kmph20170630

Common shares reserved for future issuance (in shares)

Dec. 31, 2018

42,023,072

13,641,913

Series A Preferred Stock [Member]

Common shares reserved for future issuance (in shares)

1,112,334

Series B-1 Convertible Preferred Stock [Member]

Common shares reserved for future issuance (in shares)

831,051

Warrant [Member]

Common shares reserved for future issuance (in shares)

2,423,077

2,527,763

Share-based Payment Arrangement [Member]

Common shares reserved for future issuance (in shares)

4,620,891

3,704,755

Possible Future Issuances Under Equity Incentive Plans [Member]

Common shares reserved for future issuance (in shares)

675,966

648,272

2021 Notes [Member]

Common shares reserved for future issuance (in shares)

2,727,820

4,481,182

Optional Exchange Principal Amount [Member]

Common shares reserved for future issuance (in shares)

^[1]

28,439,015

Convertible Notes Payable [Member]

Common shares reserved for future issuance (in shares)

1,192,918

1,167,607

[1]	Represents the aggregate number of shares of Common Stock issuable (i) in exchange of the Optional Exchange Principal Amount, or (ii) upon conversion of the Series B-2 Preferred Stock issuable in exchange of the Optional Exchange Principal Amount.

XML 22 R9.htm IDEA: XBRL DOCUMENT

Note C - Debt Obligations

Debt Disclosure [Text Block]

C.	Debt Obligations

Deerfield Facility Agreement

June

2014,

the Company entered into a

$60

million facility agreement (the “Deerfield Facility Agreement”) with Deerfield Private Design Fund III, LP (“Deerfield”). The

first

payment to the Company under the terms of the Deerfield Facility Agreement consisted of a term loan of

$15

million (the “Term Note”) and a senior secured loan of

$10

million (the “Deerfield Convertible Note”). As of

June 30, 2016,

Deerfield was

longer obligated to provide the Company any additional disbursements under the Deerfield Facility Agreement. All loans issued under the Deerfield Facility Agreement originally bore interest at

9.75%

per annum, and now bear interest at

6.75%

per annum. Deerfield

convert any portion of the outstanding principal and any accrued but unpaid interest on the Deerfield Convertible Note into shares of the Company’s common stock at an initial conversion price of

$5.85

per share (the "Deerfield Note Put Option").

The Company also issued to Deerfield a warrant to purchase

14,423,076

shares of Series D redeemable convertible preferred stock (“Series D Preferred”) at an exercise price of

$0.78

per share, which is exercisable until

June

2024

(the “Deerfield Warrant”). Upon completion of the Company's initial public offering (the "IPO"), the Deerfield Warrant automatically converted into a warrant to purchase

1,923,077

shares of the Company’s common stock at an exercise price of

$5.85

per share. This warrant qualifies as a participating security under ASC Topic

260,

Earnings per Share,

and is treated as such in the net loss per share calculation (Note I). If a Major Transaction occurs, as defined below, Deerfield

require the Company to redeem the Deerfield Warrant for a cash amount equal to the Black-Scholes value of the portion of the Deerfield Warrant to be redeemed (the “Warrant Put Option”). A Major Transaction is (i) a consolidation, merger, exchange of shares, recapitalization, reorganization, business combination or other similar event; (ii) the sale or transfer in

transaction or a series of related transactions of all or substantially all of the assets of the Company; (iii) a

-party purchase, tender or exchange offer made to the holders of outstanding shares, such that following such purchase, tender or exchange offer a change of control has occurred; (iv) the liquidation, bankruptcy, insolvency, dissolution or winding-up affecting the Company; (v) the shares of the Company’s common stock cease to be listed on any eligible market; and (vi) at any time, the shares of the Company’s common stock cease to be registered under Section

of the Securities Exchange Act of

1934,

as amended (the “Exchange Act”).

In addition, the Company issued to Deerfield

1,923,077

shares of Series D Preferred as consideration for the loans provided to the Company under the Deerfield Facility Agreement. Upon completion of the IPO, these shares automatically reclassified into

256,410

shares of the Company’s common stock. The Company recorded the fair value of the shares of Series D Preferred of

$1.5

million, to debt issuance costs on the date of issuance. The Company recorded the fair value of the Deerfield Warrant and the embedded Warrant Put Option to debt discount on the date of issuance. The debt issuance costs and debt discount are amortized over the term of the related debt and the expense is recorded as interest expense related to amortization of debt issuance costs and discount in the condensed statements of operations.

Pursuant to the Deerfield Facility Agreement, the Company

enter into specified transactions, including a debt financing in the aggregate value of

$750,000

or more, other than permitted indebtedness under the Deerfield Facility Agreement, a merger, an asset sale or any other change of control transaction or any joint venture, partnership or other profit sharing arrangement, without the prior approval of Deerfield. Additionally, if the Company were to enter into a major transaction, including a merger, consolidation, sale of substantially all of its assets or other change of control transaction, Deerfield would have the ability to demand that prior to consummation of such transaction the Company repay all outstanding principal and accrued interest of any notes issued under the Deerfield Facility Agreement. Under each warrant issued pursuant to the Deerfield Facility Agreement, Deerfield has the right to demand that the Company redeem the warrant for a cash amount equal to the Black-Scholes value of a portion of the warrant upon the occurrence of specified events, including a merger, an asset sale or any other change of control transaction.

The Company originally had to repay

of the outstanding principal amount of all debt issued under the Deerfield Facility Agreement on the

fourth

anniversaries of the Deerfield Facility Agreement. On September

fifth

the Company entered into an exchange agreement and amendment to facility agreement (discussed below) with Deerfield and Deerfield Special Situations Fund, L.P., which amended the Deerfield Facility Agreement, in order to (i) reduce the interest rate applicable under the Deerfield Facility Agreement from

9.75%

6.75%,

(ii) provide for “payment in kind” of interest on the Loans (as defined in the Deerfield Facility Agreement), and (iii) defer the Loan payments due pursuant to the Deerfield Facility Agreement until June

2020.

The Company is also obligated to repay

$3,333,333

of principal, as well as interest capitalized from the date of the amendment through the payment date of

February

14,

2020.

The Company prepaid all outstanding interest and principal on the Term Note in

February 2016. The outstanding principal amount due on the fourth anniversary of the Deerfield Facility Agreement and the related accrued but unpaid interest as of such date was converted in common stock of the Company in accordance with the provisions of the Deerfield Convertible Note, as amended. Refer to the section entitled Facility Agreement Waiver and Fifth Amendment to Senior Secured Convertible Note below.

Interest accrued on outstanding debt under the Deerfield Facility Agreement is due quarterly in arrears. Upon notice to Deerfield, the Company had the option to have

of such scheduled interest payments added to the outstanding principal amount of the debt issued under the Deerfield Facility Agreement, provided that all such interest was due on

July

2016.

The Company elected this option on all

eight

of the scheduled interest payments through

June 30, 2016.

The accrued interest added to outstanding principal, was paid to Deerfield on

July 1, 2016.

First Amendment to Facility Agreement, Senior Secured Convertible Note and Warrant

In connection with the IPO, in

March 2015,

the Company entered into a First Amendment (the “First Amendment) to the Deerfield Facility Agreement, the Deerfield Convertible Note and Deerfield Warrant, by and between the Company and Deerfield. The First Amendment, among other things, clarified that all references to the conversion of shares of Series D Preferred into the Company’s common stock in the Deerfield Facility Agreement, the Deerfield Convertible Note and Deerfield Warrant shall include any reclassification of the outstanding shares of Series D Preferred into shares of the Company’s common stock.

Second Amendment to Senior Secured Convertible Note and Warrant

January 2016,

the Company entered into a Second Amendment (the “Second Amendment”) to the Deerfield Convertible Note and Deerfield Warrant, by and between the Company and Deerfield. The Second Amendment, among other things, clarified the calculation of an anti-dilution adjustment of the conversion price and exercise price of the Deerfield Convertible Note and Deerfield Warrant, respectively, in the event that the Company effects a firm commitment underwritten public offering of its securities.

Issuance of

5.50%

Senior Convertible Notes and Third Amendment to Facility Agreement, Senior Secured Convertible Note and Warrant

February 2016,

the Company issued

$86.3

million aggregate principal amount of its

5.50%

Senior Convertible Notes due

Notes”) to Cowen and RBC Capital Markets, LLC, as representatives of the several initial purchasers (the “Initial Purchasers”), who subsequently resold the

(the

“2021

Notes to qualified institutional buyers (the “Note Offering”) in reliance on the exemption from registration provided by Rule

144A

under the Securities Act.

The net proceeds from the Note Offering were approximately

$82.8

million, after deducting the Initial Purchasers’ discount and estimated offering expenses. Concurrent with the Note Offering, the Company used approximately

$18.6

million of the net proceeds from the Note Offering to repay in full the Term Note, plus all accrued but unpaid interest, a make-whole interest payment and a prepayment premium on the Term Note.

Notes were issued pursuant to an Indenture, dated as of

February

2016

(the “Indenture”), between the Company and U.S. Bank National Association, as trustee (the "Trustee"). Interest on the

Notes is payable semi-annually in cash in arrears on

February

of each year, beginning on

August

unless earlier converted or repurchased. The

Notes are

redeemable prior to the maturity date, and

sinking fund is provided for the

Notes are convertible at an initial conversion rate of

58.4454

shares of the Company’s common stock per

principal amount of the

Notes, subject to adjustment under the Indenture, which is equal to an initial conversion price of approximately

$17.11

per share of common stock. Upon conversion, the

Notes will be settled in shares of the Company’s common stock, together with a cash payment in lieu of delivering any fractional share. The conversion rate will be subject to adjustment in some events but will

be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that occur prior to the maturity date, the Company will increase the conversion rate for a holder who elects to convert its

Notes in connection with such a corporate event in certain circumstances.

If the Company undergoes a “fundamental change” (as defined in the Indenture), holders

require that the Company repurchase for cash all or any portion of their

Notes at a fundamental change repurchase price equal to

100%

of the principal amount of the

Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. In addition, holders who convert their

Notes on or after the date that is

year after the last date of original issuance of the

Notes

also be entitled to receive, under certain circumstances, an interest make-whole payment payable in shares of the Company’s common stock. The Company is bifurcating the fundamental change and make-whole interest payment provisions as embedded derivatives and marking them to fair value each reporting period (Note H).

The Indenture includes customary terms and covenants, including certain events of default after which the

Notes

be due and payable immediately.

In connection with the Note Offering, in

February 2016,

the Company entered into a Third Amendment (the “Third Amendment”) to the Deerfield Facility Agreement, Deerfield Convertible Note and Deerfield Warrant with Deerfield. The Third Amendment, among other things, eliminated the Company’s ability to require Deerfield to convert the Deerfield Convertible Note into Company common stock. In addition, pursuant to the Third Amendment, Deerfield consented to the prepayment of the Term Note and the issuance of the

Refer to the sections entitled Exchange Agreement and Exchange Agreement and Fifth Amendment to Facility Agreement below for a further discussion of the exchange of a portion of the

Notes.

Notes for shares of Series A Convertible Preferred Stock, par value

per share (the "Series A Preferred Stock") and Series B-

Convertible Preferred Stock, par value

per share (the "Series B-

Preferred Stock").

Fourth Amendment to Senior Secured Convertible Note and Warrant

In connection with entering into the First ATM Agreement, in

October 2016,

the Company entered into a Fourth Amendment (the “Fourth Amendment”) to the Deerfield Convertible Note and the Deerfield Warrant with Deerfield. The Fourth Amendment, among other things, clarifies the calculation of an anti-dilution adjustment of the conversion price and exercise price of the Deerfield Convertible Note and Deerfield Warrant, respectively, in the event that the Company effects an “at the market offering” as defined in Rule

415

of the Securities Act of its common stock.

Facility Agreement Waiver and Fifth Amendment to Senior Secured Convertible Note

June 2018,

the Company entered into the Facility Agreement Waiver and Fifth Amendment (the "Fifth Amendment") to the Deerfield Convertible Note with Deerfield. The Fifth Amendment, among other things, provided that (i)

$3,333,333

of the principal amount, plus

$168,288

of accrued interest, of the Deerfield Convertible Note issued pursuant to the terms of the Deerfield Facility Agreement was converted into

598,568

shares of the Company’s common stock, with such principal conversion amount being applied against and in full satisfaction of the amortization payment due

June 2, 2018; (

ii) Deerfield waived specified rights under the Deerfield Facility Agreement with regards to such principal and interest amount; and (iii) amended specified provisions of the Deerfield Convertible Note as they relate to the delivery of shares of the Company’s common stock in connection with any conversion of the Deerfield Convertible Note.

Exchange Agreement

October 2018,

the Company entered into an Exchange Agreement (the

“October 2018

Exchange Agreement”) with Deerfield and Deerfield Special Situations Fund, L.P. (the “Holders”). Under the

Exchange Agreement, the Holders exchanged an aggregate of

$9,577,000

principal amount of the

Notes for an aggregate of

9,577

shares of Series A Preferred Stock. The Company also agreed to pay the Holders an amount of

$95,105

in cash, which represented the amount of accrued and unpaid interest on the exchanged notes. The

Exchange Agreement contains customary representations, warranties and covenants made by the Company and the Holders. The

Exchange Agreement required the Company to reimburse the Holders for up to

$25,000

of expenses relating to the exchange.

As a condition to closing of the

Exchange Agreement, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (the “Series A Certificate of Designation”) with the Secretary of State of the State Delaware, setting forth the preferences, rights and limitations of the Series A Preferred Stock.

