0001144204-19-026070.txt : 20190514 0001144204-19-026070.hdr.sgml : 20190514 20190514171713 ACCESSION NUMBER: 0001144204-19-026070 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 54 CONFORMED PERIOD OF REPORT: 20190331 FILED AS OF DATE: 20190514 DATE AS OF CHANGE: 20190514 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Cyclacel Pharmaceuticals, Inc. CENTRAL INDEX KEY: 0001130166 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 911766850 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-50626 FILM NUMBER: 19823880 BUSINESS ADDRESS: STREET 1: 200 CONNELL DRIVE STREET 2: SUITE 1500 CITY: BERKELEY HEIGHTS STATE: NJ ZIP: 07922 BUSINESS PHONE: 908-517-7330 MAIL ADDRESS: STREET 1: 200 CONNELL DRIVE STREET 2: SUITE 1500 CITY: BERKELEY HEIGHTS STATE: NJ ZIP: 07922 FORMER COMPANY: FORMER CONFORMED NAME: XCYTE THERAPIES INC DATE OF NAME CHANGE: 20001218 10-Q 1 tv521138_10q.htm FORM 10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

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

For the quarterly period ended March 31, 2019

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 000-50626

CYCLACEL PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware		91-1707622
(State or Other Jurisdiction of Incorporation or Organization)		(I.R.S. Employer Identification No.)

200 Connell Drive, Suite 1500

Berkeley Heights, New Jersey

07922

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (908) 517-7330

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 x No ¨

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See 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 x		Smaller reporting filer x
		Emerging growth company ¨

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter):

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 x

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.001 per share	CYCC	The Nasdaq Stock Market LLC
Preferred Stock, $0.001 par value	CYCCP	The Nasdaq Stock Market LLC

As of May 10, 2019 there were 17,199,974 shares of the registrant’s common stock outstanding.

CYCLACEL PHARMACEUTICALS, INC.

INDEX

			Page
Part I.	Financial Information
	Item 1.	Financial Statements (Unaudited)	3
	Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	16
	Item 3.	Quantitative and Qualitative Disclosures About Market Risk	22
	Item 4.	Controls and Procedures	22
Part II.	Other Information
	Item 1.	Legal Proceedings	23
	Item 1A.	Risk Factors	23
	Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	23
	Item 3.	Defaults Upon Senior Securities	23
	Item 4.	Mine Safety Disclosures	23
	Item 5.	Other Information	23
	Item 6.	Exhibits	23

SIGNATURE PAGE			24

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

CYCLACEL PHARMACEUTICALS, INC.

CONSOLIDATED BALANCE SHEETS

(In $000s, except share, per share, and liquidation preference amounts)

(Unaudited)

	December 31,			March 31,
	2018			2019
ASSETS
Current assets:
Cash and cash equivalents	$	17,504		$	17,934
Prepaid expenses and other current assets		2,283			2,190
Total current assets		19,787			20,124

Property and equipment, net		36			33
Right-of-use lease asset		-			1,353
Total assets	$	19,823		$	21,510

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	2,719		$	1,284
Accrued and other current liabilities		1,732			1,203
Total current liabilities		4,451			2,487
Lease liability		-			1,468
Other liabilities		100			-
Total liabilities		4,551			3,955

Stockholders’ equity:
Preferred stock, $0.001 par value; 5,000,000 shares authorized at December 31, 2018 and March 31, 2019; 6% Convertible Exchangeable preferred stock; 335,273 shares issued and outstanding at December 31, 2018 and March 31, 2019. Aggregate preference in liquidation of $4,006,512 as of December 31, 2018 and March 31, 2019.		-			-
Series A convertible preferred stock, $0.001 par value; 264 shares issued and outstanding at December 31, 2018 and March 31, 2019.		-			-
Common stock, $0.001 par value; 100,000,000 shares authorized at December 31, 2018 and March 31, 2019; 12,497,447 and 17,199,974 shares issued and outstanding at December 31, 2018 and March 31, 2019.		12			17
Additional paid-in capital		365,817			369,958
Accumulated other comprehensive loss		(760	)		(781	)
Accumulated deficit		(349,797	)		(351,639	)
Total stockholders’ equity		15,272			17,555
Total liabilities and stockholders’ equity	$	19,823		$	21,510

The accompanying notes are an integral part of these consolidated financial statements.

CYCLACEL PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(In $000s, except share and per share amounts)

(Unaudited)

	Three Months Ended March 31,
	2018			2019
Revenues:

Total revenues	$	—		$	—
Operating expenses:
Research and development		798			1,012
General and administrative		1,364			1,192
Total operating expenses		2,162			2,204
Operating loss		(2,162	)		(2,204	)
Other income (expense):
Foreign exchange (losses)		(4	)		15
Interest income		69			79
Other income, net		566			-
Total other income, net		631			94
Loss before taxes		(1,531	)		(2,110	)
Income tax benefit		182			268
Net loss		(1,349	)		(1,842	)
Dividend on 6% Convertible Exchangeable preferred stock		(50	)		(50	)
Net loss applicable to common stockholders	$	(1,399	)	$	(1,892	)

Basic and diluted earnings per common share:

Net loss per share – basic and diluted	$	(0.12	)	$	(0.14	)
Weighted average common shares outstanding		11,997,447			13,638,271

The accompanying notes are an integral part of these consolidated financial statements.

CYCLACEL PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(In $000s)

(Unaudited)

	Three Months Ended March 31,
	2018			2019
Net loss	$	(1,349	)	$	(1,842	)
Translation adjustment		(6,328	)		(3,897	)
Unrealized foreign exchange gain on intercompany loans		6,276	)		3,876
Comprehensive loss	$	(1,401	)	$	(1,863	)

The accompanying notes are an integral part of these consolidated financial statements.

CYCLACEL PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In thousands, except share amounts)

(Unaudited)

												Accumulated
									Additional			Other						Total
	Preferred Stock				Common Stock				Paid-in			Comprehensive			Accumulated			Stockholders’
	Shares		Amount		Shares		Amount		Capital			Loss			Deficit			Equity
Balances at December 31, 2017		335,537	$	-		11,997,447	$	12	$	365,057		$	(794	)	$	(342,509	)		21,766
Issue of common stock on At Market Issuance sales agreement		-		-		-		-		-			-			-			-
Stock-based compensation		-		-		-		-		81			-			-			81
Preferred stock dividends		-		-		-		-		(50	)		-			-			(50	)
Unrealized foreign exchange on intercompany loans		-		-		-		-		-			6,276			-			6,276
Translation adjustment		-		-		-		-		-			(6,328	)		-			(6,328	)
Loss for the period		-		-		-		-		-			-			(1,349	)		(1,349	)
Balances at March 31, 2018		335,537	$	-		11,997,447	$	12	$	365,088		$	(846	)	$	(343,858	)	$	20,396


Balances at December 31, 2018		335,537	$	-		12,497,447	$	12	$	365,817		$	(760	)	$	(349,797	)		15,272
Issue of common stock on At Market Issuance sales agreement		-		-		4,702,527		5		4,106			-			-			4,111
Stock-based compensation		-		-		-		-		85			-			-			85
Preferred stock dividends		-		-		-		-		(50	)		-			-			(50	)
Unrealized foreign exchange on intercompany loans		-		-		-		-		-			3,876			-			3,876
Translation adjustment		-		-		-		-		-			(3,897	)		-			(3,897	)
Loss for the period		-		-		-		-		-			-			(1,842	)		(1,842	)
Balances at March 31, 2019		335,537	$	-		17,199,974	$	17	$	369,958		$	(781	)	$	(351,639	)	$	17,555

The accompanying notes are an integral part of these consolidated financial statements.

CYCLACEL PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(In $000s)

(Unaudited)

	Three Months Ended March 31,
	2018			2019
Operating activities:
Net loss	$	(1,349	)	$	(1,842	)
Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation		7			6
Stock-based compensation		81			85
Gain on disposal of property and equipment		—			(29	)
Changes in operating assets and liabilities:
Prepaid expenses and other assets		(876	)		(1,215	)
Accounts payable and other current liabilities		(2	)		(689	)
Net cash used in operating activities		(2,139	)		(3,684	)

Investing activities:
Purchase of property, plant and equipment		(22	)		(2	)
Proceeds from sale of property and equipment		—			29
Net cash used in investing activities		(22	)		27

Financing activities:
Proceeds from issuance of common stock, net of issuance costs		—			4,106
Payment of preferred stock dividend		(50	)		(50	)
Net cash provided by / (used in) financing activities		(50	)		4,056
Effect of exchange rate changes on cash and cash equivalents		26			31
Net decrease in cash and cash equivalents		(2,185	)		430
Cash and cash equivalents, beginning of period		23,910			17,504
Cash and cash equivalents, end of period	$	21,725		$	17,934

Supplemental cash flow information:
Cash received during the period for:
Interest	$	69		$	79
Taxes		—			—

Non cash financing activities:
Accrual of preferred stock dividends		50			50

The accompanying notes are an integral part of these consolidated financial statements.

CYCLACEL PHARMACEUTICALS, INC.

NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

Company Overview

Nature of Operations

Cyclacel Pharmaceuticals, Inc. (“Cyclacel” or “the Company”), is a clinical-stage biopharmaceutical company using its expertise in cell cycle, transcriptional regulation and DNA damage response biology to develop innovative, targeted medicines for cancer and other serious diseases. Cyclacel is a pioneer company in the field of cell cycle biology with a vision to improve patient healthcare by translating insights in cancer biology into medicines.

As of March 31, 2019, substantially all efforts of the Company to date have been devoted to performing research and development, conducting clinical trials, developing and acquiring intellectual property, raising capital and recruiting and training personnel.

Summary of Significant Accounting Policies

Basis of Presentation

The consolidated balance sheet as of March 31, 2019, the consolidated statements of operations, comprehensive loss, stockholders’ equity and cash flows for the three months ended March 31, 2019 and 2018, and all related disclosures contained in the accompanying notes are unaudited. The consolidated balance sheet as of December 31, 2018 is derived from the audited consolidated financial statements included in the Annual Report on Form 10-K for the fiscal year ended December 31, 2018 filed with the Securities and Exchange Commission (“SEC”). The consolidated financial statements are presented on the basis of accounting principles that are generally accepted in the United States (“GAAP”) for interim financial information and in accordance with the rules and regulations of the SEC. Accordingly, they do not include all the information and footnotes required by accounting principles generally accepted in the United States for a complete set of financial statements. In the opinion of management, all adjustments, which include only normal recurring adjustments necessary to present fairly the consolidated balance sheet as of March 31, 2019, and the results of operations, comprehensive loss and cash flows for the three months ended March 31, 2019, have been made. The interim results for the three months ended March 31, 2019 are not necessarily indicative of the results to be expected for the year ending December 31, 2019 or for any other year. The consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the accompanying notes for the year ended December 31, 2018 that are included in the Company’s Annual Report on Form 10-K filed with the SEC.

Going Concern

Management considers that there are no conditions or events, in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern for a period of at least one year from the date the financial statements are issued. The Company expects that its cash of $17.9 million as of March 31, 2019 will be sufficient to fund its operating expenses and capital expenditure requirements through the end of 2020.

This evaluation is based on relevant conditions and events that are known and reasonably knowable at the date that the financial statements are issued, including:

The Company’s current financial condition, including its sources of liquidity;

The Company’s conditional and unconditional obligations due or anticipated within one year;

The funds necessary to maintain the Company’s operations considering its current financial condition, obligations, and other expected cash flows; and

Other conditions and events, when considered in conjunction with the above that may adversely affect the Company’s ability to meet its obligations.

The future viability of the Company beyond the end of 2020 is dependent on its ability to raise additional capital to finance its operations. The Company does not currently have sufficient funds to complete development and commercialization of any of its drug candidates. Additional funding may not be available to the Company on favorable terms, or at all. If the Company is not able to secure additional funding when needed, it may have to delay, reduce the scope of or eliminate one or more of its clinical trials or research and development programs or make changes to its operating plan. In addition, it may have to partner one or more of its product candidate programs at an earlier stage of development, which would lower the economic value of those programs to the Company. The Company’s inability to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies.

Accounting standards adopted in the period

On January 1, 2019, the Company adopted the guidance on accounting for leases (“ASC 842”) in Accounting Standards Update No, 2016-02, Leases as amended by subsequent updates issued in 2018 and 2019. The guidance requires that lessees recognize both a lease liability, which is a lessee’s obligation to make lease payments arising from a lease measured on a discounted basis, and a right-of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term at the commencement date.

The Company has elected the package of practical expedients permitted in ASC 842. Accordingly, the Company accounted for its existing operating leases as operating leases under the new guidance, without reassessing (a) whether the contracts contain a lease under ASC 842, (b) whether classification of the operating leases would be different in accordance with ASC 842, or (c) whether any unamortized initial direct costs would have met the definition of initial direct costs in ASC 842 at lease commencement. In addition, the Company has elected an accounting policy to not allocate payments made under the lease agreement between lease and non-lease components.

The Company transitioned to the new guidance at the adoption date by recognizing a lease liability of $1.5 million for the present value of the remaining minimum rental payments, as defined under prior accounting rules, and a corresponding right-of-use asset. In addition, the Company reclassified an existing deferred rent obligation of $120,000 created under prior accounting rules against the opening right-of-use asset. Because the Company adopted the new leasing guidance on a cumulative catch-up basis effective January 1, 2019, the Company has not recast prior period financial statements for the effects of this new standard. Accordingly, the Company’s financial condition as of December 31, 2018 and March 31, 2019 may not be comparable.

Recently Issued Accounting Pronouncements

In August 2018, the FASB issued ASU 2018-15, "Customer's Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement that is a Service Contract." ASU 2018-15 requires implementation costs incurred by customers in cloud computing arrangements to be deferred over the non-cancellable term of the cloud computing arrangements plus any optional renewal periods (1) that are reasonably certain to be exercised by the customer or (2) for which exercise of the renewal option is controlled by the cloud service provider. The effective date of this pronouncement is for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years, and early adoption is permitted. The standard can be adopted either using the prospective or retrospective transition approach. The Company is currently evaluating the impact of this pronouncement on the Company's consolidated financial statements and disclosures.

Fair Value of Financial Instruments

Financial instruments consist of cash equivalents, accounts payable and accrued liabilities. The carrying amounts of cash equivalents, accounts payable and accrued liabilities approximate their respective fair values due to the nature of the accounts, notably their short maturities.

Comprehensive Income (Loss)

All components of comprehensive income (loss), including net income (loss), are reported in the financial statements in the period in which they are recognized. Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net income (loss) and other comprehensive income (loss), including foreign currency translation adjustments, are reported, net of any related tax effect, to arrive at comprehensive income (loss). No taxes were recorded on items of other comprehensive income (loss). There were no reclassifications out of other comprehensive income (loss) during the three months ended March 31, 2018 and 2019.

Revenue recognition

With effect from January 1, 2018, the Company recognizes revenue using the five step-model provided in ASC 606, Revenue from Contracts with Customers (“ASC 606”):

(1)

identify the contract with a customer;

(2)

identify the performance obligations in the contract;

(3)

determine the transaction price;

(4)

allocate the transaction price to the performance obligations in the contract; and

(5)

recognize revenue when, or as, the Company satisfies a performance obligation.

