wint20180930

0001437749-18-020853.txt : 20181114 0001437749-18-020853.hdr.sgml : 20181114 20181114170726 ACCESSION NUMBER: 0001437749-18-020853 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 58 CONFORMED PERIOD OF REPORT: 20180930 FILED AS OF DATE: 20181114 DATE AS OF CHANGE: 20181114 FILER: COMPANY DATA: COMPANY CONFORMED NAME: WINDTREE THERAPEUTICS INC /DE/ CENTRAL INDEX KEY: 0000946486 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 943171943 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-26422 FILM NUMBER: 181184997 BUSINESS ADDRESS: STREET 1: 2600 KELLY ROAD STREET 2: SUITE 100 CITY: WARRINGTON STATE: PA ZIP: 18976 BUSINESS PHONE: 2154889300 MAIL ADDRESS: STREET 1: 2600 KELLY ROAD STREET 2: SUITE 100 CITY: WARRINGTON STATE: PA ZIP: 18976 FORMER COMPANY: FORMER CONFORMED NAME: DISCOVERY LABORATORIES INC /DE/ DATE OF NAME CHANGE: 19971201 FORMER COMPANY: FORMER CONFORMED NAME: ANSAN PHARMACEUTICALS INC DATE OF NAME CHANGE: 19961121 FORMER COMPANY: FORMER CONFORMED NAME: ANSAN INC DATE OF NAME CHANGE: 19950609 10-Q 1 wint20180930_10q.htm FORM 10-Q wint20180930_10q.htm

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2018

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission file number 000-26422

Windtree Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware		94-3171943
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification Number)
	2600 Kelly Road, Suite 100
	Warrington, Pennsylvania 18976-3622
	(Address of principal executive offices)

(215) 488-9300

(Registrant’s telephone number, including area code)

__________________

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES ☒ NO ☐

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). YES ☒ NO ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐	Accelerated filer ☐

Non-accelerated filer ☐ (Do not check if a smaller reporting company)	Smaller reporting company ☒

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ☐ NO ☒

As of November 2, 2018, there were outstanding 3,769,088 shares of the registrant’s common stock, par value $0.001 per share.

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PART I - FINANCIAL INFORMATION

		Page

Item 1.	Financial Statements	5

	CONDENSED CONSOLIDATED BALANCE SHEETS
	As of September 30, 2018 (unaudited) and December 31, 2017	5

	CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
	For the Three and Nine Months Ended September 30, 2018 and 2017	6

	CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited)
	For the Three and Nine Months Ended September 30, 2018 and 2017	7

	Notes to Condensed Consolidated Financial Statements (unaudited)	8

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	18

Item 3.	Quantitative and Qualitative Disclosures about Market Risk	25

Item 4.	Controls and Procedures	25

PART II - OTHER INFORMATION

Item 1.	Legal Proceedings	26

Item 1A.	Risk Factors	26

Item 6.	Exhibits	28

Signatures		29

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Unless the context otherwise requires, all references to “we,” “us,” “our,” and the “Company” include Windtree Therapeutics, Inc., and its wholly owned, presently inactive subsidiary, Discovery Laboratories, Inc.

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The forward-looking statements provide our current expectations or forecasts of future events and financial performance and may be identified by the use of forward-looking terminology, including such terms as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “will” or “should” or, in each case, their negative, or other variations or comparable terminology, though the absence of these words does not necessarily mean that a statement is not forward-looking. Forward-looking statements include all matters that are not historical facts and include, without limitation, statements concerning our business strategy, outlook, future milestones, goals and objectives, and our financial plans and future financial condition, and the time during which our existing cash and other resources may support our continued operation as a going concern. Forward-looking statements also include our expectations about our research and development programs, including planned development activities, anticipated timing of clinical trials and potential development milestones; the timing and anticipated outcomes of submitting regulatory filings in the United States and other markets; manufacturing plans for our KL4 surfactant, active pharmaceutical ingredients (APIs) and our proprietary aerosol delivery system (ADS); and our plans regarding potential collaborations and alliances, including potential licensing opportunities, and strategic transactions (including without limitation, by merger, acquisition or other corporate transaction).

We intend that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to many risks and uncertainties that could cause actual results to differ materially from any future results expressed or implied by the forward-looking statements. We caution you therefore against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. Examples of the risks and uncertainties include, but are not limited to:

Risks Related to Capital Resource Requirements

	•	we require significant additional capital to maintain operations and continue as a going concern. As of November 2, 2018, we have sufficient cash and cash equivalents to maintain our operations through mid-November 2018. We are currently engaged in active diligence and discussions for a potential strategic transaction that, if completed, would bring additional capital and diversify our assets; however, there can be no assurance that we will be able to reach agreement within an acceptable time frame, if at all, and on terms acceptable to all parties. As we work to complete the strategic transaction, Lee’s Pharmaceutical Holdings Limited (Lee’s), which owns a majority interest in our Company, has provided, and has indicated that it will continue to provide, financial support; however, there can be no assurance that additional support will be forthcoming. If we are unable to raise the capital that we require, we may be forced to severely limit our efforts and potentially cease operations. As such, there is substantial doubt about our ability to continue as a going concern;

	•	in 2017, our AEROSURF phase 2b clinical trial did not meet its primary endpoint due, we believe, to a higher-than-anticipated rate of treatment interruptions experienced with the phase 2 prototype aerosol delivery system (ADS). In 2018, we have completed design verification testing and related development activities for our new phase 3 aerosol delivery system (phase 3 ADS, which we previously referred to as “NextGen ADS”). We are also planning to conduct an additional AEROSURF bridge clinical study that is designed, among other things, to clinically evaluate the design and performance of our new phase 3 ADS. The resulting delay in the AEROSURF clinical development program has made it difficult to raise additional capital in the securities markets and, as a result, we have depended primarily upon the support of Lee’s and two previously announced loans from Panacea Venture Management Company Ltd. There can be no assurance that such support will continue, however; and in any event, we will require additional capital beyond that provided by Lee’s and Panacea to fund our bridge clinical study and there can be no assurance that we will be able to raise such additional capital, through the strategic transaction under discussion or equity offerings in the securities markets, if at all;

•

if we are successful in completing the strategic transaction that is currently being discussed, we may be exposed to potentially significant risks and uncertainties related to the transaction, the expansion of our product offerings and diversion of management’s attention and other resources from our development activities, and we may require additional capital to support our expanded operations; if we are not successful in completing the strategic transaction, we will nevertheless have incurred potentially significant legal, accounting and other professional fees that will require additional capital;

•

to restore investor confidence and attract sustained financial support, we believe that we must timely advance our AEROSURF development program through our planned device bridging clinical study and be in a position to initiate an AEROSURF phase 3 clinical program; however, due to cash resource constraints, we have been forced to slow the pace of development while we seek to complete the strategic transaction, the discussions for which have extended longer than previously anticipated, and secure the required additional capital. Even if we are successful in completing the strategic transaction and securing the required additional capital we require to fund the AEROSURF bridge study, we expect that we will continue to incur ongoing significant losses and will require significant additional capital to support our late-stage development, regulatory and business activities. In addition, our ability to raise such capital may be adversely impacted by future unforeseen adverse developments;

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•

our common stock has been quoted on the OTC Markets Group Inc.’s OTCQB® Market (OTCQB) tier since May 5, 2017, and has experienced, over time, lower trading volumes and reduced analyst interest. In addition, the share combination (1-for-20 reverse split) that was effective December 22, 2017 had the effect of reducing the number of shares outstanding and further lowering our trading volumes. These conditions may make it more difficult to raise capital when needed. Our stockholders also may find it more difficult to trade our securities on the OTCQB, and the value and liquidity of our common stock may be adversely affected, which could have a material adverse effect on our ability to raise the additional capital that we require. Moreover, even if we are successful in raising the required capital, any equity financings could result in substantial equity dilution of stockholders' interests;

•

if our AEROSURF development program is unduly delayed or should other complications arise, given our limited cash resources, we may be unable to implement the corrective actions that we might like, which potentially could adversely impact our planned development timelines. Under such circumstances, we may find it difficult to raise additional capital when needed to continue our development programs and support our operations;

•

to manage our cash resources and closely monitor cash outflows, we aggressively monitor our payables and work closely with our vendors, suppliers and service providers to assure that investment and spending decisions advance our corporate objectives at any time. During periods of limited cash resources, our paced or delayed payment practices potentially could impair our relationships with important vendors, suppliers and servicers, which could have a material adverse effect on our business, operation and development programs;

Risks related to Development Activities

•

our AEROSURF development program could be adversely affected by such risks as: our new phase 3 ADS may not perform in a consistent and predictable manner; we may miscalculate the treatment effect or comparator performance or underpower the size of a clinical study; variability in patient management among physicians, institutions and countries may adversely affect the results of our clinical study or we could experience adverse events that impact the benefit/risk profile; we may experience problems in our efforts to manufacture, test and release lyophilized KL4 surfactant and phase 3 ADS devices and procure other supplies; and our efforts to initiate, conduct and monitor clinical programs in clinical sites in multiple jurisdictions could be adversely affected by unforeseen events and requirements or delayed, which potentially could have a material adverse effect on our development programs, business and operations;

•

we must participate in rigorous regulatory processes to potentially gain approval for any drug, medical device or combination drug/device product candidate; in that regard, FDA or other regulatory authorities may withhold or delay consideration of our applications, may not agree with us on matters raised during the review process, or may require us to conduct significant unanticipated activities to advance our product candidates; FDA or other regulatory authorities may not approve our applications or may limit approval of our products to particular indications or impose unanticipated label limitations;

•

our efforts to gain regulatory approval in a timely manner for our drug and combination drug/device products in the U.S. and in international markets may be adversely affected by unforeseen developments and changed circumstances, including in the national or international political and regulatory environment and may make it more difficult to gain FDA or international regulatory approvals;

Risks Related to Strategic and Other Transactions

•

we may be unable to identify and enter into strategic alliances, collaboration agreements or other strategic transactions that would provide capital to support our AEROSURF development activities, or resources and expertise to support the registration and commercialization of AEROSURF in various markets, and potentially support the development and, if approved, commercialization, of our other potential KL4 surfactant pipeline products; or such strategic alliances, collaboration agreements and other strategic transactions may be delayed, terminated or fail, which could prevent us from advancing our development programs in accordance with our plan;

•

we believe that, even if our AEROSURF development efforts are successful, we also must seek to identify and pursue development of additional product candidates, including other KL4 surfactant product candidates, to potentially leverage our capabilities, maximize our resources, reduce our dependency upon a single product candidate, and attract the significant capital that we will require;

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Risks related to Manufacturing

•

our contract manufacturing organizations (CMOs) or any of our third-party suppliers, most of which are single-source providers, may encounter problems in manufacturing our KL4 surfactant, active pharmaceutical ingredients (APIs) and other materials used in the manufacture of our KL4 surfactant, and the ADS, related components and other materials, on a timely basis or in an amount sufficient to support our needs;

•

we have transferred manufacturing processes for our KL4 surfactant to our CMO, with elements of the final process validation pending, and to Lee’s pursuant to a License Agreement with Lee’s Pharmaceutical (HK) Ltd. (Lee’s (HK)), a subsidiary of Lee’s. We are engaged in a technology transfer of our manufacturing processes for our ADS to a device manufacturer and assembler, which is expected to produce phase 3 ADSs and disposable components for use in our planned clinical programs. Such technology transfers, related process validation and/or design verification and validation activities may be time consuming and expensive and we may experience problems, delays and setbacks that could affect our timeline for further development and clinical activities;

•

our drug product must be produced in an aseptic environment and tested using sophisticated and extensive analytical methodologies and quality control release and stability tests, which are conducted by our own analytical laboratory, third-party laboratories, most of which are also single-source providers, and our CMO, and which are expensive and could produce results that do not meet our specifications;

•

our device manufacturer and assembler, whom we expect to manufacture and assemble our ADS for our continuing clinical programs and, if approved, commercial activities, and support further ADS development and manufacturing process enhancements, may experience problems, delays and materials shortages;

•

our CMOs and suppliers of our APIs may experience problems in manufacturing our drug product, APIs and medical device components from time to time; ultimately, if our products are approved, they may experience problems complying with the final drug and medical device approval specifications;

Other Risks Affecting Our Business

	•	in the third quarter of 2017, Lee’s acquired a controlling interest in us through a subsidiary, LPH Investments Limited, and as such holds sufficient voting power to approve transactions that may not be in the best interests of other stockholders or recommended by management, or to take control of the Board of Directors by nominating and electing its own directors; in addition, we have entered into a License Agreement granting Lee’s (HK) rights to develop and commercialize our products in a specific Asian territory and Lee’s could use its voting power to benefit Lee’s (HK), which could give rise to potential or apparent conflicts of interest; and

	•	other risks and uncertainties detailed in “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q, and in the documents incorporated by reference in this report, other risks and uncertainties detailed in “Risk Factors” in our most recent Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on April 17, 2018, and our 2018 Quarterly Reports and filings with the SEC and any amendments thereto.

Pharmaceutical, biotechnology and medical technology companies have suffered significant setbacks conducting clinical trials, even after obtaining promising earlier preclinical and clinical data. Moreover, data obtained from clinical trials are susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. After gaining approval of a drug product, pharmaceutical and biotechnology companies face considerable challenges in marketing and distributing their products, and may never become profitable.

The forward-looking statements contained in this report or the documents incorporated by reference herein speak only as of their respective dates. Factors or events that could cause our actual results to differ may emerge from time to time and it is not possible for us to predict them all. Except to the extent required by applicable laws, rules or regulations, we do not undertake any obligation to publicly update any forward-looking statements or to publicly announce revisions to any of the forward-looking statements, whether as a result of new information, future events or otherwise.

Trademark Notice

AEROSURF®, SURFAXIN®, SURFAXIN LS™, WINDTREE THERAPEUTICS™, and WINDTREE™ are registered and/or common law trademarks of Windtree Therapeutics, Inc. (Warrington, PA).

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ITEM 1. Financial Statements

WINDTREE THERAPEUTICS, INC. AND SUBSIDIARY

Condensed Consolidated Balance Sheets

(in thousands, except share data)

	September 30, 2018			December 31, 2017
	Unaudited
ASSETS
Current Assets:
Cash and cash equivalents	$	640		$	1,815
Prepaid expenses and other current assets		399			422
Total current assets		1,039			2,237

Property and equipment, net		764			885
Restricted cash		140			225
Total assets	$	1,943		$	3,347

LIABILITIES & STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable	$	4,519		$	3,048
Collaboration payable		3,770			3,624
Accrued expenses		4,069			4,204
Deferred revenue - current portion		503			884
Loan payable		4,280			-
Convertible note payable, $1,500 net of discount of $531 at September 30, 2018		969			-
Total current liabilities		18,110			11,760

Restructured debt liability - contingent milestone payments		15,000			15,000
Deferred revenue - non-current portion		-			407
Other liabilities		166			100
Total liabilities		33,276			27,267

Stockholders' Equity:
Preferred stock, $0.001 par value; 5,000,000 shares authorized; 2,701 shares issued and outstanding at September 30, 2018 and December 31, 2017		-			-
Common stock, $0.001 par value; 120,000,000 shares authorized at September 30, 2018 and December 31, 2017; 3,769,162 shares issued at September 30, 2018 and December 31, 2017; 3,769,088 shares outstanding at September 30, 2018 and December 31, 2017		4			3
Additional paid-in capital		620,322			616,245
Accumulated deficit		(648,605	)		(637,114	)
Treasury stock (at cost); 74 shares		(3,054	)		(3,054	)
Total stockholders' equity		(31,333	)		(23,920	)
Total liabilities & stockholders' equity	$	1,943		$	3,347

See notes to condensed consolidated financial statements

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WINDTREE THERAPEUTICS, INC. AND SUBSIDIARY

Condensed Consolidated Statements of Operations

(Unaudited)

(in thousands, except per share data)

	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2018			2017			2018			2017

Revenues:
Grant revenue	$	70		$	17		$	765		$	1,383
License revenue with affiliate		159			-			719			-
Total revenues		229			17			1,484			1,383

Expenses:
Research and development		2,197			3,062			8,194			14,958
General and administrative		1,500			1,749			4,634			5,475
Total operating expense		3,697			4,811			12,828			20,433
Operating loss		(3,468	)		(4,794	)		(11,344	)		(19,050	)

Other income / (expense):
Interest income		1			3			9			9
Interest expense		(460	)		(652	)		(642	)		(1,878	)
Other income		-			-			486			-
Other income / (expense), net		(459	)		(649	)		(147	)		(1,869	)

Net loss	$	(3,927	)	$	(5,443	)	$	(11,491	)	$	(20,919	)

Deemed dividend on Series A preferred stock		-			(2,234	)		-			(6,370	)

Net loss attributable to common shareholders	$	(3,927	)	$	(7,677	)	$	(11,491	)	$	(27,289	)

Net loss per common share
Basic and diluted	$	(1.04	)	$	(10.53	)	$	(3.21	)	$	(48.45	)

Weighted average number of common shares outstanding
Basic and diluted		3,769			729			3,585			563

See notes to condensed consolidated financial statements

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WINDTREE THERAPEUTICS, INC. AND SUBSIDIARY

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(in thousands)

	Nine Months Ended
	September 30,
	2018			2017
Cash flows from operating activities:
Net loss	$	(11,491	)	$	(20,919	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		121			147
Amortization of debt discount		303			-
Stock-based compensation		703			839
Amortization of prepaid interest		-			818
Gain on sale of property and equipment		(9	)		-
Changes in:
Prepaid expenses and other current assets		23			264
Accounts payable		1,471			3,155
Collaboration payable		146			216
Accrued expenses		(68	)		(1,827	)
Deferred revenue		(789	)		1,070
Net cash used in operating activities		(9,590	)		(16,237	)

Cash flows from investing activities:
Proceeds from sale of property and equipment		9			-
Purchase of property and equipment		-			(24	)
Net cash used in investing activities		9			(24	)

Cash flows from financing activities:
Proceeds from loan payable, net of expenses		4,280			2,600
Proceeds from Private Placement issuance of securities, net of expenses		2,541			8,789
Proceeds from convertible note payable		1,500
Proceeds from ATM Program, net of expenses		-			1,036
Net cash provided by financing activities		8,321			12,425
Net increase/(decrease) in cash and cash equivalents		(1,260	)		(3,836	)
Cash, cash equivalents and restricted cash - beginning of year		2,040			5,813
Cash, cash equivalents and restricted cash - end of year	$	780		$	1,977

Supplementary disclosure of cash flows information:
Interest paid	$	-		$	514

See notes to condensed consolidated financial statements

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Notes to Condensed Consolidated Financial Statements (unaudited)

Note 1 –

The Company and Description of Business

Windtree Therapeutics, Inc. (referred to as “we,” “us,” or the “Company”) is a biotechnology company focused on developing novel KL4 surfactant therapies for respiratory diseases and other potential applications. Surfactants are produced naturally in the lung and are essential for normal respiratory function and survival. Our proprietary technology platform includes a synthetic, peptide-containing surfactant (KL4 surfactant) that is structurally similar to endogenous pulmonary surfactant, and novel drug delivery technologies, including our proprietary aerosol delivery system (ADS), being developed to enable noninvasive administration of aerosolized KL4 surfactant. We recently completed design verification for our new phase 3 ADS (which we previously referred to as the “NextGen ADS”), which we plan to use in our remaining AEROSURF® clinical development activities and, if approved, initial commercial activities. We believe that our proprietary technologies may make it possible to develop a pipeline of surfactant products to address a variety of respiratory diseases for which there are few or no approved therapies.

Our lead development program is AEROSURF(lucinactant for inhalation), an investigational combination drug/device product that we are developing to improve the management of respiratory distress syndrome (RDS) in premature infants who may require surfactant therapy to sustain life. The currently-available surfactants in the United States (U.S.) are administered using invasive endotracheal intubation and mechanical ventilation, each of which may result in serious respiratory conditions and other complications. To avoid these risks, many premature infants are initially treated with noninvasive respiratory support such as nasal continuous positive airway pressure (nCPAP). Because nCPAP does not address the underlying surfactant deficiency, many premature infants respond poorly to nCPAP alone (typically within the first 72 hours of life) and may require delayed surfactant therapy administered with invasive intubation (an outcome referred to as “nCPAP failure”). If surfactant therapy could be administered noninvasively, neonatologists would be able to provide surfactant therapy to premature infants earlier in their course of treatment and without exposing them to the risks associated with invasive endotracheal intubation and mechanical ventilation.

AEROSURF is designed to potentially meaningfully reduce the use of invasive endotracheal intubation and mechanical ventilation by delivering aerosolized KL4 surfactant noninvasively. We believe that AEROSURF, if approved, will allow for earlier treatment of premature infants who currently receive delayed surfactant therapy, decrease the morbidities and complications currently associated with surfactant administration, and reduce the number of premature infants who are subjected to invasive intubation and delayed surfactant therapy following nCPAP failure. We also believe that AEROSURF has the potential to address a serious unmet medical need and potentially provide transformative clinical and pharmacoeconomic benefits. Consistent with our belief, the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for our KL4 surfactant (including AEROSURF) to treat RDS.

In addition to advancing AEROSURF, we are assessing potential development pathways to potentially gain marketing approval for lyophilized KL4 surfactant as an intratracheal instillate for the treatment and/or prevention of RDS. Lyophilized KL4 surfactant may potentially provide benefits related to use, including longer shelf life, reduced cold-chain requirements and lower viscosity. We have discussed with the FDA a potential development plan, trial design and regulatory plan for approval. If we can define an acceptable development program that is achievable from a cost, timing and resource perspective, we might seek approval to treat premature infants who, because they are unable to breathe on their own or other reason, cannot benefit from AEROSURF.

We also believe that our KL4 surfactant technology may potentially support a product pipeline to address a broad range of serious respiratory conditions in children and adults. We have received support, and plan to seek additional support, from the National Institutes of Health (NIH) and other government funding sources to explore the utility of our KL4 surfactant to address a variety of such respiratory conditions as acute lung injury (ALI), including acute radiation exposure to the lung (acute pneumonitis and delayed lung injury), chemical-induced ALI, and influenza-induced ALI; as well as chronic rhinosinusitis, complications of certain major surgeries, mechanical ventilator-induced lung injury (often referred to as VILI), pneumonia, and diseases involving mucociliary clearance disorders, such as chronic obstructive pulmonary disease (COPD) and cystic fibrosis (CF). Although there can be no assurance, we may in the future support development activities to establish a proof-of-concept and, if successful, thereafter determine whether to seek strategic alliances or collaboration arrangements or pursue other financial alternatives to fund further development and, if approved, commercialization of additional KL4 surfactant indications.

To leverage our capabilities, maximize the use of our resources and potentially reduce our dependency on a single product candidate, we also seek to enter into strategic alliances, collaboration agreements and other strategic transactions (including without limitation, by merger, acquisition or other corporate transaction). We are pursuing a potential strategic transaction that could diversify our assets and bring in additional capital. There can be no assurance, however, that we will be able to reach agreement on terms and within the time frame acceptable to all parties. Moreover, even if we reach agreement and complete a transaction, there can be no assurance that we will have sufficient resources to fund the continued development of AEROSURF or any other product candidates, that any of our development efforts would be successful, or that we would obtain regulatory approvals needed to commercialize our product candidates in the world’s markets.

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Note 2 –

Liquidity Risks and Management’s Plans

As of September 30, 2018, we had cash and cash equivalents of $0.6 million and current liabilities of $18.1 million, including $4.3 million in loans payable (see Note 8 – Loan Payable) and $1.0 million of convertible note payable, net of discount (see Note 9 – Convertible Note Payable). As we remain focused on completing the potential strategic transaction that could diversify our assets and bring in additional capital to fund our activities, we are dependent upon Lee’s Pharmaceutical Holdings Limited (Lee’s), the majority holder of our common stock, to provide us financial support. Since August 2018, Lee’s has provided $2.7 million in financial support in the form of loans (see, Note 8 – Loan Payable and Note 13 – Subsequent Event); however, since we have not executed agreements for any additional advances at this time, there can be no assurance that additional support will be forthcoming. In addition, in connection with the potential strategic transaction, we are incurring and will continue to incur potentially significant legal, accounting, and other professional fees that in any event will represent an additional financial burden for which we will require additional capital. As of November 2, 2018, and before any additional financings, we believe that we will have sufficient cash resources available to support our operations through mid-November 2018.

We expect to continue to incur significant losses and will require significant additional capital to support our operations, advance our AEROSURF clinical development program, and satisfy existing obligations, and we do not currently have sufficient cash and cash equivalents for at least the next year following the date that the financial statements are issued. These conditions raise substantial doubt about our ability to continue as a going concern within one year after the date that the financial statements are issued.

To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, management plans to raise additional capital through the potential strategic transaction on which we are currently focused, which would provide access to additional products to diversify our offerings and additional capital to fund our operations. Although we are currently actively engaged in diligence and discussions to complete this strategic transaction, there can be no assurance that we will be able to complete it within an acceptable time and on terms that are favorable to us. If for any reason we are unable to complete the strategic transaction as planned, it is unlikely that we would be able to identify and enter into another suitable opportunity on acceptable terms and within a time for which we may have adequate funding. In that event, we would not have sufficient cash resources and liquidity to fund our business operations for at least the next year following the date that the financial statements are issued. Accordingly, management has concluded that substantial doubt exists with respect to our ability to continue as a going concern through one year after the issuance of the accompanying financial statements.

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.

In June 2018, we entered into a Guaranty and Replenishment Agreement with Lee’s pursuant to which Lee’s agreed to replenish up to $1 million expended by us that reduce our cash resources below our planned minimum cash (the amount that would otherwise be required to cover estimated wind-down costs should we be unable at any time to continue as a going concern). To secure its obligation to us, Lee’s delivered an Irrevocable Stand-by Letter of Credit (the Letter of Credit) in the amount of $1 million and drawn in our favor, which, following a recent extension, now expires on December 28, 2018. As of November 2, 2018, we have not drawn on the Letter of Credit.

As of November 2, 2018, there were 120 million shares of common stock and 5 million shares of preferred stock authorized under our Certificate of Incorporation, and approximately 113.3 million shares of common stock and 5.0 million shares of preferred stock available for issuance and not otherwise reserved.

Note 3 –

Basis of Presentation

These interim unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP) for interim financial information in accordance with the instructions to Form 10-Q. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete consolidated financial statements. In the opinion of management, all adjustments (consisting of normally recurring accruals) considered for fair presentation have been included. Operating results for the three and nine months ended September 30, 2018 are not necessarily indicative of the results that may be expected for the year ending December 31, 2018. There have been no changes to our critical accounting policies since December 31, 2017. For a discussion of our accounting policies, see, “– Note 4 – Summary of Significant Accounting Policies” in this Quarterly Report on Form 10-Q, and, in the Notes to Consolidated Financial Statements in our 2017 Form 10-K, “– Note 4 – Accounting Policies and Recent Accounting Pronouncements.” Readers are encouraged to review those disclosures in conjunction with this Quarterly Report on Form 10-Q.

