Marinus Pharmaceuticals (MRNS) 10-Q 8 Aug 19 2019 Q2 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	6 Months Ended
	Jun. 30, 2019	Aug. 07, 2019
Document and Entity Information [Abstract]
Entity Registrant Name	MARINUS PHARMACEUTICALS INC
Entity Central Index Key	0001267813
Document Type	10-Q
Document Period End Date	Jun. 30, 2019
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity Current Reporting Status	Yes
Entity Filer Category	Accelerated Filer
Entity Small Business	false
Entity Emerging Growth Company	true
Entity Ex Transition Period	true
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		52,578,833
Document Fiscal Year Focus	2019
Document Fiscal Period Focus	Q2

CONSOLIDATED BALANCE SHEETS

CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Jun. 30, 2019	Dec. 31, 2018
Current assets:
Cash and cash equivalents	$ 49,436	$ 67,727
Short-term investments	2,481	4,998
Prepaid expenses and other current assets	2,276	1,215
Total current assets	54,193	73,940
Property and equipment, net	2,381	1,294
Other assets	2,391
Total assets	58,965	75,234
Current liabilities:
Accounts payable	4,973	2,472
Accrued expenses	4,231	4,437
Total current liabilities	9,204	6,909
Other long-term liabilities	3,176
Total liabilities	12,380	6,909
Stockholders' equity:
Preferred stock, $0.001 par value; 25,000,000 shares authorized, no shares issued and outstanding
Common stock, $0.001 par value; 100,000,000 shares authorized, 52,583,856 issued and 52,554,625 outstanding at June 30, 2019 and 52,548,244 issued and 52,519,013 outstanding at December 31, 2018	53	53
Additional paid-in capital	252,891	249,727
Treasury stock at cost, 29,231 shares at June 30, 2019 and December 31, 2018
Accumulated other comprehensive loss		(2)
Accumulated deficit	(206,359)	(181,453)
Total stockholders’ equity	46,585	68,325
Total liabilities and stockholders’ equity	$ 58,965	$ 75,234

CONSOLIDATED BALANCE SHEETS (Pa

CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Jun. 30, 2019	Dec. 31, 2018
CONSOLIDATED BALANCE SHEETS
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized	25,000,000	25,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized	100,000,000	100,000,000
Common stock, shares issued	52,583,856	52,548,244
Common stock, shares outstanding	52,554,625	52,519,013
Treasury stock, shares	29,231	29,231

CONSOLIDATED STATEMENTS OF OPER

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018
Expenses:
Research and development	$ 10,010	$ 7,232	$ 18,882	$ 11,159
General and administrative	2,502	2,338	6,169	4,526
Loss from operations	(12,512)	(9,570)	(25,051)	(15,685)
Interest income	90	65	186	181
Other (expense) income	(1)	1	(41)
Net loss	$ (12,423)	$ (9,504)	$ (24,906)	$ (15,504)
Per share information:
Net loss per share of common stock-basic and diluted (in dollars per share)	$ (0.24)	$ (0.24)	$ (0.47)	$ (0.38)
Basic and diluted weighted average shares outstanding (in shares)	52,522,225	40,395,650	52,493,874	40,384,429
Net loss	$ (12,423)	$ (9,504)	$ (24,906)	$ (15,504)
Other comprehensive loss:
Unrealized gain (loss) on available-for-sale securities		38		27
Total comprehensive loss	$ (12,423)	$ (9,466)	$ (24,906)	$ (15,477)

CONSOLIDATED STATEMENTS OF CASH

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018
Cash flows from operating activities
Net loss	$ (24,906)	$ (15,504)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	112	65
Stock-based compensation expense	3,099	2,475
Loss on disposal of fixed assets	42
Noncash lease expense	107
Noncash lease liability interest	(143)
Amortization of discount on investments		(51)
Changes in operating assets and liabilities:
Prepaid expenses and other current assets	(1,095)	(60)
Accounts payable and accrued expenses	2,404	1,198
Net cash used in operating activities	(20,380)	(11,877)
Cash flows from investing activities
Maturities of short-term investments	5,000
Purchases of investments	(2,482)
Deposit on property and equipment	(6)
Purchases of property and equipment	(340)	(8)
Net cash provided by (used in) investing activities	2,172	(8)
Cash flows from financing activities
Proceeds from exercise of stock options	65	14
Financing costs	(148)
Repayments of short-term bank borrowings		(193)
Net cash used in financing activities	(83)	(179)
Net decrease in cash and cash equivalents	(18,291)	(12,064)
Cash and cash equivalents—beginning of period	67,727	33,531
Cash and cash equivalents—end of period	49,436	$ 21,467
Supplemental disclosure of cash flow information
Operating lease liability	3,357
Operating right-of-use asset	$ 2,458

