PDS Biotechnology (PDSB) 10-K 21 Feb 19 2018 FY Annual report Financial data

Document and Entity Information

Document and Entity Information - USD ($) $ in Millions	12 Months Ended
	Dec. 31, 2018	Feb. 14, 2019	Jun. 30, 2018
Document and Entity Information [Abstract]
Entity Registrant Name	Edge Therapeutics, Inc.
Entity Central Index Key	1,472,091
Current Fiscal Year End Date	--12-31
Entity Well-known Seasoned Issuer	No
Entity Voluntary Filers	No
Entity Current Reporting Status	Yes
Entity Shell Company	false
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	true
Entity Public Float			$ 32.3
Entity Common Stock, Shares Outstanding		31,509,822
Document Type	10-K
Amendment Flag	false
Document Period End Date	Dec. 31, 2018
Document Fiscal Year Focus	2,018
Document Fiscal Period Focus	FY

Balance Sheets

Balance Sheets - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Current assets:
Cash and cash equivalents	$ 34,645,549	$ 88,067,647
Prepaid expenses and other current assets	1,005,589	986,680
Total current assets	35,651,138	89,054,327
Property and equipment, net	426,952	3,423,880
Other assets	142,870	142,870
Total assets	36,220,960	92,621,077
Current liabilities:
Accounts payable	399,447	4,369,133
Accrued expenses	419,119	5,422,205
Restructuring reserve	5,563,186	0
Short term debt	0	3,075,421
Total current liabilities	6,381,752	12,866,759
Noncurrent liability:
Long term debt	0	17,382,907
STOCKHOLDERS' EQUITY
Preferred stock, 5,000,000 shares authorized at December 31, 2018 and 2017, zero outstanding	0	0
Common stock, $0.00033 par value, 75,000,000 shares authorized at December 31, 2018 and December 31, 2017, 31,449,989 shares and 30,869,205 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively	10,591	10,400
Additional paid-in capital	222,644,982	214,309,370
Accumulated deficit	(192,816,365)	(151,948,359)
Total stockholders' equity	29,839,208	62,371,411
Total liabilities and stockholders' equity	$ 36,220,960	$ 92,621,077

Balance Sheets (Parenthetical)

Balance Sheets (Parenthetical) - $ / shares	Dec. 31, 2018	Dec. 31, 2017
STOCKHOLDERS' EQUITY
Preferred stock, shares authorized (in shares)	5,000,000	5,000,000
Preferred stock, shares outstanding (in shares)	0	0
Common stock, par value (in dollars per share)	$ 0.00033	$ 0.00033
Common stock, shares authorized (in shares)	75,000,000	75,000,000
Common stock, shares issued (in shares)	31,449,989	30,869,205
Common stock, shares outstanding (in shares)	31,449,989	30,869,205

Statements of Operations and Co

Statements of Operations and Comprehensive Loss - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Operating expenses:
Research and development expenses	$ 16,068,769	$ 34,311,650
General and administrative expenses	14,291,008	17,654,970
Restructuring expenses	9,914,209	0
Impairment charges	2,822,581	0
Total operating expenses	43,096,567	51,966,620
Loss from operations	(43,096,567)	(51,966,620)
Other income (expense):
Interest income	871,879	700,903
Interest expense	(1,425,255)	(2,180,143)
Loss before income taxes	(43,649,943)	(53,445,860)
Benefit for income taxes	2,781,937	2,586,057
Net loss	(40,868,006)	(50,859,803)
Comprehensive loss	$ (40,868,006)	$ (50,859,803)
Loss per share attributable to common stockholders basic and diluted (in dollars per share)	$ (1.31)	$ (1.67)
Weighted average common shares outstanding basic and diluted (in shares)	31,242,176	30,393,952

Statements of Changes in Stockh

Statements of Changes in Stockholders' Equity (Deficit) - USD ($)	Common Stock [Member]	Additional Paid-in Capital [Member]	Deficit Accumulated [Member]	Total
Balance at Dec. 31, 2016	$ 9,756	$ 190,341,769	$ (101,074,968)	$ 89,276,557
Balance (in shares) at Dec. 31, 2016	28,918,516
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock based compensation expense	$ 0	6,182,841	0	6,182,841
Issuance of common stock, net of issuance costs	$ 594	17,382,349	0	17,382,943
Issuance of common stock, net of issuance costs (in shares)	1,800,000
Issuance of common stock from exercise of stock options	$ 12	118,176	0	118,188
Issuance of common stock from exercise of stock options (in shares)	35,366
Issuance of common stock from exercise of warrants	$ 31	53,118	0	53,149
Issuance of common stock from exercise of warrants (in shares)	94,200
Issuance of common stock from 401K match	$ 7	217,529	0	217,536
Issuance of common stock from 401K match (in shares)	21,123
Net loss	$ 0	0	(50,859,803)	(50,859,803)
Balance at Dec. 31, 2017	$ 10,400	214,309,370	(151,948,359)	62,371,411
Balance (in shares) at Dec. 31, 2017	30,869,205
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Cumulative-effect of new share-based compensation guidance | ASU 2016 - 09 [Member]	$ 0	13,588	(13,588)	0
Stock based compensation expense	0	7,469,441	0	7,469,441
Issuance of common stock from exercise of stock options	$ 65	721,130	0	721,195
Issuance of common stock from exercise of stock options (in shares)	198,300
Issuance of common stock from exercise of warrants	$ 58	(58)	0	0
Issuance of common stock from exercise of warrants (in shares)	175,999
Issuance of common stock from vesting of RSUs	$ 30	(30)	0	0
Issuance of common stock from vesting of RSUs (in shares)	91,432
Issuance of common stock from 401K match	$ 38	145,129	0	145,167
Issuance of common stock from 401K match (in shares)	115,053
Net loss	$ 0	0	(40,868,006)	(40,868,006)
Balance at Dec. 31, 2018	$ 10,591	$ 222,644,982	$ (192,816,365)	$ 29,839,208
Balance (in shares) at Dec. 31, 2018	31,449,989

Statements of Cash Flows

Statements of Cash Flows - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Cash flows from operating activities:
Net loss	$ (40,868,006)	$ (50,859,803)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense	7,469,442	6,182,841
Stock-based 401K company common match	145,167	217,536
Depreciation expense	174,347	182,918
Impairment of machinery and equipment	2,822,581	0
Amortization of debt discount	1,039	32,869
Amortization of debt issuance costs	125,355	108,407
Non-cash interest expense	405,278	363,909
Changes in assets and liabilities:
Prepaid expenses and other assets	(18,909)	(32,099)
Accounts payable	(3,969,686)	898,101
Accrued expenses	(5,003,087)	2,208,490
Restructuring reserve	5,563,186	0
Net cash used in operating activities	(33,153,293)	(40,696,831)
Cash flows from investing activities:
Purchases of property and equipment	0	(188,721)
Net cash used in investing activities	0	(188,721)
Cash flows from financing activities:
Proceeds from issuance of debt	0	5,000,000
Proceeds from exercise of stock options	721,195	118,188
Proceeds from exercise of warrants	0	53,149
Payments for debt back end fees	(990,000)	0
Repayment of debt	(20,000,000)	0
Proceeds from issuance of common stock, net of underwriting costs	0	17,382,943
Net cash (used in) provided by financing activities	(20,268,805)	22,554,280
Net decrease in cash	(53,422,098)	(18,331,272)
Cash and cash equivalents at beginning of period	88,067,647	106,398,919
Cash and cash equivalents at end of period	34,645,549	88,067,647
Cash paid for:
Interest	$ 1,051,167	$ 1,635,562

Nature of Operations

Nature of Operations	12 Months Ended
	Dec. 31, 2018
Nature of Operations [Abstract]
Nature of Operations	Note 1 – Nature of Operations Edge Therapeutics, Inc. (the “Company” or “Edge”) is a clinical-stage biotechnology company that seeks to discover, develop and commercialize novel therapies capable of transforming treatment paradigms in the management of medical conditions. On March 28, 2018, the Company announced that a pre-specified interim analysis performed on data from the Day 90 visit of the first 210 subjects randomized and treated in the Phase 3 multi-center, randomized, double-blind, placebo-controlled NEWTON 2 study of EG-1962 in adults with aneurysmal subarachnoid hemorrhage demonstrated a low probability of achieving a statistically significant difference compared to the standard of care in the study’s primary endpoint, if the study were to be fully enrolled. The independent Data Monitoring Committee (“DMC”) for the NEWTON 2 study recommended that the study be stopped based on this demonstration. The DMC also reported that there were no safety concerns attributed to EG-1962. Based on the DMC recommendation, the Company decided to discontinue the NEWTON 2 study and took steps to notify health authorities and clinical investigators participating in the study. On April 30, 2018, the Company announced that it was exploring strategic alternatives, which might have included, without limitation, an acquisition of another company, acquisitions or in-licensing of products or product candidates, technologies or other assets, the sale of all or substantially all of the assets of the Company, a sale of stock, a strategic merger or other business combination transaction or other transaction between the Company and a third party. The Company retained Piper Jaffray & Co. to serve as the financial advisor to its Board of Directors in certain aspects of the process. On November 23, 2018, Edge, Merger Sub and PDS, a privately-held clinical-stage cancer immunotherapy company, entered into an Agreement and Plan of Merger and Reorganization, or the Merger Agreement, pursuant to which, among other things, subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, Merger Sub will merge with and into PDS, with PDS surviving the merger as the wholly-owned subsidiary of the combined company. If the merger is completed, the business of Edge will become the business of PDS. If the merger is not completed, Edge will reconsider its strategic alternatives and may pursue one of the following courses of action, which Edge currently believes are the most likely alternatives if the merger with PDS is not completed: ● Pursue another strategic transaction similar to the merger. Edge may resume its process of evaluating other companies interested in pursuing a strategic transaction with Edge and, if a candidate is identified, focus its attention on negotiating and completing such a transaction with such candidate. ● Dissolve and liquidate its assets. If Edge is unable, or does not believe that it is able, to find a suitable candidate for another strategic transaction, Edge may dissolve and liquidate its assets. In the event of dissolution, Edge would be required to pay all of its debts and contractual obligations and to set aside certain reserves for potential future claims. If Edge dissolves and liquidates its assets, there can be no assurance as to the amount or timing of available cash that will remain for distribution to Edge’ stockholders after paying Edge’ debts and other obligations and setting aside funds for its reserves. In the second quarter of 2018, the Company recorded an initial restructuring charge of $6.3 million. The components of the restructuring charge included expenses of $4.0 million for severance benefits and $2.3 million for financial advisor fees, as well as ongoing legal fees expensed as incurred, and accrued retention compensation related to the restructuring of the organization. The restructuring activity during 2018 is as follows: Restructuring reserve at December 31, 2017 $ – Initial restructuring charge 6,276,563 Incurred legal fees 1,447,079 Severance revisions 259,529 Retention compensation 1,201,568 Restructuring expenses to date (1) 9,184,739 Payment of legal fees (493,404 ) Payment of retention compensation (56,925 ) Payment of advisor fees (500,000 ) Payment of severance benefits (2,571,224 ) Restructuring reserve as of December 31, 2018 $ 5,563,186 (1) Excludes non-cash stock based retention compensation of $729,470 expensed to date through restructuring expenses. From the Company’s inception, it has devoted substantially all of its efforts to business planning, engaging regulatory, manufacturing and other technical consultants, acquiring operating assets, planning and executing clinical trials and raising capital. The Company’s future operations are highly dependent on the success of the merger with PDS.