The transaction price includes fixed payments and an estimate of variable consideration, including milestone payments. The Company determines the variable consideration to be included in the transaction price by estimating the most likely amount that will be received and then applies a constraint to reduce the consideration to the amount which is probable of being received. When applying the constraint, the Company considers:

Whether achievement of a development milestone is highly susceptible to factors outside the entity’s influence, such as milestones involving the judgment or actions of third parties, including regulatory bodies;

Whether the uncertainty about the achievement of the milestone is not expected to be resolved for a long period of time;

Whether the Company can reasonably predict that a milestone will be achieved based on previous experience; and.

The complexity and inherent uncertainty underlying the achievement of the milestone.

The transaction price is allocated to each performance obligation based on the relative selling price of each performance obligation. The best estimate of the selling price is determined after considering all reasonably available information, including market data and conditions, entity-specific factors such as the cost structure of the deliverable and internal profit and pricing objectives.

The revenue allocated to each performance obligation is recognized as or when the Company satisfies the performance obligation.

The Company recognizes a contract asset, when the value of satisfied (or part satisfied) performance obligations is in excess of the payment due to the Company, and deferred revenue when the amount of unconditional consideration is in excess of the value of satisfied (or part satisfied) performance obligations. Once a right to receive consideration is unconditional, that amount is presented as a receivable.

With effect from January 1, 2018, grant revenue, if new grants are obtained, will be presented as a reduction against the related research and development expenses.

Leases

Effective from January 1, 2019, the Company accounts for lease contracts in accordance with ASC 842. As of March 31, 2019, all of the Company’s leases are classified as operating.

The Company recognizes an asset for the right to use an underlying leased asset for the lease term and records lease liabilities based on the present value of the Company’s obligation to make lease payments under the lease. As the Company’s leases do not indicate an implicit rate, the Company uses a best estimate of its incremental borrowing rate to discount the future lease payments. The Company estimates its incremental borrowing rate based on observable information about risk-free interest rates for that are the same tenure as the lease term, adjusted for various factors including the effects of assumed collateral, the nature of how the risk-free loan is repaid (e.g., amortizing versus bullet), and the Company’s credit risk.

The Company evaluates options included in its lease agreements to extend or terminate the lease. The Company will reflect the effects of exercising those options in the lease term when it is reasonably certain that the Company will exercise that option. In assessing whether it is reasonably certain that the Company will exercise an option, the Company considers factors such as:

The lease payments due in any optional period

Penalties for failure to exercise (or not exercise) the option

Market factors, such as the availability of similar assets and current rental rates for such assets

The nature of the underlying leased asset and its importance to the Company’s operations

The remaining useful lives of any related leasehold improvements

Lease expense for lease payments is recognized on a straight-line basis over the lease term. Variable lease payments, if any, are recognized in the period when the obligation to make those payments is incurred. Lease incentives received prior to lease commencement are recorded as a reduction in the right-of-use asset. Fixed lease incentives received after lease commencement reduce both the lease liability and the right-of-use asset.

The Company has elected an accounting policy to account for the lease and non-lease components as a single lease component.

Revenue

Revenue recognized in the three months ended March 31, 2018 and 2019 was $nil.

The aggregate transaction price that is allocated to performance obligations that are unsatisfied (or partially unsatisfied) as of March 31, 2019 was $nil.

Net Loss per Common Share

The Company calculates net loss per common share in accordance with ASC 260 “Earnings Per Share” (“ASC 260”). Basic and diluted net loss per common share was determined by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during the period.

The following potentially dilutive securities have not been included in the computation of diluted net loss per share for the three months ended March 31, 2018 and 2019, as the result would be anti-dilutive:

	March 31, 2018		March 31, 2019
Stock options		708,400		2,249,142
Convertible preferred stock		1,698		1,698
Series A preferred stock		132,000		132,000
Common stock warrants		7,490,500		7,490,500
Total shares excluded from calculation		8,332,598		9,873,340

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following (in $000s):

	December 31,		March 31,
	2018		2019
Research and development tax credit receivable	$	1,148	$	1,441
Prepayments and VAT receivable		899		677
Other current assets		236		72
	$	2,283	$	2,190

Accrued and Other Liabilities

Accrued and other current liabilities consisted of the following (in $000s):

	December 31,		March 31,
	2018		2019
Accrued research and development	$	1,110	$	804
Accrued legal and professional fees		259		228
Other current liabilities		363		171
	$	1,732	$	1,203

Leases

The Company has a single lease related to its facility in Dundee, Scotland.

As of and for the three months ended March 31, 2019

The Company recognized operating lease expense of $79,663. Cash payments made during the three months ended March 31, 2019 totaled $164,185, and were presented as cash outflows from operating activities. The remaining lease term is approximately 6.5 years as of March 31, 2019. The discount rate used by the Company in determining the lease liability was 12%.

Remaining lease payments under the lease are:

2019	$	246,348
2020		328,464
2021		328,464
2022		328,464
2023		328,464
Thereafter		574,813
	$	2,135,017

As of and for the twelve months ended December 31, 2018

Prior to January 1, 2019, the Company accounted for its Dundee facility lease under ASC 840, Leases. Rent expense, which includes lease payments related to the Company’s research and development facilities and corporate headquarters and other rent related expenses was $0.5 and $0.4 million for each of the years ended December 31, 2017 and 2018, respectively.

The following is a summary of the Company’s future contractual obligations and commitments relating to its facilities leases as at December 31, 2018 (in thousands):

	Operating Lease Obligation
2019	$	321
2020		321
2021		321
2022		321
2023		321
thereafter		581
Total future minimum lease obligations	$	2,186

Stock Based Compensation

ASC 718 requires compensation expense associated with share-based awards to be recognized over the requisite service period, which for the Company is the period between the grant date and the date the award vests or becomes exercisable. Most of the awards granted by the Company (and still outstanding) vest ratably over one to four years. The Company recognizes all share-based awards under the straight-line attribution method, assuming that all granted awards will vest. Forfeitures are recognized in the periods when they occur.

Stock based compensation has been reported within expense line items on the consolidated statement of operations for the three months ended March 31, 2018 and 2019 as shown in the following table (in $000s):

	Three Months Ended March 31,
	2018		2019
General and administrative	$	59	$	54
Research and development		22		31
Stock-based compensation costs before income taxes	$	81	$	85

2018 Plan

In May 2018, the Company’s stockholders approved the 2018 Equity Incentive Plan (the “2018 Plan”), under which Cyclacel may make equity incentive grants to its officers, employees, directors and consultants. The 2018 Plan replaces the 2015 Equity Incentive Plan (the “2015 Plan”).

The 2018 Plan allows for the issuance of up to 1,500,000 shares of the Company’s common stock pursuant to various types of award grants, including stock options and restricted stock units. In addition, the 2018 Plan allows up to 709,889 additional shares to be issued if awards outstanding under the 2018 Plan are cancelled or expire on or after the date of the Company’s 2018 annual meeting of stockholders.

As of March 31, 2019, the Company has reserved 245,208 shares of the Company’s common stock under the 2018 Plan, including shares that were available under the 2015 Plan and carried forward to the 2018 Plan. Stock option awards granted under the Company’s equity incentive plans have a maximum life of 10 years and generally vest over a one to four-year period from the date of grant.

There were 1,419,020 options granted during the three months ended March 31, 2019. These options had a grant date fair value ranging between $0.57-$0.61 per option.

There were 306,304 options granted during the year ended December 31, 2018. These options had grant date fair values ranging between $1.17-$1.29 per option. Of these options, approximately 174,272 are performance based and will vest upon the fulfillment of certain clinical objectives. The Company determined that the satisfaction of one criterion, the commencement of the HEM study by December 31, 2018, occurred as of December 31, 2018, but that the other vesting criteria related to these awards were not probable as of December 31, 2018. As such, the Company recognized compensation cost for these grants under the expectation that 25% of these awards (the portion associated with the HEM study) will vest.

There were no stock options exercised during each of the three months ended March 31, 2018 and 2019, respectively. The Company does not expect to be able to benefit from the deduction for stock option exercises that may occur because the company has tax loss carryforwards from prior periods that would be expected to offset any potential taxable income.

Outstanding Options

A summary of the share option activity and related information is as follows:

	Number of Options Outstanding			Weighted Average Exercise Price Per Share		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value ($000)
Options outstanding at December 31, 2018		831,611		$	6.68		8.13	$	—
Granted		1,419,020		$	0.72
Cancelled/forfeited		(1,488	)	$	33.60
Options outstanding at March 31, 2019		2,249,143		$	2.90		9.09	$	312
Unvested at March 31, 2019		(1,914,016	)	$	1.28		9.36	$	17
Vested and exercisable at March 31, 2019		335,127		$	12.20		7.58	$	295

The fair value of the stock options granted is calculated using the Black-Scholes option-pricing model as prescribed by ASC 718 using the following assumptions:

	Year ended December 31, 2018			Quarter ended March 31, 2019
Expected term (years)		6			5-6
Risk free interest rate		2.730% – 2.855	%		2.490% – 2.610	%
Volatility		105% – 107	%		103% – 110	%
Expected dividend yield over expected term		0.00	%		0.00	%
Resulting weighted average grant date fair value	$	1.25		$	0.58

Stockholders Equity

October 2018 At Market Issuance

On October 4, 2018, the Company entered into a Common Stock Sales Agreement, or the Sales Agreement, with H.C. Wainwright & Co., LLC, or Wainwright, as sales agent, pursuant to which Wainwright may sell shares of common stock, par value $0.001 per share, having an aggregate offering price of up to $5,000,000, by any method that is deemed to be an “at the market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended. Shares sold under the Sales Agreement were offered and sold pursuant to the Company’s previously filed and effective Registration Statement on Form S-3 and a prospectus supplement and accompanying base prospectus. The Company paid Wainwright a commission of 3.0% of the gross sales price per share sold. During the fourth quarter of 2018, the Company sold 500,000 shares under the Sales Agreement for gross proceeds of approximately $0.7 million. The Sales Agreement was concluded during the first quarter of 2019, during which the Company sold a further 4,702,527 shares for gross proceeds of approximately $4.3 million. Aggregate net proceeds to the Company were approximately $4.7 million, after deducting commissions and other expenses.

July 2017 Underwritten Public Offering

On July 21, 2017, the Company issued (i) 3,154,000 Class A Units for $2 per unit, each consisting of one share of the Company’s common stock, and a warrant to purchase one share of common stock (the “Class A Warrants”), and (ii) 8,872 Class B Units, each consisting of one share of the Company’s Series A Convertible Preferred Stock, par value $0.001 per share (the “Series A Preferred Stock”), convertible into 500 shares of Common Stock at the initial conversion price, and a warrant to purchase a number of shares of common stock equal to $1,000.00 divided by the conversion price (the “Class B Warrants”) for $1,000 per unit. The net proceeds to the Company after the underwriters’ exercise in full of the over-allotment option were approximately $13.7 million, after deducting underwriting discounts, commissions and other estimated offering expenses. The Class A Units and Class B Units have no stand-alone rights and the shares of common stock, Series A Preferred Stock and the Class A and Class B Warrants comprising those units were immediately separable.

The common stock, Class A Warrants and Class B Warrants (together the “Warrants”) and Series A Preferred Stock are freestanding financial instruments. The Warrants are classified within equity in the consolidated balance sheet and are not remeasured on a recurring basis. The Series A Preferred Stock is classified within equity in the consolidated balance sheet.

Warrants

As of March 31, 2019, there were 7,490,500 warrants outstanding, each with an exercise price of $2.00. All such warrants were issued in connection with the July 2017 Underwritten Public Offering and are immediately exercisable. The warrants expire in 2024. Subject to limited exceptions, a holder of warrants will not have the right to exercise any portion of its warrants if the holder (together with such holder’s affiliates, and any persons acting as a group together with such holder or any of such holder’s affiliates) would beneficially own a number of shares of common stock in excess of 4.99% (or, at the election of the purchaser, 9.99%) of the shares of our Common Stock then outstanding after giving effect to such exercise.

The exercise price and the number of shares issuable upon exercise of the warrants is subject to appropriate adjustment in the event of recapitalization events, stock dividends, stock splits, stock combinations, reclassifications, reorganizations or similar events affecting the Company’s common stock. The warrant holders must pay the exercise price in cash upon exercise of the warrants, unless such warrant holders are utilizing the cashless exercise provision of the warrants. On the expiration date, unexercised warrants will automatically be exercised via the “cashless” exercise provision.

Prior to the exercise of any warrants to purchase common stock, holders of the warrants will not have any of the rights of holders of the common stock purchasable upon exercise, including the right to vote, except as set forth therein.

There was no exercise of warrants during the three months ended March 31, 2019.

Series A Preferred Stock

8,872 shares of the Company’s Series A Preferred Stock were issued in the July 2017 Underwritten Public Offering. During the year ended December 31, 2017, 8,608 shares of the Series A Preferred Stock were converted into 4,304,000 shares of common stock. As of March 31, 2019, 264 shares of the Series A Preferred Stock remain issued and outstanding.

Each share of Series A Preferred Stock is convertible at any time at the option of the holder thereof, into a number of shares of common stock determined by dividing $1,000 by the initial conversion price of $2.00 per share, subject to a 4.99% blocker provision, or, upon election by a holder prior to the issuance of shares of Series A Preferred Stock, 9.99%, and is subject to adjustment for stock splits, stock dividends, distributions, subdivisions and combinations. The 264 shares of Series A Preferred Stock issued and outstanding at March 31, 2019, are convertible into 132,000 shares of common stock.

In the event of a liquidation, the holders of shares of the Series A Preferred Stock may participate on an as-converted-to-common-stock basis in any distribution of assets of the Company. The Company shall not pay any dividends on shares of common stock (other than dividends in the form of common stock) unless and until such time as dividends on each share of Series A Preferred Stock are paid on an as-converted basis. There is no restriction on the Company’s ability to repurchase shares of Series A Preferred Stock while there is any arrearage in the payment of dividends on such shares, and there are no sinking fund provisions applicable to the Series A Preferred Stock.

Subject to certain conditions, at any time following the issuance of the Series A Preferred Stock, the Company has the right to cause each holder of the Series A Preferred Stock to convert all or part of such holder’s Series A Preferred Stock in the event that (i) the volume weighted average price of our common stock for 30 consecutive trading days (the “Measurement Period”) exceeds 300% of the initial conversion price of the Series A Preferred Stock (subject to adjustment for forward and reverse stock splits, recapitalizations, stock dividends and similar transactions), (ii) the daily trading volume on each Trading Day during such Measurement Period exceeds $500,000 per trading day and (iii) the holder is not in possession of any information that constitutes or might constitute, material non-public information which was provided by the Company. The right to cause each holder of the Series A Preferred Stock to convert all or part of such holder’s Series A Preferred Stock shall be exercised ratably among the holders of the then outstanding preferred stock.

The Series A Preferred Stock has no maturity date, will carry the same dividend rights as the common stock, and with certain exceptions contains no voting rights. In the event of any liquidation or dissolution of the Company, the Series A Preferred Stock ranks senior to the common stock in the distribution of assets, to the extent legally available for distribution.