Each share of Series A Preferred Stock has an aggregate stated value of

and is convertible into shares of common stock at a price equal to

$3.00

per share (subject to adjustment to reflect stock splits and similar events). Immediately following the exchange under the

Exchange Agreement, there were an aggregate of

3,192,334

shares of common stock issuable upon conversion of the then outstanding Series A Preferred Stock (without giving effect to the limitation on conversion described below), and, as of

there were an aggregate of

1,112,334

shares of common stock issuable upon conversion of the then outstanding Series A Preferred Stock (without giving effect to the limitation on conversion described below). The Series A Preferred Stock is convertible at any time at the option of the Holders, provided that the Holders are prohibited from converting shares of Series A Preferred Stock into shares of common stock if, as a result of such conversion, such Holders (together with certain affiliates and “group” members) would beneficially own more than

4.985%

of the total number of shares of the Company’s common stock then issued and outstanding. The Series A Preferred Stock is

redeemable. In the event of the Company’s liquidation, dissolution or winding up, the Holders will receive an amount equal to

per share of Series A Preferred Stock, plus any declared but unpaid dividends, and thereafter will share ratably in any distribution of the Company’s assets with holders of common stock on an as-converted basis. With respect to rights upon liquidation, the Series A Preferred Stock ranks senior to the common stock and junior to existing and future indebtedness. Except as otherwise required by law (or with respect to approval of certain actions involving the Company’s organizational documents that materially and adversely affect the holders of Series A Preferred Stock), the Series A Preferred Stock does

have voting rights. The Series A Preferred Stock is

subject to any price-based anti-dilution protections and does

provide for any accruing dividends, but provides that holders of Series A Preferred Stock will participate in any dividends on the common stock on an as-converted basis (without giving effect to the limitation on conversion described above). The Series A Certificate of Designation also provides for partial liquidated damages in the event that the Company fails to timely convert shares of Series A Preferred Stock into common stock in accordance with the Series A Certificate of Designation.

First Supplemental Indenture, Sixth Amendment to Deerfield Convertible Note and Fifth Amendment to Deerfield Warrant

November 2018,

the Company entered into a First Supplemental Indenture (the “Supplemental Indenture”) with the Trustee. Pursuant to the Supplemental Indenture, the Indenture was amended to allow each Holder (as defined in the Indenture) or any beneficial holder of any

Notes to, at its option, elect a limit on beneficial ownership as to such Holder or beneficial owner (but

as to any other Holder or beneficial owner) that is less than or equal to the

9.985%

Cap (as defined in the Indenture) or any other limit previously elected and then applicable to such Holder or beneficial owner upon written notice delivered to the Company at least

) business days prior to the date of effectiveness of such beneficial ownership limit (or such shorter period as

(

be agreed upon by the Company), specifying the percentage of shares of the Company’s common stock outstanding for the beneficial ownership limit that shall apply to such Holder or beneficial owner.

Also in

November 2018,

in connection with entering into the Supplemental Indenture, the Company entered into an amendment (the “Sixth Amendment”) with Deerfield to the Deerfield Convertible Note and Deerfield Warrant. The Sixth Amendment, among other things, lowers the beneficial ownership limit under both the Deerfield Convertible Note and Deerfield Warrant to

4.985%

of the Company’s outstanding common stock. The Sixth Amendment also includes a notice from Deerfield that it has elected to lower the beneficial ownership limit under the

Notes, as to Deerfield and its affiliates, to

4.985%.

Seventh Amendment to Deerfield Convertible Note and Sixth Amendment to Deerfield Warrant

February 2019,

in connection with entering into the Purchase Agreement, the Company entered into an amendment (the “Seventh Amendment”), with Deerfield to the Deerfield Convertible Note and Deerfield Warrant. The Seventh Amendment, among other things, clarified that the anti-dilution protections contained in the Deerfield Convertible Note and Deerfield Warrant would

apply to sales made under the Purchase Agreement or Second ATM Agreement. The Seventh Amendment also included a waiver from Deerfield regarding any registration rights it

have under the Company’s amended and restated investor rights agreement in connection with the Registration Rights Agreement.

Exchange Agreement and Fifth Amendment to Facility Agreement

September

the Company entered into an Exchange Agreement and Amendment to Facility Agreement (the

“September 2019

Exchange Agreement”) with the Holders. Under the

Exchange Agreement, the Company issued an aggregate of

1,499,894

shares of the Company’s common stock and an aggregate of

1,576

shares of the Company’s Series B-

Convertible Preferred Stock (such shares of common stock and Series B-

Preferred Stock, the “Initial Exchange Shares”), in exchange for the cancellation of an aggregate of

$3,000,000

principal amount of the Company’s

Notes. The

Exchange Agreement provides the Holders the option to exchange up to an additional aggregate of

$27,000,000

principal amount of the

Notes (the “Optional Exchange Principal Amount”) for shares of common stock or shares of the Company’s Series B-

Convertible Preferred Stock, par value

per share (the “Series B-

Preferred Stock” and, together with the Series B-

Preferred Stock, the “Series B Preferred Stock”), subject to the terms and conditions set forth in the

Exchange Agreement, including limits as to the principal amount that can be exchanged prior to specified dates therein. If the Holders choose to exchange any portion of the Optional Exchange Principal Amount for shares of Series B-

Preferred Stock, such exchange will be effected at an exchange price of

per share. If the Holders choose to exchange any portion of the Optional Exchange Principal Amount for shares of common stock, such exchange will be effected at an exchange price equal to the greater of (i)

$0.9494,

which represents the last sale price of the common stock on the Nasdaq Global Market on

September

or (ii) the average of the volume-weighted average price of the common stock on the Nasdaq Global Market on each of the

trading days immediately preceding such exchange.

Exchange Agreement also amended the Deerfield Facility Agreement, in order to (i) reduce the interest rate applicable under the Deerfield Facility Agreement from

9.75%

6.75%,

(ii) provide for “payment in kind” of interest on the Loans (as defined in the Deerfield Facility Agreement), and (iii) defer the Loan payments pursuant to the Deerfield Facility Agreement until

Exchange Agreement contains customary representations, warranties and covenants made by the Company and the Holders. The

Exchange Agreement also requires the Company to reimburse the Holders for up to

$150,000

of expenses relating to the transactions contemplated by the

The Company determined the changes to the Deerfield Facility Agreement met the definition of a troubled debt restructuring under ASC

Exchange Agreement.

470

60,

Troubled Debt Restructurings by Debtors

, as the Company was experiencing financial difficulties and Deerfield granted a concession. The amendments to the terms of the Deerfield Facility Agreement resulted in

gain on restructuring because the total cash outflows required under the amended Deerfield Facility Agreement exceeded the carrying value of the original Deerfield Facility Agreement immediately prior to amendment. Prospectively, the Deerfield Facility Agreement, and the associated Deerfield Convertible Note will continue to be carried net of the associated discount and debt issuance costs which will be amortized and recorded as interest expense using a modified effective interest rate based on the amendments.

Exchange Agreement, were accounted for as a debt modification with the

$2.3

million change in fair value of the embedded conversion feature, associated with the Optional Exchange Principal Amount, recorded as an increase to additional paid in capital and as a debt discount to be amortized to interest expense under the effective interest method over the remaining term of the

As a condition to closing of the

Notes.

Exchange Agreement, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of Series B-

Convertible Preferred Stock (the “Series B-

Certificate of Designation”) and a Certificate of Designation of Preferences, Rights and Limitations of Series B-

Convertible Preferred Stock (the “Series B-

Certificate of Designation”) with the Secretary of State of the State Delaware, setting forth the preferences, rights and limitations of the Series B-

Preferred Stock and the Series B-

Preferred Stock, respectively.

Each share of Series B-

Preferred Stock has an aggregate stated value of

and is convertible into shares of common stock at a per share price equal to

$0.9494

per share (subject to adjustment to reflect stock splits and similar events). Immediately following the exchange under the

Exchange Agreement, there were an aggregate of

1,659,996

shares of common stock issuable upon conversion of the then outstanding Series B-

Preferred Stock (without giving effect to the limitation on conversion described below), and, as of

there was an aggregate of

831,051

shares of common stock issuable upon conversion of the then outstanding Series B-

Preferred Stock (without giving effect to the limitation on conversion described below). Each share of Series B-

Preferred Stock has an aggregate stated value of

and is convertible into shares of common stock at a per share price equal to the greater of (i)

$0.9494

(subject to adjustment to reflect stock splits and similar events), or (ii) the average of the volume-weighted average prices of the common stock on the Nasdaq Global Market on each of the

trading days immediately preceding such exchange. Immediately following the exchange under the

Exchange Agreement and as of

there was an aggregate of

28,439,015

shares of Common Stock issuable (i) in exchange of the Optional Exchange Principal Amount, or (ii) upon conversion of the Series B-

Preferred Stock issuable in exchange of the Optional Exchange Principal Amount (in each case without giving effect to the limitation on conversion described below).

4.985%

of the total number of shares of common stock then issued and outstanding. The Series B Preferred Stock is

redeemable. In the event of the Company’s liquidation, dissolution or winding up, the Holders will receive an amount equal to

per share, plus any declared but unpaid dividends, and thereafter will share ratably in any distribution of the Company’s assets with holders of common stock and with the holders of any shares of any other class or series of capital stock of the Company entitled to share in such remaining assets of the Company (including the Series A Preferred Stock on an as-converted basis). With respect to rights upon liquidation, the Series B Preferred Stock ranks senior to the common stock, on parity with the Series A Preferred Stock and junior to existing and future indebtedness. Except as otherwise required by law (or with respect to approval of certain actions involving the Company’s organizational documents that materially and adversely affect the holders of Series B Preferred Stock), the Series B Preferred Stock does

have voting rights. The Series B Preferred Stock is

subject to any price-based anti-dilution protections and does

provide for any accruing dividends, but provides that holders of Series B Preferred Stock will participate in any dividends on the common stock on an as-converted basis (without giving effect to the limitation on conversion described above). The Series B-

Certificate of Designation and the Series B-

Certificate of Designation also provide for partial liquidated damages in the event that the Company fails to timely convert shares of Series B-

Preferred Stock or Series B-

Preferred Stock, respectively, into common stock in accordance with the applicable certificate of designation.

Except as modified by the First Amendment, Second Amendment, Third Amendment, Fourth Amendment, Fifth Amendment, Sixth Amendment, Seventh Amendment and the

Exchange Agreement, all terms and conditions of the Deerfield Facility Agreement, Deerfield Warrant and Deerfield Convertible Note remained in full force and effect.

the Company opened a line of credit with a total borrowing capacity of

$1.1

million with City National Bank of Florida (the "Line of Credit Agreement") to support several irrevocable letters of credit issued by the bank on behalf of the Company. The line of credit had an original maturity date of

January 31, 2018.

January 31, 2018,

the line of credit was renewed for an additional two-year term and was set to mature on

January 31, 2020.

The Line of Credit Agreement was collateralized by a restricted money market account, equal to the total amount of the letters of credit outstanding which are supported by the line of credit. In

March 2019,

the line of credit was closed

The irrevocable letters of credit and associated money market account remain and the money market account is reported as restricted cash on the condensed balance sheets.

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Note I - Net Income (Loss) Per Share of Common Stock - Summary of Computation of Basic and Diluted Net Loss and Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended						9 Months Ended
	Sep. 30, 2019	Jun. 30, 2019	Mar. 31, 2019	Sep. 30, 2018	Jun. 30, 2018	Mar. 31, 2018	Sep. 30, 2019	Sep. 30, 2018
Net income	$ 3,063	$ (9,257)	$ (12,291)	$ (15,071)	$ (9,993)	$ (26,219)	$ (18,485)	$ (51,283)
Less: Net income attributable to participating securities	(348)
Net income attributable to shares of common stock	2,715
Less: Dividends declared or accumulated
Undistributed net income attributable to shares of common stock, basic	$ 2,715
Basic (in shares)	30,126,704			16,033,923			28,417,450	15,385,663
Basic (in dollars per share)	$ 0.09			$ (0.94)			$ (0.65)	$ (3.33)
Less: Fair value adjustment income related to Deerfield Warrant liability	$ (1,019)
Less: Fair value adjustment income related to embedded Warrant Put Option	(135)
Net income attributable to shares of common stock, diluted	$ 1,909
Weighted average number of shares of common stock outstanding (in shares)	30,126,704			16,033,923			28,417,450	15,385,663
Dilutive effect of Deerfield Warrant (in shares)
Diluted (in shares)	31,672,149			16,033,923			28,417,450	15,385,663
Diluted (in dollars per share)	$ 0.06			$ (0.94)			$ (0.65)	$ (3.33)
Series A Convertible Preferred Stock [Member]
Dilutive effect of Preferred Stock (in shares)	1,112,000
Series B-1 Convertible Preferred Stock [Member]
Dilutive effect of Preferred Stock (in shares)	433,000

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Note G - Stock-based Compensation

Share-based Payment Arrangement [Text Block]

G.	Stock-Based Compensation

The Company maintains a stock-based compensation plan (the “

Incentive Stock Plan”) that governs stock awards made to employees and directors prior to completion of the IPO.

November 2014,

the Board of Directors of the Company ("the Board"), and in

April 2015,

the Company’s stockholders, approved the Company’s

Equity Incentive Plan (the

“2014

Plan”), which became effective in

April 2015.

Plan provides for the grant of stock options, other forms of equity compensation, and performance cash awards. The maximum number of shares of common stock that

The number of shares of common stock reserved for issuance under the

Plan will automatically increase on

January 1

of each year, beginning on

January 1, 2016,

and ending on and including

January 1, 2024,

of the total number of shares of the Company’s capital stock outstanding on

December 31

of the preceding calendar year, or a lesser number of shares determined by the Board. Pursuant to the terms of the

the common stock reserved for issuance under the

Plan, on

January 1, 2019,

Plan automatically increased by

the Company granted to each non-employee member of the Company's board of directors (each a "non-employee Director")

two

separate fully vested restricted stock awards ("RSAs") under the

Plan. The RSAs were granted in lieu of the quarterly cash compensation payable under the Company's Third Amended and Restated Non-Employee Director Compensation Policy to each non-employee Director for service as a member of the Company's board of directors, and applicable committees thereof, in the

RSAs were granted for a total of

42,436

shares of common stock, respectively.