Summary of Significant Accounti

Summary of Significant Accounting Policies	12 Months Ended
	Dec. 31, 2018
Summary of Significant Accounting Policies [Abstract]
Summary of Significant Accounting Policies	Note 2 – Summary of Significant Accounting Policies (A) Use of estimates: The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. (B) Significant risks and uncertainties: The Company’s operations are subject to a number of factors that may affect its operating results and financial condition. Such factors include, but are not limited to: the Company’s ability to consummate the merger with PDS, the Company’s ability to preserve its cash resources, the Company’s ability to add product candidates to its pipeline, the Company’s intellectual property, competition from products manufactured and sold or being developed by other companies, the price of, and demand for, Company products if approved for sale, the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, and the Company’s ability to raise capital. The Company currently has no commercially approved products and has ceased all research and development activities related to EG-1962 and suspended research for its other product candidates. As such, there can be no assurance that the Company’s future research and development programs will be successfully commercialized. Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. (C) Cash equivalents and concentration of cash balance: The Company considers all highly liquid securities with a maturity weighted average of less than three months to be cash equivalents. The Company’s cash and cash equivalents in bank deposit accounts, at times, may exceed federally insured limits. (D) Property and equipment: Property and equipment is recorded at cost. Depreciation is recorded for property and equipment using the straight-line method over the estimated useful lives of three to five years. Leasehold improvements are amortized over the shorter of the estimated useful life or term of the underlying lease. The Company reviews the recoverability of all long-lived assets, including the related useful lives, whenever events or changes in circumstances indicate that the carrying amount of a long-lived asset might not be recoverable. (E) Research and development: Costs incurred in connection with research and development activities are expensed as incurred. These costs include licensing fees to use certain technology in the Company’s research and development projects as well as fees paid to consultants and various entities that perform certain research and testing on behalf of the Company. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data, such as patient enrollment, clinical site activations or information provided by vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred. Following the DMC’s recommendation that the NEWTON 2 Trial for EG-1962 be stopped, the Company decided to discontinue the NEWTON 2 study and took steps to notify health authorities and clinical investigators participating in the study. The Company has ceased all further research and development activities for EG-1962 and suspended research for its other product candidates and implemented operating cost reductions and organizational restructurings, including a reduction in the Company’s workforce, to preserve its cash resources and better align the organization with its current operating plan. The estimated costs associated with the study discontinuance have been accrued as of December 31, 2018. (F) Patent costs: The Company expenses patent costs as incurred and classifies such costs as general and administrative expenses in the accompanying statements of operations and comprehensive loss. In light of the Company’s cessation of all further research and development activities for EG-1962 and suspension of research for its other product candidates, the Company has substantially scaled back its patent prosecution activities. (G) Stock-based compensation: The Company measures employee stock-based awards at grant-date fair value and recognizes employee compensation expense on a straight-line basis over the vesting period of the award. Determining the appropriate fair value of stock-based awards requires the input of subjective assumptions, including, for stock options, the expected life of the option, and expected stock price volatility. The Company uses the Black-Scholes option pricing model to value its stock option awards. 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. As a result, if factors change and management uses different assumptions, stock-based compensation expense could be materially different for future awards. The expected life of stock options was estimated using the “simplified method,” as the Company has limited historical information to develop reasonable expectations about future exercise patterns and employment duration for its stock options grants. The simplified method is based on the average of the vesting tranches and the contractual life of each grant. For stock price volatility, the Company uses comparable public companies as a basis for its expected volatility to calculate the fair value of options grants. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected life of the option. (H) Net loss per common share: Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted average common shares outstanding during the period. For all periods presented, the common shares underlying the preferred stock, common stock options and warrants have been excluded from the calculation because their effect would be anti-dilutive. Therefore, the weighted average shares outstanding used to calculate both basic and diluted loss per common share are the same. The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as they would be anti-dilutive: As of December 31, 2018 2017 Stock options to purchase Common Stock 7,043,825 6,462,795 Unvested Restricted Stock Units 509,962 - Warrants to purchase Common Stock 78,596 374,653 Total 7,632,383 6,837,448 (I) Income taxes: The Company provides for deferred income taxes under the asset and liability method, which requires deferred tax assets and liabilities to be recognized for the future tax consequences attributable to net operating loss carryforwards and for differences between the financial statement carrying amounts and the respective tax bases of assets and liabilities. Deferred tax assets are reduced if necessary by a valuation allowance if it is more likely than not that some portion or all of the deferred tax assets will not be realized. (J) Fair value of financial instruments: Financial Accounting Standards Board (“FASB”) guidance specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: ● Level 1 — Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. ● Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly (e.g., quoted prices of similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active). Level 2 includes financial instruments that are valued using models or other valuation methodologies. ● Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. (K) Subsequent events: Subsequent events have been evaluated through the date these financial statements were issued. (L) New accounting standards not yet adopted: In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, “Leases (Topic 842).” The new standard requires organizations that lease assets—referred to as “lessees”—to recognize on the balance sheet the assets and liabilities for the rights and obligations created by those leases (see Note 9). This standard is effective for annual reporting periods beginning after December 15, 2018, and interim periods within those fiscal years. Early adoption is permitted. The standard requires a modified retroactive approach, but use of certain practical expedients is permitted as per ASU 2018-11. The Company expects to use the package of practical expedients that allows it to not reassess: (1) whether any expired or existing contracts are or contain leases, (2) lease classification for any expired or existing leases, and (3) initial direct costs for any expired or existing leases. The Company additionally expects to use the practical expedient that allows it to treat the lease and non-lease components of its leases as a single component. The Company adopted this ASU on January 1, 2019. The impact of adoption on its financial statements will be to record a Right to Use Asset and Lease Liability of $1.5 million. (M) New accounting standards adopted: In March 2016, the FASB issued ASU No. 2016-09 which simplifies several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. Public companies will be required to adopt this standard in annual reporting periods beginning after December 15, 2016, and interim periods within those annual periods. The Company adopted this ASU on January 1, 2017. The impact of adopting ASU 2016-09 resulted in the following: ● The Company recognized $84,786 of tax benefit along with a full valuation allowance as of the adoption date related to the historical excess tax benefits from historical option exercises related to employee equity award activity. ● The Company elected to recognize forfeitures as they occur. The cumulative effect adjustment as a result of the adoption of this amendment on a modified retrospective basis was not material. There were no other material impacts to our consolidated financial statements as a result of adopting this updated standard.

Fair Value of Financial Instrum

Fair Value of Financial Instruments	12 Months Ended
	Dec. 31, 2018
Fair Value of Financial Instruments [Abstract]
Fair Value of Financial Instruments	Note 3 – Fair Value of Financial Instruments Fair Value Measurements at Reporting Date Using Total Quoted Prices in Active Markets (Level 1) Quoted Prices in Inactive Markets (Level 2) Significant Unobservable Inputs (Level 3) As of December 31, 2018: Cash and cash equivalents $ 34,645,549 $ 34,645,549 $ – $ – As of December 31, 2017: Cash and cash equivalents $ 88,067,647 $ 88,067,647 $ – $ – There were no transfers between Levels 1, 2, or 3 during 2018 or 2017.

Property and Equipment

Property and Equipment	12 Months Ended
	Dec. 31, 2018
Property and Equipment [Abstract]
Property and Equipment	Note 4 – Property and Equipment Property and equipment is summarized as follows: December 31, 2018 2017 Furniture and equipment $ 439,620 $ 564,596 Leasehold Improvements 438,996 438,996 Construction in Process - 2,725,569 878,616 3,729,161 Less accumulated depreciation (451,664 ) (305,281 ) Property and equipment, net $ 426,952 $ 3,423,880 In March 2018, following the recommendation of the Data Monitoring Committee, the Company made the decision to close down the EG-1962 NEWTON 2 study. The Company believes that it would be highly unlikely that the Company would be able to use the manufacturing equipment associated with EG-1962 for future use. As a result, the Company has recorded a full equipment impairment charge in 2018 of $2,822,581.

