Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2017 | Mar. 05, 2018 | Jun. 30, 2017 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2017 | ||
Document Fiscal Year Focus | 2,017 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | ASSEMBLY BIOSCIENCES, INC. | ||
Entity Central Index Key | 1,426,800 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 324.9 | ||
Trading Symbol | ASMB | ||
Entity Common Stock, Shares Outstanding | 20,251,312 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Current assets | ||
Cash and cash equivalents | $ 82,033,209 | $ 28,575,085 |
Marketable securities, at fair value | 37,914,482 | 24,388,403 |
Accounts receivable from collaboration | 2,273,421 | 0 |
Prepaid expenses and other current assets | 897,400 | 611,176 |
Total current assets | 123,118,512 | 53,574,664 |
Long-term assets | ||
Marketable securities, at fair value | 3,347,213 | 2,435,753 |
Property, plant and equipment, net | 860,026 | 214,687 |
Security deposits | 339,558 | 255,366 |
Intangible assets | 29,000,000 | 29,000,000 |
Goodwill | 12,638,136 | 12,638,136 |
Total long-term assets | 46,184,933 | 44,543,942 |
Total assets | 169,303,445 | 98,118,606 |
Current liabilities | ||
Accounts payable | 2,123,939 | 2,368,131 |
Accrued expenses | 6,139,000 | 4,752,823 |
Deferred revenue - short-term | 5,229,227 | 0 |
Total current liabilities | 13,492,166 | 7,120,954 |
Long-term liabilities | ||
Deferred tax liabilities | 2,135,802 | 11,119,651 |
Deferred revenue - long-term | 40,555,708 | 0 |
Total long-term liabilities | 42,691,510 | 11,119,651 |
Total liabilities | 56,183,676 | 18,240,605 |
Commitments and contingencies | ||
Stockholders' equity | ||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding | 0 | 0 |
Common stock, $0.001 par value; 50,000,000 shares authorized; 20,137,974 and 17,246,754 shares issued and outstanding as of December 31, 2017 and December 31, 2016, respectively | 20,138 | 17,247 |
Additional paid-in capital | 364,528,037 | 288,688,990 |
Accumulated other comprehensive loss | (392,391) | (600,769) |
Accumulated deficit | (251,036,015) | (208,227,467) |
Total stockholders' equity | 113,119,769 | 79,878,001 |
Total liabilities and stockholders' equity | $ 169,303,445 | $ 98,118,606 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2017 | Dec. 31, 2016 |
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 50,000,000 | 50,000,000 |
Common stock, shares issued | 20,137,974 | 17,246,754 |
Common stock, shares outstanding | 20,137,974 | 17,246,754 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Collaboration revenue | $ 9,018,750 | $ 0 | $ 0 |
Operating expenses: | |||
Research and development | 44,225,021 | 33,092,977 | 18,357,937 |
General and administrative | 17,020,607 | 12,185,484 | 11,297,693 |
Total operating expenses | 61,245,628 | 45,278,461 | 29,655,630 |
Loss from operations | (52,226,878) | (45,278,461) | (29,655,630) |
Other income (expenses) | |||
Interest and other income | 983,209 | 1,539,088 | 1,228,830 |
Realized loss from marketable securities | (615,128) | (1,139,861) | (27,033) |
Total other income | 368,081 | 399,227 | 1,201,797 |
Loss before income taxes | (51,858,797) | (44,879,234) | (28,453,833) |
Income tax benefit | 9,050,249 | 617,672 | 0 |
Net loss | (42,808,548) | (44,261,562) | (28,453,833) |
Other comprehensive (loss) income | |||
Unrealized loss recognized in accumulated other comprehensive loss before reclassification, net of tax benefit of $82,245, $299,741 and $0, respectively | (258,105) | (481,981) | (848,618) |
Reclassification adjustment of unrealized loss included in net loss, net of tax expense of $148,645, $437,064 and $0, respectively | 466,483 | 702,797 | 27,033 |
Comprehensive loss | $ (42,600,170) | $ (44,040,746) | $ (29,275,418) |
Net loss per share, basic and diluted | $ (2.41) | $ (2.57) | $ (1.81) |
Weighted average common shares outstanding, basic and diluted | 17,750,380 | 17,226,245 | 15,702,646 |
CONSOLIDATED STATEMENTS OF OPE5
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Unrealized loss recognized in accumulated other comprehensive loss before reclassification, net of tax benefit | $ 82,245 | $ 299,741 | $ 0 |
Reclassification adjustment of unrealized loss included in net loss, net of tax expense | $ 148,645 | $ 437,064 | $ 0 |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY - USD ($) | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Deficit [Member] |
Balance at Dec. 31, 2014 | $ 58,571,172 | $ 10,672 | $ 194,072,572 | $ 0 | $ (135,512,072) |
Balance (in shares) at Dec. 31, 2014 | 10,672,059 | ||||
Proceeds from common stock sold, net of underwriters' discounts and cost | 81,014,989 | $ 6,389 | 81,008,600 | 0 | 0 |
Proceeds from common stock sold, net of underwriters' discounts and cost (in shares) | 6,388,888 | ||||
Proceeds from the exercise of stock options | 554,268 | $ 77 | 554,191 | 0 | 0 |
Proceeds from the exercise of stock options (in shares) | 76,422 | ||||
Cashless exercise of warrants | 0 | $ 88 | (88) | 0 | 0 |
Cashless exercise of warrants (in shares) | 88,293 | ||||
Stock-based compensation | 7,876,584 | $ 0 | 7,876,584 | 0 | 0 |
Change in unrealized gain (loss) on marketable securities | (821,585) | 0 | 0 | (821,585) | 0 |
Net loss | (28,453,833) | 0 | 0 | 0 | (28,453,833) |
Balance at Dec. 31, 2015 | 118,741,595 | $ 17,226 | 283,511,859 | (821,585) | (163,965,905) |
Balance (in shares) at Dec. 31, 2015 | 17,225,662 | ||||
Proceeds from the exercise of stock options | 152,640 | $ 21 | 152,619 | 0 | 0 |
Proceeds from the exercise of stock options (in shares) | 21,200 | ||||
Stock-based compensation | 5,024,512 | $ 0 | 5,024,512 | 0 | 0 |
Change in unrealized gain (loss) on marketable securities | 220,816 | 0 | 0 | 220,816 | 0 |
Cancellation of common stock | 0 | $ 0 | 0 | 0 | 0 |
Cancellation of common stock (in shares) | (108) | ||||
Net loss | (44,261,562) | $ 0 | 0 | 0 | (44,261,562) |
Balance at Dec. 31, 2016 | 79,878,001 | $ 17,247 | 288,688,990 | (600,769) | (208,227,467) |
Balance (in shares) at Dec. 31, 2016 | 17,246,754 | ||||
Proceeds from common stock sold, net of underwriters' discounts and cost | 64,847,354 | $ 2,541 | 64,844,813 | 0 | 0 |
Proceeds from common stock sold, net of underwriters' discounts and cost (in shares) | 2,541,500 | ||||
Proceeds from the exercise of stock options | 2,393,142 | $ 350 | 2,392,792 | 0 | 0 |
Proceeds from the exercise of stock options (in shares) | 349,720 | ||||
Stock-based compensation | 8,601,442 | $ 0 | 8,601,442 | 0 | 0 |
Change in unrealized gain (loss) on marketable securities | 208,378 | 0 | 0 | 208,378 | 0 |
Net loss | (42,808,548) | 0 | 0 | 0 | (42,808,548) |
Balance at Dec. 31, 2017 | $ 113,119,769 | $ 20,138 | $ 364,528,037 | $ (392,391) | $ (251,036,015) |
Balance (in shares) at Dec. 31, 2017 | 20,137,974 |
CONSOLIDATED STATEMENTS OF CHA7
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (Parenthetical) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Change in unrealized loss on marketable securities, net of income tax expense | $ 66,400 | $ 137,323 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Cash flows from operating activities | |||
Net loss | $ (42,808,548) | $ (44,261,562) | $ (28,453,833) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 219,225 | 80,251 | 64,989 |
Stock-based compensation | 8,601,442 | 5,024,512 | 7,876,584 |
Realized loss from marketable securities | 615,128 | 1,139,861 | 27,033 |
Deferred income tax benefit | (9,050,249) | (617,672) | 0 |
Loss on sale of fixed assets | 0 | 0 | 954 |
Changes in operating assets and liabilities: | |||
Accounts receivable from collaboration | (2,273,421) | 0 | 0 |
Prepaid expenses and other current assets | (286,224) | 93,111 | (555,849) |
Accounts payable | (244,192) | 1,004,433 | 456,097 |
Accrued expenses | 1,386,177 | 2,713,619 | 1,968,844 |
Deferred revenue | 45,784,935 | 0 | 0 |
Security deposits | (84,192) | (58,208) | (82,153) |
Net cash provided by (used in) operating activities | 1,860,081 | (34,881,655) | (18,697,334) |
Cash flows from investing activities | |||
Purchases of fixed assets | (864,564) | (146,329) | (58,261) |
Sale of fixed assets | 0 | 0 | 150 |
Purchases of marketable securities | (48,234,454) | (7,951,257) | (69,781,176) |
Redemptions of marketable securities | 33,456,565 | 44,294,160 | 4,983,777 |
Net cash (used in) provided by investing activities | (15,642,453) | 36,196,574 | (64,855,510) |
Cash flows from financing activities | |||
Proceeds from common stock sold, net of underwriters' discounts and cost | 64,847,354 | 0 | 81,014,989 |
Proceeds from the exercise of stock options | 2,393,142 | 152,640 | 554,268 |
Net cash provided by financing activities | 67,240,496 | 152,640 | 81,569,257 |
Net increase (decrease) in cash and cash equivalents | 53,458,124 | 1,467,559 | (1,983,587) |
Cash and cash equivalents at the beginning of the period | 28,575,085 | 27,107,526 | 29,091,113 |
Cash and cash equivalents at the end of the period | 82,033,209 | 28,575,085 | 27,107,526 |
Supplemental disclosure of cash flow information: | |||
Change in unrealized gain (loss) on marketable securities available-for-sale, before tax expense | 274,778 | 358,139 | (821,585) |
Cashless exercise of warrants | 0 | 0 | 88 |
Supplemental disclosure of non-cash activities: | |||
Goodwill | 0 | 0 | 99,214 |
Accounts payable and accrued expenses | 0 | 0 | (99,214) |
Cash acquired in business combination | $ 0 | $ 0 | $ 0 |
Nature of Business
Nature of Business | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Business and Basis Of Presentation [Abstract] | |
Nature of Business | Note 1 - Nature of Business Overview Assembly Biosciences, Inc., together with its subsidiaries Over 250 million people worldwide are chronically infected with HBV. The Company’s HBV-cure program is pursuing multiple drug candidates that inhibit the HBV lifecyle and block the generation of covalently closed circular DNA (cccDNA), with the aim of increasing the current low cure rates for patients with HBV. Assembly has discovered multiple novel core protein Allosteric Modulators (CpAMs), which are small molecules that directly target and allosterically modulate the HBV core (HBc) protein. The Company’s Microbiome program consists of a fully integrated platform that includes a disease targeted strain identification and selection process, methods for strain isolation and growth under current Good Manufacturing Practices (cGMP) conditions, and a patent-pending delivery system that we call GEMICEL®, which is designed to allow for targeted oral delivery of live biologic and conventional therapies to the lower gastrointestinal (GI) tract. Using its microbiome platform, the Company is developing product candidates for various disease indications, including ulcerative colitis, Crohn’s disease, irritable bowel syndrome, non-alcoholic steatohepatitis (NASH), immuno-oncology and Clostridium difficile infections (CDI), which we will develop either internally or in collaboration with partners. On January 6, 2017, the Company entered into a Research, Development, Collaboration and License Agreement (the Collaboration Agreement) with Allergan Pharmaceuticals International Limited (Allergan) to develop and commercialize select microbiome gastrointestinal programs. Pursuant to the terms of the Collaboration Agreement, in connection with the closing of the transaction on February 10, 2017, Allergan paid the Company an upfront payment of $ 50 630 2.15 75 On November 1, 2017, the Company sold to various investors an aggregate of 2,210,000 27.25 64.8 331,500 Liquidity The Company has not derived any revenue from product sales to date as it currently has no approved products. Once a product has been developed, it will need to be approved for sale by the U.S. Food and Drug Administration (FDA) or an applicable foreign regulatory agency. Since inception, the Company’s operations have been financed primarily through the sale of equity securities, the proceeds from the exercise of warrants and stock options, the issuance of debt and an up-front payment related to the Collaboration Agreement. The Company has incurred losses from operations and negative cash flows from operating activities since inception and expects to continue to incur substantial losses for the next several years as it continues its product development efforts. Management believes the Company currently has sufficient funds to meet its operating requirements for at least the next twelve months |
Summary of Significant Accounti