39,284

During the

months ended September

months ended September

30,

stock options were exercised. During the

nine

months ended September

30,

, stock options were exercised for a total of

23,682

shares of common stock.

Stock-based compensation expense recorded under the Incentive Stock Plan

and the

Plan is included in the following line items in the accompanying condensed statements of operations (in thousands):

	Three months ended September 30,				Nine months ended September 30,
	2019		2018		2019		2018
Research and development	$	400	$	409	$	1,196	$	1,196
General and administrative		657		941		2,468		2,813
Severance expense		—		1,236		—		1,236
Total stock-based compensation expense	$	1,057	$	2,586	$	3,664	$	5,245

There was

stock-based compensation expense related to performance-based awards recognized during the

XML 26 R17.htm IDEA: XBRL DOCUMENT

Note K - Leases

Lease Disclosure [Text Block]

Leases

year to

years, some of which include options to extend the leases for up to

years, and some which include options to terminate the leases within

year.

The components of lease expense were as follows (in thousands):

	Three months ended September 30,			Nine months ended September 30,
Lease Cost	2019			2019
Finance lease cost:
Amortization of right-of-use assets	$	31		$	92
Interest on lease liabilities		9			31
Total finance lease cost		40			123
Operating lease cost		124			372
Short-term lease cost		58			173
Variable lease cost		14			35
Less: sublease income		(25	)		(75	)
Total lease costs	$	211		$	628

Supplemental cash flow information related to leases was as follows (in thousands):

	Nine months ended September 30,
	2019
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from finance leases	$	31
Financing cash flows from finance leases		157
Operating cash flows from operating leases		326
Operating cash flows from short-term leases		173
Operating cash flows from variable lease costs		35

Right-of-use assets obtained in exchange for lease liabilities:
Finance leases	$	737
Operating leases		1,852

Supplemental balance sheet information related to leases was as follows (in thousands, except weighted average remaining lease term and weighted average discount rate):

	September 30,
	2019
Finance Leases
Property and equipment, at cost	$	1,013
less: accumulated depreciation and amortization		(368	)
Property and equipment, net	$	645

Other current liabilities	$	227
Other long-term liabilities		227
Total finance lease liabilities	$	454

Operating Leases
Operating lease right-of-use assets	$	1,649
Total operating lease right-of-use assets	$	1,649

Current portion of operating lease liabilities	$	369
Operating lease liabilities, less current portion		1,976
Total operating lease liabilities	$	2,345

Weighted Average Remaining Lease Term
Finance leases	2 years
Operating leases	6 years

Weighted Average Discount Rate
Finance leases		7.7	%
Operating leases		7.5	%

Maturities of lease liabilities were as follows (in thousands):

	Finance			Operating
Year Ending December 31,	Leases			Leases
2019 (excluding the nine months ended September 30, 2019)	$	66		$	144
2020		251			499
2021		163			449
2022		11			461
2023		—			472
Thereafter		—			903
Total lease payments		491			2,928
Less: future interest expense		(37	)		(583	)
Lease liabilities	$	454		$	2,345

XML 27 R29.htm IDEA: XBRL DOCUMENT

Note F - Common Stock and Warrants (Details Textual) - USD ($)							3 Months Ended	9 Months Ended		12 Months Ended	23 Months Ended
	Sep. 30, 2019	Sep. 03, 2019	Oct. 25, 2018	Oct. 10, 2018	Oct. 05, 2018	Jun. 02, 2014	Sep. 30, 2019	Sep. 30, 2019	Sep. 30, 2018	Dec. 31, 2013	Sep. 04, 2018	Dec. 31, 2018
Common Stock, Shares Authorized	250,000,000						250,000,000	250,000,000				250,000,000
Common Stock, Shares, Issued, Total	32,387,382						32,387,382	32,387,382				26,455,352
Stock Issued During Period, Shares, New Issues							1,200,000
Proceeds from Issuance of Common Stock									$ 4,828,000
Common Stock [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights										143,466
Class of Warrant or Right, Exercise Price of Warrants or Rights										$ 5.85
2013 Warrants [Member]
Debt Instrument, Face Amount										$ 3,800,000
Class of Warrant or Right Issued										1,079,453
Series D Redeemable Convertible Preferred Stock [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights										1,079,453
Deerfield Warrant [Member]
Class of Warrant or Right Issued						14,423,076
Deerfield Warrant [Member] \| Common Stock [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights						1,923,077
Class of Warrant or Right, Exercise Price of Warrants or Rights						$ 5.85
Warrant Issued to KVK [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights			500,000
Class of Warrant or Right, Exercise Price of Warrants or Rights			$ 2.30
Class of Warrant or Right, Additional Shares Exercisable for Each Milestones			125,000
Series B-1 Convertible Preferred Stock [Member]
Debt Conversion, Converted Instrument, Shares Issued		1,576
Conversion of Stock, Shares Converted	787	787
Series A Preferred Stock Converted Into Common Stock [Member]
Conversion of Stock, Shares Converted								6,240
Conversion of Stock, Shares Issued								2,080,000
2021NotesConvertedToCommonStockMember
Stock Issued During Period, Shares, Conversion of Convertible Securities		1,499,894
2021NotesConvertedToSeriesB1PreferredStockMember
Stock Issued During Period, Shares, Conversion of Convertible Securities		1,576
Series B-1 Preferred Convertible Stock Converted to Common Stock [Member]
Conversion of Stock, Shares Issued	828,945
Exchanged 2021 Notes for Series A Preferred Stock [Member]
Debt Conversion, Converted Instrument, Shares Issued					9,577
Second ATM Agreement [Member]
Stock Issued During Period, Shares, New Issues								0
Cowen and Company, LLC [Member]
Stock Issued During Period, Shares, New Issues											762,338
Proceeds from Issuance of Common Stock											$ 4,900,000
RBC Capital Markets, LLC [Member] \| Underwriting Agreement [Member]
Stock Issued During Period, Shares, New Issues				8,333,334	8,333,334

XML 28 R21.htm IDEA: XBRL DOCUMENT

Note H - Fair Value of Financial Instruments (Tables)

Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block]

Notes Tables

	Balance as of September 30, 2019		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Deerfield Warrant liability	$	192	$	—	$	—	$	192
Embedded Warrant Put Option		77		—		—		77
Fundamental change and make-whole interest provisions embedded in 2021 Notes		—		—		—		—
Deerfield Note Conversion Feature		—		—		—		—
KVK Warrant liability		66		—		66		—
Total liabilities	$	335	$	—	$	66	$	269

	Balance as of December 31, 2018		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Deerfield Warrant liability	$	1,557	$	—	$	—	$	1,557
Embedded Warrant Put Option		154		—		—		154
Fundamental change and make-whole interest provisions embedded in 2021 Notes		—		—		—		—
Deerfield Note Conversion Feature		134		—		—		134
KVK Warrant liability		273		—		273		—
Total liabilities	$	2,118	$	—	$	273	$	1,845

Trading securities:
Certificates of deposit	$	246	$	246	$	—	$	—
U.S. Treasury securities		3,014		3,014		—		—
Total assets	$	3,260	$	3,260	$	—	$	—

Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block]

	Three months ended September 30,						Nine months ended September 30,
	2019			2018			2019			2018
Balance as of beginning of period	$	1,437		$	11,888		$	1,845		$	7,709
Adjustment to fair value		(1,168	)		(4,468	)		(1,576	)		(289	)
Balance as of end of period	$	269		$	7,420		$	269		$	7,420

XML 29 R25.htm IDEA: XBRL DOCUMENT

Note B - Summary of Significant Accounting Policies (Details Textual) - USD ($)		3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 03, 2019	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018	Dec. 31, 2018	Jan. 01, 2019
Revenue from Contract with Customer, Including Assessed Tax		$ 11,463,000	$ 0	$ 11,463,000	$ 0
Accounts Receivable, after Allowance for Credit Loss, Current, Total						$ 0
Cost of Goods and Services Sold, Total		1,000,000		1,000,000		0
Deferred Revenue, Total		0		0		0
Accounts Receivable, Allowance for Credit Loss, Ending Balance		0		0		$ 0
Operating Lease, Liability, Total		2,345,000		2,345,000
Accounting Standards Update 2016-02 [Member]
Operating Lease, Liability, Total							$ 2,600,000
License [Member]
Revenue from Contract with Customer, Including Assessed Tax		10,000,000		10,000,000
Reimbursement of Out-of-pocket Third-party Research and Development Costs [Member]
Revenue from Contract with Customer, Including Assessed Tax		1,200,000		1,200,000
Accounts Receivable, after Allowance for Credit Loss, Current, Total		1,200,000		1,200,000
Consulting Services [Member]
Revenue from Contract with Customer, Including Assessed Tax		300,000		300,000
Accounts Receivable, after Allowance for Credit Loss, Current, Total		$ 300,000		$ 300,000
GPC Member \| License [Member]
Revenue from Contract with Customer, Including Assessed Tax	$ 10,000,000
Revenue Recognition, Milestone Method, Revenue to be Recognized	63,000,000
Revenue Recognition, Milestone Method, Additional Revenue to be Recognized	$ 420,000,000

XML 30 R44.htm IDEA: XBRL DOCUMENT

Note K - Leases - Maturities of lease Liabilities (Details) $ in Thousands	Sep. 30, 2019 USD ($)
2019 (excluding the nine months ended September 30, 2019)	$ 66
2019 (excluding the nine months ended September 30, 2019)	144
2020	251
2020	499
2021	163
2021	449
2022	11
2022	461
2023
2023	472
Thereafter
Thereafter	903
Total lease payments	491
Total lease payments	2,928
Less: future interest expense	(37)
Less: future interest expense	(583)
Lease liabilities	454
Operating Lease, Liability, Total	$ 2,345

XML 31 R40.htm IDEA: XBRL DOCUMENT

Note K - Leases (Details Textual)	9 Months Ended
Note K - Leases (Details Textual)	Sep. 30, 2019
Lessee, Lease, Option to Extend, Maximum Term	5 years
Lessee, Lease, Option to Terminate, Term	1 year
Minimum [Member]
Lessee, Lease, Remaining Term of Contract	1 year
Maximum [Member]
Lessee, Lease, Remaining Term of Contract	6 years

XML 32 R20.htm IDEA: XBRL DOCUMENT

Note G - Stock-based Compensation (Tables)

Share-based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block]

Notes Tables

	Three months ended September 30,				Nine months ended September 30,
	2019		2018		2019		2018
Research and development	$	400	$	409	$	1,196	$	1,196
General and administrative		657		941		2,468		2,813
Severance expense		—		1,236		—		1,236
Total stock-based compensation expense	$	1,057	$	2,586	$	3,664	$	5,245

XML 33 R24.htm IDEA: XBRL DOCUMENT

Note A - Description of Business and Basis of Presentation (Details Textual) - USD ($)					3 Months Ended		9 Months Ended		12 Months Ended	23 Months Ended
	Sep. 03, 2019	Feb. 28, 2019	Oct. 10, 2018	Oct. 05, 2018	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018	Dec. 31, 2018	Sep. 04, 2018	Oct. 31, 2019	Mar. 31, 2019
Sale of Securities, Value, Available to Issue									$ 150,000,000
Sale of Securities Covered Under Prospectus Supplement, Value, Anticipated Amount to Be Sold Under Registration Statement									18,500,000
Sale of Securities Covered Under Prospectus Supplement, Value, Anticipated Sales Under Purchase Agreement									15,300,000
Sale of Securities Covered Under Prospectus Supplement, Value, Anticipated Sales Under ATM Agreement									3,200,000
Stock Issued During Period, Shares, New Issues					1,200,000
Proceeds from Issuance of Common Stock								$ 4,828,000
Increase (Decrease) in Prepaid Expense and Other Assets, Total							(1,420,000)	960,000
Revenue from Contract with Customer, Including Assessed Tax					$ 11,463,000	$ 0	11,463,000	0
License [Member]
Revenue from Contract with Customer, Including Assessed Tax					$ 10,000,000		$ 10,000,000
Cowen and Company, LLC [Member]
Stock Issued During Period, Shares, New Issues										762,338
Proceeds from Issuance of Common Stock										$ 4,900,000
Sale of Stock, Commission Fee										3.00%
RBC Capital Markets, LLC [Member]
Sale of Stock, Authorized Offering Price										$ 50,000,000		$ 3,200,000
Lincoln Park [Member]
Sale of Securities, Value, Available to Issue		$ 15,000,000
Stock Issued During Period, Shares, New Issues							3,401,271
Proceeds from Issuance of Common Stock							$ 5.40
Purchase Agreement, Term		3 years
Purchase Agreement, Additional Shares to Be Issued as Commitment Shares		120,200
GPC Member \| License [Member]
Revenue from Contract with Customer, Including Assessed Tax	$ 10,000,000
Revenue Recognition, Milestone Method, Revenue to be Recognized	63,000,000
Revenue Recognition, Milestone Method, Additional Revenue to be Recognized	$ 420,000,000
Royalty Revenue, Percent	10.00%
Restatement Adjustment [Member]
Increase (Decrease) in Prepaid Expense and Other Assets, Total								$ (100,000)	$ (100,000)
First ATM Agreement [Member]
Stock Issued During Period, Shares, New Issues							3,401,271
Proceeds from Issuance of Common Stock							$ 5,400,000
Second ATM Agreement [Member]
Stock Issued During Period, Shares, New Issues							0
Second ATM Agreement [Member] \| RBC Capital Markets, LLC [Member]
Sale of Stock, Commission Fee										3.00%
Second ATM Agreement [Member] \| RBC Capital Markets, LLC [Member] \| Maximum [Member]
Sale of Stock, Authorized Offering Price										$ 50,000,000
Underwriting Agreement [Member] \| RBC Capital Markets, LLC [Member]
Stock Issued During Period, Shares, New Issues			8,333,334	8,333,334
Shares Issued, Price Per Share			$ 3
Proceeds from Issuance of Common Stock, Net			$ 23,100,000
Subsequent Event [Member]
Sale of Securities, Value, Available to Issue											$ 80,000,000