CONSOLIDATED STATEMENTS OF STOC

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($)	Common Stock	Additional Paid-in Capital	Treasury Stock	Accumulated Other Comprehensive Loss	Accumulated Deficit	Total
Balance at Dec. 31, 2017	$ 41,000	$ 202,790,000	$ 29,231	$ (96,000)	$ (144,727,000)	$ 58,008,000
Balance (in shares) at Dec. 31, 2017	40,549,936
Increase (Decrease) in Stockholders' Equity (Deficit)
Stock-based compensation expense		1,127,000				1,127,000
Unrealized gain (loss) on investments				(11,000)		(11,000)
Net loss					(5,999,000)	(5,999,000)
Balance at Mar. 31, 2018	$ 41,000	203,917,000	29,231	(107,000)	(150,726,000)	53,125,000
Balance (in shares) at Mar. 31, 2018	40,549,936
Balance at Dec. 31, 2017	$ 41,000	202,790,000	29,231	(96,000)	(144,727,000)	58,008,000
Balance (in shares) at Dec. 31, 2017	40,549,936
Increase (Decrease) in Stockholders' Equity (Deficit)
Net loss						(15,504,000)
Balance at Jun. 30, 2018	$ 41,000	205,279,000	29,231	(69,000)	(160,231,000)	45,020,000
Balance (in shares) at Jun. 30, 2018	40,562,244
Balance at Mar. 31, 2018	$ 41,000	203,917,000	29,231	(107,000)	(150,726,000)	53,125,000
Balance (in shares) at Mar. 31, 2018	40,549,936
Increase (Decrease) in Stockholders' Equity (Deficit)
Stock-based compensation expense		1,348,000				1,348,000
Exercise of stock options		14,000				14,000
Exercise of stock options (in shares)	12,308
Unrealized gain (loss) on investments				38,000		38,000
Net loss					(9,505,000)	(9,505,000)
Net loss						(9,504,000)
Balance at Jun. 30, 2018	$ 41,000	205,279,000	29,231	(69,000)	(160,231,000)	45,020,000
Balance (in shares) at Jun. 30, 2018	40,562,244
Balance at Dec. 31, 2018	$ 53,000	249,727,000	29,231	(2,000)	(181,453,000)	68,325,000
Balance (in shares) at Dec. 31, 2018	52,548,244
Increase (Decrease) in Stockholders' Equity (Deficit)
Stock-based compensation expense		1,836,000				1,836,000
Exercise of stock options		65,000				65,000
Exercise of stock options (in shares)	55,812
Forfeiture of restricted stock (in shares)	(20,200)
Unrealized gain (loss) on investments				2,000		2,000
Net loss					(12,483,000)	(12,483,000)
Balance at Mar. 31, 2019	$ 53,000	251,628,000	29,231		(193,936,000)	57,745,000
Balance (in shares) at Mar. 31, 2019	52,583,856
Balance at Dec. 31, 2018	$ 53,000	249,727,000	29,231	$ (2,000)	(181,453,000)	68,325,000
Balance (in shares) at Dec. 31, 2018	52,548,244
Increase (Decrease) in Stockholders' Equity (Deficit)
Net loss						(24,906,000)
Balance at Jun. 30, 2019	$ 53,000	252,891,000	29,231		(206,359,000)	46,585,000
Balance (in shares) at Jun. 30, 2019	52,583,856
Balance at Mar. 31, 2019	$ 53,000	251,628,000	29,231		(193,936,000)	57,745,000
Balance (in shares) at Mar. 31, 2019	52,583,856
Increase (Decrease) in Stockholders' Equity (Deficit)
Stock-based compensation expense		1,263,000				1,263,000
Net loss					(12,423,000)	(12,423,000)
Balance at Jun. 30, 2019	$ 53,000	$ 252,891,000	$ 29,231		$ (206,359,000)	$ 46,585,000
Balance (in shares) at Jun. 30, 2019	52,583,856