6% Convertible Exchangeable Preferred Stock

As of March 31, 2019, there were 335,273 shares of the Company’s 6% Convertible Exchangeable Preferred Stock (“6% Preferred Stock”) issued and outstanding at an issue price of $10.00 per share. Dividends on the 6% Preferred Stock are cumulative from the date of original issuance at the annual rate of 6% of the liquidation preference of the 6% Preferred Stock, payable quarterly on the first day of February, May, August and November, commencing February 1, 2005. Any dividends must be declared by the Company’s Board and must come from funds that are legally available for dividend payments. The 6% Preferred Stock has a liquidation preference of $10.00 per share, plus accrued and unpaid dividends.

The Company may automatically convert the 6% Preferred Stock into common stock if the per share closing price of the Company’s common stock has exceeded $2,961, which is 150% of the conversion price of the 6% Preferred Stock, for at least 20 trading days during any 30-day trading period, ending within five trading days prior to notice of automatic conversion.

The 6% Preferred Stock has no maturity date and no voting rights prior to conversion into common stock, except under limited circumstances.

The Company may, at its option, redeem the 6% Preferred Stock in whole or in part, out of funds legally available at the redemption price of $10.00 per share.

The 6% Preferred Stock is exchangeable, in whole but not in part, at the option of the Company on any dividend payment date beginning on November 1, 2005 (the “Exchange Date”) for the Company’s 6% Convertible Subordinated Debentures (“Debentures”) at the rate of $10.00 principal amount of Debentures for each share of 6% Preferred Stock. The Debentures, if issued, will mature 25 years after the Exchange Date and have terms substantially similar to those of the 6% Preferred Stock. No such exchanges have taken place to date.

10.

Subsequent Events

On March 7, 2019, the Board of Directors declared a quarterly cash dividend in the amount of $0.15 per share on the Company’s 6% Convertible Exchangeable Preferred Stock. The cash dividend was paid on May 1, 2019 to the holders of record of the 6% Convertible Exchangeable Preferred Stock as of the close of business on April 15, 2019.

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

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q, including, without limitation, Management’s Discussion and Analysis of Financial Condition and Results of Operations, contains “forward-looking statements” within the meaning of Section 27A of the Securities Exchange Act of 1933 as amended and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). We intend that the forward-looking statements be covered by the safe harbor for forward-looking statements in the Exchange Act. The forward-looking information is based on various factors and was derived using numerous assumptions. All statements, other than statements of historical fact, that address activities, events or developments that we intend, expect, project, believe or anticipate will or may occur in the future are forward-looking statements. Such statements are based upon certain assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements are usually accompanied by words such as “believe,” “anticipate,” “plan,” “seek,” “expect,” “intend” and similar expressions.

Forward-looking statements necessarily involve risks and uncertainties, and our actual results could differ materially from those anticipated in the forward looking statements due to a number of factors, including those set forth in Part I, Item 1A, entitled “Risk Factors,” of our Annual Report on Form 10-K for the year ended December 31, 2018, as updated and supplemented by Part II, Item 1A, entitled “Risk Factors,” of our Quarterly Reports on Form 10-Q, and elsewhere in this report. These factors as well as other cautionary statements made in this Quarterly Report on Form 10-Q, should be read and understood as being applicable to all related forward-looking statements wherever they appear herein. The forward-looking statements contained in this Quarterly Report on Form 10-Q represent our judgment as of the date hereof. We encourage you to read those descriptions carefully. We caution you not to place undue reliance on the forward-looking statements contained in this report. These statements, like all statements in this report, speak only as of the date of this report (unless an earlier date is indicated) and we undertake no obligation to update or revise the statements except as required by law. Such forward-looking statements are not guarantees of future performance and actual results will likely differ, perhaps materially, from those suggested by such forward-looking statements. In this report, “Cyclacel,” the “Company,” “we,” “us,” and “our” refer to Cyclacel Pharmaceuticals, Inc.

Overview

Through the first quarter of 2019, our primary focus has been on our transcriptional regulation program where we are evaluating CYC065, our cyclin dependent kinase, or CDK, inhibitor and our DNA damage response, or DDR, program where we are evaluating sapacitabine in combination with our CDK inhibitor seliciclib in Phase 1/2 studies in patients with solid tumors. Additionally in our SEAMLESS study of sapacitabine in Acute Myeloid Leukemia, or AML, stratified and exploratory subgroup analyses have been completed and have defined a patient population who may benefit from treatment with the experimental arm. We have begun discussing the SEAMLESS data with certain regulatory authorities.

Transcriptional Regulation Program

CDKs are a family of enzymes first discovered as regulators of the cell cycle, but that are now understood to also provide pivotal functions in the regulation of transcription, DNA repair and metastatic spread. The precise selectivity of an individual CDK inhibitor molecule for certain specific CDKs is key to targeting particular tumor types and minimizing undesirable side effects through non-specific antiproliferative activity.

In general, cell cycle regulation is less well controlled in cancer cells than in normal cells, which explains in part why cancer cells divide uncontrollably. Different CDKs are responsible for control of different aspects of proliferation, and when dysregulated, can be drivers of particular cancer sub-sets. Modulating CDK activity with targeted therapies is an attractive strategy to reinforce cell cycle control and decrease the rate of abnormal proliferation of cancer cells. The FDA approval of CDK inhibitors, palbociclib, ribociclib and abemaciclib, for a type of breast cancer, has led to great interest in the development of this class of drugs as oncology therapeutics.

Cyclacel’s founding scientist, Professor Sir David Lane, is a globally recognized authority in cell cycle biology, who discovered p53, a key tumor suppressor that malfunctions in about two-thirds of human cancers. Under his guidance, Cyclacel’s drug discovery and development programs concentrated on the CDK2/9 isoforms, which operate as key components of the p53 pathway. These efforts resulted in bringing two molecules into clinical trials: seliciclib, a first-generation CDK inhibitor, and CYC065, a second-generation CDK inhibitor, which has benefited from the Company’s clinical experience with seliciclib.

CYC065 has been evaluated in a first-in-human, Phase 1 trial in patients with advanced solid tumors and a recommended Phase 2 dose established. The study demonstrated that CYC065 durably suppresses Mcl-1, a member of the Bcl-2 family of survival proteins. CYC065 is under investigation in combination with other anticancer drugs, including Bcl-2 inhibitors such as venetoclax. Preclinical data suggests that CYC065 may benefit adults and children with hematological malignancies, including acute myeloid leukemias (AML), acute lymphocytic leukemias (ALL), and in particular leukemias with rearrangement of the Mixed Lineage Leukemia gene (MLL-r), chronic lymphocytic leukemias (CLL), B-cell lymphomas, multiple myelomas, and patients with certain solid tumors, including breast and uterine cancers, and neuroblastomas.

DNA Damage Response, or DDR, Program

Many cancers have defects in the way in which cells monitor and repair damaged DNA, collectively termed DNA damage response, or DDR. These deficiencies in DDR pathways render cells more susceptible to DNA damage. Many traditional cancer treatments, such as DNA-damaging chemotherapy and radiotherapy, are based on this finding. However, such treatments are often accompanied by significant and unwanted side effects. Developing treatments which target specific DDR deficiencies to preferentially kill cancer cells, while minimizing the impact on normal cells, has potential for more selective, better tolerated therapies to improve survival in multiple cancers.

We have focused on developing treatments targeting DNA damage pathways for several years. For example, sapacitabine is an oral nucleoside analogue prodrug whose metabolite, CNDAC, generates single-strand DNA breaks, or SSB, either leading to arrest of the cell cycle at G2 phase or development of double-strand DNA breaks, or DSB. Repair of CNDAC-induced DSB is dependent on the homologous recombination, or HR repair pathway. BRCA mutations in cancer cells are a cause of HR deficiency, making such cancer cells more susceptible to cell death induced by sapacitabine.

We are evaluating sapacitabine in a Phase 1/2 combination study with seliciclib in patients with BRCA mutations. A Phase 1b/2 investigator-sponsored clinical trial is underway to evaluate the safety and effectiveness of sapacitabine in combination with olaparib in patients with BRCA mutant breast cancer. The trial is being conducted at the Dana-Farber Cancer Institute with collaborators Cyclacel and AstraZeneca providing sapacitabine investigational drug and the approved PARP-inhibitor olaparib, respectively.

CYC140

CYC140 is a novel, small molecule, selective polo-like-kinase 1 (PLK1) inhibitor which is open for enrollment in a FIH study in patients with advanced leukemias and MDS. CYC140 is differentiated from previous clinical PLK1 inhibitors, demonstrating potent and selective target inhibition and high activity in xenograft models of human cancers when dosed orally at non-toxic doses and is the subject of a translational biology program focused on acute leukemias and esophageal cancer.

MD Anderson Clinical Collaboration

On October 1, 2018, the Company entered into a three-year Clinical Collaboration Agreement, or CCA with The University of Texas MD Anderson Cancer Center, or MD Anderson. The main objective of the CCA is to clinically evaluate the safety and efficacy of three Cyclacel medicines in patients with hematological malignancies, including chronic lymphocytic leukemias, acute myeloid leukemias, myelodysplastic syndromes and other advanced leukemias. Under the terms of the CCA, MD Anderson will conduct four clinical studies with a total projected enrollment of up to 170 patients. Under the risk-sharing agreement MD Anderson will assume the patient costs for all studies and Cyclacel, who is the sponsor, will provide investigational drugs and other limited support. Upon first commercial sale in specific indications studied in the alliance, Cyclacel will make certain payments to MD Anderson.

Cyclacel currently retains virtually all marketing rights worldwide to the compounds associated with the Company’s drug programs.

Results of Operations

Three Months Ended March 31, 2018 and 2019

Results of Continuing Operations

Revenues

Revenues for the three months ended March 31, 2018 and 2019 were $nil and $nil.

The future

Recognition of any further revenue from milestones under a collaboration, licensing and supply agreement with ManRos Therapeutics SA is dependent on the clinical progress of the program, which we do not control.

Research and development expenses

From our inception, we have focused on drug discovery and development programs, with a particular emphasis on orally-available anticancer agents, and our research and development expenses have represented costs incurred to discover and develop novel small molecule therapeutics, including clinical trial costs for sapacitabine, seliciclib, and sapacitabine in combination with seliciclib. We have also incurred costs in the advancement of product candidates toward clinical and pre-clinical trials and the development of in-house research to advance our biomarker program and technology platforms. We expense all research and development costs as they are incurred. Research and development expenses primarily include:

Clinical trial and regulatory-related costs;

Payroll and personnel-related expenses, including consultants and contract research organizations;

Preclinical studies and laboratory supplies and materials;

Technology license costs;

Stock-based compensation; and

Rent and facility expenses for our laboratories.

The following table provides information with respect to our research and development expenditures for the three months ended March 31, 2018 and 2019 (in $000s except percentages):

	Three Months Ended March 31,				Difference
	2018		2019		$			%
Transcriptional Regulation	$	470	$	620	$	150			32
DNA Damage Response		37		31		(6	)		(16	)
Sapacitabine		141		102		(39	)		(28	)
Other research and development programs and expenses		150		259		109			73
Total research and development expenses	$	798	$	1,012	$	214			27

Total research and development expenses represented 37% and 46% of our operating expenses for the three months ended March 31, 2018 and 2019, respectively.

Research and development expenditures increased by $0.2 million from $0.8 million for the three months ended March 31, 2018 to $1.0 million for the three months ended March 31, 2019. The increase was primarily as a result of expenditures relating to transcriptional regulation as the clinical evaluation of CYC065 progresses

The future

We anticipate that overall research and development expenditures for the year ended December 31, 2019 will increase compared to the year ended December 31, 2018, as we progress the clinical development of CYC065. The timing and extent of any future SEAMLESS expenditure, including the possibility of registration submissions to regulatory authorities in Europe and the U.S., are dependent upon the outcome of discussions with regulatory authorities.

General and administrative expenses

General and administrative expenses include costs for administrative personnel, legal and other professional expenses and general corporate expenses. The following table summarizes the general and administrative expenses for the three months ended March 31, 2018 and 2019 (in $000s except percentages):

	Three Months Ended March 31,				Difference
	2018		2019		$			%
Total general and administrative expenses	$	1,364	$	1,192	$	(172	)		(13	)

Total general and administration expenses represented 63% and 54% of our operating expenses for the three months ended March 31, 2018 and 2019, respectively. General and administrative expenses expenditures decreased by $0.2 million from $1.4 million for the three months ended March 31, 2018 to $1.2 million for the three months ended March 31, 2019 due to reduced professional and consultancy costs.

The future

We expect general and administrative expenditures for the year ended December 31, 2019 to decrease as compared to our expenditures for the year ended December 31, 2018 due to reduced recruitment and professional consultancy costs.

Other income (expense), net

The following table summarizes other income (expense) for the three months ended March 31, 2018 and 2019 (in $000 except percentages):

	Three Months Ended March 31,					Difference
	2018			2019		$			%
Foreign exchange gains/(losses)	$	(4	)	$	15	$	19			475
Interest income		69			79		10			14
Other income, net		566			-		(566	)		(100	)
Total other income	$	631		$	94	$	(537	)		(85	)

Total other income decreased by approximately $0.5 million, from $0.6 million for the three months ended March 31, 2018 to $0.1 million for the three months ended March 31, 2019. The decrease in other income is primarily related to lower royalties receivable under a December 2005 Asset Purchase Agreement, or APA, whereby Xcyte Therapies, Inc., or Xcyte (a business acquired by the Company in March 2006) sold certain assets and intellectual property to ThermoFisher Scientific Company, or TSC (formerly Invitrogen Corporation) through an APA and other related agreements. The assets and technology were not part of the Company’s product development plan following the transaction between Xcyte and Cyclacel in March 2006. Accordingly, the company recognized $566,000 and $0 of other income arising from sales related to this transaction during the three months ended March 31,2018 and 2019, respectively. We have no knowledge of TSC’s activities and cannot predict when we may receive income under the APA, if any.

Foreign exchange gains/(losses)

Foreign exchange gains increased by approximately $19,000, from a loss of $4,000 for the three months ended March 31, 2018, to a gain of $15,000 for the three months ended March 31, 2019.

The future

Other income (expense), net for the year ended December 31, 2019 will continue to be impacted by changes in foreign exchange rates and the receipt of income under the APA. As we are not in control of sales made by LTC we are unable to estimate the level and timing of income under the APA, if any.

Because the nature of funding advanced through intercompany loans is that of a long-term investment in nature, unrealized foreign exchange gains and losses on such funding will be recognized in other comprehensive income until repayment of the intercompany loan becomes foreseeable.

Income tax benefit

Credit is taken for research and development tax credits, which are claimed from the United Kingdom’s revenue and customs authority, or HMRC, in respect of qualifying research and development costs incurred.

The following table summarizes total income tax benefit for the three months ended March 31, 2018 and 2019 (in $000s except percentages):

	Three Months Ended March 31,				Difference
	2018		2019		$		%
Total income tax benefit	$	182	$	268	$	86		47

The total income tax benefit, which comprised of research and development tax credits recoverable, increased by $0.1 million from an income tax benefit of $0.2 million for the three months ended March 31, 2018 to an income tax benefit of $0.3 million for the three months ended March 31, 2019. The level of tax credits recoverable is linked directly to qualifying research and development expenditure incurred in any one year and the availability of trading losses.