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Note 4 –

Summary of Significant Accounting Policies

Use of Estimates

The preparation of financial statements, in conformity with U.S. GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

Restructured debt liability – contingent milestone payment

In conjunction with the November 2017 restructuring and retirement of long-term debt (See, "– Note 10 – Restructured debt liability"), we established a $15 million long-term liability for contingent AEROSURF regulatory and commercial milestone payments, beginning with the filing for marketing approval in the United States, potentially due under the Exchange and Termination Agreement dated as of October 27, 2017 (Exchange and Termination Agreement), between ourselves and affiliates of Deerfield Management Company L.P. (Deerfield). The liability has been recorded at full value of the contingent milestones and will continue to be carried at full value until the milestones are achieved and paid or milestones are not achieved and the liability is written off as a gain on debt restructuring.

Deferred revenue

Deferred revenue represents amounts received prior to satisfying the revenue recognition criteria (see, Revenue recognition) and are recognized as deferred revenue in our balance sheet. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as Deferred revenue – current portion. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as Deferred revenue – non-current portion.

Deferred revenue primarily consists of amounts related to an upfront license fee received in July 2017 in connection with the License Agreement with Lee’s. The revenue will be recognized as our performance obligations under the contract are met (see, Note 12 – Out-Licensing Agreement).

Revenue recognition

Effective January 1, 2018, we adopted Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers, using the modified retrospective transition method. Under this method, we recognize the cumulative effect of initially adopting ASC Topic 606, if any, as an adjustment to the opening balance of retained earnings. Additionally, under this method of adoption, we apply the guidance to all incomplete contracts in scope as of the date of initial application. This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments.

In accordance with ASC Topic 606, we recognize revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC Topic 606, we perform the following five steps:

	(i)	identify the contract(s) with a customer;
	(ii)	identify the performance obligations in the contract;

	(iii)	determine the transaction price;
	(iv)	allocate the transaction price to the performance obligations in the contract; and

(v)

recognize revenue when (or as) the entity satisfies a performance obligation.

We only apply the five-step model to contracts when we determine that it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. At contract inception, once the contract is determined to be within the scope of ASC Topic 606, we assess the goods or services promised within a contract and determine those that are performance obligations, and assesses whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

We have concluded that our government grants are not within the scope of ASC Topic 606 as they do not meet the definition of a contract with a customer. We have concluded that the grants meet the definition of a contribution and are non-reciprocal transactions, and have also concluded that Subtopic 958-605, Not-for-Profit-Entities-Revenue Recognition does not apply, as we are a business entity and the grants are with governmental agencies.

In the absence of applicable guidance under U.S. GAAP, effective January 1, 2018, we developed a policy for the recognition of grant revenue when the related costs are incurred and the right to payment is realized.

We believe this policy is consistent with the overarching premise in ASC Topic 606, to ensure that revenue recognition reflects the transfer of promised goods or services to customers in an amount that reflects the consideration that we expect to be entitled to in exchange for those goods or services, even though there is no exchange as defined in ASC Topic 606. We believe the recognition of revenue as costs are incurred and amounts become realizable is analogous to the concept of transfer of control of a service over time under ASC Topic 606.

Prior to January 1, 2018, we recognized revenue as related costs were incurred under the grants given that persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed and determinable, and collectability is reasonably assured. Recognized amounts reflected our performance under the grants and equal direct and indirect costs incurred. Revenue and expenses under these arrangements were presented gross. Revenue recognition under this new policy is not materially different than would have been calculated under the old guidance. As a result of the adoption of this policy, there was no change to the amounts we have historically recorded in our financial statements.

Research and development

We account for research and development expense by the following categories: (a) product development and manufacturing, (b) clinical medical and regulatory operations, and (c) direct preclinical and clinical development programs. Research and development expense includes personnel, facilities, manufacturing and quality operations, pharmaceutical and device development, research, clinical, regulatory, other preclinical and clinical activities and medical affairs. Research and development costs are charged to operations as incurred in accordance with ASC Topic 730, Research and Development.

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Net Loss per Common Share

Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per common share is computed by giving effect to all potentially dilutive securities outstanding for the period. As of September 30, 2018 and 2017, the number of shares of common stock potentially issuable upon the conversion of preferred stock or exercise of certain stock options and warrants was 1.3 million and 0.9 million shares, respectively. For the three and nine months ended September 30, 2018 and 2017, all potentially dilutive securities were anti-dilutive and therefore have been excluded from the computation of diluted net loss per share.

Net loss per common share – basic and diluted and weighted average number of common shares outstanding for the three and nine months ended September 30, 2017 have been corrected for immaterial calculation errors related to the conversion of preferred stock to common stock during those periods.

We do not have any components of other comprehensive income (loss).

Beneficial Conversion Feature

A beneficial conversion feature arises when a debt or equity security is issued with an embedded conversion option that is beneficial to the investor (or in the money) at inception due to the conversion option having an effective conversion price that is less than the fair value of the underlying stock at the commitment date.

Preferred Stock

The issuance of Series A Convertible Preferred Stock (Preferred Shares) in the first quarter of 2017 (see, “– Note 5 – Stockholders’ Equity”) resulted in a beneficial conversion feature. We recognized this feature by allocating the intrinsic value of the beneficial conversion feature, which is the number of shares of common stock available upon conversion multiplied by the difference between the effective conversion price per share and the fair value of common stock per share on the commitment date, to additional paid-in capital, resulting in a discount on the Preferred Shares. As the Preferred Shares are immediately convertible by the holders, the discount allocated to the beneficial conversion feature was immediately accreted and recognized as a $3.6 million one-time, non-cash deemed dividend to the preferred shareholders during the first quarter of 2017.

An additional discount to the Preferred Shares of $4.5 million was created due to the allocation of proceeds to the Warrants which were issued with the Preferred Shares. This discount is amortized proportionately as the Preferred Shares are converted. No Preferred Shares were converted during the three or nine months ended September 30, 2018. For the three and nine months ended September 30, 2017, we recognized a non-cash deemed dividend to the preferred shareholders of $2.2 million and $6.4 million, respectively, related to the Preferred Shares converted during the periods.

Convertible Note

The issuance on July 2, 2018 of a Secured Convertible Promissory Note (the Note) to Panacea Venture Management Company Ltd. (Panacea) with respect to a loan facility in the aggregate amount of $1.5 million resulted in a beneficial conversion feature. We recognized this feature by allocating the relative fair value of the conversion option, which is the number of shares of common stock available upon conversion multiplied by the difference between the effective conversion price per share and the fair value of common stock per share on the commitment date, resulting in a discount on the Note. We recorded the Note as current debt at its face value of $1.5 million less debt discount consisting of (i) $0.4 million related to the beneficial conversion feature and (ii) $0.4 million in fair value of the warrants issued in connection with the Note. The discount is being accreted to the $1.5 million loan over its term using the effective interest method.

Income taxes

We account for income taxes in accordance with ASC Topic 740, Accounting for Income Taxes, which requires the recognition of deferred tax liabilities and assets for the expected future tax consequences of temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities.

We use a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Because we have never realized a profit, management has fully reserved the net deferred tax asset since realization is not assured.

On December 22, 2017, the U.S. government enacted the 2017 Tax Cuts and Jobs Act (the 2017 Tax Act), which significantly revises U.S. tax law by, among other provisions, lowering the U.S. federal statutory income tax rate to 21%, imposing a mandatory one-time transition tax on previously deferred foreign earnings, and eliminating or reducing certain income tax deductions. As of December 31, 2017, we recorded the provisional impact from the 2017 Tax Act in accordance with SAB 118. As of September 30, 2018, we have not adjusted any of our provisional amounts that were recorded as of December 31, 2017. We will finalize our adjustments during the fourth quarter of 2018.

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Recently Adopted Accounting Standards

In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2014-09, Revenue from Contracts with Customers (Topic 606), which was subsequently amended by several other ASUs related to Topic 606 to, among other things, defer the effective date and clarify various aspects of the new revenue guidance including principal versus agent considerations, identifying performance obligations, licensing, and other improvements and practical expedients. We adopted ASU 2014-09, as amended, effective January 1, 2018 using the modified retrospective transition method. In June 2017, we entered into a License Agreement with Lee’s (HK), granting Lee’s (HK) rights to develop and commercialize our products in a specific Asian territory. The consideration we are eligible to receive under this agreement includes an upfront payment, contingent revenues in the form of regulatory and commercial milestones, and sales-based milestone and royalty payments. We evaluated the License Agreement under ASU 2014-09 and determined that there was no material impact to revenues for any of the years presented upon adoption. Additionally, there were no revisions to any balance sheet components of revenues such as deferred revenues or beginning retained earnings as a result of using the modified retrospective method. The primary impact on our financial statements is related to revised or additional disclosures with respect to revenues and cash flows arising from contracts with customers, which are included in Note 12 – Out-Licensing Agreement.

In May 2017, the FASB issued ASU 2017-09, Compensation—Stock Compensation (Topic 718), Scope of Modification Accounting. This ASU clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions. The ASU is effective prospectively for the annual period ending December 31, 2018 and interim periods within that annual period. We adopted ASU 2017-09 effective January 1, 2018 and the adoption did not have a material impact on our unaudited condensed consolidated financial statements and is not expected to have a material impact on the annual 2018 financial statements.

In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230), Classification of Certain Cash Receipts and Cash Payments. This ASU clarifies clarify how entities should classify certain cash receipts and cash payments related to eight specific cash flow issues, including debt prepayment or extinguishment costs, with the objective of reducing diversity in how certain cash receipts and cash payments are presented and classified in the statement of cash flows. The ASU also clarifies how the predominance principle should be applied when cash receipts and cash payments have aspects of more than one class of cash flows. The ASU is effective retrospectively for the annual period ending December 31, 2018 and interim periods within that annual period. We adopted ASU 2016-15 effective January 1, 2018 and the adoption did not have a material impact on our unaudited condensed consolidated financial statements and is not expected to have a material impact on the annual 2018 financial statements.

Recent Accounting Pronouncements

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). This ASU requires lessees to put most leases on their balance sheets but recognize expenses in the income statement in a manner similar to current accounting standards. The ASU is effective January 1, 2019. Early adoption is permitted. The standard requires a modified retrospective approach; however, the FASB recently added a transition option to the leases standard that allows entities to apply the new guidance in the year of transition rather than at the beginning of the earliest period presented. We have not elected to early adopt this standard. We are currently evaluating the effect of ASU 2016-02 and believe it may have a material impact on our consolidated financial statements and related disclosures.

Note 5 –

Stockholders’ Equity

On April 4, 2018, we completed a private placement offering pursuant to a Securities Purchase Agreement (SPA) and Registration Rights Agreement with LPH II Investments Limited (LPH II), a Cayman Islands company and wholly-owned subsidiary of Lee’s. Under this SPA, LPH II invested $2.6 million and acquired 541,667 shares of our common stock and warrants to purchase 135,417 shares of our common stock at an exercise price of $5.52 per share. The purchase price per share was $4.80. The warrants are exercisable after 6 months and through the seventh anniversary of the issue date. In addition, under the Registration Rights Agreement, we agreed to file an initial resale registration statement with the SEC to register for subsequent resale the shares and the warrant shares. We are required to seek registration of 25% of the shares and warrant shares on such initial resale registration statement. From time to time, following the 180th day from March 30, 2018, LPH II or a majority of the holders of the shares and warrant shares may require us to file additional registration statement(s) to register the resale of the balance of the shares and warrant shares, subject to certain limitations.

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Note 6 –

License Revenue with Affiliate

	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2018		2017		2018		2017

License revenue with affiliate	$	159	$	-	$	719	$	-

License revenue with affiliate for the three and nine months ended September 30, 2018 represents revenue from a License Agreement with Lee’s (HK) and constitutes a contract with a customer accounted for in accordance with ASC Topic 606, which we adopted effective January 1, 2018 (see, Note 4 – Summary of Significant Accounting Policies – Recently Adopted Accounting Standards and Note 12 – Out-Licensing Agreement). There was no impact to License revenue with affiliate previously recognized as a result of the adoption of ASC Topic 606.

Note 7 –

Fair Value of Financial Instruments

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.

Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy is based on three levels of inputs, of which the first two are considered observable and the last unobservable, as follows:

	●	Level 1 – Quoted prices in active markets for identical assets and liabilities.
	●	Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
	●	Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

Fair Value on a Recurring Basis

The tables below categorize assets and liabilities measured at fair value on a recurring basis for the periods presented:

	Fair Value		Fair value measurement using
	September 30,
(in thousands)	2018		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	640	$	640	$	-	$	-
Certificate of deposit		140		140		-		-
Total Assets	$	780	$	780	$	-	$	-

	Fair Value		Fair value measurement using
	December 31,
(in thousands)	2017		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	1,815	$	1,815	$	-	$	-
Certificate of deposit		225		225		-		-
Total Assets	$	2,040	$	2,040	$	-	$	-

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Note 8 –

Loan Payable

In January 2018 and March 2018, LPH agreed to lend us $1.5 million and $1.0 million, respectively, to support our AEROSURF development activities and sustain our operations while we seek to identify and advance one or more potential strategic initiatives as defined in the related loan agreements (Funding Event). The loans accrue interest at a rate of 6% per annum and mature upon the earlier of the closing date of the Funding Event or December 31, 2018. To secure our obligations under these loans, we granted LPH a security interest in substantially all our assets pursuant to the terms of a Security Agreement with LPH dated March 1, 2018 (LPH Security Agreement).

In August 2018 and September 2018, LPH agreed to lend us funds to sustain our operations while we continued to work on a strategic transaction. The initial loan was funded on August 14, 2018 in the amount of $300,000, and subsequent loans on the following dates and in the following amounts: August 29, 2018, in the amount of $480,000; September 12, 2018 in the amount of $500,000; and September 27, 2018 in the amount of $500,000. The loans accrue interest at a rate of 6% per annum and mature upon the earlier of (i) the closing date for the strategic transaction (as defined in the related loan agreements), provided that the Company is able to raise a minimum of $30 million in connection with such transaction, or (ii) March 31, 2019. In each case, we granted to LPH a security interest in substantially all of our assets pursuant to the terms of the LPH Security Agreement.

Note 9 –

Convertible Note Payable

	September 30,
(in thousands)	2018

Convertible note payable	$	1,500
Unamortized discount		(531	)
Convertible note payable, net of discount		969

On July 2, 2018, we issued to Panacea a Secured Convertible Promissory Note (the Note) with respect to a loan facility in the aggregate amount of up to $1.5 million, which was funded in two loans of, $1.0 million on the date of the Note and $500,000 on July 23, 2018. The Note has a maturity date of December 31, 2018 and bears interest at a rate of 15% per annum until the Note is paid in full or converted into shares of our common stock at a price per share of $4.00. In addition, in lieu of converting the Note, Panacea may deliver the Note into a private placement in which Panacea Venture Healthcare Fund I L.P., an affiliate of Panacea, may participate. There can be no assurance that such a private placement will be completed. In connection with these Loans, we granted to Panacea a security interest in substantially all our assets.

In connection with the Note, we issued to Panacea warrants (the “Series D Warrants”) to purchase 187,500 shares (the “Warrant Shares”) at an exercise price of $4.00 per Warrant Share (the “Exercise Price”). The Warrants may be exercised at any time beginning six months after the date of issuance and through the fifth anniversary of the date of issuance. The Warrants may not be exercised to the extent that the holder thereof would, following such exercise, beneficially own more than 9.99% of the Company’s outstanding shares of Common Stock, which percentage may be increased, decreased or waived by such holder upon sixty-one days’ notice to us. The Warrants also contain customary provisions that adjust the Exercise Price and the number of Warrant Shares in the event of a corporate transaction.

We recorded the Note as current debt at its face value of $1.5 million less debt discounts consisting of (i) $0.4 million fair value of the warrants issued in connection with the Note and (ii) a $0.4 million beneficial conversion feature related to an embedded conversion option that had an effective conversion price that was less than the fair value of the underlying stock at the commitment date. The discount is being accreted to the $1.5 million loan over its term using the effective interest method. The Panacea Warrants are derivatives that qualify for an exemption from liability accounting as provided for in ASC Topic 815, Derivatives and Hedging – Contracts in Entity’s Own Equity, and have been classified as equity.

The fair value at issuance of the Panacea Warrants was determined using the Black-Scholes option-pricing model. The input assumptions used in the valuation are the historical volatility of our common stock price, the expected term of the warrants, and the risk-free interest rate based on the five-year treasury bill rate in effect at the measurement date.

Significant Input Assumptions of Warrant Valuation
Historical volatility	103	%
Expected term (in years)	5
Risk-free interest rate	2.75	%

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The following amounts comprise the convertible note interest expense for the periods presented:

	September 30,
(in thousands)	2018

Cash interest expense	$	51
Non-cash amortization of debt discounts		302
Total convertible note interest expense		353

Note 10 –

Restructured debt liability

	September 30,		December 31,
(in thousands)	2018		2017

Restructured debt liability - contingent milestone payments	$	15,000	$	15,000

On November 1, 2017, we and Deerfield entered into an Exchange and Termination Agreement pursuant to which (i) promissory notes evidencing a loan with affiliates of Deerfield Management Company L.P. (Deerfield Loan) in the aggregate principal amount of $25 million and (ii) warrants to purchase up to 25,000 shares of our common stock at an exercise price of $786.80 per share held by Deerfield were cancelled in consideration for (i) a cash payment in the aggregate amount of $2.5 million, (ii) 71,111 shares of common stock, representing 2% of fully-diluted shares outstanding (as defined in the Exchange and Termination Agreement) on the closing date, and (iii) the right to receive certain milestone payments based on achievement of specified AEROSURF development and commercial milestones, which, if achieved, could potentially total up to $15 million. In addition, a related security agreement, pursuant to which Deerfield held a security interest in substantially all of our assets, was terminated. We established a $15 million long-term liability for the contingent milestone payments potentially due to Deerfield under the Exchange and Termination Agreement (see, Note 4 – Summary of Significant Accounting Policies – Restructured debt liability – contingent milestone payment).

Note 11 –

Stock Options and Stock-Based Employee Compensation

We recognize in our condensed consolidated financial statements all stock-based option awards to employees and non-employee directors based on their fair value on the date of grant, calculated using the Black-Scholes option-pricing model. Compensation expense related to stock-based option awards is recognized ratably over the vesting period, which for employees is typically three years. We recognize restricted stock unit awards to employees and non-employee directors based on their fair value on the date of grant. Compensation expense related to restricted stock unit awards is recognized ratably over the vesting period, which is typically between approximately six to 18 months.

A summary of activity under our long-term incentive plans is presented below:

(in thousands, except for weighted-average data) Stock Options	Shares			Weighted- Average Exercise Price		Weighted- Average Remaining Contractual Term (In Yrs)

Outstanding at January 1, 2018		84		$	163.20
Granted		-			-
Forfeited or expired		(1	)		729.80
Outstanding at September 30, 2018		83		$	154.80		7.1

Vested and exercisable at September 30, 2018		66		$	186.00		6.9

Vested and expected to vest at September 30, 2018		82		$	155.20		7.1

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(in thousands, except for weighted-average data)
Restricted Stock Units	Shares		Weighted- Average Grant Date Fair Value

Unvested at January 1, 2018		190	$	4.33
Awarded		-		-
Vested		-		-
Unvested at September 30, 2018		190	$	4.33

The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing formula based on the following weighted average assumptions:

	Nine Months Ended September 30,
	2017

Weighted average expected volatility		79%
Weighted average expected term (years)		6.6
Weighted average risk-free interest rate		2.22%
Expected dividends		-

The table below summarizes the total stock-based compensation expense included in the statements of operations for the periods presented:

	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2018		2017		2018		2017

Research and development	$	29	$	77	$	169	$	360
Selling, general and administrative		116		101		534		372
Total	$	145	$	178	$	703	$	732

Note 12 –

Out-Licensing Agreement

Lee’s Pharmaceutical (HK) Ltd.

In June 2017, we entered into a License, Development and Commercialization Agreement (“License Agreement”) with Lee’s Pharmaceutical (HK) Ltd., a company organized under the laws of Hong Kong (“Lee’s (HK)") and an affiliate of Lee's. Under the License Agreement, we granted to Lee’s (HK) an exclusive license with a right to sublicense, (i) to develop and commercialize our KL4 surfactant products, including SURFAXIN®, which was approved by the U.S. Food and Drug Administration (“FDA”) in 2012 for the prevention of respiratory distress syndrome (“RDS”) in premature infants, SURFAXIN LS™, the lyophilized dosage form of SURFAXIN; and AEROSURF®, an investigative combination drug/device product that is designed to deliver aerosolized KL4 surfactant noninvasively, and (ii) to register and manufacture SURFAXIN and SURFAXIN LS for use in the Licensed Territory, which includes the People’s Republic of China (“PRC”), Hong Kong, Thailand, Taiwan and 12 other countries (the “Licensed Territory”). In addition, we granted Lee’s (HK) options to potentially add Japan to the Licensed Territory and to manufacture our ADS in the Licensed Territory, in each case subject to conditions set forth in the License Agreement.

Under the License Agreement, Lee’s (HK) made an upfront payment to us of $1 million. We also may receive up to $37.5 million in potential clinical, regulatory and commercial milestone payments and will share in any sublicense income Lee’s (HK) may receive at a rate equal to low double digits. In addition, Lee’s (HK) will be responsible for all costs and expenses in and for the Licensed Territory related to development activities, including a planned AEROSURF phase 3 clinical trial, regulatory activities, and commercialization activities.

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In August 2017, we entered into a Loan Agreement, pursuant to which Lee’s (HK) agreed to lend us up to $3.9 million to support our activities through October 31, 2017, while we and Lee’s worked to complete a $10 million securities purchase agreement (Lee’s SPA) pursuant to which Lee’s acquired a controlling interest in our Company effective on November 1, 2017. In connection with the Loan Agreement, we amended the License Agreement (Amendment No. 1) to expand certain of Lee’s (HK) rights, by immediately adding Japan to the licensed territory, accelerating the right to manufacture the ADS in and for the licensed territory, reducing or eliminating certain of the milestone and royalty payments and adding an affiliate of Lee’s (HK) as a party to the License Agreement. As a result, the additional amounts for potential clinical, regulatory and commercial milestone payments were reduced to $35.8 million.

Accounting Analysis under ASC 606

In evaluating the License Agreement in accordance with ASC Topic 606, we concluded that the contract counterparty, Lee’s (HK), is a customer. We identified the following performance obligations: (i) a bundled performance obligation consisting of licensing rights to develop and commercialize our KL4 surfactant products and a technology transfer process for the manufacture of SURFAXIN and SURFAXIN LS; and (ii) a technology transfer process for the manufacture of our ADS. We determined that participation in the Joint Steering Committee (and other committees under its authority) and our ongoing product development, regulatory, and commercialization activities under the License Agreement were deemed immaterial in the context of the contract. Consistent with the guidance under ASC 606-10-25-16A, we disregarded immaterial promised goods and services when determining performance obligations.

We concluded that the licensing rights were not distinct within the context of the contract (i.e., separately identifiable) because the licensing rights do not have stand-alone value from other promised goods and services as Lee’s (HK) could not benefit from the licensing rights without the completion of the technology transfer process for the manufacture of SURFAXIN and SURFAXIN LS. The technology transfer process for the manufacture of our ADS is distinct within the context of the contract because it has stand-alone value from other promised goods and services as Lee’s (HK) could benefit from this right on a stand-alone basis. However, we determined that the ADS manufacturing right has a nominal stand-alone selling price at the time of Amendment No. 1 as the ADS is not yet verified and there is uncertainty with regard to the commercial value of the ADS given that the AEROSURF combination drug/device product is currently in clinical development.

With respect to Amendment No. 1, we elected to use the practical expedient for contract modifications that occur prior to the adoption of ASU 2014-09, and we determined that the impact was immaterial. Allocable arrangement consideration under the practical expedient comprised the upfront payment of $1 million and $0.3 million related to reductions in royalties and milestones in connection with Amendment No. 1. The $1.3 million was attributed in its entirety to the bundled performance obligation of licensing rights to develop and commercialize our KL4 surfactant products and a technology transfer process for the manufacture of SURFAXIN and SURFAXIN LS. Revenue associated with the bundled performance obligation was recognized beginning in November 2017 with the initiation of the technology transfer process for the manufacture of SURFAXIN and SURFAXIN LS and will be recognized over time as services are performed and based on the input method related to the level of effort expended. The expected completion date for the technology transfer is June 2019.

Regulatory and commercialization milestones were excluded from the transaction price, as all milestone amounts were fully constrained under the guidance. As part of our evaluation of the constraint, we considered a number of factors in determining whether there is significant uncertainty associated with the future events that would result in the milestone payments. Those factors include: our financial position; ongoing delays in our development activities and with initiating our phase 3 clinical trial; our limited experience with successful drug development; our limited experience with clinical trials; our recent failure to achieve primary endpoints in our phase 2b clinical trial; our limited experience with commercialization; our decision in 2015 to cease manufacturing and commercializing of SURFAXIN; and the fact that the uncertainty about the related consideration is not expected to be resolved for a long period of time (see, Item 1A – Risk Factors).

Consideration related to sales-based milestones and royalties will be recognized when the related sales occur, provided that the reported sales are reliably measurable and that we have no remaining performance obligations, as such sales were determined to relate predominantly to the license granted to Lee’s (HK) and therefore have also been excluded from the transaction price. We will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

Note 13 –

Subsequent Events

On October 19, 2018 and November 2, 2018, we entered into Loan Agreements (“Loan Agreements”) with LPH wherein LPH agreed to lend us $430,000 and $500,000 (together the “Loans”) to support our operations while we seek to complete a strategic transaction (as defined in the Loan Agreements, the “Strategic Transaction”). The Loans, which were funded on October 19, 2018 and November 2, 2018, each accrue interest at a rate of 6% per annum and mature upon the earlier of (i) the closing date for the Strategic Transaction, provided that the Company is able to raise a minimum of $30 million in connection with such transaction, or (ii) March 31, 2019. In each case, we granted LPH a security interest in substantially all our assets under the LPH Security Agreement.

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Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business and related financing activities, includes forward-looking statements that involve risks and uncertainties. The reader should review the “Forward-Looking Statements” section, and risk factors discussed in the Risk Factors Section and elsewhere in this Quarterly Report on Form 10-Q, which, together with the earlier Quarterly Reports on Form 10-Q for the quarter that we filed on May 21, 2018, and August xx, 2018, are in addition to and supplement the risk factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2017 that we filed with the Securities and Exchange Commission (SEC) on April 17, 2018 (2017 Form 10-K,) and our other filings with the SEC, and any amendments thereto, for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis or elsewhere in this Quarterly Report on Form 10-Q.

