LEAP THERAPEUTICS, INC. - Quarter Report: 2017 September (Form 10-Q)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended September 30, 2017

 

OR

 

o  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: 001-37990

 

LEAP THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

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 o

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x  No o

 

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

 

Large accelerated filer o		Accelerated filer o
Non-accelerated filer   o		Smaller reporting company x
(Do not check if a smaller reporting company)
		Emerging growth company x

 

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. o

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). o  Yes    x  No

 

As of November 8, 2017 there were 9,395,920 shares of the registrant’s common stock, par value $0.001 per share, outstanding.

 

 

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TABLE OF CONTENTS

 

		Page
PART I — FINANCIAL INFORMATION
Item 1	Financial Statements	5
Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	19
Item 3	Quantitative and Qualitative Disclosures About Market Risk	26
Item 4	Controls and Procedures	26
PART II — OTHER INFORMATION
Item 1	Legal Proceedings	26
Item 1A	Risk Factors	26
Item 2	Unregistered Sales of Equity Securities and Use of Proceeds	28
Item 3	Defaults Upon Senior Securities	28
Item 4	Mine Safety Disclosures	28
Item 5	Other Information	28
Item 6	Exhibits	28

 

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA

 

This Quarterly Report on Form 10-Q (this “Quarterly Report”) contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which reflect our current views with respect to, among other things, our operations and financial performance. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will” or the negative of such terms or other comparable terminology. Forward-looking statements appear in a number of places throughout this Quarterly Report and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ability and plan to develop and commercialize DKN-01 and TRX518; status, timing and results of preclinical studies and clinical trials; the potential benefits of DKN-01 and TRX518; the timing of our development programs and seeking regulatory approval of DKN-01 and TRX518; our ability to obtain and maintain regulatory approval; our estimates of expenses and future revenues and profitability; our estimates regarding our capital requirements and our needs for additional financing; our estimates of the size of the potential markets for DKN-01 and TRX518; our ability to attract collaborators with acceptable development, regulatory and commercial expertise; the benefits to be derived from any collaborations, license agreements, and other acquisition efforts, including those relating to the development and commercialization of DKN-01 and TRX518; sources of revenues and anticipated revenues, including contributions from any collaborations or license agreements for the development and commercialization of products; our ability to create an effective sales and marketing infrastructure if we elect to market and sell DKN-01 and TRX518 directly; the rate and degree of market acceptance of DKN-01 and TRX518; the timing and amount or reimbursement for DKN-01 and TRX518; the success of other competing therapies that may become available; the manufacturing capacity for DKN-01 and TRX518; our intellectual property position; our ability to maintain and protect our intellectual property rights; our results of operations, financial condition, liquidity, prospects, growth and strategies; the industry in which we operate; and the trends that may affect the industry or us.

 

By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics and industry change, and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this Quarterly Report. In addition, even if our results of operations, financial condition and liquidity, and events in the industry in which we operate are consistent with the forward-looking statements contained in this Quarterly Report, they may not be predictive of results or developments in future periods. You should carefully read this Quarterly Report and the documents that we have filed as exhibits to this Quarterly Report completely.

 

You should refer to Part II, Item 1A, Risk Factors in this Quarterly Report and Part I, Item IA, Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2016 as filed with the Securities and Exchange Commission on March 31, 2017 for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Quarterly Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified timeframe, or at all. Any forward-looking statements that we make in this Quarterly Report speaks only as of the date of such statement, and, except to the extent required by applicable law, we undertake no obligation to update such statements to reflect events or circumstances after the date of this Quarterly Report or to reflect the occurrence of unanticipated events. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Quarterly Report. Comparisons of results for current and any prior periods are not intended to express any future trends or indications of future performance, unless expressed as such, and should only be viewed as historical data.

 

DKN-01 and TRX518 are investigational drugs undergoing clinical development and have not been approved by the U.S. Food and Drug Administration (the “FDA”), nor been submitted to the FDA for approval. DKN-01 and TRX518 have not been, and may never be, approved by any regulatory agency or marketed anywhere in the world. Statements contained in this Quarterly Report should not be deemed to be promotional.

 

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INTRODUCTORY COMMENT

 

References to Leap

 

Throughout this Quarterly Report on Form 10-Q, the “Company,” “Leap,” “Leap Therapeutics,” “we,” “us,” and “our,” except where the context requires otherwise, refer to Leap Therapeutics, Inc. and its consolidated subsidiaries, and “our board of directors” refers to the board of directors of Leap Therapeutics, Inc.

 

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Part I — FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

LEAP THERAPEUTICS, INC.

 

CONDENSED CONSOLIDATED BALANCE SHEETS

 

(In thousands, except share and per share amounts)

 

		September 30,			December 31,
		2017			2016
		(Unaudited)
Assets
Current assets:
Cash and cash equivalents		$	14,203		$	793
Research and development incentive receivable		1,894			3,053
Prepaid expenses and other current assets		404			183
Total current assets		16,501			4,029
Property and equipment, net		148			119
Deferred offering costs		—			1,402
Other assets		930			907
Total assets		$	17,579		$	6,457
Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficiency)
Current liabilities:
Accounts payable		$	2,598		$	3,225
Accrued expenses		3,396			2,658
Notes payable and accrued interest - related party		—			30,274
Total current liabilities		5,994			36,157
Commitments and contingencies
Convertible preferred stock, 0 and 42,500,000 shares authorized as of September 30, 2017 and December 31, 2016
Series A redeemable convertible preferred stock, $0.001 par value; 0 and 9,000,000 shares designated as of September 30, 2017 and December 31, 2016, respectively; 0 and 9,000,000 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively; liquidiation preference of $0 and $11,800 as of September 30, 2017 and December 31, 2016, respectively		—			11,800
Series B convertible preferred stock, $0.001 par value; 0 and 21,500,000 shares designated as of September 30, 2017 and December 31, 2016, respectively; 0 and 21,500,000 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively; liquidation preference of $0 and $28,189 as of September 30, 2017 and December 31, 2016, respectively		—			28,189
Series C convertible preferred stock, $0.001 par value; 0 and 12,000,000 shares designated as of September 30, 2017 and December 31, 2017, respectively; 0 and 11,781,984 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively; liquidation preference of $0 and $30,542 as of September 30, 2017 and December 31, 2016, respectively		—			30,542
Stockholders’ equity (deficiency):
Common stock, $0.001 par value; 100,000,000 and 58,500,000 shares authorized as of September 30, 2017 and December 31, 2016, respectively; 9,395,920 and 0 shares outstanding as of September 30, 2017 and December 31, 2016, respectively		9			—
Additional paid-in capital		135,649			145
Accumulated other comprehensive income (loss)		(269		)	294
Accumulated deficit		(123,804		)	(100,670		)
Total stockholders’ equity (deficiency)		11,585			(100,231		)
Total liabilities, convertible preferred stock and stockholders’ equity (deficiency)		$	17,579		$	6,457

 

See notes to condensed consolidated financial statements.