Accrued Expenses

Accrued Expenses	12 Months Ended
	Dec. 31, 2018
Accrued Expenses [Abstract]
Accrued Expenses	Note 5 – Accrued Expenses Accrued expenses and other liabilities consist of the following: December 31, 2018 2017 Accrued research and development costs $ 76,600 $ 2,857,025 Accrued professional fees 69,083 267,646 Accrued compensation 27,405 1,886,638 Accrued other 213,074 385,896 Deferred rent 32,957 25,000 Total $ 419,119 $ 5,422,205

Stock Warrants

Stock Warrants	12 Months Ended
	Dec. 31, 2018
Stock Warrants [Abstract]
Stock Warrants	Note 6 – Stock Warrants In connection with certain of our preferred stock sales and debt issuances, we issued warrants to the placement agent and lender for preferred stock. The warrants were recorded as liabilities with changes in fair value being recorded in the statement of operations and are calculated utilizing the Black-Scholes option pricing model. At the closing of the IPO date on October 6, 2015, these warrants become exercisable for shares of our common stock. These warrants were exercisable for 600,184 shares of common stock at exercise prices ranging from $5.79 to $12.10 and expire at various dates through 2020. During 2018, 2017 and 2016, 296,057, 166,762 and 58,769 warrants were exercised resulting in the issuance of 175,999, 94,200 and 44,032 shares of common stock, respectively. As of December 31, 2018, 78,596 warrants were exercisable.

Stock Options

Stock Options	12 Months Ended
	Dec. 31, 2018
Stock Options [Abstract]
Stock Options	Note 7 – Stock Options The Company has three equity compensation plans: the 2010 Equity Incentive Plan, the 2012 Equity Incentive Plan and the 2014 Equity Incentive Plan (the “Plans”). Originally, the Company was able to grant up to 548,206 and 1,096,411 shares of Common Stock as both incentive stock options (“ISOs”) and nonqualified stock options (“NQs”) under the 2010 Equity Incentive Plan and the 2012 Equity Incentive Plan, respectively. In 2013, the Company’s stockholders approved an increase to 1,279,146 shares authorized for issuance under the 2010 Equity Incentive Plan. In 2014, the Board of Directors of the Company (the “Board”) approved an increase to 1,350,412 shares authorized for issuance under the 2010 Equity Incentive Plan. In 2014, the Company’s stockholders approved the 2014 Equity Incentive Plan pursuant to which the Company may grant up to 1,827,351 shares as ISOs, NQs and restricted stock units (“RSUs”), subject to increases as hereafter described (the “Plan Limit”). In addition, on January 1, 2015 and each January 1 thereafter prior to the termination of the 2014 Equity Incentive Plan, pursuant to the terms of the 2014 Equity Incentive Plan, the Plan Limit was and shall be increased by the lesser of (x) 4% of the number of shares of Common Stock outstanding as of the immediately preceding December 31 and (y) such lesser number as the Board of Directors may determine in its discretion. On January 1, 2016, 2017 and 2018 the Plan Limit was increased to 3,047,323 shares, 4,204,063 shares and 5,438,831 shares, respectively. Pursuant to the terms of the Plans, ISOs have a term of ten years from the date of grant or such shorter term as may be provided in the option agreement. Unless specified otherwise in an individual option agreement, ISOs generally vest over a four year term and NQs generally vest over a one, three or four year term. Unless terminated by the Board, the Plans shall continue to remain effective for a term of ten years or until such time as no further awards may be granted and all awards granted under the Plans are no longer outstanding. The Company issued the following non-qualified options to purchase shares of common stock to its newly appointed executives who are still employed by the Company. The awards were granted outside of the Company’s 2014 Equity Incentive Plan and vest over four years with 25% vesting one year following the date of hire, and the remaining 75% vesting in 36 equal monthly installments thereafter, subject to continued service to the Company through each vesting date and subject to acceleration or forfeiture upon the occurrence of certain events as set forth in the applicable option agreement and employment agreement. The grant awards were made pursuant to the Nasdaq inducement grant exception as a material component of employment compensation. Issue Date 25% Vesting Date Executive Number of Options November 16, 2015 October 30, 2016 SVP, General Counsel and Secretary 80,000 November 1, 2017 October 31, 2018 Chief Financial Officer 200,000 The Company’s stock-based compensation expense was recognized in operating expense as follows: Year Ended December 31, 2018 2017 Stock-Based Compensation Research and development $ 2,503,889 $ 2,687,975 General and administrative 4,236,083 3,494,866 Retention compensation 729,470 – Total $ 7,469,442 $ 6,182,841 The fair value of options granted during the years ended December 31, 2018 and 2017 was estimated using the Black-Scholes option valuation model utilizing the following assumptions: Year Ended December 31, 2018 2017 Weighted Average Weighted Average Volatility 86.33 % 88.87 % Risk-Free Interest Rate 2.23 % 1.88 % Expected Term in Years 6.00 6.00 Dividend Rate 0.00 % 0.00 % Fair Value of Option on Grant Date $ 5.08 $ 6.93 The following table summarizes the number of options outstanding and the weighted average exercise price: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value Options outstanding at January 1, 2017 5,316,511 $ 5.84 Granted 1,365,400 9.39 Exercised (35,366 ) 3.34 Forfeited (183,750 ) 9.46 Options outstanding at December 31, 2017 6,462,795 $ 6.50 7.13 $ 20,467,335 Vested and expected to vest at December 31, 2017 6,462,795 $ 6.50 7.13 $ 20,467,335 Exercisable at December 31, 2017 4,066,066 $ 5.14 6.21 $ 18,100,589 Options outstanding at December 31, 2017 6,462,795 $ 6.50 Granted 2,322,906 7.52 Exercised (198,300 ) 3.64 Forfeited (1,543,576 ) 10.30 Options outstanding at December 31, 2018 7,043,825 $ 6.09 5.84 $ 3,977 Vested and expected to vest at December 31, 2018 7,043,825 $ 6.09 5.84 $ 3,977 Exercisable at December 31, 2018 5,001,465 $ 5.71 5.67 $ 3,977 At December 31, 2018 there was approximately $8,725,126 of unamortized stock compensation expense, which is expected to be recognized over a remaining average vesting period of 2.52 years. The Company may grant RSUs to eligible employees, including its executives, and non-employee directors. RSUs represent a right to receive one share of the Company’s common stock, upon the completion of a specific period of continued service or achievement of a certain milestone. RSU awards are valued at the market price of the Company’s common stock on the date of grant. The Company recognizes noncash compensation expense for the fair values of these RSU awards on a straight-line basis over the requisite service period of these awards. The following table summarizes the number of RSUs outstanding and the weighted average grant price: Number of RSUs Weighted Average Grant Price RSUs outstanding at December 31, 2017 – $ – Granted 601,394 0.85 Released (91,432 ) 0.85 Forfeited – – RSUs outstanding at December 31, 2018 509,962 $ 0.85 At December 31, 2018, there was approximately $236,534 of unamortized RSU compensation expense, which is expected to be recognized over a remaining average vesting period of 0.62 years.

Income Taxes

Income Taxes	12 Months Ended
	Dec. 31, 2018
Income Taxes [Abstract]
Income Taxes	Note 8 – Income Taxes A reconciliation of the statutory U.S. federal income tax rate to the Company’s effective tax rate is as follows: Year Ended December 31, 2018 2017 Federal statutory rate 21.0 % 34.0 % State taxes 0.4 % 1.1 % Change in Statutory Rate – (25.6 )% Permanent differences (5.4 )% (11.0 )% Research and development 6.3 % 21.2 % State taxes/ sale of NOL 6.4 % 4.8 % Valuation allowance (22.3 )% (19.7 )% Effective tax rate 6.4 % 4.8 % The tax effects of temporary differences that gave rise to significant portions of the deferred tax assets were as follows: December 31, 2018 2017 Federal net operating losses $ 27,011,760 $ 21,312,121 State net operating losses 1,929,997 2,268,249 Stock options 1,847,546 1,608,750 Federal tax credit 26,815,998 24,060,243 State tax credits 506,752 384,740 Amortization 229,065 612,878 Accrued expense 813,073 7,027 Depreciation 826,109 18,498 Other 17,993 12,501 Total gross deferred tax assets 59,998,293 50,285,007 Less valuation allowance (59,998,293 ) (50,285,007 ) Net deferred tax assets $ – $ – In assessing the realizability of the net deferred tax assets, the Company considers all relevant positive and negative evidence to determine whether it is more likely than not that some portion or all of the deferred income tax assets will not be realized. The realization of the gross deferred tax assets is dependent on several factors, including the generation of sufficient taxable income prior to the expiration of the net operating loss carryforwards. There was a full valuation allowance against the net deferred tax assets as of December 31, 2018 and December 31, 2017. At December 31, 2018, the Company had federal net operating loss (“NOL”) carryforwards of approximately $101.5 million which expire between 2029 and 2037. NOLs of $27.1 million generated in 2018 have an indefinite carryforward period. At December 31, 2018, the Company had approximately $27.1 million of State of New Jersey NOLs which expire between 2030 and 2038. At December 31, 2018, the Company had approximately $0.6 million of the State of New Jersey research development credits carryforwards. The State of New Jersey has enacted legislation permitting certain corporations located in New Jersey to sell state tax loss carryforwards and state research and development credits, or net loss carryforwards. The Technology Business Tax Certificate Transfer Program enables qualified, unprofitable NJ-based technology or biotechnology companies with fewer than 225 US employees (including parent company and all subsidiaries) to sell a percentage of New Jersey NOLs and research and development (“R&D”) tax credits to unrelated profitable corporations. In 2018, the Company sold $31,689,956 of State of New Jersey NOLs and $131,214 of State of New Jersey R&D Credits for $2,824,228. In 2017, the Company sold $26,097,607 of State of New Jersey NOLs and $424,466 of State of New Jersey R&D Credits for $2,586,057. Entities are also required to evaluate, measure, recognize and disclose any uncertain income tax provisions taken on their income tax returns. The Company has analyzed its tax positions and has concluded that as of December 31, 2018, there were no uncertain positions. The Company’s U.S. federal and state net operating losses have occurred since its inception in 2009 and as such, tax years subject to potential tax examination could apply from that date because the utilization of net operating losses from prior years opens the relevant year to audit by the IRS and/or state taxing authorities. In September 2017, the IRS concluded auditing the Company’s 2015 tax year resulting in a no change letter. Interest and penalties, if any, as they relate to income taxes assessed, are included in the income tax provision. The Company did not have any unrecognized tax benefits and has not accrued any interest or penalties for 2018. On December 22, 2017, H.R. 1 (also, known as the Tax Cuts and Jobs Act (the “Tax Act”)) was signed into law. Among its numerous changes to the Internal Revenue Code, the Tax Act reduces U.S. federal corporate tax rate to 21%. As a result, the most significant impact on its financial statements was the reduction of approximately $13.6 million for the deferred tax assets related to net operating losses and other assets. Such reduction was offset by changes to the Company’s valuation allowance as of December 31, 2017. We previously provided a provisional estimate of the effect of the Tax Act in our financial statements. In the fourth quarter of 2018, we completed our analysis to determine there was no additional effect of the Tax Act as of December 31, 2018. On July 1, 2018, the New Jersey governor signed into law a bill which included significant changes to the New Jersey taxation of corporations. Chiefly, this legislation imposes a 2.5% surtax on taxpayers with allocated net income over $1 million for 2018 and 2019, and a 1.5% surtax for taxpayers with allocated net income over $1 million for 2020 and 2021. In addition, the state is changing its filing requirements from separate entity reporting to combined reporting on a water’s edge basis. Further, there are changes to the state’s computation of its dividend received deduction and application of IRC section 163(j). The Company has considered these changes and does not believe this change in law will have a material impact due to availability of significant New Jersey NOL carried forward to set off against future taxable income and a full valuation allowance against the net deferred tax assets.