XML 34 R28.htm IDEA: XBRL DOCUMENT

Note E - Preferred Stock and Warrants (Details Textual) - $ / shares				3 Months Ended	9 Months Ended
	Sep. 30, 2019	Sep. 03, 2019	Oct. 05, 2018	Sep. 30, 2019	Sep. 30, 2019	Dec. 31, 2018	Feb. 09, 2016
Preferred Stock, Shares Authorized	10,000,000			10,000,000	10,000,000
Convertible Preferred Stock, Conversion Restriction, Percentage of Common Stock		4.985%
Series B-1 Convertible Preferred Stock [Member]
Conversion of Stock, Shares Issued		828,945		828,945
Series A Preferred Stock [Member]
Preferred Stock, Shares Authorized	9,578			9,578	9,578
Preferred Stock, Shares Outstanding, Ending Balance	3,337			3,337	3,337
Preferred Stock, Shares Issued, Total						3,337
Preferred Stock, Aggregate Stated Value Per Share			$ 1,000
Convertible Preferred Stock, Conversion Price			$ 3
Convertible Preferred Stock, Shares Issuable Upon Conversion	1,112,334		3,192,334	1,112,334	1,112,334
Convertible Preferred Stock, Conversion Restriction, Percentage of Common Stock			4.985%
Preferred Stock, Par or Stated Value Per Share			$ 0.0001				$ 0.0001
Conversion of Stock, Shares Converted					6,240
Conversion of Stock, Shares Issued					2,080,000
Series B-1 Convertible Preferred Stock [Member]
Preferred Stock, Shares Authorized	1,576			1,576	1,576
Preferred Stock, Shares Outstanding, Ending Balance	789	789		789	789
Preferred Stock, Shares Issued, Total	1,576			1,576	1,576
Debt Conversion, Converted Instrument, Shares Issued		1,576
Preferred Stock, Aggregate Stated Value Per Share		$ 1,000
Convertible Preferred Stock, Conversion Price		$ 0.9494
Convertible Preferred Stock, Shares Issuable Upon Conversion		831,051
Convertible Preferred Stock, Conversion Restriction, Percentage of Common Stock		4.985%
Preferred Stock, Par or Stated Value Per Share	$ 0.0001	$ 0.0001		$ 0.0001	$ 0.0001	$ 0.0001	$ 0.0001
Conversion of Stock, Shares Converted	787	787
Conversion Of Stock Shares Issuable If Converted	831,051	1,659,996		831,051	831,051
Series B-2 Convertible Preferred Stock [Member]
Preferred Stock, Shares Authorized	27,000			27,000	27,000
Preferred Stock, Shares Outstanding, Ending Balance
Preferred Stock, Shares Issued, Total
Preferred Stock, Aggregate Stated Value Per Share		$ 1,000
Convertible Preferred Stock, Conversion Price		$ 0.9494
Preferred Stock, Par or Stated Value Per Share	$ 0.0001			$ 0.0001	$ 0.0001	$ 0.0001
Conversion Of Stock Shares Issuable If Converted		28,439,015
Preferred Stock, Liquidation Preference Per Share		$ 0.0001
Series B Preferred Stock [Member]
Preferred Stock, Shares Outstanding, Ending Balance	789			789	789
Preferred Stock, Liquidation Preference Per Share		$ 0.0001
Preferred Class A [Member]
Debt Conversion, Converted Instrument, Shares Issued			9,577
Preferred Stock, Aggregate Stated Value Per Share			$ 1,000

XML 35 R41.htm IDEA: XBRL DOCUMENT

Note K - Leases - Lease Cost (Details) - USD ($) $ in Thousands	3 Months Ended	9 Months Ended
	Sep. 30, 2019	Sep. 30, 2019
Amortization of right-of-use assets	$ 31	$ 92
Interest on lease liabilities	9	31
Total finance lease cost	40	123
Operating lease cost	124	372
Short-term lease cost	58	173
Variable lease cost	14	35
Less: sublease income	(25)	(75)
Total lease costs	$ 211	$ 628

XML 36 R39.htm IDEA: XBRL DOCUMENT

Note J - Severance Expense (Details Textual) - USD ($) $ in Thousands		3 Months Ended		9 Months Ended
	Aug. 31, 2018	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018
Share-based Payment Arrangement, Expense		$ 1,057	$ 2,586	$ 3,664	$ 5,245
Severance Expense [Member]
Share-based Payment Arrangement, Expense			$ 1,236		1,236
Employee Severance [Member] \| Severance Expense [Member]
Severance Charges	$ 400	$ 0		$ 0	$ 300
Share-based Payment Arrangement, Expense	$ 1,200

XML 37 R8.htm IDEA: XBRL DOCUMENT

Note B - Summary of Significant Accounting Policies

Significant Accounting Policies [Text Block]

B.	Summary of Significant Accounting Policies

Use of Estimates

Revenue Recognition

The Company commenced recognizing revenue in accordance with the provisions of ASC

Revenue from Contracts with Customers

However, the Company had

revenue at that time.

Arrangements with Multiple-Performance Obligations

From time to time, the Company enters into arrangements for research and development, manufacturing and/or commercialization services. Such arrangements

require the Company to deliver various rights, services, including intellectual property rights/licenses, research and development services, and/or commercialization services. The underlying terms of these arrangements generally provide for consideration to the Company in the form of nonrefundable upfront license fees, development and commercial performance milestone payments, royalty payments, and/or profit sharing.

In arrangements involving more than

performance obligation, each required performance obligation is evaluated to determine whether it qualifies as a distinct performance obligation based on whether (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available and (ii) the good or service is separately identifiable from other promises in the contract. The consideration under the arrangement is then allocated to each separate distinct performance obligation based on its respective relative stand-alone selling price. The estimated selling price of each deliverable reflects the Company's best estimate of what the selling price would be if the deliverable was regularly sold by the Company on a stand-alone basis or using an adjusted market assessment approach if selling price on a stand-alone basis is

available.

occur. Should there be royalties, the Company utilizes the sales and usage-based royalty exception in arrangements that resulted from the license of intellectual property, recognizing revenues generated from royalties or profit sharing as the underlying sales occur.

Licensing Agreements

The Company enters into licensing agreements with licensees that fall under the scope of ASC

606.

The terms of the Company’s licensing agreements typically include

or more of the following: (i) upfront fees; (ii) milestone payments related to the achievement of development, regulatory, or commercial goals; and (iii) royalties on net sales of licensed products. Each of these payments

result in licensing revenues or an offset against research and development expense.

include such estimates as, independent evidence of market price, forecasted revenues or costs, development timelines, discount rates, and probability of regulatory success. The Company evaluates each performance obligation to determine if they can be satisfied at a point in time or over time, and it measures the services delivered to the licensee which are periodically reviewed based on the progress of the related program. The effect of any change made to an estimated input component and, therefore revenue or expense recognized, would be recorded as a change in estimate. In addition, variable consideration (e.g., milestone payments) must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price.

Up-front Fees:

If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from the transaction price allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time.

Milestone Payments:

At the inception of each arrangement that includes milestone payments (variable consideration), the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would

occur, the associated milestone value is included in the transaction price. Milestone payments that are

within the Company’s or the licensee’s control, such as non-operational developmental and regulatory approvals, are generally

considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company re-evaluates the probability of achievement of milestones that are within its or the licensee’s control, such as operational developmental milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaboration revenues and earnings in the period of adjustment. Revisions to the Company’s estimate of the transaction price

also result in negative licensing revenues and earnings in the period of adjustment.

the Company entered into the

License Agreement

September 2019,

License Agreement with Commave under which the Company granted to Commave an exclusive, worldwide license to develop, manufacture and commercialize the Company's product candidates containing SDX and d-MPH, including

KP415,

KP484,

and, at the option of Commave,

KP879,

KP922

and/or any other product candidate developed by the Company containing SDX and developed to treat ADHD or any other central nervous system disorder. The license granted to Commave is distinct from other performance obligations as Commave can benefit from the license either on its own or together with other resources that are readily available and the license is separately identifiable from other promises in the

In exchange for the exclusive, worldwide license, discussed above, Commave paid the Company a non-refundable upfront payment of

License Agreement.

million. The Company is also entitled to additional payments from Commave of up to

$63.0

million, conditioned upon the achievement of specified regulatory milestones related to

In addition, the Company is entitled to payments from Commave of up to

KP484.

$420.0

million in the aggregate, conditioned upon the achievement of certain U.S. sales milestones, which are dependent upon, among other things, the timing of approval for a new drug application for

and its final approved label, if any. Further, Commave will pay the Company quarterly, tiered royalty payments ranging from a percentage in the high single digits to mid-twenties of Net Sales (as defined in the

License Agreement) in the U.S. and a percentage in the low to mid-single digits of Net Sales in each country outside of the U.S., in each case subject to specified reductions under certain conditions as described in the

License Agreement

License Agreement. As part of this agreement the Company is obligated to perform consulting services on behalf of Commave related to the licensed products. For these consulting services, Commave has agreed to pay the Company a set rate per hour on any consulting services performed on behalf of Commave for the benefit of the licensed products.

License Agreement is considered to be within the scope of ASC

as the transaction represents a contract with a customer where the the participants function in a customer / vendor relationship and are

exposed equally to the risks and rewards of the activities contemplated under the

License Agreement. Using the concepts of ASC

the Company has identified the grant of the exclusive, worldwide license and the performance of consulting services, which includes the reimbursement of out-of-pocket

-party research and development costs, as its only

two

performance obligations. The Company further determined that the transaction price under the agreement was

million upfront payment plus the fair value of the Development Costs (as defined in the

License Agreement) which was allocated among the performance obligations based on their respective related stand-alone selling price.

The consideration allocated to the grant of the exclusive, worldwide license was

million, which reflects the standalone selling price. The Company utilized the adjusted market assessment approach to determine this standalone selling price which included analyzing prospective offers received from various entities throughout our licensing negotiation process as well as the consideration paid to other competitors in the market for a similar type transaction. The Company determined that the intellectual property licensed under the

License Agreement represented functional intellectual property and it has significant standalone functionality and therefore should be recognized at a point in time as opposed to over time. The revenue related to the grant of the exclusive, worldwide license was recognized at the inception of the

The consideration allocated to the performance of consulting services, which includes the reimbursement of out-of-pocket

License Agreement.

-party research and development costs, was the fair value of the Development Costs (as defined in the

License Agreement), which reflects the standalone selling price. The Company utilized a blended approach which took into consideration the adjusted market assessment approach and the expected cost plus a margin approach to determine this standalone selling price. This blended approach utilized the adjusted market approach and expected cost plus margin approach to value the performance of consulting services which included analyzing hourly rates of vendors in the a market who perform similar services to those of the Company to develop a range and then analyzing the average cost per hour of our internal resources and applying a margin which placed the value in the median of the previously identified range. For the reimbursement of out-of-pocket

-party research and development costs the Company utilized the expected cost plus a margin approach, which included estimating the actual out-of-pocket cost the Company expects to pay to

-parties for research and development costs and applying a margin, if necessary. The Company notes determined that

margin was necessary of these out-of-pocket

-party research and development costs as these are purely pass-through costs and the margin for managing these

-party activities is included within the value of the performance of consulting services. The Company determined that the performance of consulting services, including reimbursement of out-of-pocket

-party research and development costs, is a performance obligation that is satisfied over time as the services are performed and the reimbursable costs are paid. As such, the revenue related to the performance obligation will be recognized as the consulting services are performed and the services associated with the reimbursable out-of-pocket

-party research and development costs are incurred and paid by the Company, in accordance with the practical expedient allowed under ASC

606

regarding an entity's right to consideration from a customer in an amount that corresponds directly to the value to the customer of the entity's performance completed to date.

Under the

License Agreement, Commave was granted an exclusive option to include Additional Products as Product(s) (both as defined in the

License Agreement) under the

License Agreement (the "Additional Product Option"). In addition to the Additional Product Option, Commave was also granted a right of

first

refusal ("ROFR") to acquire, license and/or commercialize any of the Additional Product Candidates should they choose

to exercise the Additional Product Option. Should Commave just to exercise the Additional Product Option on any Additional Product Candidates, Commave and the Company shall negotiate in good faith regarding the economic terms of such Additional Product. Further, should Commave exercise the ROFR on any Additional Product Candidate, the economic terms of the agreement shall be the same as those offered to the

an option to acquire additional goods or services on gives rise to a performance obligation if the option provides a material right to the customer. The Company concluded that the above described Additional Product Option and ROFR do

-party. Under ASC

606

constitute material rights to the customer as Commave would acquire the goods or services at a to be negotiated price, which the Company expects to approximate fair value and therefore Commave would

receive a material discount on these goods or services and would obtain at market rates.