This MD&A is provided as a supplement to the accompanying unaudited condensed consolidated financial statements and footnotes to help provide an understanding of our financial condition, the changes in our financial condition and our results of operations. This item should be read in connection with our accompanying interim unaudited Condensed Consolidated Financial Statements (including the notes thereto) and the 2017 Form 10-K. Unless otherwise specified, references to Notes in this MD&A shall refer to the Notes to Condensed Consolidated Financial Statements (unaudited) in this Quarterly Report on Form 10-Q.

OVERVIEW

AEROSURF is designed to potentially meaningfully reduce the use of invasive endotracheal intubation and mechanical ventilation by delivering aerosolized KL4 surfactant noninvasively. We believe that AEROSURF, if approved, will allow for earlier treatment of premature infants who currently receive delayed surfactant therapy, decrease the morbidities and complications currently associated with surfactant administration, and reduce the number of premature infants who are subjected to invasive intubation and delayed surfactant therapy following nCPAP failure. We also believe that AEROSURF has the potential to address a serious unmet medical need and potentially provide transformative clinical and pharmacoeconomic benefits. Consistent with our belief, FDA has granted Fast Track designation for our KL4 surfactant (including AEROSURF) to treat RDS.

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In 2017, our AEROSURF phase 2b clinical trial did not meet its primary endpoint due, we believe, to a higher-than-anticipated rate of treatment interruptions experienced with the phase 2 prototype aerosol delivery system (ADS). In 2018, we have completed design verification testing and related development activities for our new phase 3 aerosol delivery system (phase 3 ADS, which we previously referred to as “NextGen ADS”). We are also planning to conduct an additional AEROSURF bridge clinical study that is designed, among other things, to clinically evaluate the design and performance of our new phase 3 ADS. The resulting delay in the AEROSURF clinical development program has made it difficult to raise additional capital in the securities markets and, as a result, we have depended primarily upon the support of Lee’s and two previously announced loans from Panacea Venture Management Company Ltd. There can be no assurance that such support will continue, however; and in any event, we will require additional capital beyond that provided by Lee’s and Panacea to fund our bridge clinical study and there can be no assurance that we will be able to raise such additional capital, through the strategic transaction under discussion or equity offerings in the securities markets, if at all.

We believe that our ability to continue as a going concern in the near term is highly dependent upon continuing support from Lee’s, and our ability to continue as a going concern in the long term will be highly dependent upon our ability to complete the strategic transaction on terms that are acceptable and secure the capital necessary to timely advance our AEROSURF development program, including plans to execute the AEROSURF bridge study and be in a position to initiate an AEROSURF phase 3 clinical program.

Business and Pipeline Program Updates

The reader is referred to, and encouraged to read in its entirety, “Item 1 – Business – Company Overview” and “– Business Strategy,” in the 2017 Form 10-K, which contains a discussion of our Business and Business Strategy, as well as information concerning our proprietary technologies and potential KL4 pipeline initiatives.

The following are business and development program updates for the third quarter ending September 30, 2018:

	●	Marvin E. Rosenthale, Ph.D., a long-standing member of the Company’s Board of Directors, passed away on August 13, 2018 at the age of 84. Dr. Rosenthale served as a valued member of the Board since 1998 and throughout his tenure was an enthusiastic supporter of the Company; his presence will be greatly missed. At the time of his passing, Dr. Rosenthale was Chairman of the Board’s Nomination and Governance Committee and a member of the Audit Committee. Dr. Rosenthale’s position on the Board will remain open until the Company is able to appoint a successor.

	●	On July 2, 2018, we issued to Panacea Venture Management Company Ltd. (Panacea), a Secured Convertible Promissory Note (the Note) with respect to a loan facility in the aggregate amount of up to $1.5 million, which was funded in two loans of, 1.0 million on the date of the Note and $500,000 on July 23, 2018. The Loans bear interest at a rate of 15% per annum until the Note is paid in full or converted into shares of our common stock at a price per share of $4.00. In addition, in lieu of converting the Note, Panacea may deliver the Note into a private placement in which Panacea Venture Healthcare Fund I L.P., an affiliate of Panacea, may participate. There can be no assurance that such a private placement will be completed. In connection with these Loans, we granted to Panacea a security interest in substantially all our assets.

	●	In addition to amounts received from Panacea in connection with the Secured Convertible Promissory Note, we received from an affiliate of Lee’s several loans to sustain our operations while we seek to complete the strategic transaction in which we have been focused. These transactions are described below under Loan Payable.

	●	Previously, on June 13, 2018, we entered into a Guaranty and Replenishment Agreement (Guaranty Agreement) with Lee’s Pharmaceutical Holdings Limited (Lee’s) pursuant to which Lee’s agreed to replenish amounts that we might expend out of our Minimum Cash (as defined in the Guaranty Agreement). Lee’s secured its obligation to us with an Irrevocable Stand-by Letter of Credit (the Letter of Credit) in the amount of $1,000,000 issued in our favor. The Letter of Credit originally expired on October 31, 2018. On October 10, 2018, Lee’s amended the Letter of Credit to extend the expiry date to December 28, 2018.

●

This Quarterly Report on Form 10-Q includes information concerning our AEROSURF clinical and device development programs. The AEROSURF phase 2b clinical trial has been supported to date, in part, by a $2.6 million Phase IIb award under a Small Business Innovation Research (SBIR) grant from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) under parent award number R44HL107000. In addition, we received funding under a Phase II SBIR grant from the National Institute of Allergy and Infectious Diseases (NIAID) under parent grant number R44AI102308.

The content of this Quarterly Report on Form 10-Q is solely our responsibility and does not necessarily represent the official views of the NIH.

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CRITICAL ACCOUNTING POLICIES

There have been no changes to our critical accounting policies since December 31, 2017. For a discussion of our accounting policies, see, “Note 4 – Summary of Significant Accounting Policies” and, in the Notes to Consolidated Financial Statements (Notes) in our 2017 Form 10-K, “Note 4 – Accounting Policies and Recent Accounting Pronouncements.” Readers are encouraged to review those disclosures in conjunction with this Quarterly Report on Form 10-Q.

RESULTS OF OPERATIONS

Operating Loss and Net Loss

The operating loss for the three months ended September 30, 2018 and 2017 was $3.5 million and $4.8 million, respectively. The decrease in operating loss from 2017 to 2018 was due to a $1.1 million decrease in operating expenses and a $0.2 million increase in total revenue.

The operating loss for the nine months ended September 30, 2018 and 2017 was $11.3 million and $19.1 million, respectively. The decrease in operating loss from 2017 to 2018 was due to a $7.6 million decrease in operating expenses and a $0.1 million increase in total revenue.

The net loss for the three months ended September 30, 2018 and 2017 was $3.9 million and $5.4 million, respectively. Included in the net loss is interest expense of $0.5 million and $0.7 million in 2018 and 2017, respectively.

The net loss for the nine months ended September 30, 2018 and 2017 was $11.5 million and $20.9 million, respectively. Included in the net loss is interest expense of $0.6 million and $1.9 million in 2018 and 2017, respectively.

The net loss attributable to common shareholders for the three and nine months ended September 30, 2018 was $3.9 million (or $1.04 basic net loss per common share) and $11.5 million (or $3.21 basic net loss per common share). The net loss attributable to common shareholders for the three and nine months ended September 30, 2017 was $7.7 million (or $10.53 basic net loss per common share) and $27.3 million (or $48.45 basic net loss per common share). Included in the net loss attributable to common shareholders for the three and nine months ended September 30, 2017 is a $2.2 million and a $6.4 million non-cash deemed dividend on preferred stock, respectively (see, “Note 4 – Summary of Significant Accounting Policies – Beneficial Conversion Feature”).

Grant revenue

For the three months ended September 30, 2018, we recognized grant revenue of $0.1 million, which had previously been recorded as deferred revenue, and consists of funds received and expended under a Phase II SBIR grant from NIAID to support continued development of our aerosolized KL4 surfactant as a potential medical countermeasure to mitigate acute and chronic/late-phase radiation-induced lung injury (Radiation Grant).

For the nine months ended September 30, 2018 and 2017, we recognized grant revenue of $0.7 million and $1.4 million, respectively. Grant revenue for the nine months ended September 30, 2018 consists of $0.7 million of funds received and expended under a Phase II SBIR from the NHLBI of the NIH to support the AEROSURF phase 2b clinical trial (AEROSURF Grant). Grant revenue for the nine months ended September 30, 2017 includes $1.1 million of funds received and expended under the AEROSURF Grant and $0.3 million of funds under the Radiation Grant.

As of September 30, 2018, all funding under the AEROSURF Grant and the Radiation Grant has been received and recognized in revenue.

License Revenue with Affiliate

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In accordance with ASC Topic 606, we recognize revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the we determine are within the scope of ASC Topic 606, we perform the following five steps:

	(i)	identify the contract(s) with a customer;
	(ii)	identify the performance obligations in the contract;
	(iii)	determine the transaction price;
	(iv)	allocate the transaction price to the performance obligations in the contract; and
	(v)	recognize revenue when (or as) the entity satisfies a performance obligation.

For the three and nine months ended September 30, 2018, we recognized license revenue with affiliates of $0.2 million and $0.7 million, respectively, which had previously been included in deferred revenue – current portion.

Research and Development Expenses

Our research and development expenses are charged to operations as incurred and we account for such costs by category rather than by project. As many of our research and development activities form the foundation for the development of our KL4 surfactant and drug delivery technologies, they are expected to benefit more than a single project. For that reason, we cannot reasonably estimate the costs of our research and development activities on a project-by-project basis. We believe that tracking our expenses by category is a more accurate method of accounting for these activities. Our research and development costs consist primarily of expenses associated with (a) product development and manufacturing, (b) clinical, medical and regulatory operations, and (c) direct preclinical and clinical development programs. We also account for research and development and report annually by major expense category as follows: (i) salaries and benefits, (ii) contracted services, (iii) raw materials, aerosol devices and supplies, (iv) rents and utilities, (v) depreciation, (vi) contract manufacturing, (vii) travel, (viii) stock-based compensation and (ix) other.

Research and development expenses by category for the three and nine months ended September 30, 2018 and 2017 are as follows:

	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2018		2017		2018		2017

Product development and manufacturing	$	1,053	$	1,306	$	4,335	$	5,013
Clinical, medical and regulatory operations		966		1,277		3,162		4,654
Direct preclinical and clinical programs		178		479		697		5,291
Total Research and Development Expenses	$	2,197	$	3,062	$	8,194	$	14,958

Research and development expenses include non-cash charges associated with stock-based compensation and depreciation of $0.1 and $0.3 million for the three months ended September 30, 2018 and 2017, respectively, and $0.1 and $0.5 million for the nine months ended September 30, 2018 and 2017, respectively.

Product Development and Manufacturing

Product development and manufacturing includes (i) manufacturing operations, both in-house and with contract manufacturing organizations (CMOs), validation activities, quality assurance and analytical chemistry capabilities that support the manufacture of our KL4 surfactant used in research and development activities and our medical devices, including our ADS; (ii) design and development activities related to our ADS for use in our AEROSURF clinical development program; and (iii) pharmaceutical and manufacturing development activities, including development of a lyophilized dosage form of our KL4 surfactant. These costs include employee expenses, facility-related costs, depreciation, costs of drug substances (including raw materials), supplies, quality control and assurance activities, analytical services, and expert consultants and outside services to support pharmaceutical and device development activities.

Product development and manufacturing expenses decreased $0.2 million for the three months ended September 30, 2018 and $0.7 million for the nine months ended September 30, 2018 compared to the same periods in 2017 due to (i) our ongoing efforts to conserve cash and reduce costs and (ii) for the nine-month period, a July 2017 workforce reduction.

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Clinical, Medical and Regulatory Operations

Clinical, medical and regulatory operations include (i) medical, scientific, preclinical and clinical, regulatory, data management and biostatistics activities in support of our research and development programs; and (ii) medical affairs activities to provide scientific and medical education support for our KL4 surfactant and aerosol delivery systems under development. These costs include personnel, expert consultants, outside services to support regulatory and data management, symposiums at key medical meetings, facilities-related costs, and other costs for the management of clinical trials.

Clinical, medical and regulatory operations expenses decreased $0.3 million for the three months ended September 30, 2018 and $1.5 million for the nine months ended September 30, 2018 compared to the same periods in 2017 due to (i) our ongoing efforts to conserve cash and reduce costs and (ii) for the nine-month period, a July 2017 workforce reduction.

Direct Preclinical and Clinical Development Programs

Direct preclinical and clinical development programs include (i) development activities, toxicology studies and other preclinical studies; and (ii) activities associated with conducting clinical trials, including patient enrollment costs, clinical site costs, clinical device and drug supply, and related external costs, such as consultant fees and expenses.

Direct preclinical and clinical development programs expenses decreased $0.3 million for the three months ended September 30, 2018 and $4.6 million for the nine months ended September 30, 2018 compared to the same periods in 2017 due to a decrease in AEROSURF phase 2 clinical development program costs following the completion of enrollment in the phase 2a and phase 2b clinical trials during the second quarter of 2017.

General and Administrative Expenses

	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2018		2017		2018		2017

General and Administrative Expenses	$	1,500	$	1,749	$	4,634	$	5,475

General and administrative expenses consist of costs for executive management, business development, intellectual property, finance and accounting, legal, human resources, information technology, facility, and other administrative costs.

General and administrative expenses decreased $0.2 million for the three months ended September 30, 2018 and $0.8 million for the nine months ended September 30, 2018 compared to the same periods in 2017 due to (i) our ongoing efforts to conserve cash and reduce costs and (ii) for the nine-month period, a July 2017 workforce reduction.

Other Income and (Expense)

	Three Months Ended September 30,						Nine Months Ended September 30,
(in thousands)	2018			2017			2018			2017

Interest income	$	1		$	3		$	9		$	9
Interest expense		(460	)		(652	)		(642	)		(1,878	)
Other income		-			-			486			-
Other income / (expense), net	$	(459	)	$	(649	)	$	(147	)	$	(1,869	)

For 2018, interest expense consists of interest expense associated with the Convertible note payable, the Collaboration payable and the Loan payable. For 2017, interest expense primarily consists of interest expense associated with the Deerfield Loan (see, “Note 9 – Restructured debt liability”).

Other income primarily consists of proceeds from the sale of Commonwealth of Pennsylvania research and development tax credits.

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LIQUIDITY AND CAPITAL RESOURCES

We believe that our ability to continue as a going concern in the near term is highly dependent upon continuing support from Lee’s, and our ability to continue as a going concern in the long term will be highly dependent upon our ability to secure the capital necessary to timely advance our AEROSURF development program, including plans to execute the AEROSURF bridge study and be in a position to initiate an AEROSURF phase 3 clinical program, and achieve results that can attract investor interest. Our AEROSURF development program activities are subject to significant risks and uncertainties, such that there can be no assurance that we will be successful in completing these activities in accordance with our plans, or at all. If our AEROSURF development program activities should be delayed for any reason, we may be forced to implement cost-saving measures that may potentially have a negative impact on our activities and potentially the results of our clinical programs. Even if we complete our AEROSURF development program activities as planned, if the results are inconclusive, or present an unacceptable benefit/risk profile, we may be unable to secure the additional capital that we will require to continue our development activities and operations, which could have a material adverse effect on our business. In that event, we may be forced to curtail all of our activities and, ultimately, cease operations. Even if we are able to raise sufficient capital, such financings may only be available on unattractive terms, or result in significant dilution of stockholders’ interests and, in such event, the market price of our common stock may decline.

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Cash Flows

Cash outflows for the nine months ended September 30, 2018, consist of $9.6 million used for ongoing operating activities offset by cash inflows for the nine months ended September 30, 2018 of $8.3 million for financing activities.

Operating Activities

Net cash used in operating activities for the nine months ended September 30, 2018 and 2017 was $9.6 million and $16.2 million, respectively. Net cash used in operating activities is a result of our net losses for the period, adjusted for non-cash items and changes in working capital. The decrease in net cash used in operating activities is due to our ongoing efforts to conserve cash as well the completion of enrollment in the phase 2a and phase 2b clinical trials during the second quarter of 2017.

Investing Activities

Net cash provided by investing activities for the nine months ended September 30, 2018 represents $9,000 in proceeds from the sale of property and equipment. Net cash used in investing activities for the nine months ended September 30, 2017 represents capital expenditures of $24,000.

Financing Activities

Net cash provided by financing activities for nine months ended September 30, 2018 was $8.3 million and represents loan proceeds of $4.3 million related to loan agreements with LPH, an affiliate of Lee’s; $2.6 million from a private placement offering with LPH II, a wholly-owned subsidiary of Lee’s, from which we received net proceeds of approximately $2.5 million; and $1.5 million in proceeds from a convertible note payable with Panacea.

Net cash provided by financing activities for nine months ended September 30, 2017 was $12.4 million and represents net cash proceeds from both the February 2017 private placement of $8.8; loan proceeds of $2.6 million related to loan agreements with LPH; and the use of the ATM Program of $1.0 million.

The following sections provide a more detailed discussion of our available financing facilities.

Private Placement Offerings

April 2018 Private Placement

In April 2018, we completed a private placement with LPH II Investments Limited (LPH II), a wholly-owned subsidiary of Lee’s, for the purchase of $2.6 million of our common stock and warrants at a purchase price per share of $4.80. In connection with this offering, we issued 541,667 shares of common stock and warrants to purchase 135,417 shares of common stock at an exercise price of $5.52 per share. The warrants are exercisable after 6 months and through the seventh anniversary of the issue date.

Loan Payable

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Convertible Note Payable

On July 2, 2018, we issued to Panacea Venture Management Company Ltd. (Panacea), a Secured Convertible Promissory Note (the Note) with respect to Loans (defined below) in the aggregate amount of up to $1.5 million. In connection with the issuance of the Note, Panacea made two loans (individually, each a Loan and collectively, the Loans) to us, the first of which was in the amount of $1.0 million and paid on the date of the Note, and the second of which was in the amount of $500,000 and received on July 23, 2018. The Loans bear interest on the outstanding principal amount at a rate of 15% per annum until the Note is paid in full or converted into shares of our common stock at a price per share of $4.00. In addition, in lieu of converting the Note, Panacea may deliver the Note into a private placement in which Panacea Venture Healthcare Fund I L.P., an affiliate of Panacea, may participate. There can be no assurance that such a private placement will be completed. In connection with these Loans, we granted to Panacea a security interest in substantially all our assets. The proceeds of these Loans are being used to support our operations while we pursue the potential strategic transaction that could diversify our assets and bring in additional capital. (See, “– Overview – Business and Pipeline Program Updates.”)

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not applicable.

Item 4.

Controls and Procedures

Evaluation of disclosure controls and procedures

Our management, including our President and Chief Executive Officer (principal executive officer) and our Senior Vice President and Chief Financial Officer (principal financial officer), does not expect that our disclosure controls or our internal control over financial reporting will prevent all error and all fraud. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected. In designing and evaluating the disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives and our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Our President and Chief Executive Officer and our Senior Vice President and Chief Financial Officer have evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(e) of the Exchange Act) as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on this evaluation, our President and Chief Executive Officer and our Senior Vice President and Chief Financial Officer concluded that, as of the end of the period covered by this report, our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our President and Chief Executive Officer and our Senior Vice President and Chief Financial Officer, to allow for timely decisions regarding required disclosures, and recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.

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Changes in internal control

There were no changes in our internal control over financial reporting identified in connection with the evaluation described above that occurred during the quarter ended September 30, 2018 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II – OTHER INFORMATION

Item 1.

Legal Proceedings

We are not aware of any pending legal actions that would, if determined adversely to us, have a material adverse effect on our business and operations.

We have from time to time been involved in disputes and proceedings arising in the ordinary course of business, including in connection with the conduct of our clinical trials. In addition, as a public company, we are also potentially susceptible to litigation, such as claims asserting violations of securities laws. Any such claims, with or without merit, if not resolved, could be time-consuming and result in costly litigation. There can be no assurance that an adverse result in any future proceeding would not have a potentially material adverse effect on our business, results of operations and financial condition.

ITEM 1A.

RISK FACTORS

Investing in our securities involves risks. In addition to any risks and uncertainties described elsewhere in this Quarterly Report on Form 10-Q, stockholders and potential investors should carefully consider the risks and uncertainties discussed in "Item 1A. Risk Factors" in our 2017 Form 10-K and in our Forms 10-Q, which supplemented our Form 10-K. These risks are not the only risks that could materialize. Additional risks and uncertainties not presently known to us or that we currently consider to be immaterial may also impair our business operations and development activities. Should any of the risks and uncertainties described in our 2017 Form 10-K and Quarterly Reports on Form 10-Q actually materialize, our business, financial condition and/or results of operations could be materially adversely affected, the trading price of our common stock could decline and a stockholder could lose all or part of his or her investment. In particular, the reader’s attention is drawn to the discussion in “Item 2 – Management’s Discussion and Analysis of Financial Condition and Results of Operations – Liquidity and Capital Resources –.”

If we do not secure additional capital to support our future activities before our existing cash resources are exhausted, we likely will be unable to continue as a going concern.

As of November 2, 2018, we had cash and cash equivalents of $0.8 million. Before any additional financings, we believe that we will have sufficient cash resources available to support our operations through mid-November 2018. As we remain focused on completing a potential strategic transaction that could diversify our assets and bring in additional capital to fund our activities, we are dependent upon Lee’s Pharmaceutical Holdings Limited (Lee’s), the majority holder of our common stock, to provide us financial support; however, since we have not executed agreements for any additional advances at this time, there can be no assurance that additional support will be forthcoming. Moreover, in connection with these activities, we are incurring and will continue to incur potentially significant legal, accounting, and other professional fees that represent an additional financial burden for which we will require additional capital.

We have not yet established an ongoing source of revenue sufficient to cover our operating costs and allow us to continue as a going concern. Our ability to continue as a going concern is dependent on our ability to raise additional capital, to fund our research and development programs, support our business operations and pay our existing obligations on a timely basis. However, in 2017, our AEROSURF phase 2b clinical trial did not meet its primary endpoint due, we believe, to a higher-than-anticipated rate of treatment interruptions experienced with the phase 2 prototype aerosol delivery system (ADS). In 2018, we have completed design verification testing and related development activities for our new phase 3 aerosol delivery system (phase 3 ADS, which we previously referred to as “NextGen ADS”). We are also planning to conduct an additional AEROSURF bridge clinical study that is designed, among other things, to clinically evaluate the design and performance of our new phase 3 ADS. The resulting delay in the AEROSURF clinical development program has made it difficult to raise additional capital in the securities markets and, as a result, we have depended primarily upon the support of Lee’s and two previously announced loans from Panacea Venture Management Company Ltd. There can be no assurance that such support will continue, however; and in any event, we will require additional capital beyond that provided by Lee’s and Panacea to fund our bridge clinical study and there can be no assurance that we will be able to raise such additional capital, through the strategic transaction under discussion or equity offerings in the securities markets, if at all.

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We believe that our ability to continue as a going concern in the near term is highly dependent upon continuing support from Lee’s, and our ability to continue as a going concern in the long term will be highly dependent upon our ability to secure the capital necessary to timely advance our AEROSURF development program, including plans to execute the AEROSURF bridge study and be in a position to initiate an AEROSURF phase 3 clinical program. Our longer-term plans include securing the additional capital through a combination of public or private equity offerings, and strategic transactions, including potential alliances and collaborations focused on various individual markets, as well as potential combinations (including by merger or acquisition) or other corporate transactions. If such transactions are not available, or if available, we are unable to raise sufficient capital through such transaction, we likely will not have sufficient cash resources and liquidity to fund our business operations, which could significantly limit our ability to continue as a going concern. If we are unable to raise the required capital, we may be forced to curtail all of our activities and, ultimately, cease operations. Even if we are able to raise sufficient capital, such financings may only be available on unattractive terms, or result in significant dilution of stockholders’ interests and, in such event, the market price of our common stock may decline.

We seek to enter into strategic alliances, collaboration agreements and other strategic transactions (including without limitation, by merger, acquisition or other corporate transaction) that could potentially provide additional capital and access to additional pipeline products under development that we believe could diversify our portfolio, leverage our capabilities, and improve our ability to attract renewed investor interest and the significant capital that we will require to advance our development programs. Such strategic transactions expose us to risks and uncertainties that could have a material adverse effect on our business and the AEROSURF® development program.

We seek to enter into strategic alliances, collaboration agreements and other strategic transactions that potentially could provide the additional capital that we need, leverage our capabilities, maximize the use of our resources and reduce our dependency on a single product candidate. We also seek licensing arrangements for AEROSURF and our other KL4 surfactant products in select geographic markets that could bring strategic partners with local development and commercial expertise to support development of AEROSURF in various markets outside the U.S., and financial resources to support our AEROSURF development program. We are currently focused on completing a strategic transaction that could allow us to diversify our product offerings and provide additional capital.

The identification, evaluation, and negotiation of potential strategic transactions may divert the attention of management and entail various expenses, whether or not such transactions are ultimately completed. We also have limited experience in acquiring other businesses. In addition to transaction and opportunity costs, these transactions involve large challenges and risks, whether or not such transactions are completed, any of which could harm our business and our results of operations, including risks that:

	•	the transaction ultimately may not advance our business strategy;
	•	we may spend time and resources on opportunities that we are unable to consummate on terms acceptable to us;
	•	the transaction may not close or may be delayed;
	•	we may incur significant acquisition costs and transition costs;
	•	we may experience disruptions on our ongoing operations and divert management’s attention;
	•	we expect to assess our newly-diversified product portfolio and potentially adjust our business plan and priorities based on the potential of each product and the resources available to us;
	•	we may not realize the expected benefits from the transaction in the expected time period, or at all;
	•	we may be unable to retain key personnel;
	•	we may experience difficulty and may not be successful in integrating technologies, IT systems, data processing methods and policies, accounting systems, culture, or personnel;
	•	businesses we acquire may not have adequate controls, processes and procedures to ensure compliance with laws and regulations, and our due diligence process may not identify compliance issues or other liabilities;
	•	we may incur substantial liabilities, whether known or unknown, associated with the transaction;
	•	we may assume additional financial or legal exposure, including exposure that is known to us;
	•	we may have difficulty entering and operating in new markets or product segments;
	•	we may be unable to retain the key relationships and partners of acquired businesses;
	•	there may be unknown, underestimated, or undisclosed commitments or liabilities, including actual or threatened litigation;
	•	acquisitions could result in dilutive issuances of equity securities or the incurrence of debt; and
	•	our business, the acquired business, or the integrated business may be adversely affected by other political, business, and general economic conditions.