Commitments and Contingencies

Commitments and Contingencies	12 Months Ended
	Dec. 31, 2018
Commitments and Contingencies [Abstract]
Commitments and Contingencies	Note 9 – Commitments and Contingencies Evonik The Company entered into an agreement with SurModics Pharmaceuticals, Inc. (“SurModics”) in October 2010 for the exclusive worldwide licensing of certain technology, patent rights and know-how rights related to the production of EG-1962, (the “Evonik Agreement”). This agreement was later transferred to Evonik Industries AG (“Evonik”) when it purchased substantially all the assets of SurModics. Pursuant to the Evonik Agreement, in exchange for the license, the Company agreed to make milestone payments totaling up to $14.75 million upon the achievement of certain development, regulatory and sales milestones detailed in the Evonik Agreement. The Company paid $0.25 million upon execution of the Evonik Agreement. In August 2016, the Company paid a milestone of $1.0 million after the first patient in the Phase 3 clinical trial of EG-1962 was dosed. In addition, the Evonik Agreement calls for the Company to pay royalties on sales of certain products based on a mid-single digit percentage of net sales. The Evonik Agreement provides for the reduction of royalties in certain limited circumstances. The term of the Evonik Agreement will continue until the expiration of the Company’s obligation to pay royalties to Evonik. Either party may terminate the Evonik Agreement due to material breach by the other party. Evonik may terminate the Evonik Agreement or convert it to a non-exclusive license, in either case upon giving the Company written notice, if the Company fails to use commercially reasonable efforts to hit certain specified development, regulatory and commercial milestones. Following the discontinuation of the NEWTON 2 trial for EG-1962, the Company has ceased all research and development efforts related to EG-1962 and suspended efforts on its other product candidates. As such, unless the Company resumes such development activities, it is unlikely that the Company will have any additional milestone or royalty obligations to Evonik in the future. Oakwood Amended and Restated Master Formulation Development Agreement In June 2017, the Company entered into an Amended and Restated Master Formulation Development Agreement (the “Restated Development Agreement”) with Oakwood Laboratories, L.L.C. (“Oakwood”), pursuant to which Oakwood agreed to continue to provide the Company with certain drug formulation development and non-commercial manufacturing services for EG-1962, in accordance with project plans that may be entered into from time to time. Under the Restated Development Agreement, the Company agreed to pay Oakwood to perform services under agreed upon project plans and to pay Oakwood up to an aggregate of $4.5 million. In July 2017 and April 2018, the Company paid $1.5 million and $0.5 million, respectively, of such aggregate amount in connection with entering into the Restated Development Agreement. The remaining $2.5 million was payable no later than April 1, 2019. The remaining payment was discounted to $2.375 million and paid pursuant to an accelerated payment agreement entered into in August 2018. As of December 31, 2018, there are no remaining payments under the Restated Development Agreement. As additional consideration for performance under the Restated Development Agreement and the Supply Agreement (as defined below), the Company agreed to pay Oakwood a royalty, during the Royalty Term, in an amount equal to a low single digit percentage of net sales of EG-1962, regardless of the manufacturer or supplier thereof. The “Royalty Term” is the period commencing upon the commercial launch of EG-1962 by the Company and continuing until twelve (12) years following such launch. The term of the Restated Development Agreement continues until the expiration or termination of the Supply Agreement, unless earlier terminated (the “Term”). The Company has the right to terminate project plans upon the occurrence of various circumstances described in the Restated Development Agreement. In the event that the Company terminates the most recent project plan prior to completion (which would include the Company’s decision to discontinue the development or commercialization of EG-1962), the Company must pay to Oakwood a termination fee for work completed. There are no payments due as of December 31, 2018. Oakwood Manufacturing and Supply Agreement Concurrent with its entry into the Restated Development Agreement, on June 30, 2017, the Company entered into a Manufacturing and Supply Agreement with Oakwood (the “Supply Agreement”), pursuant to which Oakwood agreed to manufacture and supply, and the Company agreed to purchase from Oakwood, EG-1962 in commercial quantities following the commercial launch of the product. Pursuant to the Supply Agreement, the Company agreed to pay Oakwood milestone payments that could total up to an aggregate of $2.25 million upon the achievement of certain development and regulatory milestones. The term of the Supply Agreement will terminate automatically upon the termination of the Restated Development Agreement for any reason. Additionally, either party may terminate the Supply Agreement upon a material breach by the other party that fails to be cured in the applicable cure period. Following the discontinuation of the NEWTON 2 trial for EG-1962, the Company has ceased all research and development efforts related to EG-1962 and suspended efforts on its other product candidates. As such, the Company may terminate the Supply Agreement immediately upon notice to Oakwood (which will also result in the automatic termination of the Restated Development Agreement); provided, that if it chooses to do so prior to completion of the most recent project plan attached to the Restated Development Agreement, the Company must pay to Oakwood a termination fee. While certain of the Company’s milestone payments to Oakwood will remain outstanding (including the termination fee in the event the Restated Development Agreement is terminated), unless the Company resumes such development activities, it is unlikely that the Company will be required to pay additional milestone or royalty payments to Oakwood in the future pursuant to the Restated Development Agreement or the Supply Agreement. Class Action Civil Litigation On April 23, 2018, a purported securities class action complaint was filed against Edge, Brian Leuthner (Edge’s President and Chief Executive Officer) and Andrew Saik (Edge’s Chief Financial Officer) in the United States District Court for the District of New Jersey, captioned Sanfilippo v. Edge Therapeutics, Inc., Case No. 2:18-cv-8236. The complaint alleged that Edge, Mr. Leuthner and Mr. Saik violated Section 10(b) of the Securities Exchange Act of 1934 by making false and misleading statements concerning Edge’s business, operations and prospects by failing to disclose that Edge’s developmental product EG-1962 allegedly would likely fail a futility analysis. The complaint also asserted a “control” person claim against Mr. Leuthner and Mr. Saik pursuant to Section 20(a) of the Exchange Act. The complaint was brought on behalf of all purchasers of Edge’s common stock between December 27, 2017, and March 27, 2018, and sought unspecified damages. On December 7, 2018, the court appointed Sam Kirkpatrick and Amos Bakouple lead plaintiffs for the putative class and appointed the firm Glancy, Prongay & Murray LLP lead counsel for the putative class. On February 14, 2019, lead plaintiffs voluntarily dismissed the action, without prejudice, as to all defendants Edge and the Edge Board have been named as defendants in two individual lawsuits and two putative class action lawsuits regarding the merger, each of which alleges that the registration statement on Form S-4 (Registration No. 333-228937) filed by Edge on December 21, 2018 omitted material information with respect to the proposed transaction, which rendered the registration statement on Form S-4 false or misleading. The case captioned Michael Condon v. Edge Therapeutics et al., case no. 2:19-cv-00152, or the Condon Action, was filed on January 4, 2019 in the United States District Court for the District of New Jersey. The case captioned Adam Franchi et al. v. Edge Therapeutics et al., case no. 1:19-cv-00058-UNA, or the Franchi Action, was filed on January 9, 2019 in the United States District Court for the District of Delaware. The case captioned Jeffrey L. Prince v. Edge Therapeutics et al., case no. 1:19-cv-00280, or the Prince Action, was filed on January 10, 2019 in the United States District Court for the Southern District of New York. The case captioned Brian Foldenauer et al. v. Edge Therapeutics et al., case no. 1:19-cv-00280, or the Foldenauer Action, was filed on January 22, 2019 in the United States District Court for the District of Delaware. The causes of action set forth in each of the Condon Action, the Franchi Action, the Prince Action and the Foldenauer Action are (i) a claim against Edge and the Board for violations of Section 14(a) of the Exchange Act, as well as (ii) a claim against the Board for violations of Section 20(a) of the Exchange Act. In the Franchi Action, PDS was also named as a defendant in respect of the claim regarding violations of Section 20(a) of the Exchange Act. In each case, the plaintiffs seek, among other things, injunctive relief, rescissory damages, and an award of attorneys’ fees and expenses. Edge has voluntarily accepted service of process in the Franchi Action and Prince Action, but has not yet been served with process in the Condon Action or the Foldenauer Action. On January 18, 2019, the plaintiffs in the Prince Action filed a motion for a preliminary injunction barring any stockholder vote on the proposed merger until revised disclosures are made to Edge’s stockholders, and withdrew the motion for a preliminary injunction on February 1, 2019. Edge believes the litigation is without merit and in any event has been rendered moot by the final S-4 and subsequent disclosures. This litigation remains in the initial pleadings phase. Employment Matters The Company has entered into employment agreements with each of its executive officers. The agreements generally provide for, among other things, salary, bonus and severance payments. The employment agreements generally provide for between 12 months and 18 months of severance benefits to be paid to an executive (as well as certain potential bonus, COBRA and equity award benefits), subject to the effectiveness of a general release of claims, if the executive terminates his or her employment for good reason or if the Company terminates the executive’s employment without cause. Such severance payments may be provided for as long as 24 months in connection with a termination following a change of control. The continued provision of severance benefits is conditioned on each executive’s compliance with the terms of the Company’s confidentiality and invention and assignment agreement as well as his or her release of claims. On April 30, 2018, the Company initiated a corporate realignment to focus its efforts and resources on its ongoing operations and future plans that include a reduction in its workforce. This realignment was initiated following the Company’s announcement that it was discontinuing the Phase 3 NEWTON 2 study, based on the recommendation of an independent Data Monitoring Committee (the “DMC”) that the Company stop its Phase 3 NEWTON 2 study. The DMC recommendation was based on its conclusion that the study had a low probability of meeting its primary endpoint. During 2018, the Company reduced its workforce from 37 employees to 10 employees. In addition, the Company anticipates completing the payment of certain employee severance and benefits and certain retention compensation, as approved by the Compensation Committee of the Board of Directors, by the fourth quarter of fiscal year 2019. Leases Effective December 13, 2013, the Company entered into a 63 month lease for approximately 8,000 square feet of office space in Berkeley Heights, New Jersey. On February 18, 2016, the Company entered into a new 63 month lease for approximately 20,410 square feet of office space within the same office complex in Berkeley Heights, New Jersey. The terms of the new lease were structured so that the termination date of the December 13, 2013 lease coincided with the commencement date of the new lease on August 13, 2016. As a result of the lease termination, the Company wrote off $67,118 of leasehold improvements. Rent expense is recognized on a straight line basis where there are escalating payments, and was approximately $598,037 and $602,925 for the years ended December 31, 2018 and 2017, respectively. The following is a schedule by years of future minimum rental payments required under operating leases that have initial or remaining non-cancelable lease terms in excess of one year as of December 31, 2018: Year Ended December 31, 2019 $ 604,541 2020 603,371 2021 530,385 2022 and after – Total minimum payments required $ 1,738,297