The future

We expect to continue to be eligible to receive United Kingdom research and development tax credits for the foreseeable future and will elect to do so. The amount of tax credits we will receive is entirely dependent on the amount of eligible expenses we incur and having sufficient trading losses. We expect our qualifying research and development expenditure to increase for the year ended December 31, 2019 in comparison to the year ended December 31, 2018.

Liquidity and Capital Resources

The following is a summary of our key liquidity measures as of March 31, 2018 and 2019 (in thousands):

	March 31,
	2018			2019
Cash and cash equivalents	$	21,725		$	17,934
Working capital:
Current assets		24,732			20,124
Current liabilities		(4,258	)		(2,487	)
Total working capital	$	20,474		$	17,637

Since our inception, we have relied primarily on the proceeds from sales of common and preferred equity securities to finance our operations and internal growth. Additional funding has come through research and development tax credits, government grants, the sale of product rights, interest on investments, licensing revenue, and a limited amount of product revenue from operations discontinued in September 2012. We have incurred significant losses since our inception. As of March 31, 2019, we had an accumulated deficit of $ 351.6 million.

Cash Flows

Cash used in operating, investing and financing activities for the three months ended March 31, 2018 and 2019 is summarized as follows (in thousands):

	Three months ended March 31,
	2018			2019
Net cash used in operating activities	$	(2,139	)	$	(3,684	)
Net cash used in investing activities		(22	)		27
Net cash provided by (used in) financing activities		(50	)		4,056

Operating activities

Net cash used in operating activities increased by $1.6 million, from $2.1 million for the three months ended March 31, 2018 to $ 3.7 million for the three months ended March 31, 2019. The increase in cash used by operating activities was primarily the result of a change in working capital of $1.0 million and an increase in net loss of $0.5 million.

Financing activities

Net cash provided by financing activities increased by $4.1 million, for the three months ended March 31, 2019 as a direct result of receiving approximately $4.1 million in net proceeds from the issuance of common stock under the Sales Agreement with H C Wainright, offset by a $50,000 preferred dividend payment.

Operating Capital and Capital Expenditure Requirements

We expect to continue to incur substantial operating losses in the future and cannot guarantee that we will generate any significant product revenues until a product candidate has been approved by the FDA or EMA in other countries and successfully commercialized.

We believe that existing funds together with cash generated from operations, such as the R&D tax credit, and recent financing activities, are sufficient to satisfy our planned working capital, capital expenditures and other financial commitments through to the end of 2020. However, we do not currently have sufficient funds to complete development and commercialization of any of our drug candidates. Current business and capital market risks could have a detrimental effect on the availability of sources of funding and our ability to access them in the future, which may delay or impede our progress of advancing our drugs currently in the clinical pipeline to approval by the FDA or EMA for commercialization. Additionally, we plan to continue to evaluate in-licensing and acquisition opportunities to gain access to new drugs or drug targets that would fit with our strategy. Any such transaction would likely increase our funding needs in the future.

Our future funding requirements will depend on many factors, including but not limited to:

the rate of progress and cost of our clinical trials, preclinical studies and other discovery and research and development activities;

the costs associated with establishing manufacturing and commercialization capabilities;

the costs of acquiring or investing in businesses, product candidates and technologies;

the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;

the costs and timing of seeking and obtaining FDA and EMA approvals;

the effect of competing technological and market developments; and

the economic and other terms and timing of any collaboration, licensing or other arrangements into which we may enter.

Until we can generate a sufficient amount of product revenue to finance our cash requirements, which we may never do, we expect to finance future cash needs primarily through public or private equity offerings, debt financings or strategic collaborations. Although we are not reliant on institutional credit finance and therefore not subject to debt covenant compliance requirements or potential withdrawal of credit by banks, we are reliant on the availability of funds and activity in equity markets. We do not know whether additional funding will be available on acceptable terms, or at all. If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of or eliminate one or more of our clinical trials or research and development programs or make changes to our operating plan. In addition, we may have to partner one or more of our product candidate programs at an earlier stage of development, which would lower the economic value of those programs to us.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

As a smaller reporting company, we are not required to provide information in response to this item.

Item 4. Controls and Procedures

Under the supervision and with the participation of our management, including our chief executive officer and principal financial and accounting officer, we conducted an evaluation of the effectiveness, as of March 31, 2019, of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act. Based upon such evaluation, our chief executive officer and principal financial and accounting officer have concluded that, as of March 31, 2019, our disclosure controls and procedures were effective to provide reasonable assurance that the information we are required to disclose in our filings with the Securities and Exchange Commission, or SEC, under the Exchange Act (i) is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (ii) accumulated and communicated to our management, including our chief executive officer and principal financial and accounting officer, as appropriate to allow timely decisions regarding required disclosure.

Changes in Internal Control over Financial Reporting

Beginning January 1, 2019, we implemented ASU 2016-02, Leases (Topic 842). There were no significant changes made in our internal controls over financial reporting as a result of the implementation.

Inherent Limitation on the Effectiveness of Internal Controls

The effectiveness of any system of internal control over financial reporting, including ours, is subject to inherent limitations, including the exercise of judgment in designing, implementing, operating, and evaluating the controls and procedures, and the inability to eliminate misconduct completely. Accordingly, any system of internal control over financial reporting, including ours, no matter how well designed and operated, can only provide reasonable, not absolute, assurances. In addition, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. We intend to continue to monitor and upgrade our internal controls as necessary or appropriate for our business, but cannot assure you that such improvements will be sufficient to provide us with effective internal control over financial reporting.

PART II. Other Information

Item 1. Legal Proceedings

None.

Item 1A. Risk Factors

There have been no material changes to our risk factors contained in our Annual Report on Form 10-K for the year ended December 31, 2018. For a further discussion of our Risk Factors, refer to Part I, Item 1A, “Risk Factors,” of our Annual Report on Form 10-K for the year ended December 31, 2018.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

None.

Item 3. Defaults upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

None.

Item 6. Exhibits

Exhibit Number		Description
10.1		Employment Agreement between Cyclacel Pharmaceuticals, Inc. and Spiro Rombotis (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on January 7, 2019).
10.2		Employment Agreement between Cyclacel Pharmaceuticals, Inc. and Paul McBarron (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the SEC on January 7, 2019).
31.1*		Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rule 13a-14(a) As Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*		Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rule 13a-14(a) As Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1*		Certification of Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2*		Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101*		The following materials from Cyclacel Pharmaceuticals, Inc.’s Quarterly Report on Form 10-Q for the period ended March 31, 2019, formatted in XBRL (Extensible Business Reporting Language): (i) the Consolidated Statements of Income, (ii) the Consolidated Balance Sheets, (iii) the Consolidated Statements of Cash Flows, and (iv) Notes to Consolidated Financial Statements.

Filed herewith.

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) 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.

		CYCLACEL PHARMACEUTICALS, INC.

Date: May 14, 2019	By:	/s/ Paul McBarron
		Paul McBarron
		Chief Operating Officer, Chief Financial Officer and
		Executive Vice President, Finance

EX-31.1 2 tv521138_ex31-1.htm EXHIBIT 31.1

EXHIBIT 31.1

Certification of Principal Executive Officer
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Spiro Rombotis, certify that:

I have reviewed this Quarterly Report on Form 10-Q for the three months ended March 31, 2019 of Cyclacel Pharmaceuticals, Inc.;

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;

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 registrant as of, and for, the periods presented in this report;

The registrant’s other certifying officer and I are 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 registrant and have:

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 registrant, 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;

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;

evaluated the effectiveness of the registrant’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

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

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

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 registrant’s ability to record, process, summarize and report financial information; and

any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 14, 2019

/s/ Spiro Rombotis
Spiro Rombotis
President & Chief Executive Officer
(Principal Executive Officer)

EX-31.2 3 tv521138_ex31-2.htm EXHIBIT 31.2

EXHIBIT 31.2

Certification of Principal Financial Officer
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Paul McBarron, certify that:

I have reviewed this Quarterly Report on Form 10-Q for the three months ended March 31, 2019 of Cyclacel Pharmaceuticals, Inc.;

any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 14, 2019

/s/ Paul McBarron
Paul McBarron
Chief Operating Officer, Chief Financial Officer
and Executive Vice President, Finance
(Principal Financial Officer)

EX-32.1 4 tv521138_ex32-1.htm EXHIBIT 32.1

EXHIBIT 32.1

Certification of Principal Executive Officer
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

Pursuant to 18 U.S.C. s 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of Cyclacel Pharmaceuticals, Inc. ( the “Company”) hereby certifies, to such officer’s knowledge, that:

(i)

the Quarterly Report on Form10-Q of the Company for the three months ended March 31, 2019 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

(ii)

the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: May 14, 2019	/s/ Spiro Rombotis
	Spiro Rombotis
	President & Chief Executive Officer

EX-32.2 5 tv521138_ex32-2.htm EXHIBIT 32.2

EXHIBIT 32.2

Certification of Principal Financial Officer

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

(i)

(ii)

the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: May 14, 2019	/s/ Paul McBarron
	Paul McBarron
	Chief Operating Officer, Chief Financial Officer
	and Executive Vice President, Finance