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We currently require significant additional capital to (i) support our research and development activities and operations and (ii) have sufficient cash resources to pay our vendors, service providers and pay other business expenses. We routinely closely monitor and control our cash resources to assure that investment and spending decisions advance our corporate objectives at any time. While we seek to raise the additional capital that we require, our relationships with important vendors and service providers may be strained. If any of our key vendors and service providers were to cease working with us or subject the delivery of products or services to timing or payment preconditions, our development activities may be adversely affected, which could have a material adverse effect on our business and operations.

During and since completion of our AEROSURF phase 2b clinical trial and announcement of the results, our cash resources have been constrained. To manage our cash, we have controlled and plan to tightly control purchasing and retention of consultants, monitor the release of funds and may defer payment on invoices to conserve cash. As a consequence, our aged accounts payables have increased and our relationships with certain key vendors and service providers have been affected. During this period, we have depended upon Lee’s and Panacea Venture Fund to provide limited financial support while we work to complete a strategic transaction that could provide us access to additional products to diversify our portfolio and additional capital. While we seek the additional capital that we require, we are working closely with our vendors and service providers to preserve our key relationships. Failure to retain such key relationships could have a material adverse effect on our development activities and our business and operations.

The occurrence of any of these risks and any of the risks outlined in our Form 10-K could have a material adverse effect on our business, operations, financial condition, or cash flows. In addition, we may enter into strategic partnerships with third parties with the goal of gaining access to new and innovative products and technologies. Strategic partnerships pose many of the same risks as acquisitions or investments.

There can be no assurance that we will be able to complete the strategic transaction on which we are currently focused or that we will realize any anticipated benefits if we do complete it. If we do not complete the strategic transaction, it is unlikely that we would be able to find another suitable opportunity that is available at attractive valuations, if at all, within a time for which we may have adequate funding. Moreover, the relative illiquidity of our common stock may make it more difficult and expensive to initiate or complete any strategic transaction on commercially acceptable terms.

Item 6.

Exhibits

Exhibits are listed on the Index to Exhibits at the end of this Quarterly Report. The exhibits required by Item 601 of Regulation S-K, listed on such Index in response to this Item, are incorporated herein by reference.

INDEX TO EXHIBITS

The following exhibits are included with this Quarterly Report on Form 10-Q.

Exhibit No.	Description	Method of Filing

31.1	Certification of Chief Executive Officer pursuant to Rule 13a-14(a) of the Exchange Act.	Filed herewith.

31.2	Certification of Chief Financial Officer pursuant to Rule 13a-14(a) of the Exchange Act.	Filed herewith.

32.1	Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.	Furnished herewith.

101.1	The following condensed consolidated financial statements from the Windtree Therapeutics, Inc. Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, formatted in Extensive Business Reporting Language (XBRL): (i) Balance Sheets as of September 30, 2018 (unaudited) and December 31, 2017, (ii) Statements of Operations (unaudited) for the three and nine months ended September 30, 2018 and September 30, 2017 (iii) Statements of Cash Flows (unaudited) for the nine months ended September 30, 2018 and September 30, 2017, and (v) Notes to Condensed consolidated financial statements.

101.INS	Instance Document.	Filed herewith.

101.SCH	XBRL Taxonomy Extension Schema Document.	Filed herewith.

101.CAL	XBRL Taxonomy Extension Calculation Linkbase Document.	Filed herewith.

101.DEF	XBRL Taxonomy Extension Definition Linkbase Document.	Filed herewith.

101.LAB	XBRL Taxonomy Extension Label Linkbase Document.	Filed herewith.

101.PRE	XBRL Taxonomy Extension Presentation Linkbase Document.	Filed herewith.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

		Windtree Therapeutics, Inc.
		(Registrant)

Date: November 14, 2018		By: /s/ Craig Fraser
		Craig Fraser
		President and Chief Executive Officer


Date: November 14, 2018		By: /s/ John Tattory
		John Tattory
		Senior Vice President and Chief Financial Officer

EX-31.1 2 ex_128764.htm EXHIBIT 31.1 ex_128764.htm

Exhibit 31.1

CERTIFICATIONS

I, Craig Fraser, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Windtree Therapeutics, Inc. (the “Company);

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this report;

4. I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Company and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the Company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the Company’s internal control over financial reporting that occurred during the Company’s most recent fiscal quarter (the Company’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting; and

5. I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Company’s auditors and the audit committee of the Company’s board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Company’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s internal control over financial reporting.

Date: November 14, 2018	/s/ Craig Fraser
	Craig Fraser
	President and Chief Executive Officer

EX-31.2 3 ex_128766.htm EXHIBIT 31.2 ex_128766.htm

Exhibit 31.2

CERTIFICATIONS

I, John Tattory, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Windtree Therapeutics, Inc. (the “Company);

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s internal control over financial reporting.

Date: November 14, 2018	/s/John Tattory
	John Tattory
	Senior Vice President and Chief Financial Officer

EX-32.1 4 ex_128765.htm EXHIBIT 32.1 ex_128765.htm

Exhibit 32.1

CERTIFICATIONS

Pursuant to 18 U.S.C. § 1350, each of the undersigned officers of Windtree Therapeutics, Inc. (the “Company”) hereby certifies that, to his knowledge, the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2018 (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and that the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: November 14, 2018

/s/ Craig Fraser
Craig Fraser
President and Chief Executive Officer


/s/ John Tattory
John Tattory
Senior Vice President and Chief Financial Officer

A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to us and will be retained by us and furnished to the SEC or its staff upon request.

This certification is being furnished pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liability of that section. This certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934.

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101000

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372000

145000

178000

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<div style="display: inline; font-family: times new roman; font-size: 10pt"><table border="0" cellpadding="0" cellspacing="0" style="margin-right: 20%; font-size: 10pt; font-family: "Times New Roman", Times, serif; text-indent: 0px; min-; min-width: 700px;"> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">September 30,</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> </tr> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; width: 81%;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;"><div style="display: inline; font-style: italic;">(in thousands)</div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">2018</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Convertible note payable</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 16%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">1,500</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Unamortized discount</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 16%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">(531</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 1px;">)</td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Convertible note payable, net of discount</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 16%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">969</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> </tr> </table></div>

969000

400000

1500000

300000

480000

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430000

500000

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0.06

0.15

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<div style="display: inline; font-family: times new roman; font-size: 10pt"><table border="0px" cellpadding="0pt" cellspacing="0pt" style="margin: 0pt auto 0pt 0pt; font-size: 10pt; font-family: "Times New Roman", Times, serif; text-indent: 0px; min-; min-width: 700px;"> <tr style="vertical-align: bottom; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="6" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Three Months Ended<br /> September 30,</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="6" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Nine Months Ended<br /> September 30,</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> </tr> <tr style="vertical-align: bottom; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; width: 44%;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;"><div style="display: inline; font-style: italic;">(in thousands)</div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">2018</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">2017</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">2018</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">2017</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255); font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">License revenue with affiliate</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 11%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">159</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 11%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 11%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">719</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 11%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> </tr> </table></div>

<div style="display: inline; font-family: times new roman; font-size: 10pt"><table border="0" cellpadding="0" cellspacing="0" style="; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: top;"> <td style="width: 54pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><div style="display: inline; font-weight: bold;">Note </div><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">11</div></div><div style="display: inline; font-weight: bold;"> –</div></div> </td> <td> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;">Stock Options and Stock-Based Employee Compensation</div></div> </td> </tr> </table> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">We recognize in our condensed consolidated financial statements all stock-based awards to employees and non-employee directors based on their fair value on the date of grant, calculated using the Black-Scholes option-pricing model. Compensation expense related to stock-based awards is recognized ratably over the vesting period, which for employees is typically <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">three</div> years.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: justify;">A summary of activity under our long-term incentive plans is presented below:</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div> <table border="0" cellpadding="0" cellspacing="0" style="margin-right: 10%; font-size: 10pt; font-family: "Times New Roman", Times, serif; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: bottom;"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: thin solid rgb(0, 0, 0);"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt;"><div style="display: inline; font-style: italic;">(in thousands, except for weighted-average data)</div><br />  </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: center;"><div style="display: inline; font-weight: bold;">Stock Options</div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Shares</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Weighted-<br /> Average<br /> Exercise<br /> Price</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Weighted-<br /> Average<br /> Remaining<br /> Contractual<br /> Term (In Yrs)</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Outstanding at January 1, 2018</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">84</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">163.20</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; width: 45.8%;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; margin-left: 9pt;">Granted</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; margin-left: 9pt;">Forfeited or expired</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">(1</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 1px;">)</td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">729.80</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Outstanding at September 30, 2018</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">83</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">154.80</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">7.1</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Vested and exercisable at September 30, 2018</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">66</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">186.00</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">6.9</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Vested and expected to vest at September 30, 2018</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">82</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">155.20</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">7.1</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> </table> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div><div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin: 0pt; text-align: left"></div> <div> <table border="0" cellpadding="0" cellspacing="0" style="margin-right: 15%; font-size: 10pt; font-family: "Times New Roman", Times, serif; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: bottom;"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><div style="display: inline; font-style: italic;">(in thousands, except for weighted-average data)</div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-style: italic;"> </div></td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-style: italic;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-style: italic;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-style: italic;"> </div></td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-style: italic;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-style: italic;"> </div></td> </tr> <tr style="vertical-align: bottom;"> <td colspan="1" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: thin solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;">Restricted Stock Units</div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Shares</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Weighted-<br /> Average<br /> Grant<br /> Date Fair<br /> Value</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Unvested at January 1, 2018</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">190</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">4.33</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; width: 57.9%;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; margin-left: 9pt;">Awarded</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; margin-left: 9pt;">Vested</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Unvested at September 30, 2018</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">190</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">4.33</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> </table> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing formula based on the following weighted average assumptions:</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div> <table border="0" cellpadding="0" cellspacing="0" style="margin-right: 20%; font-size: 10pt; font-family: "Times New Roman", Times, serif; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Nine Months Ended<br /> September 30,</div></div></div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> </tr> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">2017</div></div></div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; width: 81%;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Weighted average expected volatility</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 16%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; text-align: center;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">79%</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Weighted average expected term (years)</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 16%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; text-align: center;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">6.6</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Weighted average risk-free interest rate</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 16%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; text-align: center;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2.22%</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" margin: 0pt; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </div> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Expected dividends</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 16%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; text-align: center;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> </table> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: center;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">The table below summarizes the total stock-based compensation expense included in the statements of operations for the periods presented:</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div> <table border="0" cellpadding="0" cellspacing="0" style="margin-right: 5%; font-size: 10pt; font-family: "Times New Roman", Times, serif; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="6" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Three Months Ended<br /> September 30,</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="6" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Nine Months Ended<br /> September 30,</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> </tr> <tr style="vertical-align: bottom;"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><div style="display: inline; font-style: italic;">(in thousands)</div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">2018</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">2017</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">2018</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">2017</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Research and development</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">29</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">77</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">169</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">360</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Selling, general and administrative</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">116</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">101</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">534</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">372</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; width: 44.9%;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; margin-left: 9pt;">Total</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">145</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">178</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">703</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">732</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> </tr> </table> </div></div>

<div style="display: inline; font-family: times new roman; font-size: 10pt"><table border="0" cellpadding="0" cellspacing="0" style="margin-right: 10%; font-size: 10pt; font-family: "Times New Roman", Times, serif; text-indent: 0px; min-; min-width: 700px;"> <tr style="vertical-align: bottom;"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: thin solid rgb(0, 0, 0);"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt;"><div style="display: inline; font-style: italic;">(in thousands, except for weighted-average data)</div><br />  </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: center;"><div style="display: inline; font-weight: bold;">Stock Options</div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Shares</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Weighted-<br /> Average<br /> Exercise<br /> Price</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Weighted-<br /> Average<br /> Remaining<br /> Contractual<br /> Term (In Yrs)</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Outstanding at January 1, 2018</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">84</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">163.20</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; width: 45.8%;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; margin-left: 9pt;">Granted</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; margin-left: 9pt;">Forfeited or expired</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">(1</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 1px;">)</td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">729.80</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Outstanding at September 30, 2018</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">83</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">154.80</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">7.1</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Vested and exercisable at September 30, 2018</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">66</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">186.00</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">6.9</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Vested and expected to vest at September 30, 2018</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">82</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">155.20</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 14%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">7.1</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> </table></div>

-1.04

-10.53

-3.21

-48.45

<div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;">Net Loss per Common Share</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per common share is computed by giving effect to all potentially dilutive securities outstanding for the period. As of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> September 30, 2018 </div>and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2017,</div> the number of shares of common stock potentially issuable upon the conversion of preferred stock or exercise of certain stock options and warrants was <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">1.3</div> million and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">0.9</div> million shares, respectively. For the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">three</div> and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">nine</div> months ended <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> September 30, 2018 </div>and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2017,</div> all potentially dilutive securities were anti-dilutive and therefore have been excluded from the computation of diluted net loss per share.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">Net loss per common share – basic and diluted and weighted average number of common shares outstanding for the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">three</div> and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">nine</div> months ended <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> September 30, 2017 </div>have been corrected for immaterial calculation errors related to the conversion of preferred stock to common stock during those periods.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">We do <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> have any components of other comprehensive income (loss).</div></div></div></div></div>

0.21

703000

839000

25000000

<div style="display: inline; font-family: times new roman; font-size: 10pt"><table border="0" cellpadding="0" cellspacing="0" style="; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: top;"> <td style="width: 54pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><div style="display: inline; font-weight: bold;">Note </div><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">7</div></div><div style="display: inline; font-weight: bold;"> –</div></div> </td> <td> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;">Fair Value of Financial Instruments</div></div> </td> </tr> </table> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: justify;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy is based on <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">three</div> levels of inputs, of which the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">first</div> <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">two</div> are considered observable and the last unobservable, as follows:</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <table border="0" cellpadding="0" cellspacing="0" style="; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: top;"> <td style="width: 18pt;"> </td> <td style="width: 18pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">●</div> </td> <td> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Level <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">1</div> – Quoted prices in active markets for identical assets and liabilities.</div> </td> </tr> <tr style="vertical-align: top;"> <td style="width: 18pt;"> </td> <td style="width: 18pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">●</div> </td> <td> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Level <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2</div> – Inputs other than Level <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">1</div> that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.</div> </td> </tr> <tr style="vertical-align: top;"> <td style="width: 18pt;"> </td> <td style="width: 18pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">●</div> </td> <td> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Level <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">3</div> – Unobservable inputs that are supported by little or <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">no</div> market activity and that are significant to the fair value of the assets or liabilities.</div> </td> </tr> </table> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: justify;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: justify;"><div style="display: inline; font-style: italic;">Fair Value on a Recurring Basis</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">The tables below categorize assets and liabilities measured at fair value on a recurring basis for the periods presented:</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div> <table border="0" cellpadding="0" cellspacing="0" style="margin-right: 5%; font-size: 10pt; font-family: "Times New Roman", Times, serif; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Fair Value</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="10" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Fair value measurement using</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">September 30,</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> </tr> <tr style="vertical-align: bottom;"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><div style="display: inline; font-style: italic;">(in thousands)</div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">2018</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Level 1</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Level 2</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Level 3</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Assets:</div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Cash and cash equivalents</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">640</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">640</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Certificate of deposit</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">140</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">140</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; width: 45.1%;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; margin-left: 9pt;">Total Assets</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">780</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">780</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> </tr> </table> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div> <table border="0" cellpadding="0" cellspacing="0" style="margin-right: 5%; font-size: 10pt; font-family: "Times New Roman", Times, serif; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Fair Value</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="10" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Fair value measurement using</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">December 31,</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> </tr> <tr style="vertical-align: bottom;"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><div style="display: inline; font-style: italic;">(in thousands)</div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">2017</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Level 1</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Level 2</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Level 3</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Assets:</div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Cash and cash equivalents</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">1,815</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">1,815</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Certificate of deposit</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">225</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">225</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; width: 45.1%;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; margin-left: 9pt;">Total Assets</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2,040</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2,040</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> </tr> </table> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"></div></div>

9000

<div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;">Income taxes</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;"> </div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">We account for income taxes in accordance with ASC Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">740,</div> Accounting for Income Taxes, which requires the recognition of deferred tax liabilities and assets for the expected future tax consequences of temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">We use a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Because we have never realized a profit, management has fully reserved the net deferred tax asset since realization is <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> assured.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">On <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> December 22, 2017, </div>the U.S. government enacted the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2017</div> Tax Cuts and Jobs Act (the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2017</div> Tax Act), which significantly revises U.S. tax law by, among other provisions, lowering the U.S. federal statutory income tax rate to <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">21%,</div> imposing a mandatory <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">one</div>-time transition tax on previously deferred foreign earnings, and eliminating or reducing certain income tax deductions. As of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> December 31, 2017, </div>we recorded the provisional impact from the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2017</div> Tax Act in accordance with SAB <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">118.</div> As of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> September 30, 2018, </div>we have <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> adjusted any of our provisional amounts that were recorded as of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> December 31, 2017. </div>We will finalize our adjustments during the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">fourth</div> quarter of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2018.</div></div></div></div></div></div>

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<div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;">Recently Adopted Accounting Standards</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">In <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> May 2014, </div>the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2014</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">09,</div> <div style="display: inline; font-style: italic;">Revenue from Contracts with Customers (Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606</div>)</div>, which was subsequently amended by several other ASUs related to Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606</div> to, among other things, defer the effective date and clarify various aspects of the new revenue guidance including principal versus agent considerations, identifying performance obligations,  licensing, and other improvements and practical expedients. We adopted ASU <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2014</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">09,</div> as amended, effective <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> January 1, 2018 </div>using the modified retrospective transition method. In <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> June 2017, </div>we entered into a License Agreement with Lee’s (HK), granting Lee’s (HK) rights to develop and commercialize our products in a specific Asian territory. The consideration we are eligible to receive under this agreement includes an upfront payment, contingent revenues in the form of regulatory and commercial milestones, and sales-based milestone and royalty payments. We evaluated the License Agreement under ASU <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2014</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">09</div> and determined that there was <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">no</div> material impact to revenues for any of the years presented upon adoption. Additionally, there were <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">no</div> revisions to any balance sheet components of revenues such as deferred revenues or beginning retained earnings as a result of using the modified retrospective method. The primary impact on our financial statements is related to revised or additional disclosures with respect to revenues and cash flows arising from contracts with customers, which are included in Note <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">12</div> – Out-Licensing Agreement.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">In <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> May 2017, </div>the FASB issued ASU <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2017</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">09,</div> <div style="display: inline; font-style: italic;">Compensation—Stock Compensation (Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">718</div>)</div><div style="display: inline; font-style: italic;">,</div><div style="display: inline; font-style: italic;"> Scope of Modification Accounting</div>. This ASU clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions. The ASU is effective prospectively for the annual period ending <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> December 31, 2018 </div>and interim periods within that annual period. We adopted ASU <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2017</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">09</div> effective <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> January 1, 2018 </div>and the adoption did <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> have a material impact on our unaudited condensed consolidated financial statements and is <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> expected to have a material impact on the annual <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2018</div> financial statements.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">In <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> August 2016, </div>the FASB issued ASU <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2016</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">15,</div> <div style="display: inline; font-style: italic;">Statement of Cash Flows (Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">230</div>), Classification of Certain Cash Receipts and Cash Payments</div>. This ASU clarifies clarify how entities should classify certain cash receipts and cash payments related to <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">eight</div> specific cash flow issues, including debt prepayment or extinguishment costs, with the objective of reducing diversity in how certain cash receipts and cash payments are presented and classified in the statement of cash flows. The ASU also clarifies how the predominance principle should be applied when cash receipts and cash payments have aspects of more than <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">one</div> class of cash flows. The ASU is effective retrospectively for the annual period ending <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> December 31, 2018 </div>and interim periods within that annual period. We adopted ASU <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2016</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">15</div> effective <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> January 1, 2018 </div>and the adoption did <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> have a material impact on our unaudited condensed consolidated financial statements and is <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> expected to have a material impact on the annual <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2018</div> financial statements.</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt 7.5pt;text-align:left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;">Recent Accounting Pronouncements</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">In <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> February 2016, </div>the FASB issued ASU <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2016</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">02,</div> <div style="display: inline; font-style: italic;">Leases</div> (Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">842</div>). This ASU requires lessees to put most leases on their balance sheets but recognize expenses in the income statement in a manner similar to current accounting standards. The ASU is effective <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> January 1, 2019. </div>Early adoption is permitted. The standard requires a modified retrospective approach; however, the FASB recently added a transition option to the leases standard that allows entities to apply the new guidance in the year of transition rather than at the beginning of the earliest period presented. We have <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> elected to early adopt this standard.  We are currently evaluating the effect of ASU <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2016</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">02</div> and believe it <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> may </div>have a material impact on our consolidated financial statements and related disclosures.</div></div></div>

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<div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;">Revenue recognition</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">Effective <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> January 1, 2018, </div>we adopted Accounting Standards Codification (“ASC”) Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606,</div> Revenue from Contracts with Customers, using the modified retrospective transition method. Under this method, we recognize the cumulative effect of initially adopting ASC Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606,</div> if any, as an adjustment to the opening balance of retained earnings.  Additionally, under this method of adoption, we apply the guidance to all incomplete contracts in scope as of the date of initial application. This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">  </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">In accordance with ASC Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606,</div> we recognize revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606,</div> we perform the following <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">five</div> steps:</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <table border="0" cellpadding="0" cellspacing="0" style="; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: top;"> <td style="width: 18pt;"> </td> <td style="width: 27pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">(i)</div> </td> <td> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">identify the contract(s) with a customer;</div> </td> </tr> <tr style="vertical-align: top;"> <td style="width: 18pt;"> </td> <td style="width: 27pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">(ii)</div> </td> <td> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">identify the performance obligations in the contract;</div> </td> </tr> </table> <table border="0" cellpadding="0" cellspacing="0" style="; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: top;"> <td style="width: 18pt;"> </td> <td style="width: 27pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">(iii)</div> </td> <td> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">determine the transaction price;</div> </td> </tr> <tr style="vertical-align: top;"> <td style="width: 18pt;"> </td> <td style="width: 27pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">(iv)</div> </td> <td> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">allocate the transaction price to the performance obligations in the contract; and</div> </td> </tr> </table> <table border="0" cellpadding="0" cellspacing="0" style="; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: top;"> <td style="width: 18pt;"> </td> <td style="width: 27pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">(v)</div> </td> <td> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">recognize revenue when (or as) the entity satisfies a performance obligation.</div> </td> </tr> </table> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">  </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">We only apply the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">five</div>-step model to contracts when we determine that it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. At contract inception, once the contract is determined to be within the scope of ASC Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606,</div> we assess the goods or services promised within a contract and determine those that are performance obligations, and assesses whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">We have concluded that our government grants are <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> within the scope of ASC Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606</div> as they do <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> meet the definition of a contract with a customer.  We have concluded that the grants meet the definition of a contribution and are non-reciprocal transactions, and have also concluded that Subtopic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">958</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">605,</div> <div style="display: inline; font-style: italic;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">Not</div>-for-Profit-Entities-Revenue Recognition</div> does <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> apply, as we are a business entity and the grants are with governmental agencies.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">In the absence of applicable guidance under US GAAP, effective <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> January 1, 2018, </div>we developed a policy for the recognition of grant revenue when the related costs are incurred and the right to payment is realized.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">We believe this policy is consistent with the overarching premise in ASC Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606,</div> to ensure that revenue recognition reflects the transfer of promised goods or services to customers in an amount that reflects the consideration that we expect to be entitled to in exchange for those goods or services, even though there is <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">no</div> exchange as defined in ASC Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606.</div> We believe the recognition of revenue as costs are incurred and amounts become realizable is analogous to the concept of transfer of control of a service over time under ASC Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606.</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">Prior to <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> January 1, 2018, </div>we recognized revenue as related costs were incurred under the grants given that persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed and determinable, and collectability is reasonably assured. Recognized amounts reflected our performance under the grants and equal direct and indirect costs incurred. Revenue and expenses under these arrangements were presented gross. Revenue recognition under this new policy is <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> materially different than would have been calculated under the old guidance. As a result of the adoption of this policy, there was <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">no</div> change to the amounts we have historically recorded in our financial statements.</div></div></div>

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1383000

<div style="display: inline; font-family: times new roman; font-size: 10pt"><table border="0" cellpadding="0" cellspacing="0" style="margin-right: 5%; font-size: 10pt; font-family: "Times New Roman", Times, serif; text-indent: 0px; min-; min-width: 700px;"> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Fair Value</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="10" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Fair value measurement using</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">September 30,</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> </tr> <tr style="vertical-align: bottom;"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><div style="display: inline; font-style: italic;">(in thousands)</div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">2018</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Level 1</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Level 2</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Level 3</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Assets:</div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Cash and cash equivalents</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">640</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">640</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Certificate of deposit</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">140</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">140</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; width: 45.1%;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; margin-left: 9pt;">Total Assets</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">780</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">780</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> </tr> </table></div><div style="display: inline; font-family: times new roman; font-size: 10pt"><table border="0" cellpadding="0" cellspacing="0" style="margin-right: 5%; font-size: 10pt; font-family: "Times New Roman", Times, serif; text-indent: 0px; min-; min-width: 700px;"> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Fair Value</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="10" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Fair value measurement using</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">December 31,</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-weight: bold;"> </div></td> </tr> <tr style="vertical-align: bottom;"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><div style="display: inline; font-style: italic;">(in thousands)</div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">2017</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Level 1</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Level 2</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Level 3</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Assets:</div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Cash and cash equivalents</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">1,815</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">1,815</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Certificate of deposit</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">225</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">225</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; width: 45.1%;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; margin-left: 9pt;">Total Assets</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2,040</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2,040</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);">$</td> <td style="width: 10%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> </tr> </table></div>

<div style="display: inline; font-family: times new roman; font-size: 10pt"><table border="0" cellpadding="0" cellspacing="0" style="margin-right: 15%; font-size: 10pt; font-family: "Times New Roman", Times, serif; text-indent: 0px; min-; min-width: 700px;"> <tr style="vertical-align: bottom;"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><div style="display: inline; font-style: italic;">(in thousands, except for weighted-average data)</div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-style: italic;"> </div></td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-style: italic;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-style: italic;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-style: italic;"> </div></td> <td style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-style: italic;"> </div></td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"><div style="display: inline; font-style: italic;"> </div></td> </tr> <tr style="vertical-align: bottom;"> <td colspan="1" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: thin solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;">Restricted Stock Units</div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Shares</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Weighted-<br /> Average<br /> Grant<br /> Date Fair<br /> Value</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Unvested at January 1, 2018</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">190</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">4.33</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; width: 57.9%;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; margin-left: 9pt;">Awarded</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; margin-left: 9pt;">Vested</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td colspan="1" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Unvested at September 30, 2018</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">190</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 15%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">4.33</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> </table></div>