 

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LEAP THERAPEUTICS, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

(In thousands, except share and per share amounts)

 

(Unaudited)

 

		Three Months Ended September 30,						Nine Months Ended September 30,
		2017			2016			2017			2016
Operating expenses:
Research and development		$	6,802		$	5,659		$	18,087		$	15,870
General and administrative		1,780			1,369			7,719			3,495
Total operating expenses		8,582			7,028			25,806			19,365
Loss from operations		(8,582		)	(7,028		)	(25,806		)	(19,365		)
Interest income (expense)		19			(2		)	118			2
Interest expense - related party		—			(380		)	(121		)	(722		)
Australian research and development incentives		961			—			1,852			—
Foreign currency gains		787			133			823			184
Net loss		(6,815		)	$	(7,277	)	(23,134		)	$	(19,901	)
Accretion of preferred stock to redemption value		—						(244		)
Net loss attributable to common stockholders		$	(6,815	)				$	(23,378	)
Net loss per share - basic and diluted		$	(0.73	)				$	(2.72	)
Weighted average common shares outstanding - basic and diluted		9,395,920						8,584,558

 

See notes to condensed consolidated financial statements.

 

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LEAP THERAPEUTICS, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

 

(In thousands)

 

(Unaudited)

 

		Three Months Ended September 30,						Nine Months Ended September 30,
		2017			2016			2017			2016
Net loss		$	(6,815	)	$	(7,277	)	$	(23,134	)	$	(19,901	)
Other comprehensive loss:
Foreign currency translation adjustments		(600		)	(158		)	(563		)	(162		)
Comprehensive loss		$	(7,415	)	$	(7,435	)	$	(23,697	)	$	(20,063	)

 

See notes to condensed consolidated financial statements.

 

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LEAP THERAPEUTICS, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND SHAREHOLDERS’ EQUITY (DEFICIT)

 

(In thousands, except share amounts)

 

(Unaudited)

 

																									Accumulated
		Series A Redeemable					Series B					Series C										Additional			Other						Total
		Convertible Preferred Stock,					Convertible Preferred Stock,					Convertible Preferred Stock,					Common Stock					Paid-in			Comprehensive			Accumulated			Stockholders’
		Shares		Amount			Shares		Amount			Shares		Amount			Shares		Amount			Capital			Loss			Deficit			Deficiency
Balances at December 31, 2016		9,000,000		$	11,800		21,500,000		$	28,189		11,781,984		$	30,542		—		$	—		$	145		$	294		$	(100,670	)	$	(100,231	)
Accretion to redemption value		—		37			—		90			—		117			—		—			(244		)	—			—			(244		)
Conversion of notes payable - related party and accrued interest into common stock		—		—			—		—			—		—			1,950,768		2			31,143			—			—			31,145
Conversion of convertible preferred stock to common stock		(9,000,000	)	(11,837		)	(21,500,000	)	(28,279		)	(11,781,984	)	(30,659		)	3,174,523		3			70,772			—			—			70,775
Issuance of common stock, net of issuance costs of $947		—		—			—		—			—		—			1,010,225		1			9,052			—			—			9,053
Issuance of common stock in connection with merger with Macrocure, net of offering costs of $1,402		—		—			—		—			—		—			3,256,898		3			19,856			—			—			19,859
Issuance of common stock upon exercise of stock options		—		—			—		—			—		—			3,506		—			20			—			—			20
Foreign currency translation adjustment		—		—			—		—			—		—			—		—			—			(563		)	—			(563		)
Stock-based compensation		—		—			—		—			—		—			—		—			4,905			—			—			4,905
Net loss		—		—			—		—			—		—			—		—			—			—			(23,134		)	(23,134		)
Balances at September 30, 2017		—		$	—		—		$	—		—		$	—		9,395,920		$	9		$	135,649		$	(269	)	$	(123,804	)	$	11,585

 

See notes to condensed consolidated financial statements.

 

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LEAP THERAPEUTICS, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

(In thousands)

 

(Unaudited)

 

		Nine Months Ended September 30,
		2017			2016
Cash flows from operating activities:
Net loss		$	(23,134	)	$	(19,901	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense		35			17
Stock-based compensation expense		4,905			27
Non-cash interest expense - related party		121			722
Changes in operating assets and liabilities, net of impact of assumed net assets of Macrocure:
Prepaid expenses and other assets		(148		)	(268		)
Research and development incentive receivable		1,318			—
Accounts payable and accrued expenses		1,135			1,363
Net cash used in operating activities		(15,768		)	(18,040		)
Cash flows from investing activities:
Purchases of property and equipment		(64		)	(136		)
Net cash used in investing activities		(64		)	(136		)
Cash flows from financing activities:
Proceeds from issuance of common stock in connection with merger with Macrocure		21,165			—
Proceeds from the sale of common stock		10,000			—
Proceeds from notes payable - related party		750			18,900
Proceeds from the exercise of stock options		20			—
Payment of deferred offering costs		(2,067		)	—
Net cash provided by financing activities		29,868			18,900
Effect of exchange rate changes on cash and cash equivalents		(626		)	(164		)
Net increase in cash and cash equivalents		13,410			560
Cash and cash equivalents at beginning of period		793			405
Cash and cash equivalents at end of period		$	14,203		$	965
Supplemental disclosure of non-cash financing activities:
Accretion of preferred stock to redemption value		$	244		$	3,483
Deferred offering costs included in accounts payable and accrued expenses		$	—		$	522
Conversion of notes payable - related party and accrued interest into common stock		$	31,145		$	—
Conversion of convertible preferred stock into common stock		$	70,775		$	—
Value of net assets acquired in connection with merger with Macrocure, excluding cash		$	96		$	—

 

See notes to condensed consolidated financial statements.

 

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Leap Therapeutics, Inc.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

(In thousands, except share and per share amounts)

 

(Unaudited)

 

1. Nature of Business, Basis of Presentation and Liquidity

 

Nature of Business

 

Leap Therapeutics, Inc. was incorporated in the state of Delaware as Dekkun Corporation on January 3, 2011 and changed its name to HealthCare Pharmaceuticals, Inc. effective May 29, 2014, and then to Leap Therapeutics, Inc. effective November 16, 2015 (the “Company”). During 2015, HealthCare Pharmaceuticals Pty Ltd. (“HCP Australia”) was formed and is a wholly owned subsidiary of the Company. During January 2017, the Company merged with Macrocure Ltd. (now “Leap Therapeutics Ltd.”) and its wholly-owned subsidiary Macrocure, Inc. (see Note 3).

 

The Company is a biopharmaceutical company acquiring and developing novel therapeutics at the leading edge of cancer biology. The Company’s approach is designed to target compelling tumor-promoting and immuno-oncology pathways to generate durable clinical benefit and enhanced outcomes for patients. The Company’s programs are monoclonal antibodies that target key cellular pathways that enable cancer to grow and spread and specific mechanisms that activate the body’s immune system to identify and attack cancer.