The Company is entitled to additional payments from Commave conditioned upon the achievement of specified regulatory milestones related to

and the achievement of certain U.S. sales milestones, which are dependent upon, among other things, the timing of approval for a new drug application for

KP484

License Agreement. The Company concluded that these regulatory milestones, sales milestones and royalty payments each contain a significant uncertainty associated with a future event. As such, these milestone and royalty payments are constrained at contract inception and are

included in the transaction price as the Company could

conclude that it is probable a significant reversal in the amount of cumulative revenue recognized will

occur surrounding these payments. At the end of each reporting period, the Company will update its assessment of whether the milestone and royalty payments are constrained by considering both the likelihood and magnitude of the potential revenue reversal.

the Company recognized revenue of

$11.5

million, which is comprised of a

million non-refundable payment for an exclusive, worldwide license,

$1.2

million of reimbursement of out-of-pocket

-party research and development costs and

$0.3

million for the performance of consulting services. In addition, as of

the Company had receivables in the amount of

-party research and development costs, respectively. The cost of revenue associated with revenue recognized under the agreement with Commave was

revenue recognized, or associated receivables and cost revenue, for the

deferred revenue related to this agreement as of

Accounts and Other Receivables

Accounts and other receivables consists of receivables under the

License Agreement, as well as income tax and other receivables due to the Company. Receivables under the

License Agreement are recorded for amounts due to the Company related to reimbursable out-of-pocket

-party research and development costs and performance of consulting services. These receivables are evaluated to determine if any reserve or allowance should be established at each reporting date. As of

September 30, 2019

reserve or allowance has been established.

December 31, 2018

Application of New or Revised Accounting Standards—Adopted

April 2012,

President Obama signed the Jump-Start Our Business Startups Act (the “JOBS Act”) into law. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for an emerging growth company. As an emerging growth company, the Company could have elected to adopt new or revised accounting standards when they become effective for non-public companies, which typically is later than public companies must adopt the standards. The Company has irrevocably elected

to take advantage of the extended transition period afforded by the JOBS Act and, as a result, will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required for non-emerging growth companies.

), which requires lessees to recognize operating and finance lease liabilities and corresponding right-of-use assets on the balance sheet and to provide enhanced disclosures surrounding the amount, timing and uncertainty of cash flows arising from leases. The Company leases office space and laboratory facilities under non-cancelable operating leases. In addition, the Company leases various laboratory equipment, furniture and office equipment and leasehold improvements that are accounted for as capital leases. The Company adopted the new standard effective

January 1, 2019

on a modified retrospective basis and did

restate comparative periods. The Company elected the package of practical expedients permitted under the transition guidance, which allowed the Company to carryforward its historical lease classification and its assessment on whether a contract is or contains a lease for any leases that existed prior to adoption of the new standard. The Company also elected to combine lease and non-lease components and to keep leases with an initial term of

months or less off the balance sheet and recognize the associated lease payments in the condensed statements of operations on a straight-line basis over the lease term. The Company did

elect the hindsight practical expedient, which would have allowed the Company to use hindsight in determining the lease term and in assessing any impairment of right-of-use assets during the lookback period. The adoption of ASU

2016

resulted in the recognition of total right-of-use assets and total lease liabilities of approximately

$2.6

million on the condensed balance sheets as of

Earnings Per Share (Topic

260

), Distinguishing Liabilities from Equity (Topic

480

), Derivatives and Hedging (Topic

815

) – I. Accounting for Certain Financial Instruments with Down Round Features and II. Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception

("ASU

2017

11"

), which addresses the complexity of accounting for certain financial instruments with down round features and addresses the difficulty of navigating Topic

480

because of the existence of extensive pending content in the ASC as a result of the indefinite deferral of accounting requirements about mandatorily redeemable financial instruments of certain nonpublic entities and certain mandatorily redeemable noncontrolling interests. This update applies to all entities that issue financial instruments that include down round features and entities that present earnings per share in accordance with Topic

260.

This guidance is effective for financial statements issued for fiscal years beginning after

December 15, 2018,

and interim periods within those fiscal years. The adoption of ASU

2017

did

have a material impact on the Company's financial statements and disclosures.

Compensation – Stock Compensation (Topic

820

) – Improvements to Nonemployee Share-Based Payment Accounting

("ASU

), which simplifies several aspects of the accounting for nonemployee share-based payment transactions resulting from expanding the scope of Topic

07"

718,

Compensation—Stock Compensation, to include share-based payment transactions for acquiring goods and services from nonemployees. This update applies to all entities that enter into share-based payment transactions for acquiring goods and services from nonemployees. This guidance is effective for financial statements issued for fiscal years beginning after

December 15, 2018,

and interim periods within those fiscal years. The amendments in this ASU expand the scope of Topic

718

to include share-based payment transactions for acquiring goods and services from nonemployees. An entity should apply the requirements of Topic

718

to nonemployee awards except for specific guidance on inputs to an option pricing model and the attribution of cost (that is, the period of time over which share-based payment awards vest and the pattern of cost recognition over that period). The amendments specify that Topic

718

applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. The adoption of ASU

did

have a material impact on the Company's financial statements and disclosures.

Application of New or Revised Accounting Standards

Fair Value Measurement (Topic

820

) – Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement

("ASU

), which modifies the disclosure requirements on fair value measurements in Topic

13"

820,

Fair Value Measurement, based on the concepts in the FASB Concepts Statement,

Conceptual Framework for Financial Reporting—Chapter

Notes to Financial Statements,

which the FASB finalized on

August 28, 2018,

including the consideration of costs and benefits. This update applies to all entities that are required, under existing GAAP, to make disclosures about recurring or nonrecurring fair value measurements. This guidance is effective for financial statements issued for fiscal years beginning after

December 15, 2019,

and interim periods within those fiscal years. The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level

fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. Early adoption is permitted. An entity is permitted to early adopt any removed or modified disclosures and delay adoption of the additional disclosures until their effective date. The Company does

expect the adoption of ASU

to have a material impact on the Company's financial statements and disclosures.

XML 38 R4.htm IDEA: XBRL DOCUMENT

Unaudited Condensed Statements of Operations - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018
Revenue	$ 11,463	$ 0	$ 11,463	$ 0
Operating expenses:
Cost of revenue	1,000		1,000
Research and development	3,616	13,330	16,950	35,455
General and administrative	3,613	2,992	9,440	9,544
Severance expense		1,636		1,636
Total operating expenses	8,229	17,958	27,390	46,635
Income (loss) from operations	3,234	(17,958)	(15,927)	(46,635)
Other (expense) income:
Interest expense related to amortization of debt issuance costs and discount	(371)	(326)	(981)	(1,106)
Interest expense on principal	(1,208)	(1,367)	(3,669)	(4,228)
Fair value adjustment related to derivative and warrant liability	1,351	4,468	1,783	289
Interest and other income, net	60	52	295	290
Total other (expense) income	(168)	2,827	(2,572)	(4,755)
Income (loss) before income taxes	3,066	(15,131)	(18,499)	(51,390)
Income tax (expense) benefit	(3)	60	14	107
Net income (loss)	$ 3,063	$ (15,071)	$ (18,485)	$ (51,283)
Net income (loss) per share of common stock:
Basic (in dollars per share)	$ 0.09	$ (0.94)	$ (0.65)	$ (3.33)
Diluted (in dollars per share)	$ 0.06	$ (0.94)	$ (0.65)	$ (3.33)
Weighted average number of shares of common stock outstanding:
Basic (in shares)	30,126,704	16,033,923	28,417,450	15,385,663
Diluted (in shares)	31,672,149	16,033,923	28,417,450	15,385,663

XML 39 R35.htm IDEA: XBRL DOCUMENT

Note H - Fair Value of Financial Instruments - Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands	Sep. 30, 2019	Dec. 31, 2018
Financial liabilities measured at fair value on recurring basis	$ 335	$ 2,118
Financial assets measured at fair value on recurring basis		3,260
Certificates of Deposit [Member]
Financial assets measured at fair value on recurring basis		246
US Treasury Securities [Member]
Financial assets measured at fair value on recurring basis		3,014
Fair Value, Inputs, Level 1 [Member]
Financial liabilities measured at fair value on recurring basis
Financial assets measured at fair value on recurring basis		3,260
Fair Value, Inputs, Level 1 [Member] \| Certificates of Deposit [Member]
Financial assets measured at fair value on recurring basis		246
Fair Value, Inputs, Level 1 [Member] \| US Treasury Securities [Member]
Financial assets measured at fair value on recurring basis		3,014
Fair Value, Inputs, Level 2 [Member]
Financial liabilities measured at fair value on recurring basis	66	273
Financial assets measured at fair value on recurring basis
Fair Value, Inputs, Level 2 [Member] \| Certificates of Deposit [Member]
Financial assets measured at fair value on recurring basis
Fair Value, Inputs, Level 2 [Member] \| US Treasury Securities [Member]
Financial assets measured at fair value on recurring basis
Fair Value, Inputs, Level 3 [Member]
Financial liabilities measured at fair value on recurring basis	269	1,845
Financial assets measured at fair value on recurring basis
Fair Value, Inputs, Level 3 [Member] \| Certificates of Deposit [Member]
Financial assets measured at fair value on recurring basis
Fair Value, Inputs, Level 3 [Member] \| US Treasury Securities [Member]
Financial assets measured at fair value on recurring basis
Deerfield Warrant Liability [Member]
Financial liabilities measured at fair value on recurring basis	192	1,557
Deerfield Warrant Liability [Member] \| Fair Value, Inputs, Level 1 [Member]
Financial liabilities measured at fair value on recurring basis
Deerfield Warrant Liability [Member] \| Fair Value, Inputs, Level 2 [Member]
Financial liabilities measured at fair value on recurring basis
Deerfield Warrant Liability [Member] \| Fair Value, Inputs, Level 3 [Member]
Financial liabilities measured at fair value on recurring basis	192	1,557
Embedded Put Option [Member]
Financial liabilities measured at fair value on recurring basis	77	154
Embedded Put Option [Member] \| Fair Value, Inputs, Level 1 [Member]
Financial liabilities measured at fair value on recurring basis
Embedded Put Option [Member] \| Fair Value, Inputs, Level 2 [Member]
Financial liabilities measured at fair value on recurring basis
Embedded Put Option [Member] \| Fair Value, Inputs, Level 3 [Member]
Financial liabilities measured at fair value on recurring basis	77	154
Fundamental Change and Make-Whole Interest Provisions Embedded in 2021 Notes [Member]
Financial liabilities measured at fair value on recurring basis
Fundamental Change and Make-Whole Interest Provisions Embedded in 2021 Notes [Member] \| Fair Value, Inputs, Level 1 [Member]
Financial liabilities measured at fair value on recurring basis
Fundamental Change and Make-Whole Interest Provisions Embedded in 2021 Notes [Member] \| Fair Value, Inputs, Level 2 [Member]
Financial liabilities measured at fair value on recurring basis
Fundamental Change and Make-Whole Interest Provisions Embedded in 2021 Notes [Member] \| Fair Value, Inputs, Level 3 [Member]
Financial liabilities measured at fair value on recurring basis
Embedded Deerfield Note Put Option [Member]
Financial liabilities measured at fair value on recurring basis		134
Embedded Deerfield Note Put Option [Member] \| Fair Value, Inputs, Level 1 [Member]
Financial liabilities measured at fair value on recurring basis
Embedded Deerfield Note Put Option [Member] \| Fair Value, Inputs, Level 2 [Member]
Financial liabilities measured at fair value on recurring basis
Embedded Deerfield Note Put Option [Member] \| Fair Value, Inputs, Level 3 [Member]
Financial liabilities measured at fair value on recurring basis		134
KVK Warrant Liability [Member]
Financial liabilities measured at fair value on recurring basis	66	273
KVK Warrant Liability [Member] \| Fair Value, Inputs, Level 1 [Member]
Financial liabilities measured at fair value on recurring basis
KVK Warrant Liability [Member] \| Fair Value, Inputs, Level 2 [Member]
Financial liabilities measured at fair value on recurring basis	66	273
KVK Warrant Liability [Member] \| Fair Value, Inputs, Level 3 [Member]
Financial liabilities measured at fair value on recurring basis

XML 40 R31.htm IDEA: XBRL DOCUMENT

Note F - Common Stock and Warrants - Common Stock Activity (Details) - shares		3 Months Ended			9 Months Ended
	Sep. 03, 2019	Sep. 30, 2019	Jun. 30, 2019	Mar. 31, 2019	Sep. 30, 2019
Balance (in shares)		28,858,543	27,976,823	26,455,352	26,455,352
Common stock issued under Purchase Agreement (in shares)		1,200,000
Restricted stock awards vested during the period (in shares)			81,720
Balance (in shares)		32,387,382	28,858,543	27,976,823	32,387,382
Series B-1 Convertible Preferred Stock [Member]
Common stock issued as a result of Series B-1 Preferred Stock conversion (in shares)	828,945	828,945
2021NotesConvertedToCommonStockMember
Common stock issued as a result of 2021 Notes principal conversion (in shares)		1,499,894
Equity Line of Credit [Member]
Common stock issued under Purchase Agreement (in shares)			800,000	1,521,471

XML 41 R12.htm IDEA: XBRL DOCUMENT

Note F - Common Stock and Warrants

Stockholders' Equity Note Disclosure [Text Block]

F.	Common Stock and Warrants

Authorized,

Issued, and Outstanding Common Shares

the Company had authorized shares of common stock of

250,000,000

shares. Of the authorized shares,

32,387,382

shares of common stock were issued and outstanding as of

26,455,352

the Company had reserved authorized shares of common stock for future issuance as follows:

	September 30, 2019		December 31, 2018
Conversion of Deerfield Convertible Note		1,192,918		1,167,607
Conversion of 2021 Notes not subject to the Optional Exchange Principal Amount		2,727,820		4,481,182
Outstanding awards under equity incentive plans		4,620,891		3,704,755
Outstanding common stock warrants		2,423,077		2,527,763
Conversion of Series A Preferred Stock		1,112,334		1,112,334
Conversion of Series B-1 Preferred Stock		831,051		—
In exchange for the Optional Exchange Principal Amount*		28,439,015
Possible future issuances under equity incentive plans		675,966		648,272
Total common shares reserved for future issuance		42,023,072		13,641,913

* Represents the aggregate number of shares of Common Stock issuable (i) in exchange of the Optional Exchange Principal Amount, or (ii) upon conversion of the Series B-

Preferred Stock issuable in exchange of the Optional Exchange Principal Amount.