Summary of Significant Accounting Policies and Recent Accounting Pronouncements | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies and Recent Accounting Pronouncements | Note 2 - Summary of Significant Accounting Policies and Recent Accounting Pronouncements The accompanying consolidated financial statements include the accounts of the Company and its subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. The Company operates in one operating segment and, accordingly, no segment disclosures have been presented herein. The preparation of consolidated financial statements in conformity with the accounting principles generally accepted in the United States of America (U.S. GAAP) requires management to make estimates and assumptions that may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Significant estimates inherent in the preparation of the accompanying consolidated financial statements include recoverability and useful lives (indefinite or finite) of intangible assets, assessment of impairment of goodwill, provisions for income taxes, and the fair value of stock options and warrants granted to employees, consultants, directors, investors, licensors, placement agents and underwriters. In addition, with the Company entering into the Collaboration Agreement in 2017, the Company believes its consolidated financial statements are also impacted by the following accounting estimates and judgments: (i) identifying deliverables under collaboration agreements involving multiple elements and determining whether such deliverables are separable from other aspects of the contractual relationship; (ii) estimating the selling price of deliverables for the purpose of allocating arrangement consideration for revenue recognition; and (iii) estimating the periods over which the allocated consideration for deliverables is recognized. The Company’s estimates could be affected by external conditions, including those unique to the Company and general economic conditions. It is reasonably possible that these external factors could have an effect on the Company’s estimates and could cause actual results to differ from those estimates and assumptions. All highly liquid investments with maturities of three months or less at the time of purchase are considered to be cash equivalents. All of the Company’s cash equivalents have liquid markets and high credit ratings. The Company maintains its cash in bank deposits and other accounts, the balances of which, at times and at December 31, 2017 and 2016, exceed federally insured limits. The Company has designated marketable securities as of December 31, 2017 and 2016 as available-for-sale securities and measures these securities at their respective fair values. Marketable securities are classified as short-term or long-term based on the maturity date and their availability to meet current operating requirements. Marketable securities that mature in one year or less are classified as short-term available-for-sale securities and are reported as a component of current assets. Marketable securities that are not considered available for use in current operations are classified as long-term available-for-sale securities and are reported as a component of long-term assets. Securities that are classified as available-for-sale are measured at fair value with temporary unrealized gains and losses reported in other comprehensive loss, and as a component of stockholders' equity until their disposition. The Company reviews all available-for-sale securities at each period end to determine if they remain available-for-sale based on their current intent and ability to sell the security if it is required to do so. The cost of securities sold is based on the specific identification method. Marketable securities are subject to a periodic impairment review. The Company may recognize an impairment charge when a decline in the fair value of investments below the cost basis is determined to be other-than-temporary. There were no marketable securities deemed to be impaired as of December 31, 2017 or 2016. As of December 31, 2017, the accounts receivable relates to the Company's collaboration with Allergan. All accounts receivable are deemed collectible. There were no accounts receivable as of December 31, 2016. Goodwill is the excess of purchase price over the fair value of identified net assets of businesses acquired. The Company’s intangible assets with an indefinite life are related to in-process research and development (IPR&D) programs acquired in the Merger, as the Company expects future research and development on these programs to provide the Company with substantial benefit for a period that extends beyond the foreseeable horizon. Intangible assets with indefinite useful lives are measured at their respective fair values as of the acquisition date. The Company does not amortize goodwill and intangible assets with indefinite useful lives. Intangible assets related to IPR&D projects are considered to be indefinite lived until the completion or abandonment of the associated R&D efforts. If and when development is complete, which generally occurs if and when regulatory approval to market a product is obtained, the associated assets would be deemed finite lived and would then be amortized based on their respective estimated useful lives at that point in time. The Company reviews goodwill and indefinite-lived intangible assets at least annually for possible impairment. Goodwill and indefinite-lived intangible assets are reviewed for possible impairment between annual tests if an event occurs or circumstances change that would more likely than not reduce the fair value of the reporting unit or the indefinite-lived intangible assets below their carrying values. The Company tests its goodwill and indefinite-lived intangible assets each year on October 1. The Company has one reporting unit. The Company tests goodwill for impairment by utilizing a market capitalization approach which was based upon the closing price of the Company’s stock price as of the beginning of the 4 th On October 1, 2017, the Company elected to bypass the qualitative assessment and performed a quantitative impairment test. On October 1, 2016, the Company performed a qualitative assessment of IPR&D. Significant assumptions used in the model include the period in which material net cash inflows are expected to commence, anticipated material changes from historical pricing, margins and expense levels and an appropriate risk adjusted discount rate applied to the estimated cash flows. As of October 1, 2017 and 2016, IPR&D was not deemed to be impaired. The Company monitors the carrying value of long-lived assets for potential impairment and tests the recoverability of such assets whenever events or changes in circumstances indicate that the carrying amounts may not be recoverable. If a change in circumstance occurs, the Company performs a test of recoverability by comparing the carrying value of the asset or asset group to its undiscounted expected future cash flows. If cash flows cannot be separately and independently identified for a single asset, the Company will determine whether impairment has occurred for the group of assets for which the Company can identify the projected cash flows. If the carrying values are in excess of undiscounted expected future cash flows, the Company measures any impairment by comparing the fair value of the asset or asset group to its carrying value. There were no indicators of impairment of long-lived assets during the year ended December 31, 2017 and 2016. Property and equipment are stated at cost and consist of lab equipment and computer hardware and software. The Company computes depreciation under the straight-line method over the following estimated useful life of the related assets: • Lab equipment 3 5 • Computer hardware and software 3 • Office equipment 7 Leasehold improvements are amortized over the remaining terms of the respective leases or the estimated useful life of the leasehold improvements, whichever is less. Maintenance and repair costs are expensed as incurred. The Company follows accounting guidance on fair value measurements for financial instruments measured on a recurring basis, as well as for certain assets and liabilities that are initially recorded at their estimated fair values. Fair value is defined as the exit price, or the amount that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The Company use the following three-level hierarchy that maximizes the use of observable inputs and minimizes the use of unobservable inputs to value its financial instruments: Level 1: Observable inputs such as unadjusted quoted prices in active markets for identical instruments. Level 2: Quoted prices for similar instruments that are directly or indirectly observable in the marketplace. Level 3: Significant unobservable inputs which are supported by little or no market activity and that are financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. Financial instruments measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The assessment of the significance of a particular input to the fair value measurement in its entirety requires us to make judgments and consider factors specific to the asset or liability. The use of different assumptions and/or estimation methodologies may have a material effect on estimated fair values. Accordingly, the fair value estimates disclosed or initial amounts recorded may not be indicative of the amount that the Company or holders of the instruments could realize in a current market exchange. The carrying amounts of cash equivalents and marketable securities approximate their fair value based upon quoted market prices. Certain of the Company’s financial instruments are not measured at fair value on a recurring basis, but are recorded at amounts that approximate their fair value due to their liquid or short-term nature, such as cash, accounts receivable, accounts payable and accrued expenses. The Company recognizes revenue when each of the following four criteria is met: (i) persuasive evidence of an arrangement exists; (ii) products are delivered or services are rendered; (iii) the sales price is fixed or determinable; and (iv) collectability is reasonably assured. The Company recognizes revenue under the Collaboration Agreement based on the relevant accounting literature. Under this guidance, multiple elements or deliverables may include (i) grants of licenses, or options to obtain licenses, to intellectual property, (ii) research and development services, (iii) participation on joint research and/or joint development committees, and/or (iv) manufacturing or supply of services. The payments entities may receive under these arrangements typically include one or more of the following: non-refundable, upfront license fees; option exercise fees; funding of research and/or development efforts; amounts due upon the achievement of specified objectives; and/or royalties on future product sales. Multiple-element arrangements require the separability of deliverables included in an arrangement into different units of accounting and the allocation of arrangement consideration to the units of accounting. The evaluation of multiple-element arrangements requires management to make judgments about (i) the identification of deliverables, (ii) whether such deliverables are separable from the other aspects of the contractual relationship, (iii) the estimated selling price of each deliverable, and (iv) the expected period of performance for each deliverable. To determine the units of accounting under a multiple-element arrangement, management evaluates certain separation criteria, including whether the deliverables have stand-alone value, based on the relevant facts and circumstances for each arrangement. Management then estimates the selling price for each unit of accounting and allocates the arrangement consideration to each unit using the relative selling price method. The relative selling price for each deliverable is determined using vendor specific objective evidence (VSOE), of selling price or third-party evidence of selling price if VSOE does not exist. If neither VSOE nor third-party evidence of selling price exists, we use our best estimate of the selling price for the deliverable. The allocated consideration for each unit of accounting is recognized based on the method most appropriate for that unit of accounting and in accordance with the revenue recognition criteria detailed above. If there are deliverables in an arrangement that are not separable from other aspects of the contractual relationship, they are treated as a combined unit of accounting, with the allocated revenue for the combined unit recognized in a manner consistent with the revenue recognition applicable to the final deliverable in the combined unit. Payments received prior to satisfying the relevant revenue recognition criteria are recorded as deferred revenue in the accompanying consolidated balance sheets and recognized as revenue when the related revenue recognition criteria are met. The Collaboration Agreement provides for non-refundable milestone payments. The Company recognizes revenue that is contingent upon the achievement of a substantive milestone in its entirety in the period in which the milestone is achieved. A milestone is considered substantive when the consideration payable to the Company for such milestone (i) is consistent with the Company’s performance necessary to achieve the milestone or the increase in value to the collaboration resulting from the Company’s performance, (ii) relates solely to the Company’s past performance and (iii) is reasonable relative to all of the other deliverables and payments within the arrangement. In making this assessment, the Company considers all facts and circumstances relevant to the arrangement, including factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the milestone, the level of effort and investment required to achieve the milestone and whether any portion of the milestone consideration is related to future performance or deliverables. The Collaboration Agreement provides Allergan with options to license additional intellectual property rights, or purchase additional research, development, or supply services. The Company concluded that these were "substantive options" under the multiple-element arrangement guidance, and accordingly, associated fees have not been considered in allocating contract consideration among deliverables with stand-alone value. If Allergan exercises one or more of these options, the associated revenue would be recognized using the method most appropriate for the particular deliverable. The Company will periodically review the estimated performance periods under the Collaboration Agreement, which provides for non-refundable upfront payments and fees. The Company will adjust the periods over which revenue should be recognized when appropriate to reflect changes in assumptions relating to the estimated performance periods. The Company could accelerate revenue recognition in the event of early termination of programs or if the Company’s expectations change. Alternatively, the Company could decelerate revenue recognition if programs are extended or delayed. While such changes to the Company’s estimates have no impact on the Company’s consolidated cash flows, the amount of revenue recorded in future periods could be materially impacted. The Company records revenues related to the reimbursement of costs incurred under the Collaboration Agreement where the Company acts as a principal, controls the research and development activities and bears credit risk. Under the Collaboration Agreement, the Company is reimbursed for associated out-of-pocket costs. The gross amount of these pass-through reimbursed costs is reported as revenue in the accompanying consolidated statements of operations, while the actual expenses for which the Company is reimbursed are reflected as research and development costs. The Company has also accounted for the milestone payments under Accounting Standards Codification (ASC) , Revenue Recognition - Milestone Method The Company expenses stock-based compensation to employees and Board members over the requisite service period based on the estimated grant-date fair value of the awards. Stock-based awards with graded-vesting schedules are recognized on a straight-line basis over the requisite service period for each separately vesting portion of the award. For stock-based compensation awards to non-employees, the Company remeasures the fair value of the non-employee awards at each reporting period prior to vesting and finally at the vesting date of the award. Changes in the estimated fair value of these non-employee awards are recognized as compensation expense in the period of change. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model and the assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. The fair value of restricted stock units is determined based on the number of shares granted and the quoted market price of the Company's common stock on the date of grant. The fair value of restricted stock units with performance conditions deemed probable of being achieved and vesting are amortized to expense over the requisite service period using the straight-line method of expense recognition. Effective on January 1, 2017, the Company elected to account for forfeited awards as they occur as permitted by Accounting Standards Update ("ASU") 2016-09. Ultimately, the actual expenses recognized over the vesting period will be for those shares that vested. Prior to making this election, the Company estimated a forfeiture rate for awards at 0 Research and development costs are expensed as incurred. Research and development costs include salaries and personnel-related costs, consulting fees, fees paid for contract research services, fees paid to clinical research organizations and other third parties associated with clinical trials, the costs of laboratory equipment and facilities, and other external costs. The Company records income taxes using the asset and liability method. Deferred income tax assets and liabilities are recognized for the future tax effects attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective income tax bases, and operating loss and tax credit carryforwards. The Company establishes a valuation allowance if it is more likely than not that the deferred tax assets will not be recovered based on an evaluation of objective verifiable evidence. For tax positions that are more likely than not of being sustained upon audit, the Company recognizes the largest amount of the benefit that is greater than 50% likely of being realized. For tax positions that are not more likely than not of being sustained upon audit, the Company does not recognize any portion of the benefit. The Financial Accounting Standards Board (“FASB”) ASC Topic 740, Income Taxes The Company’s policy for recording interest and penalties associated with audits is to record such expense as a component of income tax expense. There were no amounts accrued for penalties or interest On December 22, 2017, legislation commonly known as the Tax Cuts and Jobs Act, or the Tax Act, was signed in to law. The legislation significantly changes U.S. tax law by, among other things, lowering corporate income tax rates, implementing a territorial tax system and imposing a repatriation tax on deemed repatriated earnings of foreign subsidiaries. The Tax Act permanently reduces the U.S. corporate income tax rate to 21% from the existing applicable rate of 34 24.7 28.4 3.7 On December 22, 2017, the SEC staff issued Staff Accounting Bulletin No. 118 ("SAB 118") to address the application of GAAP in situations when a registrant does not have the necessary information available, prepared, or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the Tax Reform Act. The Company has recognized the provisional tax impacts related to the revaluation of deferred tax assets and liabilities and included these amounts in its consolidated financial statements for the year ended December 31, 2017. The ultimate impact may differ from these provisional amounts, possibly materially, due to, among other things, additional analysis, changes in interpretations and assumptions the Company has made, additional regulatory guidance that may be issued, and actions the Company may take as a result of the Tax Act. The accounting is expected to be complete when the 2017 U.S. corporate income tax return is filed in 2018. Basic net loss per common share excludes dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per common share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity unless inclusion of such shares would be anti-dilutive. Since the Company has only incurred losses, basic and diluted net loss per share is the same. Year Ended December 31, 2017 2016 2015 Warrants to purchase common stock 15,296 16,909 16,909 Options to purchase common stock 4,551,819 4,457,251 3,367,784 Restricted stock units to purchase common stock 120,000 - - Total 4,687,115 4,474,160 3,384,693 Comprehensive loss is comprised of net loss and adjustments for the change in unrealized gains and losses on investments in available-for-sale marketable securities. The Company displays comprehensive loss and its components in the consolidated statements of operations and comprehensive loss. Financial instruments which potentially subject the Company to credit risk consist primarily of cash, cash equivalents and marketable securities. The Company holds these investments in highly rated financial institutions, and, by policy, limits the amounts of credit exposure to any one financial institution. These amounts at times may exceed federally insured limits. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to any significant credit risk on these funds. The Company has no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts or other hedging arrangements. In March 2016, the FASB issued ASU 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting In January 2017, the FASB issued ASU 2017-04, Intangibles - Goodwill and Other (Topic 350) Accounting Pronouncements to Be Adopted In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606), Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date 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. In January 2016, the FASB issued ASU 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows - Classification of Certain Cash Receipts and Cash Payments, In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) Leases (Topic 840) Leases (Topic 842) Land Easement Practical Expedient for Transition to Topic 842 In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments In February 2018, the FASB issued ASU 2018-02, Income Statement - Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income, is effective for fiscal years, including interim periods within those fiscal years, beginning after December 15, 2018 with early adoption in any interim period permitted. |
Marketable Securities
Marketable Securities | 12 Months Ended |
Dec. 31, 2017 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | Note 3 - Marketable Securities December 31, 2017 Amortized Cost Gross Unrealized (1) Gross Unrealized (1) Fair Value Short-term available-for-sale securities Corporate bonds $ 38,092,585 $ 5,635 $ (183,738) $ 37,914,482 Long-term available-for-sale securities Corporate bonds 3,357,778 - (10,565) 3,347,213 Total $ 41,450,363 $ 5,635 $ (194,303) $ 41,261,695 December 31, 2016 Amortized Cost Gross Unrealized (1) Gross Unrealized (1) Fair Value Short-term available-for-sale securities Corporate bonds $ 22,032,191 $ 3,190 $ (473,056) $ 21,562,325 Government and agency obligations 1,225,000 661 - 1,225,661 Municipal bonds 1,596,160 4,257 - 1,600,417 24,853,351 8,108 (473,056) 24,388,403 Long-term available-for-sale securities Corporate bonds 2,434,251 1,502 - 2,435,753 2,434,251 1,502 - 2,435,753 Total $ 27,287,602 $ 9,610 $ (473,056) $ 26,824,156 (1) The contractual term to maturity of short-term marketable securities held by the Company as of December 31, 2017 is less than one year The proceeds from sales of available-for-sale securities were $ 33.5 44.3 5.0 0.6 1.1 27,000 As of December 31, 2017 2016 Quoted prices in active markets for identical assets (Level 1) $ - $ - Quoted prices for similar assets observable in the marketplace (Level 2) 41,261,695 26,824,156 Significant unobservable inputs (Level 3) - - Total $ 41,261,695 $ 26,824,156 The fair values of marketable securities are determined using quoted market prices from daily exchange traded markets based on the closing price as of December 31, 2017 and 2016, and are classified as Level 2. There were no transfers between levels 1, 2 or 3 for the years ended December 31, 2017 and 2016. Less than 12 Months 12 Months or More Total Fair Value Unrealized Losses Fair Value Unrealized Losses Fair Value Unrealized Losses Corporate bonds $ 36,825,138 $ (194,303) $ - $ - $ 36,825,138 $ (194,303) Total $ 36,825,138 $ (194,303) $ - $ - $ 36,825,138 $ (194,303) The Company has determined that the unrealized losses are deemed to be temporary impairments as of December 31, 2017. The Company believes that the unrealized losses generally are caused by increases in the risk premiums required by market participants rather than an adverse change in cash flows or a fundamental weakness in the credit quality of the issuer or underlying assets. Because the Company has the ability and intent to hold these investments until a recovery of fair value, which may be maturity, it does not consider the investment in corporate bonds to be other-than-temporarily impaired at December 31, 2017. |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 12 Months Ended |
Dec. 31, 2017 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets | Note 4 - Goodwill and Intangible Assets Goodwill In July 2014, the Company completed its merger with Assembly Pharmaceuticals. The fair value of consideration paid, common stock and assumed options, totaled $ 29,823,096 12,638,136 Goodwill is recorded as an indefinite-lived asset and is not amortized for financial reporting purposes but is tested for impairment on an annual basis or more frequently when indications of impairment exist. No goodwill impairment losses have been recognized. Goodwill is not deductible for income tax purposes since the tax basis is $ 0 Intangible Assets In July 2014, the Company completed its acquisition of Assembly Pharmaceuticals. The Company acquired in-process research and development related to Assembly Pharmaceuticals’ technology which is an indefinite lived intangible asset. The Company performed its annual impairment test at October 1, 2017 and 2016, and deemed there was no impairment of long-lived assets. |
Property, Plant and Equipment,
Property, Plant and Equipment, Net | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment, Net | Note 5 - Property, Plant and Equipment, Net As of December 31, Useful life (Years) 2017 2016 Computer hardware and software 3 $ 104,968 $ 86,228 Lab equipment 3 to 5 369,827 253,735 Office equipment 7 25,354 1,109 Leasehold improvement 1 to 3.25 773,700 68,213 Total property, plant and equipment 1,273,849 409,285 Less: Accumulated depreciation and amortization (413,823) (194,598) Property, plant and equipment, net $ 860,026 $ 214,687 Depreciation expense for the years ended December 31, 2017, 2016 and 2015 was approximately $ 219,000 80,000 65,000 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2017 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Note 6 - Accrued Expenses As of December 31, 2017 2016 Accrued expenses: Salaries, bonuses and employee benefits $ 4,518,128 $ 2,884,000 Accrued severance expenses - 241,737 Research and development expenses 674,686 916,674 General and administrative expenses 946,186 710,412 Total accrued expenses $ 6,139,000 $ 4,752,823 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2017 | |
Equity [Abstract] | |
Stockholders' Equity | Note 7 - Stockholders’ Equity Common and Preferred Stock Transactions 2015 Activity On March 19, 2015, the Company sold to various investors an aggregate of 5,555,555 13.50 70.4 833,333 On April 6, 2015, the underwriters exercised in full their option to purchase an additional 833,333 13.50 10.6 70.4 81.0 On December 30, 2015, the Company filed a registration statement on Form S-3 with the SEC using a “shelf” registration process, file number 333-208806, which became effective January 19, 2016. Under this shelf registration process, the Company may from time to time sell any combination of the securities described in the registration statement in one or more offerings for an aggregate offering price of up to $ 150,000,000 69.3 80.7 2016 Activity On June 29, 2016, the Company cancelled 108 2017 Activity For the year ended December 31, 2017, the Company issued an aggregate of 349,720 2.4 On November 1, 2017, the Company sold to various investors an aggregate of 2,210,000 27.25 64.8 331,500 On December 29, 2017, the Company filed a registration statement on Form S-3 with the SEC using a “shelf” registration process, file number 333-222366, which became effective January 10, 2018. Under this shelf registration process, the Company may from time to time sell any combination of the securities described in the registration statement in one or more offerings for an aggregate offering price of up to $ 250,000,000 75.0 Options, Warrants and Restricted Stock Units Options In July 2010, the stockholders approved the 2010 Equity Incentive Plan (the 2010 Plan) and on May 19, 2011, the stockholders approved an amendment to the 2010 Plan increasing the authorized shares thereunder to 793,440 595,334 In July 2014, the stockholders approved the 2014 Stock Incentive Plan (the 2014 Plan). On June 2, 2016, at the 2016 Annual Meeting of Stockholders, the stockholders of the Company approved the amendment and restatement of the Company’s 2014 Plan (the Amended and Restated 2014 Plan). Pursuant to the terms of the Amended and Restated 2014 Plan, the maximum number of shares reserved for issuance thereunder is 4,160,000 3,216,246 120,000 587,391 73,876 On April 3, 2017, the Company’s Board of Directors adopted the Assembly Biosciences, Inc. 2017 Inducement Award Plan (the Inducement Plan) pursuant to which the Company reserved 800,000 189,000 611,000 Number of Shares Weighted Average Total Intrinsic Outstanding as of December 31, 2015 3,367,784 $ 7.16 $ 3,971,205 Granted 1,196,500 $ 7.46 $ 5,676,405 Exercised (21,200) $ 7.20 - Forfeited (85,833) $ 12.18 - Outstanding as of December 31, 2016 4,457,251 $ 7.14 $ 23,258,604 Granted 706,800 $ 24.16 $ 15,792,854 Exercised (353,612) $ 7.03 - Forfeited (258,620) $ 9.51 - Outstanding as of December 31, 2017 4,551,819 $ 9.66 $ 162,002,439 Options vested and exercisable 3,128,885 $ 6.80 $ 120,316,959 Year Ended December 31, 2017 2016 2015 Exercise price $12.81 - $44.28 $5.84 - $13.21 $7.88 - $16.55 Expected stock price volatility 81.2% - 87.0% 85.8% - 91.8% 88.62% - 95.55% Risk-free rate of interest 2.02% - 2.29% 1.36% - 2.18% 1.49% - 2.27% Term (years) 5.5 - 7.0 5.3 - 7.0 5.0 - 8.2 Future Stock Year Ended December 31, 2018 $ 5,755,478 Year Ended December 31, 2019 1,760,834 Year Ended December 31, 2020 634,516 Year Ended December 31, 2021 54,968 Total $ 8,205,796 The weighted average remaining amortization period is approximately 1.2 Warrants On April 17, 2015, the Company issued an aggregate of 88,293 120,265 During the year ended December 31, 2015, 133,587 There was no warrant activity for the years ended December 31, 2016. During the year ended December 31, 2017, 1,613 Warrants Weighted Average Outstanding as of December 31, 2015 16,909 $ 30.81 Outstanding as of December 31, 2016 16,909 $ 30.81 Expired (1,613) - Outstanding as of December 31, 2017 15,296 $ 30.00 The weighted average remaining contractual life of outstanding warrants at December 31, 2017 is approximately 2.7 Restricted Stock Units On December 8, 2017, the Company issued 120,000 Number of units Weighted average Unvested as of December 31, 2016 - $ - Granted 120,000 44.28 Unvested as of December 31, 2017 120,000 $ 44.28 As of December 31, 2017, the Company had unrecognized stock-based compensation expense related to all unvested restricted stock units of $ 3.0 0.6 Year Ended December 31, 2017 2016 2015 Research and development $ 5,422,731 $ 3,025,178 $ 3,257,732 General and administrative 3,178,711 1,999,334 4,618,852 Total stock-based compensation expense $ 8,601,442 $ 5,024,512 $ 7,876,584 |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2017 | |