 

Basis of Presentation

 

The accompanying condensed consolidated financial statements as of September 30, 2017 and for the three and nine months ended September 30, 2017 and 2016 have been prepared by the Company, pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2016 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 31, 2017.

 

The condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements. In the opinion of management, the accompanying condensed consolidated financial statements contain all adjustments which are necessary for the fair presentation of the Company’s financial position as of September 30, 2017, statements of operations and statements of comprehensive loss for the three and nine months ended September 30, 2017 and 2016 and statements of cash flows for the nine months ended September 30, 2017 and 2016.  Such adjustments are of a normal and recurring nature. The results of operations for the three and nine months ended September 30, 2017 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2017.

 

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Liquidity and going concern

 

Since inception, the Company has been engaged in organizational activities, including raising capital, and research and development activities. The Company does not yet have a product that has been approved by the Food and Drug Administration (the “FDA”), has not generated any revenues and has not yet achieved profitable operations, nor has it ever generated positive cash flows from operations. There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. Further, the Company’s future operations are dependent on the success of the Company’s efforts to raise additional capital, its research and commercialization efforts, regulatory approval, and, ultimately, the market acceptance of the Company’s products.

 

In accordance with ASC 205-40, Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the condensed consolidated financial statements are issued. As of September 30, 2017, the Company had an accumulated deficit of $123,804.  During the three months ended September 30, 2017, the Company’s second full quarter operating as a public company, the Company incurred a net loss of $6,815 and its cash and cash equivalents decreased by $2,968. The Company expects to continue to generate operating losses in the foreseeable future. The Company had cash and cash equivalents of $14,203 at September 30, 2017. The foregoing matters give rise to a substantial doubt about the Company’s ability to continue as a going concern for one year after the Company’s financial statements have been issued. The Company will seek additional funding through public or private equity financings or government programs and will seek funding or development program cost-sharing through collaboration agreements or licenses with larger pharmaceutical or biotechnology companies. If the Company does not obtain additional funding or development program cost-sharing, the Company will be forced to delay, reduce or eliminate certain clinical trials or research and development programs, reduce or eliminate discretionary operating expenses, and delay company and pipeline expansion, which would adversely affect its business prospects. The inability to obtain funding, as and when needed, would have a negative impact on the Company’s financial condition and ability to pursue its business strategies.

 

2. Summary of Significant Accounting Policies

 

Principles of Consolidation

 

The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions are eliminated in the consolidation.

 

Use of Estimates

 

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

 

Research and development incentive income and receivable

 

The Company recognizes other income from Australian research and development incentives when there is reasonable assurance that the income will be received, the relevant expenditure has been incurred, and the consideration can be reliably measured. The research and development incentive is one of the key elements of the Australian Government’s support for Australia’s innovation system and is supported by legislative law primarily in the form of the Australian Income Tax Assessment Act 1997, as long as eligibility criteria are met.

 

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Management has assessed the Company’s research and development activities and expenditures to determine which activities and expenditures are likely to be eligible under the research and development incentive regime described above. At each period end, management estimates the refundable tax offset available to the Company based on available information at the time.

 

Under the program, a percentage of eligible research and development expenses incurred by the Company through its subsidiary in Australia are reimbursed.  The percentage was 45% for the year ended December 31, 2016 and 43.5% for the nine months ended September 30, 2017.

 

The research and development incentive receivable represents an amount due in connection with the above program. The Company has recorded a research and development incentive receivable of $1,894 and $3,053 as of September 30, 2017 and December 31, 2016, respectively, in the condensed consolidated balance sheets and other income from Australian research and development incentives of $961 and $1,852, in the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2017, respectively, related to refundable research and development incentive program payments in Australia.  The Company did not have other income from Australian research and development incentives for the three and nine months ended September 30, 2016.

 

The following table shows the change in the research and development incentive receivable from December 31, 2016 to September 30, 2017:

 

Balance at December 31, 2016:		$	3,053
Australian research and development incentive income		1,852		(1)
Cash received for 2016 eligible expenses		(3,245		)
Foreign currency translation		234
Balance at September 30, 2017		$	1,894

 

(1) Certain supporting research and development activity is performed outside of Australia when there are no Australian facilities that support the activity (“Overseas research and development activities”).  In October 2017, the Commonwealth of Australia issued the Company a favorable ruling on its Overseas research and development activities, considering such activities to be eligible research and development activities under the Australian Incentive Program.  As such, the Company recorded Australian research and development incentives during the three months ended September 30, 2017 for its Overseas research and development activities performed during the year ended December 31, 2016 and the six months ended June 30, 2017, of $347 and $412, respectively.

 

Foreign Currency Translation

 

The financial statements of the Company’s foreign subsidiary are measured using the local currency as the functional currency. Assets and liabilities of this subsidiary are translated into U.S. dollars at exchange rates as of the consolidated balance sheet date. Equity is translated at historical exchange rates. Revenues and expenses are translated into U.S. dollars at average rates of exchange in effect during the year. The resulting cumulative translation adjustments have been recorded as a separate component of stockholders’ equity (deficiency). Realized foreign currency transaction gains and losses are included in the results of operations.

 

Deferred Offering Costs

 

The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings as deferred offering costs until such financings are consummated. After consummation of the equity financing, these costs are recorded in stockholders’ equity (deficiency) as a reduction of additional paid-in capital generated as a result of the offering. As of December 31, 2016, the Company had recorded $1,402 of deferred offering costs in contemplation of the merger with Macrocure Ltd. and in substance recapitalization of the Company.  On January 23, 2017, the Company reclassified $1,402 of deferred offering costs to additional paid-in capital as a reduction of the proceeds from the merger with Macrocure Ltd. and in substance recapitalization of the Company (see Note 3).

 

Other Assets

 

Other assets as of September 30, 2017 and December 31, 2016 included $895 and $907, respectively, of deposits made by the Company with certain service providers that are to be applied to future payments due under the service agreements or returned to the Company if not utilized.  In addition, as of September 30, 2017, other assets included a deposit of $35 related to the operating lease for the Company’s office space in Cambridge, Massachusetts.

 

Net Loss per Share

 

Basic net loss per share is computed using the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed using the weighted average number of common shares outstanding during the period and, if dilutive, the weighted average number of potential shares of common stock, including the assumed exercise of stock options. There were no common shares outstanding during the three and nine months ended September 30, 2016, and accordingly, basic and diluted net loss per share is not presented for those periods.

 

Reclassifications

 

Certain prior period amounts have been reclassified for consistency with the current period presentation.  These reclassifications had no effect on previously reported results of operations.  During the three months ended March 31, 2017, the Company made a policy election to classify foreign exchange gains and losses as other income (expense), rather than general and administrative expenses, in its consolidated statement of operations on a prospective basis.  The reclassification had no impact on the Company’s previously reported financial position or cash flows.