Debt

Debt	12 Months Ended
	Dec. 31, 2018
Debt [Abstract]
Debt	Note 10 – Debt On August 1, 2016, the Company entered into an Amended and Restated Loan and Security Agreement (the “Amended Loan Agreement”) with Hercules Capital, Inc., formerly known as Hercules Technology Growth Capital, Inc. (“Hercules”). Pursuant to the Amended Loan Agreement, the Company was able to borrow up to $20,000,000. At closing, the Company borrowed $15,000,000 of the amount available for draw under the Amended Loan Agreement (and received proceeds net of the amount then outstanding under the Original Loan Agreement, fees and expenses). On May 23, 2017, the Company elected to draw down the second tranche of $5 million. Pursuant to the Amended Loan Agreement, in March 2018, the Company made a payment of $90,000, which is equal to 1.5% of the total amounts funded under the Original Loan Agreement. In June 2018, the Company paid off its entire outstanding debt under the Amended Loan Agreement. The payment consisted of $20.0 million for the principal amount, an additional $0.9 million in back-end fees and $0.1 million in accrued and unpaid interest. As of December 31, 2018, the Company has no outstanding debt.

Retirement Plan

Retirement Plan	12 Months Ended
	Dec. 31, 2018
Retirement Plan [Abstract]
Retirement Plan	Note 11 – Retirement Plan The Company has a 401(k) defined contribution plan for the benefit for all employees and permits voluntary contributions by employees subject to IRS-imposed limitations. The 401K employer contribution for the 2018 and 2017 plan years were $159,559 and $258,383 respectively.

Summary of Significant Accoun_2

Summary of Significant Accounting Policies (Policies)	12 Months Ended
	Dec. 31, 2018
Summary of Significant Accounting Policies [Abstract]
Use of Estimates	(A) Use of estimates: The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
Significant Risks and Uncertainties	(B) Significant risks and uncertainties: The Company’s operations are subject to a number of factors that may affect its operating results and financial condition. Such factors include, but are not limited to: the Company’s ability to consummate the merger with PDS, the Company’s ability to preserve its cash resources, the Company’s ability to add product candidates to its pipeline, the Company’s intellectual property, competition from products manufactured and sold or being developed by other companies, the price of, and demand for, Company products if approved for sale, the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, and the Company’s ability to raise capital. The Company currently has no commercially approved products and has ceased all research and development activities related to EG-1962 and suspended research for its other product candidates. As such, there can be no assurance that the Company’s future research and development programs will be successfully commercialized. Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies.
Cash Equivalents and Concentration of Cash Balance	(C) Cash equivalents and concentration of cash balance: The Company considers all highly liquid securities with a maturity weighted average of less than three months to be cash equivalents. The Company’s cash and cash equivalents in bank deposit accounts, at times, may exceed federally insured limits.
Property and Equipment	(D) Property and equipment: Property and equipment is recorded at cost. Depreciation is recorded for property and equipment using the straight-line method over the estimated useful lives of three to five years. Leasehold improvements are amortized over the shorter of the estimated useful life or term of the underlying lease. The Company reviews the recoverability of all long-lived assets, including the related useful lives, whenever events or changes in circumstances indicate that the carrying amount of a long-lived asset might not be recoverable.
Research and Development	(E) Research and development: Costs incurred in connection with research and development activities are expensed as incurred. These costs include licensing fees to use certain technology in the Company’s research and development projects as well as fees paid to consultants and various entities that perform certain research and testing on behalf of the Company. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data, such as patient enrollment, clinical site activations or information provided by vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred. Following the DMC’s recommendation that the NEWTON 2 Trial for EG-1962 be stopped, the Company decided to discontinue the NEWTON 2 study and took steps to notify health authorities and clinical investigators participating in the study. The Company has ceased all further research and development activities for EG-1962 and suspended research for its other product candidates and implemented operating cost reductions and organizational restructurings, including a reduction in the Company’s workforce, to preserve its cash resources and better align the organization with its current operating plan. The estimated costs associated with the study discontinuance have been accrued as of December 31, 2018.
Patent Costs	(F) Patent costs: The Company expenses patent costs as incurred and classifies such costs as general and administrative expenses in the accompanying statements of operations and comprehensive loss. In light of the Company’s cessation of all further research and development activities for EG-1962 and suspension of research for its other product candidates, the Company has substantially scaled back its patent prosecution activities.
Stock-Based Compensation	(G) Stock-based compensation: The Company measures employee stock-based awards at grant-date fair value and recognizes employee compensation expense on a straight-line basis over the vesting period of the award. Determining the appropriate fair value of stock-based awards requires the input of subjective assumptions, including, for stock options, the expected life of the option, and expected stock price volatility. The Company uses the Black-Scholes option pricing model to value its stock option awards. 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. As a result, if factors change and management uses different assumptions, stock-based compensation expense could be materially different for future awards. The expected life of stock options was estimated using the “simplified method,” as the Company has limited historical information to develop reasonable expectations about future exercise patterns and employment duration for its stock options grants. The simplified method is based on the average of the vesting tranches and the contractual life of each grant. For stock price volatility, the Company uses comparable public companies as a basis for its expected volatility to calculate the fair value of options grants. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected life of the option.
Net Loss per Common Share	(H) Net loss per common share: Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted average common shares outstanding during the period. For all periods presented, the common shares underlying the preferred stock, common stock options and warrants have been excluded from the calculation because their effect would be anti-dilutive. Therefore, the weighted average shares outstanding used to calculate both basic and diluted loss per common share are the same. The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as they would be anti-dilutive: As of December 31, 2018 2017 Stock options to purchase Common Stock 7,043,825 6,462,795 Unvested Restricted Stock Units 509,962 - Warrants to purchase Common Stock 78,596 374,653 Total 7,632,383 6,837,448
Income Taxes	(I) Income taxes: The Company provides for deferred income taxes under the asset and liability method, which requires deferred tax assets and liabilities to be recognized for the future tax consequences attributable to net operating loss carryforwards and for differences between the financial statement carrying amounts and the respective tax bases of assets and liabilities. Deferred tax assets are reduced if necessary by a valuation allowance if it is more likely than not that some portion or all of the deferred tax assets will not be realized.
Fair Value of Financial Instruments	(J) Fair value of financial instruments: Financial Accounting Standards Board (“FASB”) guidance specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: ● Level 1 — Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. ● Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly (e.g., quoted prices of similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active). Level 2 includes financial instruments that are valued using models or other valuation methodologies. ● Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable.
Subsequent Events	(K) Subsequent events: Subsequent events have been evaluated through the date these financial statements were issued.
New Accounting Standards Not Yet Adopted	(L) New accounting standards not yet adopted: In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, “Leases (Topic 842).” The new standard requires organizations that lease assets—referred to as “lessees”—to recognize on the balance sheet the assets and liabilities for the rights and obligations created by those leases (see Note 9). This standard is effective for annual reporting periods beginning after December 15, 2018, and interim periods within those fiscal years. Early adoption is permitted. The standard requires a modified retroactive approach, but use of certain practical expedients is permitted as per ASU 2018-11. The Company expects to use the package of practical expedients that allows it to not reassess: (1) whether any expired or existing contracts are or contain leases, (2) lease classification for any expired or existing leases, and (3) initial direct costs for any expired or existing leases. The Company additionally expects to use the practical expedient that allows it to treat the lease and non-lease components of its leases as a single component. The Company adopted this ASU on January 1, 2019. The impact of adoption on its financial statements will be to record a Right to Use Asset and Lease Liability of $1.5 million.
New Accounting Standards Adopted	(M) New accounting standards adopted: In March 2016, the FASB issued ASU No. 2016-09 which simplifies several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. Public companies will be required to adopt this standard in annual reporting periods beginning after December 15, 2016, and interim periods within those annual periods. The Company adopted this ASU on January 1, 2017. The impact of adopting ASU 2016-09 resulted in the following: ● The Company recognized $84,786 of tax benefit along with a full valuation allowance as of the adoption date related to the historical excess tax benefits from historical option exercises related to employee equity award activity. ● The Company elected to recognize forfeitures as they occur. The cumulative effect adjustment as a result of the adoption of this amendment on a modified retrospective basis was not material. There were no other material impacts to our consolidated financial statements as a result of adopting this updated standard.