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<table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0in;"></td> <td style="text-align: left; width: 0.5in;"><b>2.</b></td> <td style="text-align: justify;"><b>Summary of Significant Accounting Policies</b></td> </tr> </table> <p style="widows: 2; text-transform: none; text-indent: 20.15pt; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i> </i></b></p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.25in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Basis of Presentation</i></b></p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.25in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The consolidated balance sheet as of March 31, 2019, the consolidated statements of operations, comprehensive loss, stockholders’ equity and cash flows for the three months ended March 31, 2019 and 2018, and all related disclosures contained in the accompanying notes are unaudited. The consolidated balance sheet as of December 31, 2018 is derived from the audited consolidated financial statements included in the Annual Report on Form 10-K for the fiscal year ended December 31, 2018 filed with the Securities and Exchange Commission (“SEC”). The consolidated financial statements are presented on the basis of accounting principles that are generally accepted in the United States (“GAAP”) for interim financial information and in accordance with the rules and regulations of the SEC. Accordingly, they do not include all the information and footnotes required by accounting principles generally accepted in the United States for a complete set of financial statements. In the opinion of management, all adjustments, which include only normal recurring adjustments necessary to present fairly the consolidated balance sheet as of March 31, 2019, and the results of operations, comprehensive loss and cash flows for the three months ended March 31, 2019, have been made. The interim results for the three months ended March 31, 2019 are not necessarily indicative of the results to be expected for the year ending December 31, 2019 or for any other year. The consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the accompanying notes for the year ended December 31, 2018 that are included in the Company’s Annual Report on Form 10-K filed with the SEC.</p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.25in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.25in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Going Concern</i></b></p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.25in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i> </i></b></p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">Management considers that there are no conditions or events, in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern for a period of at least one year from the date the financial statements are issued. The Company expects that its cash of $17.9 million as of March 31, 2019 will be sufficient to fund its operating expenses and capital expenditure requirements through the end of 2020.</p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">This evaluation is based on relevant conditions and events that are known and reasonably knowable at the date that the financial statements are issued, including:</p> <p style="widows: 2; text-transform: none; text-indent: 0.5in; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;">a.</td> <td style="text-align: left;">The Company’s current financial condition, including its sources of liquidity;</td> </tr> </table> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;">b.</td> <td style="text-align: left;">The Company’s conditional and unconditional obligations due or anticipated within one year;</td> </tr> </table> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="width: 0.25in;">c.</td> <td style="text-align: left;">The funds necessary to maintain the Company’s operations considering its current financial condition, obligations, and other expected cash flows; and</td> </tr> </table> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="width: 0.25in;">d.</td> <td style="text-align: left;">Other conditions and events, when considered in conjunction with the above that may adversely affect the Company’s ability to meet its obligations.</td> </tr> </table> <p style="widows: 2; text-transform: none; text-indent: 0.5in; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The future viability of the Company beyond the end of 2020 is dependent on its ability to raise additional capital to finance its operations. The Company does not currently have sufficient funds to complete development and commercialization of any of its drug candidates. Additional funding may not be available to the Company on favorable terms, or at all. If the Company is not able to secure additional funding when needed, it may have to delay, reduce the scope of or eliminate one or more of its clinical trials or research and development programs or make changes to its operating plan. In addition, it may have to partner one or more of its product candidate programs at an earlier stage of development, which would lower the economic value of those programs to the Company. The Company’s inability to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies.</p> <p style="widows: 2; text-transform: none; text-indent: 20pt; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">  </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; margin-left: 0.25in; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Accounting standards adopted in the period</i></b></p> <p style="widows: 2; text-transform: none; text-indent: 20.15pt; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i> </i></b></p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">On January 1, 2019, the Company adopted the guidance on accounting for leases (“ASC 842”) in Accounting Standards Update No, 2016-02, <i>Leases</i> as amended by subsequent updates issued in 2018 and 2019. The guidance requires that lessees recognize both a lease liability, which is a lessee’s obligation to make lease payments arising from a lease measured on a discounted basis, and a right-of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term at the commencement date.</p> <p style="widows: 2; text-transform: none; text-indent: 0.5in; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company has elected the package of practical expedients permitted in ASC 842. Accordingly, the Company accounted for its existing operating leases as operating leases under the new guidance, without reassessing (a) whether the contracts contain a lease under ASC 842, (b) whether classification of the operating leases would be different in accordance with ASC 842, or (c) whether any unamortized initial direct costs would have met the definition of initial direct costs in ASC 842 at lease commencement. In addition, the Company has elected an accounting policy to not allocate payments made under the lease agreement between lease and non-lease components.</p> <p style="widows: 2; text-transform: none; text-indent: 0.5in; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company transitioned to the new guidance at the adoption date by recognizing a lease liability of $1.5 million for the present value of the remaining minimum rental payments, as defined under prior accounting rules, and a corresponding right-of-use asset. In addition, the Company reclassified an existing deferred rent obligation of $120,000 created under prior accounting rules against the opening right-of-use asset. Because the Company adopted the new leasing guidance on a cumulative catch-up basis effective January 1, 2019, the Company has not recast prior period financial statements for the effects of this new standard. Accordingly, the Company’s financial condition as of December 31, 2018 and March 31, 2019 may not be comparable.</p> <p style="widows: 2; text-transform: none; text-indent: 0.5in; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; margin-left: 0.25in; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Recently Issued Accounting Pronouncements</i></b></p> <p style="widows: 2; text-transform: none; text-indent: 20.15pt; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i> </i></b></p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">In August 2018, the FASB issued ASU 2018-15, "Customer's Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement that is a Service Contract." ASU 2018-15 requires implementation costs incurred by customers in cloud computing arrangements to be deferred over the non-cancellable term of the cloud computing arrangements plus any optional renewal periods (1) that are reasonably certain to be exercised by the customer or (2) for which exercise of the renewal option is controlled by the cloud service provider. The effective date of this pronouncement is for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years, and early adoption is permitted. The standard can be adopted either using the prospective or retrospective transition approach. The Company is currently evaluating the impact of this pronouncement on the Company's consolidated financial statements and disclosures.</p> <p style="widows: 2; text-transform: none; text-indent: 20.15pt; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i> </i></b></p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; margin-left: 0.25in; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Fair Value of Financial Instruments</i></b></p> <p style="widows: 2; text-transform: none; text-indent: 20.15pt; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i> </i></b></p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">Financial instruments consist of cash equivalents, accounts payable and accrued liabilities. The carrying amounts of cash equivalents, accounts payable and accrued liabilities approximate their respective fair values due to the nature of the accounts, notably their short maturities.</p> <p style="widows: 2; text-transform: none; text-indent: 20.15pt; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; margin-left: 0.25in; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Comprehensive Income (Loss)</i></b></p> <p style="widows: 2; text-transform: none; text-indent: 20.15pt; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">All components of comprehensive income (loss), including net income (loss), are reported in the financial statements in the period in which they are recognized. Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net income (loss) and other comprehensive income (loss), including foreign currency translation adjustments, are reported, net of any related tax effect, to arrive at comprehensive income (loss). No taxes were recorded on items of other comprehensive income (loss). There were no reclassifications out of other comprehensive income (loss) during the three months ended March 31, 2018 and 2019.</p> <p style="widows: 2; text-transform: none; background-color: white; text-indent: 20.15pt; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; margin-left: 0.25in; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Revenue recognition</i></b></p> <p style="widows: 2; text-transform: none; background-color: white; text-indent: 20pt; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">With effect from January 1, 2018, the Company recognizes revenue using the five step-model provided in ASC 606, <i>Revenue from Contracts with Customers </i>(“ASC 606”):</p> <p style="widows: 2; text-transform: none; background-color: white; text-indent: 20.15pt; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;">(1)</td> <td style="text-align: left;">identify the contract with a customer;</td> </tr> </table> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;">(2)</td> <td style="text-align: left;">identify the performance obligations in the contract;</td> </tr> </table> <p style="widows: 2; text-transform: none; background-color: white; text-indent: 0.5in; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"></p> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;">(3)</td> <td style="text-align: left;">determine the transaction price;</td> </tr> </table> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;">(4)</td> <td style="text-align: left;">allocate the transaction price to the performance obligations in the contract; and</td> </tr> </table> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;">(5)</td> <td style="text-align: left;">recognize revenue when, or as, the Company satisfies a performance obligation.</td> </tr> </table> <p style="widows: 2; text-transform: none; background-color: white; text-indent: 20.15pt; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">  </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The transaction price includes fixed payments and an estimate of variable consideration, including milestone payments. The Company determines the variable consideration to be included in the transaction price by estimating the most likely amount that will be received and then applies a constraint to reduce the consideration to the amount which is probable of being received. When applying the constraint, the Company considers:</p> <p style="widows: 2; text-transform: none; text-indent: 28.35pt; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;"><font style="font-family: symbol;">·</font></td> <td style="text-align: left;">Whether achievement of a development milestone is highly susceptible to factors outside the entity’s influence, such as milestones involving the judgment or actions of third parties, including regulatory bodies;</td> </tr> </table> <p style="widows: 2; text-transform: none; text-indent: 20.15pt; margin: 0pt 0px 0pt 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"></p> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;"><font style="font-family: symbol;">·</font></td> <td style="text-align: left;">Whether the uncertainty about the achievement of the milestone is not expected to be resolved for a long period of time;</td> </tr> </table> <p style="widows: 2; text-transform: none; text-indent: 20.15pt; margin: 0pt 0px 0pt 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"></p> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;"><font style="font-family: symbol;">·</font></td> <td style="text-align: left;">Whether the Company can reasonably predict that a milestone will be achieved based on previous experience; and.</td> </tr> </table> <p style="widows: 2; text-transform: none; text-indent: 20.15pt; margin: 0pt 0px 0pt 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"></p> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;"><font style="font-family: symbol;">·</font></td> <td style="text-align: left;">The complexity and inherent uncertainty underlying the achievement of the milestone.</td> </tr> </table> <p style="text-align: left; widows: 2; text-transform: none; background-color: white; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The transaction price is allocated to each performance obligation based on the relative selling price of each performance obligation. The best estimate of the selling price is determined after considering all reasonably available information, including market data and conditions, entity-specific factors such as the cost structure of the deliverable and internal profit and pricing objectives.</p> <p style="text-align: left; widows: 2; text-transform: none; background-color: white; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The revenue allocated to each performance obligation is recognized as or when the Company satisfies the performance obligation.</p> <p style="text-align: left; widows: 2; text-transform: none; background-color: white; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company recognizes a contract asset, when the value of satisfied (or part satisfied) performance obligations is in excess of the payment due to the Company, and deferred revenue when the amount of unconditional consideration is in excess of the value of satisfied (or part satisfied) performance obligations. Once a right to receive consideration is unconditional, that amount is presented as a receivable.</p> <p style="text-align: left; widows: 2; text-transform: none; background-color: white; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; background-color: white; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">With effect from January 1, 2018, grant revenue, if new grants are obtained, will be presented as a reduction against the related research and development expenses.</p> <p style="widows: 2; text-transform: none; background-color: white; text-indent: 0in; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; margin-left: 0.25in; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Leases</i></b></p> <p style="widows: 2; text-transform: none; text-indent: 20.15pt; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">Effective from January 1, 2019, the Company accounts for lease contracts in accordance with ASC 842. As of March 31, 2019, all of the Company’s leases are classified as operating.</p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company recognizes an asset for the right to use an underlying leased asset for the lease term and records lease liabilities based on the present value of the Company’s obligation to make lease payments under the lease. As the Company’s leases do not indicate an implicit rate, the Company uses a best estimate of its incremental borrowing rate to discount the future lease payments. The Company estimates its incremental borrowing rate based on observable information about risk-free interest rates for that are the same tenure as the lease term, adjusted for various factors including the effects of assumed collateral, the nature of how the risk-free loan is repaid (e.g., amortizing versus bullet), and the Company’s credit risk.</p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company evaluates options included in its lease agreements to extend or terminate the lease. The Company will reflect the effects of exercising those options in the lease term when it is reasonably certain that the Company will exercise that option. In assessing whether it is reasonably certain that the Company will exercise an option, the Company considers factors such as:</p> <p style="widows: 2; text-transform: none; text-indent: 20.15pt; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;"><font style="font-family: symbol;">·</font></td> <td style="text-align: left;">The lease payments due in any optional period</td> </tr> </table> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;"><font style="font-family: symbol;">·</font></td> <td style="text-align: left;">Penalties for failure to exercise (or not exercise) the option</td> </tr> </table> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;"><font style="font-family: symbol;">·</font></td> <td style="text-align: left;">Market factors, such as the availability of similar assets and current rental rates for such assets</td> </tr> </table> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;"><font style="font-family: symbol;">·</font></td> <td style="text-align: left;">The nature of the underlying leased asset and its importance to the Company’s operations</td> </tr> </table> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;"><font style="font-family: symbol;">·</font></td> <td style="text-align: left;">The remaining useful lives of any related leasehold improvements</td> </tr> </table> <p style="widows: 2; text-transform: none; text-indent: 20.15pt; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">Lease expense for lease payments is recognized on a straight-line basis over the lease term. Variable lease payments, if any, are recognized in the period when the obligation to make those payments is incurred. Lease incentives received prior to lease commencement are recorded as a reduction in the right-of-use asset. Fixed lease incentives received after lease commencement reduce both the lease liability and the right-of-use asset.</p> <p style="widows: 2; text-transform: none; text-indent: 20.15pt; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">  </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company has elected an accounting policy to account for the lease and non-lease components as a single lease component.</p>

<table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 1364px; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0in;"></td> <td style="text-align: left; width: 0.5in;"><b>10.</b></td> <td style="text-align: justify;"><b>Subsequent Events</b></td> </tr> </table> <p style="widows: 2; text-transform: none; text-indent: 20.15pt; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i> </i></b></p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">On March 7, 2019, the Board of Directors declared a quarterly cash dividend in the amount of $0.15 per share on the Company’s 6% Convertible Exchangeable Preferred Stock. The cash dividend was paid on May 1, 2019 to the holders of record of the 6% Convertible Exchangeable Preferred Stock as of the close of business on April 15, 2019.</p>

<p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.25in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Going Concern</i></b></p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.25in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i> </i></b></p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">Management considers that there are no conditions or events, in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern for a period of at least one year from the date the financial statements are issued. The Company expects that its cash of $17.9 million as of March 31, 2019 will be sufficient to fund its operating expenses and capital expenditure requirements through the end of 2020.</p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">This evaluation is based on relevant conditions and events that are known and reasonably knowable at the date that the financial statements are issued, including:</p> <p style="widows: 2; text-transform: none; text-indent: 0.5in; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;">a.</td> <td style="text-align: left;">The Company’s current financial condition, including its sources of liquidity;</td> </tr> </table> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;">b.</td> <td style="text-align: left;">The Company’s conditional and unconditional obligations due or anticipated within one year;</td> </tr> </table> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="width: 0.25in;">c.</td> <td style="text-align: left;">The funds necessary to maintain the Company’s operations considering its current financial condition, obligations, and other expected cash flows; and</td> </tr> </table> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="width: 0.25in;">d.</td> <td style="text-align: left;">Other conditions and events, when considered in conjunction with the above that may adversely affect the Company’s ability to meet its obligations.</td> </tr> </table> <p style="widows: 2; text-transform: none; text-indent: 0.5in; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The future viability of the Company beyond the end of 2020 is dependent on its ability to raise additional capital to finance its operations. The Company does not currently have sufficient funds to complete development and commercialization of any of its drug candidates. Additional funding may not be available to the Company on favorable terms, or at all. If the Company is not able to secure additional funding when needed, it may have to delay, reduce the scope of or eliminate one or more of its clinical trials or research and development programs or make changes to its operating plan. In addition, it may have to partner one or more of its product candidate programs at an earlier stage of development, which would lower the economic value of those programs to the Company. The Company’s inability to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies.</p>

<p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; margin-left: 0.25in; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"><b><i>Revenue recognition</i></b></p> <p style="widows: 2; text-transform: none; text-indent: 20pt; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">With effect from January 1, 2018, the Company recognizes revenue using the five step-model provided in ASC 606, <i>Revenue from Contracts with Customers </i>(“ASC 606”):</p> <p style="widows: 2; text-transform: none; text-indent: 20.15pt; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;">(1)</td> <td style="text-align: left;">identify the contract with a customer;</td> </tr> </table> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;">(2)</td> <td style="text-align: left;">identify the performance obligations in the contract;</td> </tr> </table> <p style="widows: 2; text-transform: none; text-indent: 0.5in; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"></p> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;">(3)</td> <td style="text-align: left;">determine the transaction price;</td> </tr> </table> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;">(4)</td> <td style="text-align: left;">allocate the transaction price to the performance obligations in the contract; and</td> </tr> </table> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;">(5)</td> <td style="text-align: left;">recognize revenue when, or as, the Company satisfies a performance obligation.</td> </tr> </table> <p style="widows: 2; text-transform: none; text-indent: 20.15pt; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">  </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The transaction price includes fixed payments and an estimate of variable consideration, including milestone payments. The Company determines the variable consideration to be included in the transaction price by estimating the most likely amount that will be received and then applies a constraint to reduce the consideration to the amount which is probable of being received. When applying the constraint, the Company considers:</p> <p style="widows: 2; text-transform: none; text-indent: 28.35pt; margin: 0pt 0px; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;"><font style="font-family: symbol;">·</font></td> <td style="text-align: left;">Whether achievement of a development milestone is highly susceptible to factors outside the entity’s influence, such as milestones involving the judgment or actions of third parties, including regulatory bodies;</td> </tr> </table> <p style="widows: 2; text-transform: none; text-indent: 20.15pt; margin: 0pt 0px 0pt 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"></p> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;"><font style="font-family: symbol;">·</font></td> <td style="text-align: left;">Whether the uncertainty about the achievement of the milestone is not expected to be resolved for a long period of time;</td> </tr> </table> <p style="widows: 2; text-transform: none; text-indent: 20.15pt; margin: 0pt 0px 0pt 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"></p> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;"><font style="font-family: symbol;">·</font></td> <td style="text-align: left;">Whether the Company can reasonably predict that a milestone will be achieved based on previous experience; and.</td> </tr> </table> <p style="widows: 2; text-transform: none; text-indent: 20.15pt; margin: 0pt 0px 0pt 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"></p> <table style="widows: 2; text-transform: none; margin-top: 0px; text-indent: 0px; width: 100%; font: 10pt 'times new roman', times, serif; orphans: 2; margin-bottom: 0px; letter-spacing: normal; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="text-align: justify; vertical-align: top;"> <td style="width: 0.5in;"></td> <td style="text-align: left; width: 0.25in;"><font style="font-family: symbol;">·</font></td> <td style="text-align: left;">The complexity and inherent uncertainty underlying the achievement of the milestone.</td> </tr> </table> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The transaction price is allocated to each performance obligation based on the relative selling price of each performance obligation. The best estimate of the selling price is determined after considering all reasonably available information, including market data and conditions, entity-specific factors such as the cost structure of the deliverable and internal profit and pricing objectives.</p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The revenue allocated to each performance obligation is recognized as or when the Company satisfies the performance obligation.</p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">The Company recognizes a contract asset, when the value of satisfied (or part satisfied) performance obligations is in excess of the payment due to the Company, and deferred revenue when the amount of unconditional consideration is in excess of the value of satisfied (or part satisfied) performance obligations. Once a right to receive consideration is unconditional, that amount is presented as a receivable.</p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;"> </p> <p style="text-align: left; widows: 2; text-transform: none; margin-top: 0pt; text-indent: 0.5in; font: 10pt 'times new roman', times, serif; white-space: normal; orphans: 2; margin-bottom: 0pt; letter-spacing: normal; color: #000000; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;">With effect from January 1, 2018, grant revenue, if new grants are obtained, will be presented as a reduction against the related research and development expenses.</p>