 

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New Accounting Pronouncements

 

The Company’s significant accounting policies are described in Note 2, “Summary of Significant Accounting Policies”, in the Company’s previously filed Annual Report on Form 10-K for the year ended December 31, 2016. Summarized below are the accounting pronouncements adopted subsequent to December 31, 2016.

 

Effective January 1, 2017, the Company adopted ASU 2016-09, Improvements to Employee Share-Based Payment Accounting (ASU 2016-09) which simplifies the accounting for employee share-based payment transactions, including the accounting for income taxes, forfeitures and statutory tax withholding requirements, as well as classification in the statement of cash flows.  The adoption of the new guidance had no impact on the Company’s condensed consolidated financial statements.

 

Effective January 1, 2017, the Company adopted ASU 2015-17, Balance Sheet Classification of Deferred Taxes (ASU 2015-17), which requires that all deferred tax assets and liabilities, along with any related valuation allowance, be classified as noncurrent on the balance sheet.  The adoption of the new guidance had no impact on the Company’s condensed consolidated financial statements.

 

3. Merger with Macrocure and Related Transactions

 

Merger with Macrocure Ltd.

 

The Company entered into a definitive merger agreement (the “Merger Agreement”), dated as of August 29, 2016, with Macrocure Ltd. (“Macrocure”), a publicly held, clinical-stage biotechnology company based in Petach Tikva, Israel, and M-Co Merger Sub Ltd. (“Merger Sub”), a wholly owned subsidiary of the Company which provided for the merger of Macrocure with and into Merger Sub, with Macrocure continuing after the merger as a wholly owned subsidiary of the Company.

 

On January 23, 2017, the Company issued 3,256,898 shares of its common stock, net of fractional shares paid in cash, in exchange for 100% of the outstanding ordinary shares of Macrocure Ltd. upon consummation of the merger. Pursuant to the terms of the merger agreement, each holder of Macrocure’s ordinary shares received approximately 0.1815 shares of the Company’s common stock, plus cash in lieu of fractional shares based on a value of the Company’s common stock of $9.90 per share. The exchange ratio was based on a final net cash calculation, as of the closing, of $21,875. The merger was accounted for as an in-substance recapitalization of the Company, as the transaction was, in essence, an exchange of shares of the Company’s common stock (and options and warrants exercisable therefor) for cash. Apart from cash, the net assets acquired were $96, and all Macrocure employees were terminated as of the effective time of the merger. Macrocure’s cash and nominal assets and liabilities were measured and recognized at their fair values as of the date of the merger, and combined with the assets, liabilities and results of operations of the Company.

 

All Macrocure stock options granted under the Macrocure stock option plans (whether or not then exercisable) and all warrants to purchase Macrocure ordinary shares that were outstanding prior to the effective time of the merger became options and warrants, respectively, to purchase the Company’s common stock equal to the number of ordinary shares of Macrocure issuable upon exercise of such stock options and warrants multiplied by the exchange ratio, with a corresponding exercise price equal to the exercise price of such stock options or warrants divided by the exchange ratio. All outstanding and unexercised Macrocure stock options and warrants assumed by the Company may be exercised solely for shares of the Company’s common stock.

 

Vesting of all unvested Macrocure equity awards issued and outstanding was accelerated at the effective time of the merger, and all such equity awards issued and outstanding at the time of the merger remained issued and outstanding. For accounting purposes, since the acceleration of vesting was negotiated in contemplation of the merger, the remaining unrecognized compensation expense associated with the original grant date fair value of the awards of $280 was recognized as a charge in the Company’s condensed consolidated statement of operations and comprehensive loss for the nine months ended September 30, 2017. In addition, the exercise period for all Macrocure options outstanding at the effective time of the merger was extended beyond the respective periods provided in the original awards. The Company recorded a charge of $504 in connection with the extension of the exercise periods in the unaudited consolidated statement of operations and comprehensive loss for the nine months ended September 30, 2017 equal to the difference in the fair value of the options immediately prior to and immediately following the modification of the exercise period.

 

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In connection with the merger, the Company applied to be listed on the NASDAQ Global Market. NASDAQ approved the listing, and trading in the Company’s common stock commenced on January 24, 2017, under the trading symbol “LPTX”.

 

Recapitalization and Amendments to Certificate of Incorporation

 

On January 20, 2017, in connection with and prior to the completion of the merger with Macrocure, (a) all of the Company’s outstanding shares of convertible preferred stock were converted into 3,174,523 shares of common stock, (b) the outstanding note payable and accrued interest was converted into 1,950,768 shares of common stock, and (c) the Company amended and restated its certificate of incorporation and bylaws to, among other things: (i) authorize 100,000,000 shares of common stock; (ii) eliminate all references to the previously existing series of the Company’s preferred stock; (iii) authorize 10,000,000 shares of undesignated preferred stock that may be issued from time to time by the Company’s board of directors and (iv) effect a one for 19.86754 reverse stock split of the Company’s common stock outstanding immediately prior to the filing of the amended and restated certificate of incorporation.

 

Subscription Agreement

 

On January 20, 2017, prior and subject to the consummation of the merger, the Company and HealthCare Ventures IX, L.P. (“HCV IX”) entered into a subscription agreement pursuant to which HCV IX purchased 1,010,225 shares of the Company’s common stock for $10,000, at a purchase price per share of $9.90.

 

Stock Option Grants

 

On January 20, 2017, in connection with the consummation of the merger with Macrocure, the Company made an option grant to each of three executives to purchase 330,303 of shares of common stock, for a total of 990,909 shares of common stock, pursuant to our Amended and Restated 2012 Equity Incentive Plan. The options were granted at an exercise price $9.90 per share. The options will vest 33% on the first anniversary of the date of grant, and thereafter in equal monthly installments over a period of two years, generally subject to the executive’s continued employment.

 

Royalty Agreement and Letter Agreement

 

On January 23, 2017, immediately prior to the merger, the Company entered into a royalty agreement with Leap Shareholder Royalty Vehicle, LLC, a Delaware limited liability company (the “Royalty Vehicle”), a special purpose vehicle formed for the specific purpose of entering into the royalty agreement. In connection with the transactions contemplated by the merger agreement, the Company declared a special distribution of certain royalty rights to each of its holders of common stock outstanding immediately prior to the effective time of the merger. These holders collectively beneficially owned or controlled 100% of the Company’s outstanding common stock at the time of the merger. Pursuant to the royalty agreement, the Company will pay to the special purpose vehicle (i) 5% of the Company’s net sales of products incorporating its TRX518 compound and (ii) 2% of the Company’s net sales of products incorporating its DKN-01 compound. The royalty agreement has an indefinite term, and neither the Company nor the special purpose vehicle has the right to terminate. The Company accounted for the royalty rights as a contingent liability.