Common Stock Activity

The following table summarizes common stock activity for the

nine

months ended

September 30, 2019:

	Shares of Common Stock
Balance as of December 31, 2018		26,455,352
Common stock issued under Purchase Agreement		1,521,471
Balance as of March 31, 2019		27,976,823
Common stock issued under Purchase Agreement		800,000
Restricted stock awards vested during the period		81,720
Balance as of June 30, 2019		28,858,543
Common stock issued under Purchase Agreement		1,200,000
Common stock issued as a result of 2021 Notes principal conversion		1,499,894
Common stock issued as a result of Series B-1 Preferred Stock conversion		828,945
Balance as of September 30, 2019		32,387,382

September 2018,

the Company terminated the First ATM Agreement with Cowen. Prior to termination of the First ATM Agreement, the Company sold an aggregate of

762,338

shares of common stock under the First ATM Agreement resulting in gross proceeds to the Company of

sold any shares of common stock under the Second ATM Agreement. Refer to Note A for a further discussion of the First and Second ATM Agreements.

October

2018,

the Company entered into an underwriting agreement with RBCCM pursuant to which the Company issued and sold

8,333,334

shares of common stock of the Company in an underwritten public offering pursuant to the Company's registration statement on Form S-

Refer to Note A for a further discussion of the underwritten public offering.

Also in

October

2018,

the Company entered into the

Exchange Agreement pursuant to which the Company issued to the Holders

9,577

shares of Series A Preferred Stock. As of

shares of Series A Preferred Stock have been converted into

6,240

2,080,000

shares of common stock. Refer to Note C for a further discussion of the

the Company entered into the

Exchange Agreement pursuant to which the Company issued to the Holders

1,499,894

shares of common stock and

1,576

shares of Series B-

Preferred Stock. As of

Preferred Stock have been converted into

787

shares of Series B-

828,945

shares of common stock. Refer to Note C for a further discussion of the

million of convertible notes and the warrants (the

“2013

Warrants”) to purchase

1,079,453

shares of equity securities in a future financing meeting specified requirements (a “Qualified Financing”). The

Warrants allow the holders to purchase shares of the same class and series of equity securities issued in the Qualified Financing for an exercise price equal to the per share price paid by the purchasers of such equity securities in the Qualified Financing. When the Company entered into the Deerfield Facility Agreement, the

Warrants became warrants to purchase

1,079,453

shares of Series D Preferred. Upon completion of the IPO, the

Warrants automatically converted into warrants to purchase

143,466

shares of the Company’s common stock at an exercise price of

pursuant to the terms of the Deerfield Facility Agreement, the Company issued the Deerfield Warrant to purchase

14,423,076

shares of Series D Preferred (Note C). The Company recorded the fair value of the Deerfield Warrant as a debt discount and a warrant liability. The Deerfield Warrant, if unexercised, expires on the earlier of

June 2, 2024,

or upon a liquidation event. Upon completion of the IPO, the Deerfield Warrant automatically converted into a warrant to purchase

1,923,077

shares of the Company’s common stock at an exercise price of

$5.85

per share. The Company is amortizing the debt discount over the term of the Deerfield Convertible Note and the expense is recorded as interest expense related to amortization of debt issuance costs and discount in the condensed statements of operations.

The Company determined that the

Warrants and Deerfield Warrant should be recorded as a liability and stated at fair value at each reporting period upon inception. As stated above, upon completion of the IPO, the

Warrants and the Deerfield Warrant automatically converted into warrants to purchase the Company’s common stock. The Company marked the

Warrants to fair value and reclassified them to equity upon closing of the IPO. The Deerfield Warrant remains classified as a liability and is recorded at fair value at each reporting period since it can be settled in cash. Changes to the fair value of the warrant liability are recorded through the condensed statements of operations as a fair value adjustment (Note H).

In connection with a Collaboration and License Agreement (the “APADAZ License Agreement”) with KVK Tech, Inc. (“KVK”), in

October 2018,

the Company issued to KVK a warrant to purchase up to

500,000

shares of common stock of the Company at an exercise price of

$2.30

per share, which reflected the closing price of the Company’s common stock on the Nasdaq Global Market on execution date of the APADAZ License Agreement (the “KVK Warrant”). The KVK Warrant is initially

exercisable for any shares of common stock. Upon the achievement of each of

four

specified milestones under the KVK Warrant, the KVK Warrant will become exercisable for an additional

125,000

shares, up to an aggregate of

500,000

shares of the Company’s common stock. The exercise price and the number and type of shares underlying the KVK Warrant are subject to adjustment in the event of specified events, including a reclassification of the Company’s common stock, a subdivision or combination of the Company’s common stock, or in the event of specified dividend payments. The KVK Warrant is exercisable until

October 24, 2023.

Upon exercise, the aggregate exercise price

be paid, at KVK’s election, in cash or on a net issuance basis, based upon the fair market value of the Company’s common stock at the time of exercise.

The Company determined that, since KVK qualifies as a customer under ASC

the KVK Warrant should be recorded as a contract asset and recognized as contra-revenue as the Company recognizes revenue from the APADAZ License Agreement. In addition, the Company determined that the KVK Warrant qualifies as a derivative under ASC

815

and should be recorded as a liability and stated at fair value each reporting period. The Company calculates the fair value of the KVK Warrant using a probability-weighted Black-Scholes option pricing model. Changes in fair value resulting from changes in the inputs to the Black Scholes model are accounted for as changes in the fair value of the derivative under ASC

815

and are recorded as fair value adjustment related to derivative and warrant liability in the condensed statements of operations. Changes in the number of shares that are expected to be issued are treated as changes in variable consideration under ASC

606

and are recorded as a change in contract asset in the condensed balance sheets.

XML 42 R16.htm IDEA: XBRL DOCUMENT

Note J - Severance Expense

Restructuring and Related Activities Disclosure [Text Block]

J.	Severance Expense

August 2018,

Daniel L. Cohen resigned from his position as the executive vice president, government and public relations of the Company, effective immediately. In connection with his resignation, Mr. Cohen and the Company entered into a separation and release agreement which included among other items, severance benefits. The severance benefits consisted of personnel and other related charges of approximately

$0.4

million and stock compensation expense of approximately

$1.2

September 30, 2018,

the Company had accrued severance expense recorded within accounts payable and accrued expenses in the amount of

$0.3

million. As of and for the

severance expense or accrued severance expense.

XML 43 R22.htm IDEA: XBRL DOCUMENT

Note I - Net Income (Loss) Per Share of Common Stock (Tables)

Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block]

Notes Tables

	Three months ended September 30,				Nine months ended September 30,
	2019		2018		2019		2018
Warrants to purchase common stock		500,000		2,027,763		2,423,077		2,027,763
Awards under equity incentive plans		4,620,891		3,707,421		4,620,891		3,707,421
Deerfield Convertible Note		1,192,918		1,167,607		1,192,918		1,167,607
2021 Notes*		31,166,835		5,040,914		31,166,835		5,040,914
Series A Preferred Stock		—		—		1,112,334		—
Series B-1 Preferred Stock		—		—		831,051		—
Total securities excluded from the calculation of weighted average number of shares of common stock outstanding		37,480,644		11,943,705		41,347,106		11,943,705

Schedule of Earnings Per Share, Basic and Diluted [Table Text Block]

	Three months ended
	September 30, 2019
Basic net income per share of common stock:
Net income	$	3,063
Less: Net income attributable to participating securities		(348	)
Net income attributable to shares of common stock		2,715
Less: Dividends declared or accumulated		—
Undistributed net income attributable to shares of common stock, basic	$	2,715
Weighted average number of shares of common stock outstanding		30,127
Basic net income per share of common stock	$	0.09
Diluted net income per share of common stock:
Net income	$	3,063
Less: Fair value adjustment income related to Deerfield Warrant liability		(1,019	)
Less: Fair value adjustment income related to embedded Warrant Put Option		(135	)
Net income attributable to shares of common stock, diluted	$	1,909
Weighted average number of shares of common stock outstanding		30,127
Dilutive effect of Deerfield Warrant		—
Dilutive effect of Series A Preferred		1,112
Dilutive effect of Series B-1 Preferred		433
Weighted average number of shares of common stock outstanding, diluted		31,672
Diluted net income per share of common stock	$	0.06

XML 44 R26.htm IDEA: XBRL DOCUMENT

Note C - Debt Obligations (Details Textual) - USD ($)						9 Months Ended
Note C - Debt Obligations (Details Textual) - USD ($)	Sep. 03, 2019	Oct. 05, 2018	Jun. 11, 2018	Feb. 09, 2016	Jun. 02, 2014	Sep. 30, 2019	Sep. 30, 2018	Sep. 02, 2019	Dec. 31, 2018	Nov. 20, 2018	Jun. 30, 2016
Convertible Notes Payable, Current						$ 6,718,000			$ 3,333,000
Interest Paid, Excluding Capitalized Interest, Operating Activities						4,602,000	$ 5,280,000
Convertible Preferred Stock, Conversion Restriction, Percentage of Common Stock	4.985%
Change in Fair Value of Embedded Conversion Feature						2,311,000
Conversion from Deerfield Convertible Note to Common Stock [Member]
Debt Conversion, Converted Instrument, Shares Issued			598,568
Debt Conversion, Original Debt, Amount			$ 3,333,333
Debt Conversion, Accrued Interest			$ 168,288
Exchanged 2021 Notes for Series A Preferred Stock [Member]
Debt Conversion, Converted Instrument, Shares Issued		9,577
Debt Conversion, Original Debt, Amount		$ 9,577,000
Interest Paid, Excluding Capitalized Interest, Operating Activities		95,105
Debt Conversion, Expenses, Reimbursement		$ 25,000
DebtConversionOptionToExchangeAmount	$ 27,000,000
Convertible Notes 2021 [Member]
Beneficial Ownership, Cap Limit, Percentage										9.985%
Deerfield Convertible Notes [Member]
Beneficial Ownership, Cap Limit, Percentage										4.985%
2021NotesConvertedToCommonStockMember
Debt Conversion, Converted Instrument, Shares Issued	1,499,894
Debt Conversion, Original Debt, Amount						1,424,000
2021NotesConvertedToSeriesB1PreferredStockMember
Debt Conversion, Converted Instrument, Shares Issued	1,576
Debt Conversion, Original Debt, Amount						$ 1,576,000
Conversion From Deerfield Convertible Note to Common and Preferred Stock Member
Debt Conversion, Original Debt, Amount	$ 3,000,000
Exchanged2021NotesForSeriesB2PreferredStockMember
Debt Instrument, Convertible, Conversion Price	$ 1,000
Exchanged2021NotesForCommonStockMember
Debt Instrument, Convertible, Conversion Price	$ 0.9494
Series A Preferred Stock [Member]
Preferred Stock, Par or Stated Value Per Share		$ 0.0001		$ 0.0001
Preferred Stock, Aggregate Stated Value Per Share		1,000
Convertible Preferred Stock, Conversion Price		$ 3
Convertible Preferred Stock, Shares Issuable Upon Conversion		3,192,334				1,112,334
Convertible Preferred Stock, Conversion Restriction, Percentage of Common Stock		4.985%
Series B-1 Convertible Preferred Stock [Member]
Debt Conversion, Converted Instrument, Shares Issued	1,576
Preferred Stock, Par or Stated Value Per Share	$ 0.0001			0.0001		$ 0.0001			$ 0.0001
Preferred Stock, Aggregate Stated Value Per Share	1,000
Convertible Preferred Stock, Conversion Price	$ 0.9494
Convertible Preferred Stock, Shares Issuable Upon Conversion	831,051
Convertible Preferred Stock, Conversion Restriction, Percentage of Common Stock	4.985%
Conversion Of Stock Shares Issuable If Converted	1,659,996					831,051
Series B-2 Convertible Preferred Stock [Member]
Preferred Stock, Par or Stated Value Per Share						$ 0.0001			$ 0.0001
Preferred Stock, Aggregate Stated Value Per Share	$ 1,000
Convertible Preferred Stock, Conversion Price	$ 0.9494
Conversion Of Stock Shares Issuable If Converted	28,439,015
Preferred Stock, Liquidation Preference Per Share	$ 0.0001
Series B Preferred Stock [Member]
Preferred Stock, Liquidation Preference Per Share	$ 0.0001
2021 Notes [Member]
Debt Instrument, Convertible, Conversion Price				$ 17.11
Debt Instrument, Interest Rate, Stated Percentage				5.50%
Debt Instrument, Face Amount				$ 86,300,000
Proceeds from Debt, Net of Issuance Costs				82,800,000
Repayments of Long-term Debt, Total				18,600,000
Debt Instrument, Sinking Fund Payment				$ 0
Debt Conversion, Converted Instrument, Shares Issued				58.4454
Debt Conversion, Original Debt, Amount				$ 1,000
Debt Instrument Repurchase Price Equal to Percentage of Principal Amount				100.00%
Deerfield Facility Agreement [Member]
Line of Credit Facility, Maximum Borrowing Capacity					$ 60,000,000
Line of Credit Facility, Interest Rate at Period End					9.75%						6.75%
Debt Covenant, Debt Financing Restriction					$ 750,000
Debt Instrument, Interest Rate, Stated Percentage	6.75%							9.75%
Convertible Notes Payable, Current						$ 3,333,333
Reimbursement of Debt Holders	$ 150,000
Change in Fair Value of Embedded Conversion Feature						$ 2,300,000
Deerfield Facility Agreement [Member] \| Deerfield Warrant [Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights					$ 0.78
Deerfield Facility Agreement [Member] \| Deerfield Warrant [Member] \| IPO [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights					1,923,077
Deerfield Facility Agreement [Member] \| Series D Redeemable Convertible Preferred Stock [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights					14,423,076
Own-share Lending Arrangement, Shares, Issued					1,923,077
Mandatorily Redeemable Preferred Stock, Fair Value Disclosure					$ 1,500,000
Deerfield Facility Agreement [Member] \| Initial Public Offering [Member]
Reclassification of Common Stock Shares					256,410
Deerfield Facility Agreement [Member] \| Term Notes [Member]
Proceeds from Secured Notes Payable					$ 15,000,000
Deerfield Facility Agreement [Member] \| Deerfield Convertible Notes [Member]
Proceeds from Secured Notes Payable					$ 10,000,000
Debt Instrument, Convertible, Conversion Price					$ 5.85
Third Line of Credit Agreement [Member] \| City National Bank of Florida [Member]
Line of Credit Facility, Maximum Borrowing Capacity											$ 1,100,000