Nature of Operations (Tables)

Nature of Operations (Tables)	12 Months Ended
	Dec. 31, 2018
Nature of Operations [Abstract]
Restructuring Activity	The restructuring activity during 2018 is as follows: Restructuring reserve at December 31, 2017 $ – Initial restructuring charge 6,276,563 Incurred legal fees 1,447,079 Severance revisions 259,529 Retention compensation 1,201,568 Restructuring expenses to date (1) 9,184,739 Payment of legal fees (493,404 ) Payment of retention compensation (56,925 ) Payment of advisor fees (500,000 ) Payment of severance benefits (2,571,224 ) Restructuring reserve as of December 31, 2018 $ 5,563,186 (1) Excludes non-cash stock based retention compensation of $729,470 expensed to date through restructuring expenses.

Summary of Significant Accoun_3

Summary of Significant Accounting Policies (Tables)	12 Months Ended
	Dec. 31, 2018
Summary of Significant Accounting Policies [Abstract]
Potentially Dilutive Securities Excluded from Computations of Diluted Weighted Average Shares Outstanding	The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as they would be anti-dilutive: As of December 31, 2018 2017 Stock options to purchase Common Stock 7,043,825 6,462,795 Unvested Restricted Stock Units 509,962 - Warrants to purchase Common Stock 78,596 374,653 Total 7,632,383 6,837,448

Fair Value of Financial Instr_2

Fair Value of Financial Instruments (Tables)	12 Months Ended
	Dec. 31, 2018
Fair Value of Financial Instruments [Abstract]
Fair Value of Financial Instruments	Fair Value Measurements at Reporting Date Using Total Quoted Prices in Active Markets (Level 1) Quoted Prices in Inactive Markets (Level 2) Significant Unobservable Inputs (Level 3) As of December 31, 2018: Cash and cash equivalents $ 34,645,549 $ 34,645,549 $ – $ – As of December 31, 2017: Cash and cash equivalents $ 88,067,647 $ 88,067,647 $ – $ –

Property and Equipment (Tables)

Property and Equipment (Tables)	12 Months Ended
	Dec. 31, 2018
Property and Equipment [Abstract]
Property and Equipment	Property and equipment is summarized as follows: December 31, 2018 2017 Furniture and equipment $ 439,620 $ 564,596 Leasehold Improvements 438,996 438,996 Construction in Process - 2,725,569 878,616 3,729,161 Less accumulated depreciation (451,664 ) (305,281 ) Property and equipment, net $ 426,952 $ 3,423,880

Accrued Expenses (Tables)

Accrued Expenses (Tables)	12 Months Ended
	Dec. 31, 2018
Accrued Expenses [Abstract]
Accrued Expenses and Other Liabilities	Accrued expenses and other liabilities consist of the following: December 31, 2018 2017 Accrued research and development costs $ 76,600 $ 2,857,025 Accrued professional fees 69,083 267,646 Accrued compensation 27,405 1,886,638 Accrued other 213,074 385,896 Deferred rent 32,957 25,000 Total $ 419,119 $ 5,422,205

Stock Options (Tables)

Stock Options (Tables)	12 Months Ended
	Dec. 31, 2018
Stock Options [Abstract]
Non-Qualified Stock Options	The Company issued the following non-qualified options to purchase shares of common stock to its newly appointed executives who are still employed by the Company. The awards were granted outside of the Company’s 2014 Equity Incentive Plan and vest over four years with 25% vesting one year following the date of hire, and the remaining 75% vesting in 36 equal monthly installments thereafter, subject to continued service to the Company through each vesting date and subject to acceleration or forfeiture upon the occurrence of certain events as set forth in the applicable option agreement and employment agreement. The grant awards were made pursuant to the Nasdaq inducement grant exception as a material component of employment compensation. Issue Date 25% Vesting Date Executive Number of Options November 16, 2015 October 30, 2016 SVP, General Counsel and Secretary 80,000 November 1, 2017 October 31, 2018 Chief Financial Officer 200,000
Stock-Based Compensation Expense	The Company’s stock-based compensation expense was recognized in operating expense as follows: Year Ended December 31, 2018 2017 Stock-Based Compensation Research and development $ 2,503,889 $ 2,687,975 General and administrative 4,236,083 3,494,866 Retention compensation 729,470 – Total $ 7,469,442 $ 6,182,841
Assumptions Used to Value Stock Options Granted	The fair value of options granted during the years ended December 31, 2018 and 2017 was estimated using the Black-Scholes option valuation model utilizing the following assumptions: Year Ended December 31, 2018 2017 Weighted Average Weighted Average Volatility 86.33 % 88.87 % Risk-Free Interest Rate 2.23 % 1.88 % Expected Term in Years 6.00 6.00 Dividend Rate 0.00 % 0.00 % Fair Value of Option on Grant Date $ 5.08 $ 6.93
Stock Option Activity	The following table summarizes the number of options outstanding and the weighted average exercise price: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value Options outstanding at January 1, 2017 5,316,511 $ 5.84 Granted 1,365,400 9.39 Exercised (35,366 ) 3.34 Forfeited (183,750 ) 9.46 Options outstanding at December 31, 2017 6,462,795 $ 6.50 7.13 $ 20,467,335 Vested and expected to vest at December 31, 2017 6,462,795 $ 6.50 7.13 $ 20,467,335 Exercisable at December 31, 2017 4,066,066 $ 5.14 6.21 $ 18,100,589 Options outstanding at December 31, 2017 6,462,795 $ 6.50 Granted 2,322,906 7.52 Exercised (198,300 ) 3.64 Forfeited (1,543,576 ) 10.30 Options outstanding at December 31, 2018 7,043,825 $ 6.09 5.84 $ 3,977 Vested and expected to vest at December 31, 2018 7,043,825 $ 6.09 5.84 $ 3,977 Exercisable at December 31, 2018 5,001,465 $ 5.71 5.67 $ 3,977
RSU Activity	The following table summarizes the number of RSUs outstanding and the weighted average grant price: Number of RSUs Weighted Average Grant Price RSUs outstanding at December 31, 2017 – $ – Granted 601,394 0.85 Released (91,432 ) 0.85 Forfeited – – RSUs outstanding at December 31, 2018 509,962 $ 0.85

Income Taxes (Tables)

Income Taxes (Tables)	12 Months Ended
	Dec. 31, 2018
Income Taxes [Abstract]
Statutory to Effective Federal Income Tax Rate Reconciliation	A reconciliation of the statutory U.S. federal income tax rate to the Company’s effective tax rate is as follows: Year Ended December 31, 2018 2017 Federal statutory rate 21.0 % 34.0 % State taxes 0.4 % 1.1 % Change in Statutory Rate – (25.6 )% Permanent differences (5.4 )% (11.0 )% Research and development 6.3 % 21.2 % State taxes/ sale of NOL 6.4 % 4.8 % Valuation allowance (22.3 )% (19.7 )% Effective tax rate 6.4 % 4.8 %
Deferred Tax Assets	The tax effects of temporary differences that gave rise to significant portions of the deferred tax assets were as follows: December 31, 2018 2017 Federal net operating losses $ 27,011,760 $ 21,312,121 State net operating losses 1,929,997 2,268,249 Stock options 1,847,546 1,608,750 Federal tax credit 26,815,998 24,060,243 State tax credits 506,752 384,740 Amortization 229,065 612,878 Accrued expense 813,073 7,027 Depreciation 826,109 18,498 Other 17,993 12,501 Total gross deferred tax assets 59,998,293 50,285,007 Less valuation allowance (59,998,293 ) (50,285,007 ) Net deferred tax assets $ – $ –