<div style="display: inline; font-family: times new roman; font-size: 10pt"><table border="0" cellpadding="0" cellspacing="0" style="margin-right: 20%; font-size: 10pt; font-family: "Times New Roman", Times, serif; text-indent: 0px; min-; min-width: 700px;"> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">Nine Months Ended<br /> September 30,</div></div></div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> </tr> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">2017</div></div></div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; width: 81%;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Weighted average expected volatility</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 16%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; text-align: center;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">79%</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Weighted average expected term (years)</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 16%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; text-align: center;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">6.6</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Weighted average risk-free interest rate</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 16%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; text-align: center;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2.22%</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" margin: 0pt; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </div> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Expected dividends</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 16%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; text-align: center;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">-</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> </table></div>

1500000

1749000

4634000

5475000

P3Y

190000

4.33

0.0222

0.79

66000

186

1000

729.80

84000

83000

163.20

154.80

82000

155.20

P6Y219D

P6Y328D

P7Y36D

4.80

4280000

<div style="display: inline; font-family: times new roman; font-size: 10pt"><table border="0" cellpadding="0" cellspacing="0" style="; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: top;"> <td style="width: 54pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><div style="display: inline; font-weight: bold;">Note <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">4</div> –</div></div> </td> <td> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;">Summary of Significant Accounting Policies</div></div> </td> </tr> </table> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;"> </div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;">Use of Estimates</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">The preparation of financial statements, in conformity with U.S. GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;">Restructured debt liability – contingent milestone payment</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">In conjunction with the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> November 2017 </div>restructuring and retirement of long-term debt (<div style="display: inline; font-style: italic;">See,</div> "– Note <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">10</div> – Restructured debt liability"), we established a <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$15</div> million long-term liability for contingent AEROSURF regulatory and commercial milestone payments, beginning with the filing for marketing approval in the United States, potentially due under the Exchange and Termination Agreement dated as of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> October 27, 2017 (</div>Exchange and Termination Agreement), between ourselves and affiliates of Deerfield Management Company L.P. (Deerfield). The liability has been recorded at full value of the contingent milestones and will continue to be carried at full value until the milestones are achieved and paid or milestones are <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> achieved and the liability is written off as a gain on debt restructuring.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;">Deferred revenue</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">Deferred revenue represents amounts received prior to satisfying the revenue recognition criteria (<div style="display: inline; font-style: italic;">see</div>, Revenue recognition) and are recognized as deferred revenue in our balance sheet.  Amounts expected to be recognized as revenue within the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">12</div> months following the balance sheet date are classified as Deferred revenue – current portion.  Amounts <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> expected to be recognized as revenue within the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">12</div> months following the balance sheet date are classified as Deferred revenue – non-current portion.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">Deferred revenue primarily consists of amounts related to an upfront license fee received in <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> July 2017 </div>in connection with the License Agreement with Lee’s. The revenue will be recognized as our performance obligations under the contract are met (<div style="display: inline; font-style: italic;">see</div>, Note <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">12</div> – Out-Licensing Agreement).</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;">Revenue recognition</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">Effective <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> January 1, 2018, </div>we adopted Accounting Standards Codification (“ASC”) Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606,</div> Revenue from Contracts with Customers, using the modified retrospective transition method. Under this method, we recognize the cumulative effect of initially adopting ASC Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606,</div> if any, as an adjustment to the opening balance of retained earnings.  Additionally, under this method of adoption, we apply the guidance to all incomplete contracts in scope as of the date of initial application. This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">  </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">In accordance with ASC Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606,</div> we recognize revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606,</div> we perform the following <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">five</div> steps:</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <table border="0" cellpadding="0" cellspacing="0" style="; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: top;"> <td style="width: 18pt;"> </td> <td style="width: 27pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">(i)</div> </td> <td> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">identify the contract(s) with a customer;</div> </td> </tr> <tr style="vertical-align: top;"> <td style="width: 18pt;"> </td> <td style="width: 27pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">(ii)</div> </td> <td> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">identify the performance obligations in the contract;</div> </td> </tr> </table> <table border="0" cellpadding="0" cellspacing="0" style="; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: top;"> <td style="width: 18pt;"> </td> <td style="width: 27pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">(iii)</div> </td> <td> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">determine the transaction price;</div> </td> </tr> <tr style="vertical-align: top;"> <td style="width: 18pt;"> </td> <td style="width: 27pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">(iv)</div> </td> <td> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">allocate the transaction price to the performance obligations in the contract; and</div> </td> </tr> </table> <table border="0" cellpadding="0" cellspacing="0" style="; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: top;"> <td style="width: 18pt;"> </td> <td style="width: 27pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">(v)</div> </td> <td> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">recognize revenue when (or as) the entity satisfies a performance obligation.</div> </td> </tr> </table> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">  </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">We only apply the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">five</div>-step model to contracts when we determine that it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. At contract inception, once the contract is determined to be within the scope of ASC Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606,</div> we assess the goods or services promised within a contract and determine those that are performance obligations, and assesses whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">We have concluded that our government grants are <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> within the scope of ASC Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606</div> as they do <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> meet the definition of a contract with a customer.  We have concluded that the grants meet the definition of a contribution and are non-reciprocal transactions, and have also concluded that Subtopic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">958</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">605,</div> <div style="display: inline; font-style: italic;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">Not</div>-for-Profit-Entities-Revenue Recognition</div> does <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> apply, as we are a business entity and the grants are with governmental agencies.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">In the absence of applicable guidance under US GAAP, effective <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> January 1, 2018, </div>we developed a policy for the recognition of grant revenue when the related costs are incurred and the right to payment is realized.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">We believe this policy is consistent with the overarching premise in ASC Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606,</div> to ensure that revenue recognition reflects the transfer of promised goods or services to customers in an amount that reflects the consideration that we expect to be entitled to in exchange for those goods or services, even though there is <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">no</div> exchange as defined in ASC Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606.</div> We believe the recognition of revenue as costs are incurred and amounts become realizable is analogous to the concept of transfer of control of a service over time under ASC Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606.</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">Prior to <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> January 1, 2018, </div>we recognized revenue as related costs were incurred under the grants given that persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed and determinable, and collectability is reasonably assured. Recognized amounts reflected our performance under the grants and equal direct and indirect costs incurred. Revenue and expenses under these arrangements were presented gross. Revenue recognition under this new policy is <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> materially different than would have been calculated under the old guidance. As a result of the adoption of this policy, there was <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">no</div> change to the amounts we have historically recorded in our financial statements.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">  </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;">Research and development</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">We account for research and development expense by the following categories: (a) product development and manufacturing, (b) clinical medical and regulatory operations, and (c) direct preclinical and clinical development programs. Research and development expense includes personnel, facilities, manufacturing and quality operations, pharmaceutical and device development, research, clinical, regulatory, other preclinical and clinical activities and medical affairs. Research and development costs are charged to operations as incurred in accordance with ASC Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">730,</div> <div style="display: inline; font-style: italic;">Research and Development</div>.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"></div><div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin: 0pt; text-align: left"></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;">Net Loss per Common Share</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per common share is computed by giving effect to all potentially dilutive securities outstanding for the period. As of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> September 30, 2018 </div>and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2017,</div> the number of shares of common stock potentially issuable upon the conversion of preferred stock or exercise of certain stock options and warrants was <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">1.3</div> million and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">0.9</div> million shares, respectively. For the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">three</div> and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">nine</div> months ended <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> September 30, 2018 </div>and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2017,</div> all potentially dilutive securities were anti-dilutive and therefore have been excluded from the computation of diluted net loss per share.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">Net loss per common share – basic and diluted and weighted average number of common shares outstanding for the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">three</div> and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">nine</div> months ended <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> September 30, 2017 </div>have been corrected for immaterial calculation errors related to the conversion of preferred stock to common stock during those periods.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">We do <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> have any components of other comprehensive income (loss).</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><div style="display: inline; font-weight: bold;">Beneficial Conversion Feature </div></div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><div style="display: inline; font-weight: bold;"> </div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">A beneficial conversion feature arises when a debt or equity security is issued with an embedded conversion option that is beneficial to the investor (or in the money) at inception due to the conversion option having an effective conversion price that is less than the fair value of the underlying stock at the commitment date.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-style: italic;">Preferred Stock</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">The issuance of Series A Convertible Preferred Stock (Preferred Shares) in the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">first</div> quarter of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2017</div> (<div style="display: inline; font-style: italic;">see</div>, “– Note <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">5</div> – Stockholders’ Equity”) resulted in a beneficial conversion feature. We recognized this feature by allocating the intrinsic value of the beneficial conversion feature, which is the number of shares of common stock available upon conversion multiplied by the difference between the effective conversion price per share and the fair value of common stock per share on the commitment date, to additional paid-in capital, resulting in a discount on the Preferred Shares. As the Preferred Shares are immediately convertible by the holders, the discount allocated to the beneficial conversion feature was immediately accreted and recognized as a <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$3.6</div> million <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">one</div>-time, non-cash deemed dividend to the preferred shareholders during the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">first</div> quarter of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2017.</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">An additional discount to the Preferred Shares of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$4.5</div> million was created due to the allocation of proceeds to the Warrants which were issued with the Preferred Shares. This discount is amortized proportionately as the Preferred Shares are converted. <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">No</div> Preferred Shares were converted during the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">three</div> or <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">nine</div> months ended <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> September 30, 2018. </div>For the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">three</div> and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">nine</div> months ended <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> September 30, 2017, </div>we recognized a non-cash deemed dividend to the preferred shareholders of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$2.2</div> million and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$6.4</div> million, respectively, related to the Preferred Shares converted during the periods.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-style: italic;">Convertible Note</div><div style="display: inline; font-style: italic;"> </div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">The issuance on <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> July 2, 2018 </div>of a Secured Convertible Promissory Note (the Note) to Panacea Venture Management Company Ltd. (Panacea) with respect to a loan facility in the aggregate amount of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$1.5</div> million resulted in a beneficial conversion feature. We recognized this feature by allocating the relative fair value of the conversion option, which is the number of shares of common stock available upon conversion multiplied by the difference between the effective conversion price per share and the fair value of common stock per share on the commitment date, resulting in a discount on the Note. We recorded the Note as current debt at its face value of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$1.5</div> million less debt discount consisting of (i) <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$0.4</div> million related to the beneficial conversion feature and (ii) <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$0.4</div> million in fair value of the warrants issued in connection with the Note. The discount is being accreted to the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$1.5</div> million loan over its term using the effective interest method.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;">Income taxes</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;"> </div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">We account for income taxes in accordance with ASC Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">740,</div> Accounting for Income Taxes, which requires the recognition of deferred tax liabilities and assets for the expected future tax consequences of temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">We use a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Because we have never realized a profit, management has fully reserved the net deferred tax asset since realization is <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> assured.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">On <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> December 22, 2017, </div>the U.S. government enacted the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2017</div> Tax Cuts and Jobs Act (the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2017</div> Tax Act), which significantly revises U.S. tax law by, among other provisions, lowering the U.S. federal statutory income tax rate to <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">21%,</div> imposing a mandatory <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">one</div>-time transition tax on previously deferred foreign earnings, and eliminating or reducing certain income tax deductions. As of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> December 31, 2017, </div>we recorded the provisional impact from the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2017</div> Tax Act in accordance with SAB <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">118.</div> As of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> September 30, 2018, </div>we have <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> adjusted any of our provisional amounts that were recorded as of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> December 31, 2017. </div>We will finalize our adjustments during the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">fourth</div> quarter of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2018.</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin: 0pt; text-align: left"></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;">Recently Adopted Accounting Standards</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">In <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> May 2014, </div>the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2014</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">09,</div> <div style="display: inline; font-style: italic;">Revenue from Contracts with Customers (Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606</div>)</div>, which was subsequently amended by several other ASUs related to Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606</div> to, among other things, defer the effective date and clarify various aspects of the new revenue guidance including principal versus agent considerations, identifying performance obligations,  licensing, and other improvements and practical expedients. We adopted ASU <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2014</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">09,</div> as amended, effective <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> January 1, 2018 </div>using the modified retrospective transition method. In <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> June 2017, </div>we entered into a License Agreement with Lee’s (HK), granting Lee’s (HK) rights to develop and commercialize our products in a specific Asian territory. The consideration we are eligible to receive under this agreement includes an upfront payment, contingent revenues in the form of regulatory and commercial milestones, and sales-based milestone and royalty payments. We evaluated the License Agreement under ASU <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2014</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">09</div> and determined that there was <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">no</div> material impact to revenues for any of the years presented upon adoption. Additionally, there were <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">no</div> revisions to any balance sheet components of revenues such as deferred revenues or beginning retained earnings as a result of using the modified retrospective method. The primary impact on our financial statements is related to revised or additional disclosures with respect to revenues and cash flows arising from contracts with customers, which are included in Note <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">12</div> – Out-Licensing Agreement.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">In <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> May 2017, </div>the FASB issued ASU <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2017</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">09,</div> <div style="display: inline; font-style: italic;">Compensation—Stock Compensation (Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">718</div>)</div><div style="display: inline; font-style: italic;">,</div><div style="display: inline; font-style: italic;"> Scope of Modification Accounting</div>. This ASU clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions. The ASU is effective prospectively for the annual period ending <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> December 31, 2018 </div>and interim periods within that annual period. We adopted ASU <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2017</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">09</div> effective <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> January 1, 2018 </div>and the adoption did <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> have a material impact on our unaudited condensed consolidated financial statements and is <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> expected to have a material impact on the annual <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2018</div> financial statements.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">In <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> August 2016, </div>the FASB issued ASU <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2016</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">15,</div> <div style="display: inline; font-style: italic;">Statement of Cash Flows (Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">230</div>), Classification of Certain Cash Receipts and Cash Payments</div>. This ASU clarifies clarify how entities should classify certain cash receipts and cash payments related to <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">eight</div> specific cash flow issues, including debt prepayment or extinguishment costs, with the objective of reducing diversity in how certain cash receipts and cash payments are presented and classified in the statement of cash flows. The ASU also clarifies how the predominance principle should be applied when cash receipts and cash payments have aspects of more than <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">one</div> class of cash flows. The ASU is effective retrospectively for the annual period ending <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> December 31, 2018 </div>and interim periods within that annual period. We adopted ASU <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2016</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">15</div> effective <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> January 1, 2018 </div>and the adoption did <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> have a material impact on our unaudited condensed consolidated financial statements and is <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> expected to have a material impact on the annual <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2018</div> financial statements.</div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt 7.5pt;text-align:left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;">Recent Accounting Pronouncements</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">In <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> February 2016, </div>the FASB issued ASU <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2016</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">02,</div> <div style="display: inline; font-style: italic;">Leases</div> (Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">842</div>). This ASU requires lessees to put most leases on their balance sheets but recognize expenses in the income statement in a manner similar to current accounting standards. The ASU is effective <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> January 1, 2019. </div>Early adoption is permitted. The standard requires a modified retrospective approach; however, the FASB recently added a transition option to the leases standard that allows entities to apply the new guidance in the year of transition rather than at the beginning of the earliest period presented. We have <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> elected to early adopt this standard.  We are currently evaluating the effect of ASU <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2016</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">02</div> and believe it <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> may </div>have a material impact on our consolidated financial statements and related disclosures.</div></div>

541667

-31333000

-23920000

<div style="display: inline; font-family: times new roman; font-size: 10pt"><table border="0" cellpadding="0" cellspacing="0" style=";text-indent:0;font-family:'Times New Roman', Times, serif;font-size:10pt; min-width: 700px;"> <tr> <td style="vertical-align:top;width:8.3%;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><div style="display: inline; font-weight: bold;">Note </div><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">1</div></div><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">3</div></div><div style="display: inline; font-weight: bold;"> –</div></div> </td> <td style="vertical-align:top;width:91.7%;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;">Subsequent Events</div></div> </td> </tr> </table> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">On <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> October 19, 2018 </div>and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> November 2, 2018, </div>we entered into Loan Agreements (“Loan Agreements”) with LPH wherein LPH agreed to lend us <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$430,000</div> and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$500,000</div> (together the “Loans”) to support our operations while we seek to complete a strategic transaction (as defined in the Loan Agreements, the “Strategic Transaction”). The Loans, which were funded on <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> October 19, 2018 </div>and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> November 2, 2018, </div>each accrue interest at a rate of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">6%</div></div> per annum and mature upon the earlier of (i) the closing date for the Strategic Transaction, provided that the Company is able to raise a minimum of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$30</div> million in connection with such transaction, or (ii) <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> March 31, 2019. </div>In each case, we granted LPH a security interest in substantially all our assets under the LPH Security Agreement.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"></div></div>