Description of the Business and

Description of the Business and Liquidity	6 Months Ended
	Jun. 30, 2019
Description of the Business and Liquidity
Description of the Business and Liquidity	1. Description of the Business and Liquidity We are a clinical stage pharmaceutical company focused on developing and commercializing innovative therapeutics to treat epilepsy and neuropsychiatric disorders. Our clinical stage product candidate, ganaxolone, is a positive allosteric modulator of GABA A being developed in two different routes of administration: intravenous (IV) and oral formulation. The multiple dose forms are intended to maximize the therapeutic range of ganaxolone for adult and pediatric patient populations, in acute and chronic care, and both in-patient and self-administered settings. Ganaxolone exhibits anti-seizure, anti-depression and anti-anxiety actions via its effects on synaptic and extrasynaptic GABA A receptors. Liquidity We have not generated any product revenues and have incurred operating losses since inception. There is no assurance that profitable operations will ever be achieved, and if achieved, could be sustained on a continuing basis. In addition, development activities, clinical and preclinical testing, and commercialization of our product candidates will require significant additional financing. Our accumulated deficit as of June 30, 2019 was $206.4 million and we expect to incur substantial losses in future periods. We plan to finance our future operations with a combination of proceeds from the issuance of equity securities, the issuance of debt, potential collaborations and revenues from potential future product sales, if any. We have not generated positive cash flows from operations, and there are no assurances that we will be successful in obtaining an adequate level of financing for the development and commercialization of our planned product candidates. In connection with the closing of a secondary public offering during the fourth quarter of 2018, we issued a total of 12,000,000 shares of common stock resulting in aggregate net proceeds, after underwriting discounts and commissions and other offering expenses, of $42.1 million.

Summary of Significant Accounti

Summary of Significant Accounting Policies	6 Months Ended
	Jun. 30, 2019
Summary of Significant Accounting Policies
Summary of Significant Accounting Policies	2. Summary of Significant Accounting Policies Basis of Presentation The unaudited interim consolidated financial statements included herein have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (SEC). Accordingly, they do not include all information and disclosures necessary for a presentation of our financial position, results of operations and cash flows in conformity with generally accepted accounting principles in the United States of America (GAAP) for annual financial statements. In the opinion of management, these unaudited interim consolidated financial statements reflect the elimination of all intercompany accounts and transactions and all adjustments, consisting primarily of normal recurring accruals, necessary for a fair presentation of our financial position and results of operations and cash flows for the periods presented. The results of operations for interim periods are not necessarily indicative of the results for the full year. These unaudited interim consolidated financial statements should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2018 and accompanying notes thereto included in our annual report on Form 10-K filed with the SEC on March 12, 2019. Use of Estimates The preparation of financial statements in conformity with 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 income and expenses during the reporting period. Actual results could differ from such estimates. Recent Accounting Pronouncements In February 2016, the Financial Accounting Standards Board (FASB) established Topic 842, Leases , by issuing Accounting Standards Update (ASU) No. 2016-02, which requires lessees to recognize leases on-balance sheet and disclose key information about leasing arrangements. Topic 842 was subsequently amended by ASU No. 2018-01, Land Easement Practical Expedient for Transition to Topic 842 ; ASU No. 2018-10, Codification Improvements to Topic 842, Leases ; and ASU No. 2018-11, Targeted Improvements . The new standard establishes a right-of-use model that requires a lessee to recognize a right-of-use (ROU) asset and lease liability on the balance sheet for all leases with a term longer than 12 months , and l eases are classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the income statement. We adopted ASU 2016-02 in the first quarter of 2019 utilizing the modified retrospective transition method on the effective date. Consequently, financial information has not been updated and the disclosures required under the new standard have not been provided for dates and periods before January 1, 2019. Upon adoption, we elected the ‘package of practical expedients,’ which permitted us not to reassess under the new standard our prior conclusions about lease identification, lease classification and initial direct costs. We did not elect the use-of-hindsight practical expedient nor the practical expedient pertaining to land easements, the latter not being applicable to us . The adoption of ASU 2016-02 on January 1, 2019 resulted in the recognition of right-of-use assets of $2.5 million and lease liabilities for operating leases of $3.4 million on our interim consolidated balance sheets, with no material impact to our interim consolidated statements of operations, cash flows or stockholders’ equity. The operating lease liabilities were determined based on the present value of the remaining minimum retal payments and the operating lease asset was determined based on the value of the lease liability, adjusted for the lease incentive of $0.9 million. See Note 8 for further information regarding the impact of the adoption of ASU 2016-02 on our interim consolidated financial statements.