License Arrangement [Abstract] | |
License Agreements | Note 8 - License Agreements Allergan On January 6, 2017, the Company entered into the Collaboration Agreement with Allergan to develop and commercialize select microbiome gastrointestinal programs. Pursuant to the Collaboration Agreement, the Company granted Allergan an exclusive worldwide license to certain of its intellectual property, including its intellectual property arising under the Collaboration Agreement, to develop and commercialize licensed compounds for ulcerative colitis (UC), Crohn’s disease, and irritable bowel syndrome (IBS). Under the Collaboration Agreement, Allergan and the Company will collaborate on research and development activities with respect to the licensed compounds in accordance with a mutually agreed upon research and development plan. Pursuant to the terms of the Collaboration Agreement, in connection with the closing of the transaction on February 10, 2017, Allergan paid the Company an upfront payment of $ 50 75 Allergan may terminate the Collaboration Agreement for convenience at any time upon either 90 days’ (prior to the initiation of the first POC trial of a licensed product) or 120 days’ (after the initiation of the first POC trial of a licensed product), as applicable, advance written notice to the Company. The Collaboration Agreement also contains customary provisions for termination by either party, including in the event of breach of the Collaboration Agreement, subject to cure. The Collaboration Agreement meets the definition of a collaborative arrangement and a multiple-element arrangement. The Company concluded that there were two significant deliverables under the Collaboration Agreement for each of four indicatorsthe licenses and the research and development servicesbut that the license does not have stand-alone value as Allergan cannot obtain value from the license without the research and development services, which the Company is uniquely able to perform. The deferred revenue will be amortized over a 10 50.0 5.0 45.0 12.5 4.4 4.6 2.3 |
Milestones and Research Agreeme
Milestones and Research Agreements | 12 Months Ended |
Dec. 31, 2017 | |
Milestones and Research Agreements [Abstract] | |
Milestones and Research Agreements | Note 9 - Milestones and Research Agreements HBV Research Agreement with Indiana University The Company, through its wholly-owned subsidiary, Assembly Pharmaceuticals, is party to a license agreement with Indiana University Research and Technology Corporation (IURTC) from whom it has licensed aspects of the Company’s HBV program held by IURTC. The license agreement requires the Company to make milestone payments based upon the successful accomplishment of clinical and regulatory milestones. The aggregate amount of all performance milestone payments under the IURTC license agreement, should all milestones through development be met, is $ 825,000 25,000 100,000 Microbiome Targeted Colonic Delivery Platform On November 8, 2013, the Company entered into a License and Collaboration Agreement with Therabiome, LLC (Therabiome), for all intellectual property and know-how owned or controlled by Therabiome relating to the oral delivery of pharmaceutical drugs to specific sites in the intestine, using a pH sensitive controlled release capsule-in-capsule technology. Under the agreement, Therabiome granted to the Company the exclusive worldwide license, with rights to sublicense, to develop the intellectual property for commercialization (a) in the use of bacteria, viruses, proteins and small molecules by oral delivery in (i) gastrointestinal dysbiosis, including but not limited to C. difficile For the license, the Company paid Therabiome an upfront non-refundable license fee of $ 300,000 Therabiome must pay the Company royalties on annual net sales of any product it develops, using the intellectual property, in the low double to mid-double digit percentages, depending on the level of development or involvement the Company had in the product. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 10 - Income Taxes There was no current income tax provision for the years ended December 31, 2017, 2016 and 2015. There was a deferred income tax benefit of $ 9,050,249 617,672 As of December 31, 2017 2016 Deferred tax assets: Net-operating loss carryforward $ 43,577,000 $ 59,926,000 Stock-based compensation 5,726,000 9,279,000 In-Process R&D 2,259,000 4,050,000 Deferred revenue 11,064,000 - R&D credit 5,604,000 3,962,000 Change in unrealized loss on marketable securities 46,000 178,000 Other 314,000 316,000 Total Deferred Tax Assets 68,590,000 77,711,000 Valuation allowance (63,718,000) (77,711,000) Deferred Tax Asset, Net of Allowance $ 4,872,000 $ - In-process research and development (Assembly Merger) 7,007,802 11,119,651 Net Deferred Tax Liability $ 2,135,802 $ 11,119,651 On December 22, 2017, the Tax Act, was signed into law. Among other items, the Tax Act reduces the federal corporate tax rate to 21 34 24.7 28.4 3.7 The Tax Act also permits an indefinite carry forward of net operating losses generated in taxable years ending after December 31, 2017, subject to a utilization limitation of 80% of taxable income. 4.9 9.1 8.6 The Company maintains a valuation allowance on deferred tax assets due to the uncertainty regarding the ability to utilize these deferred tax assets in the future. The deferred tax liability was recorded in connection with the acquisition of Assembly Pharmaceuticals in 2014 and relates to the difference between the carrying amount of in-process research and development for financial statement purposes relative to the amount used for income tax purposes. At December 31, 2017, the Company had potentially utilizable gross Federal net operating loss carryforwards of approximately $ 153.2 165.0 5.6 2027 2037 Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (IRC), subject the future utilization of net operating losses and certain other tax attributes to an annual limitation in the event of certain ownership changes, as defined. The Company has performed an ownership change study through December 31, 2016 and has determined that a “change in ownership” as defined by IRC Section 382 and the rules and regulations promulgated thereunder, did occur in December 2010, January 2013 and October 2014. The Company is in the process of performing an ownership change study through December 31, 2017 As of December 31, 2017 2016 2015 Statutory Federal Income Tax Rate (34.0) % (34.0) % (34.0) % State Taxes, Net of Federal Tax Benefit (2.6) % (4.3) % (11.0) % Merger Cost - % - % 0.9 % Stock based Compensation - % 3.4 % 16.7 % Credits (2.1) % (1.8) % - % Federal Rate Change 47.7 % - % - % State Rate Change 0.2 % 7.5 % - % Other 0.3 % 2.3 % 0.1 % Change in Valuation Allowance (27.0) % 25.5 % 27.3 % Income Taxes Provision (Benefit) (17.5) % (1.4) % - % |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 11 - Commitments and Contingencies Real Property Leases and Equipment Leases The Company leases office space for corporate functions in Carmel, Indiana under a lease agreement that expires in August 2023. The leased location in Carmel, Indiana supports both the HBV-cure and Microbiome programs. The Company leases office and laboratory space in San Francisco, California under a sublease that expires on December 31, 2018 unless the Company requests a six-month extension. The Company also conducted research activities for the HBV-cure program at laboratory space leased from Indiana University at Bloomington, Indiana until May 2017. The Company transferred the activities that it performed at Indiana University to its Carmel, Indiana and San Francisco, California locations. The Company also conducts research activities for the Microbiome program at office and laboratory space in Groton, Connecticut under a lease that expires in March 2019. The Company ceased leasing office and laboratory space from the University of Florida Research Foundation in Alachua, Florida in May 2017. The total real estate leasing expenses for the year ended December 31, 2017, 2016 and 2015 were approximately $ 1.3 1.2 0.7 Pursuant to a Master Lease agreement dated November 25, 2014, the Company is leasing certain laboratory equipment. The equipment lease expense for the year ended December 31, 2017, 2016 and 2015 amounted to approximately $ 758,000 705,000 107,000 2017 2021 2.9 Year Ended December 31, 2018 $ 2,974,537 Year Ended December 31, 2019 1,193,126 Year Ended December 31, 2020 827,511 Year Ended December 31, 2021 254,136 Year Ended December 31, 2022 212,625 Thereafter 106,312 $ 5,568,247 Employment Agreements The Company has employment agreements with its executive officers, which agreements set forth the terms of their employment, including severance arrangements. The Chief Executive Officer and Chief Financial Officer/Chief Operating Officer were paid an aggregate annual base salary of approximately $ 0.9 0.8 0.8 Litigation The Company is not a party to any material legal proceedings and is not aware of any claims or actions pending or threatened against it. From time to time, the Company may be subject to various legal proceedings and claims that arise in the ordinary course of its business activities. |
Selected Quarterly Financial Da
Selected Quarterly Financial Data | 12 Months Ended |
Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Financial Data | Note 12 - Selected Quarterly Financial Data (Unaudited) The following table contains quarterly financial information for fiscal years 2017 and 2016. First Quarter Second Quarter Third Quarter Fourth Quarter 2017 Collaboration revenue $ 684,369 $ 2,359,311 $ 2,659,613 $ 3,315,457 Operating expenses $ 14,614,198 $ 15,926,562 $ 15,109,793 $ 15,595,075 Interest and other income $ 136,484 $ 239,858 $ 241,326 $ 365,541 Realized loss from marketable securities $ (137,248) $ (340,984) $ (99,068) $ (37,828) Net loss $ (13,930,593) $ (13,598,864) $ (12,272,019) $ (3,007,072) Basic and diluted net loss per common share $ (0.81) $ (0.78) $ (0.71) $ (0.16) 2016 Operating expenses $ 11,277,152 $ 10,454,130 $ 11,678,925 $ 11,868,254 Interest and other income $ 490,421 $ 444,605 $ 378,381 $ 225,681 Realized loss from marketable securities $ (201,827) $ (142,675) $ (273,573) $ (521,786) Net loss $ (10,988,558) $ (10,152,200) $ (11,574,117) $ (11,546,687) Basic and diluted net loss per common share $ (0.64) $ (0.59) $ (0.67) $ (0.67) |
Summary of Significant Accoun21
Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Basis of presentation | Basis of Presentation The accompanying consolidated financial statements include the accounts of the Company and its subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. |
Segments | Segments The Company operates in one operating segment and, accordingly, no segment disclosures have been presented herein. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with the accounting principles generally accepted in the United States of America (U.S. GAAP) requires management to make estimates and assumptions that may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Significant estimates inherent in the preparation of the accompanying consolidated financial statements include recoverability and useful lives (indefinite or finite) of intangible assets, assessment of impairment of goodwill, provisions for income taxes, and the fair value of stock options and warrants granted to employees, consultants, directors, investors, licensors, placement agents and underwriters. In addition, with the Company entering into the Collaboration Agreement in 2017, the Company believes its consolidated financial statements are also impacted by the following accounting estimates and judgments: (i) identifying deliverables under collaboration agreements involving multiple elements and determining whether such deliverables are separable from other aspects of the contractual relationship; (ii) estimating the selling price of deliverables for the purpose of allocating arrangement consideration for revenue recognition; and (iii) estimating the periods over which the allocated consideration for deliverables is recognized. The Company’s estimates could be affected by external conditions, including those unique to the Company and general economic conditions. It is reasonably possible that these external factors could have an effect on the Company’s estimates and could cause actual results to differ from those estimates and assumptions. |