 

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4. Accrued Expenses

 

Accrued expenses consist of the following:

 

		September 30,			December 31,
		2017			2016
Clinical trials		$	2,593		$	2,545
Professional fees		120			88
Payroll and related expenses		683			25
Accrued expenses		$	3,396		$	2,658

 

5. Notes Payable—Related Party

 

During 2014, the Company entered into a convertible promissory note with a stockholder, and made multiple drawdowns under the note throughout 2014 and 2015.  The note accrued interest at a rate of 8% per year until the principal of the note was either repaid or otherwise converted. During 2016, the Company made additional drawdowns under the convertible promissory note totaling $25,900, and as of December 31, 2016, the Company owed $29,000 aggregate principal and $1,274 of accrued interest in connection with the promissory note.  Interest expense from the related-party note was $0 and $380 for the three months ended September 30, 2017 and 2016, respectively, and $121 and $722 for the nine months ended September 30, 2017 and 2016, respectively. The accrued interest as of December 31, 2016 of $1,274 is included in note payable and accrued interest-related party in the accompanying condensed consolidated balance sheet as of December 31, 2016.

 

On January 13, 2017, the Company received aggregate proceeds of $750 from an amendment and restatement of the promissory note.  On January 20, 2017, in accordance with its terms and in connection with and prior and subject to the consummation of the merger with Macrocure, the outstanding note payable, including principal and accrued interest totaling $31,145, was converted into 1,950,768 shares of common stock.

 

6. Equity Incentive Plans

 

Equity Incentive Plans

 

In September 2012, the Company adopted the 2012 Equity Incentive Plan, as amended (the “Plan”), which provides designated employees of the Company and its affiliates, certain consultants and advisors who perform services for the Company and its affiliates, and nonemployee members of the Board of Directors of the Company and its affiliates with the opportunity to receive grants of incentive stock options, nonqualified stock options and stock awards. As of December 31, 2016, the aggregate number of shares of common stock of the Company that may be issued under the Plan was 61,483. As of December 31, 2016, 17,963 shares remained available for future grant under the Plan.

 

On January 20, 2017, the Company’s stockholders approved the amended and restated 2012 Equity Incentive Plan (the “2012 Plan”), which amended and restated the Plan and was effective in connection with the completion of the Company’s merger with Macrocure. A total of 1,387,204 shares of common stock were reserved for issuance under the 2012 Plan.  As of September 30, 2017, no shares remained available for future grant under the 2012 Plan.

 

On January 20, 2017, the Company’s stockholders approved the 2016 Equity Incentive Plan (the “2016 Plan”), which was effective in connection with the completion of the Company’s merger with Macrocure. The number of shares of common stock issuable pursuant to outstanding awards granted under the 2016 Plan may not exceed the number that is equal to the sum of (i) 854,321 shares of common stock plus (ii) the number of shares of common stock (not to exceed 103,023 shares) subject to out-of-the-money options issued by Macrocure prior to the closing of the merger and assumed by the Company pursuant to the merger agreement upon consummation of the merger that expire unexercised. Beginning on January 1, 2018, the number of shares of common stock authorized for issuance pursuant to the 2016 Plan will be increased each January 1 by an amount equal to four percent (4%) of the Company’s outstanding common stock as of the end of the immediately preceding calendar year or such other amount as determined by the compensation committee of the Company’s Board of Directors.

 

In connection with the merger with Macrocure in January 2017, the Company assumed the Macrocure 2013 Share Incentive Plan (the “2013 Plan”), the Macrocure 2008 Stock Option Plan (the “2008 Plan”) and all stock options outstanding under each of the 2013 Plan and the 2008 Plan immediately prior to the consummation of the merger.  By virtue of the terms of the Merger Agreement and the 2013 Plan or the 2008 Plan, as applicable, each stock option outstanding immediately prior to the consummation of the merger was automatically converted into a stock option exercisable for a number of shares of the Company’s common stock calculated based on the exchange ratio and the exercise price per share of such outstanding stock option.

 

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The Company could also make awards of restricted stock under the 2012 Plan and the 2016 Plan (together, the “Equity Plans”). Restricted stock may be issued under the Equity Plans for such consideration, in cash, other property or services, or any combination thereof, as is determined by the Board of Directors. During the restriction period applicable to the shares of restricted stock, such shares shall be subject to limitations on transferability, subject to forfeiture or repurchase by the Company and/or subject to other terms and conditions. Upon lapse of such restrictions, the stock certificates representing shares of common stock shall be delivered to the grantee.

 

A summary of activity under the Equity Plans is as follows:

 

				Weighted
				Average		Weighted		Aggregate
				Exercise Price		Average Remaining		Intrinsic
		Options		Per Share		Life in Years		Value
Outstanding at December 31, 2016		53,228		$4.93		7.00
Granted		1,825,858		$13.81
Exercised		(3,506	)	$5.55
Forfeited		(12,959	)	$5.78
Outstanding at September 30, 2017		1,862,621		$13.63		8.65		$36
Options exercisable at September 30, 2017		692,103		$20.01		7.53		$35
Options vested and expected to vest at September 30, 2017		1,862,621		$13.63		8.65		$36

 

The Company did not grant any stock options during the nine months ended September 30, 2016. The grant date fair value of the options granted during the nine months ended September 30, 2017 was estimated at the date of grant using the Black-Scholes option valuation model. The expected life was estimated using the “simplified” method as defined by the Securities and Exchange Commission’s Staff Accounting Bulletin 107, Share-Based Payment. The expected volatility was based on the historical volatility of comparable public companies from a representative peer group selected based on industry and market capitalization data. The risk-free interest rate was based on the continuous rates provided by the U.S. Treasury with a term approximating the expected life of the option. The expected dividend yield was 0% because the Company does not expect to pay any dividends for the foreseeable future. The Company elected the straight-line attribution method in recognizing the grant date fair value of options issued over the requisite service periods of the awards, which are generally the vesting periods.

 

Stock options generally vest over a three or four year period, as determined by the Compensation Committee of the Board of Directors at the time of grant. The options expire ten years from the grant date. As of September 30, 2017, there was approximately $5,844 of unrecognized compensation cost related to non-vested stock options, which is expected to be recognized over a remaining weighted-average period of approximately 2.4 years.