Fair Value Measurements

Fair Value Measurements	6 Months Ended
	Jun. 30, 2019
Fair Value Measurements
Fair Value Measurements	3. Fair Value Measurements FASB accounting guidance defines fair value as the price that would be received to sell an asset or paid to transfer a liability (the exit price) in an orderly transaction between market participants at the measurement date. The accounting guidance outlines a valuation framework and creates a fair value hierarchy in order to increase the consistency and comparability of fair value measurements and the related disclosures. In determining fair value, we use quoted prices and observable inputs. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from independent sources. The fair value hierarchy is broken down into three levels based on the source of inputs as follows: · Level 1 — Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities. · Level 2 — Valuations based on observable inputs and quoted prices in active markets for similar assets and liabilities. · Level 3 — Valuations based on inputs that are unobservable and models that are significant to the overall fair value measurement. If the inputs used to measure fair value fall within different levels of the hierarchy, the category level is based on the lowest priority level input that is significant to the fair value measurement of the instrument. Valuation Techniques - Level 2 Inputs We estimate the fair values of our financial instruments categorized as level 2 in the fair value hierarchy, including U.S. Treasury securities, by taking into consideration valuations obtained from third-party pricing services. The pricing services use industry standard valuation models, including both income- and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, benchmark yields, issuer credit spreads, benchmark securities, and other observable inputs. We obtain a single price for each financial instrument and do not adjust the prices obtained from the pricing service. We validate the prices provided by our third-party pricing services by reviewing their pricing methods, obtaining market values from other pricing sources and comparing them to the share prices presented by the third-party pricing services. After completing our validation procedures, we did not adjust or override any fair value measurements provided by our third-party pricing services as of June 30, 2019. The following fair value hierarchy table presents information about each major category of our financial assets and liabilities measured at fair value on a recurring basis (in thousands): Level 1 Level 2 Level 3 Total June 30, 2019 Assets Money market funds (cash equivalents) $ 13,807 $ — $ — $ 13,807 Certificates of deposit 988 — — 988 U.S. Treasury securities — 1,493 — 1,493 Total assets $ 14,795 $ 1,493 $ — $ 16,288 December 31, 2018 Assets Money market funds (cash equivalents) $ 14,049 $ — $ — $ 14,049 U.S. Treasury securities — 4,998 — 4,998 Total assets $ 14,049 $ 4,998 $ — $ 19,047

Accrued Expenses

Accrued Expenses	6 Months Ended
	Jun. 30, 2019
Accrued Expenses
Accrued Expenses	4. Accrued Expenses Accrued expenses consisted of the following (in thousands): June 30, December 31, 2019 2018 Payroll and related costs $ 1,483 $ 1,364 Clinical trials and drug development 1,945 2,781 Professional fees 343 204 Short-term lease liabilities 321 — Other 139 88 Total accrued expenses $ 4,231 $ 4,437

Property and Equipment

Property and Equipment	6 Months Ended
	Jun. 30, 2019
Property and Equipment
Property and Equipment	5. Property and Equipment Property and equipment consisted of the following (in thousands): June 30, December 31, 2019 2018 Laboratory equipment $ 1,756 $ 1,756 Leasehold improvements 899 — Office furniture and equipment 376 148 3,031 1,904 Less: accumulated depreciation (650) (610) $ 2,381 $ 1,294

Loss Per Share of Common Stock

Loss Per Share of Common Stock	6 Months Ended
	Jun. 30, 2019
Loss Per Share of Common Stock
Loss Per Share of Common Stock	6. Loss Per Share of Common Stock Basic loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during each period. Diluted loss per share includes the effect, if any, from the potential exercise or conversion of securities, such as convertible preferred stock, convertible notes payable, warrants, stock options, and unvested restricted stock, which would result in the issuance of incremental shares of common stock. In computing the basic and diluted net loss per share applicable to common stockholders, the weighted average number of shares remains the same for both calculations due to the fact that when a net loss exists, dilutive shares are not included in the calculation. These potentially dilutive securities are more fully described in Note 7, and summarized in the table below: June 30, 2019 2018 Restricted stock 32,400 117,867 Stock options 6,618,571 4,741,109 6,650,971 4,858,976

Stockholders' Equity

Stockholders' Equity	6 Months Ended
	Jun. 30, 2019
Stockholders' Equity
Stockholders' Equity	7. Stockholders’ Equity In 2005, we adopted the 2005 Stock Option and Incentive Plan (2005 Plan) that authorizes us to grant options, restricted stock and other equity-based awards. As of June 30, 2019, 330,450 options to purchase shares of common stock were outstanding pursuant to grants in connection with the 2005 Plan. No additional shares are available for issuance under the 2005 Plan. In August 2014, we adopted our 2014 Equity Incentive Plan, amended in May 2017 (2014 Plan), that authorizes us to grant options, restricted stock, and other equity-based awards, subject to adjustment in accordance with the 2014 Plan. The amount, terms of grants, and exercisability provisions are determined and set by our board of directors. As of June 30, 2019, 5,681,121 options to purchase shares of common stock and 32,400 shares of restricted stock were outstanding pursuant to grants in connection with the 2014 Plan, and 2,018,144 shares of common stock were available for future issuance. The amount, terms of grants, and exercisability provisions are determined and set by our board of directors. Stock Options There were 6,618,571 stock options outstanding as of June 30, 2019 at a weighted-average exercise price of $5.08 per share. During thethree and six months ended June 30, 2019, 1,974,000 options were granted to employees and directors at a weighted-average exercise price of $3.90 per share. Of the options granted, 1,658,000 options were granted pursuant to the 2014 Plan and 316,000 were granted outside of the 2014 Plan as inducements for new employees. Total compensation cost recognized for all stock option awards in the statements of operations is as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Research and development $ 611 $ 503 $ 1,260 $ 816 General and administrative 642 828 1,819 1,607 Total $ 1,253 $ 1,331 $ 3,079 $ 2,423 Restricted Stock All issued and outstanding restricted shares of common stock are time-based, and become vested between one and three years after the grant date. Compensation expense is recorded ratably over the requisite service period. Compensation expense related to restricted stock is measured based on the fair value using the closing market price of our common stock on the date of the grant. We did not issue any restricted shares of common stock during the six months ended June 30, 2019 or 2018. As of June 30, 2019 there were 32,400 restricted shares of common stock outstanding, and 52,600 shares vested during the six months ended June 30, 2019. Total compensation cost recognized for all restricted stock awards in the statements of operations is as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Research and development $ 5 $ 5 $ 10 $ 12 General and administrative 5 11 10 40 Total $ 10 $ 16 $ 20 $ 52

