive Development and Sales Milestones [Member] | Maximum [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Collaboration agreement, milestone payments | 1,000,000,000 | ||||||||
AstraZeneca [Member] | Non Substantive Development and Sales Milestones [Member] | Minimum [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Collaboration agreement, milestone payments | 366,200,000 | ||||||||
AstraZeneca [Member] | Sales Milestones [Member] | Maximum [Member] | |||||||||
Deferred Revenue Arrangement [Line Items] | |||||||||
Collaboration agreement, milestone payments | $ 1,000,000,000 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2017 | Sep. 30, 2017 | |
Income Tax Disclosure [Abstract] | ||
Income tax expenses | $ 145,697 | $ 959,406 |
Effective tax rate | 3.97% | 3.97% |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Detail) - shares shares in Millions | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Stock Compensation Plan [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share amount | 0.7 | 7.4 |
Fair Value Measurement - Additi
Fair Value Measurement - Additional Information (Detail) - USD ($) | Sep. 30, 2017 | Dec. 31, 2016 |
Fair Value Disclosures [Abstract] | ||
Debt instruments fair value | $ 0 | $ 0 |
Cash equivalents | $ 0 | $ 0 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) | Sep. 30, 2017 | Dec. 31, 2016 |
Accrued expenses | ||
Accrued compensation expense | $ 1,412,121 | $ 1,198,448 |
Accrued professional fees | 1,208,945 | 867,969 |
Accrued R&D fees | 932,542 | 1,040,321 |
Accrued taxes | 1,062,072 | |
Accrued audit and tax fees | 314,656 | 454,931 |
Accrued other | 169,582 | 157,788 |
Total amount of accrued expenses | $ 5,099,918 | $ 3,719,457 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Stock Based Compensation [Line Items] | ||||
Stock based compensation expense | $ 649,948 | $ 446,113 | $ 1,962,018 | $ 1,426,341 |
Cash received from option exercises | $ 366,200 | |||
Weighted average grant date fair value | $ 3.34 | $ 1.05 | $ 2.02 | $ 1.01 |
2016 Stock Plan [Member] | ||||
Stock Based Compensation [Line Items] | ||||
Number of shares, Options granted | 114,378 | 114,378 | ||
Stock options vesting period | 4 years | |||
Common stock available for grant | 1,951,052 | 1,951,052 | ||
Number of shares, Forfeited | 218,467 | |||
Number of shares, Options exercised | 46,930 | 121,392 | ||
Cash received from option exercises | $ 0 | $ 147,950 | ||
Maximum term of stock options | 10 years | |||
2016 Stock Plan [Member] | Employees Consultants And Directors [Member] | ||||
Stock Based Compensation [Line Items] | ||||
Number of shares, Options granted | 148,306 | 1,407,061 | ||
2016 Stock Plan [Member] | Newly-Hired Executive Officer [Member] | ||||
Stock Based Compensation [Line Items] | ||||
Number of shares, Options granted | 450,000 | |||
Stock based compensation expense | $ 54,270 | $ 54,270 | ||
2014 Stock Plan [Member] | ||||
Stock Based Compensation [Line Items] | ||||
Number of shares, Options granted | 0 | 0 | ||
Number of shares, Forfeited | 14,958 | |||
Number of shares, Options exercised | 95,625 | 110,625 | ||
Cash received from option exercises | $ 188,250 | $ 218,250 | ||
2014 Stock Plan [Member] | Employees Consultants And Directors [Member] | ||||
Stock Based Compensation [Line Items] | ||||
Number of shares, Options granted | 0 | 1,157,734 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Total Stock-Based Compensation Expense Related to Share-Based Awards Under the Pieris Plan (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 649,948 | $ 446,113 | $ 1,962,018 | $ 1,426,341 |
Research and Development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | 216,328 | 142,254 | 573,758 | 444,193 |
General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 433,620 | $ 303,859 | $ 1,388,260 | $ 982,148 |