3054000

400000

1.03

0.0275

P7Y

P5Y

3769000

729000

3585000

563000

51000 786.80 25000 P180D P180D 3770000 3624000 113300000 0.0999 <div style="display: inline; font-family: times new roman; font-size: 10pt"><table border="0" cellpadding="0" cellspacing="0" style="margin-right: 20%; font-size: 10pt; font-family: "Times New Roman", Times, serif; text-indent: 0px; min-; min-width: 700px;"> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: center;"><div style="display: inline; font-weight: bold;">September 30,</div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> </tr> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; width: 81%;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">(in thousands)</div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td colspan="2" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: center;"><div style="display: inline; font-weight: bold;">2018</div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Cash interest expense</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 16%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">51</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Non-cash amortization of debt discounts</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 16%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">302</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Total convertible note interest expense</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 16%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">353</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 3px;"> </td> </tr> </table></div> <div style="display: inline; font-family: times new roman; font-size: 10pt"><table border="0" cellpadding="0" cellspacing="0" style="; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: top;"> <td style="width: 54pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><div style="display: inline; font-weight: bold;">Note </div><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">9</div></div><div style="display: inline; font-weight: bold;"> –</div></div> </td> <td> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;">Convertible Note P</div><div style="display: inline; font-weight: bold;">ayable</div><div style="display: inline; font-weight: bold;"> </div></div> </td> </tr> </table> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div> <table border="0" cellpadding="0" cellspacing="0" style="margin-right: 20%; font-size: 10pt; font-family: "Times New Roman", Times, serif; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">September 30,</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> </tr> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; width: 81%;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;"><div style="display: inline; font-style: italic;">(in thousands)</div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: center; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-weight: bold;">2018</div></div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Convertible note payable</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 16%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">1,500</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Unamortized discount</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 16%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">(531</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 1px;">)</td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Convertible note payable, net of discount</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 16%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">969</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px; margin-left: 0pt;"> </td> </tr> </table> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">On <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> July 2, 2018, </div>we issued to Panacea a Secured Convertible Promissory Note (the Note) with respect to a loan facility in the aggregate amount of up to <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$1.5</div> million, which was funded in <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">two</div> loans of, <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$1.0</div> million on the date of the Note and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$500,000</div> on <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> July 23, 2018. </div>The Note has a maturity date of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> December 31, 2018 </div>and bears interest at a rate of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">15%</div> per annum until the Note is paid in full or converted into shares of our common stock at a price per share of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$4.00.</div> In addition, in lieu of converting the Note, Panacea <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> may </div>deliver the Note into a private placement in which Panacea Venture Healthcare Fund I L.P., an affiliate of Panacea, <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> may </div>participate. There can be <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">no</div> assurance that such a private placement will be completed. In connection with these Loans, we granted to Panacea a security interest in substantially all our assets.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">In connection with the Note, we issued to Panacea warrants (the “Series D Warrants”) to purchase <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">187,500</div> shares (the “Warrant Shares”) at an exercise price of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$4.00</div> per Warrant Share (the “Exercise Price”). The Warrants <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> may </div>be exercised at any time beginning <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">six</div> months after the date of issuance and through the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">fifth</div> anniversary of the date of issuance. The Warrants <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> may </div><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> be exercised to the extent that the holder thereof would, following such exercise, beneficially own more than <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">9.99%</div> of the Company’s outstanding shares of Common Stock, which percentage <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> may </div>be increased, decreased or waived by such holder upon <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">sixty-one</div> days’ notice to us. The Warrants also contain customary provisions that adjust the Exercise Price and the number of Warrant Shares in the event of a corporate transaction.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">We recorded the Note as current debt at its face value of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$1.5</div> million less debt discounts consisting of (i) <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$0.4</div> million fair value of the warrants issued in connection with the Note and (ii) a <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$0.4</div> million beneficial conversion feature related to an embedded conversion option that had an effective conversion price that was less than the fair value of the underlying stock at the commitment date. The discount is being accreted to the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$1.5</div> million loan over its term using the effective interest method. The Panacea Warrants are derivatives that qualify for an exemption from liability accounting as provided for in ASC Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">815,</div> <div style="display: inline; font-style: italic;">Derivatives and Hedging – Contracts in Entity’s Own Equity</div>, and have been classified as equity.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">The fair value at issuance of the Panacea Warrants was determined using the Black-Scholes option-pricing model. The input assumptions used in the valuation are the historical volatility of our common stock price, the expected term of the warrants, and the risk-free interest rate based on the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">five</div>-year treasury bill rate in effect at the measurement date. </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div> <table border="0" cellpadding="0" cellspacing="0" style="margin-right: 20%; font-size: 10pt; font-family: "Times New Roman", Times, serif; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: bottom;"> <td colspan="4" style="font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: thin solid rgb(0, 0, 0);"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center;"><div style="display: inline; font-weight: bold;">Significant Input Assumptions of Warrant Valuation</div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px; border-bottom: thin solid rgb(0, 0, 0); text-align: center;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; width: 81%;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Historical volatility</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 16%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">103</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">%</td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Expected term (in years)</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 16%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">5</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Risk-free interest rate</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 16%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2.75</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">%</td> </tr> </table> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin: 0pt; text-align: left"></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">The following amounts comprise the convertible note interest expense for the periods presented:</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div> <table border="0" cellpadding="0" cellspacing="0" style="margin-right: 20%; font-size: 10pt; font-family: "Times New Roman", Times, serif; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td colspan="2" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: center;"><div style="display: inline; font-weight: bold;">September 30,</div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> </tr> <tr style="vertical-align: bottom;"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; width: 81%;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">(in thousands)</div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td colspan="2" style="text-align: left; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: center;"><div style="display: inline; font-weight: bold;">2018</div></div> </td> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom;"> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Cash interest expense</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;">$</td> <td style="width: 16%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">51</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(255, 255, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Non-cash amortization of debt discounts</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 1px;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 1px solid rgb(0, 0, 0);"> </td> <td style="width: 16%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 1px solid rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">302</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 1px;"> </td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204, 238, 255);"> <td style="font-family: "Times New Roman", Times, serif; font-size: 10pt;"> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">Total convertible note interest expense</div> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; padding-bottom: 3px;"> </td> <td style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; border-bottom: 3px double rgb(0, 0, 0);"> </td> <td style="width: 16%; text-align: right; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; border-bottom: 3px double rgb(0, 0, 0);"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">353</div></td> <td nowrap="nowrap" style="width: 1%; font-family: "Times New Roman", Times, serif; font-size: 10pt; margin-left: 0pt; padding-bottom: 3px;"> </td> </tr> </table> </div></div> <div style="display: inline; font-family: times new roman; font-size: 10pt"><table border="0" cellpadding="0" cellspacing="0" style="; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: top;"> <td style="width: 54pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><div style="display: inline; font-weight: bold;">Note <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">12</div></div><div style="display: inline; font-weight: bold;"> –</div></div> </td> <td> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;">Out-</div><div style="display: inline; font-weight: bold;">Licensing Agreement</div></div> </td> </tr> </table> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-style: italic;">Lee’s Pharmaceutical (HK) Ltd.</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">In <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> June 2017, </div>we entered into a License, Development and Commercialization Agreement (“License Agreement”) with Lee’s Pharmaceutical (HK) Ltd., a company organized under the laws of Hong Kong (<div style="display: inline; font-weight: bold;">“</div>Lee’s (HK)") and an affiliate of Lee's. Under the License Agreement, we granted to Lee’s (HK) an exclusive license with a right to sublicense, (i) to develop and commercialize our <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">KL4</div> surfactant products, including SURFAXIN®, which was approved by the U.S. Food and Drug Administration (“FDA”) in <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2012</div> for the prevention of respiratory distress syndrome (“RDS”) in premature infants, SURFAXIN LS™, the lyophilized dosage form of SURFAXIN; and AEROSURF®, an investigative combination drug/device product that is designed to deliver aerosolized <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">KL4</div> surfactant noninvasively, and (ii) to register and manufacture SURFAXIN and SURFAXIN LS for use in the Licensed Territory, which includes the People’s Republic of China (“PRC”), Hong Kong, Thailand, Taiwan and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">12</div> other countries (the “Licensed Territory”). In addition, we granted Lee’s (HK) options to potentially add Japan to the Licensed Territory and to manufacture our ADS in the Licensed Territory, in each case subject to conditions set forth in the License Agreement.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">Under the License Agreement, Lee’s (HK) made an upfront payment to us of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$1</div> million. We also <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> may </div>receive up to <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$37.5</div> million in potential clinical, regulatory and commercial milestone payments and will share in any sublicense income Lee’s (HK) <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> may </div>receive at a rate equal to low double digits. In addition, Lee’s (HK) will be responsible for all costs and expenses in and for the Licensed Territory related to development activities, including a planned AEROSURF phase <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">3</div> clinical trial, regulatory activities, and commercialization activities.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin: 0pt; text-align: left"></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">In <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> August 2017, </div>we entered into a Loan Agreement, pursuant to which Lee’s (HK) agreed to lend us up to <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$3.9</div> million to support our activities through <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> October 31, 2017, </div>while we and Lee’s worked to complete a <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$10</div> million securities purchase agreement (Lee’s SPA) pursuant to which Lee’s acquired a controlling interest in our Company effective on <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> November 1, 2017. </div>In connection with the Loan Agreement, we amended the License Agreement (Amendment <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">No.</div> <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">1</div>) to expand certain of Lee’s (HK) rights, by immediately adding Japan to the licensed territory, accelerating the right to manufacture the ADS in and for the licensed territory, reducing or eliminating certain of the milestone and royalty payments and adding an affiliate of Lee’s (HK) as a party to the License Agreement. As a result, the additional amounts for potential clinical, regulatory and commercial milestone payments were reduced to <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$35.8</div> million.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-style: italic;">Accounting Analysis under ASC <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606</div></div> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">  </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">In evaluating the License Agreement in accordance with ASC Topic <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606,</div> we concluded that the contract counterparty, Lee’s (HK), is a customer. We identified the following performance obligations: (i) a bundled performance obligation consisting of licensing rights to develop and commercialize our <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">KL4</div> surfactant products and a technology transfer process for the manufacture of SURFAXIN and SURFAXIN LS; and (ii) a technology transfer process for the manufacture of our ADS. We determined that participation in the Joint Steering Committee (and other committees under its authority) and our ongoing product development, regulatory, and commercialization activities under the License Agreement were deemed immaterial in the context of the contract. Consistent with the guidance under ASC <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">606</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">10</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">25</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">16A,</div> we disregarded immaterial promised goods and services when determining performance obligations.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">  </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">We concluded that the licensing rights were <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> distinct within the context of the contract (i.e., separately identifiable) because the licensing rights do <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> have stand-alone value from other promised goods and services as Lee’s (HK) could <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> benefit from the licensing rights without the completion of the technology transfer process for the manufacture of SURFAXIN and SURFAXIN LS. The technology transfer process for the manufacture of our ADS is distinct within the context of the contract because it has stand-alone value from other promised goods and services as Lee’s (HK) could benefit from this right on a stand-alone basis. However, we determined that the ADS manufacturing right has a nominal stand-alone selling price at the time of Amendment <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">No.</div> <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">1</div> as the ADS is <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> yet verified and there is uncertainty with regard to the commercial value of the ADS given that the AEROSURF combination drug/device product is currently in clinical development.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">  </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">With respect to Amendment <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">No.</div> <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">1,</div> we elected to use the practical expedient for contract modifications that occur prior to the adoption of ASU <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2014</div>-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">09,</div> and we determined that the impact was immaterial. Allocable arrangement consideration under the practical expedient comprised the upfront payment of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$1</div> million and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$0.3</div> million related to reductions in royalties and milestones in connection with Amendment <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">No.</div> <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">1.</div> The <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$1.3</div> million was attributed in its entirety to the bundled performance obligation of licensing rights to develop and commercialize our <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">KL4</div> surfactant products and a technology transfer process for the manufacture of SURFAXIN and SURFAXIN LS. Revenue associated with the bundled performance obligation was recognized beginning in <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> November 2017 </div>with the initiation of the technology transfer process for the manufacture of SURFAXIN and SURFAXIN LS and will be recognized over time as services are performed and based on the input method related to the level of effort expended. The expected completion date for the technology transfer is <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> June 2019.</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">Regulatory and commercialization milestones were excluded from the transaction price, as all milestone amounts were fully constrained under the guidance. As part of our evaluation of the constraint, we considered a number of factors in determining whether there is significant uncertainty associated with the future events that would result in the milestone payments. Those factors include: our financial position; ongoing delays in our development activities and with initiating our phase <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">3</div> clinical trial; our limited experience with successful drug development; our limited experience with clinical trials; our recent failure to achieve primary endpoints in our phase <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2b</div> clinical trial; our limited experience with commercialization; our decision in <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2015</div> to cease manufacturing and commercializing of SURFAXIN; and the fact that the uncertainty about the related consideration is <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> expected to be resolved for a long period of time (<div style="display: inline; font-style: italic;">see</div>, Item <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">1A</div> – Risk Factors).</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">Consideration related to sales-based milestones and royalties will be recognized when the related sales occur, provided that the reported sales are reliably measurable and that we have <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">no</div> remaining performance obligations, as such sales were determined to relate predominantly to the license granted to Lee’s (HK) and therefore have also been excluded from the transaction price. We will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.</div></div> 30000000 30000000 300000 70000 17000 765000 1383000 146000 216000 15000000 15000000 15000000 15000000 15000000 15000000 37500000 35800000 <div style="display: inline; font-family: times new roman; font-size: 10pt"><table border="0" cellpadding="0" cellspacing="0" style="; text-indent: 0px; min-width: 700px;"> <tr style="vertical-align: top;"> <td style="width: 54pt;"> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><div style="display: inline; font-weight: bold;">Note <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2</div> –</div></div> </td> <td> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;">Liquidity Risks and Management’s Plans</div></div> </td> </tr> </table> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">As of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> September 30, 2018, </div>we had cash and cash equivalents of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$0.6</div> million and current liabilities of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$18.1</div> million, including <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$4.3</div> million in loans payable (<div style="display: inline; font-style: italic;">see</div> Note <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">8</div> – Loan Payable) and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$1.0</div> million of convertible note payable, net of discount (<div style="display: inline; font-style: italic;">see</div> Note <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">9</div> – Convertible Note Payable). As we remain focused on completing the potential strategic transaction that could diversify our assets and bring in additional capital to fund our activities, we are dependent upon Lee’s Pharmaceutical Holdings Limited (Lee’s), the majority holder of our common stock, to provide us financial support. Since <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> August 2018, </div>Lee’s has provided <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$2.7</div> million in financial support in the form of loans (<div style="display: inline; font-style: italic;">see</div>, Note <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">8</div> – Loan Payable and Note <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">13</div> – Subsequent Event); however, since we have <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> executed agreements for any additional advances at this time, there can be <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">no</div> assurance that additional support will be forthcoming. In addition, in connection with the potential strategic transaction, we are incurring and will continue to incur potentially significant legal, accounting, and other professional fees that in any event will represent an additional financial burden for which we will require additional capital. As of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> November 2, 2018, </div>and before any additional financings, we believe that we will have sufficient cash resources available to support our operations through mid-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> November </div><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2018.</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">We expect to continue to incur significant losses and will require significant additional capital to support our operations, advance our AEROSURF clinical development program, and satisfy existing obligations, and we do <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> currently have sufficient cash and cash equivalents for at least the next year following the date that the financial statements are issued. These conditions raise substantial doubt about our ability to continue as a going concern within <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">one</div> year after the date that the financial statements are issued.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, management plans to raise additional capital through the potential strategic transaction on which we are currently focused, which would provide access to additional products to diversify our offerings and additional capital to fund our operations.  Although we are currently actively engaged in diligence and discussions to complete this strategic transaction, there can be <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">no</div> assurance that we will be able to complete it within an acceptable time and on terms that are favorable to us.  If for any reason we are unable to complete the strategic transaction as planned, it is unlikely that we would be able to identify and enter into another suitable opportunity on acceptable terms and within a time for which we <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> may </div>have adequate funding. In that event, we would <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> have sufficient cash resources and liquidity to fund our business operations for at least the next year following the date that the financial statements are issued. Accordingly, management has concluded that substantial doubt exists with respect to our ability to continue as a going concern through <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">one</div> year after the issuance of the accompanying financial statements.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">In <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> June 2018, </div>we entered into a Guaranty and Replenishment Agreement with Lee’s pursuant to which Lee’s agreed to replenish up to <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$1</div> million expended by us that reduce our cash resources below our planned minimum cash (the amount that would otherwise be required to cover estimated wind-down costs should we be unable at any time to continue as a going concern). To secure its obligation to us, Lee’s delivered an Irrevocable Stand-by Letter of Credit (the Letter of Credit) in the amount of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$1</div> million and drawn in our favor, which, following a recent extension, now expires on <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> December 28, 2018. </div>As of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> November 2, 2018, </div>we have <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> drawn on the Letter of Credit.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">As of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> November 2, 2018, </div>there were <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">120</div> million shares of common stock and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">5</div> million shares of preferred stock authorized under our Certificate of Incorporation, and approximately <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">113.3</div> million shares of common stock and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">5.0</div> million shares of preferred stock available for issuance and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> otherwise reserved.</div></div> 1000000 1300000 900000 5000000 2600000 0.25 140000 140000 225000 225000 <div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-weight: bold;">Restructured debt liability – contingent milestone payment</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">In conjunction with the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> November 2017 </div>restructuring and retirement of long-term debt (<div style="display: inline; font-style: italic;">See,</div> "– Note <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">10</div> – Restructured debt liability"), we established a <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$15</div> million long-term liability for contingent AEROSURF regulatory and commercial milestone payments, beginning with the filing for marketing approval in the United States, potentially due under the Exchange and Termination Agreement dated as of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> October 27, 2017 (</div>Exchange and Termination Agreement), between ourselves and affiliates of Deerfield Management Company L.P. (Deerfield). The liability has been recorded at full value of the contingent milestones and will continue to be carried at full value until the milestones are achieved and paid or milestones are <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> achieved and the liability is written off as a gain on debt restructuring.</div></div></div></div></div> 71111 0.02 <div style="display: inline; font-family: times new roman; font-size: 10pt"><div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><div style="display: inline; font-weight: bold;">Beneficial Conversion Feature </div></div> <div style=" font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><div style="display: inline; font-weight: bold;"> </div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">A beneficial conversion feature arises when a debt or equity security is issued with an embedded conversion option that is beneficial to the investor (or in the money) at inception due to the conversion option having an effective conversion price that is less than the fair value of the underlying stock at the commitment date.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-style: italic;">Preferred Stock</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">The issuance of Series A Convertible Preferred Stock (Preferred Shares) in the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">first</div> quarter of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2017</div> (<div style="display: inline; font-style: italic;">see</div>, “– Note <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">5</div> – Stockholders’ Equity”) resulted in a beneficial conversion feature. We recognized this feature by allocating the intrinsic value of the beneficial conversion feature, which is the number of shares of common stock available upon conversion multiplied by the difference between the effective conversion price per share and the fair value of common stock per share on the commitment date, to additional paid-in capital, resulting in a discount on the Preferred Shares. As the Preferred Shares are immediately convertible by the holders, the discount allocated to the beneficial conversion feature was immediately accreted and recognized as a <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$3.6</div> million <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">one</div>-time, non-cash deemed dividend to the preferred shareholders during the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">first</div> quarter of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2017.</div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">An additional discount to the Preferred Shares of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$4.5</div> million was created due to the allocation of proceeds to the Warrants which were issued with the Preferred Shares. This discount is amortized proportionately as the Preferred Shares are converted. <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">No</div> Preferred Shares were converted during the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">three</div> or <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">nine</div> months ended <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> September 30, 2018. </div>For the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">three</div> and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">nine</div> months ended <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> September 30, 2017, </div>we recognized a non-cash deemed dividend to the preferred shareholders of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$2.2</div> million and <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$6.4</div> million, respectively, related to the Preferred Shares converted during the periods.</div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><div style="display: inline; font-style: italic;">Convertible Note</div><div style="display: inline; font-style: italic;"> </div></div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"> </div> <div style=" font-family: "Times New Roman", Times, serif; font-size: 10pt; margin: 0pt; text-align: left;">The issuance on <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> July 2, 2018 </div>of a Secured Convertible Promissory Note (the Note) to Panacea Venture Management Company Ltd. (Panacea) with respect to a loan facility in the aggregate amount of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$1.5</div> million resulted in a beneficial conversion feature. We recognized this feature by allocating the relative fair value of the conversion option, which is the number of shares of common stock available upon conversion multiplied by the difference between the effective conversion price per share and the fair value of common stock per share on the commitment date, resulting in a discount on the Note. We recorded the Note as current debt at its face value of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$1.5</div> million less debt discount consisting of (i) <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$0.4</div> million related to the beneficial conversion feature and (ii) <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$0.4</div> million in fair value of the warrants issued in connection with the Note. 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Document And Entity Information - shares	9 Months Ended
Document And Entity Information - shares	Sep. 30, 2018	Nov. 02, 2018
Document Information [Line Items]
Entity Registrant Name	WINDTREE THERAPEUTICS INC /DE/
Entity Central Index Key	0000946486
Trading Symbol	wint
Current Fiscal Year End Date	--12-31
Entity Filer Category	Non-accelerated Filer
Entity Current Reporting Status	Yes
Entity Emerging Growth Company	false
Entity Small Business	true
Entity Common Stock, Shares Outstanding (in shares)		3,769,088
Document Type	10-Q
Document Period End Date	Sep. 30, 2018
Document Fiscal Year Focus	2018
Document Fiscal Period Focus	Q3
Amendment Flag	false

XML 12 R2.htm IDEA: XBRL DOCUMENT

Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands	Sep. 30, 2018	Dec. 31, 2017
Current Assets:
Cash and cash equivalents	$ 640	$ 1,815
Prepaid expenses and other current assets	399	422
Total current assets	1,039	2,237
Property and equipment, net	764	885
Restricted cash	140	225
Total assets	1,943	3,347
Current Liabilities:
Accounts payable	4,519	3,048
Collaboration payable	3,770	3,624
Accrued expenses	4,069	4,204
Deferred revenue - current portion	503	884
Loan payable	4,280
Convertible note payable, $1,500 net of discount of $531 at September 30, 2018	969
Total current liabilities	18,110	11,760
Restructured debt liability - contingent milestone payments	15,000	15,000
Deferred revenue - non-current portion		407
Other liabilities	166	100
Total liabilities	33,276	27,267
Stockholders' Equity:
Preferred stock, $0.001 par value; 5,000,000 shares authorized; 2,701 shares issued and outstanding at September 30, 2018 and December 31, 2017
Common stock, $0.001 par value; 120,000,000 shares authorized at September 30, 2018 and December 31, 2017; 3,769,162 shares issued at September 30, 2018 and December 31, 2017; 3,769,088 shares outstanding at September 30, 2018 and December 31, 2017	4	3
Additional paid-in capital	620,322	616,245
Accumulated deficit	(648,605)	(637,114)
Treasury stock (at cost); 74 shares	(3,054)	(3,054)
Total stockholders' equity	(31,333)	(23,920)
Total liabilities & stockholders' equity	$ 1,943	$ 3,347

XML 13 R3.htm IDEA: XBRL DOCUMENT

Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - USD ($) $ in Thousands	Sep. 30, 2018	Dec. 31, 2017
Discount of note payable	$ 531
Convertible note payable	$ 1,500
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized (in shares)	5,000,000	5,000,000
Preferred stock, shares issued (in shares)	2,701	2,701
Preferred stock, shares outstanding (in shares)	2,701	2,701
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized (in shares)	120,000,000	120,000,000
Common stock, shares issued (in shares)	3,769,162	3,769,162
Common stock, shares outstanding (in shares)	3,769,088	3,769,088
Treasury stock, shares (in shares)	74	74

XML 14 R4.htm IDEA: XBRL DOCUMENT

Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017	Sep. 30, 2018	Sep. 30, 2017
Revenues:
Grant revenue	$ 70	$ 17	$ 765	$ 1,383
Revenues	229	17	1,484	1,383
Expenses:
Research and development	2,197	3,062	8,194	14,958
General and administrative	1,500	1,749	4,634	5,475
Total operating expense	3,697	4,811	12,828	20,433
Operating loss	(3,468)	(4,794)	(11,344)	(19,050)
Other income / (expense):
Interest income	1	3	9	9
Interest expense	(460)	(652)	(642)	(1,878)
Other income			486
Other income / (expense), net	(459)	(649)	(147)	(1,869)
Net loss	(3,927)	(5,443)	(11,491)	(20,919)
Deemed dividend on Series A preferred stock		(2,234)		(6,370)
Net loss attributable to common shareholders	$ (3,927)	$ (7,677)	$ (11,491)	$ (27,289)
Net loss per common share
Basic and diluted (in dollars per share)	$ (1.04)	$ (10.53)	$ (3.21)	$ (48.45)
Weighted average number of common shares outstanding
Basic and diluted (in shares)	3,769	729	3,585	563
License [Member]
Revenues:
License revenue with affiliate	$ 159		$ 719

XML 15 R5.htm IDEA: XBRL DOCUMENT

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017
Cash flows from operating activities:
Net loss	$ (11,491)	$ (20,919)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	121	147
Amortization of debt discount	303
Stock-based compensation	703	839
Amortization of prepaid interest		818
Gain on sale of property and equipment	(9)
Changes in:
Prepaid expenses and other current assets	23	264
Accounts payable	1,471	3,155
Collaboration payable	146	216
Accrued expenses	(68)	(1,827)
Deferred revenue	(789)	1,070
Net cash used in operating activities	(9,590)	(16,237)
Cash flows from investing activities:
Proceeds from sale of property and equipment	9
Purchase of property and equipment		(24)
Net cash used in investing activities	9	(24)
Cash flows from financing activities:
Proceeds from loan payable, net of expenses	4,280	2,600
Proceeds from Private Placement issuance of securities, net of expenses	2,541	8,789
Proceeds from convertible note payable	1,500
Proceeds from ATM Program, net of expenses		1,036
Net cash provided by financing activities	8,321	12,425
Net increase/(decrease) in cash and cash equivalents	(1,260)	(3,836)
Cash, cash equivalents and restricted cash - beginning of year	2,040	5,813
Cash, cash equivalents and restricted cash - end of year	780	1,977
Supplementary disclosure of cash flows information:
Interest paid		$ 514

XML 16 R6.htm IDEA: XBRL DOCUMENT

Note 1 - The Company and Description of Business

9 Months Ended

Sep. 30, 2018

Notes to Financial Statements

Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block]

Note

–

The Company and Description of Business

Windtree Therapeutics, Inc. (referred to as “we,” “us,” or the “Company”) is a biotechnology company focused on developing novel

KL4

surfactant therapies for respiratory diseases and other potential applications. Surfactants are produced naturally in the lung and are essential for normal respiratory function and survival. Our proprietary technology platform includes a synthetic, peptide-containing surfactant (

KL4

surfactant) that is structurally similar to endogenous pulmonary surfactant, and novel drug delivery technologies, including our proprietary aerosol delivery system (ADS), being developed to enable noninvasive administration of aerosolized

KL4

surfactant. We recently completed design verification for our new phase

ADS (which we previously referred to as the “NextGen ADS”), which we plan to use in our remaining AEROSURF

clinical development activities and, if approved, initial commercial activities. We believe that our proprietary technologies

may

make it possible to develop a pipeline of surfactant products to address a variety of respiratory diseases for which there are few or

approved therapies.

Our lead development program is AEROSURF

(lucinactant for inhalation), an investigational combination drug/device product that we are developing to improve the management of respiratory distress syndrome (RDS) in premature infants who

may

require surfactant therapy to sustain life. The currently-available surfactants in the United States (U.S.) are administered using invasive endotracheal intubation and mechanical ventilation, each of which

may

result in serious respiratory conditions and other complications. To avoid these risks, many premature infants are initially treated with noninvasive respiratory support such as nasal continuous positive airway pressure (nCPAP). Because nCPAP does

not

address the underlying surfactant deficiency, many premature infants respond poorly to nCPAP alone (typically within the

first

hours of life) and

may

require delayed surfactant therapy administered with invasive intubation (an outcome referred to as “nCPAP failure”). If surfactant therapy could be administered noninvasively, neonatologists would be able to provide surfactant therapy to premature infants earlier in their course of treatment and without exposing them to the risks associated with invasive endotracheal intubation and mechanical ventilation.

AEROSURF is designed to potentially meaningfully reduce the use of invasive endotracheal intubation and mechanical ventilation by delivering aerosolized

KL4

surfactant noninvasively. We believe that AEROSURF, if approved, will allow for earlier treatment of premature infants who currently receive delayed surfactant therapy, decrease the morbidities and complications currently associated with surfactant administration, and reduce the number of premature infants who are subjected to invasive intubation and delayed surfactant therapy following nCPAP failure. We also believe that AEROSURF has the potential to address a serious unmet medical need and potentially provide transformative clinical and pharmacoeconomic benefits. Consistent with our belief, the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for our

KL4

surfactant (including AEROSURF) to treat RDS.

In addition to advancing AEROSURF, we are assessing potential development pathways to potentially gain marketing approval for lyophilized

KL4

surfactant as an intratracheal instillate for the treatment and/or prevention of RDS. Lyophilized

KL4

surfactant

may

potentially provide benefits related to use, including longer shelf life, reduced cold-chain requirements and lower viscosity. We have discussed with the FDA a potential development plan, trial design and regulatory plan for approval. If we can define an acceptable development program that is achievable from a cost, timing and resource perspective, we might seek approval to treat premature infants who, because they are unable to breathe on their own or other reason, cannot benefit from AEROSURF.

We also believe that our

KL4

surfactant technology

may

potentially support a product pipeline to address a broad range of serious respiratory conditions in children and adults. We have received support, and plan to seek additional support, from the National Institutes of Health (NIH) and other government funding sources to explore the utility of our

KL4

surfactant to address a variety of such respiratory conditions as acute lung injury (ALI), including acute radiation exposure to the lung (acute pneumonitis and delayed lung injury), chemical-induced ALI, and influenza-induced ALI; as well as chronic rhinosinusitis, complications of certain major surgeries, mechanical ventilator-induced lung injury (often referred to as VILI), pneumonia, and diseases involving mucociliary clearance disorders, such as chronic obstructive pulmonary disease (COPD) and cystic fibrosis (CF). Although there can be

assurance, we

may

in the future support development activities to establish a proof-of-concept and, if successful, thereafter determine whether to seek strategic alliances or collaboration arrangements or pursue other financial alternatives to fund further development and, if approved, commercialization of additional

KL4

surfactant indications.

assurance, however, that we will be able to reach agreement on terms and within the time frame acceptable to all parties. Moreover, even if we reach agreement and complete a transaction, there can be

assurance that we will have sufficient resources to fund the continued development of AEROSURF or any other product candidates, that any of our development efforts would be successful, or that we would obtain regulatory approvals needed to commercialize our product candidates in the world’s markets.

XML 17 R7.htm IDEA: XBRL DOCUMENT

Note 2 - Liquidity Risks and Management's Plans

9 Months Ended

Sep. 30, 2018

Notes to Financial Statements

Liquidity Disclosures [Text Block]

Note

–

Liquidity Risks and Management’s Plans

As of

September 30, 2018,

we had cash and cash equivalents of

$0.6

million and current liabilities of

$18.1

million, including

$4.3

million in loans payable (

see

Note

– Loan Payable) and

$1.0

million of convertible note payable, net of discount (

see

Note

– Convertible Note Payable). As we remain focused on completing the potential strategic transaction that could diversify our assets and bring in additional capital to fund our activities, we are dependent upon Lee’s Pharmaceutical Holdings Limited (Lee’s), the majority holder of our common stock, to provide us financial support. Since

August 2018,

Lee’s has provided

$2.7

million in financial support in the form of loans (

see

, Note

– Loan Payable and Note

– Subsequent Event); however, since we have

not

executed agreements for any additional advances at this time, there can be

assurance that additional support will be forthcoming. In addition, in connection with the potential strategic transaction, we are incurring and will continue to incur potentially significant legal, accounting, and other professional fees that in any event will represent an additional financial burden for which we will require additional capital. As of

November 2, 2018,

and before any additional financings, we believe that we will have sufficient cash resources available to support our operations through mid-

November

2018.

not

currently have sufficient cash and cash equivalents for at least the next year following the date that the financial statements are issued. These conditions raise substantial doubt about our ability to continue as a going concern within

one

year after the date that the financial statements are issued.

assurance that we will be able to complete it within an acceptable time and on terms that are favorable to us. If for any reason we are unable to complete the strategic transaction as planned, it is unlikely that we would be able to identify and enter into another suitable opportunity on acceptable terms and within a time for which we

may

have adequate funding. In that event, we would

not

have sufficient cash resources and liquidity to fund our business operations for at least the next year following the date that the financial statements are issued. Accordingly, management has concluded that substantial doubt exists with respect to our ability to continue as a going concern through

one

year after the issuance of the accompanying financial statements.

not

include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.

June 2018,

we entered into a Guaranty and Replenishment Agreement with Lee’s pursuant to which Lee’s agreed to replenish up to

million expended by us that reduce our cash resources below our planned minimum cash (the amount that would otherwise be required to cover estimated wind-down costs should we be unable at any time to continue as a going concern). To secure its obligation to us, Lee’s delivered an Irrevocable Stand-by Letter of Credit (the Letter of Credit) in the amount of

million and drawn in our favor, which, following a recent extension, now expires on

December 28, 2018.

As of

November 2, 2018,

we have

not

drawn on the Letter of Credit.

As of

November 2, 2018,

there were

120

million shares of common stock and

million shares of preferred stock authorized under our Certificate of Incorporation, and approximately

113.3

million shares of common stock and

5.0

million shares of preferred stock available for issuance and

not

otherwise reserved.

XML 18 R8.htm IDEA: XBRL DOCUMENT

Note 3 - Basis of Presentation

9 Months Ended

Sep. 30, 2018

Notes to Financial Statements

Basis of Accounting [Text Block]

Note

–

Basis of Presentation

-Q. Accordingly, they do

not

include all of the information and footnotes required by U.S. GAAP for complete consolidated financial statements. In the opinion of management, all adjustments (consisting of normally recurring accruals) considered for fair presentation have been included. Operating results for the

three

and

nine

months ended

September 30, 2018

are

not

necessarily indicative of the results that

may

be expected for the year ending

December

31,

2018.

There have been

changes to our critical accounting policies since

December 31, 2017.

For a discussion of our accounting policies,

see

, “– Note

– Summary of Significant Accounting Policies” in this Quarterly Report on Form

-Q, and, in the Notes to Consolidated Financial Statements in our

2017

Form

-K, “– Note

– Accounting Policies and Recent Accounting Pronouncements.” Readers are encouraged to review those disclosures in conjunction with this Quarterly Report on Form

-Q.

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Note 4 - Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2018

Notes to Financial Statements

Significant Accounting Policies [Text Block]

Note

–

Summary of Significant Accounting Policies

Use of Estimates

Restructured debt liability – contingent milestone payment

In conjunction with the

November 2017

restructuring and retirement of long-term debt (

See,

"– Note

– Restructured debt liability"), we established a

$15

million long-term liability for contingent AEROSURF regulatory and commercial milestone payments, beginning with the filing for marketing approval in the United States, potentially due under the Exchange and Termination Agreement dated as of

October 27, 2017 (

Exchange and Termination Agreement), between ourselves and affiliates of Deerfield Management Company L.P. (Deerfield). The liability has been recorded at full value of the contingent milestones and will continue to be carried at full value until the milestones are achieved and paid or milestones are

not

achieved and the liability is written off as a gain on debt restructuring.

Deferred revenue

Deferred revenue represents amounts received prior to satisfying the revenue recognition criteria (

see

, Revenue recognition) and are recognized as deferred revenue in our balance sheet. Amounts expected to be recognized as revenue within the

months following the balance sheet date are classified as Deferred revenue – current portion. Amounts

not

expected to be recognized as revenue within the

months following the balance sheet date are classified as Deferred revenue – non-current portion.

Deferred revenue primarily consists of amounts related to an upfront license fee received in

July 2017

in connection with the License Agreement with Lee’s. The revenue will be recognized as our performance obligations under the contract are met (

see

, Note

– Out-Licensing Agreement).

Revenue recognition

Effective

January 1, 2018,

we adopted Accounting Standards Codification (“ASC”) Topic

606,

Revenue from Contracts with Customers, using the modified retrospective transition method. Under this method, we recognize the cumulative effect of initially adopting ASC Topic

606,

if any, as an adjustment to the opening balance of retained earnings. Additionally, under this method of adoption, we apply the guidance to all incomplete contracts in scope as of the date of initial application. This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments.

In accordance with ASC Topic

606,

we recognize revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC Topic

606,

we perform the following

five

steps:

	(i)	identify the contract(s) with a customer;
	(ii)	identify the performance obligations in the contract;

	(iii)	determine the transaction price;
	(iv)	allocate the transaction price to the performance obligations in the contract; and

(v)

recognize revenue when (or as) the entity satisfies a performance obligation.