Leases

Leases	6 Months Ended
	Jun. 30, 2019
Leases
Leases	8. Leases We have entered into operating leases for real estate. These leases have terms which range from 36 to 78 months, and include renewal terms which can extend the lease terms by 24 to 60 months, which are included in the lease term when it is reasonably certain that we will exercise the option. As of June 30, 2019, our operating leases had a weighted average remaining lease term of 74 months. These ROU assets are included in "Other assets" on our interim consolidated balance sheet as of June 30, 2019, and represent our right to use the underlying asset for the lease term. Our obligations to make lease payments are included in "Accrued expenses" and "Other long-term liabilities" on our interim consolidated balance sheet as of June 30, 2019. The ROU assets are initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date, plus any initial direct costs incurred, less any lease incentives received. The ROU assets are subsequently measured throughout the lease term at the carrying amount of the lease liability, plus initial direct costs, plus (minus) any prepaid (accrued) lease payments, less the unamortized balance of lease incentives received. Our ROU assets as of January 1, 2019 have been adjusted for $0.9 million in lease incentives. Based on the present value of the lease payments for the remaining lease term of our existing leases, we initially recognized ROU assets of $2.5 million and lease liabilities for operating leases of $3.4 million during the first quarter of 2019. Operating lease right-of-use assets and liabilities commencing after January 1, 2019 are recognized at commencement date based on the present value of lease payments over the lease term. As of June 30, 2019, ROU assets and operating lease liabilities were $2.4 million and $3.5 million, respectively. We have entered into various short-term operating leases, primarily for clinical study equipment, with an initial term of twelve months or less. These leases are not recorded on our interim consolidated balance sheets. All operating lease expense is recognized on a straight-line basis over the lease term. During the three and six months ended June 30, 2019, we recognized $0.2 million and $0.4 million in total lease costs, respectively, which included less than $0.1 million in short-term lease costs related to short-term operating leases in both periods. Because the rate implicit in each lease is not readily determinable, we use our incremental borrowing rate to determine the present value of the lease payments. The weighted average incremental borrowing rate used to determine the initial value of right-of-use assets and lease liabilities was 11.0%, derived from a corporate yield curve based on a synthetic credit rating model using a market signal analysis. We have certain contracts for real estate which may contain lease and non-lease components which we have elected to treat as a single lease component. ROU assets for operating leases are periodically reduced by impairment losses. We use the long-lived assets impairment guidance in ASC Subtopic 360-10, Property, Plant, and Equipment – Overall, to determine whether an ROU asset is impaired, and if so, the amount of the impairment loss to recognize. As of June 30, 2019, we have not recognized any impairment losses for our ROU assets. We monitor for events or changes in circumstances that require a reassessment of one of its leases. When a reassessment results in the remeasurement of a lease liability, a corresponding adjustment is made to the carrying amount of the corresponding ROU asset unless doing so would reduce the carrying amount of the ROU asset to an amount less than zero. In that case, the amount of the adjustment that would result in a negative ROU asset balance is recorded in profit or loss. Maturities of operating lease liabilities as of June 30, 2019 were as follows (in thousands): Remaining six months of 2019 $ 206 2020 807 2021 818 2022 807 2023 823 Thereafter 1,482 4,943 Less: imputed interest (1,446) Total lease liabilities $ 3,497 Current operating lease liabilities $ 321 Non-current operating lease liabilities 3,176 Total lease liabilities $ 3,497

Commitments

Commitments	6 Months Ended
	Jun. 30, 2019
Commitments
Commitments	9. Commitments Severance Arrangement In March 2019, we entered into a Severance Agreement and General Release (Severance Agreement) with Christopher M. Cashman (Cashman), our former Chief Executive Officer. In connection with this Severance Agreement, we agreed to pay certain severance benefits for one year to Cashman, including salary and benefits continuation and a prorated bonus totaling $0.6 million. As of June 30, 2019, $0.4 million in severance benefits remained unpaid. In addition, certain of Cashman’s outstanding stock option agreements were modified to accelerate vesting and extend the exercise period, resulting in additional compensation cost of $0.4 million.