 

The Company recognized stock-based compensation expense related to the issuance of stock option awards to employees and non-employees in the condensed consolidated statements of operations and comprehensive loss as follows:

 

		Three Months Ended September 30,						Nine Months Ended September 30,
		2017			2016			2017			2016
Research and development		$	42		$	7		$	1,758		$	21
General and administrative		607			2			3,147			6
Total		$	649		$	9		$	4,905		$	27

 

7. Net Loss Per Share

 

There were no common shares outstanding during the three and nine months ended September 30, 2016, and accordingly, the Company has not presented basic and diluted net loss per share for those periods.  Basic and diluted net loss per share for the three and nine months ended September 30, 2017 was calculated as follows:

 

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		Three Months			Nine Months
		Ended September 30,			Ended September 30,
		2017			2017
Numerator:
Net loss		$	(6,815	)	$	(23,134	)
Accretion of preferred stock to redemption value		—			(244		)
Net loss attributable to common stockholders		$	(6,815	)	$	(23,378	)
Denominator:
Weighted average number of common shares outstanding - basic and diluted		9,395,920			8,584,558
Net loss per share attributable to common stockholders - basic and diluted		$	(0.73	)	$	(2.72	)

 

The Company’s potentially dilutive securities include stock options and convertible preferred stock. These securities were excluded from the computations of diluted net loss per share for the three and nine months ended September 30, 2017 and would have been excluded from the computations for the three and nine months ended September 30, 2016, as the effect would be to reduce the net loss per share. The following table includes the potential common shares, presented based on amounts outstanding at each period end, that were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:

 

		Three Months Ended September 30,				Nine Months Ended September 30,
		2017		2016		2017		2016
Options to purchase common stock		1,862,621		53,228		1,862,621		53,228
Warrants assumed from Macrocure		54,516		—		54,516		—
Convertible preferred stock and accrued dividends (as converted to common stock)		—		3,491,291		—		3,491,291
		1,917,137		3,544,519		1,917,137		3,544,519

 

In addition to the potentially dilutive securities noted above, as of September 30, 2016, the Company had outstanding notes payable—related party for which principal and unpaid accrued interest due under the notes will automatically be converted into the class of the Company’s stock issued in the Company’s next qualified financing, as defined, based on a conversion price equal to the price per share paid by the investors in the financing. Because the necessary conditions for conversion of the notes had not been met during the three and nine months ended September 30, 2016, these notes were excluded from the table above.  On January 20, 2017, in connection with and prior to the completion of the merger with Macrocure, the Company’s Charter and Bylaws were amended to reflect the conversion of all outstanding shares of the Company’s convertible preferred stock into 3,174,523 shares of common stock, and to reflect the conversion of the outstanding note payable and accrued interest into 1,950,768 shares of common stock.

 

8. Commitments and Contingencies

 

Lease Agreement—Effective January 1, 2017, the Company entered into an assignment agreement to assume an operating lease for its office space in Cambridge, Massachusetts. Annual rent under the lease, exclusive of operating expenses and real estate taxes, will be $289 for the 12-month period ending July 31, 2017, increasing to $297 for the 12-month period ending July 31, 2018 and increasing to $305 for the period ending April 30, 2019. The lease agreement expires April 30, 2019, and the Company has the option to extend the term through April 30, 2022.

 

Manufacturing Agreements—The Company is party to manufacturing agreements with vendors to manufacture TRX518 and DKN-01, our lead product candidates, for use in clinical trials. As of September 30, 2017, noncancelable commitments under these agreements totaled $3,267.

 

License and Service Agreement—On January 3, 2011, the Company entered into a license agreement with Eli Lilly and Company (“Lilly”) to grant a license to the Company for certain intellectual property rights relating to pharmaceutically active compounds that may be useful in the treatment of bone healing, cancer and, potentially, other medical conditions. The Company previously issued 9,000,000 shares of Series A Stock to Lilly in consideration for the grant of the license. As defined in the license agreement, the Company would be required to pay royalties to Lilly based upon a percentage in the low single digits of net sales of developed products, if and when achieved. However, there can be no assurance that clinical or commercialization success of developed products will occur, and no royalties have been paid or accrued through September 30, 2017.

 

License Agreement—On May 28, 2015, the Company entered into a license agreement with Lonza Sales AG (“Lonza”), pursuant to which Lonza granted the Company a world-wide, non-exclusive license for certain intellectual property relating to a gene expression system for manufacturing DKN-01. As defined in the license agreement, the Company would be required to pay royalties to Lonza based on a percentage in the low single digits of net sales of DKN-01, if and when achieved. However, there can be no assurance that clinical or commercialization success will occur, and no royalties have been paid or accrued through September 30, 2017.

 

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Legal Proceedings—At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses as incurred the costs related to its legal proceedings.

 

A patent covering TRX518 and its uses was granted to the Company by the European Patent Office. Three notices of opposition to this patent were filed by two major pharmaceutical companies and an individual, possibly on behalf of a major pharmaceutical company. At the conclusion of the opposition proceedings in 2016, the Opposition Division of the European Patent Office that heard the case issued an interlocutory decision indicating that the Company’s patent should be maintained with modified claims that differ from the claims as originally granted. These claims cover the TRX518 antibody and uses of TRX518 in a method of enhancing an immune response in a subject. In July 2016, the Company filed an appeal of the decision of the Opposition Division seeking to obtain broader claims that more closely reflect the claims as granted in the patent. The Board of Appeal has not scheduled a date for the appeal hearing. The Company is appealing the decision of the Opposition Division of the European Patent Office.

 

In 2016, a patent covering the use of TRX518 in combination with a chemotherapeutic agent for treating cancer was granted to the Company by the European patent office. In March 2017, notices of opposition to this patent were filed by ten different entities, including several major pharmaceutical companies. The Company intends to defend the patent as granted through opposition proceedings.

 

Indemnification Agreements—In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not aware of any claims under indemnification arrangements, and it has not accrued any liabilities related to such obligations in its condensed consolidated financial statements as of September 30, 2017 or December 31, 2016.

 

9. Related Party Transactions

 

During the three and nine months ended September 30, 2016, the Company reimbursed an entity related to one of its stockholders for shared office space and office related expenses. The total amount charged to the Company was approximately $86 and $213 in the three and nine months ended September 30, 2016, respectively.  Effective January 1, 2017, the Company entered into an assignment agreement to assume the operating lease for its office space in Cambridge, Massachusetts, and accordingly, the Company was not required to reimburse the related party during the three and nine months ended September 30, 2017.

 

During the three and nine months ended September 30, 2016 and the nine months ended September 30, 2017, the Company executed promissory notes with stockholders (See Note 5).

 

The Company has a license agreement with a stockholder (See Note 8).

 

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

 

The following Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) is intended to help the reader understand our results of operations and financial condition. This MD&A is provided as a supplement to, and should be read in conjunction with, our condensed consolidated financial statements and the accompanying notes thereto and other disclosures included in this Quarterly Report on Form 10-Q, including the disclosures under Part II, Item IA “Risk Factors”, and our audited condensed consolidated financial statements and the accompanying notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2016, which was filed with the Securities and Exchange Commission, or the SEC, on March 31, 2017. Our condensed consolidated financial statements have been prepared in accordance with U.S. GAAP and, unless otherwise indicated, amounts are presented in U.S. dollars.