Commitments and Contingencies (

Commitments and Contingencies (Tables)	12 Months Ended
	Dec. 31, 2018
Commitments and Contingencies [Abstract]
Future Minimum Rental Payments Required under Operating Leases	The following is a schedule by years of future minimum rental payments required under operating leases that have initial or remaining non-cancelable lease terms in excess of one year as of December 31, 2018: Year Ended December 31, 2019 $ 604,541 2020 603,371 2021 530,385 2022 and after – Total minimum payments required $ 1,738,297

Nature of Operations (Details)

Nature of Operations (Details) - USD ($)	3 Months Ended	12 Months Ended
	Jun. 30, 2018	Dec. 31, 2018
Nature of Operations [Abstract]
Severance costs	$ 4,000,000
Financial advisor fees	2,300,000
Restructuring Reserve [Roll Forward]
Restructuring reserve at beginning of period		$ 0
Initial restructuring charge	$ 6,300,000	6,276,563
Incurred legal fees		1,447,079
Severance revisions		259,529
Retention compensation		1,201,568
Restructuring expenses to date		9,184,739
Payment of legal fees		(493,404)
Payment of retention compensation		(56,925)
Payment of advisor fees		(500,000)
Payment of severance benefits		(2,571,224)
Restructuring reserve at end of period		5,563,186
Non-cash stock-based retention compensation		$ 729,470

Summary of Significant Accoun_4

Summary of Significant Accounting Policies (Details) - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Net Loss per Common Share [Abstract]
Antidilutive securities excluded from computation of earnings per share (in shares)	7,632,383	6,837,448
New Accounting Standards Adopted [Abstract]
Tax benefit	$ (2,781,937)	$ (2,586,057)
Minimum [Member]
Property and Equipment [Abstract]
Estimated useful lives of property and equipment	3 years
Maximum [Member]
Property and Equipment [Abstract]
Estimated useful lives of property and equipment	5 years
Stock Options to Purchase Common Stock [Member]
Net Loss per Common Share [Abstract]
Antidilutive securities excluded from computation of earnings per share (in shares)	7,043,825	6,462,795
Unvested Restricted Stock Units [Member]
Net Loss per Common Share [Abstract]
Antidilutive securities excluded from computation of earnings per share (in shares)	509,962	0
Warrants to Purchase Common Stock [Member]
Net Loss per Common Share [Abstract]
Antidilutive securities excluded from computation of earnings per share (in shares)	78,596	374,653
ASU 2016 - 02 [Member] | Plan [Member]
New Accounting Standards Not Yet Adopted [Abstract]
Right to use asset	$ 1,500,000
Lease liability	1,500,000
ASU 2016 - 09 [Member]
New Accounting Standards Adopted [Abstract]
Tax benefit	$ (84,786)

Fair Value of Financial Instr_3

Fair Value of Financial Instruments (Details) - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Fair Value Transfers Between Levels [Abstract]
Transfers from Level 1 to Level 2, assets	$ 0	$ 0
Transfers from Level 2 to Level 1, assets	0	0
Transfers into Level 3, assets	0	0
Transfers out of Level 3, assets	0	0
Fair Value of Financial Instruments [Abstract]
Cash and cash equivalents	34,645,549	88,067,647
Quoted Prices in Active Markets (Level 1) [Member]
Fair Value of Financial Instruments [Abstract]
Cash and cash equivalents	34,645,549	88,067,647
Quoted Prices in Inactive Markets (Level 2) [Member]
Fair Value of Financial Instruments [Abstract]
Cash and cash equivalents	0	0
Significant Unobservable Inputs (Level 3) [Member]
Fair Value of Financial Instruments [Abstract]
Cash and cash equivalents	$ 0	$ 0

Property and Equipment (Details

Property and Equipment (Details) - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Property and Equipment [Abstract]
Property and equipment	$ 878,616	$ 3,729,161
Less accumulated depreciation	(451,664)	(305,281)
Property and equipment, net	426,952	3,423,880
Equipment impairment charge	2,822,581	0
Furniture and Equipment [Member]
Property and Equipment [Abstract]
Property and equipment	439,620	564,596
Leasehold Improvements [Member]
Property and Equipment [Abstract]
Property and equipment	438,996	438,996
Construction in Process [Member]
Property and Equipment [Abstract]
Property and equipment	$ 0	$ 2,725,569

Accrued Expenses (Details)

Accrued Expenses (Details) - USD ($)	Dec. 31, 2018	Dec. 31, 2017
Accrued Expenses [Abstract]
Accrued research and development costs	$ 76,600	$ 2,857,025
Accrued professional fees	69,083	267,646
Accrued compensation	27,405	1,886,638
Accrued other	213,074	385,896
Deferred rent	32,957	25,000
Total	$ 419,119	$ 5,422,205

Stock Warrants (Details)

Stock Warrants (Details) - Warrants Issued in Connection with Certain Preferred Stock Sales and Debt Issuances [Member] - $ / shares	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017	Dec. 31, 2016	Oct. 06, 2015
Stock Warrants [Abstract]
Number of shares of stock that can be purchased with warrants (in shares)				600,184
Warrants exercised (in shares)	296,057	166,762	58,769
Issuance of common stock from exercise of warrants (in shares)	175,999	94,200	44,032
Warrants exercisable (in shares)	78,596
Minimum [Member]
Stock Warrants [Abstract]
Exercise price of warrants (in dollars per share)				$ 5.79
Maximum [Member]
Stock Warrants [Abstract]
Exercise price of warrants (in dollars per share)				$ 12.10

Stock Options, Equity Compensat

Stock Options, Equity Compensation Plans (Details)	12 Months Ended
	Dec. 31, 2018Plan	Dec. 31, 2014shares	Jan. 02, 2018shares	Jan. 02, 2017shares	Jan. 02, 2016shares	Dec. 31, 2013shares	Dec. 31, 2012shares	Dec. 31, 2010shares
Stock Options [Abstract]
Number of equity compensation plans | Plan	3
The Plans [Member]
Stock Options [Abstract]
Term of plan	10 years
The Plans [Member] | Incentive Stock Options [Member]
Stock Options [Abstract]
Vesting period	4 years
The Plans [Member] | Incentive Stock Options [Member] | Maximum [Member]
Stock Options [Abstract]
Term of option	10 years
The Plans [Member] | Nonqualified Stock Options [Member]
Stock Options [Abstract]
Vesting period	3 years
The Plans [Member] | Nonqualified Stock Options [Member] | Minimum [Member]
Stock Options [Abstract]
Vesting period	1 year
The Plans [Member] | Nonqualified Stock Options [Member] | Maximum [Member]
Stock Options [Abstract]
Vesting period	4 years
2010 Equity Incentive Plan [Member]
Stock Options [Abstract]
Number of shares authorized for issuance (in shares)		1,350,412				1,279,146		548,206
2012 Equity Incentive Plan [Member]
Stock Options [Abstract]
Number of shares authorized for issuance (in shares)							1,096,411
2014 Equity Incentive Plan [Member]
Stock Options [Abstract]
Number of shares authorized for issuance (in shares)		1,827,351	5,438,831	4,204,063	3,047,323
Percentage of Common Stock outstanding used to determine annual increase in the plan limit		4.00%

Stock Options, Non-qualified Op

Stock Options, Non-qualified Options (Details) - Nonqualified Stock Options [Member]	Nov. 01, 2017shares	Nov. 16, 2015shares	Dec. 31, 2018Installment
Executives [Member]
Stock Options [Abstract]
Vesting period			4 years
Executives [Member] | Vesting One Year Following Date of Hire [Member]
Stock Options [Abstract]
Vesting percentage			25.00%
Executives [Member] | Vesting in 36 Monthly Installments Thereafter [Member]
Stock Options [Abstract]
Vesting percentage			75.00%
Number of monthly installments for vesting | Installment			36
SVP, General Counsel and Secretary [Member]
Stock Options [Abstract]
Issue date			Nov. 16, 2015
25% vesting date			Oct. 30, 2016
Number of options (in shares)		80,000
Chief Financial Officer [Member]
Stock Options [Abstract]
Issue date			Nov. 1, 2017
25% vesting date			Oct. 31, 2018
Number of options (in shares)	200,000

Stock Options, Stock-Based Comp

Stock Options, Stock-Based Compensation Expense (Details) - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Stock-Based Compensation [Abstract]
Stock-based compensation expense	$ 7,469,442	$ 6,182,841
Research and Development [Member]
Stock-Based Compensation [Abstract]
Stock-based compensation expense	2,503,889	2,687,975
General and Administrative [Member]
Stock-Based Compensation [Abstract]
Stock-based compensation expense	4,236,083	3,494,866
Retention Compensation [Member]
Stock-Based Compensation [Abstract]
Stock-based compensation expense	$ 729,470	$ 0

Stock Options, Assumptions Used

Stock Options, Assumptions Used to Value Stock Options Granted (Details) - $ / shares	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Assumptions Used in Determining Fair Value of Stock Options Granted [Abstract]
Volatility	86.33%	88.87%
Risk-free interest rate	2.23%	1.88%
Expected term	6 years	6 years
Dividend rate	0.00%	0.00%
Fair value of option on grant date (in dollars per share)	$ 5.08	$ 6.93