Investments

Investments	6 Months Ended
	Jun. 30, 2019
Investments
Investments	10. Investments As of June 30, 2019, our investments consisted of U.S. Treasury securities, maturing at various dates through December 2019, and certificates of deposit with various financial institutions maturing in March 2020. U.S. Treasury securities are classified as short- or long-term investments on our consolidated balance sheets based on maturity and certificates of deposit are classified as short-term investments on our consolidated balance sheets. U.S Treasury securities are classified as available-for-sale and are recorded at fair value. Certificates of deposits are classified as held-to-maturity and are recorded at amortized cost, which approximates fair value. Total amortized cost and fair value were each $1.5 million as of June 30, 2019. Based on review of these securities, we believe that the cost basis of these available-for-sale securities is recoverable and that there were no other-than-temporary impairments on these securities as of June 30, 2019.

Summary of Significant Accoun_2

Summary of Significant Accounting Policies (Policies)	6 Months Ended
	Jun. 30, 2019
Summary of Significant Accounting Policies
Basis of Presentation	Basis of Presentation The unaudited interim consolidated financial statements included herein have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (SEC). Accordingly, they do not include all information and disclosures necessary for a presentation of our financial position, results of operations and cash flows in conformity with generally accepted accounting principles in the United States of America (GAAP) for annual financial statements. In the opinion of management, these unaudited interim consolidated financial statements reflect the elimination of all intercompany accounts and transactions and all adjustments, consisting primarily of normal recurring accruals, necessary for a fair presentation of our financial position and results of operations and cash flows for the periods presented. The results of operations for interim periods are not necessarily indicative of the results for the full year. These unaudited interim consolidated financial statements should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2018 and accompanying notes thereto included in our annual report on Form 10-K filed with the SEC on March 12, 2019.
Use of Estimates	Use of Estimates The preparation of financial statements in conformity with 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 income and expenses during the reporting period. Actual results could differ from such estimates.
Recent Accounting Pronouncements	Recent Accounting Pronouncements In February 2016, the Financial Accounting Standards Board (FASB) established Topic 842, Leases , by issuing Accounting Standards Update (ASU) No. 2016-02, which requires lessees to recognize leases on-balance sheet and disclose key information about leasing arrangements. Topic 842 was subsequently amended by ASU No. 2018-01, Land Easement Practical Expedient for Transition to Topic 842 ; ASU No. 2018-10, Codification Improvements to Topic 842, Leases ; and ASU No. 2018-11, Targeted Improvements . The new standard establishes a right-of-use model that requires a lessee to recognize a right-of-use (ROU) asset and lease liability on the balance sheet for all leases with a term longer than 12 months , and l eases are classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the income statement. We adopted ASU 2016-02 in the first quarter of 2019 utilizing the modified retrospective transition method on the effective date. Consequently, financial information has not been updated and the disclosures required under the new standard have not been provided for dates and periods before January 1, 2019. Upon adoption, we elected the ‘package of practical expedients,’ which permitted us not to reassess under the new standard our prior conclusions about lease identification, lease classification and initial direct costs. We did not elect the use-of-hindsight practical expedient nor the practical expedient pertaining to land easements, the latter not being applicable to us . The adoption of ASU 2016-02 on January 1, 2019 resulted in the recognition of right-of-use assets of $2.5 million and lease liabilities for operating leases of $3.4 million on our interim consolidated balance sheets, with no material impact to our interim consolidated statements of operations, cash flows or stockholders’ equity. The operating lease liabilities were determined based on the present value of the remaining minimum retal payments and the operating lease asset was determined based on the value of the lease liability, adjusted for the lease incentive of $0.9 million. See Note 8 for further information regarding the impact of the adoption of ASU 2016-02 on our interim consolidated financial statements.

Fair Value Measurements (Tables

Fair Value Measurements (Tables)	6 Months Ended
	Jun. 30, 2019
Fair Value Measurements
Summary of major categories of financial assets and liabilities measured at fair value on a recurring basis	The following fair value hierarchy table presents information about each major category of our financial assets and liabilities measured at fair value on a recurring basis (in thousands): Level 1 Level 2 Level 3 Total June 30, 2019 Assets Money market funds (cash equivalents) $ 13,807 $ — $ — $ 13,807 Certificates of deposit 988 — — 988 U.S. Treasury securities — 1,493 — 1,493 Total assets $ 14,795 $ 1,493 $ — $ 16,288 December 31, 2018 Assets Money market funds (cash equivalents) $ 14,049 $ — $ — $ 14,049 U.S. Treasury securities — 4,998 — 4,998 Total assets $ 14,049 $ 4,998 $ — $ 19,047