Cash and cash equivalents | Cash and cash equivalents All highly liquid investments with maturities of three months or less at the time of purchase are considered to be cash equivalents. All of the Company’s cash equivalents have liquid markets and high credit ratings. The Company maintains its cash in bank deposits and other accounts, the balances of which, at times and at December 31, 2017 and 2016, exceed federally insured limits. |
Marketable Securities | Marketable Securities The Company has designated marketable securities as of December 31, 2017 and 2016 as available-for-sale securities and measures these securities at their respective fair values. Marketable securities are classified as short-term or long-term based on the maturity date and their availability to meet current operating requirements. Marketable securities that mature in one year or less are classified as short-term available-for-sale securities and are reported as a component of current assets. Marketable securities that are not considered available for use in current operations are classified as long-term available-for-sale securities and are reported as a component of long-term assets. Securities that are classified as available-for-sale are measured at fair value with temporary unrealized gains and losses reported in other comprehensive loss, and as a component of stockholders' equity until their disposition. The Company reviews all available-for-sale securities at each period end to determine if they remain available-for-sale based on their current intent and ability to sell the security if it is required to do so. The cost of securities sold is based on the specific identification method. Marketable securities are subject to a periodic impairment review. The Company may recognize an impairment charge when a decline in the fair value of investments below the cost basis is determined to be other-than-temporary. There were no marketable securities deemed to be impaired as of December 31, 2017 or 2016. |
Accounts Receivable | Accounts Receivable As of December 31, 2017, the accounts receivable relates to the Company's collaboration with Allergan. All accounts receivable are deemed collectible. There were no accounts receivable as of December 31, 2016. |
Goodwill and Other Intangible Assets | Goodwill and Other Intangible Assets Goodwill is the excess of purchase price over the fair value of identified net assets of businesses acquired. The Company’s intangible assets with an indefinite life are related to in-process research and development (IPR&D) programs acquired in the Merger, as the Company expects future research and development on these programs to provide the Company with substantial benefit for a period that extends beyond the foreseeable horizon. Intangible assets with indefinite useful lives are measured at their respective fair values as of the acquisition date. The Company does not amortize goodwill and intangible assets with indefinite useful lives. Intangible assets related to IPR&D projects are considered to be indefinite lived until the completion or abandonment of the associated R&D efforts. If and when development is complete, which generally occurs if and when regulatory approval to market a product is obtained, the associated assets would be deemed finite lived and would then be amortized based on their respective estimated useful lives at that point in time. The Company reviews goodwill and indefinite-lived intangible assets at least annually for possible impairment. Goodwill and indefinite-lived intangible assets are reviewed for possible impairment between annual tests if an event occurs or circumstances change that would more likely than not reduce the fair value of the reporting unit or the indefinite-lived intangible assets below their carrying values. The Company tests its goodwill and indefinite-lived intangible assets each year on October 1. The Company has one reporting unit. The Company tests goodwill for impairment by utilizing a market capitalization approach which was based upon the closing price of the Company’s stock price as of the beginning of the 4 th On October 1, 2017, the Company elected to bypass the qualitative assessment and performed a quantitative impairment test. On October 1, 2016, the Company performed a qualitative assessment of IPR&D. Significant assumptions used in the model include the period in which material net cash inflows are expected to commence, anticipated material changes from historical pricing, margins and expense levels and an appropriate risk adjusted discount rate applied to the estimated cash flows. As of October 1, 2017 and 2016, IPR&D was not deemed to be impaired. |
Impairment of Long-lived Assets | Impairment of Long-lived Assets The Company monitors the carrying value of long-lived assets for potential impairment and tests the recoverability of such assets whenever events or changes in circumstances indicate that the carrying amounts may not be recoverable. If a change in circumstance occurs, the Company performs a test of recoverability by comparing the carrying value of the asset or asset group to its undiscounted expected future cash flows. If cash flows cannot be separately and independently identified for a single asset, the Company will determine whether impairment has occurred for the group of assets for which the Company can identify the projected cash flows. If the carrying values are in excess of undiscounted expected future cash flows, the Company measures any impairment by comparing the fair value of the asset or asset group to its carrying value. There were no indicators of impairment of long-lived assets during the year ended December 31, 2017 and 2016. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost and consist of lab equipment and computer hardware and software. The Company computes depreciation under the straight-line method over the following estimated useful life of the related assets: • Lab equipment 3 5 • Computer hardware and software 3 • Office equipment 7 Leasehold improvements are amortized over the remaining terms of the respective leases or the estimated useful life of the leasehold improvements, whichever is less. Maintenance and repair costs are expensed as incurred. |
Fair Value Measurements | Fair Value Measurements The Company follows accounting guidance on fair value measurements for financial instruments measured on a recurring basis, as well as for certain assets and liabilities that are initially recorded at their estimated fair values. Fair value is defined as the exit price, or the amount that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The Company use the following three-level hierarchy that maximizes the use of observable inputs and minimizes the use of unobservable inputs to value its financial instruments: Level 1: Observable inputs such as unadjusted quoted prices in active markets for identical instruments. Level 2: Quoted prices for similar instruments that are directly or indirectly observable in the marketplace. Level 3: Significant unobservable inputs which are supported by little or no market activity and that are financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. Financial instruments measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The assessment of the significance of a particular input to the fair value measurement in its entirety requires us to make judgments and consider factors specific to the asset or liability. The use of different assumptions and/or estimation methodologies may have a material effect on estimated fair values. Accordingly, the fair value estimates disclosed or initial amounts recorded may not be indicative of the amount that the Company or holders of the instruments could realize in a current market exchange. The carrying amounts of cash equivalents and marketable securities approximate their fair value based upon quoted market prices. Certain of the Company’s financial instruments are not measured at fair value on a recurring basis, but are recorded at amounts that approximate their fair value due to their liquid or short-term nature, such as cash, accounts receivable, accounts payable and accrued expenses. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue when each of the following four criteria is met: (i) persuasive evidence of an arrangement exists; (ii) products are delivered or services are rendered; (iii) the sales price is fixed or determinable; and (iv) collectability is reasonably assured. The Company recognizes revenue under the Collaboration Agreement based on the relevant accounting literature. Under this guidance, multiple elements or deliverables may include (i) grants of licenses, or options to obtain licenses, to intellectual property, (ii) research and development services, (iii) participation on joint research and/or joint development committees, and/or (iv) manufacturing or supply of services. The payments entities may receive under these arrangements typically include one or more of the following: non-refundable, upfront license fees; option exercise fees; funding of research and/or development efforts; amounts due upon the achievement of specified objectives; and/or royalties on future product sales. Multiple-element arrangements require the separability of deliverables included in an arrangement into different units of accounting and the allocation of arrangement consideration to the units of accounting. The evaluation of multiple-element arrangements requires management to make judgments about (i) the identification of deliverables, (ii) whether such deliverables are separable from the other aspects of the contractual relationship, (iii) the estimated selling price of each deliverable, and (iv) the expected period of performance for each deliverable. To determine the units of accounting under a multiple-element arrangement, management evaluates certain separation criteria, including whether the deliverables have stand-alone value, based on the relevant facts and circumstances for each arrangement. Management then estimates the selling price for each unit of accounting and allocates the arrangement consideration to each unit using the relative selling price method. The relative selling price for each deliverable is determined using vendor specific objective evidence (VSOE), of selling price or third-party evidence of selling price if VSOE does not exist. If neither VSOE nor third-party evidence of selling price exists, we use our best estimate of the selling price for the deliverable. The allocated consideration for each unit of accounting is recognized based on the method most appropriate for that unit of accounting and in accordance with the revenue recognition criteria detailed above. If there are deliverables in an arrangement that are not separable from other aspects of the contractual relationship, they are treated as a combined unit of accounting, with the allocated revenue for the combined unit recognized in a manner consistent with the revenue recognition applicable to the final deliverable in the combined unit. Payments received prior to satisfying the relevant revenue recognition criteria are recorded as deferred revenue in the accompanying consolidated balance sheets and recognized as revenue when the related revenue recognition criteria are met. The Collaboration Agreement provides for non-refundable milestone payments. The Company recognizes revenue that is contingent upon the achievement of a substantive milestone in its entirety in the period in which the milestone is achieved. A milestone is considered substantive when the consideration payable to the Company for such milestone (i) is consistent with the Company’s performance necessary to achieve the milestone or the increase in value to the collaboration resulting from the Company’s performance, (ii) relates solely to the Company’s past performance and (iii) is reasonable relative to all of the other deliverables and payments within the arrangement. In making this assessment, the Company considers all facts and circumstances relevant to the arrangement, including factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the milestone, the level of effort and investment required to achieve the milestone and whether any portion of the milestone consideration is related to future performance or deliverables. The Collaboration Agreement provides Allergan with options to license additional intellectual property rights, or purchase additional research, development, or supply services. The Company concluded that these were "substantive options" under the multiple-element arrangement guidance, and accordingly, associated fees have not been considered in allocating contract consideration among deliverables with stand-alone value. If Allergan exercises one or more of these options, the associated revenue would be recognized using the method most appropriate for the particular deliverable. The Company will periodically review the estimated performance periods under the Collaboration Agreement, which provides for non-refundable upfront payments and fees. The Company will adjust the periods over which revenue should be recognized when appropriate to reflect changes in assumptions relating to the estimated performance periods. The Company could accelerate revenue recognition in the event of early termination of programs or if the Company’s expectations change. Alternatively, the Company could decelerate revenue recognition if programs are extended or delayed. While such changes to the Company’s estimates have no impact on the Company’s consolidated cash flows, the amount of revenue recorded in future periods could be materially impacted. The Company records revenues related to the reimbursement of costs incurred under the Collaboration Agreement where the Company acts as a principal, controls the research and development activities and bears credit risk. Under the Collaboration Agreement, the Company is reimbursed for associated out-of-pocket costs. The gross amount of these pass-through reimbursed costs is reported as revenue in the accompanying consolidated statements of operations, while the actual expenses for which the Company is reimbursed are reflected as research and development costs. The Company has also accounted for the milestone payments under Accounting Standards Codification (ASC) , Revenue Recognition - Milestone Method |