 

Company Overview

 

We are a biopharmaceutical company acquiring and developing novel therapeutics at the leading edge of cancer biology. Our approach is designed to target compelling tumor-promoting and immuno-oncology pathways to generate durable clinical benefit and enhanced outcomes for patients. Our programs are monoclonal antibodies that target key cellular pathways that enable cancer to grow and spread and specific mechanisms that activate the body’s immune system to identify and attack cancer. Our two clinical stage programs are:

 

·    DKN-01:  A monoclonal antibody targeting Dickkopf-related protein 1, or DKK1. DKK1 is a protein that regulates the Wnt signaling pathways, and has an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment. DKN-01 has been engineered to bind to DKK1 and to generate an anti-tumor effect through altering the Wnt signaling pathways and the immune tumor microenvironment. We are testing DKN-01 in ongoing clinical trials in patients with esophagogastric cancer and biliary tract cancer. We have studied DKN-01 as a monotherapy in patients with non-small cell lung cancer. Based on the patient responses and clinical benefit in these trials, we are also studying or planning to study DKN-01 in patients with Wnt pathway alterations with gastric cancer, hepatocellular carcinoma, or endometrial cancer, and in combination with immune checkpoint inhibitors, such as Merck’s KEYTRUDA ® (pembrolizumab) or Roche’s TECENTRIQ ® (atezolizumab).

 

·    TRX518:  A monoclonal antibody targeting the glucocorticoid-induced tumor necrosis factor-related receptor, or GITR, a receptor found on the surface of a wide range of immune cells. TRX518 has been specifically engineered to enhance the immune system’s anti-tumor response by activating GITR signaling, or GITR agonism, to activate tumor fighting white blood cells, or T effector cells, and decrease the activity of potentially tumor-protective white blood cells, or T regulatory cells, without causing the immune cells to be destroyed. We believe GITR is an ideal immune system agonist target through this two-pronged approach of stimulating an anti-tumor response and reducing immune suppression. We are conducting two clinical trials of TRX518 in patients with advanced solid tumors and have evidence of biomarker modulation and clinical activity. Based on the results seen in these trials, we are planning to evaluate the combination of TRX518 with a chemotherapy, gemcitabine, and in combination with immune checkpoint inhibitors in patients with advanced solid tumors.

 

We intend to apply our extensive experience identifying and developing transformational products to aggressively develop these antibodies and build a pipeline of programs that has the potential to change the practice of cancer medicine.

 

Recent Developments

 

During the three month period ended September 30, 2017, we made progress with the clinical development of our product candidates:

 

DKN-01:

 

·      Announced updated clinical efficacy data from the P102 clinical trial evaluating DKN-01 in combination with paclitaxel in patients with advanced relapsed or refractory esophagogastric cancer. The recent data indicated that 26% of patients on combination therapy had a partial response. When analyzed by prior taxane experience, patients had a response rate of 40.9% and 12.5%, a disease control rate of 72.7% and 45.8%, and a median progression-free survival of 17.0 and 9.7 weeks, in taxane-naïve patients and taxane-experienced patients, respectively. A patient on DKN-01 monotherapy achieved a partial response by central imaging analysis and has been on therapy for over 1 year. Enrollment in the study continues.

 

·      Announced a collaborative-group sponsored study with the European Organisation for Research and Treatment of Cancer (EORTC) and Roche to evaluate DKN-01 in combination with TECENTRIQ ® (atezolizumab), a PD-L1 antagonist, ± paclitaxel in patients with advanced esophagogastric cancer or biliary tract cancer.

 

·      Filed an IND application with the FDA to initiate a clinical trial of DKN-01 in patients with gynecological malignancies, a population known to have a high frequency of Wnt pathway mutations.

 

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TRX518:

 

·      Announced clinical data from the 003 repeat-dose clinical trial evaluating TRX518 monotherapy in patients with advanced solid tumors. The Part B expansion cohort has been fully enrolled and as of August 31 2017, 50% of patients experienced a best response of stable disease, 25% had progressive disease, and 25% were non-evaluable for response. Patient follow-up, biopsy, and biomarker analysis are ongoing. Signs of pharmacodynamic activity including CD8+ T cell activation have been observed.

 

·      Announced the first combination study evaluating TRX518 in combination with a chemotherapy, gemcitabine, or in combination with immune checkpoint inhibitors in patients with advanced solid tumors.

 

Financial Overview

 

Research and Development Expenses

 

Our research and development activities have included conducting nonclinical studies and clinical trials, manufacturing development efforts and activities related to regulatory filings for DKN-01 and TRX518. We recognize research and development expenses as they are incurred. Our research and development expenses consist primarily of:

 

·            salaries and related overhead expenses for personnel in research and development functions, including costs related to stock-based compensation;

 

·            fees paid to consultants and CROs for our nonclinical and clinical trials, and other related clinical trial fees, including but not limited to laboratory work, clinical trial database management, clinical trial material management and statistical compilation and analysis;

 

·            costs related to acquiring and manufacturing clinical trial material; and

 

·            costs related to compliance with regulatory requirements.

 

We plan to increase our research and development expenses for the foreseeable future as we continue the development of DKN-01, TRX518 and any other product candidates, subject to the availability of additional funding.

 

Our direct research and development expenses are tracked on a program-by-program basis and consist primarily of internal and external costs, such as employee costs, including salaries and stock-based compensation, other internal costs, fees paid to consultants, central laboratories, contractors and CROs in connection with our clinical and preclinical trial development activities. We use internal resources to manage our clinical and preclinical trial development activities and perform data analysis for such activities.

 

We participate, through our subsidiary in Australia, in the Australian government’s research and development (“R&D”) Incentive program, such that a percentage of our eligible research and development expenses are reimbursed by the Australian government as a refundable tax offset and such incentives are reflected as other income.

 

The table below summarizes our research and development expenses incurred by development program and the R&D Incentive income for the three and nine months ended September 30, 2017 and 2016:

 

		Three Months Ended September 30,						Nine Months Ended September 30,
		2017			2016			2017			2016
		(in thousands)
Direct research and development by program:
DKN-01 program		$	4,821		$	1,994		$	12,413		$	10,159
TRX518 program		1,981			3,665			5,674			5,711
Total research and development expenses		$	6,802		$	5,659		$	18,087		$	15,870
Australian research and development incentives		$	961		$	—		$	1,852		$	—

 

The successful development of our clinical product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing or costs of the efforts that will be necessary to complete the remainder of the development of any of our product candidates or the period, if any, in which material net cash inflows from these product candidates may commence. This is due to the numerous risks and uncertainties associated with developing drugs, including the uncertainty of:

 

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·            the scope, rate of progress and expense of our ongoing, as well as any additional, clinical trials and other research and development activities;

 

·            future clinical trial results; and

 

·            the timing and receipt of any regulatory approvals.

 

A change in the outcome of any of these variables with respect to the development of a product candidate could result in a significant change in the costs and timing associated with the development of that product candidate. For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate will be required for the completion of clinical development of a product candidate, or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development.

 

General and Administrative Expenses

 

General and administrative expenses consist primarily of salaries and related costs, including stock-based compensation, for personnel in executive, finance and administrative functions. General and administrative expenses also include direct and allocated facility-related costs as well as professional fees for legal, patent, consulting, accounting and audit services.