Stock-Based Compensation - Sc31
Stock-Based Compensation - Schedule of Weighted-Average Assumptions Used for Calculating Value of Options Granted (Detail) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options Outstanding, Weighted Average Exercise Price, and Additional Disclosures [Abstract] | ||||
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Expected volatility | 77.34% | 74.90% | 75.09% | 74.90% |
Expected volatility | 78.89% | 75.12% | 78.89% | 76.00% |
Weighted average risk-free interest rate | 1.77% | 1.25% | 1.77% | 1.13% |
Weighted average risk-free interest rate | 2.02% | 1.35% | 2.16% | 1.61% |
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 | 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 | 5 years 8 months 12 days | 5 years 8 months 12 days | 5 years 8 months 12 days |
Common Stock - Additional Infor
Common Stock - Additional Information (Detail) - USD ($) | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | |
Schedule Of Stockholders Equity [Line Items] | |||
Common stock, shares authorized | 300,000,000 | 300,000,000 | |
Common stock, par value | $ 0.001 | $ 0.001 | |
Common stock, shares issued | 44,704,849 | 43,058,827 | |
Common stock, outstanding | 44,704,849 | 43,058,827 | |
Cash received from option exercises | $ 366,200 | ||
Cash proceeds from exercise of warrants | $ 3,126,778 | ||
Common Stock [Member] | |||
Schedule Of Stockholders Equity [Line Items] | |||
Number of shares, Options exercised | 232,017 | 0 | |
Cash received from option exercises | $ 400,000 | ||
Number of common stock issued upon exercise of warrants | 1,414,005 | ||
Cash proceeds from exercise of warrants | $ 3,100,000 | ||
Number of warrants exercised | 0 | ||
Cash Less Exercise Provision [Member] | Common Stock [Member] | |||
Schedule Of Stockholders Equity [Line Items] | |||
Number of shares, Options exercised | 66,392 | ||
Stock options to purchase shares of common stock | 150,000 | ||
Number of shares, warrants to purchase common stock | 89,330 | ||
Number of common stock issued upon exercise of warrants as cashless | 49,127 | ||
Cash Based Awards [Member] | Common Stock [Member] | |||
Schedule Of Stockholders Equity [Line Items] | |||
Number of shares, Options exercised | 165,625 | ||
Number of common stock issued upon exercise of warrants | 1,364,878 |
Private Placement - Additional
Private Placement - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 9 Months Ended |
Jun. 30, 2016 | Sep. 30, 2016 | |
Schedule of Capitalization, Equity [Line Items] | ||
Number of units in the transaction | 8,188,804 | |
Per unit price of private placement | $ 2.015 | |
Gross proceeds from private placement | $ 16.5 | |
Net proceeds from private placement | $ 15.3 | |
2016 PIPE [Member] | Common Stock [Member] | ||
Schedule of Capitalization, Equity [Line Items] | ||
Increase in number of shares | 3,225,804 | |
2016 PIPE [Member] | Convertible Series A Preferred Shares [Member] | ||
Schedule of Capitalization, Equity [Line Items] | ||
Increase in number of shares | 4,963 |
License and Transfer Agreemen34
License and Transfer Agreement With Enumeral Biomedical Corporation - Additional Information (Detail) - License and Transfer Agreement [Member] - Enumeral Biomedical Holdings Inc [Member] - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Apr. 18, 2016 | |
Contingencies And Commitments [Line Items] | |||||
Upfront license fee payment | $ 250,000 | ||||
Maintenance fee payment | $ 750,000 | ||||
Research and Development [Member] | |||||
Contingencies And Commitments [Line Items] | |||||
Upfront fees | $ 0 | $ 0 | $ 0 | $ 1,000,000 |
Liquidity and Going Concern - A
Liquidity and Going Concern - Additional Information (Detail) - USD ($) | Sep. 30, 2017 | Dec. 31, 2016 |
Liquidity and Going Concern [Abstract] | ||
Cash | $ 89,921,213 | $ 29,355,528 |