Stock-based Compensation | Stock-Based Compensation The Company expenses stock-based compensation to employees and Board members over the requisite service period based on the estimated grant-date fair value of the awards. Stock-based awards with graded-vesting schedules are recognized on a straight-line basis over the requisite service period for each separately vesting portion of the award. For stock-based compensation awards to non-employees, the Company remeasures the fair value of the non-employee awards at each reporting period prior to vesting and finally at the vesting date of the award. Changes in the estimated fair value of these non-employee awards are recognized as compensation expense in the period of change. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model and the assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. The fair value of restricted stock units is determined based on the number of shares granted and the quoted market price of the Company's common stock on the date of grant. The fair value of restricted stock units with performance conditions deemed probable of being achieved and vesting are amortized to expense over the requisite service period using the straight-line method of expense recognition. Effective on January 1, 2017, the Company elected to account for forfeited awards as they occur as permitted by Accounting Standards Update ("ASU") 2016-09. Ultimately, the actual expenses recognized over the vesting period will be for those shares that vested. Prior to making this election, the Company estimated a forfeiture rate for awards at 0 |
Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred. Research and development costs include salaries and personnel-related costs, consulting fees, fees paid for contract research services, fees paid to clinical research organizations and other third parties associated with clinical trials, the costs of laboratory equipment and facilities, and other external costs. |
Tax Assets and Liabilities and Income Taxes | Tax Assets and Liabilities and Income Taxes The Company records income taxes using the asset and liability method. Deferred income tax assets and liabilities are recognized for the future tax effects attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective income tax bases, and operating loss and tax credit carryforwards. The Company establishes a valuation allowance if it is more likely than not that the deferred tax assets will not be recovered based on an evaluation of objective verifiable evidence. For tax positions that are more likely than not of being sustained upon audit, the Company recognizes the largest amount of the benefit that is greater than 50% likely of being realized. For tax positions that are not more likely than not of being sustained upon audit, the Company does not recognize any portion of the benefit. The Financial Accounting Standards Board (“FASB”) ASC Topic 740, Income Taxes The Company’s policy for recording interest and penalties associated with audits is to record such expense as a component of income tax expense. There were no amounts accrued for penalties or interest On December 22, 2017, legislation commonly known as the Tax Cuts and Jobs Act, or the Tax Act, was signed in to law. The legislation significantly changes U.S. tax law by, among other things, lowering corporate income tax rates, implementing a territorial tax system and imposing a repatriation tax on deemed repatriated earnings of foreign subsidiaries. The Tax Act permanently reduces the U.S. corporate income tax rate to 21% from the existing applicable rate of 34 24.7 28.4 3.7 On December 22, 2017, the SEC staff issued Staff Accounting Bulletin No. 118 ("SAB 118") to address the application of GAAP in situations when a registrant does not have the necessary information available, prepared, or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the Tax Reform Act. The Company has recognized the provisional tax impacts related to the revaluation of deferred tax assets and liabilities and included these amounts in its consolidated financial statements for the year ended December 31, 2017. The ultimate impact may differ from these provisional amounts, possibly materially, due to, among other things, additional analysis, changes in interpretations and assumptions the Company has made, additional regulatory guidance that may be issued, and actions the Company may take as a result of the Tax Act. The accounting is expected to be complete when the 2017 U.S. corporate income tax return is filed in 2018. |
Net Loss per Share of Common Stock | Net Loss per Share of Common Stock Basic net loss per common share excludes dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per common share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity unless inclusion of such shares would be anti-dilutive. Since the Company has only incurred losses, basic and diluted net loss per share is the same. Year Ended December 31, 2017 2016 2015 Warrants to purchase common stock 15,296 16,909 16,909 Options to purchase common stock 4,551,819 4,457,251 3,367,784 Restricted stock units to purchase common stock 120,000 - - Total 4,687,115 4,474,160 3,384,693 |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is comprised of net loss and adjustments for the change in unrealized gains and losses on investments in available-for-sale marketable securities. The Company displays comprehensive loss and its components in the consolidated statements of operations and comprehensive loss. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments which potentially subject the Company to credit risk consist primarily of cash, cash equivalents and marketable securities. The Company holds these investments in highly rated financial institutions, and, by policy, limits the amounts of credit exposure to any one financial institution. These amounts at times may exceed federally insured limits. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to any significant credit risk on these funds. The Company has no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts or other hedging arrangements. |
Recent Accounting Pronouncements | Adoption of Recent Accounting Pronouncements In March 2016, the FASB issued ASU 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting In January 2017, the FASB issued ASU 2017-04, Intangibles - Goodwill and Other (Topic 350) Accounting Pronouncements to Be Adopted In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606), Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date 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. In January 2016, the FASB issued ASU 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows - Classification of Certain Cash Receipts and Cash Payments, In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) Leases (Topic 840) Leases (Topic 842) Land Easement Practical Expedient for Transition to Topic 842 In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments In February 2018, the FASB issued ASU 2018-02, Income Statement - Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income, is effective for fiscal years, including interim periods within those fiscal years, beginning after December 15, 2018 with early adoption in any interim period permitted. |
Summary of Significant Accoun22
Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Property, Plant and Equipment Estimated Useful Life | ⋅ Lab equipment 3 5 ⋅ Computer hardware and software 3 ⋅ Office equipment 7 |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | Securities that could potentially dilute loss per share in the future that were not included in the computation of diluted loss per share at December 31, 2017, 2016 and 2015 are as follows: Year Ended December 31, 2017 2016 2015 Warrants to purchase common stock 15,296 16,909 16,909 Options to purchase common stock 4,551,819 4,457,251 3,367,784 Restricted stock units to purchase common stock 120,000 - - Total 4,687,115 4,474,160 3,384,693 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Available-for-sale Securities Reconciliation | December 31, 2017 Amortized Cost Gross Unrealized (1) Gross Unrealized (1) Fair Value Short-term available-for-sale securities Corporate bonds $ 38,092,585 $ 5,635 $ (183,738) $ 37,914,482 Long-term available-for-sale securities Corporate bonds 3,357,778 - (10,565) 3,347,213 Total $ 41,450,363 $ 5,635 $ (194,303) $ 41,261,695 December 31, 2016 Amortized Cost Gross Unrealized (1) Gross Unrealized (1) Fair Value Short-term available-for-sale securities Corporate bonds $ 22,032,191 $ 3,190 $ (473,056) $ 21,562,325 Government and agency obligations 1,225,000 661 - 1,225,661 Municipal bonds 1,596,160 4,257 - 1,600,417 24,853,351 8,108 (473,056) 24,388,403 Long-term available-for-sale securities Corporate bonds 2,434,251 1,502 - 2,435,753 2,434,251 1,502 - 2,435,753 Total $ 27,287,602 $ 9,610 $ (473,056) $ 26,824,156 (1) |
Schedule Of Available For Sale Securities Fair Value Measurement Categories | The fair value of marketable securities was classified into fair value measurement categories as follows: As of December 31, 2017 2016 Quoted prices in active markets for identical assets (Level 1) $ - $ - Quoted prices for similar assets observable in the marketplace (Level 2) 41,261,695 26,824,156 Significant unobservable inputs (Level 3) - - Total $ 41,261,695 $ 26,824,156 |
Available-for-sale Securities, Continuous Unrealized Loss Position, Fair Value | The following table shows the Company’s investments’ gross unrealized losses (pre-tax) and fair value, aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position, at December 31, 2017. Less than 12 Months 12 Months or More Total Fair Value Unrealized Losses Fair Value Unrealized Losses Fair Value Unrealized Losses Corporate bonds $ 36,825,138 $ (194,303) $ - $ - $ 36,825,138 $ (194,303) Total $ 36,825,138 $ (194,303) $ - $ - $ 36,825,138 $ (194,303) |
Property, Plant and Equipment24
Property, Plant and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Property, plant and equipment, consists of the following: As of December 31, Useful life (Years) 2017 2016 Computer hardware and software 3 $ 104,968 $ 86,228 Lab equipment 3 to 5 369,827 253,735 Office equipment 7 25,354 1,109 Leasehold improvement 1 to 3.25 773,700 68,213 Total property, plant and equipment 1,273,849 409,285 Less: Accumulated depreciation and amortization (413,823) (194,598) Property, plant and equipment, net $ 860,026 $ 214,687 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Payables and Accruals [Abstract] | |
Schedule Accrued Expenses | Accrued expenses consist of the following: As of December 31, 2017 2016 Accrued expenses: Salaries, bonuses and employee benefits $ 4,518,128 $ 2,884,000 Accrued severance expenses - 241,737 Research and development expenses 674,686 916,674 General and administrative expenses 946,186 710,412 Total accrued expenses $ 6,139,000 $ 4,752,823 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure of Share-based Compensation Arrangements by Share-based Payment Award | A summary of the Company’s option activity and related information for the years ended December 31, 2017, 2016 and 2015 is as follows: Number of Shares Weighted Average Total Intrinsic Outstanding as of December 31, 2015 3,367,784 $ 7.16 $ 3,971,205 Granted 1,196,500 $ 7.46 $ 5,676,405 Exercised (21,200) $ 7.20 - Forfeited (85,833) $ 12.18 - Outstanding as of December 31, 2016 4,457,251 $ 7.14 $ 23,258,604 Granted 706,800 $ 24.16 $ 15,792,854 Exercised (353,612) $ 7.03 - Forfeited (258,620) $ 9.51 - Outstanding as of December 31, 2017 4,551,819 $ 9.66 $ 162,002,439 Options vested and exercisable 3,128,885 $ 6.80 $ 120,316,959 |
Assumptions for Weighted Average Fair Value of Options Granted | The Company expects that all outstanding unvested options will vest. The fair value of the options granted for the year ended December 31, 2017, 2016 and 2015, was based on the following assumptions: Year Ended December 31, 2017 2016 2015 Exercise price $12.81 - $44.28 $5.84 - $13.21 $7.88 - $16.55 Expected stock price volatility 81.2% - 87.0% 85.8% - 91.8% 88.62% - 95.55% Risk-free rate of interest 2.02% - 2.29% 1.36% - 2.18% 1.49% - 2.27% Term (years) 5.5 - 7.0 5.3 - 7.0 5.0 - 8.2 |
Estimated Future Stock Based Expenses Relating to Unvested Stock Options | Estimated future stock-based compensation expense relating to unvested stock options is as follows: Future Stock Year Ended December 31, 2018 $ 5,755,478 Year Ended December 31, 2019 1,760,834 Year Ended December 31, 2020 634,516 Year Ended December 31, 2021 54,968 Total $ 8,205,796 |
Schedule of Restricted Stock Number of units | A summary of the Company's restricted stock units and related information is as follows: Number of units Weighted average Unvested as of December 31, 2016 - $ - Granted 120,000 44.28 Unvested as of December 31, 2017 120,000 $ 44.28 |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs | Stock-based compensation expenses for the years ended December 31, 2017, 2016 and 2015 were as follows: Year Ended December 31, 2017 2016 2015 Research and development $ 5,422,731 $ 3,025,178 $ 3,257,732 General and administrative 3,178,711 1,999,334 4,618,852 Total stock-based compensation expense $ 8,601,442 $ 5,024,512 $ 7,876,584 |
Warrant [Member] | |
Disclosure of Share-based Compensation Arrangements by Share-based Payment Award | A summary of the Company’s warrant activity and related information is as follows: Warrants Weighted Average Outstanding as of December 31, 2015 16,909 $ 30.81 Outstanding as of December 31, 2016 16,909 $ 30.81 Expired (1,613) - Outstanding as of December 31, 2017 15,296 $ 30.00 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Schedule of Deferred Tax Assets and Liabilities | The Company’s deferred tax assets as of December 31, 2017 and 2016 consist of the following: As of December 31, 2017 2016 Deferred tax assets: Net-operating loss carryforward $ 43,577,000 $ 59,926,000 Stock-based compensation 5,726,000 9,279,000 In-Process R&D 2,259,000 4,050,000 Deferred revenue 11,064,000 - R&D credit 5,604,000 3,962,000 Change in unrealized loss on marketable securities 46,000 178,000 Other 314,000 316,000 Total Deferred Tax Assets 68,590,000 77,711,000 Valuation allowance (63,718,000) (77,711,000) Deferred Tax Asset, Net of Allowance $ 4,872,000 $ - In-process research and development (Assembly Merger) 7,007,802 11,119,651 Net Deferred Tax Liability $ 2,135,802 $ 11,119,651 |