XML 45 R43.htm IDEA: XBRL DOCUMENT

Note K - Leases - Supplement Balance Sheet Information Related to Lease (Details) - USD ($) $ in Thousands	Sep. 30, 2019	Dec. 31, 2018
Lease liabilities	$ 454
Operating lease right-of-use assets	1,649
Total operating lease right-of-use assets	1,649
Current portion of operating lease liabilities	369
Operating lease liabilities, less current portion	1,976
Total operating lease liabilities	$ 2,345
Finance leases (Year)	2 years
Operating leases (Year)	6 years
Finance leases	7.70%
Operating leases	7.50%
Property and Equipment, At Cost [Member]
Property and equipment, at cost	$ 1,013
Accumulated Depreciation and Amortization [Member]
less: accumulated depreciation and amortization	(368)
Property and Equipment, Net [Member]
Property and equipment, net	645
Other Current Liabilities [Member]
Other current liabilities	227
Other Noncurrent Liabilities [Member]
Other long-term liabilities	227
Operating Lease Right-of-Use Assets [Member]
Operating lease right-of-use assets	1,649
Total operating lease right-of-use assets	1,649
Current Portion of Operating Lease Liabilities [Member]
Current portion of operating lease liabilities	369
Operating Lease Liabilities, Less Current Portion [Member]
Operating lease liabilities, less current portion	$ 1,976

XML 46 R18.htm IDEA: XBRL DOCUMENT

Significant Accounting Policies (Policies)	9 Months Ended
Significant Accounting Policies (Policies)	Sep. 30, 2019
Accounting Policies [Abstract]
Use of Estimates, Policy [Policy Text Block]	Use of Estimates The preparation of financial statements in conformity with GAAP requires the Company to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. On an ongoing basis, the Company evaluates its estimates and assumptions, including those related to revenue recognition, the useful lives of property and equipment, the recoverability of long-lived assets, the incremental borrowing rate for leases, and assumptions used for purposes of determining stock-based compensation, income taxes, and the fair value of the derivative and warrant liability, among others. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable, the results of which form the basis for making judgments about the carrying value of assets and liabilities.
Revenue from Contract with Customer [Policy Text Block]	Revenue Recognition The Company commenced recognizing revenue in accordance with the provisions of ASC 606, Revenue from Contracts with Customers (“ASC 606” ), starting January 1, 2018. However, the Company had no revenue at that time. Arrangements with Multiple-Performance Obligations From time to time, the Company enters into arrangements for research and development, manufacturing and/or commercialization services. Such arrangements may require the Company to deliver various rights, services, including intellectual property rights/licenses, research and development services, and/or commercialization services. The underlying terms of these arrangements generally provide for consideration to the Company in the form of nonrefundable upfront license fees, development and commercial performance milestone payments, royalty payments, and/or profit sharing. In arrangements involving more than one performance obligation, each required performance obligation is evaluated to determine whether it qualifies as a distinct performance obligation based on whether (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available and (ii) the good or service is separately identifiable from other promises in the contract. The consideration under the arrangement is then allocated to each separate distinct performance obligation based on its respective relative stand-alone selling price. The estimated selling price of each deliverable reflects the Company's best estimate of what the selling price would be if the deliverable was regularly sold by the Company on a stand-alone basis or using an adjusted market assessment approach if selling price on a stand-alone basis is not available. The consideration allocated to each distinct performance obligation is recognized as revenue when control of the related goods or services is transferred. Consideration associated with at-risk substantive performance milestones is recognized as revenue when it is probable that a significant reversal of the cumulative revenue recognized will not occur. Should there be royalties, the Company utilizes the sales and usage-based royalty exception in arrangements that resulted from the license of intellectual property, recognizing revenues generated from royalties or profit sharing as the underlying sales occur. Licensing Agreements The Company enters into licensing agreements with licensees that fall under the scope of ASC 606. The terms of the Company’s licensing agreements typically include one or more of the following: (i) upfront fees; (ii) milestone payments related to the achievement of development, regulatory, or commercial goals; and (iii) royalties on net sales of licensed products. Each of these payments may result in licensing revenues or an offset against research and development expense. As part of the accounting for these agreements, the Company must develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation which determines how the transaction price is allocated among the performance obligations. Generally, the estimation of the stand-alone selling price may include such estimates as, independent evidence of market price, forecasted revenues or costs, development timelines, discount rates, and probability of regulatory success. The Company evaluates each performance obligation to determine if they can be satisfied at a point in time or over time, and it measures the services delivered to the licensee which are periodically reviewed based on the progress of the related program. The effect of any change made to an estimated input component and, therefore revenue or expense recognized, would be recorded as a change in estimate. In addition, variable consideration (e.g., milestone payments) must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price. Up-front Fees: If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from the transaction price allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time. Milestone Payments: At the inception of each arrangement that includes milestone payments (variable consideration), the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s or the licensee’s control, such as non-operational developmental and regulatory approvals, are generally not considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company re-evaluates the probability of achievement of milestones that are within its or the licensee’s control, such as operational developmental milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaboration revenues and earnings in the period of adjustment. Revisions to the Company’s estimate of the transaction price may also result in negative licensing revenues and earnings in the period of adjustment. KP415/484 License Agreement In September 2019, the Company entered into the KP415/484 License Agreement with Commave under which the Company granted to Commave an exclusive, worldwide license to develop, manufacture and commercialize the Company's product candidates containing SDX and d-MPH, including KP415, KP484, and, at the option of Commave, KP879, KP922 and/or any other product candidate developed by the Company containing SDX and developed to treat ADHD or any other central nervous system disorder. The license granted to Commave is distinct from other performance obligations as Commave can benefit from the license either on its own or together with other resources that are readily available and the license is separately identifiable from other promises in the KP415/484 License Agreement. In exchange for the exclusive, worldwide license, discussed above, Commave paid the Company a non-refundable upfront payment of $10.0 million. The Company is also entitled to additional payments from Commave of up to $63.0 million, conditioned upon the achievement of specified regulatory milestones related to KP415 and KP484. In addition, the Company is entitled to payments from Commave of up to $420.0 million in the aggregate, conditioned upon the achievement of certain U.S. sales milestones, which are dependent upon, among other things, the timing of approval for a new drug application for KP415 and its final approved label, if any. Further, Commave will pay the Company quarterly, tiered royalty payments ranging from a percentage in the high single digits to mid-twenties of Net Sales (as defined in the KP415/484 License Agreement) in the U.S. and a percentage in the low to mid-single digits of Net Sales in each country outside of the U.S., in each case subject to specified reductions under certain conditions as described in the KP415/484 License Agreement Commave also agreed to be responsible for and reimburse the Company for all of development, commercialization and regulatory expenses incurred on the licensed products, subject to certain limitations as set forth in the KP415/484 License Agreement. As part of this agreement the Company is obligated to perform consulting services on behalf of Commave related to the licensed products. For these consulting services, Commave has agreed to pay the Company a set rate per hour on any consulting services performed on behalf of Commave for the benefit of the licensed products. The KP415/484 License Agreement is considered to be within the scope of ASC 606, as the transaction represents a contract with a customer where the the participants function in a customer / vendor relationship and are not exposed equally to the risks and rewards of the activities contemplated under the KP415/484 License Agreement. Using the concepts of ASC 606, the Company has identified the grant of the exclusive, worldwide license and the performance of consulting services, which includes the reimbursement of out-of-pocket third -party research and development costs, as its only two performance obligations. The Company further determined that the transaction price under the agreement was $10.0 million upfront payment plus the fair value of the Development Costs (as defined in the KP415/484 License Agreement) which was allocated among the performance obligations based on their respective related stand-alone selling price. The consideration allocated to the grant of the exclusive, worldwide license was $10.0 million, which reflects the standalone selling price. The Company utilized the adjusted market assessment approach to determine this standalone selling price which included analyzing prospective offers received from various entities throughout our licensing negotiation process as well as the consideration paid to other competitors in the market for a similar type transaction. The Company determined that the intellectual property licensed under the KP415/484 License Agreement represented functional intellectual property and it has significant standalone functionality and therefore should be recognized at a point in time as opposed to over time. The revenue related to the grant of the exclusive, worldwide license was recognized at the inception of the KP415/484 License Agreement. The consideration allocated to the performance of consulting services, which includes the reimbursement of out-of-pocket third -party research and development costs, was the fair value of the Development Costs (as defined in the KP415/484 License Agreement), which reflects the standalone selling price. The Company utilized a blended approach which took into consideration the adjusted market assessment approach and the expected cost plus a margin approach to determine this standalone selling price. This blended approach utilized the adjusted market approach and expected cost plus margin approach to value the performance of consulting services which included analyzing hourly rates of vendors in the a market who perform similar services to those of the Company to develop a range and then analyzing the average cost per hour of our internal resources and applying a margin which placed the value in the median of the previously identified range. For the reimbursement of out-of-pocket third -party research and development costs the Company utilized the expected cost plus a margin approach, which included estimating the actual out-of-pocket cost the Company expects to pay to third -parties for research and development costs and applying a margin, if necessary. The Company notes determined that no margin was necessary of these out-of-pocket third -party research and development costs as these are purely pass-through costs and the margin for managing these third -party activities is included within the value of the performance of consulting services. The Company determined that the performance of consulting services, including reimbursement of out-of-pocket third -party research and development costs, is a performance obligation that is satisfied over time as the services are performed and the reimbursable costs are paid. As such, the revenue related to the performance obligation will be recognized as the consulting services are performed and the services associated with the reimbursable out-of-pocket third -party research and development costs are incurred and paid by the Company, in accordance with the practical expedient allowed under ASC 606 regarding an entity's right to consideration from a customer in an amount that corresponds directly to the value to the customer of the entity's performance completed to date. Under the KP415/484 License Agreement, Commave was granted an exclusive option to include Additional Products as Product(s) (both as defined in the KP415/484 License Agreement) under the KP415/484 License Agreement (the "Additional Product Option"). In addition to the Additional Product Option, Commave was also granted a right of first refusal ("ROFR") to acquire, license and/or commercialize any of the Additional Product Candidates should they choose not to exercise the Additional Product Option. Should Commave just to exercise the Additional Product Option on any Additional Product Candidates, Commave and the Company shall negotiate in good faith regarding the economic terms of such Additional Product. Further, should Commave exercise the ROFR on any Additional Product Candidate, the economic terms of the agreement shall be the same as those offered to the third -party. Under ASC 606 an option to acquire additional goods or services on gives rise to a performance obligation if the option provides a material right to the customer. The Company concluded that the above described Additional Product Option and ROFR do not constitute material rights to the customer as Commave would acquire the goods or services at a to be negotiated price, which the Company expects to approximate fair value and therefore Commave would not receive a material discount on these goods or services and would obtain at market rates. The Company is entitled to additional payments from Commave conditioned upon the achievement of specified regulatory milestones related to KP415 and KP484 and the achievement of certain U.S. sales milestones, which are dependent upon, among other things, the timing of approval for a new drug application for KP415 and its final approved label, if any. Further, Commave will pay the Company quarterly, tiered royalty payments ranging from a percentage in the high single digits to mid-twenties of Net Sales (as defined in the KP415/484 License Agreement) in the U.S. and a percentage in the low to mid-single digits of Net Sales in each country outside of the U.S., in each case subject to specified reductions under certain conditions as described in the KP415/484 License Agreement. The Company concluded that these regulatory milestones, sales milestones and royalty payments each contain a significant uncertainty associated with a future event. As such, these milestone and royalty payments are constrained at contract inception and are not included in the transaction price as the Company could not conclude that it is probable a significant reversal in the amount of cumulative revenue recognized will not occur surrounding these payments. At the end of each reporting period, the Company will update its assessment of whether the milestone and royalty payments are constrained by considering both the likelihood and magnitude of the potential revenue reversal. During the three and nine months ended September 30, 2019, the Company recognized revenue of $11.5 million, which is comprised of a $10.0 million non-refundable payment for an exclusive, worldwide license, $1.2 million of reimbursement of out-of-pocket third -party research and development costs and $0.3 million for the performance of consulting services. In addition, as of September 30, 2019, the Company had receivables in the amount of $0.3 million and $1.2 million related to the performance of consulting services and the reimbursement of out-of-pocket third -party research and development costs, respectively. The cost of revenue associated with revenue recognized under the agreement with Commave was $1.0 million for the three and nine months ended September 30, 2019. There was no revenue recognized, or associated receivables and cost revenue, for the three and nine months ended September 30, 2018 or as of December 31, 2018. There was no deferred revenue related to this agreement as of September 30, 2019 or December 31, 2018.
Receivable [Policy Text Block]	Accounts and Other Receivables Accounts and other receivables consists of receivables under the KP415/484 License Agreement, as well as income tax and other receivables due to the Company. Receivables under the KP415/484 License Agreement are recorded for amounts due to the Company related to reimbursable out-of-pocket third -party research and development costs and performance of consulting services. These receivables are evaluated to determine if any reserve or allowance should be established at each reporting date. As of September 30, 2019 and December 31, 2018 no reserve or allowance has been established.
New Accounting Pronouncements, Policy [Policy Text Block]	Application of New or Revised Accounting Standards—Adopted From time to time, the Financial Accounting Standards Board (the “FASB”) or other standard-setting bodies issue accounting standards that are adopted by the Company as of the specified effective date. In April 2012, President Obama signed the Jump-Start Our Business Startups Act (the “JOBS Act”) into law. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for an emerging growth company. As an emerging growth company, the Company could have elected to adopt new or revised accounting standards when they become effective for non-public companies, which typically is later than public companies must adopt the standards. The Company has irrevocably elected not to take advantage of the extended transition period afforded by the JOBS Act and, as a result, will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required for non-emerging growth companies. In February 2016, the FASB issued ASU 2016 - 02, Leases (Topic 842 ) (“ASU 2016 - 02” ), which requires lessees to recognize operating and finance lease liabilities and corresponding right-of-use assets on the balance sheet and to provide enhanced disclosures surrounding the amount, timing and uncertainty of cash flows arising from leases. The Company leases office space and laboratory facilities under non-cancelable operating leases. In addition, the Company leases various laboratory equipment, furniture and office equipment and leasehold improvements that are accounted for as capital leases. The Company adopted the new standard effective January 1, 2019 on a modified retrospective basis and did not restate comparative periods. The Company elected the package of practical expedients permitted under the transition guidance, which allowed the Company to carryforward its historical lease classification and its assessment on whether a contract is or contains a lease for any leases that existed prior to adoption of the new standard. The Company also elected to combine lease and non-lease components and to keep leases with an initial term of 12 months or less off the balance sheet and recognize the associated lease payments in the condensed statements of operations on a straight-line basis over the lease term. The Company did not elect the hindsight practical expedient, which would have allowed the Company to use hindsight in determining the lease term and in assessing any impairment of right-of-use assets during the lookback period. The adoption of ASU 2016 - 02 resulted in the recognition of total right-of-use assets and total lease liabilities of approximately $2.6 million on the condensed balance sheets as of January 1, 2019. In July 2017, the FASB issued ASU 2017 - 11, Earnings Per Share (Topic 260 ), Distinguishing Liabilities from Equity (Topic 480 ), Derivatives and Hedging (Topic 815 ) – I. Accounting for Certain Financial Instruments with Down Round Features and II. Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception ("ASU 2017 - 11" ), which addresses the complexity of accounting for certain financial instruments with down round features and addresses the difficulty of navigating Topic 480 because of the existence of extensive pending content in the ASC as a result of the indefinite deferral of accounting requirements about mandatorily redeemable financial instruments of certain nonpublic entities and certain mandatorily redeemable noncontrolling interests. This update applies to all entities that issue financial instruments that include down round features and entities that present earnings per share in accordance with Topic 260. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. The adoption of ASU 2017 - 11 did not have a material impact on the Company's financial statements and disclosures. In June 2018, the FASB issued ASU 2018 - 07, Compensation – Stock Compensation (Topic 820 ) – Improvements to Nonemployee Share-Based Payment Accounting ("ASU 2018 - 07" ), which simplifies several aspects of the accounting for nonemployee share-based payment transactions resulting from expanding the scope of Topic 718, Compensation—Stock Compensation, to include share-based payment transactions for acquiring goods and services from nonemployees. This update applies to all entities that enter into share-based payment transactions for acquiring goods and services from nonemployees. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. The amendments in this ASU expand the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. An entity should apply the requirements of Topic 718 to nonemployee awards except for specific guidance on inputs to an option pricing model and the attribution of cost (that is, the period of time over which share-based payment awards vest and the pattern of cost recognition over that period). The amendments specify that Topic 718 applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. The adoption of ASU 2018 - 07 did not have a material impact on the Company's financial statements and disclosures. Application of New or Revised Accounting Standards —Not Yet Adopted In August 2018, the FASB issued ASU 2018 - 13, Fair Value Measurement (Topic 820 ) – Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement ("ASU 2018 - 13" ), which modifies the disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement, based on the concepts in the FASB Concepts Statement, Conceptual Framework for Financial Reporting—Chapter 8: Notes to Financial Statements, which the FASB finalized on August 28, 2018, including the consideration of costs and benefits. This update applies to all entities that are required, under existing GAAP, to make disclosures about recurring or nonrecurring fair value measurements. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. Early adoption is permitted. An entity is permitted to early adopt any removed or modified disclosures and delay adoption of the additional disclosures until their effective date. The Company does not expect the adoption of ASU 2018 - 13 to have a material impact on the Company's financial statements and disclosures.