<table style="widows: 2; text-transform: none; text-indent: 0px; width: 90%; border-collapse: collapse; font: 10pt 'times new roman', times, serif; orphans: 2; letter-spacing: normal; margin-left: 0.5in; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="vertical-align: bottom;"> <td style="font-size: 10pt;"> </td> <td style="padding-bottom: 1pt; font-size: 10pt; font-weight: bold;"> </td> <td style="border-bottom: black 1pt solid; text-align: center; font-size: 10pt; font-weight: bold;" colspan="2">Number of<br />Options<br />Outstanding</td> <td style="padding-bottom: 1pt; font-size: 10pt; font-weight: bold;"> </td> <td style="padding-bottom: 1pt; font-size: 10pt; font-weight: bold;"> </td> <td style="border-bottom: black 1pt solid; text-align: center; font-size: 10pt; font-weight: bold;" colspan="2">Weighted<br />Average<br />Exercise<br />Price Per Share</td> <td style="padding-bottom: 1pt; font-size: 10pt; font-weight: bold;"> </td> <td style="padding-bottom: 1pt; font-size: 10pt; font-weight: bold;"> </td> <td style="border-bottom: black 1pt solid; text-align: center; font-size: 10pt; font-weight: bold;" colspan="2">Weighted<br />Average<br />Remaining<br />Contractual<br />Term (Years)</td> <td style="padding-bottom: 1pt; font-size: 10pt; font-weight: bold;"> </td> <td style="padding-bottom: 1pt; font: bold 10pt 'times new roman', times, serif;"> </td> <td style="border-bottom: black 1pt solid; text-align: center; font: bold 10pt 'times new roman', times, serif;" colspan="2">Aggregate<br />Intrinsic<br />Value ($000)</td> <td style="padding-bottom: 1pt; font: bold 10pt 'times new roman', times, serif;"> </td> </tr> <tr style="background-color: #cceeff; vertical-align: bottom;"> <td style="text-indent: 0in; width: 692px; font-size: 10pt;">Options outstanding at December 31, 2018</td> <td style="width: 15px; font-size: 10pt;"> </td> <td style="text-align: left; width: 15px; font-size: 10pt;"> </td> <td style="text-align: right; width: 145px; font-size: 10pt;">831,611</td> <td style="text-align: left; width: 15px; font-size: 10pt;"> </td> <td style="width: 15px; font-size: 10pt;"> </td> <td style="text-align: left; width: 14px; font-size: 10pt;">$</td> <td style="text-align: right; width: 144px; font-size: 10pt;">6.68</td> <td style="text-align: left; width: 14px; font-size: 10pt;"> </td> <td style="width: 14px; font-size: 10pt;"> </td> <td style="text-align: left; width: 14px; font-size: 10pt;"> </td> <td style="text-align: right; width: 144px; font-size: 10pt;">8.13</td> <td style="text-align: left; width: 14px; font-size: 10pt;"> </td> <td style="width: 14px; font-size: 10pt;"> </td> <td style="text-align: left; width: 14px; font-size: 10pt;">$</td> <td style="text-align: right; width: 144px; font-size: 10pt;">—</td> <td style="text-align: left; width: 14px; font-size: 10pt;"> </td> </tr> <tr style="background-color: white; vertical-align: bottom;"> <td style="text-indent: 0in; font-size: 10pt;">Granted</td> <td style="font-size: 10pt;"> </td> <td style="text-align: left; font-size: 10pt;"> </td> <td style="text-align: right; font-size: 10pt;">1,419,020</td> <td style="text-align: left; font-size: 10pt;"> </td> <td style="font-size: 10pt;"> </td> <td style="text-align: left; font-size: 10pt;">$</td> <td style="text-align: right; font-size: 10pt;">0.72</td> <td style="text-align: left; font-size: 10pt;"> </td> <td style="font-size: 10pt;"> </td> <td style="text-align: left; font-size: 10pt;"> </td> <td style="text-align: right; font-size: 10pt;"> </td> <td style="text-align: left; font-size: 10pt;"> </td> <td style="font-size: 10pt;"> </td> <td style="text-align: left; font-size: 10pt;"> </td> <td style="text-align: right; font-size: 10pt;"> </td> <td style="text-align: left; font-size: 10pt;"> </td> </tr> <tr style="background-color: #cceeff; vertical-align: bottom;"> <td style="padding-bottom: 1pt; text-indent: 0in; font-size: 10pt;">Cancelled/forfeited</td> <td style="padding-bottom: 1pt; font-size: 10pt;"> </td> <td style="border-bottom: black 1pt solid; text-align: left; font-size: 10pt;"> </td> <td style="border-bottom: black 1pt solid; text-align: right; font-size: 10pt;">(1,488</td> <td style="text-align: left; padding-bottom: 1pt; font-size: 10pt;">)</td> <td style="padding-bottom: 1pt; font-size: 10pt;"> </td> <td style="border-bottom: black 1pt solid; text-align: left; font-size: 10pt;">$</td> <td style="border-bottom: black 1pt solid; text-align: right; font-size: 10pt;">33.60</td> <td style="text-align: left; padding-bottom: 1pt; font-size: 10pt;"> </td> <td style="padding-bottom: 1pt; font-size: 10pt;"> </td> <td style="border-bottom: black 1pt solid; text-align: left; font-size: 10pt;"> </td> <td style="border-bottom: black 1pt solid; text-align: right; font-size: 10pt;"> </td> <td style="text-align: left; padding-bottom: 1pt; font-size: 10pt;"> </td> <td style="padding-bottom: 1pt; font-size: 10pt;"> </td> <td style="border-bottom: black 1pt solid; text-align: left; font-size: 10pt;"> </td> <td style="border-bottom: black 1pt solid; text-align: right; font-size: 10pt;"> </td> <td style="text-align: left; padding-bottom: 1pt; font-size: 10pt;"> </td> </tr> <tr style="background-color: white; vertical-align: bottom;"> <td style="text-indent: 0in; font-size: 10pt;">Options outstanding at March 31, 2019</td> <td style="font-size: 10pt;"> </td> <td style="text-align: left; font-size: 10pt;"> </td> <td style="text-align: right; font-size: 10pt;">2,249,143</td> <td style="text-align: left; font-size: 10pt;"> </td> <td style="font-size: 10pt;"> </td> <td style="text-align: left; font-size: 10pt;">$</td> <td style="text-align: right; font-size: 10pt;">2.90</td> <td style="text-align: left; font-size: 10pt;"> </td> <td style="font-size: 10pt;"> </td> <td style="text-align: left; font-size: 10pt;"> </td> <td style="text-align: right; font-size: 10pt;">9.09</td> <td style="text-align: left; font-size: 10pt;"> </td> <td style="font-size: 10pt;"> </td> <td style="text-align: left; font-size: 10pt;">$</td> <td style="text-align: right; font-size: 10pt;">312</td> <td style="text-align: left; font-size: 10pt;"> </td> </tr> <tr style="background-color: #cceeff; vertical-align: bottom;"> <td style="padding-bottom: 1pt; text-indent: 0in; font-size: 10pt;">Unvested at March 31, 2019</td> <td style="padding-bottom: 1pt; font-size: 10pt;"> </td> <td style="border-bottom: black 1pt solid; text-align: left; font-size: 10pt;"> </td> <td style="border-bottom: black 1pt solid; text-align: right; font-size: 10pt;">(1,914,016</td> <td style="text-align: left; padding-bottom: 1pt; font-size: 10pt;">)</td> <td style="padding-bottom: 1pt; font-size: 10pt;"> </td> <td style="border-bottom: black 1pt solid; text-align: left; font-size: 10pt;">$</td> <td style="border-bottom: black 1pt solid; text-align: right; font-size: 10pt;">1.28</td> <td style="text-align: left; padding-bottom: 1pt; font-size: 10pt;"> </td> <td style="padding-bottom: 1pt; font-size: 10pt;"> </td> <td style="border-bottom: black 1pt solid; text-align: left; font-size: 10pt;"> </td> <td style="border-bottom: black 1pt solid; text-align: right; font-size: 10pt;">9.36</td> <td style="text-align: left; padding-bottom: 1pt; font-size: 10pt;"> </td> <td style="padding-bottom: 1pt; font-size: 10pt;"> </td> <td style="border-bottom: black 1pt solid; text-align: left; font-size: 10pt;">$</td> <td style="border-bottom: black 1pt solid; text-align: right; font-size: 10pt;">17</td> <td style="text-align: left; padding-bottom: 1pt; font-size: 10pt;"> </td> </tr> <tr style="background-color: white; vertical-align: bottom;"> <td style="text-align: left; padding-bottom: 2.5pt; text-indent: 0in; font-size: 10pt;">Vested and exercisable at March 31, 2019</td> <td style="padding-bottom: 2.5pt; font-size: 10pt;"> </td> <td style="border-bottom: black 2.5pt double; text-align: left; font-size: 10pt;"> </td> <td style="border-bottom: black 2.5pt double; text-align: right; font-size: 10pt;">335,127</td> <td style="text-align: left; padding-bottom: 2.5pt; font-size: 10pt;"> </td> <td style="padding-bottom: 2.5pt; font-size: 10pt;"> </td> <td style="border-bottom: black 2.5pt double; text-align: left; font-size: 10pt;">$</td> <td style="border-bottom: black 2.5pt double; text-align: right; font-size: 10pt;">12.20</td> <td style="text-align: left; padding-bottom: 2.5pt; font-size: 10pt;"> </td> <td style="padding-bottom: 2.5pt; font-size: 10pt;"> </td> <td style="border-bottom: black 2.5pt double; text-align: left; font-size: 10pt;"> </td> <td style="border-bottom: black 2.5pt double; text-align: right; font-size: 10pt;">7.58</td> <td style="text-align: left; padding-bottom: 2.5pt; font-size: 10pt;"> </td> <td style="padding-bottom: 2.5pt; font-size: 10pt;"> </td> <td style="border-bottom: black 2.5pt double; text-align: left; font-size: 10pt;">$</td> <td style="border-bottom: black 2.5pt double; text-align: right; font-size: 10pt;">295</td> <td style="text-align: left; padding-bottom: 2.5pt; font-size: 10pt;"> </td> </tr> </table>

8332598

708400

1698

7490500

132000

9873340

2249142

1698

7490500

132000

1148000

1441000

899000 677000

236000

72000

1110000 804000

259000

228000

363000

171000

81000

59000

22000

85000

54000

31000

831611

2249143

306304

1419020

174272

1488

1914016

335127

6.68

2.90

0.72

33.6

1.28

12.20

P8Y1M17D

P9Y1M2D

P9Y4M10D

P7Y6M29D

312000

17000

295000

1500000

709889

245208

P10Y

P1Y

P4Y

1.25

1.17

1.29

0.58

0.57

0.61

0.25

Black-Scholes option-pricing model

8872

3154000

13700000

0.001

2961

500

4304000

1000.00 1000 1000

7490500

2.00

The Warrants expire in 2024. Subject to limited exceptions, a holder of warrants will not have the right to exercise any portion of its warrants if the holder (together with such holder's affiliates, and any persons acting as a group together with such holder or any of such holder's affiliates) would beneficially own a number of shares of common stock in excess of 4.99% (or, at the election of the purchaser, 9.99%) of the shares of our Common Stock then outstanding after giving effect to such exercise 1

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P5Y

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<table style="widows: 2; text-transform: none; text-indent: 0px; width: 80%; border-collapse: collapse; font: 10pt 'times new roman', times, serif; orphans: 2; letter-spacing: normal; margin-left: 0.5in; word-spacing: 0px; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial;" border="0" cellspacing="0" cellpadding="0"> <tr style="background-color: #cceeff; vertical-align: bottom;"> <td style="text-align: left; text-indent: 0in; width: 1070px; font-size: 10pt;">2019</td> <td style="width: 12px; font-size: 10pt;"> </td> <td style="text-align: left; width: 12px; font-size: 10pt;">$</td> <td style="text-align: right; width: 162px; font-size: 10pt;">246,348</td> <td style="text-align: left; width: 13px; font-size: 10pt;"> </td> </tr> <tr style="background-color: white; vertical-align: bottom;"> <td style="text-align: left; text-indent: 0in; font-size: 10pt;">2020</td> <td style="font-size: 10pt;"> </td> <td style="text-align: left; font-size: 10pt;"> </td> <td style="text-align: right; font-size: 10pt;">328,464</td> <td style="text-align: left; font-size: 10pt;"> </td> </tr> <tr style="background-color: #cceeff; vertical-align: bottom;"> <td style="text-align: left; text-indent: 0in; font-size: 10pt;">2021</td> <td style="font-size: 10pt;"> </td> <td style="text-align: left; font-size: 10pt;"> </td> <td style="text-align: right; font-size: 10pt;">328,464</td> <td style="text-align: left; font-size: 10pt;"> </td> </tr> <tr style="background-color: white; vertical-align: bottom;"> <td style="text-align: left; text-indent: 0in; font-size: 10pt;">2022</td> <td style="font-size: 10pt;"> </td> <td style="text-align: left; font-size: 10pt;"> </td> <td style="text-align: right; font-size: 10pt;">328,464</td> <td style="text-align: left; font-size: 10pt;"> </td> </tr> <tr style="background-color: #cceeff; vertical-align: bottom;"> <td style="text-align: left; text-indent: 0in; font-size: 10pt;">2023</td> <td style="font-size: 10pt;"> </td> <td style="text-align: left; font-size: 10pt;"> </td> <td style="text-align: right; font-size: 10pt;">328,464</td> <td style="text-align: left; font-size: 10pt;"> </td> </tr> <tr style="background-color: white; vertical-align: bottom;"> <td style="padding-bottom: 1pt; text-indent: 0in; font-size: 10pt;">Thereafter</td> <td style="padding-bottom: 1pt; font-size: 10pt;"> </td> <td style="border-bottom: black 1pt solid; text-align: left; font-size: 10pt;"> </td> <td style="border-bottom: black 1pt solid; text-align: right; font-size: 10pt;">574,813</td> <td style="text-align: left; padding-bottom: 1pt; font-size: 10pt;"> </td> </tr> <tr style="background-color: #cceeff; vertical-align: bottom;"> <td style="padding-bottom: 2.5pt; text-indent: 20.15pt; font-size: 10pt;"> </td> <td style="padding-bottom: 2.5pt; font-size: 10pt;"> </td> <td style="border-bottom: black 2.5pt double; text-align: left; font-size: 10pt;">$</td> <td style="border-bottom: black 2.5pt double; text-align: right; font-size: 10pt;">2,135,017</td> <td style="text-align: left; padding-bottom: 2.5pt; font-size: 10pt;"> </td> </tr> </table>

246348

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164185

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Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2019	May 10, 2019
Document and Entity Information [Abstract]
Entity Registrant Name	Cyclacel Pharmaceuticals, Inc.
Entity Central Index Key	0001130166
Trading Symbol	cycc
Current Fiscal Year End Date	--12-31
Entity Filer Category	Non-accelerated Filer
Entity Common Stock, Shares Outstanding		17,199,974
Document Type	10-Q
Document Period End Date	Mar. 31, 2019
Amendment Flag	false
Document Fiscal Year Focus	2019
Document Fiscal Period Focus	Q1
Entity Small Business	true
Entity Emerging Growth Company	false

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CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Mar. 31, 2019	Dec. 31, 2018
Current assets:
Cash and cash equivalents	$ 17,934	$ 17,504
Prepaid expenses and other current assets	2,190	2,283
Total current assets	20,124	19,787
Property and equipment, net	33	36
Right-of-use lease asset	1,353
Total assets	21,510	19,823
Current liabilities:
Accounts payable	1,284	2,719
Accrued and other current liabilities	1,203	1,732
Total current liabilities	2,487	4,451
Lease liability	1,468
Other liabilities		100
Total liabilities	3,955	4,551
Stockholders' equity:
Preferred stock, value
Common stock, $0.001 par value; 100,000,000 shares authorized at December 31, 2018 and March 31, 2019; 12,497,447 and 17,199,974 shares issued and outstanding at December 31, 2018 and March 31, 2019.	17	12
Additional paid-in capital	369,958	365,817
Accumulated other comprehensive loss	(781)	(760)
Accumulated deficit	(351,639)	(349,797)
Total stockholders' equity	17,555	15,272
Total liabilities and stockholders' equity	21,510	19,823
Convertible Exchangeable Preferred Stock
Stockholders' equity:
Preferred stock, value
Series A convertible preferred stock
Stockholders' equity:
Preferred stock, value

XML 14 R3.htm IDEA: XBRL DOCUMENT

CONSOLIDATED BALANCE SHEETS (Parentheticals) - USD ($) $ in Thousands	Mar. 31, 2019	Dec. 31, 2018
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized	5,000,000	5,000,000
Preferred stock, liquidation preference value (in dollars)	$ 4,006,512	$ 4,006,512
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized	100,000,000	100,000,000
Common stock, shares issued	17,199,974	12,497,447
Common stock, shares outstanding	17,199,974	12,497,447
6% Convertible Exchangeable Preferred Stock
Preferred stock, shares issued	335,273	335,273
Preferred stock, shares outstanding	335,273	335,273
Series A convertible preferred stock
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares issued	264	264
Preferred stock, shares outstanding	264