Federal Income Tax Note | The following is a reconciliation of the U.S. federal statutory rate to the effective income tax rates for the year ended December 31, 2017, 2016 and 2015: As of December 31, 2017 2016 2015 Statutory Federal Income Tax Rate (34.0) % (34.0) % (34.0) % State Taxes, Net of Federal Tax Benefit (2.6) % (4.3) % (11.0) % Merger Cost - % - % 0.9 % Stock based Compensation - % 3.4 % 16.7 % Credits (2.1) % (1.8) % - % Federal Rate Change 47.7 % - % - % State Rate Change 0.2 % 7.5 % - % Other 0.3 % 2.3 % 0.1 % Change in Valuation Allowance (27.0) % 25.5 % 27.3 % Income Taxes Provision (Benefit) (17.5) % (1.4) % - % |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Rental Payments for Operating Leases | Future minimum rental payments for real estate and equipment required as of December 31, 2017 are as follows: Year Ended December 31, 2018 $ 2,974,537 Year Ended December 31, 2019 1,193,126 Year Ended December 31, 2020 827,511 Year Ended December 31, 2021 254,136 Year Ended December 31, 2022 212,625 Thereafter 106,312 $ 5,568,247 |
Selected Quarterly Financial 29
Selected Quarterly Financial Data (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Information | First Quarter Second Quarter Third Quarter Fourth Quarter 2017 Collaboration revenue $ 684,369 $ 2,359,311 $ 2,659,613 $ 3,315,457 Operating expenses $ 14,614,198 $ 15,926,562 $ 15,109,793 $ 15,595,075 Interest and other income $ 136,484 $ 239,858 $ 241,326 $ 365,541 Realized loss from marketable securities $ (137,248) $ (340,984) $ (99,068) $ (37,828) Net loss $ (13,930,593) $ (13,598,864) $ (12,272,019) $ (3,007,072) Basic and diluted net loss per common share $ (0.81) $ (0.78) $ (0.71) $ (0.16) 2016 Operating expenses $ 11,277,152 $ 10,454,130 $ 11,678,925 $ 11,868,254 Interest and other income $ 490,421 $ 444,605 $ 378,381 $ 225,681 Realized loss from marketable securities $ (201,827) $ (142,675) $ (273,573) $ (521,786) Net loss $ (10,988,558) $ (10,152,200) $ (11,574,117) $ (11,546,687) Basic and diluted net loss per common share $ (0.64) $ (0.59) $ (0.67) $ (0.67) |
Nature of Business - Additional
Nature of Business - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | Feb. 10, 2017 | Nov. 02, 2017 | Nov. 01, 2017 | Dec. 31, 2017 |
Overview [Line Items] | ||||
Licenses Revenue | $ 50 | $ 50 | ||
Development Milestone Payments | 630 | |||
Commercial Milestone Payments | 2,150 | |||
Revenue Recognition, Milestone Method, Description | the Company is eligible to receive up to approximately $630 million in payments related to seven development milestones and up to approximately $2.15 billion in payments related to 12 commercial development and sales milestones in connection with the successful development and commercialization of licensed compounds for up to six different indications | |||
Allergan Pharmaceuticals International Limited [Member] | ||||
Overview [Line Items] | ||||
Agreed To Share Maximum Amount Development Cost | $ 75 | |||
Revenue Recognition, Milestone Method, Description | the Company is eligible to receive up to approximately $630 million in payments related to seven development milestones and up to approximately $2.15 billion in payments related to 12 commercial development and sales milestones in connection with the successful development and commercialization of licensed compounds for up to six different indications | |||
Common Stock [Member] | ||||
Overview [Line Items] | ||||
Stock Issued During Period, Shares, New Issues | 331,500 | 2,210,000 | ||
Shares Issued, Price Per Share | $ 27.25 | |||
Proceeds from Issuance of Common Stock | $ 64.8 |
Summary of Significant Accoun31
Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Details) | 12 Months Ended |
Dec. 31, 2017 | |
Lab equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment, Useful Life | 3 years |
Lab equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment, Useful Life | 5 years |
Computer hardware and software [Member] | |
Property, Plant and Equipment, Useful Life | 3 years |
Office equipment [Member] | |
Property, Plant and Equipment, Useful Life | 7 years |
Summary of Significant Accoun32
Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Details 1) - shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 4,687,115 | 4,474,160 | 3,384,693 |
Warrants To Purchase Common Stock [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 15,296 | 16,909 | 16,909 |
Options To Purchase Common Stock [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 4,551,819 | 4,457,251 | 3,367,784 |
Restricted stock units to purchase common stock [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 120,000 | 0 | 0 |
Summary of Significant Accoun33
Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Additional Information (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 34.00% | 34.00% | 34.00% | |
Accounts Receivable, Net, Current | $ 2,273,421 | $ 0 | ||
Income Tax Examination, Penalties Accrued | 0 | $ 0 | ||
Increase (Decrease) in Deferred Income Taxes | 24,700,000 | |||
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | 28,400,000 | |||
Increase (Decrease) in Income Taxes | $ 3,700,000 | |||
Share Based Compensation Arrangement By Share Based Payment Award Forfeiture Rate | 0.00% | |||
Deferred Tax Assets, Net of Valuation Allowance, Current | $ 4,900,000 | |||
Operating Loss Carryforwards, Limitations on Use | The TaxActalso permits an indefinite carry forward of net operating losses generated in taxable years ending after December 31, 2017, subject to a utilization limitation of 80% of taxable income. | |||
Scenario, Plan [Member] | ||||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 34.00% |
Marketable Securities (Details)
Marketable Securities (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 | |
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | $ 41,450,363 | $ 27,287,602 | |
Gross Unrealized Gain | [1] | 5,635 | 9,610 |
Gross Unrealized Loss | [1] | (194,303) | (473,056) |
Fair Value | 41,261,695 | 26,824,156 | |
Short-term Investments [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 24,853,351 | ||
Gross Unrealized Gain | [1] | 8,108 | |
Gross Unrealized Loss | [1] | (473,056) | |
Fair Value | 24,388,403 | ||
Short-term Investments [Member] | Corporate Bond Securities [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 38,092,585 | 22,032,191 | |
Gross Unrealized Gain | [1] | 5,635 | 3,190 |
Gross Unrealized Loss | [1] | (183,738) | (473,056) |
Fair Value | 37,914,482 | 21,562,325 | |
Short-term Investments [Member] | US Government Agencies Debt Securities [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 1,225,000 | ||
Gross Unrealized Gain | [1] | 661 | |
Gross Unrealized Loss | [1] | 0 | |
Fair Value | 1,225,661 | ||
Short-term Investments [Member] | Municipal Bonds [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 1,596,160 | ||
Gross Unrealized Gain | [1] | 4,257 | |
Gross Unrealized Loss | [1] | 0 | |
Fair Value | 1,600,417 | ||
Long-term Investments [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 2,434,251 | ||
Gross Unrealized Gain | [1] | 1,502 | |
Gross Unrealized Loss | [1] | 0 | |
Fair Value | 2,435,753 | ||
Long-term Investments [Member] | Corporate Bond Securities [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 3,357,778 | 2,434,251 | |
Gross Unrealized Gain | [1] | 0 | 1,502 |
Gross Unrealized Loss | [1] | (10,565) | 0 |
Fair Value | $ 3,347,213 | $ 2,435,753 | |
[1] | Gross unrealized gain (loss) is pre-tax. |
Marketable Securities (Details
Marketable Securities (Details 1) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Schedule of Available-for-sale Securities [Line Items] | ||
Available-for-sale Securities | $ 41,261,695 | $ 26,824,156 |
Fair Value, Inputs, Level 1 [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Available-for-sale Securities | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Available-for-sale Securities | 41,261,695 | 26,824,156 |
Fair Value, Inputs, Level 3 [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Available-for-sale Securities | $ 0 | $ 0 |
Marketable Securities (Detail36
Marketable Securities (Details 2) | Dec. 31, 2017USD ($) |
Schedule of Available-for-sale Securities [Line Items] | |
Fair Value, Less than 12 Months | $ 36,825,138 |
Unrealized Losses, Less than 12 Months | (194,303) |
Fair Value, 12 Months or More | 0 |
Unrealized Losses,12 Months or More | 0 |
Fair Value, Total | 36,825,138 |
Unrealized Losses, Total | (194,303) |
Corporate Bond Securities [Member] | |
Schedule of Available-for-sale Securities [Line Items] | |
Fair Value, Less than 12 Months | 36,825,138 |
Unrealized Losses, Less than 12 Months | (194,303) |
Fair Value, 12 Months or More | 0 |
Unrealized Losses,12 Months or More | 0 |
Fair Value, Total | 36,825,138 |
Unrealized Losses, Total | $ (194,303) |
Marketable Securities - Additio
Marketable Securities - Additional Information (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Proceeds from Sale of Available-for-sale Securities | $ 33,500,000 | $ 44,300,000 | $ 5,000,000 | ||||||||
Marketable Securities, Realized Gain (Loss), Total | $ (37,828) | $ (99,068) | $ (340,984) | $ (137,248) | $ (521,786) | $ (273,573) | $ (142,675) | $ (201,827) | $ (615,128) | $ (1,139,861) | $ (27,033) |
Short-term Investments [Member] | |||||||||||
Available For Sale Securities Maturity Term | less than one year | ||||||||||
Other Long-term Investments [Member] | |||||||||||
Available For Sale Securities Maturity Term | 1.1 to 1.2 years |
Goodwill and Intangible Assets
Goodwill and Intangible Assets - Additional Information (Details) - USD ($) | 1 Months Ended | |
Jul. 11, 2014 | Dec. 31, 2017 | |
Business Combination, Consideration Transferred | $ 29,823,096 | |
Allocation of goodwill | $ 12,638,136 | |
Business Acquisition, Goodwill, Expected Tax Deductible Amount | $ 0 |
Property, Plant and Equipment39
Property, Plant and Equipment, Net (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment | $ 1,273,849 | $ 409,285 |
Less: Accumulated depreciation and amortization | (413,823) | (194,598) |
Property, plant and equipment, net | 860,026 | 214,687 |
Computer hardware and software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment | $ 104,968 | 86,228 |
Property, Plant and Equipment, Useful Life | 3 years | |
Lab equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment | $ 369,827 | 253,735 |
Lab equipment [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Useful Life | 3 years | |
Lab equipment [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Useful Life | 5 years | |
Office equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment | $ 25,354 | 1,109 |
Property, Plant and Equipment, Useful Life | 7 years | |
Leasehold improvement [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant and equipment | $ 773,700 | $ 68,213 |
Leasehold improvement [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Useful Life | 1 year | |
Leasehold improvement [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Useful Life | 3 years 3 months |
Property, Plant and Equipment40
Property, Plant and Equipment, Net - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Property, Plant and Equipment [Line Items] | |||
Depreciation | $ 219,225 | $ 80,251 | $ 64,989 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Accrued expenses: | ||
Salaries, bonuses and employee benefits | $ 4,518,128 | $ 2,884,000 |
Accrued severance expenses | 0 | 241,737 |
Research and development expenses | 674,686 | 916,674 |
General and administrative expenses | 946,186 | 710,412 |
Total accrued expenses | $ 6,139,000 | $ 4,752,823 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - Stock Option [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Number of Shares | ||
Option, Outstanding at beginning of period | 4,457,251 | 3,367,784 |
Option, Granted | 706,800 | 1,196,500 |
Option, Exercised | (353,612) | (21,200) |
Option, Forfeited | (258,620) | (85,833) |
Option, Outstanding at end of period | 4,551,819 | 4,457,251 |
Options vested and exercisable | 3,128,885 | |
Weighted Average Exercise Price | ||
Option, Outstanding at beginning of period | $ 7.14 | $ 7.16 |
Option, Granted | 24.16 | 7.46 |
Option, Exercised | 7.03 | 7.2 |
Option, Forfeited | 9.51 | 12.18 |
Option, Outstanding at end of period | 9.66 | $ 7.14 |
Options vested and exercisable | $ 6.8 | |
Total Intrinsic Value | ||
Option, Outstanding at beginning of period | $ 23,258,604 | $ 3,971,205 |
Option, Granted | 15,792,854 | 5,676,405 |
Option, Exercised | 0 | 0 |
Option, Forfeited | 0 | 0 |
Option, Outstanding at end of period | 162,002,439 | $ 23,258,604 |
Options vested and exercisable | $ 120,316,959 |
Stockholders' Equity (Details 1
Stockholders' Equity (Details 1) - $ / shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Maximum [Member] | |||
Share based Compensation Arrangement by Share based Payment Award, Fair Value Assumptions, Method Used [Line Items] | |||
Exercise price | $ 44.28 | $ 13.21 | $ 16.55 |
Expected stock price volatility | 87.00% | 91.80% | 95.55% |
Risk-free rate of interest | 2.29% | 2.18% | 2.27% |
Term (years) | 7 years | 7 years | 8 years 2 months 12 days |
Minimum [Member] | |||
Share based Compensation Arrangement by Share based Payment Award, Fair Value Assumptions, Method Used [Line Items] | |||
Exercise price | $ 12.81 | $ 5.84 | $ 7.88 |
Expected stock price volatility | 81.20% | 85.80% | 88.62% |
Risk-free rate of interest | 2.02% | 1.36% | 1.49% |
Term (years) | 5 years 6 months | 5 years 3 months 18 days | 5 years |
Stockholders' Equity (Details 2
Stockholders' Equity (Details 2) | Dec. 31, 2017USD ($) |
Stockholders Equity Note [Line Items] | |
Year Ended December 31, 2018 | $ 5,755,478 |
Year Ended December 31, 2019 | 1,760,834 |
Year Ended December 31, 2020 | 634,516 |
Year Ended December 31, 2021 | 54,968 |
Total | $ 8,205,796 |
Stockholders' Equity (Details 3
Stockholders' Equity (Details 3) - $ / shares | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Warrants | ||
Warrants, Expired | ||
Weighted Average Exercise Price | ||
Warrants, Expired | ||
Warrant [Member] | ||
Warrants | ||
Beginning of period | 16,909 | 16,909 |