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Note D - Commitments and Contingencies

Commitments and Contingencies Disclosure [Text Block]

D.	Commitments and Contingencies

From time to time, the Company is involved in various legal proceedings arising in the normal course of business. For some matters, a liability is

probable, or the amount cannot be reasonably estimated and, therefore, an accrual has

been made. However, for such matters when it is probable that the Company has incurred a liability and can reasonably estimate the amount, the Company accrues and discloses such estimates. As of

accruals have been made related to commitments and contingencies.

XML 48 R14.htm IDEA: XBRL DOCUMENT

Note H - Fair Value of Financial Instruments

Fair Value Disclosures [Text Block]

H.	Fair Value of Financial Instruments

The Company uses a

-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring basis, in periods subsequent to their initial measurement. The hierarchy requires the Company to use observable inputs when available, and to minimize the use of unobservable inputs, when determining fair value. The

tiers are defined as follows:

	●	Level 1—Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets;
	●	Level 2—Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and
	●	Level 3—Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions.

The fair value of the Deerfield Convertible Note was

$6.5

million and

$6.2

million, respectively, as of September

The fair value of the

million, respectively, as of September

Both the Deerfield Convertible Note and

of the fair value hierarchy as their value is based on the credit worthiness of the Company, which is an unobservable input. The Company used a Tsiveriotis-Fernandes model to value the Deerfield Convertible Note and

Notes fall within Level

Assets and Liabilities Measured at Fair Value on a Recurring Basis

Notes as of September

	Balance as of September 30, 2019		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Deerfield Warrant liability	$	192	$	—	$	—	$	192
Embedded Warrant Put Option		77		—		—		77
Fundamental change and make-whole interest provisions embedded in 2021 Notes		—		—		—		—
Deerfield Note Conversion Feature		—		—		—		—
KVK Warrant liability		66		—		66		—
Total liabilities	$	335	$	—	$	66	$	269

	Balance as of December 31, 2018		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Deerfield Warrant liability	$	1,557	$	—	$	—	$	1,557
Embedded Warrant Put Option		154		—		—		154
Fundamental change and make-whole interest provisions embedded in 2021 Notes		—		—		—		—
Deerfield Note Conversion Feature		134		—		—		134
KVK Warrant liability		273		—		273		—
Total liabilities	$	2,118	$	—	$	273	$	1,845

Trading securities:
Certificates of deposit	$	246	$	246	$	—	$	—
U.S. Treasury securities		3,014		3,014		—		—
Total assets	$	3,260	$	3,260	$	—	$	—

The Company’s Deerfield Warrant liability, embedded Warrant Put Option, the fundamental change and the make-whole interest provisions embedded in the

Notes and the embedded Deerfield Note Put Option, as well as the trading securities are measured at fair value on a recurring basis. As of

September 30, 2019 and December 31, 2018,

the Deerfield Warrant liability, embedded Warrant Put Option, the fundamental change and make-whole interest provisions embedded in the

Notes and the embedded Deerfield Note Put Option are reported on the condensed balance sheets in derivative and warrant liability. As of December

31,

2018,

the trading securities are reported on the condensed balance sheets in marketable securities.

The Company used a Monte Carlo simulation to value the Deerfield Warrant liability, embedded Warrant Put Option, the fundamental change and make-whole interest provisions embedded in the

Notes, and the embedded Deerfield Note Put Option as of

September 30, 2019 and December 31, 2018.

Significant unobservable inputs used in measuring the fair value of these financial instruments included the Company’s estimated enterprise value, an estimate of the timing of a liquidity or fundamental change event and a present value discount rate. Changes in the fair value of the Deerfield Warrant liability, embedded Warrant Put Option, the fundamental change and make-whole interest provisions embedded in the

Notes and the embedded Deerfield Note Put Option are reflected in the condensed statements of operations for the

September 30, 2019 and 2018

as a fair value adjustment related to derivative and warrant liability.

The Company’s KVK Warrant liability is measured at fair value on a recurring basis. As of

September 30, 2019

the KVK Warrant liability is reported on the condensed balance sheets in derivative and warrant liability. The Company estimates the fair value of the KVK Warrant using a probability-weighted Black-Scholes option-pricing model, which requires the use of subjective assumptions, including the expected term of the warrant, the expected stock price volatility, expected dividend yield and the risk-free interest rate for the expected term of the warrant. The expected term represents the period of time the warrant is expected to be outstanding. For the KVK Warrant, the Company used an expected term equal to the contractual term of the warrant. Expected volatility is based on the Company's historical volatility since the IPO. The Company assumes

December 31, 2018,

dividend yield because dividends are

expected to be paid in the near future, which is consistent with the Company’s history of

paying dividends. Changes in the fair value of the KVK Warrant liability are reflected in the statements of operations for the

as a fair value adjustment related to derivative and warrant liability. The changes in the fair value of the KVK Warrant liability are

reflected in the condensed statements of operations for the

A reconciliation of the beginning and ending balances for the derivative and warrant liability measured at fair value on a recurring basis using significant unobservable inputs (Level

) is as follows (in thousands):

	Three months ended September 30,						Nine months ended September 30,
	2019			2018			2019			2018
Balance as of beginning of period	$	1,437		$	11,888		$	1,845		$	7,709
Adjustment to fair value		(1,168	)		(4,468	)		(1,576	)		(289	)
Balance as of end of period	$	269		$	7,420		$	269		$	7,420

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

XML 49 R6.htm IDEA: XBRL DOCUMENT

Unaudited Condensed Statements of Cash Flows - USD ($) $ in Thousands	3 Months Ended				9 Months Ended		12 Months Ended
	Sep. 30, 2019	Mar. 31, 2019	Sep. 30, 2018	Mar. 31, 2018	Sep. 30, 2019	Sep. 30, 2018	Dec. 31, 2018
Cash flows from operating activities:
Net loss	$ 3,063	$ (12,291)	$ (15,071)	$ (26,219)	$ (18,485)	$ (51,283)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense					3,664	5,245
Non-cash interest expense					988	1,123
Amortization of debt issuance costs and debt discount	371		326		981	1,106
Depreciation and amortization expense					229	245
Fair value adjustment related to derivative and warrant liability	(1,351)		(4,468)		(1,783)	(289)
Write-off of deferred offering costs					10
Change in assets and liabilities:
Accounts and other receivables					(1,498)	(86)
Prepaid expenses and other assets					1,420	(960)
Operating lease right-of-use assets					(1,649)
Accounts payable and accrued expenses					(6,073)	5,780
Operating lease liabilities					2,345
Other liabilities					(788)	(86)
Net cash used in operating activities					(20,639)	(39,205)
Cash flows from investing activities:
Purchases of property and equipment					(21)	(6)
Maturities of marketable securities					3,260	25,374
Net cash provided by investing activities					3,239	25,368
Cash flows from financing activities:
Proceeds from equity line of credit					5,446
Proceeds from at-the-market offering, net of commissions						4,828
Repayment of obligations under capital lease						(142)
Repayment of principal on finance lease liabilities					(157)
Proceeds from exercise of common stock options						68
Net cash provided by financing activities					5,289	4,754
Net decrease in cash, cash equivalents and restricted cash					(12,111)	(9,083)
Cash, cash equivalents and restricted cash, beginning of period		$ 19,119		$ 11,971	19,119	11,971	$ 11,971
Cash, cash equivalents and restricted cash, end of period	$ 7,008		$ 2,888		7,008	2,888	$ 19,119
Supplemental cash flow information:
Cash paid for interest					4,602	5,280
Deferred offering costs included in accounts payable and accrued expenses					105	68
Deerfield Convertible Note principal and interest converted to common stock						3,502
Property and equipment financed under a lease agreement						52
Change in fair value of embedded conversion feature recorded as debt discount in connection with debt modification					2,311
2021NotesConvertedToCommonStockMember
Supplemental cash flow information:
2021 Notes principal converted to common stock					1,424
2021NotesConvertedToSeriesB1PreferredStockMember
Supplemental cash flow information:
2021 Notes principal converted to common stock					$ 1,576

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Note I - Net Income (Loss) Per Share of Common Stock - Anti-dilutive Securities (Details) - shares

Warrants to Purchase Common Stock [Member]

Share-based Payment Arrangement [Member]

Convertible Debt Securities [Member]

Series A Preferred Stock [Member]

^[1]

Series B-1 Convertible Preferred Stock [Member]

1,112,334