XML 15 R4.htm IDEA: XBRL DOCUMENT

CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Revenues:
Total revenues	$ 0	$ 0
Operating expenses:
Research and development	1,012	798
General and administrative	1,192	1,364
Total operating expenses	2,204	2,162
Operating loss	(2,204)	(2,162)
Other income (expense):
Foreign exchange (losses)	15	(4)
Interest income	79	69
Other income, net		566
Total other income, net	94	631
Loss before taxes	(2,110)	(1,531)
Income tax benefit	268	182
Net loss	(1,842)	(1,349)
Dividend on 6% Convertible Exchangeable preferred stock	(50)	(50)
Net loss applicable to common stockholders	$ (1,892)	$ (1,399)
Basic and diluted earnings per common share:
Net loss per share-basic and diluted (in dollars per share)	$ (0.14)	$ (0.12)
Weighted average common shares outstanding (in shares)	13,638,271	11,997,447

XML 16 R5.htm IDEA: XBRL DOCUMENT

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
Net loss	$ (1,842)	$ (1,349)
Translation adjustment	(3,897)	(6,328)
Unrealized foreign exchange gain on intercompany loans	3,876	6,276
Comprehensive loss	$ (1,863)	$ (1,401)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References + Details

XML 17 R6.htm IDEA: XBRL DOCUMENT

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands	Preferred Stock	Common Stock	Additional Paid-in Capital	Accumulated Other Comprehensive Loss	Accumulated Deficit	Total
Balance at Dec. 31, 2017		$ 12	$ 365,057	$ (794)	$ (342,509)	$ 21,766
Balance (in shares) at Dec. 31, 2017	335,537	11,997,447
Increase (Decrease) in Stockholders' Equity
Issue of common stock on At Market Issuance sales agreement	$ 0	$ 0				0
Issue of common stock on At Market Issuance sales agreement (in shares)	0	0
Stock-based compensation			81			81
Preferred stock dividends			(50)			(50)
Unrealized foreign exchange on intercompany loans				6,276		6,276
Translation adjustment				(6,328)		(6,328)
Loss for the period					(1,349)	(1,349)
Balance at Mar. 31, 2018		$ 12	365,088	(846)	(343,858)	20,396
Balance (in shares) at Mar. 31, 2018	335,537	11,997,447
Balance at Dec. 31, 2018		$ 12	365,817	(760)	(349,797)	15,272
Balance (in shares) at Dec. 31, 2018	335,537	12,497,447
Increase (Decrease) in Stockholders' Equity
Issue of common stock on At Market Issuance sales agreement		$ 5	4,106			4,111
Issue of common stock on At Market Issuance sales agreement (in shares)		4,702,527
Stock-based compensation			85			85
Preferred stock dividends			(50)			(50)
Unrealized foreign exchange on intercompany loans				3,876		3,876
Translation adjustment				(3,897)		(3,897)
Loss for the period					(1,842)	(1,842)
Balance at Mar. 31, 2019		$ 17	$ 369,958	$ (781)	$ (351,639)	$ 17,555
Balance (in shares) at Mar. 31, 2019	335,537	17,199,974

XML 18 R7.htm IDEA: XBRL DOCUMENT

CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Operating activities:
Net loss	$ (1,842)	$ (1,349)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	6	7
Stock-based compensation	85	81
Gain on disposal of property and equipment	(29)
Changes in operating assets and liabilities:
Prepaid expenses and other assets	(1,215)	(876)
Accounts payable and other current liabilities	(689)	(2)
Net cash used in operating activities	(3,684)	(2,139)
Investing activities:
Purchase of property, plant and equipment	(2)	(22)
Proceeds from sale of property and equipment	29
Net cash used in investing activities	27	(22)
Financing activities:
Proceeds from issuance of common stock, net of issuance costs	4,106
Payment of preferred stock dividend	(50)	(50)
Net cash provided by / (used in) financing activities	4,056	(50)
Effect of exchange rate changes on cash and cash equivalents	31	26
Net decrease in cash and cash equivalents	430	(2,185)
Cash and cash equivalents, beginning of period	17,504	23,910
Cash and cash equivalents, end of period	17,934	21,725
Cash received during the period for:
Interest	79	69
Taxes	0	0
Non cash financing activities:
Accrual of preferred stock dividends	$ 50	$ 50

XML 19 R8.htm IDEA: XBRL DOCUMENT

Company Overview

3 Months Ended

Mar. 31, 2019

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Company Overview

1.	Company Overview

Nature of Operations

XML 20 R9.htm IDEA: XBRL DOCUMENT

Summary of Significant Accounting Policies

3 Months Ended

Mar. 31, 2019

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

Summary of Significant Accounting Policies

Basis of Presentation

Going Concern

This evaluation is based on relevant conditions and events that are known and reasonably knowable at the date that the financial statements are issued, including:

The Company’s current financial condition, including its sources of liquidity;

The Company’s conditional and unconditional obligations due or anticipated within one year;

The funds necessary to maintain the Company’s operations considering its current financial condition, obligations, and other expected cash flows; and

Other conditions and events, when considered in conjunction with the above that may adversely affect the Company’s ability to meet its obligations.

Accounting standards adopted in the period

Recently Issued Accounting Pronouncements

Fair Value of Financial Instruments

Comprehensive Income (Loss)

Revenue recognition

With effect from January 1, 2018, the Company recognizes revenue using the five step-model provided in ASC 606, Revenue from Contracts with Customers (“ASC 606”):

(1)

identify the contract with a customer;

(2)

identify the performance obligations in the contract;

(3)

determine the transaction price;

(4)

allocate the transaction price to the performance obligations in the contract; and

(5)

recognize revenue when, or as, the Company satisfies a performance obligation.

Whether the uncertainty about the achievement of the milestone is not expected to be resolved for a long period of time;

Whether the Company can reasonably predict that a milestone will be achieved based on previous experience; and.

The complexity and inherent uncertainty underlying the achievement of the milestone.

The revenue allocated to each performance obligation is recognized as or when the Company satisfies the performance obligation.

With effect from January 1, 2018, grant revenue, if new grants are obtained, will be presented as a reduction against the related research and development expenses.

Leases

Effective from January 1, 2019, the Company accounts for lease contracts in accordance with ASC 842. As of March 31, 2019, all of the Company’s leases are classified as operating.

The lease payments due in any optional period

Penalties for failure to exercise (or not exercise) the option

Market factors, such as the availability of similar assets and current rental rates for such assets

The nature of the underlying leased asset and its importance to the Company’s operations

The remaining useful lives of any related leasehold improvements

The Company has elected an accounting policy to account for the lease and non-lease components as a single lease component.

XML 21 R10.htm IDEA: XBRL DOCUMENT

Revenue

3 Months Ended

Mar. 31, 2019

Revenue Recognition [Abstract]

Revenue

3.	*Revenue*

Revenue recognized in the three months ended March 31, 2018 and 2019 was $nil.

The aggregate transaction price that is allocated to performance obligations that are unsatisfied (or partially unsatisfied) as of March 31, 2019 was $nil.

XML 22 R11.htm IDEA: XBRL DOCUMENT

Net Loss Per Common Share

3 Months Ended

Mar. 31, 2019

Earnings Per Share [Abstract]

Net Loss Per Common Share

4.	*Net Loss per Common Share*

	March 31, 2018		March 31, 2019
Stock options		708,400		2,249,142
Convertible preferred stock		1,698		1,698
Series A preferred stock		132,000		132,000
Common stock warrants		7,490,500		7,490,500
Total shares excluded from calculation		8,332,598		9,873,340

XML 23 R12.htm IDEA: XBRL DOCUMENT

Prepaid Expenses and Other Current Assets

3 Months Ended

Mar. 31, 2019

Prepaid Expenses And Other Current Assets [Abstract]

Prepaid Expenses and Other Current Assets

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following (in $000s):

	December 31,		March 31,
	2018		2019
Research and development tax credit receivable	$	1,148	$	1,441
Prepayments and VAT receivable		899		677
Other current assets		236		72
	$	2,283	$	2,190

XML 24 R13.htm IDEA: XBRL DOCUMENT

Accrued and Other Liabilities

3 Months Ended

Mar. 31, 2019

Payables And Accruals [Abstract]

Accrued and Other Liabilities

Accrued and Other Liabilities

Accrued and other current liabilities consisted of the following (in $000s):

	December 31,		March 31,
	2018		2019
Accrued research and development	$	1,110	$	804
Accrued legal and professional fees		259		228
Other current liabilities		363		171
	$	1,732	$	1,203

XML 25 R14.htm IDEA: XBRL DOCUMENT

Leases

3 Months Ended

Mar. 31, 2019

Leases [Abstract]

Leases

7.	Leases

The Company has a single lease related to its facility in Dundee, Scotland.

As of and for the three months ended March 31, 2019

Remaining lease payments under the lease are:

2019	$	246,348
2020		328,464
2021		328,464
2022		328,464
2023		328,464
Thereafter		574,813
	$	2,135,017

As of and for the twelve months ended December 31, 2018

The following is a summary of the Company’s future contractual obligations and commitments relating to its facilities leases as at December 31, 2018 (in thousands):

	Operating Lease Obligation
2019	$	321
2020		321
2021		321
2022		321
2023		321
thereafter		581
Total future minimum lease obligations	$	2,186

XML 26 R15.htm IDEA: XBRL DOCUMENT

Stock Based Compensation

3 Months Ended

Mar. 31, 2019

Disclosure Of Compensation Related Costs Share-Based Payments [Abstract]

Stock Based Compensation

Stock Based Compensation

	Three Months Ended March 31,
	2018		2019
General and administrative	$	59	$	54
Research and development		22		31
Stock-based compensation costs before income taxes	$	81	$	85

2018 Plan

There were 1,419,020 options granted during the three months ended March 31, 2019. These options had a grant date fair value ranging between $0.57-$0.61 per option.

Outstanding Options

A summary of the share option activity and related information is as follows:

	Number of Options Outstanding			Weighted Average Exercise Price Per Share		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value ($000)
Options outstanding at December 31, 2018		831,611		$	6.68		8.13	$	—
Granted		1,419,020		$	0.72
Cancelled/forfeited		(1,488	)	$	33.60
Options outstanding at March 31, 2019		2,249,143		$	2.90		9.09	$	312
Unvested at March 31, 2019		(1,914,016	)	$	1.28		9.36	$	17
Vested and exercisable at March 31, 2019		335,127		$	12.20		7.58	$	295

The fair value of the stock options granted is calculated using the Black-Scholes option-pricing model as prescribed by ASC 718 using the following assumptions:

	Year ended December 31, 2018			Quarter ended March 31, 2019
Expected term (years)		6			5-6
Risk free interest rate		2.730% – 2.855	%		2.490% – 2.610	%
Volatility		105% – 107	%		103% – 110	%
Expected dividend yield over expected term		0.00	%		0.00	%
Resulting weighted average grant date fair value	$	1.25		$	0.58

XML 27 R16.htm IDEA: XBRL DOCUMENT

Stockholders' Equity

3 Months Ended

Mar. 31, 2019

Stockholders' Equity Note [Abstract]

Stockholders Equity

Stockholders Equity

October 2018 At Market Issuance

July 2017 Underwritten Public Offering

Warrants

There was no exercise of warrants during the three months ended March 31, 2019.

Series A Preferred Stock

6% Convertible Exchangeable Preferred Stock

The 6% Preferred Stock has no maturity date and no voting rights prior to conversion into common stock, except under limited circumstances.

The Company may, at its option, redeem the 6% Preferred Stock in whole or in part, out of funds legally available at the redemption price of $10.00 per share.

XML 28 R17.htm IDEA: XBRL DOCUMENT

Subsequent Events

3 Months Ended

Mar. 31, 2019

Subsequent Events [Abstract]

Subsequent Events

10.

Subsequent Events

XML 29 R18.htm IDEA: XBRL DOCUMENT

Summary of Significant Accounting Policies (Policies)

3 Months Ended

Mar. 31, 2019

Accounting Policies [Abstract]

Basis of Presentation

Basis of Presentation

Going Concern

Going Concern

This evaluation is based on relevant conditions and events that are known and reasonably knowable at the date that the financial statements are issued, including:

The Company’s current financial condition, including its sources of liquidity;

The Company’s conditional and unconditional obligations due or anticipated within one year;

The funds necessary to maintain the Company’s operations considering its current financial condition, obligations, and other expected cash flows; and

Other conditions and events, when considered in conjunction with the above that may adversely affect the Company’s ability to meet its obligations.

Recently Issued Accounting Pronouncements

Accounting standards adopted in the period

Recently Issued Accounting Pronouncements

Fair Value of Financial Instruments

Fair Value of Financial Instruments

Comprehensive Income (Loss)

Comprehensive Income (Loss)

Revenue recognition

Revenue recognition

With effect from January 1, 2018, the Company recognizes revenue using the five step-model provided in ASC 606, Revenue from Contracts with Customers (“ASC 606”):

(1)

identify the contract with a customer;

(2)

identify the performance obligations in the contract;

(3)

determine the transaction price;

(4)

allocate the transaction price to the performance obligations in the contract; and

(5)

recognize revenue when, or as, the Company satisfies a performance obligation.

Whether the uncertainty about the achievement of the milestone is not expected to be resolved for a long period of time;

Whether the Company can reasonably predict that a milestone will be achieved based on previous experience; and.

The complexity and inherent uncertainty underlying the achievement of the milestone.

The revenue allocated to each performance obligation is recognized as or when the Company satisfies the performance obligation.

With effect from January 1, 2018, grant revenue, if new grants are obtained, will be presented as a reduction against the related research and development expenses.

Leases

Leases

Effective from January 1, 2019, the Company accounts for lease contracts in accordance with ASC 842. As of March 31, 2019, all of the Company’s leases are classified as operating.

The lease payments due in any optional period

Penalties for failure to exercise (or not exercise) the option

Market factors, such as the availability of similar assets and current rental rates for such assets

The nature of the underlying leased asset and its importance to the Company’s operations

The remaining useful lives of any related leasehold improvements

The Company has elected an accounting policy to account for the lease and non-lease components as a single lease component.