We only apply the

five

-step model to contracts when we determine that it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. At contract inception, once the contract is determined to be within the scope of ASC Topic

606,

we assess the goods or services promised within a contract and determine those that are performance obligations, and assesses whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

We have concluded that our government grants are

not

within the scope of ASC Topic

606

as they do

not

meet the definition of a contract with a customer. We have concluded that the grants meet the definition of a contribution and are non-reciprocal transactions, and have also concluded that Subtopic

958

605,

Not

-for-Profit-Entities-Revenue Recognition

does

not

apply, as we are a business entity and the grants are with governmental agencies.

In the absence of applicable guidance under US GAAP, effective

January 1, 2018,

we developed a policy for the recognition of grant revenue when the related costs are incurred and the right to payment is realized.

We believe this policy is consistent with the overarching premise in ASC Topic

606,

to ensure that revenue recognition reflects the transfer of promised goods or services to customers in an amount that reflects the consideration that we expect to be entitled to in exchange for those goods or services, even though there is

exchange as defined in ASC Topic

606.

We believe the recognition of revenue as costs are incurred and amounts become realizable is analogous to the concept of transfer of control of a service over time under ASC Topic

606.

Prior to

January 1, 2018,

we recognized revenue as related costs were incurred under the grants given that persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed and determinable, and collectability is reasonably assured. Recognized amounts reflected our performance under the grants and equal direct and indirect costs incurred. Revenue and expenses under these arrangements were presented gross. Revenue recognition under this new policy is

not

materially different than would have been calculated under the old guidance. As a result of the adoption of this policy, there was

change to the amounts we have historically recorded in our financial statements.

Research and development

730,

Research and Development

Net Loss per Common Share

September 30, 2018

and

2017,

the number of shares of common stock potentially issuable upon the conversion of preferred stock or exercise of certain stock options and warrants was

1.3

million and

0.9

million shares, respectively. For the

three

and

nine

months ended

September 30, 2018

and

2017,

all potentially dilutive securities were anti-dilutive and therefore have been excluded from the computation of diluted net loss per share.

Net loss per common share – basic and diluted and weighted average number of common shares outstanding for the

three

and

nine

months ended

September 30, 2017

have been corrected for immaterial calculation errors related to the conversion of preferred stock to common stock during those periods.

We do

not

have any components of other comprehensive income (loss).

Beneficial Conversion Feature

Preferred Stock

The issuance of Series A Convertible Preferred Stock (Preferred Shares) in the

first

quarter of

2017

(

see

, “– Note

– Stockholders’ Equity”) resulted in a beneficial conversion feature. We recognized this feature by allocating the intrinsic value of the beneficial conversion feature, which is the number of shares of common stock available upon conversion multiplied by the difference between the effective conversion price per share and the fair value of common stock per share on the commitment date, to additional paid-in capital, resulting in a discount on the Preferred Shares. As the Preferred Shares are immediately convertible by the holders, the discount allocated to the beneficial conversion feature was immediately accreted and recognized as a

$3.6

million

one

-time, non-cash deemed dividend to the preferred shareholders during the

first

quarter of

2017.

An additional discount to the Preferred Shares of

$4.5

million was created due to the allocation of proceeds to the Warrants which were issued with the Preferred Shares. This discount is amortized proportionately as the Preferred Shares are converted.

Preferred Shares were converted during the

three

nine

months ended

September 30, 2018.

For the

three

and

nine

months ended

September 30, 2017,

we recognized a non-cash deemed dividend to the preferred shareholders of

$2.2

million and

$6.4

million, respectively, related to the Preferred Shares converted during the periods.

Convertible Note

The issuance on

July 2, 2018

of a Secured Convertible Promissory Note (the Note) to Panacea Venture Management Company Ltd. (Panacea) with respect to a loan facility in the aggregate amount of

$1.5

million resulted in a beneficial conversion feature. We recognized this feature by allocating the relative fair value of the conversion option, which is the number of shares of common stock available upon conversion multiplied by the difference between the effective conversion price per share and the fair value of common stock per share on the commitment date, resulting in a discount on the Note. We recorded the Note as current debt at its face value of

$1.5

million less debt discount consisting of (i)

$0.4

million related to the beneficial conversion feature and (ii)

$0.4

million in fair value of the warrants issued in connection with the Note. The discount is being accreted to the

$1.5

million loan over its term using the effective interest method.

Income taxes

We account for income taxes in accordance with ASC Topic

740,

Accounting for Income Taxes, which requires the recognition of deferred tax liabilities and assets for the expected future tax consequences of temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities.

not

assured.

December 22, 2017,

the U.S. government enacted the

2017

Tax Cuts and Jobs Act (the

2017

Tax Act), which significantly revises U.S. tax law by, among other provisions, lowering the U.S. federal statutory income tax rate to

21%,

imposing a mandatory

one

-time transition tax on previously deferred foreign earnings, and eliminating or reducing certain income tax deductions. As of

December 31, 2017,

we recorded the provisional impact from the

2017

Tax Act in accordance with SAB

118.

As of

September 30, 2018,

we have

not

adjusted any of our provisional amounts that were recorded as of

December 31, 2017.

We will finalize our adjustments during the

fourth

quarter of

2018.

Recently Adopted Accounting Standards

May 2014,

the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU)

2014

09,

Revenue from Contracts with Customers (Topic

606

)

, which was subsequently amended by several other ASUs related to Topic

606

to, among other things, defer the effective date and clarify various aspects of the new revenue guidance including principal versus agent considerations, identifying performance obligations, licensing, and other improvements and practical expedients. We adopted ASU

2014

09,

as amended, effective

January 1, 2018

using the modified retrospective transition method. In

June 2017,

we entered into a License Agreement with Lee’s (HK), granting Lee’s (HK) rights to develop and commercialize our products in a specific Asian territory. The consideration we are eligible to receive under this agreement includes an upfront payment, contingent revenues in the form of regulatory and commercial milestones, and sales-based milestone and royalty payments. We evaluated the License Agreement under ASU

2014

and determined that there was

material impact to revenues for any of the years presented upon adoption. Additionally, there were

revisions to any balance sheet components of revenues such as deferred revenues or beginning retained earnings as a result of using the modified retrospective method. The primary impact on our financial statements is related to revised or additional disclosures with respect to revenues and cash flows arising from contracts with customers, which are included in Note

– Out-Licensing Agreement.

May 2017,

the FASB issued ASU

2017

09,

Compensation—Stock Compensation (Topic

718

)

Scope of Modification Accounting

. This ASU clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions. The ASU is effective prospectively for the annual period ending

December 31, 2018

and interim periods within that annual period. We adopted ASU

2017

effective

January 1, 2018

and the adoption did

not

have a material impact on our unaudited condensed consolidated financial statements and is

not

expected to have a material impact on the annual

2018

financial statements.

August 2016,

the FASB issued ASU

2016

15,

Statement of Cash Flows (Topic

230

), Classification of Certain Cash Receipts and Cash Payments

. This ASU clarifies clarify how entities should classify certain cash receipts and cash payments related to

eight

specific cash flow issues, including debt prepayment or extinguishment costs, with the objective of reducing diversity in how certain cash receipts and cash payments are presented and classified in the statement of cash flows. The ASU also clarifies how the predominance principle should be applied when cash receipts and cash payments have aspects of more than

one

class of cash flows. The ASU is effective retrospectively for the annual period ending

December 31, 2018

and interim periods within that annual period. We adopted ASU

2016

effective

January 1, 2018

and the adoption did

not

have a material impact on our unaudited condensed consolidated financial statements and is

not

expected to have a material impact on the annual

2018

financial statements.

Recent Accounting Pronouncements

February 2016,

the FASB issued ASU

2016

02,

Leases

(Topic

842

). This ASU requires lessees to put most leases on their balance sheets but recognize expenses in the income statement in a manner similar to current accounting standards. The ASU is effective

January 1, 2019.

Early adoption is permitted. The standard requires a modified retrospective approach; however, the FASB recently added a transition option to the leases standard that allows entities to apply the new guidance in the year of transition rather than at the beginning of the earliest period presented. We have

not

elected to early adopt this standard. We are currently evaluating the effect of ASU

2016

and believe it

may

have a material impact on our consolidated financial statements and related disclosures.

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Note 5 - Stockholders' Equity

9 Months Ended

Sep. 30, 2018

Notes to Financial Statements

Stockholders' Equity Note Disclosure [Text Block]

Note

–

Stockholders

’

Equity

April 4, 2018,

we completed a private placement offering pursuant to a Securities Purchase Agreement (SPA) and Registration Rights Agreement with LPH II Investments Limited (LPH II), a Cayman Islands company and wholly-owned subsidiary of Lee’s. Under this SPA, LPH II invested

$2.6

million and acquired

541,667

shares of our common stock and warrants to purchase

135,417

shares of our common stock at an exercise price of

$5.52

per share. The purchase price per share was

$4.80.

The warrants are exercisable after

months and through the

seventh

anniversary of the issue date. In addition, under the Registration Rights Agreement, we agreed to file an initial resale registration statement with the SEC to register for subsequent resale the shares and the warrant shares. We are required to seek registration of

25%

of the shares and warrant shares on such initial resale registration statement. From time to time, following the

180th

day from

March 30, 2018,

LPH II or a majority of the holders of the shares and warrant shares

may

require us to file additional registration statement(s) to register the resale of the balance of the shares and warrant shares, subject to certain limitations.

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Note 6 - License Revenue with Affiliate

9 Months Ended

Sep. 30, 2018

Notes to Financial Statements

Revenue from Contract with Customer [Text Block]

Note

–

License

evenue with

ffiliate

	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2018		2017		2018		2017

License revenue with affiliate	$	159	$	-	$	719	$	-

License revenue with affiliate for the

three

and

nine

months ended

September 30, 2018

represents revenue from a License Agreement with Lee’s (HK) and constitutes a contract with a customer accounted for in accordance with ASC Topic

606,

which we adopted effective

January 1, 2018 (

see

, Note

– Summary of Significant Accounting Policies – Recently Adopted Accounting Standards and Note

– Out-Licensing Agreement). There was

impact to License revenue with affiliate previously recognized as a result of the adoption of ASC Topic

606.

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Note 7 - Fair Value of Financial Instruments

9 Months Ended

Sep. 30, 2018

Notes to Financial Statements

Fair Value Disclosures [Text Block]

Note

–

Fair Value of Financial Instruments

Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy is based on

three

levels of inputs, of which the

first

two

are considered observable and the last unobservable, as follows:

	●	Level 1 – Quoted prices in active markets for identical assets and liabilities.
	●	Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
	●	Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

Fair Value on a Recurring Basis

The tables below categorize assets and liabilities measured at fair value on a recurring basis for the periods presented:

	Fair Value		Fair value measurement using
	September 30,
(in thousands)	2018		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	640	$	640	$	-	$	-
Certificate of deposit		140		140		-		-
Total Assets	$	780	$	780	$	-	$	-

	Fair Value		Fair value measurement using
	December 31,
(in thousands)	2017		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	1,815	$	1,815	$	-	$	-
Certificate of deposit		225		225		-		-
Total Assets	$	2,040	$	2,040	$	-	$	-

- 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

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Note 8 - Loan Payable

9 Months Ended

Sep. 30, 2018

Notes to Financial Statements

Short-term Debt [Text Block]

Note

–

Loan Payable

January 2018

and

March 2018,

LPH agreed to lend us

$1.5

million and

$1.0

million, respectively, to support our AEROSURF development activities and sustain our operations while we seek to identify and advance

one

or more potential strategic initiatives as defined in the related loan agreements (Funding Event). The loans accrue interest at a rate of

per annum and mature upon the earlier of the closing date of the Funding Event or

December 31, 2018.

To secure our obligations under these loans, we granted LPH a security interest in substantially all our assets pursuant to the terms of a Security Agreement with LPH dated

March 1, 2018 (

LPH Security Agreement).

August 2018

and

September 2018,

LPH agreed to lend us funds to sustain our operations while we continued to work on a strategic transaction. The initial loan was funded on

August 14, 2018

in the amount of

$300,000,

and subsequent loans on the following dates and in the following amounts:

August 29, 2018,

in the amount of

$480,000;

September 12, 2018

in the amount of

$500,000;

and

September 27, 2018

in the amount of

$500,000.

The loans accrue interest at a rate of

per annum and mature upon the earlier of (i) the closing date for the strategic transaction (as defined in the related loan agreements), provided that the Company is able to raise a minimum of

$30

million in connection with such transaction, or (ii)

March 31, 2019.

In each case, we granted to LPH a security interest in substantially all of our assets pursuant to the terms of the LPH Security Agreement.

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Note 9 - Convertible Note Payable

9 Months Ended

Sep. 30, 2018

Notes to Financial Statements

Convertible Note Payable Disclosure [Text Block]

Note

–

Convertible Note P

ayable

	September 30,
(in thousands)	2018

Convertible note payable	$	1,500
Unamortized discount		(531	)
Convertible note payable, net of discount		969

July 2, 2018,

we issued to Panacea a Secured Convertible Promissory Note (the Note) with respect to a loan facility in the aggregate amount of up to

$1.5

million, which was funded in

two

loans of,

$1.0

million on the date of the Note and

$500,000

July 23, 2018.

The Note has a maturity date of

December 31, 2018

and bears interest at a rate of

15%

per annum until the Note is paid in full or converted into shares of our common stock at a price per share of

$4.00.

In addition, in lieu of converting the Note, Panacea

may

deliver the Note into a private placement in which Panacea Venture Healthcare Fund I L.P., an affiliate of Panacea,

may

participate. There can be

assurance that such a private placement will be completed. In connection with these Loans, we granted to Panacea a security interest in substantially all our assets.

In connection with the Note, we issued to Panacea warrants (the “Series D Warrants”) to purchase

187,500

shares (the “Warrant Shares”) at an exercise price of

$4.00

per Warrant Share (the “Exercise Price”). The Warrants

may

be exercised at any time beginning

six

months after the date of issuance and through the

fifth

anniversary of the date of issuance. The Warrants

may

not

be exercised to the extent that the holder thereof would, following such exercise, beneficially own more than

9.99%

of the Company’s outstanding shares of Common Stock, which percentage

may

be increased, decreased or waived by such holder upon

sixty-one

days’ notice to us. The Warrants also contain customary provisions that adjust the Exercise Price and the number of Warrant Shares in the event of a corporate transaction.

We recorded the Note as current debt at its face value of

$1.5

million less debt discounts consisting of (i)

$0.4

million fair value of the warrants issued in connection with the Note and (ii) a

$0.4

million beneficial conversion feature related to an embedded conversion option that had an effective conversion price that was less than the fair value of the underlying stock at the commitment date. The discount is being accreted to the

$1.5

million loan over its term using the effective interest method. The Panacea Warrants are derivatives that qualify for an exemption from liability accounting as provided for in ASC Topic

815,

Derivatives and Hedging – Contracts in Entity’s Own Equity

, and have been classified as equity.

five

-year treasury bill rate in effect at the measurement date.

Significant Input Assumptions of Warrant Valuation
Historical volatility	103	%
Expected term (in years)	5
Risk-free interest rate	2.75	%

The following amounts comprise the convertible note interest expense for the periods presented:

	September 30,
(in thousands)	2018

Cash interest expense	$	51
Non-cash amortization of debt discounts		302
Total convertible note interest expense		353

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Note 10 - Restructured Debt Liability

9 Months Ended

Sep. 30, 2018

Notes to Financial Statements

Long-term Debt [Text Block]

Note

–

Restructured debt liability

	September 30,		December 31,
(in thousands)	2018		2017

Restructured debt liability - contingent milestone payments	$	15,000	$	15,000

November 1, 2017,

we and Deerfield entered into an Exchange and Termination Agreement pursuant to which (i) promissory notes evidencing a loan with affiliates of Deerfield Management Company L.P. (Deerfield Loan) in the aggregate principal amount of

$25

million and (ii) warrants to purchase up to

25,000

shares of our common stock at an exercise price of

$786.80

per share held by Deerfield were cancelled in consideration for (i) a cash payment in the aggregate amount of

$2.5

million, (ii)

71,111

shares of common stock, representing

of fully-diluted shares outstanding (as defined in the Exchange and Termination Agreement) on the closing date, and (iii) the right to receive certain milestone payments based on achievement of specified AEROSURF development and commercial milestones, which, if achieved, could potentially total up to

$15

million. In addition, a related security agreement, pursuant to which Deerfield held a security interest in substantially all of our assets, was terminated. We established a

$15

million long-term liability for the contingent milestone payments potentially due to Deerfield under the Exchange and Termination Agreement (

see

, Note

– Summary of Significant Accounting Policies – Restructured debt liability – contingent milestone payment).

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Note 11 - Stock Options and Stock-based Employee Compensation

9 Months Ended

Sep. 30, 2018

Notes to Financial Statements

Disclosure of Compensation Related Costs, Share-based Payments [Text Block]

Note

–

Stock Options and Stock-Based Employee Compensation

We recognize in our condensed consolidated financial statements all stock-based awards to employees and non-employee directors based on their fair value on the date of grant, calculated using the Black-Scholes option-pricing model. Compensation expense related to stock-based awards is recognized ratably over the vesting period, which for employees is typically

three

years.

A summary of activity under our long-term incentive plans is presented below:

(in thousands, except for weighted-average data) Stock Options	Shares			Weighted- Average Exercise Price		Weighted- Average Remaining Contractual Term (In Yrs)

Outstanding at January 1, 2018		84		$	163.20
Granted		-			-
Forfeited or expired		(1	)		729.80
Outstanding at September 30, 2018		83		$	154.80		7.1

Vested and exercisable at September 30, 2018		66		$	186.00		6.9

Vested and expected to vest at September 30, 2018		82		$	155.20		7.1

(in thousands, except for weighted-average data)
Restricted Stock Units	Shares		Weighted- Average Grant Date Fair Value

Unvested at January 1, 2018		190	$	4.33
Awarded		-		-
Vested		-		-
Unvested at September 30, 2018		190	$	4.33

The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing formula based on the following weighted average assumptions:

	Nine Months Ended September 30,
	2017

Weighted average expected volatility		79%
Weighted average expected term (years)		6.6
Weighted average risk-free interest rate		2.22%
Expected dividends		-

The table below summarizes the total stock-based compensation expense included in the statements of operations for the periods presented:

	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2018		2017		2018		2017

Research and development	$	29	$	77	$	169	$	360
Selling, general and administrative		116		101		534		372
Total	$	145	$	178	$	703	$	732

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Note 12 - Out-Licensing Agreement

9 Months Ended

Sep. 30, 2018

Notes to Financial Statements

Corporate Partnership, Licensing and Research Funding Agreements [Text Block]

Note

–

Out-

Licensing Agreement

Lee’s Pharmaceutical (HK) Ltd.

June 2017,

we entered into a License, Development and Commercialization Agreement (“License Agreement”) with Lee’s Pharmaceutical (HK) Ltd., a company organized under the laws of Hong Kong (

“

Lee’s (HK)") and an affiliate of Lee's. Under the License Agreement, we granted to Lee’s (HK) an exclusive license with a right to sublicense, (i) to develop and commercialize our

KL4

surfactant products, including SURFAXIN®, which was approved by the U.S. Food and Drug Administration (“FDA”) in

2012

for the prevention of respiratory distress syndrome (“RDS”) in premature infants, SURFAXIN LS™, the lyophilized dosage form of SURFAXIN; and AEROSURF®, an investigative combination drug/device product that is designed to deliver aerosolized

KL4

surfactant noninvasively, and (ii) to register and manufacture SURFAXIN and SURFAXIN LS for use in the Licensed Territory, which includes the People’s Republic of China (“PRC”), Hong Kong, Thailand, Taiwan and

other countries (the “Licensed Territory”). In addition, we granted Lee’s (HK) options to potentially add Japan to the Licensed Territory and to manufacture our ADS in the Licensed Territory, in each case subject to conditions set forth in the License Agreement.

Under the License Agreement, Lee’s (HK) made an upfront payment to us of

million. We also

may

receive up to

$37.5

million in potential clinical, regulatory and commercial milestone payments and will share in any sublicense income Lee’s (HK)

may

receive at a rate equal to low double digits. In addition, Lee’s (HK) will be responsible for all costs and expenses in and for the Licensed Territory related to development activities, including a planned AEROSURF phase

clinical trial, regulatory activities, and commercialization activities.

August 2017,

we entered into a Loan Agreement, pursuant to which Lee’s (HK) agreed to lend us up to

$3.9

million to support our activities through

October 31, 2017,

while we and Lee’s worked to complete a

$10

million securities purchase agreement (Lee’s SPA) pursuant to which Lee’s acquired a controlling interest in our Company effective on

November 1, 2017.

In connection with the Loan Agreement, we amended the License Agreement (Amendment

No.

) to expand certain of Lee’s (HK) rights, by immediately adding Japan to the licensed territory, accelerating the right to manufacture the ADS in and for the licensed territory, reducing or eliminating certain of the milestone and royalty payments and adding an affiliate of Lee’s (HK) as a party to the License Agreement. As a result, the additional amounts for potential clinical, regulatory and commercial milestone payments were reduced to

$35.8

million.

Accounting Analysis under ASC

606

In evaluating the License Agreement in accordance with ASC Topic

606,

we concluded that the contract counterparty, Lee’s (HK), is a customer. We identified the following performance obligations: (i) a bundled performance obligation consisting of licensing rights to develop and commercialize our

KL4

surfactant products and a technology transfer process for the manufacture of SURFAXIN and SURFAXIN LS; and (ii) a technology transfer process for the manufacture of our ADS. We determined that participation in the Joint Steering Committee (and other committees under its authority) and our ongoing product development, regulatory, and commercialization activities under the License Agreement were deemed immaterial in the context of the contract. Consistent with the guidance under ASC

606

16A,

we disregarded immaterial promised goods and services when determining performance obligations.

We concluded that the licensing rights were

not

distinct within the context of the contract (i.e., separately identifiable) because the licensing rights do

not

have stand-alone value from other promised goods and services as Lee’s (HK) could

not

benefit from the licensing rights without the completion of the technology transfer process for the manufacture of SURFAXIN and SURFAXIN LS. The technology transfer process for the manufacture of our ADS is distinct within the context of the contract because it has stand-alone value from other promised goods and services as Lee’s (HK) could benefit from this right on a stand-alone basis. However, we determined that the ADS manufacturing right has a nominal stand-alone selling price at the time of Amendment

No.

as the ADS is

not

yet verified and there is uncertainty with regard to the commercial value of the ADS given that the AEROSURF combination drug/device product is currently in clinical development.

With respect to Amendment

No.

we elected to use the practical expedient for contract modifications that occur prior to the adoption of ASU

2014

09,

and we determined that the impact was immaterial. Allocable arrangement consideration under the practical expedient comprised the upfront payment of

million and

$0.3

million related to reductions in royalties and milestones in connection with Amendment

No.

The

$1.3

million was attributed in its entirety to the bundled performance obligation of licensing rights to develop and commercialize our

KL4

surfactant products and a technology transfer process for the manufacture of SURFAXIN and SURFAXIN LS. Revenue associated with the bundled performance obligation was recognized beginning in

November 2017

with the initiation of the technology transfer process for the manufacture of SURFAXIN and SURFAXIN LS and will be recognized over time as services are performed and based on the input method related to the level of effort expended. The expected completion date for the technology transfer is

June 2019.

clinical trial; our limited experience with successful drug development; our limited experience with clinical trials; our recent failure to achieve primary endpoints in our phase

clinical trial; our limited experience with commercialization; our decision in

2015

to cease manufacturing and commercializing of SURFAXIN; and the fact that the uncertainty about the related consideration is

not

expected to be resolved for a long period of time (

see

, Item

– Risk Factors).

Consideration related to sales-based milestones and royalties will be recognized when the related sales occur, provided that the reported sales are reliably measurable and that we have

remaining performance obligations, as such sales were determined to relate predominantly to the license granted to Lee’s (HK) and therefore have also been excluded from the transaction price. We will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

XML 28 R18.htm IDEA: XBRL DOCUMENT

Note 13 - Subsequent Events

9 Months Ended

Sep. 30, 2018

Notes to Financial Statements

Subsequent Events [Text Block]

Note

–

Subsequent Events

October 19, 2018

and

November 2, 2018,

we entered into Loan Agreements (“Loan Agreements”) with LPH wherein LPH agreed to lend us

$430,000

and

$500,000

(together the “Loans”) to support our operations while we seek to complete a strategic transaction (as defined in the Loan Agreements, the “Strategic Transaction”). The Loans, which were funded on

October 19, 2018

and

November 2, 2018,

each accrue interest at a rate of

per annum and mature upon the earlier of (i) the closing date for the Strategic Transaction, provided that the Company is able to raise a minimum of

$30

million in connection with such transaction, or (ii)

March 31, 2019.

In each case, we granted LPH a security interest in substantially all our assets under the LPH Security Agreement.

XML 29 R19.htm IDEA: XBRL DOCUMENT

Significant Accounting Policies (Policies)

9 Months Ended

Sep. 30, 2018

Accounting Policies [Abstract]

Use of Estimates, Policy [Policy Text Block]

Use of Estimates

Restructured Debt Liability, Contingent Milestone Payment, Policy [Policy Text Block]

Restructured debt liability – contingent milestone payment

In conjunction with the

November 2017

restructuring and retirement of long-term debt (

See,

"– Note

– Restructured debt liability"), we established a

$15

October 27, 2017 (

not

achieved and the liability is written off as a gain on debt restructuring.

Revenue Recognition, Deferred Revenue [Policy Text Block]

Deferred revenue

Deferred revenue represents amounts received prior to satisfying the revenue recognition criteria (

see

, Revenue recognition) and are recognized as deferred revenue in our balance sheet. Amounts expected to be recognized as revenue within the

months following the balance sheet date are classified as Deferred revenue – current portion. Amounts

not

expected to be recognized as revenue within the

months following the balance sheet date are classified as Deferred revenue – non-current portion.

Deferred revenue primarily consists of amounts related to an upfront license fee received in

July 2017

in connection with the License Agreement with Lee’s. The revenue will be recognized as our performance obligations under the contract are met (

see

, Note

– Out-Licensing Agreement).

Revenue Recognition, Multiple-deliverable Arrangements, Description [Policy Text Block]

Revenue recognition

Effective

January 1, 2018,

we adopted Accounting Standards Codification (“ASC”) Topic

606,

Revenue from Contracts with Customers, using the modified retrospective transition method. Under this method, we recognize the cumulative effect of initially adopting ASC Topic

606,

In accordance with ASC Topic

606,

we perform the following

five

steps:

	(i)	identify the contract(s) with a customer;
	(ii)	identify the performance obligations in the contract;

	(iii)	determine the transaction price;
	(iv)	allocate the transaction price to the performance obligations in the contract; and

(v)

recognize revenue when (or as) the entity satisfies a performance obligation.