Accrued Expenses (Tables)

Accrued Expenses (Tables)	6 Months Ended
	Jun. 30, 2019
Accrued Expenses
Schedule of accrued expenses	Accrued expenses consisted of the following (in thousands): June 30, December 31, 2019 2018 Payroll and related costs $ 1,483 $ 1,364 Clinical trials and drug development 1,945 2,781 Professional fees 343 204 Short-term lease liabilities 321 — Other 139 88 Total accrued expenses $ 4,231 $ 4,437

Property and Equipment (Tables)

Property and Equipment (Tables)	6 Months Ended
	Jun. 30, 2019
Property and Equipment
Schedule of property and equipment	Property and equipment consisted of the following (in thousands): June 30, December 31, 2019 2018 Laboratory equipment $ 1,756 $ 1,756 Leasehold improvements 899 — Office furniture and equipment 376 148 3,031 1,904 Less: accumulated depreciation (650) (610) $ 2,381 $ 1,294

Loss Per Share of Common Stock

Loss Per Share of Common Stock (Tables)	6 Months Ended
	Jun. 30, 2019
Loss Per Share of Common Stock
Schedule of antidilutive securities excluded from the computation of diluted weighted average shares outstanding	June 30, 2019 2018 Restricted stock 32,400 117,867 Stock options 6,618,571 4,741,109 6,650,971 4,858,976

Stockholders' Equity (Tables)

Stockholders' Equity (Tables)	6 Months Ended
	Jun. 30, 2019
Stock options
Schedule of total compensation cost recognized in the statement of operations	Total compensation cost recognized for all stock option awards in the statements of operations is as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Research and development $ 611 $ 503 $ 1,260 $ 816 General and administrative 642 828 1,819 1,607 Total $ 1,253 $ 1,331 $ 3,079 $ 2,423
Restricted stock
Schedule of total compensation cost recognized in the statement of operations	Total compensation cost recognized for all restricted stock awards in the statements of operations is as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Research and development $ 5 $ 5 $ 10 $ 12 General and administrative 5 11 10 40 Total $ 10 $ 16 $ 20 $ 52

Leases (Tables)

Leases (Tables)	6 Months Ended
	Jun. 30, 2019
Leases
Schedule of maturities of operating lease liabilities	Remaining six months of 2019 $ 206 2020 807 2021 818 2022 807 2023 823 Thereafter 1,482 4,943 Less: imputed interest (1,446) Total lease liabilities $ 3,497 Current operating lease liabilities $ 321 Non-current operating lease liabilities 3,176 Total lease liabilities $ 3,497

Description of the Business a_2

Description of the Business and Liquidity (Details) - USD ($) $ in Thousands	3 Months Ended
	Dec. 31, 2018	Jun. 30, 2019
Liquidity
Accumulated deficit	$ (181,453)	$ (206,359)
Secondary public offering
Liquidity
Issuance of common stock in connection with secondary public offering (in shares)	12,000,000
Proceeds from issuance of common stock, net of issuance costs	$ 42,100

Summary of Significant Accoun_3

Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands	Jun. 30, 2019	Jan. 01, 2019
Summary of Significant Accounting Policies
Right-of-use assets	$ 2,400	$ 2,500
Operating lease liabilities	3,497	3,400
ROU adjustment for lease incentives	$ 900	$ 900

Fair Value Measurements (Detail

Fair Value Measurements (Details) - Recurring basis - USD ($) $ in Thousands	Jun. 30, 2019	Dec. 31, 2018
Assets
Total assets	$ 16,288	$ 19,047
U.S. Treasury securities
Assets
Investments	1,493	4,998
Money market funds
Assets
Cash and cash equivalents, fair value	13,807	14,049
Certificates of deposit
Assets
Investments	988
Level 1
Assets
Total assets	14,795	14,049
Level 1 | Money market funds
Assets
Cash and cash equivalents, fair value	13,807	14,049
Level 1 | Certificates of deposit
Assets
Investments	988
Level 2
Assets
Total assets	1,493	4,998
Level 2 | U.S. Treasury securities
Assets
Investments	$ 1,493	$ 4,998

Accrued Expenses (Details)

Accrued Expenses (Details) - USD ($) $ in Thousands	Jun. 30, 2019	Dec. 31, 2018
Accrued Expenses
Payroll and related costs	$ 1,483	$ 1,364
Clinical studies and drug development	1,945	2,781
Professional fees	343	204
Short-term lease liabilities	321
Other	139	88
Total accrued expenses	$ 4,231	$ 4,437