XML 30 R19.htm IDEA: XBRL DOCUMENT

Net Loss Per Common Share (Tables)

3 Months Ended

Mar. 31, 2019

Earnings Per Share [Abstract]

Schedule of antidilutive shares excluded from computation of diluted net loss per share

	March 31, 2018		March 31, 2019
Stock options		708,400		2,249,142
Convertible preferred stock		1,698		1,698
Series A preferred stock		132,000		132,000
Common stock warrants		7,490,500		7,490,500
Total shares excluded from calculation		8,332,598		9,873,340

XML 31 R20.htm IDEA: XBRL DOCUMENT

Prepaid Expenses and Other Current Assets (Tables)

3 Months Ended

Mar. 31, 2019

Prepaid Expenses And Other Current Assets [Abstract]

Schedule of prepaid expenses and other current assets

	December 31,		March 31,
	2018		2019
Research and development tax credit receivable	$	1,148	$	1,441
Prepayments and VAT receivable		899		677
Other current assets		236		72
	$	2,283	$	2,190

XML 32 R21.htm IDEA: XBRL DOCUMENT

Accrued and Other Liabilities (Tables)

3 Months Ended

Mar. 31, 2019

Payables And Accruals [Abstract]

Schedule of accrued and other current liabilities

	December 31,		March 31,
	2018		2019
Accrued research and development	$	1,110	$	804
Accrued legal and professional fees		259		228
Other current liabilities		363		171
	$	1,732	$	1,203

XML 33 R22.htm IDEA: XBRL DOCUMENT

Leases (Tables)

3 Months Ended

Mar. 31, 2019

Leases [Abstract]

Schedule of remaining lease payments

2019	$	246,348
2020		328,464
2021		328,464
2022		328,464
2023		328,464
Thereafter		574,813
	$	2,135,017

Schedule of the Company's contractual obligations and commitments relating to its facilities leases

	Operating Lease Obligation
2019	$	321
2020		321
2021		321
2022		321
2023		321
thereafter		581
Total future minimum lease obligations	$	2,186

XML 34 R23.htm IDEA: XBRL DOCUMENT

Stock Based Compensation (Tables)

3 Months Ended

Mar. 31, 2019

Disclosure Of Compensation Related Costs Share-Based Payments [Abstract]

Schedule of stock based compensation expense

	Three Months Ended March 31,
	2018		2019
General and administrative	$	59	$	54
Research and development		22		31
Stock-based compensation costs before income taxes	$	81	$	85

Schedule of share option activity

	Number of Options Outstanding			Weighted Average Exercise Price Per Share		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value ($000)
Options outstanding at December 31, 2018		831,611		$	6.68		8.13	$	—
Granted		1,419,020		$	0.72
Cancelled/forfeited		(1,488	)	$	33.60
Options outstanding at March 31, 2019		2,249,143		$	2.90		9.09	$	312
Unvested at March 31, 2019		(1,914,016	)	$	1.28		9.36	$	17
Vested and exercisable at March 31, 2019		335,127		$	12.20		7.58	$	295

Schedule of fair value of the stock options granted

	Year ended December 31, 2018			Quarter ended March 31, 2019
Expected term (years)		6			5-6
Risk free interest rate		2.730% – 2.855	%		2.490% – 2.610	%
Volatility		105% – 107	%		103% – 110	%
Expected dividend yield over expected term		0.00	%		0.00	%
Resulting weighted average grant date fair value	$	1.25		$	0.58

XML 35 R24.htm IDEA: XBRL DOCUMENT

Summary of Significant Accounting Policies (Detail Textuals) - USD ($)	Mar. 31, 2019	Dec. 31, 2018	Mar. 31, 2018	Dec. 31, 2017
Accounting Policies [Abstract]
Cash and cash equivalents	$ 17,934,000	$ 17,504,000	$ 21,725,000	$ 23,910,000
Lease liability	1,468,000
Deferred rent obligation	$ 120,000

XML 36 R25.htm IDEA: XBRL DOCUMENT

Revenue (Detail Textuals) - USD ($) $ in Thousands	3 Months Ended
Revenue (Detail Textuals) - USD ($) $ in Thousands	Mar. 31, 2019	Mar. 31, 2018
Revenue Recognition [Abstract]
Revenue	$ 0	$ 0
Aggregate price of transaction allocated to performance obligations	$ 0

XML 37 R26.htm IDEA: XBRL DOCUMENT

Net Loss Per Common Share (Details) - shares	3 Months Ended
Net Loss Per Common Share (Details) - shares	Mar. 31, 2019	Mar. 31, 2018
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total shares excluded from calculation	9,873,340	8,332,598
Stock options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total shares excluded from calculation	2,249,142	708,400
Convertible preferred stock
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total shares excluded from calculation	1,698	1,698
Series A preferred stock
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total shares excluded from calculation	132,000	132,000
Common stock warrants
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total shares excluded from calculation	7,490,500	7,490,500

XML 38 R27.htm IDEA: XBRL DOCUMENT

Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands	Mar. 31, 2019	Dec. 31, 2018
Prepaid Expense and Other Assets, Current [Abstract]
Research and development tax credit receivable	$ 1,441	$ 1,148
Prepayments and VAT receivable	677	899
Other current assets	72	236
Prepaid expenses and other current assets	$ 2,190	$ 2,283

XML 39 R28.htm IDEA: XBRL DOCUMENT

Accrued and Other Liabilities (Details) - USD ($) $ in Thousands	Mar. 31, 2019	Dec. 31, 2018
Payables And Accruals [Abstract]
Accrued research and development	$ 804	$ 1,110
Accrued legal and professional fees	228	259
Other current liabilities	171	363
Accrued and other current liabilities	$ 1,203	$ 1,732

XML 40 R29.htm IDEA: XBRL DOCUMENT

Leases (Details)	Mar. 31, 2019 USD ($)
Leases [Abstract]
2019	$ 246,348
2020	328,464
2021	328,464
2022	328,464
2023	328,464
Thereafter	574,813
Lease payments, Total	$ 2,135,017

XML 41 R30.htm IDEA: XBRL DOCUMENT

Leases (Details 1) $ in Thousands	Mar. 31, 2019 USD ($)
Operating Lease Obligation
2019	$ 321
2020	321
2021	321
2022	321
2023	321
thereafter	581
Total future minimum lease obligations	$ 2,186

XML 42 R31.htm IDEA: XBRL DOCUMENT

Leases (Detail Textuals) - USD ($)	3 Months Ended	12 Months Ended
Leases (Detail Textuals) - USD ($)	Mar. 31, 2019	Dec. 31, 2018	Dec. 31, 2017
Leases [Abstract]
Operating lease expense	$ 79,663
Operating lease, payments	$ 164,185
Remaining lease term	6 years 6 months
Discount rate lease liability	12.00%
Other rent related expenses		$ 400,000	$ 500,000

XML 43 R32.htm IDEA: XBRL DOCUMENT

Stock Based Compensation (Details) - USD ($) $ in Thousands	3 Months Ended
Stock Based Compensation (Details) - USD ($) $ in Thousands	Mar. 31, 2019	Mar. 31, 2018
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation costs before income taxes	$ 85	$ 81
General and administrative
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation costs before income taxes	54	59
Research and development
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation costs before income taxes	$ 31	$ 22

XML 44 R33.htm IDEA: XBRL DOCUMENT

Stock Based Compensation (Details 1) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended	12 Months Ended
	Mar. 31, 2019	Dec. 31, 2018
Number of Options Outstanding
Granted	1,419,020	306,304
Stock options
Number of Options Outstanding
Options outstanding at December 31, 2018	831,611
Granted	1,419,020
Cancelled/forfeited	(1,488)
Options outstanding at March 31, 2019	2,249,143	831,611
Unvested at March 31, 2019	(1,914,016)
Vested and exercisable at March 31, 2019	335,127
Weighted Average Exercise Price Per Share
Options outstanding at December 31, 2018	$ 6.68
Granted	0.72
Cancelled/forfeited	33.6
Options outstanding at March 31, 2019	2.90	$ 6.68
Unvested at March 31, 2019	1.28
Vested and exercisable at March 31, 2019	$ 12.20
Weighted Average Remaining Contractual Term (Years)
Options outstanding	9 years 1 month 2 days	8 years 1 month 17 days
Unvested at March 31, 2019	9 years 4 months 10 days
Vested and exercisable at March 31, 2019	7 years 6 months 29 days
Aggregate Intrinsic Value
Options outstanding	$ 312	$ 0
Unvested at March 31, 2019	17
Vested and exercisable at March 31, 2019	$ 295

XML 45 R34.htm IDEA: XBRL DOCUMENT

Stock Based Compensation (Details 2) - Stock options - $ / shares	3 Months Ended		12 Months Ended
	Mar. 31, 2019	Mar. 31, 2018	Dec. 31, 2018
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract]
Expected term (years)		6 years
Expected dividend yield over expected term	0.00%	0.00%
Resulting weighted average grant date fair value	$ 0.58	$ 1.25
Minimum
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract]
Expected term (years)	5 years
Risk free interest rate	2.49%	2.73%
Volatility	103.00%	105.00%
Resulting weighted average grant date fair value	$ 0.57		$ 1.17
Maximum
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract]
Expected term (years)	6 years
Risk free interest rate	2.61%	2.855%
Volatility	110.00%	107.00%
Resulting weighted average grant date fair value	$ 0.61		$ 1.29

XML 46 R35.htm IDEA: XBRL DOCUMENT

Stock Based Compensation (Detail Textuals) - $ / shares	3 Months Ended		12 Months Ended
Stock Based Compensation (Detail Textuals) - $ / shares	Mar. 31, 2019	Mar. 31, 2018	Dec. 31, 2018
Stock-based compensation
Options granted (in shares)	1,419,020		306,304
Percentage of vesting of awards	25.00%
Fair value assumptions method used	Black-Scholes option-pricing model
Stock options
Stock-based compensation
Options granted (in shares)	1,419,020
Grant date fair value	$ 0.58	$ 1.25
Stock options \| Minimum
Stock-based compensation
Grant date fair value	0.57		$ 1.17
Stock options \| Maximum
Stock-based compensation
Grant date fair value	$ 0.61		$ 1.29
Performance based options
Stock-based compensation
Options granted (in shares)	174,272
2018 Equity Incentive Plan (the "2018 Plan")
Stock-based compensation
Number of authorized shares	1,500,000
Number of authorized additional shares to be issued	709,889
2018 Equity Incentive Plan (the "2018 Plan") \| Minimum
Stock-based compensation
Maximum life of stock option awards granted	1 year
2018 Equity Incentive Plan (the "2018 Plan") \| Maximum
Stock-based compensation
Maximum life of stock option awards granted	4 years
2018 Equity Incentive Plan (the "2018 Plan") \| Stock options
Stock-based compensation
Number of shares reserved for issuance	245,208
Maximum life of stock option awards granted	10 years

XML 47 R36.htm IDEA: XBRL DOCUMENT

Stockholders' Equity (Detail Textuals) - USD ($)		1 Months Ended	3 Months Ended
Stockholders' Equity (Detail Textuals) - USD ($)	Oct. 04, 2018	Jul. 21, 2017	Mar. 31, 2019	Dec. 31, 2018
Stockholders Equity [Line Items]
Common stock, par value (in dollars per share)			$ 0.001	$ 0.001
Proceeds from issuance of common stock			$ 4,106,000
Number of warrant outstanding			$ 7,490,500
Warrant exercise price			$ 2.00
Condition related to exercising warrants			The Warrants expire in 2024. Subject to limited exceptions, a holder of warrants will not have the right to exercise any portion of its warrants if the holder (together with such holder's affiliates, and any persons acting as a group together with such holder or any of such holder's affiliates) would beneficially own a number of shares of common stock in excess of 4.99% (or, at the election of the purchaser, 9.99%) of the shares of our Common Stock then outstanding after giving effect to such exercise
Underwriting Agreement \| Ladenburg Thalmann & Co. Inc.
Stockholders Equity [Line Items]
Number of units authorized for issuance and sale		13,700,000
Underwriting Agreement \| Ladenburg Thalmann & Co. Inc. \| Class A Units
Stockholders Equity [Line Items]
Number of units authorized for issuance and sale		3,154,000
Share price per unit (in dollars per share)		$ 2
Underwriting Agreement \| Ladenburg Thalmann & Co. Inc. \| Class A Units \| Common Stock
Stockholders Equity [Line Items]
Number of securities called by each unit		1
Number of securities called by each warrant		1
Underwriting Agreement \| Ladenburg Thalmann & Co. Inc. \| Class B Units
Stockholders Equity [Line Items]
Number of units authorized for issuance and sale		8,872
Share price per unit (in dollars per share)		$ 0.001
Underwriting Agreement \| Ladenburg Thalmann & Co. Inc. \| Class B Units \| Common Stock
Stockholders Equity [Line Items]
Number of shares issued upon conversion		500
Price per share used to determine number of shares of common stock		$ 1,000.00
Conversion price		$ 1,000
Sales agreement \| H.C. Wainwright & Co., LLC
Stockholders Equity [Line Items]
Common stock, par value (in dollars per share)	$ 0.001
Aggregate offering price	$ 5,000,000
Selling commissions, percentage	3.00%
Number of share sold under the sales agreement			4,702,527	500,000
Proceeds from issuance of common stock			$ 4,300,000	$ 700,000
Net proceeds from issuance of common stock			$ 4,700,000

XML 48 R37.htm IDEA: XBRL DOCUMENT

Stockholders' Equity (Detail Textuals 1) - $ / shares	1 Months Ended	3 Months Ended	12 Months Ended
Stockholders' Equity (Detail Textuals 1) - $ / shares	Jul. 31, 2017	Mar. 31, 2019	Dec. 31, 2017	Dec. 31, 2018
Series A convertible preferred stock
Class of Stock [Line Items]
Preferred stock, shares issued	8,872	264		264
Preferred stock, shares outstanding		264
Number of shares issued upon conversion			4,304,000
Number of shares converted		132,000	8,608
Price per share used to determine number of shares of common stock	$ 1,000
Conversion price of convertible preferred stock	$ 2.00
Percentage of blocker provision	4.99%
Conversion percentage	9.99%
Condition related to events occurrence for conversion of preferred stock		(i) the volume weighted average price of our common stock for 30 consecutive trading days (the "Measurement Period") exceeds 300% of the initial conversion price of the Series A Preferred Stock (subject to adjustment for forward and reverse stock splits, recapitalizations, stock dividends and similar transactions), (ii) the daily trading volume on each Trading Day during such Measurement Period exceeds $500,000 per trading day and (iii) the holder is not in possession of any information that constitutes or might constitute, material non-public information which was provided by the Company.
6% Convertible Exchangeable Preferred Stock
Class of Stock [Line Items]
Preferred stock, shares issued		335,273		335,273
Preferred stock, shares outstanding		335,273		335,273
Number of trading days during which closing price of common stock must exceed conversion price for at least 20 days in order for the preferred stock to be convertible		30 days
Dividend rate on convertible exchangeable preferred stock (in percent)		6.00%
Share issue price per share		$ 10.00
Liquidation preference (in dollars per share)		10.00
Share Price		$ 2,961
Percentage of closing sales price of common stock that conversion price must exceed in order for preferred stock to be convertible		150.00%
Number of trading days within 30 trading days in which the closing price of common stock must exceed conversion price for preferred stock to be convertible		20 days
Number of trading days prior to notice of automatic conversion		5 days
Redemption price per share (in dollars per share)		$ 10.00
Interest rate of Convertible Subordinated Debentures (as a percent)		6.00%
Debt principal amount per share, basis for exchange (in dollars per share)		$ 10.00
Debt instrument, term		25 years

XML 49 R38.htm IDEA: XBRL DOCUMENT

Subsequent Events (Detail Textuals) - Board of Directors	Mar. 07, 2019 $ / shares
Subsequent Event [Line Items]
Dividend declared, date	Mar. 07, 2019
Preferred stock dividend declared, amount per share	$ 0.15
Dividends payable, date to be paid	May 01, 2019
Dividend, record date	Apr. 15, 2019

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