Stock Options, Stock Option Act

Stock Options, Stock Option Activity (Details) - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Unamortized Stock Compensation Expense [Abstract]
Unamortized stock compensation expense	$ 8,725,126
Stock Options [Member]
Number of Shares [Roll Forward]
Options outstanding, beginning balance (in shares)	6,462,795	5,316,511
Granted (in shares)	2,322,906	1,365,400
Exercised (in shares)	(198,300)	(35,366)
Forfeited (in shares)	(1,543,576)	(183,750)
Options outstanding, ending balance (in shares)	7,043,825	6,462,795
Vested and expected to vest (in shares)	7,043,825	6,462,795
Exercisable (in shares)	5,001,465	4,066,066
Weighted Average Exercise Price [Roll Forward]
Options outstanding, beginning balance (in dollars per share)	$ 6.50	$ 5.84
Granted (in dollars per share)	7.52	9.39
Exercised (in dollars per share)	3.64	3.34
Forfeited (in dollars per share)	10.30	9.46
Options outstanding, ending balance (in dollars per share)	6.09	6.50
Vested and expected to vest (in dollars per share)	6.09	6.50
Exercisable (in dollars per share)	$ 5.71	$ 5.14
Remaining Contractual Life and Aggregate Intrinsic Value [Abstract]
Options outstanding, weighted average remaining contractual life	5 years 10 months 2 days	7 years 1 month 17 days
Options outstanding, aggregate intrinsic value	$ 3,977	$ 20,467,335
Vested and expected to vest, weighted average contractual life	5 years 10 months 2 days	7 years 1 month 17 days
Vested and expected to vest, aggregate intrinsic value	$ 3,977	$ 20,467,335
Exercisable, weighted average contractual life	5 years 8 months 1 day	6 years 2 months 16 days
Exercisable, aggregate intrinsic value	$ 3,977	$ 18,100,589
Unamortized Stock Compensation Expense [Abstract]
Period for recognition	2 years 6 months 7 days

Stock Options, RSU Activity (De

Stock Options, RSU Activity (Details)	12 Months Ended
	Dec. 31, 2018USD ($)$ / sharesshares
Stock Options [Abstract]
Number of shares of common stock received with an RSU (in shares)	1
Unamortized Stock Compensation Expense [Abstract]
Unamortized stock compensation expense | $	$ 236,534
RSUs [Member]
Number of RSUs [Roll Forward]
RSUs outstanding, beginning balance (in shares)	0
Granted (in shares)	601,394
Released (in shares)	(91,432)
Forfeited (in shares)	0
RSUs outstanding, ending balance (in shares)	509,962
Weighted Average Grant Price [Roll Forward]
RSUs outstanding, beginning balance (in dollars per share) | $ / shares	$ 0
Granted (in dollars per shares)) | $ / shares	0.85
Released (in dollars per share) | $ / shares	0.85
Forfeited (in dollars per share)) | $ / shares	0
RSUs outstanding, ending balance (in dollars per share) | $ / shares	$ 0.85
Unamortized Stock Compensation Expense [Abstract]
Period for recognition	7 months 13 days

Income Taxes (Details)

Income Taxes (Details) - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Effective Federal Income Tax Rate Reconciliation [Abstract]
Federal statutory rate	21.00%	34.00%
State taxes	0.40%	1.10%
Change in Statutory Rate	(0.00%)	(25.60%)
Permanent differences	(5.40%)	(11.00%)
Research and development	6.30%	21.20%
State taxes/ sale of NOL	6.40%	4.80%
Valuation allowance	(22.30%)	(19.70%)
Effective tax rate	6.40%	4.80%
Deferred Tax Assets [Abstract]
Federal net operating losses	$ 27,011,760	$ 21,312,121
State net operating losses	1,929,997	2,268,249
Stock options	1,847,546	1,608,750
Amortization	229,065	612,878
Accrued expense	813,073	7,027
Depreciation	826,109	18,498
Other	17,993	12,501
Total gross deferred tax assets	59,998,293	50,285,007
Less valuation allowance	(59,998,293)	(50,285,007)
Net deferred tax assets	0	0
Tax Cuts and Jobs Act [Abstract]
Tax benefit related to Tax Act		(13,600,000)
Income Tax Uncertainties [Abstract]
Uncertain tax positions	0
Federal [Member]
Tax Carryforwards [Abstract]
Net operating loss carryforwards	101,500,000
Operating loss carryforward generated	$ 27,100,000
Income Tax Uncertainties [Abstract]
Tax year under examination	2,015
Unrecognized tax benefits	$ 0
Accrued interest and penalties	$ 0
Federal [Member] | Minimum [Member]
Tax Carryforwards [Abstract]
Expiration date of net operating loss carryforwards	Dec. 31, 2029
Federal [Member] | Maximum [Member]
Tax Carryforwards [Abstract]
Expiration date of net operating loss carryforwards	Dec. 31, 2037
New Jersey [Member]
Tax Carryforwards [Abstract]
Net operating loss carryforwards	$ 27,100,000
NOL's sold	31,689,956	26,097,607
Proceeds from sale of NOL's and R&D tax credits	$ 2,824,228	2,586,057
New Jersey [Member] | Minimum [Member]
Tax Carryforwards [Abstract]
Expiration date of net operating loss carryforwards	Dec. 31, 2030
New Jersey [Member] | Maximum [Member]
Tax Carryforwards [Abstract]
Expiration date of net operating loss carryforwards	Dec. 31, 2038
Research and Development Credit [Member] | Federal [Member]
Tax Carryforwards [Abstract]
Tax credit carryforwards	$ 2,400,000
Research and Development Credit [Member] | New Jersey [Member]
Tax Carryforwards [Abstract]
Tax credit carryforwards	600,000
Tax credit carryforwards sold	131,214	424,466
Orphan Drug Credit [Member] | Federal [Member]
Tax Carryforwards [Abstract]
Tax credit carryforwards	24,400,000
Federal [Member]
Deferred Tax Assets [Abstract]
Tax credits	26,815,998	24,060,243
State [Member]
Deferred Tax Assets [Abstract]
Tax credits	$ 506,752	$ 384,740

Commitments and Contingencies_2

Commitments and Contingencies (Details)	1 Months Ended						12 Months Ended
	Jan. 31, 2019Lawsuit	Aug. 31, 2018USD ($)	Apr. 30, 2018USD ($)	Jul. 31, 2017USD ($)	Aug. 31, 2016USD ($)	Oct. 31, 2010USD ($)	Dec. 31, 2018USD ($)ft²Employee	Dec. 31, 2017USD ($)Employee	Jun. 30, 2017USD ($)
Commitments and Contingencies [Abstract]
Number of employees | Employee							10	37
Leases [Abstract]
Rent expense							$ 598,037	$ 602,925
Future Minimum Rental Payments Required under Operating Leases [Abstract]
2,019							604,541
2,020							603,371
2,021							530,385
2022 and after							0
Total minimum payments required							1,738,297
Subsequent Event [Member]
Commitments and Contingencies [Abstract]
Number of individual lawsuits in which the Company and Board have been named as defendants | Lawsuit	2
Number of putative class action lawsuits in which the Company and Board have been named as defendants | Lawsuit	2
Evonik [Member]
Commitments and Contingencies [Abstract]
Milestone payments paid					$ 1,000,000	$ 250,000
Evonik [Member] | Maximum [Member]
Commitments and Contingencies [Abstract]
Milestone payments to be paid						$ 14,750,000
Oakwood Amended and Restated Master Formulation Development Agreement [Member]
Commitments and Contingencies [Abstract]
Milestone payments paid		$ 2,375,000	$ 500,000	$ 1,500,000
Remaining milestone payments to have been paid no later than April 1, 2019			$ 2,500,000
Remaining milestone payments to be paid							$ 0
Royalty Term							12 years
Oakwood Amended and Restated Master Formulation Development Agreement [Member] | Maximum [Member]
Commitments and Contingencies [Abstract]
Milestone payments to be paid									$ 4,500,000
Oakwood Manufacturing and Supply Agreement [Member] | Maximum [Member]
Commitments and Contingencies [Abstract]
Milestone payments to be paid									$ 2,250,000
Employment Agreements [Member]
Commitments and Contingencies [Abstract]
Term for payment of severance benefits							24 months
Employment Agreements [Member] | Minimum [Member]
Commitments and Contingencies [Abstract]
Term for payment of severance benefits							12 months
Employment Agreements [Member] | Maximum [Member]
Commitments and Contingencies [Abstract]
Term for payment of severance benefits							18 months
Office Space in Berkeley Heights, New Jersey Under Lease Effective December 13, 2013 [Member]
Leases [Abstract]
Term of lease							63 months
Area of leased property | ft²							8,000
Write-off of leasehold improvements							$ 67,118
Office Space in Berkeley Heights, New Jersey Under Lease Entered into February 18, 2016 [Member]
Leases [Abstract]
Term of lease							63 months
Area of leased property | ft²							20,410

Debt (Details)

Debt (Details) - USD ($)	1 Months Ended	3 Months Ended	12 Months Ended
	Jun. 30, 2018	Mar. 31, 2018	Dec. 31, 2018	Dec. 31, 2017	May 23, 2017	Aug. 01, 2016
Loan and Security Agreement [Abstract]
Payments for debt issuance costs			$ 990,000	$ 0
Repayments of debt			20,000,000	$ 0
Outstanding debt			$ 0
Original Loan Agreement [Member]
Loan and Security Agreement [Abstract]
Payments for debt issuance costs		$ 90,000
Additional interest rate charged on due date		1.50%
Amended Loan Agreement [Member]
Loan and Security Agreement [Abstract]
Aggregate principal amount of borrowing capacity						$ 20,000,000
Payments for debt issuance costs	$ 900,000
Repayments of debt	20,000,000
Payment for accrued and unpaid interest	$ 100,000
First Term Loan under Amended Loan Agreement [Member]
Loan and Security Agreement [Abstract]
Face amount						$ 15,000,000
Second Term Loan under Amended Loan Agreement [Member]
Loan and Security Agreement [Abstract]
Face amount					$ 5,000,000

Retirement Plan (Details)

Retirement Plan (Details) - USD ($)	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2017
Retirement Plan [Abstract]
401(k) employer contribution	$ 159,559	$ 258,383