Property and Equipment (Details

Property and Equipment (Details) - USD ($) $ in Thousands	Jun. 30, 2019	Dec. 31, 2018
Property and equipment
Property and equipment, gross	$ 3,031	$ 1,904
Less: accumulated depreciation	(650)	(610)
Property and equipment	2,381	1,294
Laboratory equipment
Property and equipment
Property and equipment, gross	1,756	1,756
Leasehold improvements
Property and equipment
Property and equipment, gross	899
Office furniture and equipment
Property and equipment
Property and equipment, gross	$ 376	$ 148

Loss Per Share of Common Stoc_2

Loss Per Share of Common Stock (Details) - shares	6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018
Loss per share of common stock
Antidilutive securities excluded from the computation of diluted weighted average shares outstanding (in shares)	6,650,971	4,858,976
Restricted stock
Loss per share of common stock
Antidilutive securities excluded from the computation of diluted weighted average shares outstanding (in shares)	32,400	117,867
Stock options.
Loss per share of common stock
Antidilutive securities excluded from the computation of diluted weighted average shares outstanding (in shares)	6,618,571	4,741,109

Stockholders' Equity (Details)

Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018
Stock options
Stock option and incentive plans
Total compensation cost	$ 1,253	$ 1,331	$ 3,079	$ 2,423
Stock Options
Outstanding (in shares)	6,618,571		6,618,571
Outstanding, weighted-average exercise price (in dollars per share)	$ 5.08		$ 5.08
Granted (in shares)	1,974,000		1,974,000
Granted (in dollars per share)	$ 3.90		$ 3.90
Stock options | Research and development
Stock option and incentive plans
Total compensation cost	$ 611	503	$ 1,260	816
Stock options | General and administrative
Stock option and incentive plans
Total compensation cost	642	828	1,819	1,607
Restricted stock
Stock option and incentive plans
Total compensation cost	$ 10	16	$ 20	52
Shares
Outstanding (in shares)	32,400		32,400
Issued (in shares)			0
Vested (in shares)			52,600
Restricted stock | Minimum
Stock option and incentive plans
Vesting period			1 year
Restricted stock | Maximum
Stock option and incentive plans
Vesting period			3 years
Restricted stock | Research and development
Stock option and incentive plans
Total compensation cost	$ 5	5	$ 10	12
Restricted stock | General and administrative
Stock option and incentive plans
Total compensation cost	$ 5	$ 11	$ 10	$ 40
2005 Plan
Stock option and incentive plans
Common stock reserved for issuance (in shares)	0		0
2005 Plan | Stock options
Stock Options
Outstanding (in shares)	330,450		330,450
2014 Plan
Stock option and incentive plans
Common stock reserved for issuance (in shares)	2,018,144		2,018,144
2014 Plan | Stock options
Stock Options
Outstanding (in shares)	5,681,121		5,681,121
Granted (in shares)	1,658,000		1,658,000
2014 Plan | Restricted stock
Shares
Outstanding (in shares)	32,400		32,400
Equity Incentive Plan, Employee Inducments | Stock options
Stock Options
Granted (in shares)	316,000		316,000

Leases (Details)

Leases (Details) - USD ($) $ in Thousands	3 Months Ended	6 Months Ended
	Jun. 30, 2019	Jun. 30, 2019	Jan. 01, 2019
Leases
Weighted average remaining lease term	77 months	77 months
ROU adjustment for lease incentives	$ 900	$ 900	$ 900
Right-of-use assets	2,400	2,400	2,500
Operating lease liabilities	3,497	3,497	3,400
Total lease costs	$ 200	$ 400
Weighted-average incremental borrowing rate used to determine right-of-use assets and lease liabilities	11.00%	11.00%
Maturities of operating lease liabilities
Remaining six months of 2019	$ 206	$ 206
2020	807	807
2021	818	818
2022	807	807
2023	823	823
Thereafter	1,482	1,482
Total lease payments	4,943	4,943
Less: imputed interest	(1,446)	(1,446)
Total lease liabilities	3,497	3,497	$ 3,400
Current operating lease liabilities	321	321
Non-current operating lease liabilities	$ 3,176	$ 3,176
Minimum
Leases
Operating lease agreement term	36 months	36 months
Operating lease renewal term	24 months	24 months
Maximum
Leases
Operating lease agreement term	78 months	78 months
Operating lease renewal term	60 months	60 months
Short-term operating lease costs	$ 100	$ 100

Commitments (Details)

Commitments (Details) - Severance Agreement $ in Millions	1 Months Ended
	Mar. 31, 2019USD ($)
Salary and benefits continuation and prorated bonus	$ 0.6
Unpaid benefits	0.4
Accelerated vesting of stock option agreements	$ 0.4

Investments (Details)

Investments (Details) $ in Millions	Jun. 30, 2019USD ($)
Investments
Total amortized cost	$ 1.5
Total fair value	$ 1.5