Warrants, Expired | (1,613) | |
Ending of period | 15,296 | 16,909 |
Weighted Average Exercise Price | ||
Beginning of period | $ 30.81 | $ 30.81 |
Warrants, Expired | 0 | |
Ending of period | $ 30 | $ 30.81 |
Stockholders' Equity (Details 4
Stockholders' Equity (Details 4) - Restricted Stock Units (RSUs) [Member] | 12 Months Ended |
Dec. 31, 2017$ / sharesshares | |
Beginning of period | shares | 0 |
Number of units, Granted | shares | 120,000 |
Ending of period | shares | 120,000 |
Beginning of period | $ / shares | $ 0 |
Weighted average grant price, Granted | $ / shares | 44.28 |
Ending of period | $ / shares | $ 44.28 |
Stockholders' Equity (Details 5
Stockholders' Equity (Details 5) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Allocated Share-based Compensation Expense | $ 8,601,442 | $ 5,024,512 | $ 7,876,584 |
Research and Development [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Allocated Share-based Compensation Expense | 5,422,731 | 3,025,178 | 3,257,732 |
General and Administrative [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Allocated Share-based Compensation Expense | $ 3,178,711 | $ 1,999,334 | $ 4,618,852 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) | Nov. 01, 2017 | Apr. 06, 2015 | Dec. 08, 2017 | Nov. 02, 2017 | Nov. 01, 2017 | Jun. 29, 2016 | Apr. 17, 2015 | Mar. 19, 2015 | May 19, 2011 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 29, 2017 | Nov. 06, 2017 | Apr. 03, 2017 | Jun. 02, 2016 | Dec. 30, 2015 |
Stockholders Equity Note [Line Items] | |||||||||||||||||
Common Stock, Capital Shares Reserved for Future Issuance | 800,000 | ||||||||||||||||
Issuance of Stock and Warrants for Services or Claims | $ 0 | ||||||||||||||||
Proceeds From Issuance Initial Public Offering | $ 64,847,354 | $ 0 | $ 81,014,989 | ||||||||||||||
Initial Public Offering Value Of Shares Authorized | $ 250,000,000 | $ 150,000,000 | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 6 years 9 months 18 days | ||||||||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 1 year 2 months 12 days | ||||||||||||||||
Proceeds from Stock Options Exercised | $ 2,400,000 | ||||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award Options Non vested In Period Fair Value1 | $ 3,000,000 | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Weighted Average Remaining Contractual Term | 7 months 6 days | ||||||||||||||||
Restricted Stock Units (RSUs) [Member] | |||||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 120,000 | ||||||||||||||||
Warrant [Member] | |||||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||||
Stock Issued During Period, Shares, New Issues | 88,293 | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 2 years 8 months 12 days | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 120,265 | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Non-Option Equity Instruments, Expirations | 133,587 | ||||||||||||||||
Amended And Restated 2014 Plan [Member] | |||||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 73,876 | ||||||||||||||||
Common Stock [Member] | |||||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||||
Net proceeds raised from common stock issued in a public offering | $ 64,800,000 | ||||||||||||||||
Stock Issued During Period, Shares, New Issues | 331,500 | 2,210,000 | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 349,720 | 21,200 | 76,422 | ||||||||||||||
Stock Redeemed or Called During Period, Shares | 108 | ||||||||||||||||
Company Offering Price | $ 69,300,000 | ||||||||||||||||
Securities Offering Price | $ 80,700,000 | ||||||||||||||||
Underwritten Public Offering [Member] | Common Stock [Member] | |||||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||||
Net proceeds raised from common stock issued in a public offering | $ 70,400,000 | ||||||||||||||||
Stock Issued During Period, Value, New Issues | $ 10,600,000 | ||||||||||||||||
Stock Issued During Period, Shares, New Issues | 833,333 | ||||||||||||||||
Sale of Stock, Price Per Share | $ 13.50 | ||||||||||||||||
Proceeds From Issuance Initial Public Offering | $ 81,000,000 | ||||||||||||||||
Underwriters [Member] | Common Stock [Member] | |||||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||||
Stock Issued During Period, Shares, New Issues | 331,500 | 833,333 | |||||||||||||||
Investors [Member] | Common Stock [Member] | |||||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||||
Stock Issued During Period, Value, New Issues | $ 64,800,000 | $ 70,400,000 | |||||||||||||||
Stock Issued During Period, Shares, New Issues | 2,210,000 | 5,555,555 | |||||||||||||||
Sale of Stock, Price Per Share | $ 27.25 | $ 27.25 | $ 13.50 | ||||||||||||||
Maximum [Member] | At the Market Offerings [Member] | Common Stock [Member] | |||||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||||
Initial Public Offering Value Of Shares Authorized | $ 75 | ||||||||||||||||
2010 Stock Incentive Plan [Member] | |||||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number | 595,334 | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 793,440 | ||||||||||||||||
2014 Stock Incentive Plan [Member] | |||||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number | 3,216,246 | ||||||||||||||||
Common Stock, Capital Shares Reserved for Future Issuance | 4,160,000 | ||||||||||||||||
Share-Based Compensation Arrangement By Share-Based Payment Award, Options, Grants In Period, Gross | 587,391 | ||||||||||||||||
2014 Stock Incentive Plan [Member] | Restricted Stock Units (RSUs) [Member] | |||||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||||
Share-Based Compensation Arrangement By Share-Based Payment Award, Options, Grants In Period, Gross | 120,000 | ||||||||||||||||
2017 Stock Incentive Plan [Member] | |||||||||||||||||
Stockholders Equity Note [Line Items] | |||||||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number | 189,000 | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 611,000 |
License Agreements - Additional
License Agreements - Additional Information (Details) - USD ($) | Feb. 10, 2017 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Revenue Recognition, Milestone Method, Description | the Company is eligible to receive up to approximately $630 million in payments related to seven development milestones and up to approximately $2.15 billion in payments related to 12 commercial development and sales milestones in connection with the successful development and commercialization of licensed compounds for up to six different indications | |||||||
Deferred Revenue Amortization Period Over Service Tenure | 10 years | |||||||
Licenses Revenue | $ 50,000,000 | $ 50,000,000 | ||||||
Deferred Revenue, Current | $ 5,229,227 | 5,229,227 | $ 0 | |||||
Deferred Revenue, Noncurrent | 40,555,708 | 40,555,708 | 0 | |||||
Cost of Reimbursable Expense | 4,600,000 | |||||||
Accounts Receivable, Net, Current | 2,273,421 | 2,273,421 | 0 | |||||
License and Services Revenue | 3,315,457 | $ 2,659,613 | $ 2,359,311 | $ 684,369 | 9,018,750 | $ 0 | $ 0 | |
Collaborative Arrangement [Member] | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Deferred Revenue, Current | 5,000,000 | 5,000,000 | ||||||
Deferred Revenue, Noncurrent | $ 45,000,000 | 45,000,000 | ||||||
Revenue Recognition, Multiple-deliverable Arrangements, Determination of Selling Price, Amount | 12,500,000 | |||||||
License and Services Revenue | 4,400,000 | |||||||
Allergan Pharmaceuticals International Limited [Member] | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Proceeds From Upfront Payment | 50,000,000 | |||||||
Agreed To Share Maximum Amount Development Cost | $ 75,000,000 | |||||||
Description Of Agree To Share Development Cost | In the event any pre-POC development costs exceed $75 million in the aggregate, the Company may elect either (a) to fund ⅓ of such costs in excess of $75 million or (b) to allow Allergan to deduct from future development milestone payments ⅓ of the development costs funded by Allergan in excess of $75 million plus a premium of 25%. | |||||||
Revenue Recognition, Milestone Method, Description | the Company is eligible to receive up to approximately $630 million in payments related to seven development milestones and up to approximately $2.15 billion in payments related to 12 commercial development and sales milestones in connection with the successful development and commercialization of licensed compounds for up to six different indications | |||||||
POC Development Costs | 7,200,000 | |||||||
Agreed To Share Amount Development Cost | $ 2,400,000 |
Milestones and Research Agree50
Milestones and Research Agreements - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2014 | |
Therabiome, LLC [Member] | ||
Payment For Nonrefundable License Fee | $ 300,000 | |
Indiana University Research and Technology Corporation [Member] | ||
Potential Milestone Payments | $ 825,000 | |
Indiana University Research and Technology Corporation [Member] | Minimum [Member] | ||
Diligence maintenance fees Obligation | $ 25,000 | |
Indiana University Research and Technology Corporation [Member] | Maximum [Member] | ||
Diligence maintenance fees Obligation | $ 100,000 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Deferred tax assets: | ||
Net-operating loss carryforward | $ 43,577,000 | $ 59,926,000 |
Stock-based compensation | 5,726,000 | 9,279,000 |
In-Process R&D | 2,259,000 | 4,050,000 |
Deferred revenue | 11,064,000 | 0 |
R&D credit | 5,604,000 | 3,962,000 |
Change in unrealized loss on marketable securities | 46,000 | 178,000 |
Other | 314,000 | 316,000 |
Total Deferred Tax Assets | 68,590,000 | 77,711,000 |
Valuation allowance | (63,718,000) | (77,711,000) |
Deferred Tax Asset, Net of Allowance | 4,872,000 | 0 |
In-process research and development (Assembly Merger) | 7,007,802 | 11,119,651 |
Net Deferred Tax Liability | $ 2,135,802 | $ 11,119,651 |
Income Taxes (Details 1)
Income Taxes (Details 1) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Effective Income Tax [Line Items] | |||
Statutory Federal Income Tax Rate | (34.00%) | (34.00%) | (34.00%) |
State Taxes, Net of Federal Tax Benefit | (2.60%) | (4.30%) | (11.00%) |
Merger Cost | 0.00% | 0.00% | 0.90% |
Stock based Compensation | 0.00% | 3.40% | 16.70% |
Credits | (2.10%) | (1.80%) | 0.00% |
Federal Rate Change | 47.70% | 0.00% | 0.00% |
State Rate Change | 0.20% | 7.50% | 0.00% |
Other | 0.30% | 2.30% | 0.10% |
Change in Valuation Allowance | (27.00%) | 25.50% | 27.30% |
Income Taxes Provision (Benefit) | (17.50%) | (1.40%) | 0.00% |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Taxes [Line Items] | ||||
Deferred Tax Assets, Net of Valuation Allowance, Current | $ 4,900,000 | |||
Statutory Federal tax rate | 34.00% | 34.00% | 34.00% | |
Deferred Tax Assets, Operating Loss Carryforwards, State and Local | $ 165,000,000 | |||
Deferred Tax Assets, Tax Credit Carryforwards, Research | 5,600,000 | |||
Deferred Tax Assets, Operating Loss Carryforwards, Federal | 153,200,000 | |||
Deferred Income Tax Expense (Benefit) | (9,050,249) | $ (617,672) | $ 0 | |
Increase (Decrease) in Deferred Income Taxes | 24,700,000 | |||
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | 28,400,000 | |||
Increase (Decrease) in Income Taxes | $ 3,700,000 | |||
Operating Loss Carryforwards, Limitations on Use | The TaxActalso permits an indefinite carry forward of net operating losses generated in taxable years ending after December 31, 2017, subject to a utilization limitation of 80% of taxable income. | |||
Income Tax Expense (Benefit) | $ (9,050,249) | $ (617,672) | $ 0 | |
Effective Income Tax Rate Reconciliation, Change in Enacted Tax Rate, Amount | $ 8,600,000 | |||
Scenario, Plan [Member] | ||||
Income Taxes [Line Items] | ||||
Statutory Federal tax rate | 34.00% | |||
Maximum [Member] | ||||
Income Taxes [Line Items] | ||||
Operating Loss Carry forwards Expiration Period | 2,037 | |||
Minimum [Member] | ||||
Income Taxes [Line Items] | ||||
Operating Loss Carry forwards Expiration Period | 2,027 |
Commitments and Contingencies54
Commitments and Contingencies (Details) | Dec. 31, 2017USD ($) |
Commitments and Contingencies Disclosure [Line Items] | |
Year Ended December 31, 2018 | $ 2,974,537 |
Year Ended December 31, 2019 | 1,193,126 |
Year Ended December 31, 2020 | 827,511 |
Year Ended December 31, 2021 | 254,136 |
Year Ended December 31, 2022 | 212,625 |
Thereafter | 106,312 |
Operating Leases, Future Minimum Payments Receivable, Total | $ 5,568,247 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Line Items] | |||
Operating Leases, Rent Expense | $ 1,300,000 | $ 1,200,000 | $ 700,000 |
Operating Leases, Future Minimum Payments Due | 2,900,000 | ||
Equipment Lease [Member] | |||
Commitments and Contingencies Disclosure [Line Items] | |||
Operating Leases, Rent Expense | $ 758,000 | 705,000 | 107,000 |
Maximum [Member] | Equipment Lease [Member] | |||
Commitments and Contingencies Disclosure [Line Items] | |||
Operating Lease Expiration Year | 2,021 | ||
Minimum [Member] | Equipment Lease [Member] | |||
Commitments and Contingencies Disclosure [Line Items] | |||
Operating Lease Expiration Year | 2,017 | ||
Chief Executive Officer And Chief Financial Officer [Member] | |||
Commitments and Contingencies Disclosure [Line Items] | |||
Officers Compensation | $ 900,000 | $ 800,000 | $ 800,000 |
Selected Quarterly Financial 56
Selected Quarterly Financial Data (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Collaboration revenue | $ 3,315,457 | $ 2,659,613 | $ 2,359,311 | $ 684,369 | $ 9,018,750 | $ 0 | $ 0 | ||||
Operating expenses | 15,595,075 | 15,109,793 | 15,926,562 | 14,614,198 | $ 11,868,254 | $ 11,678,925 | $ 10,454,130 | $ 11,277,152 | 61,245,628 | 45,278,461 | 29,655,630 |
Interest and other income | 365,541 | 241,326 | 239,858 | 136,484 | 225,681 | 378,381 | 444,605 | 490,421 | 983,209 | 1,539,088 | 1,228,830 |
Realized loss from marketable securities | (37,828) | (99,068) | (340,984) | (137,248) | (521,786) | (273,573) | (142,675) | (201,827) | (615,128) | (1,139,861) | (27,033) |
Net loss | $ (3,007,072) | $ (12,272,019) | $ (13,598,864) | $ (13,930,593) | $ (11,546,687) | $ (11,574,117) | $ (10,152,200) | $ (10,988,558) | $ (42,808,548) | $ (44,261,562) | $ (28,453,833) |
Basic and diluted net loss per common share | $ (0.16) | $ (0.71) | $ (0.78) | $ (0.81) | $ (0.67) | $ (0.67) | $ (0.59) | $ (0.64) | $ (2.41) | $ (2.57) | $ (1.81) |