We only apply the

five

606,

We have concluded that our government grants are

not

within the scope of ASC Topic

606

as they do

not

meet the definition of a contract with a customer. We have concluded that the grants meet the definition of a contribution and are non-reciprocal transactions, and have also concluded that Subtopic

958

605,

Not

-for-Profit-Entities-Revenue Recognition

does

not

apply, as we are a business entity and the grants are with governmental agencies.

In the absence of applicable guidance under US GAAP, effective

January 1, 2018,

we developed a policy for the recognition of grant revenue when the related costs are incurred and the right to payment is realized.

We believe this policy is consistent with the overarching premise in ASC Topic

606,

exchange as defined in ASC Topic

606.

We believe the recognition of revenue as costs are incurred and amounts become realizable is analogous to the concept of transfer of control of a service over time under ASC Topic

606.

Prior to

January 1, 2018,

not

materially different than would have been calculated under the old guidance. As a result of the adoption of this policy, there was

change to the amounts we have historically recorded in our financial statements.

Research and Development Expense, Policy [Policy Text Block]

Research and development

730,

Research and Development

Earnings Per Share, Policy [Policy Text Block]

Net Loss per Common Share

September 30, 2018

and

2017,

the number of shares of common stock potentially issuable upon the conversion of preferred stock or exercise of certain stock options and warrants was

1.3

million and

0.9

million shares, respectively. For the

three

and

nine

months ended

September 30, 2018

and

2017,

all potentially dilutive securities were anti-dilutive and therefore have been excluded from the computation of diluted net loss per share.

Net loss per common share – basic and diluted and weighted average number of common shares outstanding for the

three

and

nine

months ended

September 30, 2017

have been corrected for immaterial calculation errors related to the conversion of preferred stock to common stock during those periods.

We do

not

have any components of other comprehensive income (loss).

Stockholders' Equity Note, Convertible Preferred Stock, Beneficial Conversion Feature, Policy [Policy Text Block]

Beneficial Conversion Feature

Preferred Stock

The issuance of Series A Convertible Preferred Stock (Preferred Shares) in the

first

quarter of

2017

(

see

, “– Note

$3.6

million

one

-time, non-cash deemed dividend to the preferred shareholders during the

first

quarter of

2017.

An additional discount to the Preferred Shares of

$4.5

million was created due to the allocation of proceeds to the Warrants which were issued with the Preferred Shares. This discount is amortized proportionately as the Preferred Shares are converted.

Preferred Shares were converted during the

three

nine

months ended

September 30, 2018.

For the

three

and

nine

months ended

September 30, 2017,

we recognized a non-cash deemed dividend to the preferred shareholders of

$2.2

million and

$6.4

million, respectively, related to the Preferred Shares converted during the periods.

Convertible Note

The issuance on

July 2, 2018

of a Secured Convertible Promissory Note (the Note) to Panacea Venture Management Company Ltd. (Panacea) with respect to a loan facility in the aggregate amount of

$1.5

million less debt discount consisting of (i)

$0.4

million related to the beneficial conversion feature and (ii)

$0.4

million in fair value of the warrants issued in connection with the Note. The discount is being accreted to the

$1.5

million loan over its term using the effective interest method.

Income Tax, Policy [Policy Text Block]

Income taxes

We account for income taxes in accordance with ASC Topic

740,

not

assured.

December 22, 2017,

the U.S. government enacted the

2017

Tax Cuts and Jobs Act (the

2017

Tax Act), which significantly revises U.S. tax law by, among other provisions, lowering the U.S. federal statutory income tax rate to

21%,

imposing a mandatory

one

-time transition tax on previously deferred foreign earnings, and eliminating or reducing certain income tax deductions. As of

December 31, 2017,

we recorded the provisional impact from the

2017

Tax Act in accordance with SAB

118.

As of

September 30, 2018,

we have

not

adjusted any of our provisional amounts that were recorded as of

December 31, 2017.

We will finalize our adjustments during the

fourth

quarter of

2018.

New Accounting Pronouncements, Policy [Policy Text Block]

Recently Adopted Accounting Standards

May 2014,

the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU)

2014

09,

Revenue from Contracts with Customers (Topic

606

)

, which was subsequently amended by several other ASUs related to Topic

606

2014

09,

as amended, effective

January 1, 2018

using the modified retrospective transition method. In

June 2017,

2014

and determined that there was

material impact to revenues for any of the years presented upon adoption. Additionally, there were

– Out-Licensing Agreement.

May 2017,

the FASB issued ASU

2017

09,

Compensation—Stock Compensation (Topic

718

)

Scope of Modification Accounting

December 31, 2018

and interim periods within that annual period. We adopted ASU

2017

effective

January 1, 2018

and the adoption did

not

have a material impact on our unaudited condensed consolidated financial statements and is

not

expected to have a material impact on the annual

2018

financial statements.

August 2016,

the FASB issued ASU

2016

15,

Statement of Cash Flows (Topic

230

), Classification of Certain Cash Receipts and Cash Payments

. This ASU clarifies clarify how entities should classify certain cash receipts and cash payments related to

eight

one

class of cash flows. The ASU is effective retrospectively for the annual period ending

December 31, 2018

and interim periods within that annual period. We adopted ASU

2016

effective

January 1, 2018

and the adoption did

not

have a material impact on our unaudited condensed consolidated financial statements and is

not

expected to have a material impact on the annual

2018

financial statements.

Recent Accounting Pronouncements

February 2016,

the FASB issued ASU

2016

02,

Leases

(Topic

842

). This ASU requires lessees to put most leases on their balance sheets but recognize expenses in the income statement in a manner similar to current accounting standards. The ASU is effective

January 1, 2019.

not

elected to early adopt this standard. We are currently evaluating the effect of ASU

2016

and believe it

may

have a material impact on our consolidated financial statements and related disclosures.

XML 30 R20.htm IDEA: XBRL DOCUMENT

Note 6 - License Revenue with Affiliate (Tables)

9 Months Ended

Sep. 30, 2018

Notes Tables

Disaggregation of Revenue [Table Text Block]

	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2018		2017		2018		2017

License revenue with affiliate	$	159	$	-	$	719	$	-

XML 31 R21.htm IDEA: XBRL DOCUMENT

Note 7 - Fair Value of Financial Instruments (Tables)

9 Months Ended

Sep. 30, 2018

Notes Tables

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

	Fair Value		Fair value measurement using
	September 30,
(in thousands)	2018		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	640	$	640	$	-	$	-
Certificate of deposit		140		140		-		-
Total Assets	$	780	$	780	$	-	$	-

	Fair Value		Fair value measurement using
	December 31,
(in thousands)	2017		Level 1		Level 2		Level 3

Assets:
Cash and cash equivalents	$	1,815	$	1,815	$	-	$	-
Certificate of deposit		225		225		-		-
Total Assets	$	2,040	$	2,040	$	-	$	-

XML 32 R22.htm IDEA: XBRL DOCUMENT

Note 9 - Convertible Note Payable (Tables)

9 Months Ended

Sep. 30, 2018

Notes Tables

Convertible Debt [Table Text Block]

	September 30,
(in thousands)	2018

Convertible note payable	$	1,500
Unamortized discount		(531	)
Convertible note payable, net of discount		969

Convertible Note Interest Expense [Table Text Block]

	September 30,
(in thousands)	2018

Cash interest expense	$	51
Non-cash amortization of debt discounts		302
Total convertible note interest expense		353

Warrant [Member]

Notes Tables

Fair Value Measurement Inputs and Valuation Techniques [Table Text Block]

Significant Input Assumptions of Warrant Valuation
Historical volatility	103	%
Expected term (in years)	5
Risk-free interest rate	2.75	%

XML 33 R23.htm IDEA: XBRL DOCUMENT

Note 10 - Restructured Debt Liability (Tables)

9 Months Ended

Sep. 30, 2018

Notes Tables

Schedule of Long-term Debt Instruments [Table Text Block]

	September 30,		December 31,
(in thousands)	2018		2017

Restructured debt liability - contingent milestone payments	$	15,000	$	15,000

- Definition

Tabular disclosure of long-debt instruments or arrangements, including identification, terms, features, collateral requirements and other information necessary to a fair presentation. These are debt arrangements that originally required repayment more than twelve months after issuance or greater than the normal operating cycle of the entity, if longer.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 210
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.5-02.22)
-URI http://asc.fasb.org/extlink&oid=6877327&loc=d3e13212-122682

Reference 2: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 835
-SubTopic 30
-Section 45
-Paragraph 1A
-URI http://asc.fasb.org/extlink&oid=114775744&loc=d3e28541-108399

Reference 3: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 6
-URI http://asc.fasb.org/extlink&oid=109259400&loc=d3e21506-112644

Reference 4: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08.(e),(f))
-URI http://asc.fasb.org/extlink&oid=26873400&loc=d3e23780-122690

Reference 5: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 835
-SubTopic 30
-Section 45
-Paragraph 2
-URI http://asc.fasb.org/extlink&oid=114775744&loc=d3e28551-108399

Reference 6: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 7
-URI http://asc.fasb.org/extlink&oid=109259400&loc=d3e21521-112644

Reference 7: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 8
-URI http://asc.fasb.org/extlink&oid=109259400&loc=d3e21538-112644

Reference 8: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 470
-Section 50
-Paragraph 3
-URI http://asc.fasb.org/extlink&oid=75038535&loc=d3e64711-112823

Reference 9: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 835
-SubTopic 30
-Section 55
-Paragraph 8
-URI http://asc.fasb.org/extlink&oid=114775985&loc=d3e28878-108400

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 3
-URI http://asc.fasb.org/extlink&oid=109259400&loc=d3e21475-112644

+ Details

XML 34 R24.htm IDEA: XBRL DOCUMENT

Note 11 - Stock Options and Stock-based Employee Compensation (Tables)

9 Months Ended

Sep. 30, 2018

Notes Tables

Disclosure of Share-based Compensation Arrangements by Share-based Payment Award [Table Text Block]

(in thousands, except for weighted-average data) Stock Options	Shares			Weighted- Average Exercise Price		Weighted- Average Remaining Contractual Term (In Yrs)

Outstanding at January 1, 2018		84		$	163.20
Granted		-			-
Forfeited or expired		(1	)		729.80
Outstanding at September 30, 2018		83		$	154.80		7.1

Vested and exercisable at September 30, 2018		66		$	186.00		6.9

Vested and expected to vest at September 30, 2018		82		$	155.20		7.1

Schedule of Nonvested Restricted Stock Units Activity [Table Text Block]

(in thousands, except for weighted-average data)
Restricted Stock Units	Shares		Weighted- Average Grant Date Fair Value

Unvested at January 1, 2018		190	$	4.33
Awarded		-		-
Vested		-		-
Unvested at September 30, 2018		190	$	4.33

Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block]

	Nine Months Ended September 30,
	2017

Weighted average expected volatility		79%
Weighted average expected term (years)		6.6
Weighted average risk-free interest rate		2.22%
Expected dividends		-

Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table Text Block]

	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2018		2017		2018		2017

Research and development	$	29	$	77	$	169	$	360
Selling, general and administrative		116		101		534		372
Total	$	145	$	178	$	703	$	732

XML 35 R25.htm IDEA: XBRL DOCUMENT

Note 2 - Liquidity Risks and Management's Plans (Details Textual) - USD ($)	1 Months Ended		3 Months Ended
	Mar. 31, 2018	Jan. 31, 2018	Nov. 02, 2018	Sep. 30, 2018	Jun. 30, 2018	Dec. 31, 2017
Cash and Cash Equivalents, at Carrying Value, Ending Balance				$ 640,000		$ 1,815,000
Liabilities, Current, Total				18,110,000		11,760,000
Loans Payable, Current, Total				4,300,000
Convertible Notes Payable, Current				$ 969,000
Common Stock, Shares Authorized				120,000,000		120,000,000
Preferred Stock, Shares Authorized				5,000,000		5,000,000
Lee's [Member]
Line of Credit Facility, Maximum Borrowing Capacity					$ 1,000,000
Maximum Amount of Cash Resources to Expend					$ 1,000,000
Letters of Credit Outstanding, Amount			$ 0
Subsequent Event [Member]
Common Stock, Shares Authorized			120,000,000
Preferred Stock, Shares Authorized			5,000,000
Common Stock, Capital Shares Available for Issuance			113,300,000
Preferred Stock, Capital Shares Available for Issuance			5,000,000
LPH [Member]
Proceeds from Issuance of Debt	$ 1,000,000	$ 1,500,000
LPH [Member] \| Subsequent Event [Member]
Proceeds from Issuance of Debt			$ 2,700,000

XML 36 R26.htm IDEA: XBRL DOCUMENT

Note 4 - Summary of Significant Accounting Policies (Details Textual) - USD ($) $ in Thousands, shares in Millions	3 Months Ended			9 Months Ended		12 Months Ended
	Sep. 30, 2018	Sep. 30, 2017	Mar. 31, 2017	Sep. 30, 2018	Sep. 30, 2017	Dec. 31, 2018	Dec. 31, 2017	Nov. 01, 2017
Liability for Contingent Milestone Payment, Noncurrent	$ 15,000			$ 15,000			$ 15,000
Number of Shares of Common Stock Potentially Issuable upon the Exercise of Stock Options and Warrants				1.3	0.9
Preferred Stock Dividends, Income Statement Impact		$ 2,234	$ 3,600		$ 6,370
Preferred Stock, Discount on Shares							4,500
Debt Instrument, Face Amount	1,500			1,500
Scenario, Forecast [Member]
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent						21.00%
Conversion of Preferred Stock [Member]
Preferred Stock Dividends, Income Statement Impact	0			0
Panacea [Member] \| Warrant Issued Related to Secured Convertible Promissory Note [Member]
Warrants and Rights Outstanding	400			400
Panacea [Member] \| Secured Convertible Promissory Note [Member]
Debt Instrument, Face Amount	1,500			1,500
Debt Instrument, Convertible, Beneficial Conversion Feature				400
Deerfield Loan [Member]
Liability for Contingent Milestone Payment, Noncurrent	$ 15,000			$ 15,000			$ 15,000
Deerfield Loan [Member] \| Exchange and Termination Agreement [Member] \| Deerfield Management, L.P. [Member]
Liability for Contingent Milestone Payment, Noncurrent								$ 15,000

XML 37 R27.htm IDEA: XBRL DOCUMENT

Note 5 - Stockholders' Equity (Details Textual) - Private Placement [Member] - LPH II [Member] $ / shares in Units, $ in Millions	Apr. 04, 2018 USD ($) $ / shares shares
Private Placement, Purchase Price of Common Stock and Warrants \| $	$ 2.6
Stock Issued During Period, Shares, New Issues \| shares	541,667
Class of Warrant or Right, Number of Securities Called by Warrants or Rights \| shares	135,417
Class of Warrant or Right, Exercise Price of Warrants or Rights \| $ / shares	$ 5.52
Shares Issued, Price Per Share \| $ / shares	$ 4.80
Class of Warrant or Right, Vesting Period	180 days
Warrants and Rights Outstanding, Term	7 years
Registration Rights Agreement, Rights Percentage	25.00%

XML 38 R28.htm IDEA: XBRL DOCUMENT

Note 6 - License Revenue with Affiliate - Disaggregation of Revenue (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017	Sep. 30, 2018	Sep. 30, 2017
License [Member]
License revenue with affiliate	$ 159		$ 719

XML 39 R29.htm IDEA: XBRL DOCUMENT

Note 7 - Fair Value of Financial Instruments - Assets and Liabilities Measured at Fair Value (Details) - Fair Value, Measurements, Recurring [Member] - USD ($) $ in Thousands	Sep. 30, 2018	Dec. 31, 2017
Assets:
Cash and cash equivalents	$ 640	$ 1,815
Total Assets	780	2,040
Certificates of Deposit [Member]
Assets:
Certificate of deposit	140	225
Fair Value, Inputs, Level 1 [Member]
Assets:
Cash and cash equivalents	640	1,815
Total Assets	780	2,040
Fair Value, Inputs, Level 1 [Member] \| Certificates of Deposit [Member]
Assets:
Certificate of deposit	140	225
Fair Value, Inputs, Level 2 [Member]
Assets:
Cash and cash equivalents
Total Assets
Fair Value, Inputs, Level 2 [Member] \| Certificates of Deposit [Member]
Assets:
Certificate of deposit
Fair Value, Inputs, Level 3 [Member]
Assets:
Cash and cash equivalents
Total Assets
Fair Value, Inputs, Level 3 [Member] \| Certificates of Deposit [Member]
Assets:
Certificate of deposit

XML 40 R30.htm IDEA: XBRL DOCUMENT

Note 8 - Loan Payable (Details Textual) - USD ($)	1 Months Ended
Note 8 - Loan Payable (Details Textual) - USD ($)	Mar. 31, 2018	Jan. 31, 2018	Sep. 30, 2018	Sep. 27, 2018	Sep. 12, 2018	Aug. 29, 2018	Aug. 14, 2018
Debt Instrument, Face Amount			$ 1,500,000
LPH [Member]
Proceeds from Issuance of Debt	$ 1,000,000	$ 1,500,000
Debt Instrument, Interest Rate, Stated Percentage			6.00%
Debt Instrument, Face Amount				$ 500,000	$ 500,000	$ 480,000	$ 300,000
LPH II [Member]
Debt Instrument Requirement For Minimum Amount Rise			$ 30,000,000

XML 41 R31.htm IDEA: XBRL DOCUMENT

Note 9 - Convertible Note Payable (Details Textual) - USD ($)			9 Months Ended
	Jul. 23, 2018	Jul. 02, 2018	Sep. 30, 2018	Sep. 30, 2017
Debt Instrument, Face Amount			$ 1,500,000
Proceeds from Convertible Debt			1,500,000
Panacea [Member] \| Series D Warrants [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights		187,500
Class of Warrant or Right, Exercise Price of Warrants or Rights		$ 4
Class of Warrant or Right, Vesting Period		180 days
Warrants and Rights Outstanding, Term		5 years
Common Stock Maximum Ownership Percentage For Warrant Exercise		9.99%
Panacea [Member] \| Series D Warrants [Member] \| Warrant [Member]
Derivative Liability, Total			400,000
Convertible Notes Payable [Member] \| Panacea [Member]
Debt Instrument, Face Amount		$ 1,500,000
Proceeds from Convertible Debt	$ 500,000	$ 1,000,000
Debt Instrument, Interest Rate, Stated Percentage		15.00%
Debt Instrument, Convertible, Conversion Price		$ 4
Debt Instrument, Convertible, Beneficial Conversion Feature			$ 400,000

XML 42 R32.htm IDEA: XBRL DOCUMENT

Note 9 - Convertible Note Payable -Schedule of Convertible Note Payable (Details) - USD ($) $ in Thousands	Sep. 30, 2018	Dec. 31, 2017
Debt Instrument, Face Amount	$ 1,500
Unamortized discount	(531)
Convertible note payable, net of discount	$ 969

XML 43 R33.htm IDEA: XBRL DOCUMENT

Note 9 - Convertible Note Payable - Significant Input Assumptions of Warrant Valuation (Details)	Sep. 30, 2018
Measurement Input, Price Volatility [Member]
Significant Input Assumption of Warrant Valuation	1.03
Measurement Input, Expected Term [Member]
Significant Input Assumption of Warrant Valuation	5
Measurement Input, Risk Free Interest Rate [Member]
Significant Input Assumption of Warrant Valuation	0.0275

XML 44 R34.htm IDEA: XBRL DOCUMENT

Note 9 - Convertible Note Payable - Convertible Note Interest Expense (Details) - Convertible Notes Payable [Member] $ in Thousands	9 Months Ended
	Sep. 30, 2018 USD ($)
Cash interest expense	$ 51
Non-cash amortization of debt discounts	302
Total convertible note interest expense	$ 353

XML 45 R35.htm IDEA: XBRL DOCUMENT

Note 10 - Restructured Debt Liability (Details Textual) - USD ($) $ / shares in Units, $ in Thousands	Nov. 01, 2017	Sep. 30, 2018	Dec. 31, 2017
Liability for Contingent Milestone Payment, Noncurrent		$ 15,000	$ 15,000
Deerfield Loan [Member]
Liability for Contingent Milestone Payment, Noncurrent		$ 15,000	$ 15,000
Deerfield Loan [Member] \| Exchange and Termination Agreement [Member] \| Deerfield Management, L.P. [Member]
Extinguishment of Debt, Amount	$ 25,000
Class of Warrant or Right, Number of Warrants Cancelled	25,000
Class of Warrant or Right, Exercise Price of Cancelled Warrants	$ 786.80
Repayments of Long-term Debt, Total	$ 2,500
Stock Issued During Period, Shares, Cancellation of Debt and Warrant Obligations	71,111
Stock Issued During Period, Shares, Cancellation of Debt and Warrant Obligations, Percentage of Fully-diluted Shares Outstanding	2.00%
Liability for Contingent Milestone Payment, Noncurrent	$ 15,000

XML 46 R36.htm IDEA: XBRL DOCUMENT

Note 10 - Restructured Debt Liability - Long-term Debt (Details) - USD ($) $ in Thousands	Sep. 30, 2018	Dec. 31, 2017
Restructured debt liability - contingent milestone payments	$ 15,000	$ 15,000
Deerfield Loan [Member]
Restructured debt liability - contingent milestone payments	$ 15,000	$ 15,000

XML 47 R37.htm IDEA: XBRL DOCUMENT

Note 11 - Stock Options and Stock-based Employee Compensation (Details Textual)	9 Months Ended
	Sep. 30, 2018
The 2011 Long-term Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Award Requisite Service Period	3 years

XML 48 R38.htm IDEA: XBRL DOCUMENT

Note 11 - Stock Options and Stock-based Employee Compensation - Summary of Stock Option Activity (Details) shares in Thousands	9 Months Ended
	Sep. 30, 2018 $ / shares shares
Shares Outstanding, Beginning Balance (in shares) \| shares	84
Weighted Average Exercise Price, Outstanding, at Beginning Period (in dollars per share) \| $ / shares	$ 163.20
Shares Granted (in shares) \| shares
Weighted Average Exercise Price, Granted (in dollars per share) \| $ / shares
Shares Forfeited or Expired (in shares) \| shares	(1)
Weighted Average Exercise Price, Forfeited or Expired (in dollars per share) \| $ / shares	$ 729.80
Shares Outstanding, Ending Balance (in shares) \| shares	83
Weighted Average Exercise Price, Outstanding, at Ending Period (in dollars per share) \| $ / shares	$ 154.80
Weighted Average Remaining Contractual Life, Outstanding (Year)	7 years 36 days
Shares Vested and Exercisable (in shares) \| shares	66
Weighted Average Exercise Price, Vested and Exercisable (in dollars per share) \| $ / shares	$ 186
Weighted Average Remaining Contractual Life, Vested and Exercisable (Year)	6 years 328 days
Vested and expected to vest (in shares) \| shares	82
Weighted Average Exercise Price, Vested and Expected to Vest (in dollars per share) \| $ / shares	$ 155.20
Weighted Average Remaining Contractual Life, Vested and Expected to Vest (Year)	7 years 36 days

XML 49 R39.htm IDEA: XBRL DOCUMENT

Note 11 - Stock Options and Stock-based Employee Compensation - Summary of Restricted Stock Units Activity (Details) - Restricted Stock Units (RSUs) [Member] shares in Thousands	9 Months Ended
	Sep. 30, 2018 $ / shares shares
Unvested, Beginning Balance (in shares) \| shares	190
Unvested, Beginning Balance (in dollars per share) \| $ / shares	$ 4.33
Awarded (in shares) \| shares
Awarded (in dollars per share) \| $ / shares
Vested (in shares) \| shares
Vested (in dollars per share) \| $ / shares
Unvested, Ending Balance (in shares) \| shares	190
Unvested, Ending Balance (in dollars per share) \| $ / shares	$ 4.33

XML 50 R40.htm IDEA: XBRL DOCUMENT

Note 11 - Stock Options and Stock-based Employee Compensation - Stock Options Valuation Assumptions (Details)	9 Months Ended
	Sep. 30, 2017
Weighted average expected volatility	79.00%
Weighted average expected term (years) (Year)	6 years 219 days
Weighted average risk-free interest rate	2.22%
Expected dividends

XML 51 R41.htm IDEA: XBRL DOCUMENT

Note 11 - Stock Options and Stock-based Employee Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2018	Sep. 30, 2017	Sep. 30, 2018	Sep. 30, 2017
Stock-based compensation expense	$ 145	$ 178	$ 703	$ 732
Research and Development Expense [Member]
Stock-based compensation expense	29	77	169	360
Selling, General and Administrative Expenses [Member]
Stock-based compensation expense	$ 116	$ 101	$ 534	$ 372

XML 52 R42.htm IDEA: XBRL DOCUMENT

Note 12 - Out-Licensing Agreement (Details Textual) - USD ($) $ in Thousands		1 Months Ended			3 Months Ended	9 Months Ended
	Nov. 01, 2017	Aug. 31, 2017	Jul. 31, 2017	Jun. 30, 2017	Oct. 31, 2017	Sep. 30, 2018	Sep. 30, 2017
Proceeds from Short-term Debt, Total						$ 4,280	$ 2,600
LPH [Member] \| Acquisition of Windtree [Member]
Business Combination, Consideration Transferred, Total	$ 10,000
Maximum [Member] \| Lee's [Member] \| Lee's Loan to Support Operations [Member]
Proceeds from Short-term Debt, Total					$ 3,900
License Agreement With Lee’s [Member]
Proceeds from License Fees Received			$ 1,000	$ 1,000
License Agreement, Contingent Receivable, Maximum		$ 35,800		$ 37,500
Fair Value of Royalties and Milestones Foregone		$ 300
Revenue, Remaining Performance Obligation, Amount						$ 1,300

XML 53 R43.htm IDEA: XBRL DOCUMENT

Note 13 - Subsequent Events (Details Textual) - USD ($)	Nov. 02, 2018	Oct. 19, 2018	Sep. 30, 2018	Sep. 27, 2018	Sep. 12, 2018	Aug. 29, 2018	Aug. 14, 2018
Debt Instrument, Face Amount			$ 1,500,000
Subsequent Event [Member] \| Panacea [Member] \| Secured Convertible Promissory Note [Member]
Debt Instrument, Interest Rate, Stated Percentage		6.00%
LPH [Member]
Debt Instrument, Face Amount				$ 500,000	$ 500,000	$ 480,000	$ 300,000
Debt Instrument, Interest Rate, Stated Percentage			6.00%
LPH [Member] \| Subsequent Event [Member]
Debt Instrument, Face Amount	$ 500,000	$ 430,000
Debt Instrument Requirement For Minimum Amount Rise	$ 30,000,000
LPH [Member] \| Subsequent Event [Member] \| Secured Convertible Promissory Note [Member]
Debt Instrument, Interest Rate, Stated Percentage	6.00%

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