 

We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued research activities and development of our product candidates. We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance, director and officer insurance costs as well as investor and public relations expenses associated with being a public company.

 

Interest income

 

Interest income consists primarily of interest income earned on cash and cash equivalents. Our interest income has not been significant due to nominal cash and investment balances prior to the Macrocure merger and low interest earned on invested balances.

 

Interest expense—related party

 

Interest expense consists of interest accrued on notes payable—related party that we issued during 2017, 2016 and 2015. On January 20, 2017, prior and subject to the consummation of our merger with Macrocure, all of our notes payable and accrued interest were converted into 1,950,768 shares of common stock.

 

Research and development incentive income

 

Research and development incentive income includes payments under the R&D Incentive program from the government of Australia. The R&D Incentive is one of the key elements of the Australian Government’s support for Australia’s innovation system. It was developed to assist businesses to recover some of the costs of undertaking research and development. The research and development tax incentive provides a tax offset to eligible companies that engage in research and development activities.

 

Companies engaged in research and development may be eligible for either:

 

·            a 45% refundable tax offset for entities with an aggregated turnover of less than A$20 million per annum, (the legislative rate for the tax year commencing July 1, 2016 will be reduced to 43.5%), or

 

·            a 40% non-refundable tax offset for all other entities (the legislative rate for the tax year commencing July 1, 2016 will be reduced to 38.5%).

 

We recognize as income the amount we expect to be reimbursed for qualified expenses. We commenced recognizing expected reimbursements as income during the three months ended December 31, 2016, based upon the applicable percentage of eligible research and development activities under the Australian Incentive Program.

 

Foreign currency translation adjustment

 

Foreign currency translation adjustment consists of gains (losses) due to the revaluation of foreign currency transactions attributable to changes in foreign currency exchange rates associated with our Australian subsidiary.

 

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Critical Accounting Policies and Estimates

 

Our condensed consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States, or GAAP. The preparation of our financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue, costs and expenses, and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis.

 

Our actual results may differ from these estimates under different assumptions or conditions. During the nine months ended September 30, 2017, there were no material changes to our critical accounting policies. Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations— Critical Accounting Policies and Significant Judgments and Estimates” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 31, 2017 and the notes to the condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q. We believe that of our critical accounting policies, the following accounting policies involve the most judgment and complexity:

 

·            accrued research and development expenses

 

·            research and development incentive receivable; and

 

·            stock-based compensation

 

Results of Operations

 

Comparison of the Three Months Ended September 30, 2017 and 2016

 

The following table summarizes our results of operations for the three months ended September 30, 2017 and 2016:

 

		Three Months Ended September 30,
		2017			2016			Change
		(in thousands)
Operating expenses:
Research and development		$	6,802		$	5,659		$	1,143
General and administrative		1,780			1,369			411
Total operating expenses		8,582			7,028			1,554
Loss from operations		(8,582		)	(7,028		)	(1,554		)
Interest income (expense)		19			(2		)	21
Interest expense - related party		—			(380		)	380
Australian research and development incentives		961			—			961
Foreign currency gains		787			133			654
Net loss		$	(6,815	)	$	(7,277	)	$	462

 

Research and Development Expenses

 

		Three Months Ended September 30,						Increase
		2017			2016			(Decrease)
		(in thousands)
Direct research and development by program:
DKN-01 program		$	4,821		$	1,994		$	2,827
TRX518 program		1,981			3,665			(1,684		)
Total research and development expenses		$	6,802		$	5,659		$	1,143
Australian research and development incentives		$	961		$	—		$	961

 

Research and development expenses were $6.8 million for the three months ended September 30, 2017, compared to $5.7 million for the three months ended September 30, 2016. The increase of $1.1 million was primarily due to an increase of $1.1 million in clinical trial costs, an increase of $0.2 million in consulting fees associated with research and development activities and an increase in rent expense of $0.1 million due to our use of a research laboratory.  These increases were partially offset by a decrease of $0.3 million in manufacturing costs related to clinical trial material.

 

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General and Administrative Expenses

 

General and administrative expenses were $1.8 million for the three months ended September 30, 2017, compared to $1.4 million for the three months ended September 30, 2016. The increase of $0.4 million in general and administrative expenses was primarily due to an increase of $0.6 million of stock based compensation expense and an increase of $0.3 million in payroll and other related expenses due to an increase in headcount related to general and administrative full time employees for the three months ended September 30, 2017 as compared to the same period in 2016.  These increases were partially offset by a $0.5 million decrease in legal, audit and consulting fees associated with corporate and business development activities.

 

Interest Income

 

We recorded an immaterial amount of interest income for both the three months ended September 30, 2017 and 2016.

 

Interest Expense—Related Party

 

We recorded interest expense—related party of $0 for the three months ended September 30, 2017 compared to $0.4 million for the three months ended September 30, 2016 related to borrowings under our note payable—related party.   On January 20, 2017, in connection with and prior to the completion of the merger with Macrocure, the outstanding note payable and accrued interest was converted into 1,950,768 shares of common stock.

 

Australian Research and Development Incentives

 

We recorded R&D incentive income of $1.0 million in the three months ended September 30, 2017, based upon the applicable percentage of eligible research and development activities under the Australian Incentive Program, which expenses included the cost of manufacturing clinical trial material.  We did not record any R&D incentive income during the three months ended September 30, 2016.

 

We perform certain supporting research and development activity outside of Australia when there are no Australian facilities that support the activity (“Overseas research and development activities”).  In October 2017, the Commonwealth of Australia issued us a favorable ruling on our Overseas research and development activities, considering such activities to be eligible research and development activities under the Australian Incentive Program.  As such, we recorded R&D incentive income during the three months ended September 30, 2017 for our Overseas research and development activities performed during the year ended December 31, 2016 and the six months ended June 30, 2017, of $0.3 million and $0.4 million, respectively.

 

The R&D incentive receivable has been recorded as “Research and development incentive receivable” in the consolidated balance sheets.

 

During the three months ended September 30, 2017, we received $3.2 million of research and development tax incentive payments from the Commonwealth of Australia as a result of the 2016 research and development activities of our Australian subsidiary, HCP Australia.

 

Comparison of the Nine Months Ended September 30, 2017 and 2016

 

The following table summarizes our results of operations for the nine months ended September 30, 2017 and 2016:

 

		Nine Months Ended September 30,
		2017			2016			Change
		(in thousands)
Operating expenses:
Research and development		$	18,087		$	15,870		$	2,217
General and administrative		7,719			3,495			4,224
Total operating expenses		25,806			19,365			6,441
Loss from operations		(25,806		)	(19,365		)	(6,441		)
Interest income		118			2			116
Interest expense - related party		(121		)	(722		)	601
Australian research and development incentives		1,852			—			1,852
Foreign currency gains		823			184			639
Net loss		$	(23,134	)	$	(19,901	)	$	(3,233	)

 

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